Deep Remission at 1 Year Prevents Progression of Early Crohn's Disease

Gastroenterology. 2020 Jul;159(1):139-147. doi: 10.1053/j.gastro.2020.03.039. Epub 2020 Mar 26.

Abstract

Background & aims: We investigated the effects of inducing deep remission in patients with early Crohn's disease (CD).

Methods: We collected follow-up data from 122 patients (mean age, 31.2 ± 11.3 y) with early, moderate to severe CD (median duration, 0.2 years; interquartile range, 0.1-0.5) who participated in the Effect of Tight Control Management on CD (CALM) study, at 31 sites, representing 50% of the original CALM patient population. Fifty percent of patients (n = 61) were randomly assigned to a tight control strategy (increased therapy based on fecal level of calprotectin, serum level of C-reactive protein, and symptoms), and 50% were assigned to conventional management. We categorized patients as those who were vs were not in deep remission (CD endoscopic index of severity scores below 4, with no deep ulcerations or steroid treatment, for 8 or more weeks) at the end of the follow-up period (median, 3.02 years; range, 0.05-6.26 years). The primary outcome was a composite of major adverse outcomes that indicate CD progression during the follow-up period: new internal fistulas or abscesses, strictures, perianal fistulas or abscesses, or hospitalization or surgery for CD. Kaplan-Meier and penalized Cox regression with bootstrapping were used to compare composite rates between patients who achieved or did not achieve remission at the end of the follow-up period.

Results: Major adverse outcomes were reported for 34 patients (27.9%) during the follow-up period. Significantly fewer patients in deep remission at the end of the CALM study had major adverse outcomes during the follow-up period (P = .01). When we adjusted for potential confounders, deep remission (adjusted hazard ratio, 0.19; 95% confidence interval, 0.07-0.31) was significantly associated with a lower risk of major adverse outcome.

Conclusions: In an analysis of follow-up data from the CALM study, we associated induction of deep remission in early, moderate to severe CD with decreased risk of disease progression over a median time of 3 years, regardless of tight control or conventional management strategy.

Trial registration: ClinicalTrials.gov NCT01235689.

Keywords: Adalimumab; CDEIS; IBD; Inflammatory Bowel Diseases.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab / administration & dosage
  • Adalimumab / adverse effects
  • Adult
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Azathioprine / administration & dosage
  • Azathioprine / adverse effects
  • Crohn Disease / diagnosis
  • Crohn Disease / drug therapy*
  • Crohn Disease / immunology
  • Crohn Disease / pathology
  • Disease Progression
  • Drug Therapy, Combination / adverse effects
  • Drug Therapy, Combination / methods
  • Female
  • Follow-Up Studies
  • Hospitalization / statistics & numerical data
  • Humans
  • Male
  • Prednisone / administration & dosage
  • Prednisone / adverse effects
  • Remission Induction / methods
  • Retrospective Studies
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Tumor Necrosis Factor-alpha / immunology
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • TNF protein, human
  • Tumor Necrosis Factor-alpha
  • Adalimumab
  • Azathioprine
  • Prednisone

Associated data

  • ClinicalTrials.gov/NCT01235689