Etrasimod 2mg tablets

BackgroundThe study aims to assess the efficacy and safety of the recently approved S1PR modulator etrasimod in adults with ulcerative colitis during the induction phase through meta-analysis.MethodsA 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 adverse effects (AEs), serious AEs (SAEs), and AE-related treatment discontinuation were statistically analyzed to determine the safety of etrasimod.ResultsThis 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.ConclusionThis study demonstrates that etrasimod is effective in treating moderately to severely active ulcerative colitis 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.

Abstract licence: CC BY 4.0

Background: Many IBD patients do not react to traditional or biological therapies. Research suggests that Mirikizumab and Etrasimod may be effective therapy options for these individuals. This research aimed to evaluate the efficacy and safety of utilizing Mirikizumab and Etrasimod to treat moderate to severe IBD, including Crohn's disease (CD) and ulcerative colitis. Methods: We searched PubMed, Medline, Web of Science, Scopus, Cochrane Library, Embase, Google Scholar, CINAHL, Clinical Trials.gov, and WHO Trials Registry (ICTRP). We included RCTs that compared Mirikizumab and Etrasimod to placebo in patients with active CD or UC. The principal results were mucosal healing as well as the clinical response and remission throughout the induction and maintenance periods. The frequency of severe adverse events was the secondary outcome. Comprehensive Meta-analysis version 4 (Biostat Inc., USA) was utilized in the study. Results: A total of Seventeen randomized controlled trials were included in the analysis. Of these, fourteen studies examined the effectiveness and safety of Mirikizumab and Etrasimod in patients with UC, while three research looked at same topics in patients with CD. In people with moderately to highly active CD or UC, the meta-analysis showed that both Mirikizumab and Etrasimod therapies were more effective than placebo in inducing clinical response and achieving clinical remission during the induction and maintenance stages of treatment. Interestingly, we discovered that for patients with UC but not CD, Mirikizumab was a better first-line therapy than Etrasimod. Conclusion: Mirikizumab and Etrasimod are safe and effective treatments for patients with CD and UC. RCTs including a greater number of patients are still necessary, nevertheless, in order to more accurately evaluate the safety profile of Mirikizumab and Etrasimod.

Abstract licence: CC BY