Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

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

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

For Healthcare
Professionals

For adults with moderate to severe plaque psoriasis WELL-STUDIED SAFETY PROFILE Across 11 trials1,2

Long-term data was evaluated for all patients receiving ≥1 dose of SKYRIZI from
PHASE 1-3 TRIALS, INCLUDING OPEN-LABEL EXTENSION AND DOSE-RANGING STUDIES2

REPRESENTING*

Group of Patients Icon

2,673

PATIENTS

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ACROSS

5,583

PATIENT-YEARS (PYs)

SERIOUS ADVERSE EVENT (AE) RATES FROM 16 WEEKS UP TO ~5 YEARS OF EXPOSURE

WEEK 16

17.4

EVENTS PER 100 PYs

PLACEBO

(n=300, PYs=92)

9.9

EVENTS PER 100 PYs

SKYRIZI

(n=1,306, PYs=402)

~5 YEARS EXPOSURE†‡

8.6§

EVENTS PER 100 PYs

SKYRIZI

(n=2,673, PYs=5,583)

§Representing different pools of
patients* with
varying lengths
of treatment exposure

Long-term safety was evaluated in an all-SKYRIZI data set comprising 11 phase 1-3 studies in patients with moderate to severe plaque psoriasis encompassing 5 trials using integrated data evaluated at Week 16 (including UltIMMa-1, UltIMMa-2, IMMhance, and IMMVent), and 6 additional trials including LIMMitless.2

STUDY DESIGN:

LIMMitless is an ongoing, single-arm, multicenter, open-label extension of Phase 2 and 3 studies 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.3-5

*Long-term safety (58.6 months) from an 11-study pool, includes phase I through open-label extension data, representing different pools of patients with varying lengths of treatment exposure. The long-term all-SKYRIZI psoriasis analysis set assessed safety of patients with psoriasis who received ≥1 dose of all explored doses of SKYRIZI through the end of exposure.2

Long-term data (58.6 months) included 2,673 patients treated with ≤18 mg, 90 mg, 150 mg, or 180 mg of SKYRIZI. The FDA-approved dose is 150 mg at Week 0, Week 4, and every 12 weeks thereafter.1,2

Analysis 7/22/2019.

Safety through 16 weeks1,4,6,7

ACROSS 4 PIVOTAL TRIALS

Safety through 16 weeks Safety through 16 weeks Safety through 16 weeks

Safety up to ~5 years of exposure:

With SKYRIZI, rates of adverse events (AEs) at Week 52 were similar to those observed at Week 16. Overall long-term AE rates remained consistent up to ~5 years of exposure.1,2

STUDY DESIGN:

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.1,8

IMMvent was a phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI compared to HUMIRA (adalimumab) in adult patients with moderate to severe plaque psoriasis over 44 weeks.9

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.1,10

Warnings and precautions include infections, tuberculosis, and immunizations.

NO LABELED WARNINGS or precautions on: malignancy, IBD, or depression.1

Initially evaluate for tuberculosis and instruct patients to report signs and symptoms of infection.

No routine lab monitoring required during treatment.1

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.

At Week 16, see results of patients achieving  PASI 90 in the UltIMMa studies.

Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including
BOXED WARNING for Serious Infections and Malignancy

ADVERSE EVENTS OF INTEREST
THROUGH 52 WEEKS1,11,12

POOLED DATA FROM 2 PIVOTAL TRIALS AT WEEK 521,11,12

Adverse events of interest of treatments through 52 weeks Adverse events of interest of treatments through 52 weeks Adverse events of interest of treatments through 52 weeks

Safety up to ~5 years of exposure:

With SKYRIZI, rates of adverse events (AEs) at Week 52 were similar to those observed at Week 16. Overall long-term AE rates remained consistent up to ~5 years of exposure.1,2

STUDY DESIGN:

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 ustekinumab 52 weeks in adult patients with moderate to severe plaque psoriasis.1,8

Warnings and precautions include infections, tuberculosis, and immunizations.

NO LABELED WARNINGS or precautions on: malignancy, IBD, or depression.1

Initially evaluate for tuberculosis and instruct patients to report signs and symptoms of infection.

No routine lab monitoring required during treatment.1

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 was obtained beyond Week 16.

Warnings and precautions include infections, tuberculosis, and immunizations.

NO LABELED WARNINGS or precautions on: malignancy, IBD, or depression.1

Initially evaluate for tuberculosis and instruct patients to report signs and symptoms of infection.

No routine lab monitoring required during treatment.1

Patient with Skyrizi Complete

ADVERSE EVENTS OF INTEREST UP
TO ~5 YEARS OF EXPOSURE2,13

ACROSS 11 TRIALS

Adverse Events of Interest of Treatments Up To 5 Years of Exposure Adverse Events of Interest of Treatments Up To 5 Years of Exposure Adverse Events of Interest of Treatments Up To 5 Years of Exposure

RESULTS PRESENTED INCLUDE VARYING LENGTHS OF TREATMENT EXPOSURE AND ALL EXPLORED DOSING
REGIMENTS FOR SKYRIZI, INCLUDING THE APPROVED 150 MG/DOSE.

