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1. Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab.

Author

Laharie D, Bourreille A, Branche J, Allez M, Bouhnik Y, Filippi J, Zerbib F, Savoye G, Vuitton L, Moreau J, Amiot A, Cosnes J, Ricart E, Dewit O, Lopez-Sanroman A, Fumery M, Carbonnel F, Bommelaer G, Coffin B, Roblin X, van Assche G, Esteve M, Farkkila M, Gisbert JP, Marteau P, Nahon S, de Vos M, Lambert J, Mary JY, and Louis E

Subjects
Adult, Colectomy, Colitis, Ulcerative surgery, Disease-Free Survival, Drug Resistance, Female, Humans, Male, Middle Aged, Steroids therapeutic use, Time Factors, Treatment Outcome, Colitis, Ulcerative drug therapy, Cyclosporine therapeutic use, Gastrointestinal Agents therapeutic use, Immunosuppressive Agents therapeutic use, Infliximab therapeutic use
Abstract

Objective: Ciclosporin and infliximab have demonstrated short-term similar efficacy as second-line therapies in patients with acute severe UC (ASUC) refractory to intravenous steroids. The aim of this study was to assess long-term outcome of patients included in a randomised trial comparing ciclosporin and infliximab., Design: Between 2007 and 2010, 115 patients with steroid-refractory ASUC were randomised in 29 European centres to receive ciclosporin or infliximab in association with azathioprine. Patients were followed until death or last news up to January 2015. Colectomy-free survival rates at 1 and 5 years and changes in therapy were estimated through Kaplan-Meier method and compared between initial treatment groups through log-rank test., Results: After a median follow-up of 5.4 years, colectomy-free survival rates (95% CI) at 1 and 5 years were, respectively, 70.9% (59.2% to 82.6%) and 61.5% (48.7% to 74.2%) in patients who received ciclosporin and 69.1% (56.9% to 81.3%) and 65.1% (52.4% to 77.8%) in those who received infliximab (p=0.97). Cumulative incidence of first infliximab use at 1 and 5 years in patients initially treated with ciclosporin was, respectively, 45.7% (32.6% to 57.9%) and 57.1% (43.0% to 69.0%). Only four patients from the infliximab group were subsequently switched to ciclosporin. Three patients died during the follow-up, none directly related to UC or its treatment., Conclusions: In this cohort of patients with steroid-refractory ASUC initially treated by ciclosporin or infliximab, long-term colectomy-free survival was independent from initial treatment. These long-term results further confirm a similar efficacy and good safety profiles of both drugs and do not favour one drug over the other., Trial Registration Number: EudraCT: 2006-005299-42; ClinicalTrials.gouv number: NCT00542152; post-results., Competing Interests: Competing interests: DL: consulting and/or lecture fees from Abbvie, Ferring, Janssen, MSD, Pfizer, Takeda. AB: consulting and/or lecture fees from Abbvie, Ferring, MSD, Pfizer, Takeda. MA: consulting and/or lecture fees from Janssen, MSD, Takeda. YB: consulting and/or lecture fees from Abbvie, Ferring, Hospira, Janssen, MSD, Pfizer, Takeda. JF: consulting and/or lecture fees from Abbvie, Ferring, MSD, Takeda. FZ: lecture fees for Abbvie, Takeda. GS: lecture fees from Abbvie, Ferring, MSD, Takeda. LV: lecture fees from Abbvie, Ferring, MSD, Hospira and Takeda and consulting fees from Abbvie. JM: lecture fees from Abbvie, Ferring, MSD, Takeda. AA: consulting and/or lecture fees from Abbvie, Ferring, MSD, Takeda. JC: consulting fees from Abbvie, Vifor. ER: consulting and/or lecture fees from Abbvie, MSD. OD: lecture fees from MSD. AL-S: lecture fees from Abbvie, MSD. MF: lecture fees from Abbvie, MSD, Takeda. GB: lecture fees from Abbvie, MSD, Takeda. BC: lecture fees from Abbvie, MSD. XR: consulting and/or lecture fees from Abbvie, Ferring, Janssen, MSD, Pfizer, Takeda, Theradiag. GvA: consulting and/or lecture fees and research support from MSD, Novartis. ME: consulting and/or lecture fees for MSD, Abbott, Shire Pharmaceuticals. JPG: consulting and/or lecture fees Abbvie, Janssen, Hospira, MSD, Pfizer, Takeda. PM: consulting and/or lecture fees from Abbvie, Ferring, MSD, Pfizer, Takeda. SN: consulting and/or lecture fees from Abbvie, Ferring, MSD, Takeda. MdV: consulting and/or lecture fees from Abbott, Ferring, MSD. EL: research grants from AstraZeneca, Schering-Plough; consulting and/or lecture fees from Abbott, Abbvie, AstraZeneca, Ferring, Schering-Plough, MSD, Chiesi, Menarini, Millenium, Mitsubishi Pharma, Nycomed, Falk, Takeda, UCB., (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/.)

