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3. Impact of vedolizumab therapy on extra‐intestinal manifestations in patients with inflammatory bowel disease: a multicentre cohort study nested in the OBSERV‐IBD cohort

Author

Tadbiri, S., Peyrin‐Biroulet, L., Serrero, M., Filippi, J., Pariente, B., Roblin, X., Buisson, A., Stefanescu, C., Trang‐Poisson, C., Altwegg, R., Marteau, P., Vaysse, T., Bourrier, A., Nancey, S., Laharie, D., Allez, M., Savoye, G., Gilletta, C., Gagniere, C., Vuitton, L., Viennot, S., Aubourg, A., Pelletier, A.‐L., Bouguen, G., Abitbol, V., Fumery, M., Claudepierre, P., Bouhnik, Y., Amiot, A., Amiot, Aurelien, Gagniere, Charlotte, Serrero, Melanie, Grimaud, Jean‐Charles, Peyrin‐Biroulet, Laurent, Zallot, Camille, Bigard, Marc‐Andre, Filippi, Jerome, Hebuterne, Xavier, Pariente, Benjamin, Nachury, Maria, Desreumaux, Pierre, Roblin, Xavier, Del Tedesco, Emilie, Buisson, Anthony, Bommelaer, Gilles, Stefanescu, Carmen, Bouhnik, Yoram, Boureille, Arnaud, Trang‐Poisson, Caroline, Altwegg, Romain, Marteau, Philippe, Dray, Xavier, Carbonnel, Franck, Vaysse, Thibaud, Seksik, Philippe, Beaugerie, Laurent, Cosnes, Jacques, Sokol, Harry, Landman, Cecilia, Bourrier, Anne, Nancey, Stephane, Boschetti, Gilles, Laharie, David, Poullenot, Florian, Allez, Matthieu, Gornet, Jean‐Marc, Baudry, Clautilde, Savoye, Guillaume, Moreau, Jacques, Vuitton, Lucine, Koch, Stephane, Viennot, Stephanie, Aubourg, Alexandre, Picon, Laurence, Pelletier, Anne‐Laure, Sickersen, Gaelle, Bouguen, Guillaume, Abitbol, Vered, Chaussade, Stanislas, Fumery, Mathurin, Nahon, Stephane, Winkfield, Betsy, Brixi‐benmansour, Hedia, Gincul, Rodica, Barberis, Jean‐Christophe, Bonaz, Bruno, Michiels, Christophe, Zerbib, Franck, Bourrier de Beauregard, Marie, Locher, Christophe, Davin‐Couve, Sophie, Poirette, Armelle, Guillem, Laurence, Stetiu‐Mocanu, Monica, Philippe, Beau, Beorchia, Sylvain, and Al Qaddi, Jawad

Published
2018
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6. Prediction of Relapse After Anti-Tumor Necrosis Factor Cessation in Crohn's Disease: Individual Participant Data Meta-analysis of 1317 Patients From 14 Studies.

Author

Pauwels, R.W.M., Woude, C.Janneke van der, Nieboer, D., Steyerberg, Ewout W., Casanova, M.J., Gisbert, J.P., Kennedy, N.A., Lees, C.W., Louis, E., Molnár, T., Szántó, K., Leo, E., Bots, S., Downey, R., Lukas, M., Lin, W.C., Amiot, A., Lu, C., Roblin, X., Farkas, K., Seidelin, J.B., Duijvestein, M., D'Haens, G.R.A.M., Vries, A.C.M. de, Pauwels, R.W.M., Woude, C.Janneke van der, Nieboer, D., Steyerberg, Ewout W., Casanova, M.J., Gisbert, J.P., Kennedy, N.A., Lees, C.W., Louis, E., Molnár, T., Szántó, K., Leo, E., Bots, S., Downey, R., Lukas, M., Lin, W.C., Amiot, A., Lu, C., Roblin, X., Farkas, K., Seidelin, J.B., Duijvestein, M., D'Haens, G.R.A.M., and Vries, A.C.M. de

