Rheumatology
Moderate to Severe
Rheumatoid Arthritis
Active
Psoriatic Arthritis
Active
Ankylosing Spondylitis
Moderate to Severe
Juvenile Idiopathic Arthritis
Non-Infectious
Intermediate, Posterior and Panuveitis
Dermatology
Moderate to Severe
Chronic Plaque Psoriasis
Active
Psoriatic Arthritis
Moderate to Severe
Hidradenitis Suppurativa
Gastroenterology
Moderate to Severe
Crohn's Disease
Moderate to Severe
Pediatric Crohn's Disease
Moderate to Severe
Ulcerative Colitis
Moderate to Severe
Pediatric Ulcerative Colitis
Ophthalmology
Non-Infectious
Intermediate, Posterior and Panuveitis
Nothing more than 4 doses per year
after initiation doses1
Reliable 3-MONTH DOSING1
2 PREFILLED SYRINGES PER DOSE,
ADMINISTERED BY SUBCUTANEOUS INJECTION AT:
Initiation
DOSE
WEEK 0
DOSE
WEEK 4
Month 3
DOSE
WEEK 16
Month 6
DOSE
WEEK 28
Month 9
DOSE
WEEK 40
Month 12
DOSE
WEEK 52
3-MONTH DOSING
after 2 initiation doses
(150 mg/dose) at Weeks 0 and 4
2 administration options
for in-office use or
self-administration
after training
1 DOSAGE FOR ALL PATIENTS
regardless of baseline weight,
disease severity, or prior treatment
Dosing Considerations
SKYRIZI is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject SKYRIZI after training in subcutaneous injection technique. Instruct patients to inject 2 prefilled 75-mg syringes for the full 150 mg/dose and to read the Instructions for Use before administration.1
Dosing Schedules
Dosing schedules FOR IL-17 and IL-23 INHIBITORS1-6
This presentation is not intended to compare the efficacy or safety of the treatments shown. While these factors are important, there are additional considerations for selecting a treatment. Please refer to each product’s Prescribing Information for additional information.
*Based on doses required in each 48-week maintenance treatment period.
SKYRIZI is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject SKYRIZI after training in subcutaneous injection technique. Instruct patients to inject 2 prefilled 75 mg syringes for the full 150 mg dose and to read the Instructions for Use before administration.
SKYRIZI® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
ILUMYA™ is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
TREMFYA® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Taltz® is indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
COSENTYX® is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
SILIQ® is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
Indication
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
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.
Pre-Treatment Evaluation for 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.
Immunizations
Prior to initiating SKYRIZI, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with SKYRIZI.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
Please see Full Prescribing Information.
US-SKZD-190350
REFERENCES
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- ILUMYA [package insert]. Princeton, NJ; Sun Pharmaceuticals, Inc.
- TREMFYA [package insert]. Horsham, PA; Janssen Biotech, Inc.
- Taltz [package insert]. Indianapolis, IN; Eli Lilly and Company.
- COSENTYX [prescribing information]. East Hanover, NJ; Novartis Pharmaceuticals Corporation.
- SILIQ [package insert]. Bridgewater, NJ; Valeant Pharmaceuticals North America LLC.
- Lebwohl M, Bachelez H, Valdecantos WC, Wu T, Gordon K. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis: an integrated analysis of UltIMMa-1 and UltIMMa-2. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
STUDY DESIGN – IMMvent9
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:
- Non-responders (PASI <50) at Week 16 (n=38) were treated with SKYRIZI during Part B
- PASI 90 responders at Week 16 (n=144) continued treatment with adalimumab during Part B
- PASI 50 to <PASI 90 were re-randomized to either continue adalimumab or switch to SKYRIZI
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
- PASI 90 and sPGA 0/1 at Week 16 compared to HUMIRA
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
- PASI 90 at Week 44 among those with PASI 50 to <90 after 16 weeks of adalimumab treatment
Key secondary endpoints included
- PASI 100 at Week 16
- PASI 100 at Week 44 for patients who were re-randomized at Week 16
Key inclusion criteria
- ≥18 years of age
- Diagnosis of chronic plaque psoriasis ≥6 months before Week 0
- Stable moderate to severe chronic plaque psoriasis based on ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for adalimumab therapy in accordance with local labels
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
SELECTED BASELINE CHARACTERISTICS9,14
ADA=Adalimumab
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
US-SKZD-200400
STUDY DESIGN – IMMhance1,10
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
- PASI 90 and sPGA 0/1 at Week 16
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
- Percentage of patients with an sPGA 0/1 at 1 year
Key inclusion criteria
- ≥18 years of age
- Diagnosis of chronic moderate to severe plaque psoriasis ≥6 months before Week 0
- Stable plaque psoriasis based on ≥10% body surface area, with a PASI score ≥12 and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy
Key secondary endpoints included
- PASI 75 at Week 16
- PASI 100 at Week 16
- sPGA 0 at Week 16
- DLQI 0/1 at Week 16
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
SELECTED BASELINE CHARACTERISTICS10
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.
US-SKZD-200400
STUDY DESIGN – UltIMMa-1 and UltIMMa-21,2
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.
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
- Percentage of patients with at least a 90% improvement in the PASI score (PASI 90) at Week 16 compared to placebo
- Percentage of patients with an sPGA score of clear or almost clear (0/1) at Week 16 compared to placebo
Key secondary endpoints included
- PASI 90 and PASI 100 at Week 52 compared to ustekinumab
Key inclusion criteria
- ≥18 years of age
- Stable (≥6 months) moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis
- ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy and ustekinumab therapy in accordance with local labels
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
SELECTED BASELINE CHARACTERISTICS2
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.
US-SKZD-200400