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.
Miettinen O. Am J Epidemiol. 1976; 103:226–35.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.