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
SERIOUS ADVERSE EVENT (AE) RATES FROM 16 WEEKS UP TO ~5 YEARS OF EXPOSURE
EVENTS PER 100 PYs
EVENTS PER 100 PYs
~5 YEARS EXPOSURE†‡
EVENTS PER 100 PYs
§Representing different pools of
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
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
- 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.
- fIncludes respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis.
- gIncludes headache, tension headache, sinus headache, cervicogenic headache.
- hIncludes fatigue, asthenia.
- iIncludes injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth.
- jIncludes tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis.
- kIncludes data from UltIMMa-1 and UltIMMa-2 studies.
- lOne placebo-treated patient had a positive mycobacterium tuberculosis complex test.
MACE=Major Adverse Cardiac Events;
NMSC=Non-melanoma Skin Cancer;
IBD=Inflammatory Bowel Disease.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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
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.
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.
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.
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- 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.
- 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.
- 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.
- 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.
- 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.
- Data on file, ABVRRTI68139.
- 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.
- 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.
- 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.
- Data on file, ABVRRTI68164.
- 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.
- 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.
- 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.
- 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.
- Data on file, ABVRRTI68151.