Thématique :
Originalité :
Solidité :
Très solide
Doit faire évoluer notre pratique :
Nom du veilleur :
Professeur Philippe MARTEAU
Coup de coeur :
Inflammatory Bowel Diseases
  2017 May;23(5):822-832  
  doi: 10.1097/MIB.0000000000001065.  
  2.4 g Mesalamine (Asacol 400 mg tablet) Once Daily is as Effective as Three Times Daily in Maintenance of Remission in Ulcerative Colitis: A Randomized, Noninferiority, Multi-center Trial  
  Suzuki Y, Iida M, Ito H, Nishino H, Ohmori T, Arai T, Yokoyama T, Okubo T, Hibi T  



The noninferiority of pH-dependent release mesalamine (Asacol) once daily (QD) to 3 times daily (TID) administration was investigated.


This was a phase 3, multicenter, randomized, double-blind, parallel-group, active-control study, with dynamic and stochastic allocation using central registration. Patients with ulcerative colitis in remission (a bloody stool score of 0, and an ulcerative colitis disease activity index of ≤2), received the study drug (Asacol 2.4 g/d) for 48 weeks. The primary efficacy endpoint of the nonrecurrence rate was assessed on the full analysis set. The noninferiority margin was 10%.


Six hundred and four subjects were eligible and were allocated; 603 subjects received the study drug. The full analysis set comprised 602 subjects (QD: 301, TID: 301). Nonrecurrence rates were 88.4% in the QD and 89.6% in the TID. The difference between nonrecurrence rates was -1.3% (95% confidence interval: -6.2, 3.7), confirming noninferiority. No differences in the safety profile were observed between the two treatment groups. On post hoc analysis by integrating the QD and the TID, nonrecurrence rate with a mucosal appearance score of 0 at determination of eligibility was significantly higher than the score of 1. The mean compliance rates were 97.7% in the QD and 98.1% in the TID.


QD dosing with Asacol is as effective and safe as TID for maintenance of remission in patients with ulcerative colitis. Additionally, this study indicated that maintaining a good mucosal state is the key for longer maintenance of remission.

Question posée
Une prise unique quotidienne de 5-ASA de 2,4 g est-elle « non inférieure » à (aussi efficace que) la même dose en prises multiples pour maintenir la rémission de RCH?
Question posée

Ce travail en confirme d’autres: une prise unique de 5-ASA par jour est au moins aussi efficace que la même dose répartie dans la journée et plus facile à prendre (donc à observer).