On October 15, 2021, AbbVie announced that the European Medicines Agency (EMA) Committee for Medicines for Human Use (CHMP) recommended to approve risankizumab (trade name Skyrizi) as a single drug or in combination with methotrexate (MTX). It is used for the treatment of active psoriatic arthritis in adults with insufficient response or intolerance to one or more anti-rheumatic drugs (DMARDs) that alter the progression of the disease. The press release pointed out that if approved, this will be the second indication for risankizumab in the EU.

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations in multiple systems (including joints and skin). Inflammation produced by the immune system can cause joint pain, fatigue, stiffness, and cause a red scaly rash.

Risankizumab is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23 is a cytokine involved in the inflammatory process and is believed to be involved in many chronic immune-mediated diseases, including psoriasis. It has been approved by the US FDA and the European Union for the treatment of psoriasis. In addition, a phase 3 trial of risankizumab in the treatment of psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis is ongoing.

This positive opinion of CHMP is supported by two pivotal Phase 3 clinical trials. The results of the trial showed that compared with placebo, risankizumab reached the primary endpoint of ACR20 response (20% improvement in joint swelling and tenderness) at week 24. In addition, risankizumab also reached several secondary endpoints, including the improvement of several clinical manifestations of psoriatic arthritis, such as skin clearance (PASI 90), physical function (HAQ-DI), and minimum disease activity at week 24 ( MDA).

In terms of safety, the most common adverse reactions associated with risankizumab are upper respiratory tract infections, headaches, fatigue, injection site reactions and ringworm infections. In addition, the efficacy and safety characteristics of risankizumab administered for up to 52 weeks are consistent with those observed at 24 weeks.