- aIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.
- bIncludes data from UltIMMa-1, UltIMMa-2, and phase 2 study 1311.2.
- cIncludes data from IMMvent study.
- dIncludes data from UltIMMa-1, UltIMMa-2, and IMMhance studies.
- eIncludes respiratory tract infection (viral, bacterial, or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), and tonsillitis.
- fIncludes headache, tension headache, sinus headache, and cervicogenic headache.
- gIncludes fatigue and asthenia.
- hIncludes injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, and warmth.
- iIncludes tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, and tinea infection.
- jSKYRIZI (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).
- kMycobacterium tuberculosis complex test positive.
- lIdentified by standard MedDra query (SMQ).
- mIncludes data from UltIMMa-1 and UltIMMa-2 studies.
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.
- 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.
- Data on file, ABVRRTI68139.
- 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.
- 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.
- 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.
- 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.
- Reich K, Gordon KB, Tyring S, et al. Malignancy rates in patients with moderate to severe psoriasis during treatment with risankizumab: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
- 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.
- Data on file, ABVRRTI68164.
- 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 website. https://clinicaltrials.gov/ct2/show/NCT02672852. Updated August 9, 2018. Accessed March 29, 2019.
- Data on file, ABVRRTI68151.