IS EVERYTHING CONTROL
For adults with moderately to severely active ulcerative colitis (UC) 1
SKYRIZI provides the opportunity for endoscopic and symptom control. For your patients, that’s everything.
ENDOSCOPIC HEALING Endoscopic improvement,* endoscopic remission, † and histo-endoscopic mucosaI improvement (HEMI) ‡ at Week 52 1 The relationship between HEMI to disease progression and long-term outcomes was not evaluated. 1 DURABLE REMISSION Clinical remission § and steroid-free clinical remission || at Week 52 1 EARLY DISEASE CONTROL • Clinical response ¶ as early as Week 4 1 • Clinical remission § and endoscopic improvement* at Week 12 1
WELL-STUDIED SAFETY Safety profile established across 4 indications with up to ~9 years of clinical trial experience 1,2 EXCEPTIONAL ACCESS & SUPPORT Committed to exceptional access and support from AbbVie
SCAN TO SEE THE DATA WWW.SKYRIZIHCP.COM/UC
INDICATIONS 1 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. Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults. SAFETY CONSIDERATIONS 1 SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of its excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately. 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. Drug-induced liver injury was reported in a patient with Crohn’s disease during induction dosing of SKYRIZI. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks). Interrupt treatment with SKYRIZI if drug-induced liver injury is suspected, until this diagnosis is excluded. Avoid use of live vaccines in SKYRIZI patients.
STUDY DESIGN INSPIRE Induction (N=966) was a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SKYRIZI 1200 mg IV, at Weeks 0, 4, and 8 vs placebo over 12 weeks in adult patients with moderate to severe UC. The primary endpoint was clinical remission § at Week 12. 1 COMMAND Maintenance (N=547) was a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SKYRIZI 180 mg or 360 mg SC vs placebo up to 52 weeks in adult patients who were clinical responders to one of three SKYRIZI induction regimens consisting of 600 mg, 1200 mg or 1800 mg IV (the 600 mg and 1800 mg IV are not FDA-approved induction regimens) in the INSPIRE Phase 2b or Phase 3 studies. The primary endpoint was clinical remission at Week 52. COMMAND also included a prespecified subgroup analysis inclusive only of patients who responded to the FDA-approved induction dosing of SKYRIZI 1200 mg IV (N=271). 1
Please see additional Important Safety Information on the following spread. Please see adjacent pages for the Brief Summary of full Prescribing Information.
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Revista Puertorriqueña de Medicina y Salud Pública
Revista Puertorriqueña de Medicina y Salud Pública
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