Abstract

01 augustus 2022, Item does not contain fulltext, BACKGROUND & AIMS: Tools for stratification of relapse risk of Crohn's disease (CD) after anti-tumor necrosis factor (TNF) therapy cessation are needed. We aimed to validate a previously developed prediction model from the diSconTinuation in CrOhn's disease patients in stable Remission on combined therapy with Immunosuppressants (STORI) trial, and to develop an updated model. METHODS: Cohort studies were selected that reported on anti-TNF cessation in 30 or more CD patients in remission. Individual participant data were requested for luminal CD patients and anti-TNF treatment duration of 6 months or longer. The discriminative ability (concordance-statistic [C-statistic]) and calibration (agreement between observed and predicted risks) were explored for the STORI model. Next, an updated prognostic model was constructed, with performance assessment by cross-validation. RESULTS: This individual participant data meta-analysis included 1317 patients from 14 studies in 11 countries. Relapses after anti-TNF cessation occurred in 632 of 1317 patients after a median of 13 months. The pooled 1-year relapse rate was 38%. The STORI prediction model showed poor discriminative ability (C-statistic, 0.51). The updated model reached a moderate discriminative ability (C-statistic, 0.59), and included clinical symptoms at cessation (hazard ratio [HR], 2.2; 95% CI, 1.2-4), younger age at diagnosis (HR, 1.5 for A1 (age at diagnosis ≤16 years) vs A2 (age at diagnosis 17 - 40 years); 95% CI, 1.11-1.89), no concomitant immunosuppressants (HR, 1.4; 95% CI, 1.18-172), smoking (HR, 1.4; 95% CI, 1.15-1.67), second line anti-TNF (HR, 1.3; 95% CI, 1.01-1.69), upper gastrointestinal tract involvement (HR, 1.3 for L4 vs non-L4; 95% CI, 0.96-1.79), adalimumab (HR, 1.22 vs infliximab; 95% CI, 0.99-1.50), age at cessation (HR, 1.2 per 10 years younger; 95% CI, 1-1.33), C-reactive protein (HR, 1.04 per doubling; 95% CI, 1.00-1.08), and longer disease duration (HR, 1.07 per 5 years; 95% CI, 0.98-1.17)

Published
2022

13. Management of perianal fistulas in Crohn's disease: a 2021 update of the French National Society of Coloproctology consensus.

Author

Bouchard, D., Pigot, F., de Parades, V., Staumont, G., Abramowitz, L., Siproudhis, L., Members of the SNFCP, Tracanelli, L., Fathallah, N., Babin-Pigot, E., Ferry, M., Members of the GETAID, Bouguen, G., Laharie, D., Cotte, E., Panis, Y., Peyrin-Biroulet, L., Roblin, X., and Zerbib, P.

Subjects
CROHN'S disease, ANAL diseases, TUMOR necrosis factors, MAGNETIC resonance imaging, FISTULA, STEM cells
Abstract

Background: Since our last publication of algorithms for the management of perianal fistulas in patients with Crohn's disease, researchers have proposed a treat to target strategy systematic combotherapy for anal lesions, and indications for stem cell injection. In the absence robust publications, the Société Nationale Française de Coloproctologie (French National Society of Coloproctology [SNFCP]) wished to establish a group consensus using the Delphi method. Methods: From October 2020 to January 2021, a scientific committee and panel of gastroenterologists and surgeons established answers which were submitted to the members of the SNFCP during a national conference in November 2020. Three questions were clarified and reformulated, and then submitted during a third and final round of consultation of members of the SNFCP. Results: The target was defined as being the response obtained in every domain (symptoms, physical and radiological evaluation) which could be considered satisfactory, without the need to intensify therapeutic management. By consensus, the time required for clinical evaluation of the efficacy of treatment was 6 months. A response on magnetic resonance imaging (MRI) should include the absence of a collection of 10 mm or more in size at 6 months, and a frank decrease or complete disappearance of hyperintensity in T1 and T2 sequences of the main tract at 12 months. Systematic association of an immunosuppressant with tumor necrosis factor inhibitors did not reach the consensus level for adalimumab (50%), but just did for infliximab (70%). The majority of the respondents considered failure of one, or even two lines of different biotherapies to be potential indications for injection of stem cells. Conclusions: These findings reinforce the importance of composite targets including MRI evaluation, and underscore the need for precise timing of evaluation. Combotherapy is only recommended with infliximab. Injection of stem cells is a second- or third-line option. [ABSTRACT FROM AUTHOR]

Published
2022
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14. P465 Is golimumab serum level predictive of clinical remission after intensification for loss of response in patients with ulcerative colitis?

Author

Fumery, Mathurin, Nancey, S., Filippi, J., Altwegg, R., Hebuterne, X., Boschetti, G., Veyrard, P., Yzet, Clara, Paul, S., Roblin, X., CHU Amiens-Picardie, Périnatalité et Risques Toxiques - UMR INERIS_I 1 (PERITOX), Institut National de l'Environnement Industriel et des Risques (INERIS)-Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Département de Gastroentérologie, Hôpital de l'Archet 2, Simplification des soins chez les patients complexes - UR UPJV 7518 (SSPC), Université de Picardie Jules Verne (UPJV), and Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)

Subjects
[SDV]Life Sciences [q-bio], Gastroenterology, General Medicine, ComputingMilieux_MISCELLANEOUS
Abstract

