The IL-23 inhibitor from AbbVie indicated for the treatment of adults with
active psoriatic arthritis (PsA) and for moderate to severe plaque psoriasis (Ps)
in adults who are candidates for systemic therapy or phototherapy.1
US-MULT-230356
The IL-23 inhibitor from AbbVie indicated for the treatment of adults with
active psoriatic arthritis (PsA) and for moderate to severe plaque psoriasis (Ps)
in adults who are candidates for systemic therapy or phototherapy.1
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Important Safety Information
Hypersensitivity Reactions
SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.
Infection
SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.
Tuberculosis (TB)
Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.
Hepatotoxicity in Treatment of Crohn’s Disease
Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn’s disease, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Administration of Vaccines
Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.
Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance.
Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease.
Dosage Forms and Strengths: SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, and a 600 mg/10 mL single-dose vial for intravenous infusion.
INDICATIONS
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Please see Full Prescribing Information.
US-SKZG-220547
REFERENCE
SKYRIZI (risankizumab-rzaa)
Injection Training Video
Hi, it’s good to be here with you. I’m Kate. And you are 1 of the many people who have been prescribed SKYRIZI. After starting on SKYRIZI, there were 2 directions you could go: continue with in-office injections or inject at home.
You had a discussion with your doctor, and have decided to inject at home.
I’m going to show you how to do that...step by step, and address any questions you may have.
Still, there are probably a million things you’d rather be doing right now than learning about injecting your medicine. I get it. But this video will be helpful. So, stay with it. Because, well, there’s more to making SKYRIZI a part of your life than just learning how to inject.
When you sign up for Skyrizi Complete, you get a dedicated Nurse Ambassador.
They will get to know you and help you start and stay on track with your treatment plan.
So, let’s get started.
Leave SKYRIZI at room temperature for 15 to 30 minutes before injecting.
If you’re a little nervous, I totally get it. It may help you relax if you watch or listen to something that is soothing.
First, wash your hands. Then get the things you need, and settle into a place where you feel relaxed.
Now I’ll take you through the process step by step.
Make sure you have everything you need laid out:
2 alcohol swabs that are included in the package,
2 cotton balls, you can also use gauze pads,
your sharps container, which ensures your syringes are disposed of safely,
and of course, your 2 SKYRIZI prefilled syringes.
For 1 full dose, 2 injections are required.
We’re going to break the injection process down into 4 simple steps.
Let’s call them the 4 Ps.
Pick the injection site.
Prepare the syringe.
Pinch the skin.
And Push the plunger in.
There’s an “R” too for “Repeat.” Remember, 1 dose is 2 injections.
So, you will need to repeat the same injection steps for the second injection.
Pick the injection site—your left or right thigh or your stomach.
When you are using your second syringe, pick an injection site at least 1 inch away from the first site. Do not inject into the same site.
If you choose your lower stomach area, make sure you inject at least 2 inches away from your belly button.
Wipe the injection site in a circular motion with the alcohol swab (before both injections). Don’t inject through clothes, or into skin that doesn’t look normal.
Start with 1 syringe for the first injection. Now prepare the syringe.
Holding the syringe with the needle pointing down, check the liquid in the syringe.
It is normal to see 1 or more bubbles in the window.
The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
DO NOT use if the liquid is cloudy or contains flakes or large particles.
To remove the needle cover, hold the syringe in 1 hand.
With the other hand, gently pull the needle cover straight off and throw it away.
You may see a drop of liquid at the end of the needle. This is normal.
DO NOT touch the needle with your fingers or let the needle touch anything.
For this demonstration, I’ll be using a practice pad.
Hold the body of the prefilled syringe in 1 hand between the thumb and index finger.
Gently pinch the area of cleaned skin with your other hand and hold it firmly.
Insert the needle into the skin at about a 45-degree angle using a quick, short movement. Hold the angle steady.
Slowly push the plunger all the way in until all of the liquid is injected and the syringe is empty.
Pull the needle out of the skin while keeping the syringe at the same angle. Release the plunger and allow the syringe to move up until the entire needle is covered by the needle guard.
The syringe needle guard will not activate unless all the liquid has been injected.
Press a cotton ball or gauze pad over the injection site and hold for 10 seconds.
DO NOT rub the injection site. You may have slight bleeding. This is normal.
Now that the syringe is empty, drop it into the sharps container.
Repeat these injection steps for the second syringe immediately following your first injection. Do not inject into the same site.
Be sure to pick a new site at least 1 inch away from your first injection.
In a nutshell here’s what you did.
You picked the injection site, prepared the syringe, pinched the skin, and pushed the plunger in. Then you did it again, using the second syringe.
Okay, so now you know how to inject.
After your starter doses at Week 0 and Week 4, SKYRIZI is dosed quarterly. That’s just 4 times a year or 1 dose for each season.
It’s important you don’t forget.
So, make sure you place reminders for ordering your medication and note your injection day on your calendar. You can also do this through the Skyrizi Complete App.
The Skyrizi Complete Sharps Disposal and Mail-back Service ensures your syringes are disposed of safely and in a socially responsible way.
There’s a bit to remember.
But you’ll get the hang of it. And you can always refer to this video or call us.
You’ve got this.
US-SKZD-210080
SKYRIZI IN BIO-NAÏVE PATIENTS
SFX:
Music up, then under.
TITLE CARD:
Nothing is Everything
Nothing less than the opportunity to reach for their treatment goals. For your patients, that’s everything.
Dr. Sergio Schwartzman, MD:
Hello. My name is Dr Sergio Schwartzman. I’ve been a rheumatologist for 35 years, long enough to have a daughter who’s currently a rheumatologist. During those 35 years, I have worked in academics and currently I am in a private practice.
Animation:
Blue bar expands from right to left and reveals name of doctor speaking.
Dr. Saakshi Khattri, MD:
My name is Dr. Saakshi Khattri and I am a board certified dermatologist, rheumatologist and internist working in the department of dermatology at the Icahn School of Medicine at Mount Sinai. Thank you so much for having me today.
Animation:
As soon as the second doctor speaks, the previous doctor’s name will fade out quickly and the second doctor’s name will fade in place.
Dr. Sergio Schwartzman, MD:
As rheumatologists, our main treatment goal is the same as our patients’—to achieve relief from the symptoms of psoriatic arthritis.
Making treatment decisions for individual patients with psoriatic arthritis can be challenging due to the heterogeneity of clinical characteristics and the simultaneous involvement of different domains, often with varying degrees of severity.
So let’s begin by discussing how these patients can present in clinical practice and then talk about the type of patient who may be a candidate for a biologic.
Dr. Saakshi Khattri, MD:
Sounds good, Doctor Schwartzman.
To better inform decisions around treatment selection, it is important to identify where in their disease progression a patient may be and assess their level of disease activity.
Some patients come to me and need a biologic from the start. However, if a patient is on standard therapy and still has residual swollen and/or tender joints, reports pain and morning stiffness, and also has some level of skin involvement, then I’d typically sit down with them and discuss starting on a biologic.
Dr. Sergio Schwartzman, MD:
Before I sit down with my patients, I often refer back to clinical guidelines.
And interestingly, 2021 GRAPPA treatment recommendations are a domain-based strategy for psoriatic arthritis.
As a member of GRAPPA, we use a systematic literature search and grading system to update treatment recommendations.
These treatment recommendations provide up-to-date evidence-based guidance to providers who manage and treat patients with psoriatic arthritis.
The domain-based strategy considers all 6 domains of psoriatic arthritis. These domains include peripheral arthritis, axial arthritis, enthesitis, dactylitis, skin, and nail disease. For example, if a clinician were looking for a treatment option for a patient presenting with psoriasis, peripheral arthritis, enthesitis, and dactylitis, GRAPPA strongly recommends interleukin 23 inhibitors as treatment options for first-line therapy just like TNF and interleukin 17 inhibitors.
