SOURCE: Colombel JF, et al. Effect of tight control management on Crohn’s disease (CALM): A multicentre, randomised, controlled phase 3 trial. Lancet 2018;390:2779-2789.
Colombel et al investigated the effect of including biomarkers, in addition to clinical signs and symptoms, for management of Crohn’s disease. This multinational study enrolled patients with Crohn’s disease into an open-label study with two treatment arms: tight control (i.e., intensification of treatment based on clinical signs and symptoms, as well as optimization based on levels of C-reactive protein and fecal calprotectin) vs. clinical management (treatment intensification based on symptoms/signs of disease activity alone). Main treatments included prednisone, adalimumab, and azathioprine. The primary endpoint was mucosal healing with absence of deep ulcers at 48 weeks.
A statistically significantly greater proportion of subjects in the tight control group achieved the primary endpoint than the clinical management group (46% vs. 30%), while adverse effects and dropouts were similar between the two groups. The authors suggested that treatment escalation based on the combination of clinical symptoms with biomarkers produces more favorable outcomes.