Patients with early Crohn disease (CD) who underwent a tight control strategy had similar rates of deep remission as patients who underwent a conventional management strategy, according to results from a long-term follow-up study published in Gastroenterology.
Follow-up data were collected from 122 patients with early, moderate to severe CD who participated in the CALM study (ClinicalTrials.gov Identifier: NCT01235689), which was a multicenter, randomized, open-label, phase 3 trial of management strategies in early CD. Half of the study participants (n=61) were randomly assigned to undergo tight control (a scaled therapy based on fecal calprotectin levels, serum C-reactive protein levels, and symptoms) and half were assigned to undergo a conventional management strategy. All patients were assessed for deep remission (CD endoscopic index of severity score <4, no deep ulcerations, and no steroid treatment for >8 weeks) after a median follow-up time of 3.02 years.
The investigators observed no statistically significant difference in risk of disease progression among the 2 cohorts and reported a hazard ratio (HR) of 0.89 (95% CI, 0.45-1.75).
For the entire patient population, the investigators reported a deep remission HR of 0.23 (95% CI, 0.09-0.32), an endoscopic remission HR of 0.46 (95% CI, 0.31-0.60), and a clinical remission HR of 0.64 (95% CI, 0.34-0.61), indicating that clinical remission was the most likely outcome while deep remission was less common among study participants. The authors reported that several confounding factors contributed to disease progression in the patients, specifically disease duration (adjusted HR [aHR], 0.69; 95% CI, 0.53-0.81), a history of structuring disease (aHR, 2.18; 95% CI, 1.22-3.78), and prior surgery (aHR, 3.83; 95% CI, 1.50-8.16).
In total, major adverse conditions were reported by 34 patients (27.9%), and significantly fewer patients in deep remission reported experiencing adverse effects (P =.01).
The major limitation of this study is that all analyzed data were collected retrospectively from medical records; furthermore, follow-up data were available for only half of the total CALM study participants.
The study authors concluded that remission and disease progression of early, moderate to severe CD were not dependent on the management strategy used, but that CD progression was decreased in patients who had achieved deep remission.
Disclosures: The clinical trial referenced in the study was funded by AbbVie. Some authors declared a financial relationship with the pharmaceutical industry. A complete list of disclosures can be found in the original study.
Ungaro RC, Yzet C, Bossuyt P, et al. Deep remission at 1 year prevents progression of early Crohn’s disease [published online March 25, 2020]. Gastroenterol. doi:10.1053/j.gastro.2020.03.039