Animation:
A domain image will quickly pop up on screen as soon as it is called.
Dr. Saakshi Khattri, MD:
Agreed, the GRAPPA guidelines are one of the factors contributing to my treatment decision. As a clinician, it is my job to consider the individualized treatment goals for each patient to inform the optimal treatment choice for them. It is important to know that we, as treating rheumatologists, have another option like the IL-23 class you mentioned as a patient transitions from conventional therapy like methotrexate.
Dr. Sergio Schwartzman, MD:
Since you brought that up, let’s discuss an IL-23 inhibitor, specifically SKYRIZI, that was studied as a first-line biologic therapy in bio-naïve adults with active PsA.
Animation:
Text will appear onscreen as soon as doctor mentions SKYRIZI.
VO:
Please see Important Safety Information at the end of this video and review the Full Prescribing Information at the link onscreen or on the website at SKYRIZIhcp.com.
VO:
SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
SFX:
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VO TALENT:
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reactions to risankizumab or any of its excipients. Serious hypersensitivity reactions may occur and also an increased risk of infection. Instruct patients to report signs and symptoms of infection. Evaluate patients for TB infection prior to initiating treatment. Avoid use of live vaccines.
Dr. Sergio Schwartzman, MD:
Let’s get into the trial!
Dr. Sergio Schwartzman, MD:
As I mentioned, KEEPsAKE-1 was a study in bio-naïve adults with active psoriatic arthritis. The eligibility criteria included patients who had symptom onset for at least 6 months and had at least 5 tender and 5 swollen joints among other criteria.
All of the patients enrolled had experienced an inadequate response, intolerance, or contraindication to at least 1 DMARD; however, they had no prior exposure to biologics.
Animation:
Bullets fade in upon description.
Dr. Sergio Schwartzman, MD:
It is important to keep in mind that when looking at clinical trials, we often see baseline characteristics that are somewhat different than what we usually see in clinical practice.
But tell me what stands out to you about the baseline characteristics of these patients.
Dr. Saakshi Khattri, MD:
Well, these patients’ baseline characteristics seem higher than the typical bio-naïve patient I might see in my practice, especially in regards to the number of swollen and tender joints.
We can see that these patients had a mean disease duration just over 7 years and had active joint and skin disease.
In this study at baseline, patients had a mean count of 12 swollen and 21 tender joints, which is much higher than the typical bio-naive patient I see in my clinical practice. Average body surface area was over 16% and enthesitis was reported in over 60% of patients and dactylitis in over 30%.
Animation:
Rows enlarge upon description.
Dr. Sergio Schwartzman, MD:
I would agree. Even though these patients were previously treated with conventional therapy, like methotrexate, the baseline characteristics shown represent patients with disease that involved multiple domains.
Dr. Saakshi Khattri, MD:
This helps put into perspective the results I might expect to see with SKYRIZI in my bio-naïve patients.
In addition to questions about efficacy, oftentimes in the discussions I have with my patients, questions about safety come up as well. Some of my patients also ask about dosing and administration.
Dr. Saakshi Khattri, MD:
For adult patients with active psoriatic arthritis, clinical trials showed that SKYRIZI provided joint symptom improvement and skin clearance.
We also know that SKYRIZI’s safety profile has been established in psoriatic arthritis and psoriasis across 19 trials—2 in psoriatic arthritis and 17 in psoriasis. That translates to over 11,000 patient-years of exposure across indications.
Animation:
Columns/row will become fully visible upon description.
Dr. Sergio Schwartzman, MD:
Since you brought up dosing, some patients appreciate the reliable quarterly dosing, after 2 initiation doses at Weeks 0 and 4.
It is nice to know when considering a treatment that SKYRIZI has exceptional formulary access with over 95% of national commercial and Medicare Part D patients having preferred coverage.
Animation:
Columns/row will become fully visible upon description.
Dr. Saakshi Khattri, MD:
It’s always good to have a vast arsenal of different treatment options to choose from. However, I think it’s critical for us as clinicians to understand the nuances of the therapies we’re using and recognize how they may apply to the patient we are treating.
Patients may have questions about efficacy and safety, and we should take into account how these specific variables may be applicable to them as we work together to determine the best treatment option for individual patients.
Dr. Sergio Schwartzman, MD:
I agree. And as we’ve seen, SKYRIZI, the #1 prescribed biologic in new and switching patients with psoriasis, may be an option for adult patients with active psoriatic arthritis presenting earlier in their disease progression, including for those who have not had experience with a prior biologic.
VO Talent:
Important Safety Information
Hypersensitivity Reactions
SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.
Infection
SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.
Tuberculosis (TB)
Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB
VO Talent:
Administration of Vaccines
Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age appropriate vaccinations according to current immunization guidelines.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.
Please see Full Prescribing Information available at the link onscreen.
References
[SKYRIZI and AbbVie logos]
US-SKZR-220080
EFFICACY & SAFETY RESULTS WITH SKYRIZI
SFX:
Music up, then under.
TITLE CARD:
NOTHING IS EVERYTHING
NOTHING LESS THAN THE OPPORTUNITY TO REACH FOR THEIR TREATMENT GOALS FOR YOUR PATIENTS, THAT’S EVERYTHING.
ANIMATED/FADE IN:
[Skyrizi logo]
TITLE CARD:
FOR ADULTS WITH ACTIVE PSORIATIC ARTHRITIS JOINT EFFICACY & SAFETY RESULTS WITH SKYRIZI
ANIMATED/FADE IN:
Copy fade in.
VO:
SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
VO:
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reactions to risankizumab and any of its excipients. Serious hypersensitivity reactions may occur and also an increased risk of infection. Instruct patients to report signs and symptoms of infection. Evaluate patients for TB infection prior to initiating treatment. Avoid use of live vaccines.
Please see additional Important Safety Information at the end of this video and review the Full Prescribing Information at the link onscreen or on the website at SKYRIZIhcp.com.
Dr. Sergio Schwartzman, MD:
Hello. My name is Dr. Sergio Schwartzman. I’ve been a rheumatologist for 35 years, long enough to have a daughter who’s currently a rheumatologist. During those 35 years, I have worked in academics and currently I am in a private practice.
Dr. Saakshi Khattri, MD:
My name is Dr. Saakshi Khattri and I am a board certified dermatologist, rheumatologist and internist working in the department of dermatology at the Icahn School of Medicine at Mount Sinai. Thank you so much for having me today.
Dr. Sergio Schwartzman, MD:
As a rheumatologist, let’s discuss what endpoints you look for when reviewing the efficacy and safety of a clinical trial.
Besides the ACR scores, are there other clinical endpoints that are important to you and your patients?
[Cut to KOL 2]
Dr. Saakshi Khattri, MD:
ACR scores, for sure. Most clinical trials look at ACR20 as their primary endpoint, but what I like to look for are ACR70 and ACR50 response rates as well.
I also look at things like complete resolution of enthesitis and dactylitis, which can be clinical manifestations of psoriatic arthritis. But I want to hear from my patients too—how are they feeling, how are they doing across various components of ACR, particularly the patient-reported assessments, like pain—those are important.
[Cut to KOL 1]
Dr. Sergio Schwartzman, MD:
Let’s take a look at the data from the SKYRIZI PsA trials for some of these endpoints.
KEEPsAKE-1 and -2 were two randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of SKYRIZI 150 mg versus placebo over 24 weeks with a long-term extension for up to an additional 204 weeks. Both studies enrolled adult patients with active psoriatic arthritis.
