Shehab Mohammad, Hassan Amro, Alrashed Fatema, Abbas Adnan, Ma Christopher, Narula Neeraj, Jairath Vipul, Singh Siddharth, Bessissow Talat
Division of Gastroenterology, Department of Internal Medicine, Mubarak Alkabeer University Hospital, Jabriya, Kuwait.
Department of Translational Research, Dasman Institute, Kuwait City, Kuwait.
Inflamm Bowel Dis. 2025 May 12;31(5):1272-1280. doi: 10.1093/ibd/izae163.
Ulcerative colitis (UC) is a chronic disorder with a considerable negative impact on health-related quality of life (HRQoL), which has been recently recognized as an important treatment target. The purpose of this study is to compare the efficacy of different biologics and small molecule therapies in achieving better patient-reported outcomes and HRQoL in patients with UC.
We performed a systematic review and network meta-analysis of the EMBASE, MEDLINE, and Cochrane Central databases from inception until February 1, 2024. The primary endpoint was clinical remission in the patient-reported outcome (PRO-2) score in UC patients who were treated with different biologics or small molecules during induction and maintenance phases. PRO-2 score is the sum of both stool frequency and rectal bleeding subscores. The secondary outcome was improvement of HRQoL defined as an increase in Inflammatory Bowel Disease Questionnaire score of ≥16 points from baseline or any change in total score from baseline. A random effects model was used, and outcomes were reported as odds ratio with 95% confidence interval. Interventions were ranked per the SUCRA (surface under the cumulative ranking curve) score.
A total of 54 studies were included in the primary outcome analysis and 15 studies were included in the secondary outcome analysis. The primary analysis showed that during the induction phase all of included drugs were better than placebo in improving the PRO-2 score. Interestingly, upadacitinib was found to be superior to most medications in improving PRO-2 scores. The secondary analysis showed that guselkumab ranked first in the improvement of the Inflammatory Bowel Disease Questionnaire score, followed by upadacitinib during the induction phase.
Upadacitinib ranked first in PRO-2 clinical remission during the induction and maintenance phases. Guselkumab, mirikizumab, tofacitinib, and upadacitinib were the only novel medications that were superior to placebo in improving HRQoL in UC, with guselkumab ranking the highest, followed by tofacitinib and upadacitinib. During maintenance of remission, tofacitinib ranked highest in improving HRQoL.
溃疡性结肠炎（UC）是一种慢性疾病，对健康相关生活质量（HRQoL）有相当大的负面影响，最近已被视为一个重要的治疗目标。本研究的目的是比较不同生物制剂和小分子疗法在改善UC患者报告的结局和HRQoL方面的疗效。
我们对EMBASE、MEDLINE和Cochrane Central数据库从建库至2024年2月1日进行了系统评价和网络荟萃分析。主要终点是在诱导期和维持期接受不同生物制剂或小分子治疗的UC患者的患者报告结局（PRO-2）评分中的临床缓解。PRO-2评分是大便频率和直肠出血子评分的总和。次要结局是HRQoL的改善，定义为炎症性肠病问卷评分较基线增加≥16分或总分较基线有任何变化。采用随机效应模型，结局以比值比及95%置信区间报告。干预措施根据累积排序曲线下面积（SUCRA）评分进行排序。
共有54项研究纳入主要结局分析，15项研究纳入次要结局分析。主要分析表明，在诱导期，所有纳入的药物在改善PRO-2评分方面均优于安慰剂。有趣的是，发现乌帕替尼在改善PRO-2评分方面优于大多数药物。次要分析表明，在诱导期，古塞库单抗在炎症性肠病问卷评分改善方面排名第一，其次是乌帕替尼。
在诱导期和维持期，乌帕替尼在PRO-2临床缓解方面排名第一。古塞库单抗、mirikizumab、托法替布和乌帕替尼是仅有的在改善UC患者HRQoL方面优于安慰剂的新型药物，古塞库单抗排名最高，其次是托法替布和乌帕替尼。在缓解维持期，托法替布在改善HRQoL方面排名最高。
