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4 results on '"Service de médecine interne [hôpitaux privés de Metz]"'

1. Reducing the initial number of rituximab maintenance-therapy infusions for ANCA-associated vasculitides: randomized-trial post-hoc analysis.

Author

Charles P, Dechartres A, Terrier B, Cohen P, Faguer S, Huart A, Hamidou M, Agard C, Bonnotte B, Samson M, Karras A, Jourde-Chiche N, Lifermann F, Gobert P, Hanrotel-Saliou C, Godmer P, Martin-Silva N, Pugnet G, Matignon M, Aumaitre O, Viallard JF, Maurier F, Meaux-Ruault N, Rivière S, Sibilia J, Puéchal X, Mouthon L, and Guillevin L

Subjects
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis blood, Antibodies, Antineutrophil Cytoplasmic blood, Antigens, CD19, Disease-Free Survival, Drug Administration Schedule, Humans, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis drug therapy, Antirheumatic Agents administration & dosage, Maintenance Chemotherapy methods, Rituximab administration & dosage
Abstract

Objective: The randomized, controlled MAINRITSAN2 trial was designed to compare the capacity of an individually tailored therapy [randomization day 0 (D0)], with reinfusion only when CD19+ lymphocytes or ANCA had reappeared, or if the latter's titre rose markedly, with that of five fixed-schedule 500-mg rituximab infusions [D0 + D14, then months (M) 6, 12 and 18] to maintain ANCA-associated vasculitis (AAV) remissions. Relapse rates did not differ at M28. This ancillary study was undertaken to evaluate the effect of omitting the D14 rituximab infusion on AAV relapse rates at M12., Methods: MAINRITSAN2 trial data were subjected to post-hoc analyses of M3, M6, M9 and M12 relapse-free survival rates in each arm as primary end points. Exploratory subgroup analyses were run according to CYC or rituximab induction and newly diagnosed or relapsing AAV., Results: At M3, M6, M9 and M12, respectively, among the 161 patients included, 79/80 (98.8%), 76/80 (95%), 74/80 (92.5%) and 73/80 (91.3%) from D0, and 80/81 (98.8%), 78/81 (96.3%), 76/81 (93.8%) and 76/81 (93.8%) from D0+D14 groups were alive and relapse-free. No between-group differences were observed. Results were not affected by CYC or rituximab induction, or newly diagnosed or relapsing AAV., Conclusions: We were not able to detect a difference between the relapse-free survival rates for up to M12 for the D0 and D0+D14 rituximab-infusion groups, which could suggest that omitting the D14 rituximab remission-maintenance dose did not modify the short-term relapse-free rate. Nevertheless, results at M12 may also have been influenced by the rituximab-infusion strategies for both groups., (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2020
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2. Efficacy of anti-TNF alpha in severe and refractory major vessel involvement of Behcet's disease: A multicenter observational study of 18 patients.

Author

Desbois AC, Biard L, Addimanda O, Lambert M, Hachulla E, Launay D, Ackermann F, Pérard L, Hot A, Maurier F, Mausservey C, Bernard F, Noel N, Alric L, Mirault T, Cohen F, Boussouar S, Resche-Rigon M, Cacoub P, and Saadoun D

Subjects
Adult, Aortic Diseases etiology, Aortic Diseases physiopathology, Behcet Syndrome complications, Behcet Syndrome physiopathology, Budd-Chiari Syndrome etiology, Budd-Chiari Syndrome physiopathology, Female, Heart Diseases etiology, Heart Diseases physiopathology, Humans, Immunosuppressive Agents therapeutic use, Infections, Logistic Models, Male, Middle Aged, Pulmonary Artery physiopathology, Pulmonary Edema, Recurrence, Remission Induction, Retrospective Studies, Severity of Illness Index, Thrombosis etiology, Tumor Necrosis Factor-alpha antagonists & inhibitors, Vascular Diseases etiology, Vascular Diseases physiopathology, Vena Cava, Inferior physiopathology, Young Adult, Adalimumab therapeutic use, Antirheumatic Agents therapeutic use, Behcet Syndrome drug therapy, Infliximab therapeutic use, Thrombosis physiopathology
Abstract

Objective: To describe the outcome and tolerance in patients treated with anti-TNFα in severe and refractory major vessel disease in Behçet's disease (BD)., Methods: A multicenter study evaluating 18 refractory BD patients with major vessel involvement [pulmonary artery (n = 4), aorta (n = 4) or peripheral artery aneurysm (n = 1) and/or pulmonary artery (n = 7), inferior vena cava (n = 5), or intra-cardiac (n = 3) thrombosis or Budd Chiari Syndrome (n = 2)] treated with anti-TNFα agents., Results: Vascular remission was achieved in 16 (89%) patients. The 9 months risk of relapse was significantly higher with conventional immunosuppressants used prior anti-TNFα agents as compared to anti-TNFα therapy [OR = 8.7 (1.42-62.6), p = 0.03]. The median daily dose of corticosteroids significantly decreased at 12 months. Side effects included infection (n = 4) and pulmonary edema (n = 1)., Conclusion: TNFα-antagonists are safe and might be associated with a decreased risk of relapse at 9 months compared to conventional immunosuppressants in BD patients with major vessels disease., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Published
2018
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3. Comparison of individually tailored versus fixed-schedule rituximab regimen to maintain ANCA-associated vasculitis remission: results of a multicentre, randomised controlled, phase III trial (MAINRITSAN2).