In KEEPsAKE-1, patients were bio-naïve—they had an inadequate response or intolerance to at least 1 DMARD. In KEEPsAKE-2, the population was composed of approximately 50% DMARD-IR and 50% bio-IR patients; they previously had an inadequate response or intolerance to at least 1 biologic therapy or at least 1 DMARD.
Dr. Sergio Schwartzman, MD:
Now for the results!
In both studies, treatment with SKYRIZI resulted in significant improvement in measures of disease activity compared with placebo at Week 24. Here are the ACR response rates for KEEPsAKE-1, a population of bio-naïve patients.
ACR20 at Week 24, the primary endpoint, was achieved by 57% of SKYRIZI patients compared to 34% of patients on placebo.
Dr. Saakshi Khattri, MD:
Taking a step back and looking at the responses before that, as early as Week 4, we begin to see a response—after the first visit.
Then, at Week 8, after the second initiation dose and visit, we see further responses with the patients on SKYRIZI.
At 1 year in the open-label extension, ACR20 was observed in 70% of SKYRIZI patients.
Animation:
Chart can build in with ACR20; ACR50 and ACR70 can grow upon description.
Dr. Sergio Schwartzman, MD:
If we look at ACR50 response rates in KEEPsAKE-1, we see that after 3 SKYRIZI doses, at Week 24, one-third of patients achieved ACR50 compared to 11% on placebo. And this response was observed in 43% of patients at 1 year in the open-label extension—after 2 additional SKYRIZI doses.
It is important to note that the timepoints on the graph show a higher response rate with SKYRIZI at 52 weeks.
Dr. Saakshi Khattri, MD:
Overall, in both trials, more patients in the SKYRIZI group experienced robust joint efficacy, not only achieving ACR20, but also ACR50, compared to placebo.
Animation:
Lines can extend from 0 to Week 24, then to ~1 year.
Dr. Sergio Schwartzman, MD:
What is interesting to me about this data is that although patients in KEEPsAKE-1 were bio-naïve, they also had multiple active domains, including at least 5 swollen and 5 tender joints, to even be eligible for the trial.
Dr. Saakshi Khattri, MD:
These results help give me confidence in treating my adult patients with active PsA with SKYRIZI especially because ACR scores take into account a variety of physician- and patient-reported factors to evaluate improvement in joint symptoms.
Dr. Sergio Schwartzman, MD:
On that note, let’s take a closer look at the mean change from baseline to Week 24 in ACR components from KEEPsAKE-1 & KEEPsAKE-2.
Dr. Saakshi Khattri, MD:
Overall, we are seeing patients symptomatically improving across all measures. Tender and swollen joints, patient’s assessment of pain, patient’s global assessment—they all improved.
And I believe the minimal clinically important difference, or MCID, in patient’s assessment of pain was also evaluated. Isn’t that right, Doctor Schwartzman?
Animation:
Criteria will increase in size during the voiceover.
Dr. Saakshi Khattri, MD:
It was. In KEEPsAKE 1, patient’s assessment of pain at baseline was 57.1 for both SKYRIZI and placebo groups. At Week 24, scores were 35.7 in the SKYRIZI group and 46.2 in the placebo group.
Animation:
Criteria will increase in size during the voiceover.
Dr. Saakshi Khattri, MD:
A post hoc assessment found that 61% of SKYRIZI patients reported a minimal clinically important reduction in pain compared to 43% on placebo at Week 24 in KEEPsAKE-1.
This is important because pain has become an increasingly critical outcome measure that is now being evaluated by validated metrics. And in this analysis, the MCID shown was based on a 10- or more point decrease on a visual analog scale from 0, meaning no pain, to 100, meaning severe pain.
Dr. Sergio Schwartzman, MD:
Enthesitis and dactylitis are also present in many patients and are hallmarks of psoriatic arthritis, so let’s review the results seen with SKYRIZI.
Dr. Sergio Schwartzman, MD:
Integrated results from the KEEPsAKE trials showed complete resolution of enthesitis and dactylitis in patients. Baseline involvement was 2.7 in enthesitis, measured in a mean of 6 joints, and 98 in dactylitis, measured in a mean of 2.5 joints.
In the 63% of patients who presented with enthesitis at baseline, at Week 24, 48% of SKYRIZI patients had complete resolution of enthesitis compared to 35% of placebo patients. Even more SKYRIZI patients experienced complete resolution at 1 year in the open-label extension—55%.
27% of patients had dactylitis at baseline. In those patients, by Week 24, complete resolution was seen in 68% of SKYRIZI patients, compared to 51% in the placebo group. Again, more SKYRIZI patients experienced complete resolution at 1 year in the open-label extension—76%.
Animation:
Week 24 numbers appear onscreen followed by the respective Week 52 pie chart. Each pie chart animates [clockwise up from 0].
Dr. Saakshi Khattri, MD:
That’s good to see! In my opinion, it’s very important to not only look at ACR response rates, but also ACR components, such as a reduction in tender and swollen joint counts and pain.
Those measures, as well as others such as enthesitis and dactylitis, are important to consider when selecting an appropriate treatment to help adult patients with psoriatic arthritis effectively manage their disease.
Dr. Sergio Schwartzman, MD:
You’re absolutely correct, but let’s not forget about safety, which is also a crucial element with regards to choosing an appropriate therapy.
SKYRIZI’s safety profile is backed by a large clinical program in psoriasis and psoriatic arthritis and is generally consistent across indications.
It has been well-studied in 19 clinical trials—2 in psoriatic arthritis and 17 in psoriasis.
This translates to safety data from over 11,000 patient-years of exposure in over 4,700 patients.
Dr. Saakshi Khattri, MD:
I think it’s important to note that SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of its excipients.
Dr. Sergio Schwartzman, MD:
In addition, a lot of my patients ask about lab monitoring. With SKYRIZI, during treatment, no routine lab monitoring is required. Therefore, it is important to initially evaluate for tuberculosis and ask your patients to report any signs of infection.
Dr. Sergio Schwartzman, MD:
The warnings and precautions for SKYRIZI include hypersensitivity, infections including tuberculosis, and the recommendation to avoid the use of live vaccines.
There are no labeled warnings and precautions on malignancy, IBD, depression, or candidiasis with SKYRIZI; however, these events were seen in clinical trials for both psoriasis as well as psoriatic arthritis.
Dr. Saakshi Khattri, MD:
Safety data are extremely important when choosing a treatment, especially long-term data when we’re treating chronic conditions like psoriatic arthritis. I also like to take into consideration risks for comorbidities, which can be higher in patients with psoriatic arthritis.
Dr. Saakshi Khattri, MD:
In the SKYRIZI Prescribing Information, the most common adverse reactions include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. There was also observed incidence of hepatic events.
Let’s look closely at the clinical trials; the proportion of patients reporting an adverse event was generally consistent across both indications.
Dr. Sergio Schwartzman, MD:
In the 1-year safety data, we see the adverse events of interest from psoriatic arthritis trials as well as psoriasis trials. Additional safety information will be shared at the end of this video.
Dr. Saakshi Khattri, MD:
It’s clear that SKYRIZI has demonstrated robust joint efficacy in psoriatic arthritis across multiple clinical endpoints. In both psoriatic arthritis and psoriasis patients, SKYRIZI may provide skin clearance. SKYRIZI also has a well-studied safety profile across two indications.
Dr. Sergio Schwartzman, MD:
It is nice to know when considering an appropriate treatment that SKYRIZI has exceptional formulary coverage. In fact, greater than 95% of commercial and Medicare Part D patients with psoriatic arthritis have access to SKYRIZI. I think we can agree that SKYRIZI may be a treatment option for adults with active psoriatic arthritis looking for an opportunity to reach for their treatment goals.
