52-Week clinical efficacy with adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/or immunosuppressants

Abstract

Introduction We report week-52 results from an open-label extension that assessed the efficacy and safety of adalimumab (ADA) in anti-TNF–naïve patients with moderately to severely active ulcerative colitis (UC). Methods Patients were adults with UC (Mayo scores ≥6 points and endoscopic subscores ≥2 points) despite treatment with corticosteroids and/or immunosuppressants. After an 8-week, randomised, placebo-controlled period, patients could enter an open-label extension to receive ADA 40 mg every other week (eow) as maintenance therapy through week 52. Data were analyzed with non-responder imputation (NRI); missing scores and values after adjustment to weekly dosing (for flares/non-response) were imputed as treatment failures. Modified NRI (mNRI) analyses (post-hoc), which did not count patients who dose escalated as failures, and as-observed analyses were also performed. Results Of 390 patients in the primary analysis population, 360 received open-label ADA eow and 117 had their dosages increased to weekly ADA. Mean/median changes in Mayo (0–12) and partial Mayo (0–9) scores from baseline to week 52 (observed values, N=274) were –5.0/–5.0 and –3.7/–4.0, respectively (all pConclusion Treatment with open-label ADA 40-mg eow/weekly generally maintained clinical remission and other efficacy end points in patients with moderately to severely active UC. The safety profile in UC was consistent with the known safety profile of ADA.