PMID- 28119352 OWN - NLM STAT- MEDLINE DCOM- 20171218 LR - 20181113 IS - 1468-3288 (Electronic) IS - 0017-5749 (Print) IS - 0017-5749 (Linking) VI - 67 IP - 1 DP - 2018 Jan TI - Efficacy of adalimumab in patients with Crohn's disease and symptomatic small bowel stricture: a multicentre, prospective, observational cohort (CREOLE) study. PG - 53-60 LID - 10.1136/gutjnl-2016-312581 [doi] AB - OBJECTIVE: The efficacy of anti-tumour necrosis factors (anti-TNFs) in patients with Crohn's disease (CD) and symptomatic small bowel stricture (SSBS) is controversial. The aim of this study was to estimate the efficacy of adalimumab in these patients and to identify the factors predicting success. DESIGN: We performed a multicentre, prospective, observational cohort study in patients with CD and SSBS. The included patients underwent magnetic resonance enterography at baseline and subsequently received adalimumab. The primary endpoint was success at week 24, defined as adalimumab continuation without prohibited treatment (corticosteroids after the eight week following inclusion, other anti-TNFs), endoscopic dilation or bowel resection. The baseline factors independently associated with success were identified using a logistic regression model, leading to a simple prognostic score. Secondary endpoints were prolonged success after week 24 (still on adalimumab, without dilation nor surgery) and time to bowel resection in the whole cohort. RESULTS: From January 2010 to December 2011, 105 patients were screened and 97 were included. At week 24, 62/97 (64%) patients had achieved success. The prognostic score defined a good prognosis group with 43/49 successes, an intermediate prognosis group with 17/28 successes and a poor prognosis group with 1/16 successes. After a median follow-up time of 3.8 years, 45.7%+/-6.6% (proportion+/-SE) of patients who were in success at week 24 (ie, 29% of the whole cohort) were still in prolonged success at 4 years. Among the whole cohort, 50.7%+/-5.3% of patients did not undergo bowel resection 4 years after inclusion. CONCLUSIONS: A successful response to adalimumab was observed in about two-thirds of CD patients with SSBS and was prolonged in nearly half of them till the end of follow-up. More than half of the patients were free of surgery 4 years after treatment initiation. CLINICAL TRIAL REGISTRATION NUMBER: NCT01183403; Results. CI - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. FAU - Bouhnik, Yoram AU - Bouhnik Y AD - Gastroenterologie, MICI et Assistance Nutritive, Hopital Beaujon, Clichy, France. FAU - Carbonnel, Franck AU - Carbonnel F AD - Gastro-enterologie, Hopital Bicetre, Le Kremlin Bicetre, France. FAU - Laharie, David AU - Laharie D AD - Hepato-gastroenterologie et d'oncologie digestive, Hopital Haut-Leveque, Pessac, France. FAU - Stefanescu, Carmen AU - Stefanescu C AD - Gastroenterologie, MICI et Assistance Nutritive, Hopital Beaujon, Clichy, France. FAU - Hebuterne, Xavier AU - Hebuterne X AD - Gastro-Enterologie & Nutrition Clinique, Hopital de l'Archet 2, Nice, France. FAU - Abitbol, Vered AU - Abitbol V AD - Gastro Enterologie, Hopital Cochin, Paris, France. FAU - Nachury, Maria AU - Nachury M AD - Maladies de l'appareil digestif et nutrition, Hopital Claude Huriez, Lille, France. FAU - Brixi, Hedia AU - Brixi H AD - Gastro Enterologie, Hopital Robert Debre, Reims, France. FAU - Bourreille, Arnaud AU - Bourreille A AD - Hepato-gastro-enterologie et cancerologie digestive, Hopital Hotel Dieu, Nantes, France. FAU - Picon, Laurence AU - Picon L AD - Hepato-Gastro-Onco-Enterologie, Hopital Trousseau, Tours, France. FAU - Bourrier, Anne AU - Bourrier A AD - Gastroenterologie & Nutrition, Hopital Saint-Antoine, Paris, France. FAU - Allez, Matthieu AU - Allez M AD - Hepato-gastroenterologie, Hopital Saint-Louis, Paris, France. FAU - Peyrin-Biroulet, Laurent AU - Peyrin-Biroulet L AD - Hepato Gastro-Enterologie, Hopital de Brabois, Nancy, France. FAU - Moreau, Jacques AU - Moreau J AD - Gastro-enterologie et Nutrition, Hopital Rangueil, Toulouse, France. FAU - Savoye, Guillaume AU - Savoye G AD - Hepato-gastro-enterologie et de nutrition, Hopital Charles Nicolle, Rouen, France. FAU - Fumery, Mathurin AU - Fumery M AD - Hepato-Gastroenterologie, Hopital