Published
2018
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2. Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab

Author

Laharie, D, Bourreille, A, Branche, J, Allez, M, Bouhnik, Y, Filippi, J, Zerbib, F, Savoye, G, Vuitton, L, Moreau, J, Amiot, A, Cosnes, J, Ricart, E, Dewit, Olivier, Lopez-Sanroman, A, Fumery, M, Carbonnel, F, Bommelaer, G, Coffin, B, Roblin, X, van Assche, G, Esteve, M, Farkkila, M, Gisbert, J P, Marteau, P, Nahon, S, de Vos, M, Lambert, J, Mary, J Y, Louis, E, Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives, Department of Gastroenterology, Centre Hospitalier Général Cannes, Institut de Radioprotection et de Sûreté Nucléaire (IRSN), Laboratoire Électronique Ondes et Signaux pour les Transports (IFSTTAR/COSYS/LEOST), Institut Français des Sciences et Technologies des Transports, de l'Aménagement et des Réseaux (IFSTTAR)-PRES Université Lille Nord de France, Université Pierre et Marie Curie - Paris 6 (UPMC), CHU Amiens-Picardie, Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte - Clermont Auvergne (M2iSH), Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), Groupe Immunité des Muqueuses et Agents Pathogènes (GIMAP), Université Jean Monnet [Saint-Étienne] (UJM), Service de Gastroentérologie [CHU Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Lariboisière, Ghent University Hospital, Institut de biologie et chimie des protéines [Lyon] (IBCP), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Science et Ingénierie des Matériaux et Procédés (SIMaP), Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-Institut National Polytechnique de Grenoble (INPG)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Institut des Maladies de l'Appareil Digestif, Université de Nantes (UN), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Claude Huriez [Lille], CHU Lille, Hôpital Saint-Louis, Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire de Nice (CHU Nice), Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Hôpital de Rangueil, CHU Toulouse [Toulouse], Service d'hépato-gastro-entérologie [APHP Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de Gastroentérologie et nutrition [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Cliniques Universitaires Saint-Luc [Bruxelles], Hospital Universitario Ramón y Cajal [Madrid], Universidad de Alcalá - University of Alcalá (UAH), Service d'Hépato Gastroenterologie [CHU Amiens-Picardie], Hôpital Bicêtre, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, CHU Clermont-Ferrand, Hôpital Louis Mourier - AP-HP [Colombes], Service de gastroentérologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), University Hospitals Leuven [Leuven], Hospital Universitario Mutua de Terrassa, University of Helsinki, Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain., Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Liège (CHU-Liège), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Recherche Agronomique (INRA)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière, Science et Ingénierie des Matériaux et Procédés (SIMaP ), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Service d'hépato-gastroentérologie [CHU Nantes], Hôpital Claude Huriez, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service d'hépato-gastro-entérologie [Hôpital Saint-Louis, APHP], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Hôpital Beaujon, AP HP, Departement de Gastroenterologie et d'assistance Nutritive, Université Paris Diderot - Paris 7 (UPD7), CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Hépato-Gastroentérologie [Rouen], Institute for Research and Innovation in Biomedicine (IRIB), Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Saint-Antoine [APHP], Cliniques Universitaires Saint-Luc, UCL, 1200 Bruxelles, Belgique, parent, Service d'Hépato-gastro-entérologie [APHP Kremlin-Bicêtre], AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Service d'Hépato-Gastroentérologie [CHRU Clermont-Ferrand], Centre Hospitalier Universitaire de Clermont-Ferrand, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Hopital Louis Mourier - AP-HP [Colombes], Department of Gastroenterology, Hospital Universitari Mútua de Terrassa, University of Barcelona, Terrassa. CIBEREHD, Catalonia, Spain., Helsinki University, and Helsinki University Central Hospital, Clinic of Gastroenterology, HUS, Finland., Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) y Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain., Hôpital St-Antoine, service de Gastroentérologie, Paris, France., Nutrition, Métabolisme, Aquaculture (NuMéA), Institut National de la Recherche Agronomique (INRA)-Université de Pau et des Pays de l'Adour (UPPA), Ghent University Hospital, Gent, Belgium., Department of Gastroenterology, University Hospital CHU of Liège, Liège, Belgium., Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Helsingin yliopisto = Helsingfors universitet = University of Helsinki, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, and UCL - (SLuc) Service de gastro-entérologie

