Supovec Eva, Hanžel Jurij, Novak Gregor, Manevski Damjan, Štabuc Borut, Drobne David
Faculty of Medicine, University of Ljubljana.
Department of Gastroenterology, University Medical Centre Ljubljana.
Eur J Gastroenterol Hepatol. 2025 May 1;37(5):557-564. doi: 10.1097/MEG.0000000000002940. Epub 2025 Feb 6.
Real-word comparisons between first-line biologicals in inflammatory bowel disease (IBD) are scarce.
The aim of this study is to compare drug persistence and patient reported outcome-2 (PRO-2) remission rates of first-line biological classes [anti-tumor necrosis factor (TNF) agents vs anti-integrin vedolizumab vs IL-12/23 inhibitor ustekinumab] in real life cohort.
Individual level data of 946 adults (588 Crohn's disease and 358 ulcerative colitis) were retrieved from UR-CARE IBD platform. Adjusted drug survival curves using a pooled logistic model and PRO-2 remission rates for each class of biologicals were calculated and compared.
In Crohn's disease, no differences in drug survival were observed for anti-TNF agents vs vedolizumab vs ustekinumab as estimated survival with 95% confidence intervals were 0.81 (0.77-0.84) vs 0.89 (0.82-0.96) vs 0.88 (0.79-0.97) at year 1 and 0.52 (0.46-0.58) vs 0.58 (0.37-0.78) vs 0.58 (0.39-0.77) at year 4. In ulcerative colitis, however, anti-TNF agents had shorter drug survival than vedolizumab with estimated drug survival with 95% confidence intervals 0.60 (0.52-0.67) vs 0.76 (0.67-0.84) at year 1 and 0.37 (0.30-0.44) vs 0.50 (0.36-0.64) at year 4. No differences in PRO-2 remission rates were observed between drug classes in Crohn's disease ( P = 0.95), but more patients enjoyed PRO-2 remission in ulcerative colitis treated with anti-TNF agents compared to vedolizumab (94.8 vs 78.9%, P = 0.002).
Our real-world data suggest similar drug persistence and efficacy of first-line treatments with anti-TNF agents, vedolizumab and ustekinumab in Crohn's disease. In ulcerative colitis, however, drug persistence was higher for vedolizumab compared to anti-TNF agents, but on the cost of lower PRO-2 remission rates.
炎症性肠病(IBD)一线生物制剂之间的真实世界比较很少。
本研究的目的是比较一线生物制剂类别[抗肿瘤坏死因子(TNF)药物与抗整合素维多珠单抗与IL-12/23抑制剂乌司奴单抗]在真实队列中的药物持久性和患者报告结局-2(PRO-2)缓解率。
从UR-CARE IBD平台检索了946名成年人(588例克罗恩病和358例溃疡性结肠炎)的个体水平数据。使用汇总逻辑模型计算并比较了各生物制剂类别的调整后药物生存曲线和PRO-2缓解率。
在克罗恩病中,抗TNF药物与维多珠单抗与乌司奴单抗之间在药物生存方面未观察到差异,因为第1年的估计生存率及95%置信区间为0.81(0.77-0.84)、0.89(0.82-0.96)、0.88(0.79-0.97),第4年为0.52(0.46-0.58)、0.58(0.37-0.78)、0.58(0.39-0.77)。然而,在溃疡性结肠炎中,抗TNF药物的药物生存时间比维多珠单抗短,第1年的估计药物生存率及95%置信区间为0.60(0.52-0.67)对0.76(0.67-0.84),第4年为0.37(0.30-0.44)对0.50(0.36-0.64)。在克罗恩病中,各药物类别之间在PRO-2缓解率方面未观察到差异(P = 0.95),但与维多珠单抗相比,接受抗TNF药物治疗的溃疡性结肠炎患者中更多患者实现了PRO-2缓解(94.8%对78.9%,P = 0.002)。
我们的真实世界数据表明,抗TNF药物、维多珠单抗和乌司奴单抗在克罗恩病的一线治疗中具有相似的药物持久性和疗效。然而,在溃疡性结肠炎中,维多珠单抗的药物持久性高于抗TNF药物,但代价是PRO-2缓解率较低。