- Fecal Incontinence
Better Crohn's disease outcomes with 'tight control' management
Last Updated: 2017-11-10
By Will Boggs MD
NEW YORK (Reuters Health) - Crohn's disease outcomes are better when therapy is monitored using symptoms plus biomarkers of inflammation rather than symptoms alone, according to results from the phase 3 CALM study.
"This reinforces the need to monitor our patients closely using objective data," Dr. Jean-Frederic Colombel from Icahn School of Medicine at Mount Sinai, New York, told Reuters Health by email. "Every therapeutic decision should be made on the basis of clinical data and objective markers of inflammation."
As in other inflammatory diseases, a treat-to-target approach aimed at achieving both clinical and endoscopic remission is increasingly used for patients with Crohn's disease.
Dr. Colombel and colleagues from 22 countries investigated the effectiveness and safety of two treatment algorithms in achieving mucosal healing, defined as a Crohn's Disease Endoscopic Index of Severity (CDEIS) score <4 and no deep ulcers 48 weeks after randomization. Findings were published online October 31 in The Lancet.
In the open-label study, 244 patients (ages 18 to 75) with active Crohn's disease were randomized to one of two treatment strategies after eight weeks of prednisone induction therapy:
- tight control, with possible treatment escalation guided by both clinical symptoms and biomarkers of inflammation (e.g., fecal calprotectin, C-reactive protein)
- clinical management with possible treatment escalation guided by clinical symptoms alone.
In both groups, stepwise treatment escalation could involve adalimumab induction and, potentially, adalimumab plus azathioprine.
Significantly more patients in the tight-control group than in the clinical management group (46% vs. 30%) exhibited mucosal healing at 48 weeks after randomization. The tight-control group also was significantly more likely to achieve deep remission, biological remission, and CDEIS score <4 by 48 weeks.
Throughout the study (at weeks 11, 23, 35, and 48), significantly more patients in the tight-control group than in the clinical management group maintained steroid-free remission.
Treatment-emergent adverse events and serious adverse events occurred with similar frequency in the two groups.
"With current drug armamentarium, treating patients early during the 'window of opportunity' and then applying the strategies of treat-to-target (clinical and endoscopic remission) and tight control with biomarkers should allow to block progression of Crohn's disease in most patients," Dr. Colombel said.
Dr. Adam Cheifitz from the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center's and Harvard Medical School, Boston, told Reuters Health by email, "This study provides further evidence for what many gastroenterologists are doing, which is early aggressive treatment of Crohn's disease. Introducing anti-TNF (anti-tumor necrosis factor) therapies earlier and treating to clinical and biochemical remission is associated with improved rates of mucosal healing when compared to treatment based solely on clinical symptoms."
"Patients with Crohn's disease should be closely monitored, both clinically and with more objective markers of inflammation," said Dr. Cheifitz, who was not involved in the study.
AbbVie (maker of adalimumab) funded the study, employed several of the authors, and had various relationships with others, including Dr. Colombel.