Background Loss of response to golimumab occurs in nearly 40% of patients with ulcerative colitis (UC). Unlike others anti-TNF, no study has reported a correlation between serum golimumab level and response to drug intensification. The objective of this study was therefore to determine a threshold of serum golimumab before intensification predictive of clinical remission after optimization. Methods We included consecutive patients with UC and loss of response to golimumab (Mayo score between 6 and 12 and an endoscopic Mayo sub-score> 1) in a prospective multicentric cohort. Patients with loss of response at 50 mg / 4 weeks (W) and 100 mg / 4W underwent therapeutic intensification at 100 mg / 4W and 100 mg / 2W, respectively. Patients were followed prospectively with a first evaluation between weeks 2 and 4 (visit 2) and between weeks 4 and 8 (visit 3) after intensification. Clinical remission was defined by partial Mayo score ≤ 1. Serum level and anti-golimumab antibodies were evaluated at each visit (Lisa Tracker, Theradiag France). Results A total of 47 patients (female, 50%; median age, 39 years (IQR, 27–52) treated with golimumab for a median of 20.4 weeks (IQR, 10.7–38.3) were included. The median partial Mayo score was 6 (IQR, 5–7) and the endoscopic Mayo score was 3 (IQR, 2–3). The median golimumab serum level before intensification was 2.23 µg / mL (IQR, 1.02–3.96) and only three patients (6.2%) had anti-drug antibodies. After a total of 50 drug intensification, 23 (48.9%) patients had clinical response (100 mg / 4W: 14/25 (58.3%); 100 mg / 2W: 9/25 (36%)), 10 (21%) clinical remission and 18 (39%) endoscopic response. The median golimumab levels before intensification were respectively 2.17 µg / mL (IQR, 0.97–3.25) and 2.47 (IQR, 1.10–4.05) in responders and non-responders (p = 0.66), and 1.11 µg / mL (IQR, 0.59–2.29) and 2.47 µg / mL (IQR, 1.21–3.83) in patients with and without clinical remission after intensification (p = 0.054). In multivariate analysis, intensification to golimumab 100 mg / 2W (vs 100 mg / 4W) (OR, 0.11 [95%CI, 0.01 - 0.87], p=0.037) and change of golimumab level between V1 and V2 (OR, 1.48 [95%CI, 1.02 - 2.14], p=0.037) were significantly associated with clinical remission after intensification. Only one serious adverse event (infection) was reported during the 24-week follow-up. Conclusion In this prospective multicentric study, half of patients recaptured response following golimumab intensification in UC. Change of golimumab level was predictive of clinical remission after intensification.

Published
2022
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29. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

