Oral 5-aminosalicylic acid for maintenance of surgically-induced remission in Crohn's disease

• Published in: Cochrane database of systematic reviews 2019-06, Vol.6 (6), p.CD008414-CD008414
• Main Authors: Gjuladin-Hellon, Teuta, Gordon, Morris, Iheozor-Ejiofor, Zipporah, Akobeng, Anthony K
• Format: Article
• Language: English
• Subjects: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Child health; Crohn Disease - drug therapy; Crohn Disease - surgery; CROHN'S DISEASE ‐ MAINTENANCE OF REMISSION; Gastroenterology & hepatology; Humans; Mesalamine - therapeutic use; Quality of Life; Randomized Controlled Trials as Topic; Recurrence
• ISSN: 1469-493X
• DOI: 10.1002/14651858.CD008414.pub3

Crohn's disease (CD) is a chronic inflammatory disorder that can involve any part of the gastrointestinal tract. 5-Aminosalicylates (5-ASAs) are locally acting, anti-inflammatory compounds that reduce inflammation of the colonic mucosa with release profiles that vary among various commercially available formulations. This updated Cochrane review summarizes current evidence on the use of 5-ASA formulations for maintenance of surgically-induced remission in CD. To assess the efficacy and safety of 5-ASA agents for the maintenance of surgically-induced remission in CD. We searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Register from inception to 16 July 2018. We also searched references, conference abstracts, and trials registers. Randomised controlled trials (RCTs) that included participants with CD in remission following surgery and compared 5-ASAs to no treatment, placebo or any other active intervention with duration of at least three months were considered for inclusion. We used standard methodological procedures expected by Cochrane. The primary outcome was clinical relapse. Secondary outcomes included endoscopic recurrence, radiologic and surgical relapse, adverse events, serious adverse events and withdrawal due to adverse events. Fourteen RCTs (1867 participants) were included in the review. Participants (15 to 70 years) were recruited from gastroenterology hospitals and medical clinics in Europe and North America and followed up between 3 and 72 months. The risk of bias was assessed as 'low' in one study, 'unclear' in seven and as 'high' in six.At 12 months, 36% (20/55) of participants in the 5-ASA group experienced clinical relapse compared to 51% (28/55) in the no treatment control group (RR 0.71, 95% CI 0.46 to 1.10; low certainty evidence). Moderate certainty evidence suggests that 5-ASAs are more effective for preventing clinical relapse than placebo. During a follow-up period of 12 to 72 months, 36% (131/361) of 5-ASA participants relapsed compared to 43% (160/369) of placebo participants (RR 0.83, 95% CI 0.72 to 0.96; I² = 0%; moderate certainty evidence). At 12 months, 17% (17/101) of the 4 g/day mesalamine group relapsed compared to 26% (27/105) of the 2.4 g/day group (RR 0.65, 95% CI 0.38 to 1.13; moderate certainty evidence). There was no evidence of a difference in clinical relapse rates when 5-ASA compounds were compared to purine antimetabolites. At 24 months, 61% (103/170) of mesalamine participants relapsed comp