Iain B McInnes, Philip J Mease, Yoshiya Tanaka, Laure Gossec, M Elaine Husni, Lars Erik Kristensen, Richard B Warren, Barbara Ink, Rajan Bajracharya, Jason Coarse, Alice B Gottlieb
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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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":93845,"journal":{"name":"ACR open rheumatology","volume":" ","pages":"720-731"},"PeriodicalIF":2.9000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557990/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Bimekizumab in Patients With Psoriatic Arthritis With or Without Methotrexate: 52-Week Results From Two Phase 3 Studies.\",\"authors\":\"Iain B McInnes, Philip J Mease, Yoshiya Tanaka, Laure Gossec, M Elaine Husni, Lars Erik Kristensen, Richard B Warren, Barbara Ink, Rajan Bajracharya, Jason Coarse, Alice B Gottlieb\",\"doi\":\"10.1002/acr2.11727\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%]). 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引用次数: 0
摘要
研究目的本研究旨在评估比美单抗对基线时同时接受或未同时接受甲氨蝶呤（+/-MTX）治疗的活动性银屑病关节炎（PsA）患者52周的疗效和安全性：我们对BE OPTIMAL（NCT03895203；生物制剂改变病情抗风湿药[bDMARD]-na-ïve）、BE COMPLETE（NCT03896581；之前对肿瘤坏死因子抑制剂[TNFi-IR]反应不足或不耐受）和BE VITAL开放标签扩展研究（NCT04009499）的患者进行了事后分析。患者被随机分为以下治疗组：bimekizumab 160 毫克，每四周一次；安慰剂；或参比药物（阿达木单抗 40 毫克，每两周一次；仅 BE OPTIMAL）。从第 16 周开始，安慰剂随机患者接受比美单抗治疗。缺失数据通过非应答者归因、多重归因或最差类别归因进行归因：到第52周时，bimekizumab治疗的患者中达到美国风湿病学会50%（ACR50）反应标准的+MTX和-MTX比例相似（BE OPTIMAL：54.4% +MTX，54.7% -MTX；BE COMPLETE：56.3% +MTX，48.0% -MTX）。在+MTX组和-MTX组中，接受过bimekizumab治疗的患者实现皮肤完全清除（银屑病面积和严重程度指数100% [PASI100]反应）和疾病活动性最小的比例相似。安慰剂/bimekizumab治疗的患者也出现了类似的趋势。到第52周时，+MTX组和-MTX组中出现≥1次治疗突发不良事件的bimekizumab治疗患者比例相似（BE OPTIMAL 410例中的325例[79.3%] vs 292例中的230例[78.8%]，BE COMPLETE 168例中的105例[62.5%] vs 220例中的138例[62.7%]）。各亚组之间的安全性相当，与比美单抗之前的安全性一致：bimekizumab对bDMARD无效和TNFi-IR的PsA患者具有持续52周的疗效，且耐受性良好，与是否同时使用MTX无关。
Efficacy and Safety of Bimekizumab in Patients With Psoriatic Arthritis With or Without Methotrexate: 52-Week Results From Two Phase 3 Studies.
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.
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