Risankizumab (SKYRIZI®) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients
NORTH CHICAGO, Ill., Jan. 5, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from two Phase 3 studies in adults with active psoriatic arthritis, KEEPsAKE-1 and KEEPsAKE-2, showing that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo.1 In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001).1
Results of ranked secondary endpoints showed significant improvements in skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]), physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24.1 These two Phase 3 studies evaluated risankizumab in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).1
"We are encouraged by these positive results showing the potential of risankizumab in psoriatic arthritis," said Michael Severino, M.D., vice chairman and president, AbbVie. "These results underscore our commitment to research that can provide health care practitioners with important treatment options for patients with psoriatic disease."
In KEEPsAKE-1, the ranked secondary endpoint of PsA Sharp/van der Heijde Score (PsA-mTSS) was 0.23 and 0.32 at week 24 in the risankizumab and placebo groups, respectively (p=0.496 [note: a lower score denotes lower radiographic progression]).1
In these studies, the safety profile of risankizumab through week 24 was generally consistent with safety findings in previous studies in psoriasis.1-4 Serious adverse events occurred in 2.5 percent and 4.0 percent of patients treated with risankizumab in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 3.7 percent and 5.5 percent on placebo.1 Rates of serious infections were similar between treatment groups (1.0 and 0.9 percent in risankizumab-treated patients in KEEPsAKE-1 and KEEPsAKE-2, respectively, and 1.2 and 2.3 percent in patients who received placebo).1 The rates of adverse events leading to discontinuation of the study drug were 0.8 percent and 0.9 percent of patients treated with risankizumab in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 0.8 percent and 2.3 percent on placebo.1 In KEEPsAKE-1, there was one death in the risankizumab group not related to the study drug per investigator.1 There were no deaths reported in KEEPsAKE-2.1
Full results from the KEEPsAKE studies will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of risankizumab in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.8,9 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.8,9
About KEEPsAKE-1 and KEEPsAKE-21,10,11
KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of risankizumab in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated risankizumab in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to risankizumab 150 mg or placebo followed by risankizumab 150 mg at week 24.
The primary endpoint for both studies was the achievement of ACR20 response at week 24 from the treatment with the study medication. Ranked secondary endpoints included change from baseline in HAQ-DI, as well as the achievement of PASI 90 and MDA at week 24. Other secondary endpoints included ACR50 and ACR70 (not controlled for multiplicity) at week 24. The studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of risankizumab in patients who have completed the placebo-controlled period.
More information on these trials can be found at www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148).
About risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.12,13 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease and psoriatic arthritis are ongoing.5-7,10,11 Use of SKYRIZI in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
About SKYRIZI (risankizumab-rzaa) in the United States13
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Important Safety Information13
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.
This is not a complete summary of all safety information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Globally, prescribing information varies; refer to the individual country product label for complete information.
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.
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, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.
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