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, IBD, Drug Resistance, Azathioprine, Disease-Free Survival, 03 medical and health sciences, COLORECTAL SURGERY, 0302 clinical medicine, Refractory, Gastrointestinal Agents, Internal medicine, medicine, Humans, Cumulative incidence, Colectomy, ComputingMilieux_MISCELLANEOUS, business.industry, Gastroenterology, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, [SDV.BBM.BM]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Molecular biology, Middle Aged, medicine.disease, Ciclosporin, Ulcerative colitis, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Colorectal surgery, Infliximab, 3. Good health, Surgery, Treatment Outcome, ULCERATIVE COLITIS, 030220 oncology & carcinogenesis, Cohort, Cyclosporine, 030211 gastroenterology & hepatology, Colitis, Ulcerative, Female, Steroids, business, Immunosuppressive Agents, medicine.drug
Abstract

ObjectiveCiclosporin and infliximab have demonstrated short-term similar efficacy as second-line therapies in patients with acute severe UC (ASUC) refractory to intravenous steroids. The aim of this study was to assess long-term outcome of patients included in a randomised trial comparing ciclosporin and infliximab.DesignBetween 2007 and 2010, 115 patients with steroid-refractory ASUC were randomised in 29 European centres to receive ciclosporin or infliximab in association with azathioprine. Patients were followed until death or last news up to January 2015. Colectomy-free survival rates at 1 and 5 years and changes in therapy were estimated through Kaplan-Meier method and compared between initial treatment groups through log-rank test.ResultsAfter a median follow-up of 5.4 years, colectomy-free survival rates (95% CI) at 1 and 5 years were, respectively, 70.9% (59.2% to 82.6%) and 61.5% (48.7% to 74.2%) in patients who received ciclosporin and 69.1% (56.9% to 81.3%) and 65.1% (52.4% to 77.8%) in those who received infliximab (p=0.97). Cumulative incidence of first infliximab use at 1 and 5 years in patients initially treated with ciclosporin was, respectively, 45.7% (32.6% to 57.9%) and 57.1% (43.0% to 69.0%). Only four patients from the infliximab group were subsequently switched to ciclosporin. Three patients died during the follow-up, none directly related to UC or its treatment.ConclusionsIn this cohort of patients with steroid-refractory ASUC initially treated by ciclosporin or infliximab, long-term colectomy-free survival was independent from initial treatment. These long-term results further confirm a similar efficacy and good safety profiles of both drugs and do not favour one drug over the other.Trial registration numberEudraCT: 2006-005299-42; ClinicalTrials.gouv number: NCT00542152; post-results.

Published
2018

3. Incidence, Clinical Characteristics, and Management of Psoriasis Induced by Anti-TNF Therapy in Patients with Inflammatory Bowel Disease: A Nationwide Cohort Study

Author

Guerra I, Perez-Jeldres T, Iborra M, Algaba A, Monfort D, Calvet X, Chaparro M, Manosa M, Hinojosa E, Minguez M, Ortiz de Zarate J, Marquez L, Prieto V, Garcia-Sanchez V, Guardiola J, Esther Rodriguez G, Dolores Martin-Arranz M, Garcia-Tercero I, Sicilia B, Masedo A, Lorente R, Rivero M, Fernandez-Salazar L, GUTIERREZ A, Van Domselaar M, Lopez-SanRoman A, Ber Y, Garcia-Sepulcre M, Ramos L, Bermejo F, Gisbert J, and Spanish GETECCU Grp

Subjects
Male, Anti-Inflammatory Agents, Inflammatory bowel disease, Gastroenterology, Cohort Studies, 030207 dermatology & venereal diseases, 0302 clinical medicine, Crohn Disease, adalimumab, Immunology and Allergy, Incidence (epidemiology), Incidence, psoriasis, Prognosis, side effects, Crohn's disease, Cohort, 030211 gastroenterology & hepatology, Tumor necrosis factor alpha, Female, Cohort study, Adult, medicine.medical_specialty, Adolescent, 03 medical and health sciences, Gastrointestinal Agents, inflammatory bowel disease, Psoriasis, Internal medicine, medicine, Humans, Colitis, ulcerative colitis, business.industry, Tumor Necrosis Factor-alpha, Case-control study, Adalimumab, anti-TNF, medicine.disease, Infliximab, Withholding Treatment, Spain, Case-Control Studies, Physical therapy, Colitis, Ulcerative, business, infliximab, Follow-Up Studies
Abstract