Author

Charles P, Terrier B, Perrodeau É, Cohen P, Faguer S, Huart A, Hamidou M, Agard C, Bonnotte B, Samson M, Karras A, Jourde-Chiche N, Lifermann F, Gobert P, Hanrotel-Saliou C, Godmer P, Martin-Silva N, Pugnet G, Matignon M, Aumaitre O, Viallard JF, Maurier F, Meaux-Ruault N, Rivière S, Sibilia J, Puéchal X, Ravaud P, Mouthon L, and Guillevin L

Subjects
Adult, Aged, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis immunology, Antibodies, Antineutrophil Cytoplasmic blood, Antirheumatic Agents adverse effects, Antirheumatic Agents therapeutic use, B-Lymphocyte Subsets drug effects, Biomarkers blood, Drug Administration Schedule, Drug Monitoring methods, Female, Humans, Infusions, Intravenous, Kaplan-Meier Estimate, Lymphocyte Count, Male, Middle Aged, Precision Medicine methods, Recurrence, Remission Induction methods, Rituximab adverse effects, Rituximab therapeutic use, Severity of Illness Index, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis drug therapy, Antirheumatic Agents administration & dosage, Rituximab administration & dosage
Abstract

Objective: To compare individually tailored, based on trimestrial biological parameter monitoring, to fixed-schedule rituximab reinfusion for remission maintenance of antineutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAVs)., Methods: Patients with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in complete remission after induction therapy were included in an open-label, multicentre, randomised controlled trial. All tailored-arm patients received a 500 mg rituximab infusion at randomisation, with rituximab reinfusion only when CD19+B lymphocytes or ANCA had reappeared or ANCA titre rose markedly based on trimestrial testing until month 18. Controls received a fixed 500 mg rituximab infusion on days 0 and 14 postrandomisation, then 6, 12 and 18 months after the first infusion. The primary endpoint was the number of relapses (new or reappearing symptom(s) or worsening disease with Birmingham Vasculitis Activity Score (BVAS)>0) at month 28 evaluated by an independent Adjudication Committee blinded to treatment group., Results: Among the 162 patients (mean age: 60 years; 42% women) included, 117 (72.2%) had GPA and 45 (27.8%) had MPA. Preinclusion induction therapy included cyclophosphamide for 100 (61.7%), rituximab for 61 (37.6%) and methotrexate for 1 (0.6%). At month 28, 21 patients had suffered 22 relapses: 14/81 (17.3%) in 13 tailored-infusion recipients and 8/81 (9.9%) in 8 fixed-schedule patients (p=0.22). The tailored-infusion versus fixed-schedule group, respectively, received 248 vs 381 infusions, with medians (IQR) of 3 (2-4) vs 5 (5-5) administrations., Conclusion: AAV relapse rates did not differ significantly between individually tailored and fixed-schedule rituximab regimens. Individually tailored-arm patients received fewer rituximab infusions., Trial Registration Number: NCT01731561; Results., Competing Interests: Competing interests: BT has received consulting and speaking fees (Roche, LFB, Grifols, GSK). MH has received personal fees from Roche. AK has received personal fees and non-financial support from Roche. XP has received speaking fees and honoraria (Pfizer, LFB, Roche) and a research grant (Pfizer)., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Published
2018
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4. Comparison of individually tailored versus fixed-schedule rituximab regimen to maintain ANCA-associated vasculitis remission: results of a multicentre, randomised controlled, phase III trial (MAINRITSAN2)

