Effectiveness and safety of a third‐line rescue treatment for acute severe ulcerative colitis refractory to infliximab or ciclosporin (REASUC study)

Abstract

SummaryBackgroundThe advent of new therapeutic agents and the improvement of supporting care might change the management of acute severe ulcerative colitis (ASUC) and avoid colectomy.AimsTo evaluate the colectomy‐free survival and safety of a third‐line treatment in patients with ASUC refractory to intravenous steroids and who failed either infliximab or ciclosporin.MethodsMulticentre retrospective cohort study of patients with ASUC refractory to intravenous steroids who had failed infliximab or ciclosporin and received a third‐line treatment during the same hospitalisation. Patients who stopped second‐line treatment due to disease activity or adverse events (AEs) were eligible. We assessed short‐term colectomy‐free survival by logistic regression analysis. Kaplan–Meier curves and Cox regression models were used for long‐term assessment.ResultsAmong 78 patients, 32 received infliximab and 46 ciclosporin as second‐line rescue treatment. Third‐line treatment was infliximab in 45 (58%), ciclosporin in 17 (22%), tofacitinib in 13 (17%) and ustekinumab in 3 (3.8%). Colectomy was performed in 29 patients (37%) during follow‐up (median 21 weeks). Of the 78 patients, 32 and 18 were in clinical remission at, respectively, 12 and 52 weeks. At the last visit, 25 patients were still on third‐line rescue treatment, while 12 had stopped it due to clinical remission. AEs were reported in 26 (33%) patients. Two patients died (2.6%), including one following colectomy.ConclusionThird‐line rescue treatment avoided colectomy in over half of the patients with ASUC and may be considered a therapeutic strategy.

Letter: Third‐line therapy in acute severe ulcerative colitis, exploring the uncertainty and unanswered questions—Authors' reply

“…Nevertheless, our results showed that a third-line rescue treatment may avoid colectomy in ASUC, which was, precisely, its main purpose. 2 Since this strategy has been recently implemented in referral centres, particularly following the approval of new agents with rapid onset of action, its effectiveness needed to be evaluated. We acknowledged that this strategy is not exempt from risks.…”

Letter: Third‐line therapy in acute severe ulcerative colitis, exploring the uncertainty and unanswered questions

“…In the REASUC study, Garcia and colleagues explored third-line ASUC treatments and provided much-needed granularity to this therapeutic landscape. 2 The study comes with limitations. These include its retrospective nature, potential time bias, uncontrolled baseline differences, the bio-naïve baseline cohort, possible centre-and clinician-specific variations in practice, and the fact that patients who were historically considered for third-line therapy (vs. those who proceeded straight to colectomy) would probably be discretionary and chosen without defined criteria.…”