EULAR 2022: Bimekizumab to Benefit Psoriatic Arthritis

Bimekizumab in patients with active Psoriatic arthritis and an inadequate response to tumor necrosis factor inhibitors: 16-week efficacy and safety from BE COMPLETE, a Phase III, multicenter, randomized, placebo-controlled study (Abstract # OP0255).

Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A. The pivotal Phase III study, BE COMPLETE, assessed the efficacy and safety of bimekizumab versus placebo in patients with active PsA and prior inadequate TNFi response.

The primary endpoint (ACR50) and all ranked secondary endpoints (HAQ-DI CfB, PASI90, SF-36 PCS CfB, and MDA response) were fulfilled at Week 16. Patients treated with bimekizumab had much greater ACR50 response rates, with 43.4% versus placebo 6.8%. Treatment-emergent adverse events (TEAEs) occurred in 40.1% of bimekizumab participants and 33.3% of placebo participants, respectively. Fungal infections, nasopharyngitis, oral candidiasis, and upper respiratory tract infection were the most common TEAEs, afflicting 4.5%, 3.7%, 2.6%, and 2.2% of bimekizumab-treated patients, respectively. Overall, bimekizumab displayed a good safety and tolerability profile.

KOL insights

“The outcomes of the BE COMPLETE study show that bimekizumab, a dual IL,-17A and IL-17F inhibitor, has a promising future in the treatment of active psoriatic arthritis. This chronic and painful disease can significantly influence a patient’s life. The goal of treatment is to achieve minimal disease activity, which can lead to an improved quality of life for persons with psoriatic arthritis.”– Expert Opinion

Conclusion

The BE COMPLETE Phase III study met all its primary and secondary endpoints. Compared to placebo, bimekizumab-treated individuals demonstrated improvements in joint, skin, and HRQoL-related outcomes in Week 16.

Treatment with bimekizumab also improved the composite outcome of minimal disease activity, demonstrating the efficacy of dual inhibition across PsA disease manifestations. The study has displayed good safety and tolerability profile in line with past studies, which hints toward its potential in treating this chronic condition. 

As the submission of the regulatory application for bimekizumab in PsA is due this year, it is expected that these results will play a major role in the approval of bimekizumab for the treatment of this indication. Bimekizumab is expected to offer tough competition in the current PsA market if approved.