Author

Sands, B. E., Sandborn, W. J., Panaccione, R., O'Brien, C. D., Zhang, H., Johanns, J., Adedokun, O. J., Li, K., Peyrin-Biroulet, L., Van Assche, G., Danese, S., Targan, S., Abreu, M. T., Hisamatsu, T., Szapary, P., Brown S, Marano C., Connor, S, De Cruz, P, Ding, Nj, Florin, T, Hendy, P, Leong, R, Moore, G, Pavli, P, Sparrow, M, Gassner, S, Vogelsang, H, Baert, F, Colard, A, De Vos, M, D'Heygere, F, Ferrante, M, Louis, E, Staessen, D, Berova, T, Churchev, J, Draganova, R, Gancheva, D, Ivanova, N, Marinova, I, Markov, M, Nikolov, R, Tsonev, N, Vassileva, G, Afif, W, Berstein, C, Bressler, B, Jairath, V, Lachance, Jr, Singh, R, Tilbe, K, Komarek, V, Kozeluhova, J, Lukas, M, Volfova, M, Dahlerup, J, Altwegg, R, Beorchia, S, Bouguen, G, Cadiot, G, Dupas, Jl, Desreumaux, P, Flourie, B, Grimaud, Jc, Guillaud, O, Moreau, J, Roblin, X, Zerbib, F, Baumgart, D, Beckebaum, S, Bokemeyer, B, Ebert, M, Hasselblatt, P, Lügering, A, Maaser, C, Schiefke, I, Schreiber, S, Seidler, U, Altorjay, I, Kiss, Gg, Literati-Nagy, B, Patai, A, Pecsi, G, Salamon, A, Schnabel, R, Székely, A, Tulassay, Z, Varga, M, Fich, A, Fishman, S, Konikoff, F, Lichtenstein, L, Rainis, T, Sbeit, W, Schwartz, D, Annese, V, Biancone, L, Bossa, F, Costintino, R, Danese, S, Fries, W, Gasbarrini, A, Guidi, L, Kohn, A, Maconi, G, Rocca, R, Rogai, F, Villa, E, Zoli, G, Akiho, H, Aoyama, N, Arisawa, T, Hidaka, H, Hisamatsu, T, Horiki, N, Inaba, T, Inoue, S, Ishida, T, Ishida, H, Ishiguro, Y, Ishihara, S, Iwabuchi, M, Kato, J, Katsushima, S, Kobayashi, T, Kojima, Y, Kurihara, H, Masuo, T, Matsui, T, Matsumoto, T, Matsuoka, K, Mitsuyama, K, Motoya, S, Nakagawa, T, Nakai, K, Nakamura, S, Niihara, T, Ohnishi, Y, Ohta, A, Osada, T, Ryuichi, I, Sakai, Y, Sakata, Y, Sameshima, Y, Sano, K, Shibatoge, M, Shibuya, T, Suzuki, Y, Takeshima, F, Tanaka, S, Taruishi, M, Tokito, S, Ueo, T, Watanabe, K, Yamagami, H, Cheon, Jh, Cho, Kb, Knowles, Kim, Kim, Hj, Kim, Y, Lee, Km, Yang, Sk, D'Haens, G, Pierik, M, Gearry, R, Inns, S, Rowbotham, D, Schultz, M, Bochenek, A, Gawdis-Wojnarska, B, Kleczkowski, D, Leszczyszyn, J, Malecka-Panas, E, Mamos, A, Petryka, R, Regula, J, Rozciecha, J, Stefanuik, P, Wozniak-Stolarska, B, Cimpoeru, N, Craciun, E, Ovidiu, Cf, Goldis, E, Ionita-Radu, F, Lazar, D, Suciu, I, Abdulkhakov, R, Alikhanov, B, Apartsin, K, Bakulin, I, Belousova, E, Gofman, A, Grinevich, V, Kulyapin, A, Nizov, A, Osipenko, M, Simanenkov, V, Tkachev, A, Uspenskiy, Y, Valuyskikh, E, Jovanovic, I, Nagorni, A, Svorcan, P, Zdravkovic, N, Bunganic, I, Abrahamovych, O, Bilianskyi, L, Datsenko, O, Golovchenko, O, Kharchenko, N, Klymenko, V, Levchenko, O, Lozynskyy, Y, Murenets, N, Oliinyk, O, Prystupa, L, Pyrogovskyi, V, Reznikova, V, Rishko, I, Stanislavchuk, M, Vizir, V, Yatsyshyn, R, Arasaradnam, R, Bloom, S, Cummings, F, Iqbal, T, Irving, P, Kaser, A, Shonde, A, Subramanian, S, Aberra, F, Aguilar, H, Araya, V, Bakken, A, Beaulieu, D, Cappa, Ja, Chiorean, M, Cohen, N, Dryden, G, Duvall, G, Ehrlich, A, Eisner, M, Ertan, A, Fogel, R, Friedenberg, K, Gatof, D, Glover, S, Grosman, I, Gunaratnam, N, Gupta, N, Haynes, P, Hemaidan, A, Higgins, P, Hou, J, Hudesman, D, Iskandar, H, Jazrawi, S, Jones, M, Karnam, U, Khurana, S, Killpack, M, Kreines, M, Lawlor, G, Lee, S, Loftus, E, Lukin, Dj, Marcet, J, Mattar, M, Melmed, G, Minor, T, Mirkin, K, Mutlu, E, Nichols, M, Nudell, J, Rai, R, Ramos, C, Mcleod, Randall, Rausher, D, Ritter, T, Singh Saini, S, Salzberg, B, Saubermann, L, Scherl, E, Sedghi, S, Sellin, J, Shafran, I, Sorrentino, D, Suiter, D, Swaminath, A, Tiongco, F, Vrabie, R, Walp, K, Warner, N, Winstead, N, Wolf, Dc, Woods, J, Yen, E, Younes, Z., Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Humanitas Clinical and Research Center [Rozzano, Milan, Italy], RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Maag Darm Lever (9), Interne Geneeskunde, Sands, Be, Sandborn, Wj, Panaccione, R, O'Brien, Cd, Zhang, H, Johanns, J, Adedokun, Oj, Li, K, Peyrin-Biroulet, L, Van Assche, G, Danese, S, Targan, S, Abreu, Mt, Hisamatsu, T, Szapary, P, and Marano, C

Subjects
Adult, Male, Infusions, [SDV]Life Sciences [q-bio], Injections, Subcutaneous, Anti-Inflammatory Agents, Ulcerative, Klinikai orvostudományok, Article, Injections, Maintenance Chemotherapy, Dose-Response Relationship, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, INFLIXIMAB, Colitis, Ulcerative, Dose-Response Relationship, Drug, Female, Humans, Induction Chemotherapy, Infusions, Intravenous, Patient Acuity, Remission Induction, Ustekinumab, ComputingMilieux_MISCELLANEOUS, ACTIVITY INDEXES, Subcutaneous, Orvostudományok, General Medicine, EFFICACY, Colitis, 3. Good health, INFECTIONS, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Drug, Intravenous
Abstract

