US FDA approves second indication for Skyrizi to treat adults with active psoriatic arthritis

AbbVie recently announced that 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 per cent of patients with psoriasis.

In a statement, the company said that 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 biologics therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Across the two phase-III 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, MD, Senior Vice President, Research and Development, and Chief Scientific Officer, AbbVie.

The statement also said that 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 zero and four) – 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. 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,” said Alan J Kivitz, MD, CPI, founder and Medical Director, Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Duncansville, Pa. and KEEPsAKE clinical trial investigator.

Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation of Skyrizi globally, the statement concluded.