Biological therapies for inflammatory pouch disorders: insights and outcomes from the RESERVO study of GETECCU

Abstract

Background: Inflammatory pouch disorders can be refractory to conventional therapy. Evidence on biological therapy from large cohorts is scarce. Objective: To explore the use and effectiveness of biological therapy for inflammatory pouch disorders. Design: A retrospective and multicentre study. Methods: We included patients diagnosed with pouchitis, Crohn's Disease of the Pouch (CDP) or cuffitis and treated with biological therapy. Effectiveness was evaluated at 12 months based on normalisation of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or as any improvement in these symptoms (clinical response). We also compared the effectiveness of a second biologic after anti-tumour necrosis factor (anti-TNF) failure using descriptive and comparative statistics. Results: In total, 145 patients were included; 62% were men and the median age was 54 (20-71) years. Overall, 212 lines of treatment were evaluated (95 infliximab, 69 adalimumab, 7 golimumab, 35 vedolizumab and 26 ustekinumab). At least a second line of treatment was received by 41% of patients. Overall, 66% had chronic pouchitis and 29% had CDP. Clinical remission rates at 12 months were 45%, 44%, 43%, 39% and 45% for infliximab, adalimumab, golimumab, vedolizumab and ustekinumab, respectively. No differences were found based on the type of disease. Vedolizumab was the only treatment to show better results as a first-line therapy (50% vs 33%, p < 0.05). Thirty-nine patients received a second therapy after anti-TNF failure. Second anti-TNF use had higher risks of failure (odds ratio (OR) 4.8, 95% confidence interval (CI) 2.3-19) and discontinuation (OR 5.52, 95% CI 1.94-25.5). Conclusion: Biological therapy is a cornerstone in the treatment of pouch disorders, demonstrating consistently high effectiveness. After anti-TNF failure, another mechanism of action should be employed.