The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of ≤2 on the Mayo scale [range, 0 to 12, with higher scores indicating more severe disease] and no subscore1 [range, 0 to 3] on any of the four Mayo scale components).The percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P0.001 for both comparisons). Among patients who had a response to induction therapy with ustekinumab and underwent a second randomization, the percentage of patients who had clinical remission at week 44 was significantly higher among patients assigned to 90 mg of subcutaneous ustekinumab every 12 weeks (38.4%) or every 8 weeks (43.8%) than among those assigned to placebo (24.0%) (P = 0.002 and P0.001, respectively). The incidence of serious adverse events with ustekinumab was similar to that with placebo. Through 52 weeks of exposure, there were two deaths (one each from acute respiratory distress syndrome and hemorrhage from esophageal varices) and seven cases of cancer (one each of prostate, colon, renal papillary, and rectal cancer and three nonmelanoma skin cancers) among 825 patients who received ustekinumab and no deaths and one case of cancer (testicular cancer) among 319 patients who received placebo.Ustekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.).

Published
2019
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31. Comparison of Adalimumab Serum Drug Levels When Delivered by Pen Versus Syringe in Patients with Inflammatory Bowel Disease. An International, Multicentre Cohort Analysis.

Author

Shelton E., Ward M.G., Roblin X., Little R.D., Chu I.E., Connor S.J., Van Der Zanden E.P., Flanagan E., Bell S.J., Gibson P.R., Sparrow M.P., Shelton E., Ward M.G., Roblin X., Little R.D., Chu I.E., Connor S.J., Van Der Zanden E.P., Flanagan E., Bell S.J., Gibson P.R., and Sparrow M.P.

Abstract

Background: Adalimumab is administered via a pre-filled syringe or spring-loaded pen. In a previous study in Crohn's disease, higher drug levels were observed in syringe users. The aim of this study was to evaluate the impact of delivery device on adalimumab drug levels in patients with Crohn's disease. Method(s): Consecutive Crohn's disease patients treated with maintenance adalimumab [40 mg fortnightly] were recruited from five centres. The first recorded drug level with matched clinical and biochemical markers of disease activity was compared between pen and syringe users. Result(s): Of 218 patients, 64% used pen, with a median faecal calprotectin 110 mug/g and serum C-reactive protein 4 mg/L. In comparison to pen, syringe users had higher albumin [39 vs 42 g/L; p = 0.016], lower Harvey-Bradshaw Index [2 vs 1; p = 0.017], and higher rates of concomitant immunomodulation [54% vs 71%; p = 0.014]. Drug levels were equivalent between pen and syringe users [median 5.3 vs 5.2 mug/ml; p = 0.584], even after controlling for disease activity and immunomodulation. Syringe users at Alfred Health had higher drug levels than pen [6.1 vs 4.5 mug/ml; p = 0.039]; a greater proportion achieved therapeutic levels [75% vs 44%; p = 0.045]. A higher proportion of pen users from Saint-Etienne had therapeutic levels [79% vs 42%; p = 0.027], yet no significant difference in drug levels [7.9 vs 4.5 mug/ml; p = 0.119]. Conclusion(s): Delivery device does not appear to significantly affect adalimumab drug levels. Given differences between study sites, studies evaluating administration education and technique are warranted.Copyright © 2019 European Crohn's and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved.

Published
2020

34. Adalimumab for patients with Crohn’s disease complicated by intra-abdominal abscess: a multicentre, prospective, observational cohort study

Author

Pineton de Chambrun, G., Pariente, B., Seksik, P., Altwegg, R., Vuitton, L., Stefasnescu, C, Nancey, S., Aubourg, A, Serrero, M, Peyrin-Biroulet, L., Filippi, J., Viennot, S, Abitbol, V., Boualit, M., Boureille, A, Moreau, J., Buisson, A., Roblin, X., Nachury, M., Zappa, M., Lambert, J., Bouhnik, Y., Study Group, Getaid-Mica, Herrada, Anthony, Département d'Hépato-Gastroentérologie et de Transplantation Hépatique [CHU Saint-Eloi], Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université de Montpellier (UM), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Hôpital Claude Huriez [Lille], CHU Lille, Service de Gastroentérologie et nutrition [CHU Saint-Antoine], 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), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service de Gastroentérologie [Hôpital Beaujon], Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service d'Hépatologie et de Gastroentérologie [Lyon], Hospices Civils de Lyon (HCL), Département d'hépato-gastro-entérologie [Hôpital Trousseau : CHRU Tours], CHU Trousseau [APHP], Hôpital Nord [CHU - APHM], Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Universitaire de Nice (CHU Nice), Service d'Hépato-Gastro-Enterologie et Nutrition [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de Gastro-entérologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier [Valenciennes, Nord], Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Clermont-Ferrand, Service de gastroentérologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Service de biostatistiques et information médicale [Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université de Montpellier (UM)-CHU Saint-Eloi, Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), 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), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-CHU Trousseau [APHP], CHU Toulouse [Toulouse], Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)-CHU Trousseau [APHP], and Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris]

