Reduced Steroid Usage in Ulcerative Colitis Patients With Week 8 Response to Adalimumab: Subanalysis of ULTRA 2

Abstract

Purpose: To investigate corticosteroid (CS)-free remission and reduction in CS use in adult patients (pts) with moderately to severely active ulcerative colitis (UC) failing conventional therapy who responded to induction with the anti-TNF agent adalimumab (ADA) in the 52-week (wk), double-blind (DB), placebo (PBO)-controlled ULTRA 2 trial.1 Methods: Pts were stratified by prior anti-TNF use and randomized 1:1 to receive ADA induction (160/80 mg) or PBO at wks 0/2, then ADA 40 mg every other week or PBO from wk4. Pts using CS at baseline (BL) were included; CS tapering was allowed (not required) from wk8. Response to induction was assessed at wk8 in ADA-treated pts using full Mayo score (FMS; response=Mayo score decrease of ≥3 points and ≥30% from BL and decrease in rectal bleeding score [RBS] ≥1 or absolute RBS ≤1) and partial Mayo score (PMS, Mayo score without endoscopy subscore; response=PMS decrease ≥2 points and ≥30% from BL, and RBS criteria as above). At wk52, the proportion achieving CS-free remission (Mayo score ≤2, no subscore >1) and the proportion free of CS were compared for ADA-treated pts who responded at wk8 (FMS or PMS) vs. PBO-treated pts, overall (Cochran-Mantel-Haenszel) and by prior anti-TNF use (chi-square). Mean percent changes in CS dose from BL to end of DB treatment were compared (ANOVA). Results: Of 150 ADA-treated pts using CS at BL, 90 (60%) responded per FMS, and 90 (60%) responded per PMS at wk8. Compared with all PBO-treated pts using CS at BL (n=140), significantly more ADA wk8 responders (by FMS or PMS) achieved CS-free remission or were CS-free at wk52 (Table). Similar wk52 results were observed for anti-TNF-naïve and -exposed pts. For ADA-treated wk8 responders, mean percent changes in CS dose from BL to end of DB treatment were -64.4% (FMS) and -68.3% (PMS), vs. -17.5% for PBO-treated pts (P<0.003).Table: No Caption available.Conclusion: In pts with moderately to severely active UC who used CS at BL in ULTRA 2, clinically meaningful long-term CS-free remission and CS-sparing efficacy with ADA was seen at wk52 in pts with wk8 response by full or partial Mayo score. ADA treatment resulted in clinically meaningful reductions in CS doses.