7 results on '"Boualit, M"'
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2. DOP65 Infliximab plus azathioprine and quick steroids discontinuation versus azathioprine plus steroids in patients with acute severe Ulcerative Colitis responding to intravenous steroids: a parallel, open-label randomized controlled trial
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Amiot, A, primary, Seksik, P, additional, Meyer, A, additional, Stefanescu, C, additional, Wils, P, additional, Altwegg, R, additional, Vuitton, L, additional, Plastaras, L, additional, Nicolau, A, additional, Buisson, A, additional, Duveau, N, additional, Laharie, D, additional, Boualit, M, additional, Allez, M, additional, Coffin, B, additional, Chanteloup, E, additional, Bouguen, G, additional, Vicaut, E, additional, and Peyrin-Biroulet, L, additional
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- 2024
- Full Text
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3. A Novel 8-Predictors Signature to Predict Complicated Disease Course in Pediatric-onset Crohn’s Disease: A Population-based Study
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Sarter, Hélène, Savoye, Guillaume, Marot, Guillemette, Ley, Delphine, Turck, Dominique, Hugot, Jean-Pierre, Vasseur, Francis, Duhamel, Alain, Wils, Pauline, Princen, Fred, Colombel, Jean-Frédéric, Gower-Rousseau, Corinne, Fumery, Mathurin, Al Hameedi, R, Al Khatib, M, Al Turk, S, Agoute, E, Andre, J, Antonietti, M, Aouakli, A, Armand, A, Armengol-Debeir, L, Aroichane, I, Assi, F, Aubet, J, Auxenfants, E, Avram, A, Ayafi-Ramelot, F, Azzouzi, K, Bankovski, D, Barbry, B, Bardoux, N, Baron, P, Baudet, A, Bayart, P, Bazin, B, Bebahani, A, Becqwort, J, Bellati, S, Benet, V, Benali, H, Benard, C, Benguigui, C, Ben Soussan, E, Bental, A, Berkelmans, I, Bernet, J, Bernou, K, Bernou-Dron, C, Bertot, P, Bertiaux-Vandaële, N, Bertrand, V, Billoud, E, Biron, N, Bismuth, B, Bleuet, M, Blondel, F, Blondin, V, Bobula, M, Bohon, P, Bondjemah, V, Boniface, E, Bonkovski, D, Bonnière, P, Bonvarlet, E, Bonvarlet, P, Boruchowicz, A, Bostvironnois, R, Boualit, M, Bouazza, A, Bouche, B, Boudaillez, C, Bourgeaux, C, Bourgeois, M, Bourguet, A, Bourienne, A, Boutaleb, H, Bouthors, A, Branche, J, Bray, G, Brazier, F, Breban, P, Bridenne, M, Brihier, H, Bril, L, Brung-Lefebvre, V, Bulois, P, Burgiere, P, Butel, J, Canva, J, Canva-Delcambre, V, Capron, J, Cardot, F, Carette, S, Carpentier, P, Cartier, E, Cassar, J, Cassagnou, M, Castex, J, Catala, P, Cattan, S, Catteau, S, Caujolle, B, Cayron, G, Chandelier, C, Chantre, M, Charles, J, Charneau, T, Chavance-Thelu, M, Cheny, A, Chirita, D, Choteau, A, Claerbout, J, Clergue, P, Coevoet, H, Cohen, G, Collet, R, Colin, M, Colombel, J, Coopman, S, Cordiez, L, Corvisart, J, Cortot, A, Couttenier, F, Crinquette, J, Crombe, V, Dadamessi, I, Daoudi, H, Dapvril, V, Davion, T, Dautreme, S, Debas, J, Decoster, S, Degrave, N, Dehont, F, Delatre, C, Delcenserie, R, Delesalle, D, Delette, O, Delgrange, T, Delhoustal, L, Delmotte, J, Demmane, S, Deregnaucourt, G, Descombes, P, Desechalliers, J, Desmet, P, Desreumaux, P, Desseaux, G, Desurmont, P, Devienne, A, Devouge, E, Devred, M, Devroux, A, Dewailly, A, Dharancy, S, Di Fiore, A, Djedir, D, Djedir, R, Doleh, W, Dreher-Duwat, M, Dubois, R, Duburque, C, Ducatillon, P, Duclay, J, Ducrocq, B, Ducrot, F, Ducrotte, P, Dufilho, A, Duhamel, C, Dujardin, D, Dumant-Forest, C, Dupas, J, Dupont, F, Duranton, Y, Duriez, A, Duveau, N, El