Subjects
0301 basic medicine, medicine.medical_specialty, medicine.medical_treatment, 03 medical and health sciences, 0302 clinical medicine, medicine, Adalimumab, Abscess, Crohn's disease, business.industry, General surgery, Gastroenterology, Abdominal Abscess, Intra-abdominal Abscess, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, General Medicine, Bowel resection, medicine.disease, Crohn's Disease Activity Index, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, 3. Good health, 030104 developmental biology, 030211 gastroenterology & hepatology, business, Cohort study, medicine.drug
Abstract

International audience; doi:10.1093/ecco-jcc/jjy222 Abstract P528 from the 'Poster presentations' section of the main abstract book has been withdrawn and re-inserted as DOP63 in the 'Late-breaking abstracts' section.

Published
2019
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35. Patient Perspectives on Biosimilars: A Survey by the European Federation of Crohn's and Ulcerative Colitis Associations

Author

Peyrin-Biroulet L, Lonnfors S, Roblin X, Danese S, Avedano L, Peyrin-Biroulet, L, Lonnfors, S, Roblin, X, Danese, S, and Avedano, L

Abstract

Background and Aim: The aim of this survey was to find out the patients' perspectives concerning biosimilars. Methods: An online survey consisting of 14 questions was made available between November 2014 and October 2015. Only respondents who had heard of biosimilars were asked to respond the final twelve questions. Results: A total of 1181 patients responded. Of these, 38% had heard of biosimilars. The respondents worried about biosimilars' safety profile [47.0%], efficacy [40.3%], and molecular basis [35.0%]. Only 25.2% of the respondents had no concerns about biosimilars. Just over half [55.9%] of the respondents thought that the lower cost of the biosimilars should not come before their safety and efficacy. Only 12.5% of respondents felt that extrapolation made sense. The survey showed that 39.9% felt that patients should be systematically informed, and 26.7% felt that patient associations should be informed and able to give their opinions. It also revealed that 20.9% of the respondents would be against the idea of interchangeability if the patient was not aware 65.7% of the respondents would want to know whether they were receiving the reference drug or the biosimilar, and have all necessary information in writing before the drug was administered. Only 31.0% of the respondents would be fully confident about biosimilars, even if they were prescribed and explained by the treating physician. Conclusions: Most patients were not familiar with biosimilars, and those who were had doubts and concerns about the biosimilars' safety and efficacy. The patients wished to be informed and involved in decision-making concerning biosimilars.

Published
2017

37. 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
Full Text
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40. Is there a difference in adalimumab drug levels according to pen versus syringe use: An international, multicenter retrospective analysis.

Author

Little R.D., Shelton E., Sparrow M.P., Bell S.J., Flanagan E., Van Der Zanden E.P., Chu I.E., Ward M.G., Roblin X., Connor S.J., Little R.D., Shelton E., Sparrow M.P., Bell S.J., Flanagan E., Van Der Zanden E.P., Chu I.E., Ward M.G., Roblin X., and Connor S.J.

Abstract

Introduction: In an intensive pharmacokinetic study of adalimumab (ADA) in Crohn's disease (CD), trough drug levels were significantly higher in syringe compared with pen users. Further data addressing the impact of delivery device on ADA drug level are lacking. Aim(s): Our aim was to compare drug levels associated with the use of pen and syringe delivery in patients undergoing maintenance ADA therapy for CD. Method(s): This was a retrospective observational study of adult patients with CD receiving 40 mg ADA fortnightly (for >14 weeks) across five centers. Therapeutic drug monitoring (TDM) was performed with ELISA as per manufacturer's instructions. Data on the first recorded drug level (independent of indication); markers of disease activity, including Harvey Bradshaw Index (HBI), C-reactive protein (CRP), and fecal calprotectin (FCP); and patient and disease characteristics were collected. Drug levels >4.9 mug/mL were considered therapeutic, and active disease was defined as CRP >5 mg/L or FCP >150 mug/g. Result(s): A total of 218 patients were included; 52% were male, the mean age was 39 years, and 60% received concomitant immunomodulation. Mean FCP level was 283 mug/g, and CRP level was 10.2 mg/L at TDM. Pens were used by 64% of the cohort. Syringe users had a higher albumin level (40 vs 38 g/L; P = 0.016), lower HBI (2.2 vs 3.4; P = 0.017), and higher rates of concomitant immunomodulation (71% vs 54%; P = 0.014) than pen users. No significant differences in disease activity (CRP or FCP), duration, or patient demographics between delivery device were observed. Considering all patients, there was no difference in drug levels in pen versus syringe (5.3 vs 5.2 mug/mL; P = 0.442; Fig. 1a). Fur-thermore, drug levels did not differ between pen and syringe users when controlling for disease activity (CRP or FCP). On subgroup analyses by center, syringe users at Alfred Health had significantly higher drug levels than pen users (6.1 vs 4.5 mug/mL; P = 0.039; Fig. 1b), a

Published
2018

41. Is there a difference in adalimumab drug levels according to pen vs. syringe use: An international, multi-centre retrospective analysis.

