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16. 52-week clinical efficacy with adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/or immunosuppressants

16. 52-week clinical efficacy with adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/or immunosuppressants

W. Reinisch1, W.J. Sandborn2, A. Kumar3, P.F. Pollack3, A. Lazar4, R. Thakkar3

1Universitätsklinik für Innere Medizin III, Vienna, Austria; 2Mayo Clinic, Rochester, MN, United States; 3Abbott, Abbott Park, IL, United States; 4Abbott GmbH & Co. KG, Ludwigshafen, Germany

Aim: 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, randomized, 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 nonresponder imputation (NRI); missing scores and values after adjustment to weekly dosing (for flares/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.

Clinical Remission and Major Secondary Endpoints at Week 52: All ADA
 NRI (N = 390)mNRI (N = 390)As Observed (N = 274)
Clinical remissionb, n (%)100 (25.6)115 (29.5)115 (42.0)
Clinical responsec, n (%)166 (42.6)209 (53.6)209 (76.3)
Endoscopy subscore ≤1, n (%)148 (37.9)182 (46.7)182 (66.4)
Rectal bleeding score ≤1, n (%)185 (47.4)246 (63.1)246 (89.1)d
Stool frequency score ≤1, n (%)145 (37.2)175 (44.9)175 (63.4)d
aPools all randomized groups. bMayo score ≤2 with no individual subscore >1. cDecrease from baseline in Mayo score ≥3 points and ≥30%, and rectal bleeding subscore 0 or 1 or decrease from baseline ≥1 point.dN = 276.

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 summarizes rates of clinical remission and other secondary endpoints 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 efficacy endpoints in patients with moderately to severely active UC. The safety profile in UC was consistent with the known safety profile of ADA.