Dr. Saakshi Khattri, MD:
Absolutely!
VO:
[ISI]
SUPER:
[ISI]
VO:
[ISI]
SUPER:
[ISI]
VO:
[SKYRIZI and AbbVie logos]
[SKYRIZI and AbbVie logos]
[SKYRIZI and AbbVie logos]
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CTA ANIMATES IN:
DISCOVER IF SKYRIZI MAY BE AN OPTION FOR YOUR PsA PATIENTS Visit SKYRIZIhcp.com/rheumatology
US-SKZR-220080
IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to HUMIRA® (adalimumab) in adult patients with moderate to severe plaque psoriasis over 44 weeks.
Patients treated with adalimumab during Part A:
Part A
In the first phase, patients were randomized 1:1 to either SKYRIZI (150 mg), given as a subcutaneous injection at Weeks 0 and 4 and every 12 weeks thereafter or HUMIRA, given as a subcutaneous injection, with an initial dose of 80 mg followed by 40 mg every other week starting 1 week after the initial dose over 44 weeks.
The Part A co-primary endpoints were
Part B
Patients originally randomized to SKYRIZI received it throughout the study (Parts A & B). Among patients originally randomized to receive HUMIRA, those with a PASI 50 but less than PASI 90 response were re-randomized 1:1 to switch to SKYRIZI or continue HUMIRA.
The Part B primary endpoint was
Key secondary endpoints included
Key inclusion criteria
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q2W=Once every 2 weeks
sPGA=static Physician's Global Assessment
Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q2W=Once every 2 weeks
sPGA=static Physician's Global Assessment
REFERENCE
ADA=Adalimumab
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
REFERENCES
US-SKZR-220084
IMMerge was a Phase 3, global, multicenter, randomized, open-label, efficacy–assessor-blinded, active-comparator study that evaluated the safety and efficacy of SKYRIZI 150 mg vs COSENTYX 300 mg in moderate to severe plaque psoriasis subjects, who were candidates for systemic therapy.
The primary endpoints were
Ranked secondary endpoints (all superiority)
Key inclusion criteria
Sourcing
In this study, 46 patients outside of the US received non–US-licensed secukinumab.
Data regarding comparability between US and non-US secukinumab are not publicly available.
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
REFERENCE
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
RZB=Risankizumab-rzaa
SEC=Secukinumab
sPGA=static Physician's Global Assessment
aMean baseline body weight was 92 kg in the secukinumab group and 91.1 kg in the risankizumab group.2
bStratification factors at randomization.
REFERENCES
US-SKZR-220084
IMMhance was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the impact of treatment withdrawal and re-treatment of SKYRIZI compared to placebo in adult patients with moderate to severe plaque psoriasis.
Part A
In the first phase, patients were randomized 4:1 to SKYRIZI (150 mg), given as a subcutaneous injection at baseline, 4 weeks later, and every 12 weeks thereafter, or placebo.
The Part A co-primary endpoints were
Part B
In the second phase of this study (Week 28 through Week 104), patients originally randomized to SKYRIZI who achieved sPGA 0/1 at Week 28 were re-randomized (1:2) to SKYRIZI (maintenance) or placebo (withdrawal). Beginning at Week 32, patients with sPGA ≥2 continued on SKYRIZI (150 mg) once every 12 weeks up to Week 88, with a final follow-up at Week 104.
The Part B primary endpoint was
Key inclusion criteria
Key secondary endpoints included
DLQI=Dermatology Life Quality Index
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 75=≥75% improvement in Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q12W=Once every 12 weeks
sPGA=static Physician's Global Assessment
REFERENCES
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
aStratification factors at randomization.
REFERENCES
US-SKZR-220084
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
LIMMitless is an ongoing, single-arm, multicenter, open-label extension study evaluating the long-term efficacy and safety of SKYRIZI (150 mg). Patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate.
Active comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
The co-primary endpoints were
Key secondary endpoints included
Key inclusion criteria
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
REFERENCES
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
UST=Ustekinumab
aStratification factors at randomization.
REFERENCE
US-SKZR-220084
YOU ARE LEAVING SKYRIZIHCP.COM
You are leaving the SKYRIZIHCP.com website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.
Conversely, the presence of this link does not imply the linked site's endorsement of SKYRIZIHCP.com or AbbVie.
US-SKZ-220057
You are about to enter a site that is for U.S. Healthcare Professionals Only.
By selecting "Yes" below, you certify that you are a Healthcare Professional and that you wish to proceed to the Healthcare Professionals Only section on the AbbVie Medical Information site. Products or treatments described on this site are available in the U.S. but may not be available in all other countries. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only AbbVie Medical Information Site.
You are about to enter a site that is for U.S. Healthcare Professionals Only.
By selecting "Yes" below, you certify that you are a Healthcare Professional and that you wish to proceed to the Healthcare Professionals Only section on the AbbVie Medical Information site. Products or treatments described on this site are available in the U.S. but may not be available in all other countries. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only AbbVie Medical Information Site.
YOU ARE LEAVING SKYRIZIHCP.COM
You are leaving the SKYRIZIHCP.com website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.
Conversely, the presence of this link does not imply the linked site's endorsement of SKYRIZIHCP.com or AbbVie.
US-SKZR-220084
YOU ARE LEAVING SKYRIZIHCP.COM
You are leaving the SKYRIZIHCP.com website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.
Conversely, the presence of this link does not imply the linked site's endorsement of SKYRIZIHCP.com or AbbVie.
US-SKZR-220084
Bridge Program Update:
If your eligible, commercially insured patient receives an insurance denial due to step therapy requirements and you wish to appeal based on medical necessity:
Eligibility criteria: Available to patients aged 63 or younger with commercial insurance coverage. Patients must have a valid prescription for SKYRIZI® (risankizumab-rzaa) for an FDA approved indication and a denial of insurance coverage based on a prior authorization request on file along with a confirmation of appeal. Continued eligibility for the program requires the submission of an appeal of the coverage denial every 180 days. Program provides for SKYRIZI at no charge to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier, and is not contingent on purchase requirements of any kind. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage. No claims for payment may be submitted to any third party for product dispensed by program. Limitations may apply.
US-SKZD-220459
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
Active comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
The co-primary endpoints were
Key secondary endpoints included
Key inclusion criteria
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
REFERENCES
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
UST=Ustekinumab
aStratification factors at randomization.
REFERENCE:
US-SKZR-220084
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
Active comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
The co-primary endpoints were
Key secondary endpoints included
Key inclusion criteria
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
REFERENCES
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
UST=Ustekinumab
aStratification factors at randomization.
REFERENCE:
US-SKZR-220084
High Levels of Durable Skin Clearance
Uncovering Clearance
Watch Jeff Crowley, MD, and Jennifer Soung, MD, walk through the PASI 90 and PASI 100 data through 1 year of treatment with SKYRIZI.
Please see Safety Considerations at the end of this video and review the full Prescribing Information available at SKYRIZIHCP.com.
Dr. Soung: Biologics have helped many patients with moderate to severe plaque psoriasis by offering additional treatment options for clearing skin.
Dr. Crowley: Today, Dr. Soung and I are going to share with you the key features of SKYRIZI and how it's helped patients like ours.
In 2 pivotal trials, UltIMMa-1 and UltIMMa-2, SKYRIZI was proven to deliver high levels of clearance in patients with moderate to severe plaque psoriasis, with 4 doses a year after 2 initial doses.
The co-primary endpoints in the trials were PASI 90 and sPGA O or 1 at Week 16 for SKYRIZI versus placebo. SKYRIZI met both co-primary endpoints in each trial. In addition to placebo, SKYRIZI was evaluated against a biologic active comparator, ustekinumab, which was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.
