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从美泊利单抗转换为贝那利珠单抗治疗嗜酸性肉芽肿性多血管炎（EGPA）

Switching from mepolizumab to benralizumab in eosinophilic granulomatosis with polyangiitis (EGPA).

临床研究鼻科IF 10.1Q1

文献信息

PMID42855125
原文在 PubMed 查看原文 ↗
发表日期2026
作者Adrien Cottu
查看其他 37 位作者

Irene Mattioli；Matthieu Groh；Xavier Puéchal；Allyson Egan；Roberto Padoan；Luisa Brussino；Jan Schroeder；Camille Taillé；Maxime Samson；Pascal Cathébras；Francesco Cinetto；Halil Yildiz；Gregory Pugnet；Pierre Chauvin；Stéphane Jouneau；Elisabeth Diot；Sarah Nicolas；François Lifermann；Jean-Philippe Martellosio；Laurent Guilleminault；Yann Nguyen；Claire De Moreuil；Philippe Guilpain；Vincent Cottin；Luca Moroni；Paolo Delvino；Franco Franceschini；Edoardo Conticini；Claudia Crimi；Gianluca Moroncini；Milena Bond；Laura Moi；David Jayne；Augusto Vaglio；Colas Tcherakian；Giacomo Emmi；Benjamin Terrier

作者单位Department of Internal Medicine, Cochin Hospital, National Referral Center for Rare Systemic Autoimmune and Autoinflammatory Diseases of Ile de France, East and West, Assistance Publique - Hôpitaux de Paris, Paris, France.
查看其他 34 条单位信息

Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.；Université de Versailles St Quentin-en-Yvelines, National Referral Center for Hypereosinophilic Syndrome (CEREO), Department of Internal Medicine, Clinical Immunology and Hematology, Hôpital Foch, Suresnes, France; Paris Cité University, INSERM U1342, Research Institute of Saint-Louis, Paris, France.；Trinity Health Kidney Centre, Department of Nephrology, Tallaght University Hospital, Dublin, Ireland.；Rheumatology Unit, Department of Medicine - DIMED, University of Padua, Padua, Italy.；Department of Medical Sciences, University of Torino & Mauriziano Hospital, Torino, Italy.；Unit of Allergology and Immunology, Niguarda Hospital, Milan, Italy (J.W.S.).；AP-HP, Bichat Hospital, Reference Center for Rare Pulmonary Diseases and University of Paris Cité, Inserm UMR 1149, 75018 Paris, France.；Department of Internal Medicine and Clinical Immunology, Referral Center for Rare Systemic Autoimmune and Autoinflammatory Diseases, University EPE Bourgogne Europe, Dijon-Bourgogne University Hospital, F-CRIN CRI-IMIDIATE network, Dijon, France.；Department of internal medicine, University Hospital of Saint-Etienne, France.；Rare Diseases Referral Center, Internal Medicine 1, Ca' Foncello Hospital, Treviso, Department of Medicine, University of Padova, Italy.；Department of Internal Medicine and Infectious Diseases, Cliniques Universitaires Saint-Luc, Brussels, Brussels, Belgium.；Department of Internal Medicine and Clinical Immunology, CHU Toulouse Rangueil, Toulouse, France.；Department of Respiratory Diseases, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France.；Department of Internal Medicine, CHU Tours, France.；Department of Internal Medicine, Centre Hospitalier de Dax, Dax, France.；Department of Internal Medicine, infectious and tropical diseases, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.；Department of Respiratory Medicine, Faculty of Medicine, Toulouse University Hospital, 31300 Toulouse, France; Toulouse Institute for Infectious and Inflammatory Diseases (Infinity), Inserm U1291, University of Toulouse, CNRS U5282.；Department of Internal Medicine, Beaujon Hospital, AP-HP.Nord, Université Paris Cité, , Clichy, France. Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics, 75004 Paris, France.；Univ Brest, INSERM U1304-GETBO, Brest, France; F-CRIN INNOVTE, Saint-Étienne, France; Department of Internal Medicine.；Department of Vascular Diseases, St Eloi Teaching Hospital (CHU Montpellier), Faculty of Medicine - University of Montpellier & INSERM U1183.；National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, UMR 754, ERN-LUNG, Lyon, France.；Unit of Immunology, Rheumatology, Allergy and Rare Disease (UniRAR), IRCCS San Raffaele Hospital, 20132 Milan, Italy.；School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy; Rheumatology Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.；Rheumatology and Clinical Immunology - ASST Spedali Civili di Brescia; Department of Clinical and Experimental Sciences - University of Brescia, Brescia, Italy.；Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.；Department of Clinical and Experimental Medicine, University of Catania, 95123 Catania, Italy. Respiratory Medicine Unit, Policlinico "G. Rodolico-San Marco" University Hospital, Catania, Italy.；Department of Clinical and Molecular Sciences, Marche Polytechnic University and Clinica Medica, Department of Internal Medicine, Marche University Hospital, Ancona, Italy.；Department of Rheumatology, Hospital of Bruneck (ASAA-SABES), Teaching Hospital of the Paracelsus Medical University, Brunico, Italy.；Immunology and Allergology, Institut Central des Hôpitaux, Valais Hospital, 1951, Sion, Switzerland.；Department of Medicine, University of Cambridge, United Kingdom.；Department of Biomedical, Experimental and Clinical Sciences "Mario Serio", University of Florence, Florence, Italy; Nephrology and Dialysis Unit, Meyer Children's Hospital IRCCS, Florence, Italy.；Department of Pulmonology, Foch Hospital, Suresnes, France; VIM-Suresnes Laboratory, V2I-INRAE, UMR 0892, Paris-Saclay University, Suresnes, France.；Immunology and Allergy Service, Lausanne University Hospital (CHUV), University of Lausanne, Lausanne, Switzerland; Centre for Inflammatory Diseases, Department of Medicine, Monash University, Monash Medical Centre, Melbourne, Australia; Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.；Department of Internal Medicine, Cochin Hospital, National Referral Center for Rare Systemic Autoimmune and Autoinflammatory Diseases of Ile de France, East and West, Assistance Publique - Hôpitaux de Paris, Paris, France. Electronic address: benjamin.terrier@aphp.fr.

