Randomised clinical trials: Early assessment after two weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question

Timothy Orchard (1) , Stefan van Der Geest (2) , Simon P L Travis (3)

1 GI Unit
2 Warner Chilcott UK Ltd
3 Gastroenterology

Background Rapid resolution of rectal bleeding (RB) and stool frequency (SF) is an important goal for ulcerative colitis (UC) therapy and may help guide therapeutic decisions. Aim To explore patient diary data from ASCEND I and II for their relevance to clinical decision making. Methods Data from two randomized, double-blind, Phase III studies were combined. Patients received mesalazine 4.8g/day (Asacol® 800mg MR) or 2.4g/day (Asacol® 400mg MR). Time to improvement or resolution of RB and SF was assessed and the proportion of patients experiencing symptom improvement or resolution at day 14 evaluated using survival analysis. Symptoms after 14 days were compared to week 6. A combination of pre-specified and post-hoc analyses were used. Results Median time to resolution and improvement of both RB and SF was shorter with 4.8g/day than 2.4g/day (resolution, 19 vs 29 days, p=0.020; improvement, 7 vs 9 days, p=0.024). 73% of patients experienced improvement in both RB and SF by day 14 with 4.8g/day, compared to 61% with 2.4g/day. More patients achieved symptom resolution by day 14 with 4.8g/day than 2.4g/day (43% vs 30%; p=0.035). Symptom relief after 14 days was associated with a high rate of symptom relief after 6 weeks. Conclusions High-dose mesalazine 4.8g/day provides rapid relief of the cardinal symptoms of moderately active UC. Symptom relief within 14 days was associated with symptom relief at 6 weeks in the majority of patients. Day 14 is a practical timepoint at which response to treatment may be assessed and decisions regarding therapy escalation made.

Mots clés: Medicine

Timothy Orchard, Stefan van Der Geest, Simon P L Travis. Randomised clinical trials: Early assessment after two weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Alimentary Pharmacology and Therapeutics, 2011, 33 (9), pp.1028. ⟨10.1111/j.1365-2036.2011.04620.x⟩. ⟨hal-00620577⟩