Efficacy and Safety of Bimekizumab in Patients With Psoriatic Arthritis With or Without Methotrexate: 52‐Week Results From Two Phase 3 Studies.

Autor:	McInnes, Iain B., Mease, Philip J., Tanaka, Yoshiya, Gossec, Laure, Husni, M. Elaine, Kristensen, Lars Erik, Warren, Richard B., Ink, Barbara, Bajracharya, Rajan, Coarse, Jason, Gottlieb, Alice B.
Předmět:	ANTI-inflammatory agents PSORIATIC arthritis PATIENT safety RESEARCH funding DATA analysis PLACEBOS BODY mass index METHOTREXATE STATISTICAL sampling BLIND experiment INVESTIGATIONAL drugs SEX distribution QUESTIONNAIRES ANTIRHEUMATIC agents RANDOMIZED controlled trials DESCRIPTIVE statistics AGE distribution SEVERITY of illness index MONOCLONAL antibodies DRUG efficacy RESEARCH STATISTICS COMPARATIVE studies CONFIDENCE intervals SUBCUTANEOUS injections LIVER function tests C-reactive protein INTERLEUKINS CHEMICAL inhibitors
Zdroj:	ACR Open Rheumatology; Nov2024, Vol. 6 Issue 11, p720-731, 12p
Abstrakt:	Objective: The objective of this study was to assess 52‐week efficacy and safety of bimekizumab in patients with active psoriatic arthritis (PsA) with or without concomitant methotrexate (+/−MTX) treatment at baseline. Methods: We conducted a post hoc analysis of patients in BE OPTIMAL (NCT03895203; biologic disease‐modifying antirheumatic drug [bDMARD]‐naïve), BE COMPLETE (NCT03896581; prior inadequate response or intolerance to tumor necrosis factor inhibitors [TNFi‐IR]), and the BE VITAL open‐label extension (NCT04009499) study. Patients were randomized to one of the following treatment groups: bimekizumab 160 mg every four weeks, placebo, or a reference drug (adalimumab 40 mg every two weeks; BE OPTIMAL only). From Week 16, placebo‐randomized patients received bimekizumab. Missing data were imputed using non‐responder imputation, multiple imputation, or worst‐category imputation. Results: Through Week 52, similar proportions of bimekizumab‐treated patients achieved American College of Rheumatology 50% (ACR50) response criteria for both +MTX and −MTX (BE OPTIMAL: 54.4% +MTX, 54.7% −MTX; BE COMPLETE: 56.3% +MTX, 48.0% −MTX). Similar proportions of bimekizumab‐treated patients achieved complete skin clearance (Psoriasis Area and Severity Index 100% [PASI100] response) and minimal disease activity in both +MTX and −MTX groups. Similar trends were seen in placebo/bimekizumab‐treated patients. Through Week 52, the proportion of bimekizumab‐treated patients with ≥1 treatment‐emergent adverse event were similar between the +MTX and −MTX groups (BE OPTIMAL 325 of 410 [79.3%] vs 230 of 292 [78.8%], BE COMPLETE 105 of 168 [62.5%] vs 138 of 220 [62.7%]). The safety profile was comparable between subgroups and consistent with the prior safety profile of bimekizumab. Conclusion: Treatment with bimekizumab demonstrated consistent, sustained efficacy to 52 weeks in bDMARD‐naïve and TNFi‐IR patients with PsA and was well tolerated, irrespective of concomitant MTX. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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