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-naive 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 fl ares/nonresponse) 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 p<0.001). The table 1 summarises rates of clinical remission and other secondary end points at week 52. Remission rates at week 52 were 25.6% (NRI) and 29.5% (mNRI). No deaths or cases of tuberculosis were reported. Conclusion Treatment with open-label ADA 40-mg eow/ weekly generally maintained clinical remission and other effib- cacy end points in patients with moderately to severely active UC. The safety profible in UC was consistent with the known safety profible of ADA. Competing interests W. Reinisch Speaker bureau with: Ferring, Confl ict with: Abbott, Centocor, UCB, W. Sandborn Grant/Research Support from: Abbott, CentocorOrthoBiotech, UCB, Consultant for: Abbott, CentocorOrthoBiotech, UCB, A. Kumar Confl ict with: Abbott, P. Pollack Shareholder with: Abbott, Employee of: Abbott, A. Lazar Shareholder with: (Table presented) Abbott, Employee of: Abbott, R. Thakkar Shareholder with: Abbott, Employee of: Abbott