Author

Charles, Pierre, Terrier, Benjamin, Perrodeau, Elodie, Cohen, Pascal, Faguer, Stanislas, Huart, Antoine, Hamidou, Mohamed, Agard, Christian, Bonnotte, Bernard, Samson, Maxime, Karras, Alexandre, Jourde-Chiche, Noémie, Lifermann, François, Gobert, Pierre, Hanrotel-Saliou, Catherine, Godmer, Pascal, MARTIN-SILVA, nicolas, Pugnet, Grégory, Matignon, Marie, Aumaître, Olivier, Viallard, Jean-François, Maurier, François, Meaux-Ruault, Nadine, Rivière, Sophie, Sibilia, Jean, Puéchal, Xavier, Ravaud, Philippe, Mouthon, Luc, Guillevin, Loïc, for the French Vasculitis Study Group,, Service de médecine interne et centre de référence des maladies rares [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Institut Mutualiste de Montsouris (IMM), CHU Cochin [AP-HP], Université Paris Descartes - Paris 5 (UPD5), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), 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), Centre d'épidémiologie Clinique [Hôtel-Dieu], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Hôtel Dieu, Université Sorbonne Paris Cité (USPC), Département de Néphrologie et Transplantation d'organes, Hôpital de Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Service de médecine interne [Nantes], Université de Nantes (UN)-Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (HOTE GREFFON), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-France-Comté] (EFS [Bourgogne-France-Comté])-Université de Franche-Comté (UFC), Service de médecine interne et immunologie clinique (SOC 1) [CHU de Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre de néphrologie et transplantation rénale [Hôpital de la Conception - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Service de Médecine Interne [Dax], Centre Hospitalier de Dax, Centre Hospitalier Henri Duffaut, CHRU - Service de néphrologie, dialyse et transplantation rénale, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de Médecine interne - Maladies hématologiques - Maladies infectieuses [Vannes], Centre Hospitalier Bretagne Atlantique [Vannes], Service de médecine interne [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), Normandie Université (NU), Service de Médecine Interne, Centre Hospitalier Universitaire de Toulouse, PRES Université de Toulouse, Service de néphrologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Henri Mondor, Service de médecine interne, hôpital Gabriel-Montpied, CHU Clermont-Ferrand, Service de médecine interne et maladies infectieuses [Bordeaux], CHU Bordeaux [Bordeaux]-Groupe hospitalier Saint-André, Service de médecine interne [hôpitaux privés de Metz], Hôpitaux Privés de Metz (HPMetz), Service de médecine interne (Med Int - BESANCON), Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz, Département de médecine interne, centre d'investigation clinique, CHU de Montpellier, Service de rhumatologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Cochin [AP-HP], 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), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Hôtel Dieu, Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté]), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre Hospitalier Henri Duffaut (Avignon), Centre hospitalier Bretagne Atlantique (Morbihan) (CHBA), 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), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Henri Mondor, Service de Médecine Interne [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), and Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)

Subjects
Male, Birmingham Vasculitis Activity Score, Kaplan-Meier Estimate, CD19+ B lymphocytes, Severity of Illness Index, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Recurrence, Clinical endpoint, Immunology and Allergy, 030212 general & internal medicine, Precision Medicine, Infusions, Intravenous, microscopic polyangiitis, ANCA, Remission Induction, Middle Aged, 3. Good health, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Rituximab, Female, Drug Monitoring, Microscopic polyangiitis, Granulomatosis with polyangiitis, medicine.drug, Adult, medicine.medical_specialty, Cyclophosphamide, Immunology, B-Lymphocyte Subsets, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, ANCA vasculitis, General Biochemistry, Genetics and Molecular Biology, Drug Administration Schedule, Antibodies, Antineutrophil Cytoplasmic, 03 medical and health sciences, Rheumatology, Internal medicine, medicine, Humans, Lymphocyte Count, Aged, 030203 arthritis & rheumatology, granulomatosis with polyangiitis, business.industry, medicine.disease, Regimen, business, Biomarkers
Abstract

ObjectiveTo compare individually tailored, based on trimestrial biological parameter monitoring, to fixed-schedule rituximab reinfusion for remission maintenance of antineutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAVs).MethodsPatients with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in complete remission after induction therapy were included in an open-label, multicentre, randomised controlled trial. All tailored-arm patients received a 500 mg rituximab infusion at randomisation, with rituximab reinfusion only when CD19+B lymphocytes or ANCA had reappeared or ANCA titre rose markedly based on trimestrial testing until month 18. Controls received a fixed 500 mg rituximab infusion on days 0 and 14 postrandomisation, then 6, 12 and 18 months after the first infusion. The primary endpoint was the number of relapses (new or reappearing symptom(s) or worsening disease with Birmingham Vasculitis Activity Score (BVAS)>0) at month 28 evaluated by an independent Adjudication Committee blinded to treatment group.ResultsAmong the 162 patients (mean age: 60 years; 42% women) included, 117 (72.2%) had GPA and 45 (27.8%) had MPA. Preinclusion induction therapy included cyclophosphamide for 100 (61.7%), rituximab for 61 (37.6%) and methotrexate for 1 (0.6%). At month 28, 21 patients had suffered 22 relapses: 14/81 (17.3%) in 13 tailored-infusion recipients and 8/81 (9.9%) in 8 fixed-schedule patients (p=0.22). The tailored-infusion versus fixed-schedule group, respectively, received 248 vs 381 infusions, with medians (IQR) of 3 (2–4) vs 5 (5–5) administrations.ConclusionAAV relapse rates did not differ significantly between individually tailored and fixed-schedule rituximab regimens. Individually tailored-arm patients received fewer rituximab infusions.Trial registration numberNCT01731561; Results.

Published
2018

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