Achkar, K, El Farisi, M, Elie, C, Elie-Legrand, M, Elkhaki, A, Eoche, M, Essmaeel, E, Evrard, D, Evrard, J, Fatome, A, Filoche, B, Finet, L, Flahaut, M, Flamme, C, Foissey, D, Fournier, P, Foutrein-Comes, M, Foutrein, P, Fremond, D, Frere, T, Gallais, P, Gamblin, C, Ganga, S, Gerard, R, Geslin, G, Gheyssens, Y, Ghossini, N, Ghrib, S, Gilbert, T, Gillet, B, Godart, D, Godard, P, Godchaux, J, Godchaux, R, Goegebeur, G, Goria, O, Gottrand, F, Gower, P, Grandmaison, B, Groux, M, Guedon, C, Guerbeau, L, Gueroult-Dero, M, Guillard, J, Guillem, L, Guillemot, F, Guimberd, D, Haddouche, B, Hakim, S, Hanon, D, Hautefeuille, V, Heckestweiller, P, Hecquet, G, Hedde, J, Hellal, H, Henneresse, P, Heyman, B, Heraud, M, Herve, S, Hochain, P, Houssin-Bailly, L, Houcke, P, Huguenin, B, Iobagiu, S, Istanboli, S, Ivanovic, A, Iwanicki-Caron, I, Janicki, E, Jarry, M, Jeu, J, Joly, J, Jonas, C, Jouvenet, A, Katherin, F, Kerleveo, A, Khachfe, A, Kiriakos, A, Kiriakos, J, Klein, O, Kohut, M, Kornhauser, R, Koutsomanis, D, Laberenne, J, Lacotte, E, Laffineur, G, Lagarde, M, Lalanne, A, Lalieu, A, Lannoy, P, Lapchin, J, Laprand, M, Laude, D, Leblanc, R, Lecieux, P, Lecleire, S, Leclerc, N, Le Couteulx, C, Ledent, J, Lefebvre, J, Lefiliatre, P, Le Goffic, C, Legrand, C, Le Grix, A, Lelong, P, Leluyer, B, Lemaitre, C, Lenaerts, C, Lepeut, G, Lepileur, L, Leplat, A, Lepoutre-Dujardin, E, Leroi, H, Leroy, M, Le Roy, P, Lesage, B, Lesage, J, Lesage, X, Lescanne-Darchis, I, Lescut, J, Lescut, D, Leurent, B, Levy, P, Lhermie, M, Libier, L, Lion, A, Lisambert, B, Loge, I, Loire, F, Loreau, J, Louf, S, Louvet, A, Lubret, L, Luciani, M, Lucidarme, D, Lugand, J, Macaigne, O, Maetz, D, Maillard, D, Mancheron, H, Manolache, O, Marks-Brunel, A, Marre, C, Marti, R, Martin, F, Martin, G, Marzloff, E, Mathurin, P, Mauillon, J, Maunoury, V, Maupas, J, Medam Djomo, M, Mechior, C, Melki, Z, Mesnard, B, Metayer, P, Methari, L, Meurisse, B, Meurisse, F, Michaud, L, Mirmaran, X, Modaine, P, Monthe, A, Morel, L, Mortier, P, Moulin, E, Mouterde, O, Mozziconaci, N, Mudry, J, Nachury, M, Ngo, M, N’guyen Khac, Eric, Notteghem, B, Ollevier, V, Ostyn, A, Ouraghi, A, Oussadou, B, Ouvry, D, Paillot, B, Painchart, C, Panien-Claudot, N, Paoletti, C, Papazian, A, Parent, B, Pariente, B, Paris, J, Patrier, P, Paupard, T, Pauwels, B, Pauwels, M, Penninck, E, Petit, R, Piat, M, Piotte, S, Plane, C, Plouvier, B, Pollet, E, Pommelet, P, Pop, D, Pordes, C, Pouchain, G, Prades, P, Prevost, A, Prevost, J, Quartier, G, Quesnel, B, Queuniet, A, Quinton, J, Rabache, A, Rabelle, P, Raclot, G, Ratajczyk, S, Rault, D, Razemon, V, Reix, N, Renaut-Vantroys, T, Revillion, M, Riachi, G, Richez, C, Robinson, P, Rodriguez, J, Roger, J, Roux, J, Rudelli, A, Saber, A, Savoye, G, Schlossberg, P, Sefrioui, D, Segrestin, M, Seguy, D, Seminur, C, Serin, M, Seryer, A, Sevenet, F, Shekh, N, Silvie, J, Simon, V, Spyckerelle, C, Talbodec, N, Tavernier, N, Tchandeu, H, Techy, A, Thelu, J, Thevenin, A, Thiebault, H, Thomas, J, Thorel, J, Thuillier, C, Tielman, G, Tode, M, Toisin, J, Tonnel, J, Touchais, J, Toumelin, P, Touze, Y, Tranvouez, J, Triplet, C, Triki, N, Turck, D, Uhlen, S, Vaillant, E, Valmage, C, Vanco, D, Vandaele-Bertiaux, N, Vandamme, H, Vanderbecq, E, Vander