NORTH CHICAGO, Ill., Jan. 14, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Skyrizi™ met both primary and all ranked secondary endpoints, including superiority at week 52, versus Cosentyx®* in a head-to-head Phase 3 study.1 Skyrizi showed significantly higher rates of skin clearance compared to Cosentyx®*, meeting the primary endpoint of superiority with at least a 90 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) at week 52.1 Of patients treated with Skyrizi, 87 percent achieved PASI 90 compared to 57 percent of Cosentyx®* treated patients at 52 weeks (p<0.001).1 At week 16, Skyrizi also met the other primary endpoint of non-inferiority to Cosentyx®* with 74 percent of Skyrizi patients achieving PASI 90 compared to 66 percent of Cosentyx®* patients.1
"In this study, Skyrizi showed superior efficacy compared to Cosentyx®* in helping patients achieve and maintain high levels of skin clearance at week 52," said Michael Severino, M.D., vice chairman and president, AbbVie. "Head-to-head data like these are crucial to help patients and their doctors make informed treatment decisions. We are pleased to add these results to the growing body of evidence supporting Skyrizi as a differentiated treatment option for adults living with psoriasis."
Skyrizi also showed superiority compared to Cosentyx®* for all ranked secondary endpoints, including PASI 100, and PASI 75, as well as a static Physician Global Assessment score of clear or almost clear (sPGA 0/1) at week 52 (p<0.001).1
Current safety data available demonstrated that the safety profile of Skyrizi was consistent with that observed 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 rate 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 Head-to-Head Phase 3 Study1,5
This Phase 3, multicenter, randomized, open-label, efficacy assessor-blinded, active-comparator study was 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, 4 weeks later and every 12 weeks thereafter, or Cosentyx®* (n=163) (300 mg) given as two 150 mg subcutaneous injections, at baseline, weeks 1, 2, 3 and 4, and then every 4 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) in the European Union6
Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Important EU Safety Information6
Skyrizi is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Skyrizi may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Prior to initiating treatment with Skyrizi, patients should be evaluated for tuberculosis (TB) infection. Patients receiving Skyrizi should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with Skyrizi, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.
This is not a complete summary of all safety information. See Skyrizi full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
- AbbVie. Data on File. ABVRRTI69849.
- Gordon K, 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. The Lancet. 2018 Aug 25;392(10148):650-661.
- Reich, K., et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3.
- Blauvelt, A., et al. Efficacy and Safety of Continuous Q12W Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded Results from the Phase 3 IMMhance Trial. Poster #478. 24th World Congress of Dermatology. 2019.
- Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03478787.
- Skyrizi [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu.
*Cosentyx® is a registered trademark of Novartis AG.