Dr. Soung: Let's take a look at SKYRIZl's 52-week data.
Here we see in this chart SKYRIZl's PASI 90 efficacy over 52 weeks from the pooled UltlMMa-1 and -2 trials. I want to bring your attention to the dosing schedule you see on the x-axis, as indicated by an arrow.
After 2 doses of SKYRIZI, 75% of patients achieved PASI 90 at Week 16, compared to 4% for placebo. The dosing schedule is every 12 weeks for maintenance. At 1 year after 5 doses, the proportion of patients achieving PASI 90 increases to 81%.
In addition, SKYRIZI also maintained response over time. 88% of patients who saw PASI 90 results at Week 16 maintained PASI 90 at Week 52.
Many of my patients tell me that completely clear skin matters. Let's take a look at the PASI 100 responses from the pooled UltlMMa-1 and -2 trials.
43% of SKYRIZl-treated patients achieved PASI 100 at Week 16 after just 2 doses, compared to 1% with placebo. In 1 year, after just 5 doses, 58% of SKYRIZl-treated patients achieved PASI 100.
Dr. Crowley: Safety is another important consideration for patients and providers alike. SKYRIZI has a well-studied safety profile across 4 pivotal trials, with a total of 1,306 patients receiving SKYRIZI. Here we see the rates of adverse events through Week 16. In the trials, the SKYRIZI safety profile was similar to that of EU-sourced ustekinumab.
Rates of adverse events with SKYRIZI through 52 weeks were similar to the safety profile observed during the first 16 weeks.
With SKYRIZI, warnings and precautions include risk of infections, tuberculosis, and avoiding the use of live vaccines. There are no labeled warnings or precautions on malignancy, inflammatory bowel disease, or depression.
In summary, SKYRIZI offers patients with moderate to severe plaque psoriasis the opportunity for high levels of durable skin clearance with a well-studied safety profile, making it an excellent treatment option.
Dr. Soung: The fact that the majority of patients during the trials were completely clear at 1 year is exciting for our patients.
Indication
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Safety Considerations
SKYRIZI may increase the risk of infection. Instruct patients to report signs or symptoms of clinically important infection during treatment. Should such an infection occur, discontinue SKYRIZI until infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with SKYRIZI. Avoid use of live vaccines in SKYRIZI patients.
Please see additional Important Safety Information at the bottom of this page. Please see full Prescribing Information by clicking the link at the top of this page.
US-SKZD-190187
US-SKZD-200190
Expectation Setting and Mean PASI Data
Clear Conversations
Hear from Cynthia Trickett, PA-C, MPAS, and Jason M. Cheyney, PA-C, MPAS, as they discuss setting patient expectations on efficacy and safety with SKYRIZI.
Please see Safety Considerations at the end of this video and review the full Prescribing Information available at SKYRIZIHCP.com.
Cynthia: When my patients start a biologic, having clear conversations on efficacy and safety are essential. Two common questions I get from patients are "How fast will this treatment work?" and "What are the risks?"
In 2 pivotal trials, UltlMMa-1 and UltlMMa-2, SKYRIZI demonstrated high levels of skin clearance in patients with moderate to severe plaque psoriasis.
The co-primary endpoints in the trials were PASI 90 and sPGA O or 1 at Week 16 for SKYRIZI versus placebo. In both trials, the co-primary endpoints were met.
SKYRIZI patients also saw rapid responses, with results seen as early as Week 4.
Jason: It can be difficult at times for patients to understand PASI 90 data. Another way to help explain clinical trial results to patients is mean PASI.
Mean PASI improvement is the average improvement in skin clearance from baseline—it's what the average patient experienced in the clinical trials, measured at set time periods.
When discussing efficacy with my patients starting SKYRIZI, I incorporate mean PASI, which was a pre-specified, non-ranked endpoint in the clinical trials.
I let my patients know that in the clinical trials, the average skin clearance on SKYRIZI was 58% from baseline at 4 weeks after just 1 dose, 91% clearance at 16 weeks after 2 doses, and 95% at 1 year after the 5th dose. In comparison, the PASI 90 response at Week 4 was 6%.
Individual results may vary for patients. 88% of PASI 90 responders at Week 16 maintained their response at Week 52.
Here, you can see rapid skin clearance on an actual patient from the UltlMMa-2 trial. As early as Week 4, this patient saw a 63% improvement in their skin after just 1 dose of SKYRIZI. At Week 16, the patient had 88% clearer skin, and at 1 year, the patient had 94% clearer skin from baseline.
Cynthia: In addition, SKYRIZI is dosed 4 times a year after 2 initiation doses—with 2 injections per dose. Patients have the flexibility to receive injections in-office or to self-inject after proper training.
Communicating the risks and benefits of a biologic like SKYRIZI is important. SKYRIZI has a well-studied safety profile across 4 pivotal trials, with a total of 1,306 patients receiving SKYRIZI. The adverse events through Week 16 included upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
With all biologics, I discuss important safety considerations. With SKYRIZI, I let patients know that warnings and precautions include risk of infections, tuberculosis, and avoiding the use of live vaccines.
There are no labeled warnings or precautions around malignancy, IBD, or depression. Also, there is no routine monitoring after an initial TB test.
Jason: In summary, I can communicate to my patients that SKYRIZI is proven to deliver high levels of skin clearance, including results as early as 4 weeks.
Cynthia: In addition, SKYRIZl's dosing schedule and well-studied safety profile are important pieces of my clear conversations with patients.
Indication
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Safety Considerations
SKYRIZI may increase the risk of infection. Instruct patients to report signs or symptoms of clinically important infection during treatment. Should such an infection occur, discontinue SKYRIZI until infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with SKYRIZI. Avoid use of live vaccines in SKYRIZI patients.
Please see additional Important Safety Information at the bottom of this page. Please see full Prescribing Information by clicking the link at the top of this page.
US-SKZD-190188
If emailing to yourself, please provide only your own information.
US-SKZR-220084
SKYRIZI (risankizumab-rzaa) 150 mg/mL Pen Injection Video
INJECTING WITH THE SKYRIZI PEN
DISCLAIMER
SUPER: This demonstration is a guide to injecting with the SKYRIZI Pen. Watch it and also read the entire SKYRIZI Instructions for Use leaflet, inserted with your medication package. Don’t try to inject SKYRIZI until your doctor has decided you can, and you’ve been shown the right way to inject. Please see Instructions for Use and Important Safety Information within the website. Please see accompanying full Prescribing Information, including Medication Guide, and discuss with your doctor.
AUDIO: This demonstration is a guide to injecting with the SKYRIZI Pen. Watch it and also read the entire SKYRIZI Instructions for Use leaflet, inserted with your medication package. Don’t try to inject SKYRIZI until your doctor has decided you can, and you’ve been shown the right way to inject.
A GUIDE TO INJECTING SKYRIZI
VIDEO: We see the patient comfortably seated on a chair at his dining table. Patient looks into camera and introduces himself.
SUPER: MICHAEL
AUDIO: Hi, I’m Michael and I’m here to show you how to inject using a SKYRIZI Pen. If this is your first time, hello and welcome to the family. If you’ve done this before, great! I hope this is a helpful refresher.
VIDEO: Patient speaks to camera, points to “Lauren (Nurse Ambassador)” contact on phone.
SUPER:
Don’t have a Nurse Ambassador?*
Call 1.866.SKYRIZI or visit www.SKYRIZI.com
Nurse Ambassadors are provided by AbbVie and do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.
AUDIO: So, I’ve been doing this for a while now, and I feel like I have a good handle on it. My doctor showed me how to inject when I first started, and I called Lauren (my Nurse Ambassador) and she helped me the first few times I did it at home by myself.