Eecken, E, Vandermolen, P, Vandevenne, P, Vandeville, L, Vandewalle, A, Vandewalle, C, Vaneslander, P, Vanhoove, J, Vanrenterghem, A, Vanveuren, C, Varlet, P, Vasies, I, Verbiese, G, Verlynde, J, Vernier-Massouille, G, Vermelle, P, Verne, C, Vezilier-Cocq, P, Vigneron, B, Vincendet, M, Viot, J, Voiment, Y, Wacrenier, A, Waeghemaecker, L, Wallez, J, Wantiez, M, Wartel, F, Weber, J, Willocquet, J, Wizla, N, Wolschies, E, Zaharia, O, Zaoui, S, Zalar, A, Zaouri, B, Zellweger, A, Ziade, C, Beaugerie, L, Allez, M, Ruemmele, F, Lamer, A, Roy, M, CHU Lille, Institute for Translational Research in Inflammation - U 1286 (INFINITE (Ex-Liric)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Nutrition, Inflammation et axe Microbiote-Intestin-Cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Normandie Université (NU), Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service des Maladies de l'Appareil Digestif et de la Nutrition [CHRU Lille], Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Universitaire de Reims (CHU Reims), 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, CHU Amiens-Picardie, Registre EPIMAD, Normandie Université (NU)-Normandie Université (NU)-CHU Amiens-Picardie-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Department of Colloid Chemistry [Potsdam], Max Planck Institute of Colloids and Interfaces, Max-Planck-Gesellschaft-Max-Planck-Gesellschaft, Groupe de Recherche sur l'alcool et les pharmacodépendances - UMR INSERM_S 1247 (GRAP), and Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Crohn’s disease ,inflammatory bowel disease ,complication ,genetics ,prediction ,prognosis ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
International audience; Background The identification of patients at high risk of a disabling disease course would be invaluable in guiding initial therapy in Crohn’s disease (CD). Our objective was to evaluate a combination of clinical, serological, and genetic factors to predict complicated disease course in pediatric-onset CD. Methods Data for pediatric-onset CD patients, diagnosed before 17 years of age between 1988 and 2004 and followed more than 5 years, were extracted from the population-based EPIMAD registry. The main outcome was defined by the occurrence of complicated behavior (stricturing or penetrating) and/or intestinal resection within the 5 years following diagnosis. Lasso logistic regression models were used to build a predictive model based on clinical data at diagnosis, serological data (ASCA, pANCA, anti-OmpC, anti-Cbir1, anti-Fla2, anti-Flax), and 369 candidate single nucleotide polymorphisms. Results In total, 156 children with an inflammatory (B1) disease at diagnosis were included. Among them, 35% (n = 54) progressed to a complicated behavior or an intestinal resection within the 5 years following diagnosis. The best predictive model (PREDICT-EPIMAD) included the location at diagnosis, pANCA, and 6 single nucleotide polymorphisms. This model showed good discrimination and good calibration, with an area under the curve of 0.80 after correction for optimism bias (sensitivity, 79%, specificity, 74%, positive predictive value, 61%, negative predictive value, 87%). Decision curve analysis confirmed the clinical utility of the model. Conclusions A combination of clinical, serotypic, and genotypic variables can predict disease progression in this population-based pediatric-onset CD cohort. Independent validation is needed before it can be used in clinical practice.