Background: Psoriasis induced by anti-tumor necrosis factor-alpha (TNF) therapy has been described as a paradoxical side effect. Aim: To determine the incidence, clinical characteristics, and management of psoriasis induced by anti-TNF therapy in a large nationwide cohort of inflammatory bowel disease patients. Methods: Patients with inflammatory bowel disease were identified from the Spanish prospectively maintained Estudio Nacional en Enfermedad Inflamatoria Intestinal sobre Determinantes geneticos y Ambientales registry of Grupo Espanol de Trabajo en Enfermedad de Croh y Colitis Ulcerosa. Patients who developed psoriasis by anti-TNF drugs were the cases, whereas patients treated with anti-TNFs without psoriasis were controls. Cox regression analysis was performed to identify predictive factors. Results: Anti-TNF-induced psoriasis was reported in 125 of 7415 patients treated with anti-TNFs (1.7%; 95% CI, 1.4-2). The incidence rate of psoriasis is 0.5% (95% CI, 0.4-0.6) per patient-year. In the multivariate analysis, the female sex (HR 1.9; 95% CI, 1.3-2.9) and being a smoker/former smoker (HR 2.1; 95% CI, 1.4-3.3) were associated with an increased risk of psoriasis. The age at start of anti-TNF therapy, type of inflammatory bowel disease, Montreal Classification, and first anti-TNF drug used were not associated with the risk of psoriasis. Topical steroids were the most frequent treatment (70%), achieving clinical response in 78% of patients. Patients switching to another anti-TNF agent resulted in 60% presenting recurrence of psoriasis. In 45 patients (37%), the anti-TNF therapy had to be definitely withdrawn. Conclusions: The incidence rate of psoriasis induced by anti-TNF therapy is higher in women and in smokers/former smokers. In most patients, skin lesions were controlled with topical steroids. More than half of patients switching to another anti-TNF agent had recurrence of psoriasis. In most patients, the anti-TNF therapy could be maintained.

Published
2016

4. Open-label infliximab therapy in ulcerative colitis: a multicenter survey of results and predictors of response

Author

Yago, Gonzalez-Lama, Ignacio, Fernandez-Blanco, Antonio, Lopez-SanRoman, Carlos, Taxonera, Begoña, Casis, Susana, Tabernero, Fernando, Bermejo, Francisca, Martinez-Silva, Juan Luis, Mendoza, Pilar, Martinez-Montiel, Jose Antonio, Carneros, Fernando, Sanchez, Jose, Maté, and Javier P, Gisbert

Subjects
Adult, Aged, 80 and over, Male, Adolescent, Tumor Necrosis Factor-alpha, Antibodies, Monoclonal, Middle Aged, Infliximab, Humans, Colitis, Ulcerative, Female, Aged, Randomized Controlled Trials as Topic, Retrospective Studies
Abstract

Results of randomized controlled trials showing efficacy of infliximab in ulcerative colitis (UC) should be confirmed in clinical practice. We aimed to evaluate the efficacy and safety of infliximab in UC patients of the Madrid area, looking for clinical predictors of response.Multicenter retrospective survey of all UC patients treated with infliximab in the region of Madrid (Spain).47 UC patients were included (45% males, mean age 44 +/- 15 yrs), mean follow up of 4.7 months (range 0.5-21), and a total number of 211 infliximab infusions. Clinical response and steroid-free remission rates were, respectively, 97/42% in the 2nd week, 93/69% in the 6th week, and 80/65% at the long-term follow up (mean 8.2 months, range 3.5-21). Colectomy rate was 10.6% (five patients). Age, gender, disease duration, indication (steroid-resistance/dependence), disease severity, C-reactive protein, concomitant thiopurinic therapy or smoking habit did not influence on efficacy. Extent of the disease was the only predictive factor (p=0.02). Only 4 cases of mild adverse events were reported.Infliximab is effective and safe for UC. Real life clinical practice may have better outcome than showed in randomized controlled trials. Extent of the disease was the only predictive factor for clinical response in our experience.

Published
2008

5. Outcomes of Medical and Surgical Therapy for Entero-urinary Fistulas in Crohn's Disease.

Author

Taxonera, Carlos, Barreiro-de-Acosta, Manuel, Bastida, Guillermo, Martinez-Gonzalez, Javier, Merino, Olga, García-Sánchez, Valle, Gisbert, Javier P., Marín-Jiménez, Ignacio, López-Serrano, Pilar, Gómez-García, María, Iglesias, Eva, Lopez-Sanroman, Antonio, Chaparro, María, Saro, Cristina, Bermejo, Fernando, Pérez-Carazo, Leticia, Plaza, Rocio, Olivares, David, Alba, Cristina, and Mendoza, Juan L.

