Bimekizumab for the treatment of active PsA granted EC marketing authorization

On June 7, 2023, the European Commission (EC) granted marketing authorization to bimekizumab, a monoclonal antibody which inhibits interleukin-17, for use in patients with active psoriatic arthritis (PsA).¹ Bimekizumab has been approved as monotherapy or in combination with methotrexate in adult patients with PsA who are intolerant or did not respond to treatment with disease-modifying antirheumatic drugs. This follows the EC approval of bimekizumab in 2021 for moderate-to-severe plaque psoriasis.¹

This approval is based on positive results from the BE OPTIMAL and BE COMPLETE phase III trials. The primary endpoint of a 50% improvement in American College of Rheumatology (ACR50) response at Week 16 versus placebo, was met (Figure 1).¹ The most common treatment-emergent adverse events included nasopharyngitis and upper respiratory tract infection.¹

Figure 1. ACR50 response in BE OPTIMAL and BE COMPLETE* 

ACR50, 50% improvement in American College of Rheumatology response; bDMARD, biologic disease-modifying antirheumatic drug; TNF, tumor necrosis factor.
*Data from McInnes, et al.² and Merola, et al.³