Author

Ward M., Sparrow M., Shelton E., Connor S., Roblin X., Little R., Chu I., Van Der Zanden E., Flanagan E., Bell S., Ward M., Sparrow M., Shelton E., Connor S., Roblin X., Little R., Chu I., Van Der Zanden E., Flanagan E., and Bell S.

Abstract

Background: In an intensive pharmacokinetic study of adalimumab (ADA) in Crohn's disease (CD), trough drug levels were significantly higher in syringe compared with pen users.1 Further data addressing the impact of delivery device on ADA drug level are lacking. Method(s): Retrospective observational study of adult CD patients receiving 40 mg ADA fortnightly (for >14 weeks) across five centres. Therapeutic drug monitoring (TDM) was performed with the following ELISA kits: Shikari (Matriks) at Alfred Health, St Vincent's Hospital, Monash Health and 54% of samples from Liverpool Hospital, Australia; LISA Tracker (Theradiag) at CHU Saint-Etienne, France; Promonitor (Grifols) for 46% of samples from Liverpool Hospital. The first recorded drug level (independent of indication), markers of disease activity including Harvey Bradshaw Index (HBI), C-reactive protein (CRP) and faecal calprotectin (FCP), and patient/disease demographics were collected. Drug levels >4.9 mug/ml were considered therapeutic, active disease was defined as CRP >5 mg/l or FCP >150 mug/g. Result(s): A total of 218 patients were included. 52% of patients were male, mean age 39 years, 60% received concomitant immunomodulation. Mean FCP was 283 mug/g and CRP 10.2 mg/l at TDM. Pens were used by 64% of the cohort. Syringe users had a higher albumin, lower HBI and higher rates of concomitant immunomodulation than pen users (40 vs. 38 g/l, p = 0.016; 2.2 vs. 3.4, p = 0.017; 71 vs. 54%, p = 0.014). No significant differences in disease activity (CRP or FCP), duration or patient demographics between delivery device were observed. Considering all patients, there was no difference in drug levels in pen vs. syringe (5.3 vs. 5.2 mug/ml, p = 0.442, Figure 1a). Furthermore, drug levels did not differ between pen vs. syringe when controlling for disease activity (CRP or FCP). On subgroup analyses by centre, syringe users at Alfred Health had significantly higher drug levels than pen users (6.1 vs. 4.5 mug/ml, p = 0.03

Published
2018

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

Author

UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, 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, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, 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, and Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives

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.

Published
2018

43. Methotrexate for Corticosteroid- Dependent Ulcerative Colitis: Results of a Placebo Randomized Controlled Trial

Author

Carbonnel F, Colombel JF, Filippi J, Katsanos K, Peyrin-Biroulet L, Allez M, Nachury M, Novacek G, Danese S, Abitbol V, Bossa F, Moreau J, Bommelaer G, Bourreille A, Dupas JL, Roblin X, Bouhnik Y, Reinisch W, Farkkila MA, Brixi H, Seksik P, Malamut G, Coulibaly B, Dewit O, Louis E, Deplanque D, Michetti PF, Sarter H, Laharie D, Carbonnel, F, Colombel, Jf, Filippi, J, Katsanos, K, Peyrin-Biroulet, L, Allez, M, Nachury, M, Novacek, G, Danese, S, Abitbol, V, Bossa, F, Moreau, J, Bommelaer, G, Bourreille, A, Dupas, Jl, Roblin, X, Bouhnik, Y, Reinisch, W, Farkkila, Ma, Brixi, H, Seksik, P, Malamut, G, Coulibaly, B, Dewit, O, Louis, E, Deplanque, D, Michetti, Pf, Sarter, H, and Laharie, D

Published
2015

47. Azathioprine dose reduction in inflammatory bowel disease patients on combination therapy: an open-label, prospective and randomised clinical trial

Author

Roblin, X., primary, Boschetti, G., additional, Williet, N., additional, Nancey, S., additional, Marotte, H., additional, Berger, A., additional, Phelip, J. M., additional, Peyrin-Biroulet, L., additional, Colombel, J. F., additional, Del Tedesco, E., additional, Paul, S., additional, and Flourie, B., additional

Published
2017
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48. Addition of an immunomodulator can reverse antibody formation and loss of response in patients treated with adalimumab

Author

Ungar, B., primary, Kopylov, U., additional, Engel, T., additional, Yavzori, M., additional, Fudim, E., additional, Picard, O., additional, Lang, A., additional, Williet, N., additional, Paul, S., additional, Chowers, Y., additional, Bar-Gil Shitrit, A., additional, Eliakim, R., additional, Ben-Horin, S., additional, and Roblin, X., additional

Published
2016
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49. One-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multicentre cohort study.

