Division of Gastroenterology, Department of Surgery, Oncological and Gastroenterological Sciences (DISCOG), University of Padua, Padua, Italy.
Division of Gastroenterology, Department of Surgery, Oncological and Gastroenterological Sciences (DISCOG), University of Padua, Padua, Italy,
Dig Dis. 2021;39(1):16-24. doi: 10.1159/000508865. Epub 2020 May 25.
Head-to-head comparison studies evaluating the effectiveness and tolerability of anti-tumor necrosis factor (anti-TNF) drugs in inflammatory bowel disease patients are lacking.
To compare the effectiveness and tolerability of anti-TNF-α drugs used in clinical practice in a cohort of patients with moderate-to-severe ulcerative colitis (UC).
Retrospectively, 122 UC patients treated with infliximab (IFX) originator and biosimilar, adalimumab (ADA), and golimumab (GOL) were included. We performed an ITT analysis to evaluate clinical response and remission, steroid-free clinical remission, and endoscopy response according to the different time points of the follow-up. Baseline and post induction predictor factors of these outcomes were evaluated using multivariate logistic regression models. Moreover, a propensity score-based weighting analysis was performed. Data were analyzed using R and STATA11 software.
The overall clinical response was 77% after induction, 81.4% at 30 weeks, and 76.9% at 52 weeks, while the steroid-free clinical remission was 39.7, 46, and 54.6%, respectively. After induction, a higher rate of treatment failure was observed in the GOL group. At the end of follow-up, lower rates of steroid-free clinical remission and clinical response were obtained by GOL. At week 52, endoscopic response was achieved by 46.5% of the population.
Among the different anti-TNF treatments, moderate-to-severe UC seems to respond better to IFX and ADA, whereas GOL seems to be less effective, despite a similar good safety profile.
缺乏头对头比较研究来评估抗肿瘤坏死因子(anti-TNF)药物在炎症性肠病患者中的疗效和耐受性。
比较在中重度溃疡性结肠炎(UC)患者队列中临床使用的抗 TNF-α药物的疗效和耐受性。
回顾性纳入 122 例接受英夫利昔单抗(IFX)原研药和生物类似药、阿达木单抗(ADA)和戈利木单抗(GOL)治疗的 UC 患者。我们进行了意向治疗(ITT)分析,以评估临床缓解和缓解、无激素临床缓解和内镜缓解,根据随访的不同时间点进行评估。使用多变量逻辑回归模型评估这些结局的基线和诱导后预测因素。此外,还进行了倾向评分加权分析。使用 R 和 STATA11 软件分析数据。
诱导后总体临床缓解率为 77%,30 周时为 81.4%,52 周时为 76.9%,而无激素临床缓解率分别为 39.7%、46%和 54.6%。诱导后,GOL 组的治疗失败率更高。随访结束时,GOL 组的无激素临床缓解率和临床缓解率较低。在第 52 周时,46.5%的患者达到内镜缓解。
在不同的抗 TNF 治疗中,中重度 UC 似乎对 IFX 和 ADA 的反应更好,而 GOL 的疗效似乎较差,尽管安全性相似。