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- 2023
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4. DOP89 Impact of biologics on the risk of early postoperative complications in Crohn's disease: a French nationwide study
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Fumery, Mathurin, Nancey, S, Nachury, M, Allez, M, Rouillon, C, Boureille, A, Altwegg, R, Serrero, M, Vuitton, L, Bouguen, G, Abitbol, V, Boualit, M, Biron, A, Panis, Y, Laharie, D, Amiot, A, Simon, M, Caillo, L, Hébuterne, X, Vidon, M, Benezech, A, Elgharabawy, Y, Peyrin-Biroulet, L, 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), Hôpital Claude Huriez [Lille], CHU Lille, Hôpital Saint-Louis, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Institut de Chimie de Clermont-Ferrand (ICCF), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Technocentre Renault [Saint-Quentin-en-Yvelines], RENAULT, CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Marseille, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Pontchaillou [Rennes], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier [Valenciennes, Nord], CHU Bordeaux [Bordeaux], Institut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Département de Gastroentérologie, and Hôpital de l'Archet 2
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[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
International audience; Background While the effect of anti-TNFs on postoperative outcomes in patients with Crohn's disease (CD) has been widely studied, the impact of vedolizumab and ustekinumab on the risk of postoperative complications remains poorly known. Methods All consecutive patients who underwent intestinal resection for CD between July 2014 and April 2022 within 22 French centers were included in a retrospective cohort. The risk of early post-operative complications (≤30days) in patients exposed to biologics was compared to patients not exposed by logistic regression and propensity score-matched analysis adjusted for age, previous intestinal resection, corticosteroids or immunosuppressants exposure, disease activity, presence of abscess, urgent surgery and initial stoma (preoperative contra-indication to anastomosis). Results Among the 1201 patients included, respectively 491 (41%), 76 (6.3%) and 57 (4.7%) were exposed to anti-TNFs, ustekinumab, or vedolizumab within six months before surgery. A total of 317 (26.4%) patients had at least one complication of which 123 (38%) were considered as severe (DINDO III/IV). New surgery was necessary in 69 (5.7%) patients and secondary stoma in 23 (1.9%). Three deaths were observed (0.25%). The rates of overall complications in patients not exposed to biologics, exposed to anti-TNFs, ustekinumab or vedolizumab were respectively 26.1%, 25.1%, 34.7% and 29.8%. The risks of intra-abdominal infectious complications in these four groups were respectively 13.5%, 11.1%, 13.3% and 8.8%. In multivariate analysis, age [OR, 1.02 (1.01-1.04); p=0.004], disease activity [OR, 8.36 (1.79 – 149); p=0.037], the presence of an abscess [OR, 2.01 (1.25-3.20); p=0.004] and initial stoma [OR, 1.70 (1.10 –2.61); p=0.016] were significantly associated with intra-abdominal infectious complications. Conversely, preoperative enteral nutrition [OR, 0.12 (0.01 -0.59); p=0.040] was associated with a reduction in this risk. Exposure to anti-TNFs [OR, 0.80 (0.51-1.24); p=0.31], ustekinumab [OR, 1.17 (0.39-3.51); p=0.78] and vedolizumab [OR, 1.28 (0.32-5.17); p=0.72] within the 3 months before surgery were not associated with the risk of intra-abdominal infectious complications. Similar results were observed in patients exposed to these treatments in the month before surgery. Conclusion In this large cohort, a quarter of patients operated on for CD presented an early postoperative complication and 10% a severe complication. Preoperative exposure to anti-TNFs, vedolizumab or ustekinumab was not associated with an increased risk of early postoperative complications. Preoperative enteral nutrition was associated with a reduced risk of intra-abdominal infectious complication.