CHAPTER 2: INJECTION PREP
VIDEO: Patient walks to fridge, pulls out SKYRIZI package, shows to camera, places on counter. SUPERs rotate through on screen.
SUPER: Do not warm SKYRIZI in any other way (for example, do not warm it in the microwave or in hot water).
Do not use SKYRIZI if liquid has been frozen even if it has been thawed.
AUDIO: Okay, let’s get into it! Now, I get my SKYRIZI by mail and I keep it in the fridge until I’m ready to inject. Here it is. Okay. Very important – I’ll leave it at room temperature and out of direct sunlight for 30 to 90 minutes before injecting.
VIDEO: Patient puts in headphones.
SUPER: 30 to 90 minutes
Keep SKYRIZI in the original carton to protect from light until time to use.
AUDIO: Now, this will take some time, so while I wait, I like to listen to some music. A good tune really helps to relax me.
VIDEO: Patient sits down at dining table with items needed.
SUPER:
Do not shake SKYRIZI
Do not use if the SKYRIZI Pen has been dropped or damaged.
Do not use SKYRIZI if package perforations are broken. Return product to the pharmacy.
Do not remove the dark gray cap until right before injection.
Do not use SKYRIZI if expiration date (EXP) has passed.
SKYRIZI Pen, Instructions for Use, alcohol swab, cotton ball, sharps container
AUDIO: Now that I’ve washed and dried my hands, I’m good to go. So, I take out everything I need: I’ve got my SKYRIZI Pen, I’ve got the Instructions for Use for reference. I’ve also got an alcohol swab, a cotton ball, and my sharps container. So, I do my injections here because there’s plenty of light and a lot of good space.
CHAPTER 3: HOW TO INJECT STEP BY STEP
VIDEO: Patient points to 4 Ps graphic on package.
AUDIO: Okay. I like to think about the injection process in 4 steps: the 4 Ps. You can see them right here on the package. Pick, pull, place, and press.
SUPER: PICK the injection site
AUDIO: So first, I’ll pick my injection site. I’m going to go with my left thigh, but you can also inject into your stomach or your other thigh.
ANIMATION: 2 inches graphic animates.
SUPER: 2 INCHES
AUDIO: If you choose your stomach, make sure that you inject at least 2 inches away from your belly button.
VIDEO: Patient demonstrates step.
ANIMATION: SUPERs rotate through on screen.
SUPER:
Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting.
Do not inject through clothes.
AUDIO: Grab your alcohol swab, and clean your skin in a circular motion, like this, and let it dry.
VIDEO: Patient holds Pen upright, removes cap. SUPERs rotate through on screen.
SUPER: Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis.
PULL the cap off
AUDIO: Now, I hold the Pen with the dark gray cap pointing up. I pull the cap straight off and throw it away.
VIDEO: Patient demonstrates steps and holds inspection window to camera
SUPER: Do not use if the liquid is cloudy or contains flakes or large particles.
AUDIO: Now I check the liquid through the inspection window. It should look clear to slightly yellow and may contain tiny white or clear particles. It’s normal to see one or more bubbles in the liquid.
VIDEO: Patient demonstrates steps and points to green button.
AUDIO: So, I hold my Pen with my fingers on the gray grips. See? And I turn the Pen so that the white needle sleeve points toward my injection site and I can see the green activator button.
VIDEO: Patient demonstrates step.
SUPER:
PLACE Pen on site
90°
AUDIO: I gently squeeze my skin at my injection site to make a raised area and hold it firmly. Then I place the white needle sleeve straight against my injection site at a 90-degree angle.
VIDEO: Demonstrate steps based on copy. 15-second countdown graphic.
SUPER: PRESS the button
AUDIO: I can see the green activator button and inspection window. The Pen only activates if the white needle sleeve is pressed down against me before pressing the green activator button. A loud “click” means the start of the injection. There it goes.
VIDEO: Patient demonstrates step.
15-second countdown graphic.
Close up overlay of yellow indicator in inspection window.
AUDIO: And hold it like that for 15 seconds. I’ll keep pressing the Pen down against my skin until I hear a second “click” or the yellow indicator has filled the inspection window – either one signals the injection is complete. And there it goes.
VIDEO: Demonstrate steps based on copy.
AUDIO: When it’s over, I slowly pull the Pen straight out from my skin. You might notice one last click. And look at this – you see how the white needle sleeve covers the needle tip?
VIDEO: Patient speaks to camera. SUPERs rotate through on screen.
SUPER: Press a cotton ball or gauze pad over the injection site and hold for 10 seconds.
AUDIO: And that’s it! Now I press a cotton ball where I injected – you can also use a gauze pad.
VIDEO: Patient demonstrates steps.
SUPER: Do not rub the injection site. You may have slight bleeding. This is normal.
AUDIO: And I drop my used Pen in one of these sharps disposal containers.
VIDEO: Patient places the sharps container on closet shelf.
AUDIO: There – safe and sound, and also out of reach. Another injection complete!
CHAPTER 4: HELPFUL TIPS FOR SELF-INJECTING
ANIMATION: Text animates on screen for each step.
SUPER:
PICK the injection site
PULL the cap off
PLACE Pen on site
PRESS the button
AUDIO: To recap, I prepare myself and my space, pick an injection site, pull the cap off the Pen, place the Pen on the injection site, press the button to inject,
SUPER: DISCARD used Pen
AUDIO: And safely discard the used Pen. That’s the whole injection process!
VIDEO: Patient speaks to camera
AUDIO: When I started injecting at home, it didn’t take me long to get it down. Lauren, my Nurse Ambassador, she suggested I create a routine – inject at the same time and place. I also like to treat myself after each injection – maybe I’ll cycle or listen to a new album.
VIDEO: Patient points to App on phone.
AUDIO: This Skyrizi Complete App helps me stay on track and I don’t know what I’d do without it. I used it to log my first starter dose so I knew when to take my second starter dose 4 weeks later.
VIDEO: Patient points to App on phone.
AUDIO: And you can set reminders for future doses, too, since, after 2 starter doses,
VIDEO: Patient speaks to camera
SUPER: 1 INJECTION 4x A YEAR
AUDIO: SKYRIZI is only 1 injection 4 times a year.
VIDEO: Patient points to phone.
App notification reminder appears on phone screen.
AUDIO: And when I get those reminders, I know to contact my specialty pharmacy to get my next injection on time.
SUPER: Get sharps containers for no additional cost at www.SKYRIZI.com or call 1.866.SKYRIZI
AUDIO: And don’t forget about the Skyrizi Complete sharps disposal and mail-back service. I signed up online, so once my sharps container gets full, I request a new one, which is sent to me with a box to send my full one back. It’s so convenient and it doesn’t cost me anything.
VIDEO: Patient speaks to camera
SUPER: CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE
AUDIO: I’m lucky that my family’s always around if I need help. I’ve got Skyrizi Complete, too. Like Lauren, who has answers to my questions,
VIDEO: Patient points to App on phone.
AUDIO: And a pretty awesome App!
VIDEO: Patient speaks to camera.
AUDIO: You’ve got this.
VIDEO: GSS
US-SKZ-220108
SKYRIZI (risankizumab-rzaa) 150 mg/mL Prefilled Syringe Injection Video
Video Transcripts
Syringe Injection Video
Disclaimer
SUPER: This demonstration is a guide to injecting with the SKYRIZI prefilled syringe. Watch it and also read the entire SKYRIZI Instructions for Use leaflet, inserted with your medication package. Don’t try to inject SKYRIZI until your doctor has decided you can, and you’ve been shown the right way to inject. Please see Instructions for Use and Important Safety Information within the website. Please see accompanying full Prescribing Information, including Medication Guide, and discuss with your doctor.
