Background: A medical intervention with sequential rescue treatments among patients with steroid refractory ulcerative colitis showed encouraging results, with lower adverse events (AE) risk than previously reported. Despite the potential risk, many patients like to have additional rescue therapies to avoid colectomy. Our recent study showed that a second or even third line rescue therapy in steroid-refractory UC patients might reduce the colectomy rate at one year. Still, it is unknown whether sequential therapies will only postpone colectomy and what percentage of patients will remain in a long- term remission.
Aim: To evaluate two-year outcome of the cohort of patients with refractory UC treated either with single or sequential rescue therapies.
Methods: The outcome after two years follow up of the cohort of 108 patients with steroid-refractory moderate to severe ulcerative colitis treated with a single or sequential rescue treatments with Infliximab (5mg/kg intravenously at week 0, 2, 6 and then every 8 weeks), Cyclosporine (iv CsA 2mg/kg/daily and then oral CsA 5mg/kg/daily) or Tacrolimus (0.05mg/kg divided in 2 doses, aiming for serum trough levels of 7–12 ng/mL) was retrospectively evaluated. The primary endpoint was two-year colectomy rate; the secondary endpoint was corticosteroid free remission rate.
Results: Out of 108 patients in the primary cohort, 103 patients (95%) were followed at least 2 years; 74/76 patients treated with single, 23/26 patients with double and all 6 patients on triple rescue treatment. Five patients were lost to follow up (FUP). Two-year colectomy rate was non-significantly increased to 25% (26/103) compared to 18% (19/108) after first year (p=0.121, OR 1.69; 95% CI 0.87–3.30). During the 2nd year of FUP no new colectomy was observed among the group of patients with triple rescue treatments (3/6 after 1st year), while among the patients on the double rescue treatments only 1 new colectomy was identified. Steroid free remission rate slightly decreased from 39% (42/108) after first year to 30% (31/103) [p=0.118 OR 1.59 CI 0.89–2.86]. The AE rate in the 2nd year of follow up was 13.6% (14/103). Additionally, 14.5% (15/103) of patients were withdrawn from the last rescue agent during 2nd year of FUP.
Conclusions: Considering our results, it seems that second and third line rescue therapies in steroid refractory UC have prolonged beneficial effects in avoiding colectomy even two years after the induction. Still, further follow up and adverse effects analysis will be necessary for the estimation of future role of sequential rescue therapies in UC patients.