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- 2023
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5. EE781 Budget Impact Analysis of Dimethyl Fumarate for the Treatment of Relapsing-Remitting Multiple Sclerosis in Algeria
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Kamel, M, Al-Homsi, RS, Hammas, Y, Boudache, F, Birouk, L, Tibouche, M, Boualit, M, and Aburmilah, A
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- 2024
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6. Top-down infliximab plus azathioprine versus azathioprine alone in patients with acute severe ulcerative colitis responsive to intravenous steroids: a parallel, open-label randomised controlled trial, the ACTIVE trial.
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Amiot A, Seksik P, Meyer A, Stefanescu C, Wils P, Altwegg R, Vuitton L, Plastaras L, Nicolau A, Pereira B, Duveau N, Laharie D, Mboup B, Boualit M, Allez M, Rajca S, Chanteloup E, Bouguen G, Bazin T, Goutorbe F, Richard N, Moussata D, Vicaut E, and Peyrin-Biroulet L
- Abstract
Background: It is unknown which maintenance therapy is the most effective option for patients admitted for an acute severe ulcerative colitis (ASUC) episode responding to intravenous steroids., Methods: We conducted a multicentre, parallel-group, open-label randomised controlled trial among 23 French centres in thiopurine and biologics-naïve adults admitted for ASUC responding to intravenous steroids. Eligible patients were randomly assigned to receive infliximab (IFX) and azathioprine (AZA) with a 7-day steroid tapering scheme (IFX+AZA arm) or AZA and conventional standardised steroid tapering regimen (AZA arm). The primary composite endpoint was treatment failure at week 52, defined as the absence of steroid-free clinical remission, the absence of endoscopic response, the use of a prohibited treatment for relapse, severe adverse event leading to treatment interruption, colectomy or death. Multiple imputation for missing data was performed., Findings: Among the 64 patients randomised (Lichtiger score 13.5±2.0; median age of 34.5 (P25-P75 26.3-50.3) years, median C reactive protein of 29.0 (12.8-96.8) mg/L at baseline): 32 were assigned to the IFX+AZA arm and 32 to the AZA arm. In the ITT population, treatment failure at week 52 was observed in 22/27 (81.5%) in the AZA arm and 16/30 (53.3%) in the IFX+AZA arm (risk ratio 3.85, 95% CI (1.15 to 12.88), p=0.03). 29 adverse events were severe, including 13 disease exacerbations, 6 severe infections without any difference between both arms., Interpretation: Combination therapy with IFX+AZA was more effective at 1 year than AZA alone to avoid treatment failure in patients with ASUC responding to intravenous steroids., Trial Registration Number: NCT02425852., Competing Interests: Competing interests: AA received consulting fees from Abbvie, Pfizer, Takeda, Tillotts Pharma, Janssen and Sandoz as well as lecture fees and travel accommodations from Abbvie, Janssen, Pfizer, Takeda, Biogen, Fresenius Kabi, Amgen and Celltrion. PS reports consulting fees from Pfizer, Astellas, Janssen, Fresenius Kabi, Takeda, Abbvie, Merck-MSD, Pilège, Lilly, Celltrion and Biocodex; and grants from Biocodex and Janssen. CS declare lecture and/or consulting fees from Abbvie, Amgen, Celltrion, Janssen, Lilly, Takeda, Tillots. PW received board membership, consultancy, or lecture fees from Abbvie, Amgen, Celltrion, Ferring, Janssen, and Takeda. LV received fees from Abbvie, Amgen, MSD, Ferring, Takeda, Pfizer, Celltrion, Janssen, Galapagos, Dr Falk. RA declares lecture fees from MSD, Abbvie, Pfizer, Takeda, and Janssen. GB received lecture fees from Abbvie, Ferring, Takeda and Pfizer and consultant fees from Takeda, Janssen, Lilly, Celltrion, Sandoz, Abbvie. MB has received lecture fees and travel accommodation from Abbvie, Fresenius Kabi, Janssen, Pfizer and Takeda. DL has received counseling, boards, transports and/or fees from Abbvie, Amgen, Biogen, Ferring, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Tillots. MA has served