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Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU (EXIT)
Gisbert J et al. BMJ Gut (December 2024)
Bottom Line: This prospective, quadruple-blind, multicentre, randomized, controlled trial aimed to compare the rates of sustained clinical remission at 12 months in patients with inflammatory bowel disease (IBD) treated with anti-tumour necrosis factor (anti-TNF) and immunomodulators who either withdrew or maintained anti-TNF treatment. The study included 140 patients with ulcerative colitis or Crohn’s disease in clinical remission for more than 6 months and absence of severe endoscopic (and radiological in Crohn’s disease) lesions. Patients were randomized to maintain anti-TNF treatment or withdraw it. All patients maintained immunomodulators. The primary outcome was sustained clinical remission at 12 months, with 84% of patients in the maintenance arm (95% CI=74% to 92%) and 76% in the withdrawal arm (95% CI=64% to 85%) maintaining remission. There was no significant difference in sustained clinical remission between the two groups, though the proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the maintenance arm and 19% in the withdrawal arm (p=0.1). There were similar rates of adverse events and serious adverse events in both groups. In conclusion, anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year, although objective markers of activity were higher in patients who withdrew treatment.
Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion (ESCAPE-MeVO)
Goyal M et al. NEJM (February 2025)
Bottom line: This multicenter, prospective, randomized, open-label trial with blinded outcome evaluation enrolled 530 patients with acute ischemic stroke due to medium-vessel occlusion. Participants were assigned to receive endovascular thrombectomy (EVT) plus usual care or usual care alone. The primary outcome was the modified Rankin scale score (range, 0 [no symptoms] to 6 [death]) at 90 days. 41.6% of the EVT group achieved a score of 0 or 1 compared to 43.1% in the usual care group (adjusted rate ratio, 0.95; 95% confidence interval [CI], 0.79 to 1.15; P=0.61). 90-day mortality was 13.3% in the EVT group compared to 8.4% in the usual care group (adjusted hazard ratio, 1.82; 95% CI, 1.06 to 3.12), while symptomatic intracranial hemorrhage occurred in 5.4% of patients in the EVT group and 2.2% of patients in the usual-care group. The study concluded that EVT did not improve outcomes compared to usual care.
Exenatide once a week versus placebo as a potential disease-modifying treatment for people with Parkinson’s disease in the UK: a phase 3, multicentre, double-blind, parallel-group, randomised, placebo-controlled trial
Vijiaratnam N et al. The Lancet (February 2025)
Bottom Line: This phase 3, multicentre, double-blind, parallel-group, randomized, placebo-controlled trial evaluated the effects of exenatide in 194 participants with Parkinson’s disease, aged 25-80 years, at Hoehn and Yahr stage 2.5 or less when on dopaminergic treatment, and on dopaminergic treatment for at least 4 weeks before enrolment. Participants were randomized 1:1 to receive either exenatide extended release 2 mg subcutaneously once per week over 96 weeks or placebo. The primary outcome was the Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III score, off dopaminergic medication at 96 weeks. MDS-UPDRS scores were increased (worsened) by 5.7 points in the exenatide group and 4.5 points in the placebo group (adjusted coefficient for the effect of exenatide 0.92 [95% CI –1.56 to 3.39]; p=0.47). Safety outcomes indicated that 9% of participants in the exenatide group experienced serious adverse events compared to 11% in the placebo group. The study concluded that exenatide is safe but does not support its use as a disease-modifying treatment for Parkinson’s disease.
Trial Files Issue #2025-07