Comparative Effectiveness of Bimekizumab and Ustekinumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2024-10-01 Epub Date: 2024-08-09 DOI:10.1007/s40744-024-00705-x

Philip J Mease, Richard B Warren, Peter Nash, Jean-Marie Grouin, Nikos Lyris, Vanessa Taieb, Jason Eells, Iain B McInnes

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Abstract

Introduction: A matching-adjusted indirect comparison (MAIC) was conducted to assess the relative efficacy at 52 weeks (Wk52) of bimekizumab 160 mg every 4 weeks (Q4W) and ustekinumab 45 or 90 mg every 12 weeks (Q12W) in patients with psoriatic arthritis (PsA) who were biologic disease-modifying anti-rheumatic drug naïve (bDMARD naïve) or who had a previous inadequate response or an intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Methods: Relevant trials were systematically identified. Individual patient data from the bimekizumab trials BE OPTIMAL (NCT03895203; N = 431) and BE COMPLETE (NCT03896581; N = 267) were matched with summary data on patients receiving ustekinumab in the PSUMMIT 1 trial (NCT01009086; 45 mg, N = 205; 90 mg; N = 204) and a subgroup of TNFi-IR patients receiving ustekinumab in the PSUMMIT 2 trial (NCT01077362; 45 mg, N = 60; 90 mg, N = 58), respectively. Patients from the bimekizumab trials were re-weighted using propensity scores to match the baseline characteristics of the ustekinumab trial patients. Adjustment variables were selected based on expert consensus (n = 5) and adherence to established MAIC guidelines. Non-placebo-adjusted comparisons of recalculated bimekizumab and ustekinumab outcomes for the American College of Rheumatology (ACR) 20/50/70 response criteria (non-responder imputation) were analyzed.

Results: In patients who were bDMARD naïve, bimekizumab had a greater likelihood of response than ustekinumab at Wk52 for ACR20 (odds ratio [95% confidence interval] 45 mg: 2.14 [1.35, 3.40]; 90 mg: 1.98 [1.24, 3.16]), ACR50 (45 mg: 2.74 [1.75, 4.29]; 90 mg: 2.29 [1.48, 3.55]), and ACR70 (45 mg: 3.33 [2.04, 5.46]; 90 mg: 3.05 [1.89, 4.91]). In patients who were TNFi-IR, bimekizumab had a greater likelihood of response than ustekinumab at Wk52 for ACR20 (45 mg: 4.17 [2.13, 8.16]; 90 mg: 4.19 [2.07, 8.49]), ACR50 (45 mg: 5.00 [2.26, 11.05]; 90 mg: 3.86 [1.70, 8.79]), and ACR70 (45 mg: 9.85 [2.79, 34.79]; 90 mg: 6.29 [1.98, 20.04]).

Conclusions: Using MAIC, bimekizumab showed greater efficacy than ustekinumab in achieving all ACR responses in patients with PsA who were bDMARD naïve and TNFi-IR at Wk52.

Trial registration: NCT03895203, NCT03896581, NCT01009086, NCT01077362.

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使用匹配调整间接比较法评估银屑病关节炎患者使用 Bimekizumab 和 Ustekinumab 在 52 周时的疗效比较。

简介：我们进行了一项匹配调整间接比较（MAIC），以评估在52周（Wk52）时，bimekizumab每4周（Q4W）160毫克和ustekinumab每12周（Q12W）45或90毫克的相对疗效。(bDMARD)或对肿瘤坏死因子抑制剂（TNFi-IR）反应不足或不耐受的银屑病关节炎（PsA）患者。方法：系统识别相关试验。将 bimekizumab 试验 BE OPTIMAL（NCT03895203；N = 431）和 BE COMPLETE（NCT03896581；N = 267）的患者个体数据与 PSUMMIT 1 试验（NCT01009086；45毫克，N = 205；90毫克，N = 204）和在PSUMMIT 2试验（NCT01077362；45毫克，N = 60；90毫克，N = 58）中接受乌司替尼治疗的TNFi-IR患者亚组的汇总数据进行了比对。使用倾向评分对来自 bimekizumab 试验的患者进行了重新加权，以匹配乌司替库单抗试验患者的基线特征。调整变量的选择基于专家共识（n = 5）并遵循既定的 MAIC 指南。分析了根据美国风湿病学会（ACR）20/50/70应答标准（无应答者归因）重新计算的bimekizumab和乌司替库单抗结果的非处方调整比较：在 bDMARD 天真的患者中，bimekizumab 在第 52 周 ACR20 反应的可能性高于乌司替尼（几率比[95% 置信区间] 45 mg：2.14[1.35，3.40]；90毫克：1.98[1.24，3.40]：45毫克：2.14 [1.35，3.40]；90毫克：1.98 [1.24，3.16]）、ACR50（45毫克：2.74 [1.75，4.29]；90毫克：2.29 [1.48，3.55]）和ACR70（45毫克：3.33 [2.04，5.46]；90毫克：3.05 [1.89，4.91]）。在 TNFi-IR 患者中，bimekizumab 在 Wk52 的 ACR20（45 毫克：4.17 [2.13, 8.16]；90 毫克：4.19[2.07，8.49]）、ACR50（45毫克：5.00[2.26，11.05]；90毫克：3.86[1.70，8.79]）和ACR70（45毫克：9.85[2.79，34.79]；90毫克：6.29[1.98，20.04]）：结论：使用MAIC，bimekizumab在PsA患者中实现所有ACR应答方面的疗效优于ustekinumab：试验注册：NCT03895203、NCT03896581、NCT01009086、NCT01077362。

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. 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