as a speaker, consultant, and/or advisory board member for Abbvie, Amgen, Biogen, Boehringer-Ingelheim, Celgene, Celltrion, Ferring, Galapagos, Genentech, IQVIA, Janssen, Lilly, MSD, Pfizer, Roche, Takeda, Tillotts. FG declares counseling, boards, transports and lectures fees from Abbvie, Amgen, Biogen, Celltrion, Janssen, Lilly, MSD, Pfizer, Takeda. NR has received lecture fees from AbbVie and Takeda. LP-B received consulting fees from Merck, Abbvie, Janssen, Genentech, Ferring, Norgine, Tillots, Vifor, Shire, Therakos, Pharmacosmos, Pilège, BMS, UCB-Pharma, Hospira, Celltrion, Takeda, Biogaran, Boerhinger-Ingelheim, Lilly, Pfizer and HAC-Pharma. This author also received lecture fees from Merck, Abbvie, Takeda, Janssen Cilag, Ferring, Norgine, Tillots, Vifor, Therakos, HAC-Pharma and Mitsubishi. No conflicts of interest are claimed by the remaining authors., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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7. Adalimumab in Biologic-naïve Patients With Crohn's Disease After Resolution of an Intra-abdominal Abscess: A Prospective Study From the GETAID.
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Bouhnik Y, Pineton de Chambrun G, Lambert J, Nachury M, Seksik P, Altwegg R, Vuitton L, Stefanescu C, Nancey S, Aubourg A, Serrero M, Filippi J, Desseaux K, Viennot S, Abitbol V, Boualit M, Bourreille A, Giletta C, Buisson A, Roblin X, Dib N, Malamut G, Amiot A, Fumery M, Louis E, Elgharabawy Y, and Peyrin-Biroulet L
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- Humans, Male, Adult, Female, Adalimumab therapeutic use, Prospective Studies, Abscess drug therapy, Treatment Outcome, Recurrence, Crohn Disease complications, Crohn Disease drug therapy, Abdominal Abscess drug therapy, Biological Products therapeutic use
- Abstract
Background & Aims: The management of intra-abdominal abscesses complicating Crohn's disease (CD) is challenging, and surgery with delayed intestinal resection is often recommended. The aims of this study were to estimate the success rate of adalimumab (ADA) in patients with CD with an intra-abdominal abscess resolved without surgery, and to identify predictive factors for success., Methods: A multicenter, prospective study was conducted in biologic-naïve patients with CD with resolved intra-abdominal abscess treated with ADA with a 2-year follow-up. The primary endpoint was ADA failure at week (W) 24 defined as a need for steroids after W12, intestinal resection, abscess recurrence, and clinical relapse. Secondary post-hoc endpoint was the long-term success defined as the survival without abscess relapse or intestinal resection at W104. The factors associated with ADA failure at W24 and W104 were identified using a logistic and a Cox regression, respectively., Results: From April 2013 to December 2017, 190 patients from 27 GETAID centers were screened, and 117 were included in the analysis. Fifty-eight patients (50%) were male, and the median age at baseline was 28 years. At W24, 87 patients (74%; 95% confidence interval [CI], 65.5%-82.0%; n = 117) achieved ADA success. Among the 30 patients with ADA failure, 15 underwent surgery. At W104, the survival rate without abscess recurrence or surgery was 72.9% (95% CI, 62.1%-79.8%; n = 109). Abscess drainage was significantly associated with ADA failure at W24 (odds ratio, 4.18; 95% CI, 1.06-16.5; P =0 .043). Disease duration (hazard ratio [HR], 1.32; 95% CI, 1.09-1.59; P = .008), abscess drainage (HR, 5.59; 95% CI, 2.21-14.15; P = .001), and inflammatory changes in mesenteric fat (HR, 0.4; 95% CI, 0.17-0.94; P = .046) were significantly associated with ADA failure at W104., Conclusion: Provided that the abscess was carefully managed before initiating medical treatment, this study showed the high efficacy of ADA in the short and long term in biologic-naïve patients with CD complicated by an intra-abdominal abscess., Clinicaltrials: gov, Number: NCT02856763., (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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