Warren Richard B, McInnes Iain B, Nash Peter, Grouin Jean-Marie, Lyris Nikos, Willems Damon, Taieb Vanessa, Eells Jason, Mease Philip J
Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, The University of Manchester, Manchester, UK.
College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Rheumatol Ther. 2024 Jun;11(3):829-839. doi: 10.1007/s40744-024-00659-0. Epub 2024 Mar 15.
Matching-adjusted indirect comparisons (MAIC) were used to assess the relative efficacy of bimekizumab 160 mg every 4 weeks (Q4W) compared to guselkumab 100 mg Q4W or every 8 weeks (Q8W) at 48/52 weeks in patients with psoriatic arthritis (PsA) who were biologic disease-modifying antirheumatic drug-naïve (bDMARD-naïve) or with previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).
Relevant trials were identified as part of a systematic literature review. For patients who were bDMARD-naïve, individual patient data (IPD) from BE OPTIMAL (N = 431) was matched to summary data from DISCOVER-2 (Q4W, n = 245; Q8W, n = 248). For patients who were TNFi-IR, IPD from BE COMPLETE (n = 267) and summary data from COSMOS (Q8W, N = 189). Trial populations were re-weighted using propensity scores. Unanchored comparisons of recalculated bimekizumab and guselkumab 48- or 52-week non-responder imputation outcomes for 20/50/70% improvement in American College of Rheumatology score (ACR20/50/70) and minimal disease activity (MDA) index were analyzed.
In patients who were bDMARD-naïve, bimekizumab was associated with a greater likelihood of ACR50 (odds ratio [95% confidence interval] 1.62 [1.07, 2.44]; p = 0.021), ACR70 (2.20 [1.43, 3.38]; p < 0.001), and MDA (1.82 [1.20, 2.76]; p = 0.005) compared to guselkumab Q4W at week 52. Bimekizumab also had a greater likelihood of ACR70 response (2.08 [1.34, 3.22]; p = 0.001) and MDA (2.07 [1.35, 3.17]; p < 0.001) compared to guselkumab Q8W at week 52. In patients who were TNFi-IR, bimekizumab had a greater likelihood in achieving all evaluated outcomes compared to guselkumab Q8W at week 48/52 (ACR20, 1.77 [1.15, 2.72]; p = 0.010; ACR50, 1.56 [1.03, 2.36]; p = 0.037; ACR70, 1.66 [1.05, 2.61]; p = 0.028; and MDA, 1.95 [1.27, 3.02]; p = 0.003).
According to MAICs, bimekizumab demonstrated greater or comparable efficacy on ACR50/70 and MDA outcomes than guselkumab in patients with PsA who were bDMARD-naïve and TNFi-IR at week 48/52. Bimekizumab had a more favorable likelihood than guselkumab in achieving more stringent treatment outcomes.
NCT03895203, NCT03896581, NCT04009499, NCT03158285, NCT03796858.
采用匹配调整间接比较（MAIC）评估每4周一次皮下注射160mg比美吉珠单抗与每4周或每8周一次皮下注射100mg古塞库单抗治疗生物改善病情抗风湿药初治（bDMARD初治）或既往对肿瘤坏死因子抑制剂反应不足或不耐受（TNFi-IR）的银屑病关节炎（PsA）患者48/52周时的相对疗效。
相关试验作为系统文献综述的一部分被识别。对于bDMARD初治患者，将BE OPTIMAL（N = 431）的个体患者数据（IPD）与DISCOVER-2（每4周一次，n = 245；每8周一次，n = 248）的汇总数据进行匹配。对于TNFi-IR患者，使用BE COMPLETE（n = 267）的IPD和COSMOS（每8周一次，N = 189）的汇总数据。使用倾向评分对试验人群进行重新加权。分析重新计算的比美吉珠单抗和古塞库单抗48或52周无反应者推算结局的未锚定比较，以评估美国风湿病学会（ACR）20/50/70改善和最小疾病活动度（MDA）指数。
在bDMARD初治患者中，与第52周每4周一次皮下注射古塞库单抗相比，比美吉珠单抗在第52周时达到ACR50（优势比[95%置信区间]1.62[1.07, 2.44]；p = 0.021）、ACR70（2.20[1.43, 3.38]；p < 0.001）和MDA（1.82[1.20, 2.76]；p = 0.005）的可能性更大。与第52周每8周一次皮下注射古塞库单抗相比，比美吉珠单抗在第52周时达到ACR70反应（2.08[1.34, 3.22]；p = 0.001）和MDA（2.07[1.35, 3.17]；p < 0.001）的可能性也更大。在TNFi-IR患者中，与第48/52周每8周一次皮下注射古塞库单抗相比，比美吉珠单抗在实现所有评估结局方面的可能性更大（ACR20，1.77[1.15, 2.72]；p = 0.010；ACR50，1.56[1.03, 2.36]；p = 0.037；ACR70，1.66[1.05, 2.61]；p = 0.028；MDA，1.95[1.27, 3.02]；p = 0.003）。
根据MAIC，在第48/52周时，比美吉珠单抗在bDMARD初治和TNFi-IR的PsA患者中，在ACR50/70和MDA结局方面显示出比古塞库单抗更大或相当的疗效。在实现更严格的治疗结局方面，比美吉珠单抗比古塞库单抗具有更有利的可能性。
NCT03895203、NCT03896581、NCT04009499、NCT03158285、NCT03796858。
