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.

2nd Department of Internal Medicine University Hospital Hradec Králové Hradec Králové Czech Republic

AbbVie Inc North Chicago Illinois

Amiens University Hospital Department of Gastroenterology Amiens France

AZ Delta Roeselare Roeselare Belgium

Central Clinical Hospital of Ministry of Interior and Administration in Warsaw Warsaw Poland

Claude Huriez Hospital Lille University Lille France

Department of Gastroenterology and Hepatology Academic Medical Center University of Amsterdam Amsterdam The Netherlands

Department of Gastroenterology and Hepatology University Hospital Zurich Zurich Switzerland

Department of Gastroenterology Faculty of Medicine and Health Örebro University Örebro Sweden

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

Department of Internal Medicine 1 Kiel University Kiel Germany

Division of Gastroenterology and Hepatology Medical University of Vienna Vienna Austria

Gastroenterology and Clinical Nutrition Department Centre Hospitalier Universitaire of Nice University of Nice Sophia Antipolis Nice France

Grigore T Popa University of Medicine and Pharmacy Iasi Romania

Hépato Gastro Entérologie Hôpital de Brabois Nancy France

Hepato Gastroenterology Department North Hospital University of Mediterranean Marseille France

Hospital Clínico de Zaragoza IIS Aragón Zaragoza Spain

Humanitas University Istituto Clinico Humanitas Milan Italy

Icahn School of Medicine at Mount Sinai Division of Gastroenterology New York New York

Imelda Gastroenterology Clinical Research Center Department of Gastroenterology Imelda General Hospital Bonheiden Belgium

Inflammatory Bowel Disease Center Sapporo Kosei General Hospital Sapporo Japan

Inflammatory Bowel Disease Unit Fondazione Policlinico Universitario A Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy

Inflammatory Bowel Disease Unit University of Calgary Calgary Canada

Kingsbury Hospital Cape Town South Africa

Medical Clinical Investigational Center of Medical Center Health Clinic LLC Vinnytsia Ukraine

Military Medical Academy named after S M Kirov Saint Petersburg Russian Federation

Service d'Hépato gastroentérologie et Oncologie Digestive Hôpital Haut Lévêque Bordeaux France

Skane University Hospital Lund Sweden

Translational Gastroenterology Unit Nuffield Department of Experimental Medicine University of Oxford Oxford United Kingdom

Universitatea de Medicina si Farmacie Timisoara Romania

University Hospitals Leuven Leuven Belgium

University of Medicine and Pharmacy Carol Davila Bucharest Romania

Uppsala University Hospital Uppsala Sweden

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