| Gaia: | <h4>Background</h4> <p>Aminosalicylates are the most frequently prescribed drugs for patients with Crohn’s disease (CD), yet evidence to support their efficacy as induction or maintenance therapy is controversial.</p> <h4>Aims</h4> <p>To quantify aminosalicylate use in CD clinical trials, identify factors associated with use, and estimate direct annual treatment costs of therapy.</p> <h4>Methods</h4> <p>MEDLINE, Embase, and CENTRAL were searched to April 2017 for placebo-controlled trials in adults with CD treated with corticosteroids, immunosuppressants, or biologics. The proportion of patients co-prescribed aminosalicylates in placebo arms was pooled using a random effects model. Meta-regression was used to identify factors associated with aminosalicylate use. Annual treatment costs were estimated using the 2016 Ontario Drug Benefit Program.</p> <h4>Results</h4> <p>Forty-two induction and ten maintenance trials were included. The pooled proportion of patients co-prescribed aminosalicylates was 44% [95% CI: 39%-49%] in induction trials and 49% [95% CI: 35%-64%] in maintenance trials. There was substantial to considerable heterogeneity (I2=86.0%, 91.8% for induction and maintenance trials, respectively). In multivariable meta-regression, aminosalicylate use has decreased over time in induction trials (OR 0.50 [95% CI: 0.34, 0.74] per 10-year increment). Whilst a decline has been seen over time, 35% of CD patients were still using aminosalicylates in contemporary trials from the last five years. The estimated annual cost for the lowest price mesalamine formulation is approximately $32 million for the Canadian CD population.</p> <h4>Conclusions</h4> <p>Over one-third of CD patients entering clinical trials are still co-prescribed aminosalicylates. A definitive trial is needed to inform the conventional practice of using aminosalicylates as CD maintenance therapy.</p>
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