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SYSTEMATIC REVIEW article
Front. Pharmacol.
Sec. Gastrointestinal and Hepatic Pharmacology
Volume 15 - 2024 |
doi: 10.3389/fphar.2024.1420455
Efficacy and safety of the S1PR modulator etrasimod in the treatment of moderately to severely active ulcerative colitis during the induction phase: A systematic review and meta-analysis of randomized controlled trials
Provisionally accepted- 1 Department of Pharmacy, PLA Strategic Support Force Medical Center, Beijing, China
- 2 Department of Pharmacy, PLA Rocket Force Medical Center, Beijing, China
- 3 shandong provincial center for ADR monitoring, Jinan, Shandong Province, China
- 4 Department of Pharmacy, The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan Province, China
- 5 Clinical Medical College, Chengdu Medical College, Chengdu, China
The study aims to assess the efficacy and safety of the recently approved S1PR modulator etrasimod in adults with ulcerative colitis (UC) during the induction phase through meta-analysis.Methods: A systemic search was performed for randomized controlled trials evaluating the efficacy and safety of the S1PR modulator etrasimod using electronic databases PubMed, Embase, the Cochrane Library, Clinical Trials, and the International Clinical Trials Registry Platform. Three studies with 943 patients met the inclusion criteria and were included in this analysis. The study's primary endpoint was the proportion of patients who achieved clinical remission at week 12. Key secondary endpoints included the proportion of patients with clinical response, endoscopic improvement, and histologic remission. The incidence of AEs, serious AEs, and AE-related treatment discontinuation were statistically analyzed to determine the safety of etrasimod.Results: This study revealed that etrasimod is superior to placebo at the primary endpoint clinical remission (OR = 3.09, 95% CI: 2.04 -4.69), as well as at the secondary endpoints clinical response (OR = 2.56, 95% CI: 1.91 -3.43), endoscopic improvement (OR = 2.15, 95% CI: 1.51 -3.05), and histologic remission (OR = 3.39, 95% CI: 2.03 -5.68). The proportion of patients with TEAE (OR = 1.34, 95% CI: 1.01 -1.78) and SAE (OR = 0.77, 95% CI: 0.41 -1.43) was similar between the etrasimod and placebo groups. Patients receiving etrasimod had slightly higher odds of experiencing headache (OR = 2.07, 95% CI: 1.01 -4.23), and nausea (OR = 1.84, 95% CI: 0.72 -4.72). The incidences of upper respiratory tract infection (OR = 0.79, 95% CI: 0.27 -2.32), nasopharyngitis (OR = 0.40, 95% CI: 0.15 -1.07), and urinary tract infection (OR = 1.82, 95% CI: 0.59 -5.60) were generally lower in the etrasimod groups and no treatment-related serious infections were reported.This study demonstrates that etrasimod is effective in treating moderately to severely active UC with a favorable benefit-risk profile at week 12. Etrasimod shows promise as a potential first-line oral therapy for individuals suffering from this disease. Additional RCTs with larger sample sizes and longer observation periods are needed to confirm the sustained efficacy of etrasimod beyond the initial phase
Keywords: S1PR modulator, Etrasimod, ulcerative colitis, auto-immune disease, Meta-analysis
Received: 20 Apr 2024; Accepted: 26 Aug 2024.
Copyright: © 2024 Qiu, Liu, Cai, Xu, Liu, Lin and Shi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Jiakuo Liu, Department of Pharmacy, PLA Strategic Support Force Medical Center, Beijing, China
Ting Xu, Department of Pharmacy, PLA Rocket Force Medical Center, Beijing, China
Wenwen Liu, shandong provincial center for ADR monitoring, Jinan, Shandong Province, China
Fei Lin, Department of Pharmacy, The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan Province, China
Ning Shi, Department of Pharmacy, PLA Strategic Support Force Medical Center, Beijing, China
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