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OP35 Endoscopic and deep remission at 1 year prevents disease progression in early Crohn’s disease: long-term data from CALM

C. Yzet1, R. Ungaro*2, P. Bossuyt3, F. Baert4, T. Vanasek5, G. D’Haens6, V. Joustra6, R. Panaccione7, G. Novacek8, A. Armuzzi9, O. Golovchenko10, O. Prymak10, A. Goldis11, S. Travis12, X. Hébuterne13, M. Ferrante14, G. Rogler15, M. Fumery1, S. Danese16, G. Rydzewska17, B. Pariente18, E. Hertervig19, C. Stanciu20, J-C. Grimaud21, M-M. Diculescu22, L. Peyrin-Biroulet23, D. Laharie24, J. P. Wright25, F. Gomollón26, I. Gubonina27, S. Schreiber28, S. Motoya29, P. Hellström30, J. Halfvarson31, J-F. Colombel2

1Amiens University Hospital, Amiens, France, 2Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, USA, 3IBD Clinic, Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium, 4AZ Delta Roeselare, Roeselare, Belgium, 52nd Department of Internal Medicine, University Hospital Hradec Králové, Hradec Králové, Czech Republic, 6Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands, 7Cumming School of Medicine, University of Calgary, Calgary, Canada, 8Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria, 9Presidio Columbus Fondazione Policlinico A. Gemelli IRCCS – Università Cattolica del Sacro Cuore, Rome, Italy, 10Medical Clinical Investigational Center of Medical Center Health Clinic LLC, Vinnytsia, Ukraine, 11Universitatea de Medicina si Farmacie, Timisoara, Romania, 12Translational Gastroenterology Unit, Nuffield Department of Experimental Medicine, University of Oxford, Oxford, UK, 13Gastro-Entérologie and Nutrition Clinique, Hopital de l’Archet 2, Nice, France, 14University Hospitals Leuven, Leuven, Belgium, 15Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland, 16Humanitas University, Istituto Clinico Humanitas, Milan, Italy, 17Central Clinical Hospital of the Ministry of Interior in Warsaw, Warsaw, Poland, 18Claude Huriez Hospital, Lille University, Lille, France, 19Skane University Hospital, Lund, Sweden, 20Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania, 21Hepato-Gastroenterology Department, North Hospital, University of Mediterranean, Marseille, France, 22University of Medicine and Pharmacy ‘Carol Davila’, Bucharest, Romania, 23Hépato Gastro-Entérologie, Hôpital de Brabois, Nancy, France, 24Hépato-gastroentérologie et d’Oncologie Digestive, Hôpital Haut-Lévêque, Pessac, France, 25Kingsbury Hospital, Cape Town, South Africa, 26Hospital Clínico de Zaragoza, IIS Aragón, Zaragoza, Spain, 27Military Medical Academy Named After S.M.Kirov, Saint-Petersburg, Russian Federation, 28Department of Internal Medicine I, Kiel University, Kiel, Germany, 29IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan, 30Uppsala University Hospital, Uppsala, Sweden, 31Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden

Background

We aimed to describe the long-term impact of achieving endoscopic and deep remission among participants in the effect of tight control management on CD (CALM) trial.

Methods

We analysed medical records from patients with follow-up data since end of CALM. Patients were stratified by outcomes in CALM at 1 year: clinical remission (Crohn’s disease activity index, CDAI <150), endoscopic remission (Crohn’s disease endoscopic index of severity, CDEIS <4 with no deep ulcerations), and deep remission (CDAI <150, CDEIS <4 with no deep ulcerations, and no steroids for ≥8 weeks). The primary outcome was a composite of major adverse outcomes reflecting CD progression: new internal fistula/abscess, stricture, perianal fistula/abscess, CD hospitalisation, or CD surgery since end of CALM. Kaplan–Meier and Cox regression methods were used to compare composite rates between patients who achieved or did not achieve remission at 1 year. Adjusted hazard ratios (aHR) with 95% confidence intervals (CI) are reported, controlling for randomisation arm and baseline variables significant at p < 0.2 level.

Results

One hundred twenty-two patients with median age 29 years (IQR 22.5–37) and median disease duration 0.2 years (IQR 0.1–0.8) were included. Median follow-up time from end of CALM was 3.02 years (range 0.05–6.26 years). Fifty per cent were randomised to the tight control arm. There were no significant differences in baseline characteristics in patients with follow-up data and those lost to follow-up with the exception of a slightly higher CDEIS score in patients lost to follow-up (14.6 vs. 12.9, p = 0.04). Thirty-four patients (27.9%) had a major adverse outcome during follow-up. Patients in clinical remission at 1 year did not have significantly lower rates of the composite endpoint (log-rank p = 0.15). Patients in endoscopic and deep remission at the end of CALM were significantly less likely to have a major adverse event over time (Figures 1 and 2). After adjusting for age, disease duration, prior surgery, prior stricture, and randomisation arm, endoscopic remission (aHR 0.44, 95% CI 0.20–0.96, p = 0.038) and deep remission (aHR 0.25, 95% CI 0.09–0.72, p = 0.01) were significantly associated with lower risk of major adverse events.

Conclusion

Early CD patients who achieve endoscopic or deep remission after 1 year of intensive treatment are less likely to have disease progression over a median of 3 years.

Abstract OP035 – Figure 1. Kaplan–Meier estimates of CD disease progression based on endoscopic remission at 1 year

Abstract OP035 – Figure 2. Kaplan–Meier estimates of CD disease progression based on deep remission at 1 year.