Abstract

Background and Aims: The aims of this study were to evaluate the frequency of entero-urinary fistulas in a cohort of Crohn's disease (CD) patients and to analyse the outcomes of medical and surgical therapy. Methods: This multicentre retrospective study included all CD patients with entero-urinary fistulas diagnosed by the presence of clinical symptoms and confirmed at surgery or by radiological or endoscopic techniques. We evaluated outcomes of medical and surgical therapy. We defined remission as absence of clinical symptoms with a radiological confirmation of fistula closure. Cox regression analysis was performed to evaluate factors predictive of achieving remission without need for surgery. Results: Of 6081 CD patients screened, 97 had entero-urinary fistulas (frequency 1.6%). Seventy-five percent of fistulas occurred in men. After a median follow-up of 91 months, 96% of patients were in sustained remission. Thirty-three patients (35%) received anti-tumour necrosis factor (TNF) therapy. Of these, 45% achieved sustained remission (median follow-up 35 months) without needing surgery. More than 80% of patients required surgery, which induced remission (median follow-up 101 months) in 99% of them. Only the use of anti-TNF agents was associated with an increased rate of remission without need for surgery (hazard ratio 0.23, 95% confidence interval 0.12-0.44; p< 0.001). Conclusion: In this large cohort of CD patients, the frequency of entero-urinary fistulas was lower than previously described. More than 80% of patients required surgery, and in all but one of them surgery induced sustained remission. In a selected subgroup of patients, anti-TNF may induce long-term fistula remission and radiographic closure, making it possible to avoid surgery. [ABSTRACT FROM AUTHOR]

Published
2016
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6. Evolution of Endoscopic Lesions in Steroid-Refractory Acute Severe Ulcerative Colitis Responding to Infliximab or Cyclosporine.

Author

Laharie, David, Bourreille, Arnaud, Branche, Julien, Allez, Matthieu, Bouhnik, Yoram, Filippi, Jerome, Zerbib, Frank, Savoye, Guillaume, Vuitton, Lucine, Moreau, Jacques, Amiot, Aurelien, Beaugerie, Laurent, Ricart, Elena, Dewit, Olivier, Lopez-Sanroman, Antonio, Fumery, Mathurin, Carbonnel, Franck, Buisson, Anthony, Coffin, Benoit, and Roblin, Xavier

Abstract

Few data on the evolution of endoscopic findings are available in patients with acute severe ulcerative colitis (ASUC). The aim of this study was to describe this evolution in a prospective cohort. Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing infliximab and cyclosporine were eligible if they achieved steroid-free clinical remission at day 98. Flexible sigmoidoscopies were performed at baseline, days 7, 42 and 98. Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion - were post-hoc calculated. Global endoscopic remission was defined by a UCEIS of 0, and partial endoscopic remission by any UCEIS sub-score of 0. Among the 55 patients analyzed (29 infliximab and 26 cyclosporine), 49 (83%) had UCEIS ≥6 at baseline at baseline. Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n = 55); p =.004 and p=.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<.001 for both] and at day 98 [78% and 92% vs. 56% (n = 50); p =.007 and p <.001]. Global endoscopic remission rates at day 98 were higher in patients treated with infliximab than with cyclosporine [73% vs. 25% (n = 26 and 24); p <.001]. In steroid-refractory ASUC patients responding to a second-line medical therapy, endoscopic remission process started with bleeding remission and was not achieved in half the patients at day 98 for vascular pattern. Infliximab provided a higher endoscopic remission rate than cyclosporine at day 98. [ABSTRACT FROM AUTHOR]

Published
2021
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7. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial.

Author

Laharie, David, Bourreille, Arnaud, Branche, Julien, Allez, Matthieu, Bouhnik, Yaram, Filippi, Jerome, Zerbib, Frank, Savaye, Guillaume, Nachury, Maria, Moreau, Jacques, Delchier, Jean-Charles, Cosnes, Jacques, Ricart, Elena, Dewit, Olivier, Lopez-Sanroman, Antonio, Dupas, Jean-Louis, Carbannel, Franck, Bommelaer, Gilles, Coffin, Benoit, and Roblin, Xavier

Subjects
*CLINICAL trials, *INFLIXIMAB, *ULCERATIVE colitis, *STEROIDS, *PHYSICIANS
Abstract

The article discusses a randomized clinical trial which compared the effectiveness and safety of ciclosporin and infliximab in patients with severe ulcerative colitis refractory to intravenous steroids. Results of the trial revealed that ciclosporin is not more effective in comparison to infliximab. It is suggested that the choice of treatment should be guided by physician and center experience.

Published
2012
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