Long-term safety was evaluated in an all-SKYRZI data set comprising 11 phase 1-3 studies in patients with moderate to severe plaque psoriasis encompassing 5 trials using integrated data evaluated at Week 16 (including UltIMMa-1, UltIMMa-2, IMMhance, and IMMVent), and 6 additional trials including LIMMitless.2

STUDY DESIGN:

LIMMitless is an ongoing, single-arm, multicenter, open-label extension of Phase 2 and 3 studies 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.3-5

Long-term safety (58.6 months) from an 11-study pool, includes phase 1 through open-label extension data, representing different pools of patients with varying lengths of treatment exposure. The long-term all-SKYRIZI psoriasis analysis set assessed safety of patients with psoriasis who received ≥1 dose of all explored doses of SKYRIZI through the end of exposure.2

Long-term data (58.6 months) included 2,673 patients treated with ≤18 mg, 90 mg, 150 mg, or 180 mg of SKYRIZI. The FDA-approved dose is 150 mg at Week 0, Week 4, and every 12 weeks thereafter.1,2

  1. aIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.
  2. bIncludes data from UltIMMa-1, UltIMMa-2, and phase 2 study 1311.2.
  3. 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).
  4. dIncludes data from IMMvent study.
  5. eIncludes data from UltIMMa-1, UltIMMa-2, and IMMhance studies.
  6. fIncludes respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis.
  7. gIncludes headache, tension headache, sinus headache, cervicogenic headache.
  8. hIncludes fatigue, asthenia.
  9. iIncludes injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth.
  10. jIncludes tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis.
  11. kIncludes data from UltIMMa-1 and UltIMMa-2 studies.
  12. lOne placebo-treated patient had a positive mycobacterium tuberculosis complex test.

 

MACE=Major Adverse Cardiac Events;

NMSC=Non-melanoma Skin Cancer;

TB=Tuberculosis;

PYs=Patient-years;

IBD=Inflammatory Bowel Disease.

See SkyriziResults

after 1 dose12

Patient Icon

Only 4 doses per year

3-month dosing after 2 initiation doses at Weeks 0 and 4 (150 mg/dose)1

Calendar Icon
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

  1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
  2. Gordon KB, Bachelez H, Blauvelt A, et al. Pooled long-term safety analysis of risankizumab in patients with moderate to severe psoriasis. Presented at the Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
  3. Leonardi C, Lebwohl M, Bachelez H, et al. Maintenance of response through 136 weeks of long-term continuous risankizumab treatment: an analysis of patients from UltIMMA-1 and UltIMMA-2. Presented at the Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
  4. Leonardi C, Bachelez H, Wu JJ, et al. Long-term safety of risankizumab in patients with moderate to severe psoriasis: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  5. Papp K, Lebwohl M, Ohtsuki M, et al. Long-term efficacy and safety of continuous Q12W risankizumab: results from open-label extension study LIMMitless. Presented at the Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
  6. Strober B, Blauvelt A, Menter A, et al. Risankizumab treatment is associated with low and consistent infection rates over time in patients with moderate to severe psoriasis: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  7. Data on file, ABVRRTI68139.
  8. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661.
  9. Reich K, Gooderham M, Thaçi D, et al. Efficacy and safety of continuous risankizumab or switching from adalimumab to risankizumab treatment in patients with moderate-to-severe plaque psoriasis: results from the phase 3 IMMvent trial. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  10. Langley RG, Blauvelt A, Gooderham M, et al. Efficacy and safety of continuous Q12W risankizumab versus treatment withdrawal: results from the phase 3 IMMhance trial. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC. 
  11. Data on file, ABVRRTI68164.
  12. 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.  
  13. Strober B, Blauvelt A, Menter A, et al. Risankizumab is associated with low and consistent infection rates in patients with moderate to severe psoriasis: analysis of short-term and long-term pooled clinical trial data. Poster presented at: 24th World Congress of Dermatology; June 10-15, 2019; Milan, Italy. 
  14. Ryan C, Crowley J, Valdecantos WC, Wu T, Reich K. Efficacy of switching to risankizumab compared with continued adalimumab treatment in patients with moderate-to-severe plaque psoriasis. Poster presented at: 6th Congress of the Skin and Inflammation and Psoriasis International Network; April 25-27, 2019; Paris, France. 
  15. BI 655066/ABBV-066 (risankizumab) in moderate to severe plaque psoriasis with randomized withdrawal and re-treatment. ClinicalTrials.gov identifier: NCT02672852. https://clinicaltrials.gov/ct2/show/NCT02672852. Updated October 9, 2019. Accessed June 5, 2020. 
  16. Data on file, ABVRRTI68151.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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. 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.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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. 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.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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
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