In the BE OPTIMAL trial, bimekizumab demonstrated sustained efficacy in patients with psoriatic arthritis (PsA) at 52 weeks, with no new safety concerns.
(NCT03895203), bimekizumab was investigated for its ability to maintain efficacy in participants with PsA. These findings were presented at EULAR 2023, held May 31 to June 3, in Italy. Patients in the initial phase 3 cohort were randomly assigned to receive either bimekizumab, placebo, or adalimumab as active reference. The analysis showed outcomes for responders at week 16 and were followed through a subsequent 36-week active treatment-blind period. The results were presented using non-responder imputation (NRI) as well as observed case (OC) reporting.
The baseline characteristics of the 431 participants treated with bimekizumab included a mean age of 48.5, mean duration of PsA of 6 years, and a BMI kg/m2 of 29.2. Enthesitis was present in about one-third of the cohort, and the mean Psoriasis Area and Severity Index (PASI) score was 8.2.
The results after 1 year revealed that out of the initial 43.9% participants on bimekizumab who achieved an AmericanCollege of Rheumatology (ACR) response of 50 (ACR50) at week 16, 86.8% (NRI) and 91.1% (OC) were able to sustain their response to week 52. In the adalimumab reference arm, with 64 responders out of 140, the corresponding rates were 79.7% and 86.4%. PASI100 was sustained in 79.6% on bimekizumab and 71.4% on adalimumab (both NRI). Minimal disease activity, reached by 45% in both active groups at week 16, persisted in 85.6% (bimekizumab) and 82.5% (adalimumab). Of note, the simultaneous maintenance of ACR50 and PASI100 was present at week 52 in 86.7% (NRI) or 89.7% (OC) participants receiving bimekizumab, and 54.5% (NRI) or 66.7% (OC) participants on adalimumab, respectively.
Up to 1 year, a 79.1% rate of at least one treatment-emergent adverse event was observed in bimekizumab recipients, and 6.6% were reported as serious, which was in line with prior findings.
As long-term disease control is important in PsA, the investigators emphasized the key finding that robust efficacy responses were maintained to week 52 in a high proportion of bimekizumab-treated patients.
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