Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
University of North Carolina at Chapel Hill.
Arthritis Care Res (Hoboken). 2022 Nov;74(11):1792-1805. doi: 10.1002/acr.24630. Epub 2022 Jul 8.
To compare the risk of serious infections requiring hospitalization in patients with psoriasis (PsO) or psoriatic arthritis (PsA) initiating ustekinumab versus other biologics or apremilast.
In this multi-database cohort study, we identified patients with PsO/PsA who initiated therapy with adalimumab, apremilast, certolizumab, etanercept, golimumab, ixekizumab, secukinumab, or ustekinumab between 2009 and 2018. The primary outcome measure was hospitalizations due to serious infections, which included bacterial, viral, or opportunistic infections. We estimated hazard ratios (HRs) comparing each study drug to ustekinumab after applying propensity score fine stratification weights for confounding control in each database. Database-specific weighted HRs were combined by meta-analysis.
We identified 123,383 patients with PsO/PsA who initiated one of the study drugs. During a total of 117,744 person-years of follow-up, 1,514 serious infections occurred with a crude incidence of 1.29 per 100 person-years. After propensity score fine stratification and weighting, the incidence rates of serious infection among ustekinumab initiators ranged from 0.59 to 0.95 per 100 person-years. Compared with ustekinumab, the combined weighted HRs (95% confidence interval [95% CI]) for serious infections were 1.66 (95% CI 1.34-2.06) for adalimumab, 1.42 (95% CI 1.02-1.96) for apremilast, 1.09 (95% CI 0.68-1.75) for certolizumab, 1.39 (95% CI 1.01-1.90) for etanercept, 1.74 (95% CI 1.00-3.03) for golimumab, 2.92 (95% CI 1.80-4.72) for infliximab, 2.98 (95% CI 1.20-7.41) for ixekizumab, and 1.84 (95% CI 1.24-2.72) for secukinumab.
Other biologics and apremilast were associated with a 1.4- to 3-times higher risk of hospitalization for serious infections in PsO/PsA patients when compared to ustekinumab; this finding should be considered in the safety profile of these therapies when selecting appropriate treatment regimens in patients with PsO/PsA.
比较银屑病（PsO）或银屑病关节炎（PsA）患者起始乌司奴单抗与其他生物制剂或阿普米司特治疗相比，严重感染需要住院治疗的风险。
在这项多数据库队列研究中，我们确定了 2009 年至 2018 年间接受阿达木单抗、阿普米司特、依那西普、戈利木单抗、优特克单抗、司库奇尤单抗、赛妥珠单抗或乌司奴单抗治疗的 PsO/PsA 患者。主要结局指标是因严重感染（包括细菌、病毒或机会性感染）导致的住院治疗。我们应用倾向评分精细分层权重，在每个数据库中进行混杂控制后，比较每种研究药物与乌司奴单抗的风险比（HR）。通过荟萃分析合并数据库特异性加权 HR。
我们确定了 123383 名接受研究药物之一治疗的 PsO/PsA 患者。在总计 117744 人年的随访期间，1514 例发生严重感染，粗发病率为每 100 人年 1.29 例。在进行倾向评分精细分层和加权后，乌司奴单抗起始治疗者的严重感染发生率为 0.59 至 0.95 例/100 人年。与乌司奴单抗相比，阿达木单抗、阿普米司特、依那西普、依那西普、戈利木单抗、英夫利昔单抗、司库奇尤单抗和司库奇尤单抗的合并加权 HR（95%置信区间[95%CI]）分别为 1.66（95%CI 1.34-2.06）、1.42（95%CI 1.02-1.96）、1.09（95%CI 0.68-1.75）、1.39（95%CI 1.01-1.90）、1.74（95%CI 1.00-3.03）、2.92（95%CI 1.80-4.72）、2.98（95%CI 1.20-7.41）和 1.84（95%CI 1.24-2.72）。
与乌司奴单抗相比，其他生物制剂和阿普米司特与银屑病关节炎患者严重感染住院治疗风险增加 1.4 至 3 倍相关；在选择银屑病关节炎患者的适当治疗方案时，应考虑这些治疗方法的安全性。