Nord, Amiens, France. FAU - Nancey, Stephane AU - Nancey S AD - Hepato-gastro-enterologie, Centre Hospitalier Lyon-Sud, Lyon, France. FAU - Roblin, Xavier AU - Roblin X AD - Gastro-enterologie et Hepatologie, CHU Saint-Etienne, Saint-Etienne, France. FAU - Altwegg, Romain AU - Altwegg R AD - Hepato-gastro-enterologie, Hopital Saint Eloi, Montpellier, France. FAU - Bouguen, Guillaume AU - Bouguen G AD - Maladies de l'appareil digestif, Hopital Pontchaillou, Rennes, France. FAU - Bommelaer, Gilles AU - Bommelaer G AD - Hepatologie Gastro-Enterologie, CHU Estain, Clermont Ferrand, France. FAU - Danese, Silvio AU - Danese S AD - Instituto Clinico Humanitas-Department of Gastroenterology, Milan, Italy. FAU - Louis, Edouard AU - Louis E AD - Gastro-enterologie, CHU Sart Tilman, Liege University, Liege, Belgium. FAU - Zappa, Magaly AU - Zappa M AD - Radiologie, Hopital Beaujon, Clichy, France. FAU - Mary, Jean-Yves AU - Mary JY AD - UMR-S-1153 Inserm, Denis Diderot-Paris 7 university, Hopital Saint-Louis, Paris, France. CN - GETAID CREOLE Study Group LA - eng SI - ClinicalTrials.gov/NCT01183403 PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20170124 PL - England TA - Gut JT - Gut JID - 2985108R RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 0 (Tumor Necrosis Factor-alpha) RN - FYS6T7F842 (Adalimumab) SB - IM CIN - Gut. 2018 Jan;67(1):198. PMID: 28381522 CIN - Gut. 2018 Jan;67(1):199. PMID: 28601842 MH - Adalimumab/administration & dosage/adverse effects/*therapeutic use MH - Adult MH - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse effects/*therapeutic use MH - Crohn Disease/complications/diagnostic imaging/*drug therapy MH - Drug Administration Schedule MH - Female MH - Humans MH - Intestinal Obstruction/diagnostic imaging/*drug therapy/etiology MH - *Intestine, Small/diagnostic imaging MH - Magnetic Resonance Imaging MH - Male MH - Middle Aged MH - Prognosis MH - Prospective Studies MH - Severity of Illness Index MH - Treatment Outcome MH - Tumor Necrosis Factor-alpha/antagonists & inhibitors PMC - PMC5754855 OTO - NOTNLM OT - ABDOMINAL MRI OT - CROHN'S DISEASE OT - IBD CLINICAL COIS- Competing interests: Consultancies: BMS, Shire, Sanofi, Norgine Pharma, MSD, Abbvie, Astra Zeneca, Roche, Takeda Millenium, Janssen Cilag, Pfizer Stock ownership: Inception IBD, San Diego, CA, USA Honoraria: BMS, MSD, Abbvie, Teva, Ferring, Vifor Pharma, HAC, Mayoli-Spindler Paid expert testimony: Abbvie Patent applications: None Travel grants: Abbvie, MSD, Ferring, Takeda, Vifor Pharma. FIR - Arrive, Lionel IR - Arrive L FIR - Aubourg, Alexandre IR - Aubourg A FIR - Baillon, Audrey IR - Baillon A FIR - Baudin, Guillaume IR - Baudin G FIR - Beaugerie, Laurent IR - Beaugerie L FIR - Bolivar, Julie IR - Bolivar J FIR - Brun, Vanessa IR - Brun V FIR - Buisson, Anthony IR - Buisson A FIR - Cadiot, Guillaume IR - Cadiot G FIR - Chevalier, Patrick IR - Chevalier P FIR - Colombel, Jean Frederic IR - Colombel JF FIR - Cuilleron, Muriel IR - Cuilleron M FIR - Dupas, Jean Louis IR - Dupas JL FIR - Filippi, Jerome IR - Filippi J FIR - Flourie, Bernard IR - Flourie B FIR - Frampas, Eric IR - Frampas E FIR - Gayet, Mathilde IR - Gayet M FIR - Gornet, Jean Marc IR - Gornet JM FIR - Hordonneau, Constance IR - Hordonneau C FIR - Lapuyade, Bruno IR - Lapuyade B FIR - Laurent, Valerie IR - Laurent V FIR - Leroy, Christophe IR - Leroy C FIR - Lewin, Maite IR - Lewin M FIR - Otal, Philippe IR - Otal P FIR - Oudjit, Ammar IR - Oudjit A FIR - Panis, Yves IR - Panis Y FIR - Pariente, Benjamin IR - Pariente B FIR - Scotto, Beatrice IR - Scotto B FIR - Simon, Marion IR - Simon M FIR - Treton, Xavier IR - Treton X FIR - Valette, Pierre-Jean IR - Valette PJ FIR - Yzet, Thierry IR - Yzet T FIR - Zagdanski, Anne Marie IR - Zagdanski AM EDAT- 2017/01/26 06:00 MHDA- 2017/12/19 06:00 PMCR- 2018/01/05 CRDT- 2017/01/26 06:00 PHST- 2016/07/05 00:00 [received] PHST- 2016/11/15 00:00 [revised] PHST- 2016/12/02 00:00 [accepted] PHST- 2017/01/26 06:00 [pubmed] PHST- 2017/12/19 06:00 [medline] PHST- 2017/01/26 06:00 [entrez] PHST- 2018/01/05 00:00 [pmc-release] AID - gutjnl-2016-312581 [pii] AID - 10.1136/gutjnl-2016-312581 [doi] PST - ppublish SO - Gut. 2018 Jan;67(1):53-60. doi: 10.1136/gutjnl-2016-312581. Epub 2017 Jan 24.