Abstract
BackgroundThe 52-week safety and efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis were demonstrated in a placebo-controlled phase 2/3 trial. Data from patients who enrolled in the open-label extension study are presented.MethodsRemission and response per the full Mayo score (FMS) and the partial Mayo score (PMS), remission per the Inflammatory Bowel Disease Questionnaire (IBDQ) score, corticosteroid-free remission, and mucosal healing were assessed up to week 196 (week 208 for remission/response per PMS) of adalimumab treatment in patients who received one or more doses of adalimumab with use of a hybrid nonresponder imputation (hNRI) method. Nonresponder imputation was used for missing data up to the latest possible follow-up date for each patient, followed by observed case. Adalimumab trough concentrations were reported from week 52 to week 196 of treatment. Treatment-emergent adverse events were reported for all adalimumab-treated patients.ResultsTwo hundred sixty-six patients received adalimumab. At week 196 of treatment, remission and response rates per FMS, remission and response rates per PMS, remission rate per IBDQ score, mucosal healing rate, and corticosteroid-free remission rate were 19.2%, 32.2%, 22.5%, 32.5%, 33.1%, 30.5% (hNRI), and 40.5% (17/42; as observed), respectively. Serum adalimumab concentrations remained constant in patients receiving 40 mg every other week but increased in patients who underwent dose escalation. The safety profile was consistent with that in the 52-week study.ConclusionsThe efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis was maintained for up to 4 years of treatment. No new safety signals were observed.
Highlights
Ulcerative colitis is an inflammatory bowel disease in which inflammation of the colonic mucosal surface is characterized by bloody diarrhea, urgency, tenesmus, abdominal pain, and fever in some cases [1]
Background The 52-week safety and efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis were demonstrated in a placebocontrolled phase 2/3 trial
Remission and response per the full Mayo score (FMS) and the partial Mayo score (PMS), remission per the Inflammatory Bowel Disease Questionnaire (IBDQ) score, corticosteroid-free remission, and mucosal healing were assessed up to week 196 of adalimumab treatment in patients who received one or more doses of adalimumab with use of a Electronic supplementary material The online version of this article contains supplementary material, which is available to authorized users
Summary
Ulcerative colitis is an inflammatory bowel disease in which inflammation of the colonic mucosal surface is characterized by bloody diarrhea, urgency, tenesmus, abdominal pain, and fever in some cases [1]. The prefecture prevalence of ulcerative colitis and Crohn’s disease in Japan in 2011, when this study began, ranged from 64.8 to 117.4 per 100 000 person-years [8]. The 52-week efficacy and safety of adalimumab, a fully human monoclonal antibody that targets TNFa, in Western patients with moderately to severely active, treatment-refractory ulcerative colitis were demonstrated in the phase 3 studies ULTRA 1 and ULTRA 2 [13,14,15,16]. A long-term open-label extension study that enrolled patients from both of these studies (ULTRA 3) demonstrated that the efficacy and safety of adalimumab are maintained for up to 208 weeks of treatment [17]. The 52-week safety and efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis were demonstrated in a placebocontrolled phase 2/3 trial. Data from patients who enrolled in the open-label extension study are presented
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