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CALM trial showed tight control resulted in better outcomes for patients with Crohn’s disease
CALM trial compared endoscopic and clinical outcomes in patients with moderate to severe Crohn’s disease who were managed with a tight control algorithm, using clinical symptoms and biomarkers, versus patients managed with a clinical management algorithm.1 This was an open-label, randomised, controlled phase 3 study, done in 22 countries which evaluated adult patients with active endoscopic Crohn’s disease, and no previous use of immunomodulators or biologics. Patients were randomly assigned at a 1:1 ratio to tight control or clinical management groups, stratified by smoking, weight and disease duration after 8 weeks of prednisone induction therapy, or earlier if they had active disease. Treatment was escalated in both groups in a stepwise manner, from no treatment, to adalimumab induction followed by adalimumab every other week, adalimumab every week and, lastly, to both weekly adalimumab and daily azathioprine. In the tight control group the therapy escalation was initiated if a patient’s Crohn’s Disease Activity Index (CDAI) score was at …
Contributors RM is the sole contributor to this paper.
Competing interests RM has received speaker fees, travel support and research grants, or has performed consultancy work with MSD Immunology, AbbVie, Dr Falk Pharma, 4D Pharma, Tillotts Pharma, Nestle, Takeda, Ferring and Pfizer.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.