CALM Study: Tight Control Improves Outcomes in Crohn’s Disease

A recent study (JF Colombel et al. Lancet 2017; http://dx.doi.org/10.1016/S0140-6736(17)32641-7 ) shows that “tight control” improves outcomes in Crohn’s disease.  This study was alluded to in a previous post: CCFA 2017 Updates (part 2)

Background: The CALM study was an open-label, randomized study.  122 adult patients were randomized to typical clinical management and 122 patients received “tight control” in which treatment was modified by fecal calprotectin (≥250 mcg/g) and CRP (≥ 0.5 mg/dL) values in addition to clinical symptoms.

Treatment was escalated in both groups in a stepwise manner.  Initial treatment was with adalimumab induction and then every other week. If patient did not meet treatment objectives, which differed in the groups, then adalimumab would be given every week, and then, if still needed, azathioprine would be added. Interestingly, both groups had ~25% of participants who were smokers which is known to worsen outcomes.

Key Findings:

  • Mucosal healing (CDEIS <4) was significantly improved in tight control group at week 48: 46% vs. 30%.
  • Similarly, steroid-free remission based on CDAI <150 was better in tight control group compared with standard treatment at week 48: 59.8% vs. 39.3%.  Endoscopic response was 50.8% compared with 40.2% respectively.

My take (1st part borrowed from authors): “Tight control of inflammation in patients with Crohn’s disease, with objective markers of disease activity  and clinical symptoms to drive treatment decisions, achieved better endoscopic and clinical outcomes than conventional care based on symptoms alone.” Yet, there are a large number who do not respond adequately and better treatments in these patients are needed.

As an aside, these response rates based on objective markers are far lower than the remission rates claimed by ImproveCareNow; thus, while ImproveCareNow is forward-thinking and helping improve outcomes with inflammatory bowel disease, we need to be careful about citing remission rate trends that are not directly linked to objective markers.

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