Clinical outcome of adalimumab therapy in patients with ulcerative colitis previously treated with infliximab: a Danish single-center cohort study

摘要

Objective. TNF inhibitors are effective in the treatment of ulcerative colitis. Adalimumab (ADL), a fully human TNF inhibitor, is increasingly used both as primary anti-TNF agent and in patients switching from another TNF inhibitor due to treatment failure or side effects. This study investigated clinical outcomes of ADL therapy in a clinical setting where infliximab (IFX) had been used as first choice of anti-TNF agent, and followed by ADL as second line agent. Methods. Retrospective, observational single-center cohort study including all ulcerative colitis patients treated with ADL at a tertiary Danish inflammatory bowel disease center until 2014. Clinical outcomes were assessed after 12 and 52 weeks and classified according to physician's global evaluation. Results. The study population comprised 33 patients. Main reasons for switching from IFX to ADL were infusion reactions to IFX (45%) or IFX treatment failure (33%). Short-term efficacy of ADL after 12 weeks revealed 15 patients (45%) with clinical response, and 6 (18%) in clinical remission. Twenty-three patients continued ADL for more than 12 weeks, and at long-term follow-up after 1 year of ADL treatment, eight of these (34%) had clinical response (24% of the entire cohort) and six (26%) were in clinical remission (18% of the entire cohort). A total of five patients (15%) were colectomized mainly due to primary ADL failure (four of five patients). Conclusion. Efficacy of ADL therapy in ulcerative colitis patients previously treated with IFX appears to be modest in clinical practice, and with higher colectomy rates than reported for anti-TNF-naive patients in the registration trials.