What Results Does Bimekizumab Achieve in Patients with PsA After 3 Years of Treatment?
Fresh findings from the BE ACTIVE study were published this year in the journal Rheumatology, which evaluated the effects of long-term treatment of individuals with psoriatic arthritis (PsA) with bimekizumab in terms of patient-reported outcomes (PROs).
Study Methodology
The results were analyzed as mean (S.E.M.) changes from baseline values (CfB) from week 0 to the end of the open extension study (3 years) and as the proportion of patients who achieved a symptom state acceptable to patients (PASS) in terms of overall impact (overall PsAID-9 score ≤ 4) and normal function (overall HAQ-DI score < 0.5).
Results
Out of a total of 206 patients (average age 49 years; 51% men), 161 people (78.2%) completed the 152-week follow-up. Treatment with bimekizumab was associated with sustained long-term pain relief (CfB arthritis pain according to VAS: Week 48 −29.9; Week 152 −32.0) and fatigue reduction (CfB fatigue according to PsAID-9 −2.4, resp. −2.7). A substantial proportion of patients achieved an acceptable symptom state (PASS according to PsAID-9: 75.2%, resp. 65.0%) and normalization of function (HAQ-DI < 0.5 achieved by 49.0%, resp. 46.1%). Improvement in the overall patient assessment and SF-36 was also maintained.
Conclusion and Discussion
Patients with PsA treated with bimekizumab in this phase IIb study for up to 3 years showed sustainable improvement in all assessed PROs. The long-term improvement was reflected in functionality and overall health-related quality of life (HRQoL). Treatment with bimekizumab was associated with long-term reduction in pain and fatigue, leading to a decreased overall impact of PsA on patients. This study thus provides the most extensive evidence to date of the sustained efficacy of bimekizumab evaluated using PROs parameters.
The main limitations were the inherently limited sample size (n = 206), the use of post hoc data, and the absence of placebo control after week 12. Additionally, patients who participate in long-term study extensions are likely responders in the earlier part of the study, thus a greater degree of success is expected in these patients. The results should therefore be interpreted in this context. Ongoing phase III studies in this indication should allow a more detailed evaluation of bimekizumab in the specified PROs parameters in a larger setting.
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Source: Mease P. J., Asahina A., Gladman D. D. et al. Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE. Rheumatology (Oxford) 2023 Feb 1; 62 (2): 617–628, doi: 10.1093/rheumatology/keac353.
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