Second Department of Internal Medicine, University Hospital Hradec Králové, Hradec Králové, Czech Republic.
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Inflammatory Bowel Disease Unit, University of Calgary, Calgary, Canada.
Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
Inflammatory Bowel Disease Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.
Medical Clinical Investigational Center of Medical Center Health Clinic LLC, Vinnytsia, Ukraine.
Medical Clinical Investigational Center of Medical Center Health Clinic LLC, Vinnytsia, Ukraine.
Universitatea de Medicina si Farmacie, Timisoara, Romania.
Translational Gastroenterology Unit, Nuffield Department of Experimental Medicine, University of Oxford, Oxford, United Kingdom.
Gastroenterology and Clinical Nutrition Department, Centre Hospitalier Universitaire of Nice, University of Nice Sophia-Antipolis, Nice, France.
University Hospitals Leuven, Leuven, Belgium.
Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.
Amiens University Hospital, Department of Gastroenterology, Amiens, France.
Humanitas University, Istituto Clinico Humanitas, Milan, Italy.
Central Clinical Hospital of Ministry of Interior and Administration in Warsaw, Warsaw, Poland.
Claude Huriez Hospital, Lille University, Lille, France.
Skåne University Hospital, Lund, Sweden.
Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania.
Hepato-Gastroenterology Department, North Hospital, University of Mediterranean, Marseille, France.
University of Medicine and Pharmacy "Carol Davila," Bucharest, Romania.
Hépato Gastro-Entérologie, Hôpital de Brabois, Nancy, France.
Service d'Hépato-gastroentérologie et Oncologie Digestive, Hôpital Haut-Lévêque, Bordeaux, France.
Kingsbury Hospital, Cape Town, South Africa.
Hospital Clínico de Zaragoza, IIS Aragón, Zaragoza, Spain.
Military Medical Academy named after S.M. Kirov, Saint Petersburg, Russian Federation.
Department of Internal Medicine I, Kiel University, Kiel, Germany.
Inflammatory Bowel Disease Center, Sapporo Kosei General Hospital, Sapporo, Japan.
Uppsala University Hospital, Uppsala, Sweden.
AbbVie, Inc, North Chicago, Illinois.
AbbVie, Inc, North Chicago, Illinois.
Department of Genetics and Genomic Sciences and Icahn Institute for Data Science and Genomic Technology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, New York, USA.
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.
W. B. Saunders Company , 2020. Vol. 159, no 1, p. 139-147, article id S0016-5085(20)30390-5