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: Etrasimod, a newly approved oral sphingosine-1-phosphate receptor modulator, treats moderate-to-severe ulcerative colitis (UC) by inhibiting lymphocyte migration and reducing intestinal inflammation. This meta-analysis evaluates its efficacy and safety to strengthen evidence for clinical decision-making in UC management. Methods: PubMed, Scopus, and Web of Science servers were used to conduct a systematic search in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The meta-analysis of pooled effect estimates is produced using Review Manager and R software. A random-effects model was used. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach and publication bias through funnel plots and Egger test. Results: A total of 2 studies (3 randomized controlled trials) comprising 943 participants were included in this analysis. Pooled effect estimates demonstrated that etrasimod significantly improved clinical response, endoscopic improvement, clinical remission, and histological remission. The most commonly reported adverse events were UC worsening or flare (5.73%), headache (5.26%), anemia (3.57%), pyrexia (2.96%), and arthralgia (2.42%). Conclusion: Overall, etrasimod therapy demonstrates a favorable benefit-to-risk profile, with its therapeutic advantages outweighing the likelihood of associated side effects.

Abstract licence: CC BY-NC 4.0

BackgroundEtrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Here, we evaluate the impact of etrasimod 2 mg QD on health-related quality of life (HRQoL) in patients with UC.MethodsThis post hoc analysis used data from the Phase 3 randomized controlled trials, ELEVATE UC 52 and ELEVATE UC 12. HRQoL measures included: Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Survey (SF-36), and Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI:UC) completed at baseline, Week 12 (both trials), and Week 52 (ELEVATE UC 52 only). For IBDQ analyses, patients were stratified by prior exposure to biologics/Janus kinase inhibitors (JAKi) and baseline modified Mayo score (MMS; 4-6 or 7-9).ResultsGenerally, significantly greater proportions of patients receiving etrasimod (N = 527) vs placebo (N = 260) achieved IBDQ remission (IBDQ total score ≥170) and IBDQ response (IBDQ total score increase from baseline ≥16), with significant improvement in all IBDQ domain scores at Week 12 and maintained through Week 52. Significant differences in IBDQ remission and IBDQ response rates between etrasimod and placebo were more consistent among biologic/JAKi-naive patients vs those who were biologic/JAKi-experienced and in those with baseline MMS 7-9 vs 4-6. Significant improvements were observed in several SF-36 domain and summary scores and WPAI:UC domain scores at Week 12 and Week 52.ConclusionsEtrasimod 2 mg QD demonstrated significant and clinically meaningful improvements across multiple HRQoL measures, including WPAI, vs placebo.Clinical trial registrationClinicalTrials.gov: NCT03945188; NCT03996369.

Abstract licence: CC BY-NC