AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new late-breaking Phase 3b head-to-head data showing superior rates of skin clearance for SKYRIZI® (risankizumab-rzaa) to COSENTYX®
| NORTH CHICAGO, Ill., June 12, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new late-breaking Phase 3b head-to-head data showing superior rates of skin clearance for SKYRIZI® (risankizumab-rzaa) to COSENTYX® (secukinumab) at week 52.1 Particularly, 66 percent of psoriasis patients receiving SKYRIZI achieved completely clear skin—100 percent clearance in the Psoriasis Area and Severity Index (PASI 100)—versus 40 percent of patients receiving COSENTYX at week 52 (p<0.001).1 These new head-to-head results from the IMMerge Phase 3b open-label study were shared today during an online late-breaking presentation by the American Academy of Dermatology (AAD). AbbVie previously announced top-line results from this study in January. “I’ve seen first-hand how achieving and maintaining completely clear skin can have an incredibly positive impact on the lives of my psoriasis patients,” said chief investigator Richard B. Warren, M.D., Ph.D., professor and honorary consultant dermatologist at the Dermatology Centre Salford Royal NHS Foundation Trust, University of Manchester. “These new data are critical as they underscore that complete skin clearance is a realistic treatment goal for people living with psoriasis.” SKYRIZI met both PASI 90 primary endpoints of non-inferiority to COSENTYX at week 16 and superiority to COSENTYX at week 52.1 At week 16, 74 percent of SKYRIZI-treated patients achieved PASI 90 compared to 66 percent of COSENTYX-treated patients.1 Of patients treated with SKYRIZI, 87 percent achieved PASI 90 at week 52 compared to 57 percent of patients treated with COSENTYX (p<0.001).1 Additional results demonstrated a significantly higher proportion of patients treated with SKYRIZI achieved a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) compared to those treated with COSENTYX at week 52 (88 percent versus 58 percent, respectively, p<0.001).1 Current safety data available demonstrated that the safety profile of SKYRIZI was consistent with that seen in previously reported studies, with no new safety signals observed through week 52.1-4 The rates of adverse events (AEs) were comparable between SKYRIZI and COSENTYX.1 The most common AEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhea.1 The rates of serious AEs were 5.5 percent in the SKYRIZI group and 3.7 percent in the COSENTYX group.1 Adverse events leading to discontinuation of the study drug were 1.2 percent in the SKYRIZI group and 4.9 percent in the COSENTYX group.1 There were no deaths in either treatment group.1 SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About the IMMerge Phase 3b Study1,5 IMMerge is a Phase 3b, multicenter, randomized, open-label (both arms), efficacy assessor-blinded, active-comparator study designed to evaluate the safety and efficacy of SKYRIZI compared to COSENTYX in adult patients with moderate to severe plaque psoriasis. Patients were randomized 1:1 to SKYRIZI (n=164) (150 mg), given as two 75 mg subcutaneous injections at baseline, four weeks later and every 12 weeks thereafter, or to COSENTYX (n=163) (300 mg), given as two 150 mg subcutaneous injections at baseline, weeks 1, 2, 3 and 4, and then every four weeks thereafter. The study has two primary endpoints (non-inferiority at week 16 as well as superiority at week 52, both at PASI 90) and three ranked secondary endpoints (PASI 100 at week 52, sPGA 0/1 at week 52 and PASI 75 at week 52). Safety was assessed in all patients. More information on this trial can be found at www.clinicaltrials.gov (NCT03478787). About SKYRIZI (risankizumab-rzaa) in the United States6 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. This is not a complete summary of all safety information. See SKYRIZI.com for full prescribing information. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in Dermatology For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease. For more information on AbbVie in dermatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.html. About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements References:
COSENTYX® is a registered trademark of Novartis AG SOURCE AbbVie | ||
Company Codes: NYSE:ABBV |
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