Introduction Two double-blind, placebo-controlled trials (ULTRA 1 and 2) revealed that adalimumab (ADA) therapy significantly reduces hospitalisation and non-significantly decreases colectomy rates in patients with moderate to severe ulcerative colitis (UC).1
Methods We assessed the effect of an ADA 160/80/40 mg treatment regimen on risk reduction of all-cause and UC-related hospitalisation and colectomy in these 2 trials among initial ADA responders. The pooled dataset included 963 patients (480 ADA, 483 placebo [PBO]). Hospitalization and colectomy events were based on safety reports reviewed by 2 gastroenterologists who were blinded to treatment. Conservatively, hospitalizations from initial ADA non-responders (per Mayo score at Week 8) through Week 8 were counted, but were censored after Week 8 to reflect the clinical practise pattern of continuing treatment in initial ADA responders. Risk and number of hospitalizations were compared between groups using person-year (PY)–based incidence rates (IRs) and Poisson regression, respectively; Z-scores were used to assess statistical differences.2
Results 35% and 34% reductions in the number of patients hospitalised and number of hospitalizations for any reason, respectively, were observed with ADA therapy vs. PBO (table, P < 0.05 for both comparisons). When UC-related hospitalizations were compared, reductions for rate (50%) and number (54%) of hospitalizations were both statistically significant, too.
Conclusion Initial ADA-responders had a significantly lower risk for UC-related and all-cause hospitalisation compared with PBO. Reduction of all-cause hospitalisation is unique for ADA compared with any other anti–tumour necrosis factor agent. A non-significantly lower colectomy rate in patients receiving ADA vs. those receiving PBO was also observed.
Disclosure of Interest B. Feagan Grant/Research Support from: AbbVie, Consultant for: AbbVie, W. Sandborn Grant/Research Support from: AbbVie, Consultant for: AbbVie, Conflict with: AbbVie, M. Skup Shareholder of: AbbVie, Employee of: AbbVie, M. Yang Shareholder of: AbbVie, Employee of: AbbVie, A. Lazar Shareholder of: AbbVie, Employee of: AbbVie, R. Thakkar Shareholder of: AbbVie, Employee of: AbbVie, J. Chao Shareholder of: AbbVie, Employee of: AbbVie, P. Mulani Shareholder of: AbbVie, Employee of: AbbVie
Feagan BG, et al. Presentation OP209, UEGW, Stockholm, Sweden. October 22–26, 2011.
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