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P307 Clinical outcome of adalimumab therapy in patients with ulcerative colitis previously treated with infliximab: a Danish single center cohort study

K. Risager Christensen*, C. Steenholdt, J. Brynskov

Herlev University Hospital, Department of Gastroenterology, Copenhagen, Denmark

Background

Controlled trials have shown that anti-TNF-alpha inhibitors are of proven value in the treatment of active ulcerative colitis. Adalimumab (ADL), a fully humanized TNF-inhibitor, is increasingly used both as primary anti-TNF agent and in patients switching from another TNF-inhibitor due to loss of response or side effects. This study investigated clinical outcomes of ADL therapy in an everyday 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 IBD center until 2014. Clinical outcomes were assessed after 12 and 52 weeks and classified according to physicians' global evaluation and supported by endoscopy.

Results

The study population comprised 33 patients. All patients had previously received IFX. Main reasons for switching 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 one year of ADL treatment, 8 of these (34%) had clinical response (24% of the entire cohort), and 6 (26%) were in clinical remission (18% of the entire cohort). A total of 5 patients (15%) were colectomized during the study, and this was generally caused by primary ADL treatment failure (4 of 5 patients).

Conclusion

Long term efficacy of ADL therapy in ulcerative colitis patients previously treated with IFX appears to be modest in clinical practice and associated with a more than 3 fold higher colectomy rate than reported in the pivotal ULTRA registration trials. [1] The Results raise interest in introduction of biologic drugs with a different therapeutic target, such as cell migration inhibitors, as an alternative to switching between TNF-inhibitors in patients with chronic active ulcerative colitis.

References:

[1] Feagan BG et al, (2014), Adalimumab therapy is associated with reduced risk of hospitalization in patients with ulcerative colitis, Gastroenterology