AUDIO: This demonstration is a guide to injecting with the SKYRIZI prefilled syringe. Watch it and also read the entire SKYRIZI Instructions for Use leaflet, inserted with your medication package. Don’t try to inject SKYRIZI until your doctor has decided you can, and you’ve been shown the right way to inject
VIDEO: N/A (TITLE CARD: “A GUIDE TO INJECTING SKYRIZI”)
VIDEO: We see the patient comfortably seated on a couch in their living room. Patient looks into camera and introduces himself.
SUPER: MAYA
AUDIO: Hey there! I’m Maya and I’m here to walk you through how to inject yourself with SKYRIZI. Now, if it’s your first time, don’t worry! If it’s not your first time, I hope you pick up some new tips while you’re here.
VIDEO: Patient speaks to camera, points to “Bryan (Nurse Ambassador)” contact on phone.
SUPER:
Don’t have a Nurse Ambassador?*
Call 1.866.SKYRIZI or visit www.SKYRIZI.com
Nurse Ambassadors are provided by AbbVie and do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.
AUDIO: Now, I’ve done this a few times by myself, but my doctor originally walked me through how to inject, and I called Bryan, who’s my Nurse Ambassador, when I first started injecting on my own at home.
VIDEO: Patient stands and walks out of frame. (TITLE CARD: “INJECTION PREP”)
VIDEO: Patient walks to fridge, pulls out SKYRIZI package, shows to camera, places on counter. SUPERs rotate through on screen.
SUPER: Do not warm SKYRIZI in any other way (for example, do not warm it in the microwave or in hot water).
Do not use SKYRIZI if liquid has been frozen even if it has been thawed.
15 to 30 minutes
Keep SKYRIZI in the original carton to protect from light until time to use.
AUDIO: Alright, let’s get started. So, when my SKYRIZI comes in the mail, it goes straight in the fridge. Now, before I inject, I let it sit out for 15 to 30 minutes, out of direct sunlight, to get to room temperature. And while I wait, I try to relax.
VIDEO: Patient sits down on couch with items needed on the table in front of her, SUPERs rotate through on screen. Supply names animate on screen next to each item, as she speaks their names.
SUPER:
Do not shake SKYRIZI
Do not use SKYRIZI if the syringe has been dropped or damaged.
Do not use SKYRIZI if package perforations are broken. Return product to the pharmacy.
Do not remove the needle cover until right before injection.
Do not use SKYRIZI if expiration date (EXP) has passed.
SKYRIZI syringe, alcohol swab, Instructions for Use, cotton ball, sharps container
AUDIO: Okay, that should be enough time. So, once my hands are clean, I like to put out everything that I’ll need. So, I have my SKYRIZI syringe. I have an alcohol swab, which I got from my local pharmacy. I also have the Instructions for Use, just in case. And I also like to grab a cotton ball (I had some right in my medicine cabinet) and then a sharps container. Now, I like this spot because there’s a lot of space and I don’t have to leave my couch.
VIDEO: N/A (TITLE CARD: “HOW TO INJECT step-by-step”)
VIDEO: Patient points to 4 Ps graphic on package.
AUDIO: So, it helps me to break down the injection process into 4 simple steps: the 4 Ps. You can see them here on the package. We have: pick, prepare, pinch, push. Okay?
SUPER: PICK the injection site
AUDIO: So, first I pick my injection site. So, I’ll go with my left thigh. But, you can also pick your right thigh or your lower stomach.
ANIMATION: 2 inches graphic animates.
SUPER: 2 INCHES
AUDIO: But, if you choose your stomach, make sure to inject at least 2 inches away from your belly button. Okay?
VIDEO: Patient demonstrates step.
AUDIO: So, you want to grab your alcohol swab to clean your skin in a circular motion, like this, and let it dry.
VIDEO: Patient holds syringe with needle pointing down, removes cap to check liquid, shows to camera. SUPERs rotate through on screen.
SUPER:
Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting.
Do not inject through clothes.
Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis.
Do not use if the liquid is cloudy or contains flakes or large particles.
AUDIO: Now, I hold my syringe with the needle facing down, and I check the liquid inside to make sure that everything looks okay. It should be clear to slightly yellow, which it is. See that? There are a few bubbles in there, but that’s normal. Looks like we’re good to go!
VIDEO: Patient removes the needle cover by holding the syringe in one hand and gently pulling the needle cover straight off with the other hand.
SUPER:
PREPARE the syringe
Do not hold or pull plunger when removing the needle cover.
Do not touch the needle with your fingers or let the needle touch anything.
AUDIO: Alright, so I hold my syringe in one hand, and I take the needle cover off with the other hand, okay? Like this, and then you want to throw it away. You see? You may see a drop of liquid at the end of the needle, which is normal, okay?
VIDEO: Patient demonstrates steps.
SUPER:
PINCH the skin
AUDIO: So, I’ve got my syringe in one hand, and with the other hand, I’m gently pinching the area of my cleaned skin to hold firmly.
VIDEO: Patient demonstrates step.
SUPER:
PUSH the plunger in
45°
AUDIO: Now I’ll inject the needle into my skin at about a 45-degree angle using a quick, short movement — like this. Now, holding the angle steady, I slowly push the plunger in all the way until all of the liquid is injected, and the syringe is empty. There we go.
VIDEO: Patient demonstrates step.
AUDIO: Now, I pull the needle out of my skin while keeping the syringe at the same angle, like this. I release the plunger to allow the syringe to move up.
VIDEO: Patient points to needle guard on syringe.
AUDIO: Until the entire needle is covered up by the needle guard. See how that works? The needle guard won’t come back down unless all the liquid has been injected.
VIDEO: Patient demonstrates step. SUPERs rotate through on screen.
SUPER:
Press a cotton ball or gauze pad over the injection site and hold for 10 seconds.
Do not rub the injection site. You may have slight bleeding. This is normal.
AUDIO: Alright, so now, I press my cotton ball where I just injected, and that’s it!
VIDEO: Patient demonstrates step.
SUPER:
Do not rub the injection site. You may have slight bleeding. This is normal.
AUDIO: I drop my used syringe in one of these handy sharps disposal containers. Voilá – safe and sound.
VIDEO: Patient places the sharps container on closet shelf.
AUDIO: Now I’ll just put it back out of reach. Just like that, another injection complete.
VIDEO: N/A (TITLE CARD: “HELPFUL TIPS for self-injecting”)
ANIMATION/SUPER:
PICK the injection site
PREPARE the syringe
PINCH the skin
PUSH the plunger in
Text animates on screen for each step.
AUDIO: So, to recap, I prepare myself and my space. I pick an injection site, prepare the syringe, pinch the skin, push the plunger in.
VIDEO: Patient demonstrates step.
AUDIO: And safely discard the syringe. That’s the whole injection process!
VIDEO: Patient speaks to camera.
AUDIO: Now, it seemed tricky at first, but I got it down soon enough. And Bryan, my Nurse Ambassador, he recommended I create a routine – injecting at the same time, same place – that sort of thing. I also do something nice for myself after each injection – maybe I’ll paint as a reward.
VIDEO: Patient holds up phone to camera.
AUDIO: Oh, and this Skyrizi Complete App has helped me so much.
VIDEO: Patient points to App on phone.
AUDIO: I mean I used it to log my first starter dose so I knew when to take my second starter dose 4 weeks later. You can set reminders for future doses, too.
VIDEO: Patient speaks to camera.
SUPER: 1 INJECTION 4x A YEAR
AUDIO: Since, after 2 starter doses, SKYRIZI is only 1 injection 4 times a year.
VIDEO: Patient points to phone.
App notification reminder appears on phone screen.
AUDIO: And when I get those reminders, I know to contact my specialty pharmacy to get my next injection on time.
