P206 - Which patient population profits best from a high dose, once daily treatment with 3.0g mesalazine for maintaining clinical remission in ulcerative colitis? A subgroup analysis of a double-blind, double-dummy, randomised, controlled, dose-ranging study

2009 
of 6 patients (50%) completed the studies (1 CHARM, 2 GAIN). Reasons for discontinuation included PSC-related pancreatitis (1 patient), CD flare (1 patient), and total body rash (1 patient). CDAI responses at last visit were 50% (3/6) remission, 67% (4/6) CR-100, and 83% (5/6) CR-70. Half had abnormal liver biochemistry at baseline, with no notable change or worsening of liver biochemistry, either acutely or during longer exposure to adalimumab. Conclusions: In this small cohort of PSC patients, adalimumab was well-tolerated, without changes in liver biochemistry in patients with concomitant CD treated during CHARM and GAIN. For the 3 patients who completed the trials, adalimumab sustained remission and/or response, with no appreciable difference in the efficacy rates vs. those for patients without PSC.
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