Approval

AbbVies Skyrizi Receives US FDA Approval To Treat Adults With Active Psoriatic Arthritis

January 24,2022 10:14 AM
- By Admin

AbbVie, a global biopharmaceutical company, announced the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis.

The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of Skyrizi in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs). Across the two phase 3 studies, Skyrizi met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender and painful joints.

"Patients often do not suspect a connection between their psoriasis skin symptoms and the joint pain, swelling and stiffness they may be experiencing, potentially leading to a delay in diagnosis and treatment of psoriatic arthritis," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We're proud to expand the use of Skyrizi to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms."

Skyrizi maintains a dosing regimen for PsA that is consistent with the existing regimen for moderate to severe plaque psoriasis patients – a single 150 mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4) – and can be administered alone or in combination with DMARDs.

"In the pivotal KEEPsAKE trials, Skyrizi demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis," said Alan J. Kivitz, M.D., CPI, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Duncansville, Pennsylvania and KEEPsAKE clinical trial investigator. "This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with active psoriatic arthritis, alongside a quarterly dosing schedule that may fit their patients' lifestyle."

Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of Skyrizi globally.

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of Skyrizi in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated Skyrizi in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated Skyrizi in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to Skyrizi 150 mg or placebo followed by Skyrizi 150 mg at week 24 in the open-label extension. Patients randomized to Skyrizi received four maintenance doses a year, following two initiation doses.

The primary endpoint for both studies was the achievement of ACR20 response at week 24. Some of the ranked secondary endpoints included change from baseline in Health Assessment Questionnaire-Disability Index and the achievement of PASI 90 at week 24. The studies are ongoing, and patients in the long-term extension remain blinded to the original randomized allocation for the duration of the study, which will evaluate the long-term safety, tolerability and efficacy of Skyrizi in patients who have completed the placebo-controlled period.

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. Skyrizi is approved in the US to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, as well as to treat active psoriatic arthritis in adults. The approved dose for Skyrizi is 150 mg (one 150 mg pre-filled pen or pre-filled syringe) administered by subcutaneous injection at weeks 0 and 4, and every 12 weeks thereafter. Phase 3 trials of Skyrizi in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.