欧盟委员会批准SKYRIZI®用于治疗成人活动性银屑病关节炎

On November 17, 2021, AbbVie announced that the European Commission (EC) has approved SKYRIZI® (risankizumab) as monotherapy or in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis in adults with an inadequate response to or intolerance to one or more antirheumatic drugs (DMARDs). This is the second indication for SKYRIZI and the marketing authorization will be valid in all EU member states as well as Iceland, Liechtenstein, Norway and Northern Ireland.

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with characteristic manifestations across multiple domains, including joints and skin. In psoriatic arthritis, inflammation produced by the immune system can lead to pain, fatigue, joint stiffness, and the appearance of psoriatic lesions.

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to the p19 subunit of IL-23. IL-23 is a cytokine involved in inflammatory processes and is associated with some chronic immune-mediated diseases, including psoriasis. The approved dose of SKYRIZI is 150 mg (either as two 75 mg prefilled syringes or as one 150 mg prefilled syringe) administered by subcutaneous injection at weeks 0 and 4, and every 12 weeks thereafter. SKYRIZI 150 mg formulation received EU approval in May 2021. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.

The approval was based on data from two Phase 3 clinical studies (KEEPsAKE-1 and KEEPsAKE-2). In these studies, SKYRIZI met the primary endpoint of ACR20 response at Week 24 and ranked secondary endpoints, including, but not limited to, improvement in several clinical manifestations of psoriatic arthritis, such as physical function (measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at Week 24, compared to placebo.

"We are pleased that the EU has approved SKYRIZI for the treatment of adults with active psoriatic arthritis," said Michael Severino, M.D., vice chairman and president of AbbVie. "People with psoriatic arthritis struggle with the swelling and pain caused by psoriatic skin lesions and joint inflammation. Reducing these symptoms may allow patients to return to normal life and improve their quality of life."

References:

https://news.abbvie.com/news/press-releases/abbvie-expands-immunology-portfolio-in-european-union-with-european-commission-approval-skyrizi-risankizumab-for-treatment-adults-with-active-psoriatic-arthritis.htm