Author

Amiot, A., Serrero, M., Peyrin‐Biroulet, L., Filippi, J., Pariente, B., Roblin, X., Buisson, A., Stefanescu, C., Trang‐Poisson, C., Altwegg, R., Marteau, P., Vaysse, T., Bourrier, A., Nancey, S., Laharie, D., Allez, M., Savoye, G., Moreau, J., Vuitton, L., and Viennot, S.

Subjects
VEDOLIZUMAB, INFLAMMATORY bowel disease diagnosis, CROHN'S disease, ULCERATIVE colitis diagnosis, CLINICAL competence, PHYSIOLOGY, THERAPEUTICS
Abstract

Background We recently showed that vedolizumab is effective in patients with Crohn's disease (CD) and ulcerative colitis (UC) with prior anti-TNF failure in a multicentre compassionate early-access programme before marketing authorisation was granted to vedolizumab. Aims To assess effectiveness and safety of vedolizumab at week 54 in patients UC and CD. Methods Between June and December 2014, 173 patients with Crohn's disease (CD) and 121 with ulcerative colitis (UC) were treated with vedolizumab induction therapy. Among those 294 patients, 272 completed the induction period and were evaluated at the week 14 visit (161 patients with CD and 111 with UC). Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. The primary outcome was steroid-free clinical remission at week 54. Results At week 54, steroid-free clinical remission rates at week 54 were 27.2% and 40.5% in patients with CD and UC respectively. In addition, the sustained steroid-free clinical remission (from week 14 to week 54) rates were 8.1% and 19.0% respectively. No deaths were observed. Severe adverse events occurred in 17 (7.2%) patients, including six (2.5%) leading to vedolizumab discontinuation. Conclusion Vedolizumab is able to maintain steroid-free clinical remission in up to one-third of patients with UC and CD at week 54 with a reasonable safety profile. A significant number of patients experienced loss of response during the first year of treatment, particularly in patients with CD. [ABSTRACT FROM AUTHOR]

Published
2017
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50. Factors associated with pregnancy outcome in anti-TNF treated women with inflammatory bowel disease

Author

UCL - (MGD) Service de gastro-entérologie, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, Seirafi, M., De Vroey, B., Amiot, A., Seksik, P., Roblin, X., Allez, M., Peyrin-Biroulet, L., Marteau, P., Cadiot, G., Laharie, D., Boureille, A., De Vos, M., Savoye, G., Rahier, Jean-François, Carbonnel, F., Bonaz, B., Colombel, J.-F., Bouhnik, Y., UCL - (MGD) Service de gastro-entérologie, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, Seirafi, M., De Vroey, B., Amiot, A., Seksik, P., Roblin, X., Allez, M., Peyrin-Biroulet, L., Marteau, P., Cadiot, G., Laharie, D., Boureille, A., De Vos, M., Savoye, G., Rahier, Jean-François, Carbonnel, F., Bonaz, B., Colombel, J.-F., and Bouhnik, Y.

Abstract

Background The safety of anti-tumour necrosis factor (TNF) agents during pregnancy is a major concern for child-bearing women and physicians. Aim To assess the impact of anti-TNF therapy on adverse pregnancy and foetal outcomes in women with inflammatory bowel disease (IBD). Methods Pregnancies occurring during anti-TNF treatment or less than 3 months after its cessation in IBD patients followed in GETAID centres were recorded from January 2009 to December 2010. Ninety-nine pregnancies in women without anti-TNF treatment were identified from the CESAME registry. We compared pregnancy and neonatal outcomes by a case-control study. Results In the 124 IBD patients followed, 133 pregnancies were reported. At the conception time, 23% of patients had active disease. Eighty-eight per cent (n = 117) of the 133 pregnancies followed until delivery resulted in 118 liveborns (one twin pregnancy). Complications were observed in 47 (35%) women and 24 (20%) newborns. In multivariate analysis, factors associated with pregnancy complications were: current smoking (P = 0.004), a B2 (stenotic) phenotype in CD women (P = 0.004), occurrence of a flare during pregnancy (P = 0.006) and a past history of complicated pregnancy (P = 0.007). Current smoking was the only factor associated with severe (i.e. potentially lethal) pregnancy complications (P = 0.02). Having IBD for more than 10 years prior to conception was associated with newborn complications (P = 0.007). No difference was found with the control group for any of the pregnancy and neonatal outcomes. Conclusion In our series, the safety profile of anti-TNF therapy during pregnancy and the neonatal period appears similar to control group of IBD women not treated with anti-TNF therapy. © 2014 John Wiley & Sons Ltd.

Published
2014

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