About the trial
5-ASA and Crohn’s Disease
Crohn’s disease is a chronic inflammatory disorder of the gastrointestinal system characterized by diarrhea, weight loss, and abdominal pain. Pharmacological agents commonly used to induce remission in CD include steroids, immunosuppressives, 5-aminosalicylates, tumor necrosis factor inhibitors, and anti-integrins.
As a therapeutic class, 5-ASAs are perceived to be generally safe and inexpensive. For CD, 5-ASA has been used as a treatment option for induction or maintenance of remission, or for prevention of postoperative recurrence. However, there is uncertainty regarding their effectiveness for CD. For induction of remission in CD, a Cochrane review of randomized controlled trials found no evidence that low- or high-dose mesalazine was superior to placebo, although there was moderate benefit for sulfasalazine over placebo in CD.
Several studies originating from North America and Europe indicate that aminosalicylates are the most commonly prescribed drug class for patients with CD. This is surprising considering the uncertainty regarding their effectiveness for induction or maintenance of remission in CD. Therefore, there is a discordance between clinical prescribing practice and evidence from Randomized Clinical Trials.
Cochrane review of randomized controlled trials found no evidence that low- or high-dose mesalazine was superior to placebo, although there was moderate benefit for sulfasalazine over placebo in CD.1
- Lim WC, Wang Y, MacDonald JK, et al. Aminosalicylates for induction of remission or response in Crohn's disease. Cochrane Database Syst Rev 2016;7:Cd008870.
- Schoepfer AM, Bortolotti M, Pittet V, et al. The gap between scientific evidence and clinical practice: 5-aminosalicylates are frequently used for the treatment of Crohn's disease. Aliment Pharmacol Ther 2014;40:930-7.
- Rubin DT, Mody R, Davis KL, et al. Real-world assessment of therapy changes, suboptimal treatment and associated costs in patients with ulcerative colitis or Crohn's disease. Aliment Pharmacol Ther 2014;39:1143-55.
- Bernstein CN, Nugent Z, Blanchard JF. 5-aminosalicylate is not chemoprophylactic for colorectal cancer in IBD: a population based study. Am J Gastroenterol 2011;106:731-6.
- UK IBD Audit Steering Group RCoP. Executive summary of the results for the national clinical audit of adult inflammatory bowel disease inpatient care in the UK. Round 3. 2012.