期刊Chest
SCI 分区Q1
IF10.1
研究类型临床研究 · 临床
所属专科鼻科

中文摘要

背景： 嗜酸性肉芽肿性多血管炎（EGPA）是一种ANCA相关性血管炎，以嗜酸性哮喘和耳鼻喉受累为特征。美泊利单抗和贝那利珠单抗均已在EGPA中显示出疗效，目前均被视为一线选择。对于对美泊利单抗无反应的患者，贝那利珠单抗可能是一种有价值的替代方案，因为它能增强对嗜酸性粒细胞的清除。我们评估了在EGPA中从美泊利单抗转换为贝那利珠单抗的疗效和安全性。
研究问题： 鉴于贝那利珠单抗增强的嗜酸性粒细胞清除作用，它在美泊利单抗治疗失败后的EGPA患者中是否有效且安全？
研究设计和方法： 我们开展了一项欧洲多中心回顾性研究，纳入68例在美泊利单抗治疗失败后接受贝那利珠单抗治疗的成人EGPA患者。完全缓解（CR）和部分缓解（PR）分别定义为BVAS=0且泼尼松≤4 mg/天和>4 mg/天。
结果： 贝那利珠单抗的中位随访期为28[20-39]个月。32%和25%的患者分别达到CR和PR，并在末次随访时分别有19%和16%维持缓解。达到CR的中位时间为6[4-12]个月。第一秒用力呼气容积从73%改善至79%，38%的患者停用糖皮质激素。6例患者发生血管炎复发。原发性美泊利单抗失败与较低的CR率相关（OR 0.19，95% CI 0.06-0.60）。18%的患者因持续呼吸道症状而停用贝那利珠单抗。5例患者发生不良事件，包括2例严重SARS-CoV-2感染。
结论： 在美泊利单抗治疗失败后仍有持续呼吸道表现的EGPA患者中，转换为贝那利珠单抗可能是一种有价值的选择，可改善肺功能并减少糖皮质激素使用。需要进一步的前瞻性研究来优化治疗顺序和患者选择。

英文摘要

BACKGROUND: Eosinophilic granulomatosis with polyangiitis (EGPA) is an ANCA-associated vasculitis characterized by eosinophilic asthma and ENT involvement. Both mepolizumab and benralizumab have demonstrated efficacy in EGPA and are now considered front-line options. In patients who do not respond to mepolizumab, benralizumab may be a valuable alternative owing to its enhanced depletion of eosinophils. We assessed the efficacy for and safety of switching from mepolizumab to benralizumab in EGPA.
RESEARCH QUESTION: Is benralizumab effective and safe in EGPA patients after mepolizumab failure, given its enhanced depletion of eosinophil?
STUDY DESIGN AND METHODS: We conducted a retrospective European multicenter study including 68 adult EGPA patients who received benralizumab after mepolizumab failure. Complete (CR) and partial (PR) response were defined as BVAS=0, with prednisone ≤4 mg/day and > 4 mg/day, respectively.
RESULTS: Median benralizumab follow-up period was 28 [20-39] months. CR and PR were achieved in 32% and 25% of patients, and maintained at last follow-up in 19% and 16%. Median time to CR was 6 [4-12] months. Forced expiratory volume in one second improved from 73% to 79%, and 38% of patients discontinued glucocorticoids. Vasculitis flares occurred in six patients. Primary mepolizumab failure was associated with lower CR rates (OR 0.19, 95% CI 0.06-0.60). Benralizumab was discontinued in 18% due to persistent respiratory symptoms. Adverse events occurred in five patients, including two severe SARS-CoV-2 infections.
INTERPRETATION: In EGPA patients with persistent respiratory manifestations after mepolizumab failure, switching to benralizumab could represent a valuable option, improving lung function and reducing glucocorticoid use. Further prospective studies are needed to optimize sequencing and patient selection.