Effectiveness and safety of anti-IL-5/Rα biologics in eosinophilic granulomatosis with polyangiitis: a two-year multicenter observational study

Frontiers in Immunology

Immunology

Francesco Papia¹  Giuseppe Valenti¹  Giuseppe Spadaro²  Nunzio Crimi³  Santi Nolasco⁴  Claudia Crimi⁴  Corrado Pelaia⁵  Girolamo Pelaia⁵  Maria Filomena Caiaffa⁶  Giulia Scioscia⁷  Massimo Triggiani⁸  Aikaterini Detoraki⁹  Alida Benfante^1,10  Nicola Scichilone^1,10  Alessandra Tomasello^1,10  Andrea Portacci^1,11  Enrico Buonamico^1,11  Giovanna Elisiana Carpagnano^1,11  Raffaele Campisi^1,12 

[1] Allergology and Pulmonology Unit, Provincial Outpatient Center of Palermo, Palermo, Italy;Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy;Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy;Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy;Respiratory Medicine Unit, Policlinico “G. Rodolico-San Marco” University Hospital, Catania, Italy;Department of Health Sciences, University “Magna Graecia” of Catanzaro, Catanzaro, Italy;Department of Medical and Surgical Sciences, School and Chair of Allergology and Clinical Immunology, University of Foggia, Foggia, Italy;Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy;Division of Allergy and Clinical Immunology, University of Salerno, Salerno, Italy;Division of Internal Medicine and Clinical Immunology, Department of Internal Medicine and Clinical Complexity University of Naples Federico II, Naples, Italy;Division of Respiratory Diseases, Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, Palermo, Italy;Institute of Respiratory Disease, Department of Translational Biomedicine and Neuroscience, University “Aldo Moro”, Bari, Italy;Respiratory Medicine Unit, Policlinico “G. Rodolico-San Marco” University Hospital, Catania, Italy;

关键词: EGPA;    eosinophilic granulomatosis with polyangiitis;    Churg-Strauss;    mepolizumab;    benralizumab;    IL-5;    remission;    oral corticosteroid;   

DOI  :  10.3389/fimmu.2023.1204444

 received in 2023-04-12, accepted in 2023-06-05,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundEosinophilic granulomatosis with polyangiitis (EGPA) is a rare vasculitis characterized by asthma, systemic manifestations, and blood and tissue eosinophilia.ObjectiveTo assess the effectiveness and safety of mepolizumab (anti-IL-5) and benralizumab (anti-IL-5Rα) in EGPA for 24 months.MethodsWe conducted a multicenter observational study, including patients with EGPA treated with anti-IL-5/Rα biologics in 9 Italian specialized facilities. Systemic disease activity, remission and relapse rate were evaluated from 3 to 24 months after treatment initiation. Respiratory outcomes, hematological parameters, corticosteroid (OCS) and immunosuppressants consumption were also assessed.Results49 patients with relapsing-refractory EGPA were included [26 (53.1%) benralizumab 30mg, 20 (40.8%) mepolizumab 100mg, 3 (6.1%) mepolizumab 300mg]. Overall, 38.8% and 57.1% achieved remission after 12 and 24 months, respectively (69.2% benralizumab and 43.5% mepolizumab). Lower OCS intake and higher blood eosinophil count at baseline were associated with remission at 24 months. Both biologics exerted beneficial effects on severe asthma outcomes. Indeed, 61.2% (61.5% benralizumab and 60.8% mepolizumab) remained exacerbation-free during treatment. Lung function parameters showed improvements in the overall cohort (all p<0.05), but began to decline from month 12, especially with mepolizumab. Marked reduction in blood eosinophils was registered with mepolizumab (p<0.0001), while benralizumab depleted both eosinophils (p<0.0001) and basophils (p<0.0001). In general, 69.6% (76% benralizumab and 61.9% mepolizumab) of OCS-dependent patients lowered their daily dose by 75%, while 28.3% discontinued these drugs. Immunosuppressants were suspended in 88.2% of cases. Adverse events were reported in 8.2% of patients.ConclusionsThese real-world data suggest that anti-IL-5/Rα biologics are effective and safe in the long-term as add-on treatments for patients with EGPA.

【 授权许可】

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Copyright © 2023 Nolasco, Portacci, Campisi, Buonamico, Pelaia, Benfante, Triggiani, Spadaro, Caiaffa, Scioscia, Detoraki, Valenti, Papia, Tomasello, Crimi, Scichilone, Pelaia, Carpagnano and Crimi