VIDEO: Patient speaks to camera.
SUPER: Get sharps containers for no additional cost at www.SKYRIZI.com or call 1.866.SKYRIZI
AUDIO: Oh, and I can’t forget about the Skyrizi Complete sharps disposal and mail-back service.
ANIMATION: SUPER animates over sharps container
SUPER: Get sharps containers for no additional cost at www.SKYRIZI.com or call 1.866.SKYRIZI
FULL
AUDIO: Once my sharps container gets full, I request a new one that’s sent to me with a box to mail this one back. I signed up for the service online, and it doesn’t cost me anything!
VIDEO: Patient speaks to camera. SUPER animates on screen.
SUPER: CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE
AUDIO: I’m lucky to have people around to support me. I’ve got Skyrizi Complete on my team, too. Like Bryan, who’s such a good listener,
VIDEO: Patient picks up phone from table.
SUPER: CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE
AUDIO: and this App!
VIDEO: Patient speaks to camera.
AUDIO: There’s always someone to reach out to if you need help. You’ve got this.
VIDEO: GSS
US-SKZ-220107
KEEPsAKE 1: csDMARD-IR. KEEPsAKE 2: Mixed population (50% csDMARD-IR, 50% Bio-IR)
KEEPsAKE 1 (N=964) and KEEPsAKE 2 (N=443) were 2 randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 24 weeks with an open-label extension for up to an additional 204 weeks in adult patients with active psoriatic arthritis.
In both studies, patients were randomized to receive SKYRIZI 150 mg or placebo at Weeks 0, 4, and 16. Starting from Week 28, all patients received SKYRIZI every 12 weeks. 59.6% of patients from both studies were receiving concomitant MTX, 11.6% were receiving concomitant non-biologic DMARDs other than MTX, and 28.9% were receiving SKYRIZI monotherapy.
Patients in KEEPsAKE 1 previously experienced an inadequate response, intolerance, or contraindication to ≥1 csDMARD. Patients in KEEPsAKE 2 were bio-IR and/or csDMARD-IR.
In both studies, similar responses were seen regardless of concomitant non-biologic DMARD use, number of prior non-biologic DMARDs, age, gender, race, and BMI. In KEEPsAKE 2, responses were seen regardless of prior biologic therapy.
*The first n-value is for KEEPsAKE 1; the second n-value is for KEEPsAKE 2.
†At Week 16, patients classified as nonresponders (defined as not achieving at least a 20% improvement in either or both tender joint count and swollen joint count at both Week 12 and Week 16 compared to baseline) had the option to add or modify rescue concomitant medications/therapy. Starting at Week 36, patients classified as nonresponders were discontinued from study drug.
‡To maintain the blind to the original treatment at Week 24, patients randomized to placebo received blinded risankizumab 150 mg, and patients randomized to risankizumab received blinded placebo.
Primary endpoint
Select ranked secondary endpoints
Non-ranked secondary endpoints
Key inclusion criteria
ACR=American College of Rheumatology
Bio-IR=inadequate response or intolerance to a biologic
BMI=body mass index
csDMARD=conventional synthetic disease-modifying antirheumatic drugs
csDMARD-IR=intolerance or inadequate response to conventional synthetic disease-modifying antirheumatic drug(s)
LDI=Leeds Dactylitis Index
LEI=Leeds Enthesitis Index
mTSS=modified total Sharp Score
MTX=methotrexate
NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19
OLE=open-label extension
PASI=Psoriasis Area Severity Index
PBO=placebo
RZB=risankizumab-rzaa
aAmong patients with ≥3% body surface area affected by psoriasis at baseline.
bNot included in KEEPsAKE 2.
cAmong patients with nail psoriasis at baseline.
dDefined as LEI=0 among patients with LEI >0 at baseline. Prespecified analysis of pooled data from the KEEPsAKE 1 and KEEPsAKE 2 trials (RZB, n=444; PBO, n=448).
eDefined as LDI=0 among patients with LDI >0 at baseline. Prespecified analysis of pooled data from the KEEPsAKE 1 and KEEPsAKE 2 trials (RZB, n=188; PBO, n=204).
REFERENCES
aBased on 68 joints.
bBased on 66 joints.
BMI=body mass index
BSA=body surface area
csDMARD=conventional synthetic disease-modifying antirheumatic drugs
mTSS=modified Total Sharp Score
MTX=methotrexate
NSAID=nonsteroidal anti-inflammatory drug
PBO=placebo
PsA=psoriatic arthritis
RZB=risankizumab-rzaa
BMI=body mass index
BSA=body surface area
csDMARD=conventional synthetic disease-modifying antirheumatic drugs
mTSS=modified Total Sharp Score
MTX=methotrexate
NSAID=nonsteroidal anti-inflammatory drug
PBO=placebo
PsA=psoriatic arthritis
RZB=risankizumab-rzaa
REFERENCES
US-SKZR-220084
US-SKZR-220084
Abbvie
US-SKZR-220084
To achieve an ACR20, 50, or 70 response, a patient must have at least a 20%, 50%, or 70%, respectively, improvement in tender and swollen joint counts and three of five scores of individual elements:
REFERENCES
1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. Mease PJ, Antoni CE, Gladman DD, Taylor WJ. Psoriatic arthritis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(suppl II):ii49-ii54. 3. Data on file, AbbVie Inc. ABVRRTI71868. 4. Mease P, Strand V, Gladman D. Functional impairment measurement in psoriatic arthritis: importance and challenges. Semin Arthritis Rheum. 2018;48(3):436-448.
US-SKZR-220084
ACROSS 4 PIVOTAL TRIALS
Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including
BOXED WARNING for Serious Infections and Malignancy. See Full Prescribing Information.
ACTIVE COMPARATOR
The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established. See Full Prescribing Information for US-approved ustekinumab, which reflects different rates of adverse events from those observed for EU-approved ustekinumab in the UltIMMa trials.
Safety analyses were performed using a safety analysis set (all patients who received ≥1 dose of study drug). No safety data for adalimumab or placebo were obtained beyond Week 16.
aIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.
bIncludes data from UltIMMa-1, UltIMMa-2, and Phase 2 study 1311.2.
cSKYRIZI (150 mg), adalimumab, and placebo were only evaluated in Phase 3 trials; the ustekinumab group includes Phase 3 patients (N=199) in addition to Phase 2 patients (n=40).
dIncludes data from IMMvent study.
eIncludes data from UltIMMa-1, UltIMMa-2, and IMMhance studies.
IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; Ps=psoriasis; TB=tuberculosis.
STELARA is a registered trademark of Johnson & Johnston. See US prescribing information for further information.
REFERENCES
US-SKZR-220084
Active Comparator
The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established. See Full Prescribing Information for US-approved ustekinumab, which reflects different rates of adverse events from those observed for EU-approved ustekinumab in the UltIMMa trials.
Safety analyses were performed using a safety analysis set (all patients who received ≥1 dose of study drug). No safety data for adalimumab or placebo were obtained beyond Week 16.
aIncludes data from UltIMMa-1 and UltIMMa-2 studies.
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
REFERENCES
US-SKZR-220084
US-SKZR-220084
US-SKZR-220084
US-SKZR-220084
US-SKZR-220084
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Important Safety Information
Hypersensitivity Reactions
SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.
Infection
SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.
Tuberculosis (TB)
Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.
Hepatotoxicity in Treatment of Crohn’s Disease
Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn’s disease, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Administration of Vaccines
Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.
Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance.
Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease.
Dosage Forms and Strengths: SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, and a 600 mg/10 mL single-dose vial for intravenous infusion.
INDICATIONS
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Please see Full Prescribing Information.
US-SKZG-220547