Bimekizumab provides durable control over 3 years for PsA patients after TNF inhibitor failure

Three-year data from the phase 3 BE COMPLETE study and its open-label extension confirm that bimekizumab delivers sustained efficacy and a favourable safety profile in patients with active psoriatic arthritis (PsA) after TNF inhibitor failure.

Patients with PsA who previously experienced an inadequate response to TNF inhibitors are often challenging to treat, often showing diminished treatment responses compared biologic-naïve patients. The latest results from the Phase 3 BE COMPLETE trial (NCT03896581) and its open-label extension (BE VITAL; NCT04009499) present compelling evidence of the durability of bimekizumab’s efficacy across joint, skin, and composite disease outcomes [1].

Following completion of week 16 in the double-blind, placebo-controlled phase of BE COMPLETE, participants were eligible to continue into the open-label BE VITAL, where all received bimekizumab. Of the 400 participants initially enrolled, 74.8% completed the full 156-week period. Among them, key clinical outcomes remained consistent and favourable. ACR50 response rates were sustained from 50.4% at week 52 to 55.2% at week 156. Skin outcomes were equally robust: among participants with ≥3% body surface area psoriasis at baseline, complete skin clearance (PASI100) was achieved by 66.2% at week 52 and 67.5% at the end of the study. Additionally, nearly half (48.8%) of the participants reached minimal disease activity, and resolution of swollen joints was observed in 59.1% by week 156.

Safety data over the full period showed a manageable profile. The 3 most frequently reported adverse events were mild infections such as COVID-19 (7.6/100 patient-years [PY]), nasopharyngitis (4.8/100 PY), and upper respiratory tract infections (4.1/100 PY). Fungal infections, mostly oral candidiasis, were observed at a rate of 5.8/100 PY, and none were serious. Only 4 patients discontinued due to Candida. There was 1 reported death, which was deemed unrelated to the treatment. No new safety signals were observed.

This long-term data supports the use of bimekizumab as a durable, effective, and safe therapeutic option for active PsA patients who have failed TNF inhibitors.

1. McInnes IB et al. Dual inhibition of IL-17A and IL-17F with bimekizumab demonstrated long-term safety and efficacy in patients with active psoriatic arthritis and prior inadequate response to TNF inhibitors: final 3-year results from the BE COMPLETE study and its open-label extension. POS0105, EULAR 2025, 11–14 June, Barcelona, Spain.

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Posted on 20 June 20258 August 2025