Parameswaran K Nair,Bernhard Hellmich,Arnaud Bourdin,David R W Jayne,Florence Roufosse,Nader Khalidi,Lena Börjesson Sjö,Ying Fan,Christopher McCrae,Sofia Necander,Eva Rodríguez-Suárez,Anat Shavit,Claire Walton,Peter A Merkel,Michael E Wechsler
{"title":"The Effect of Benralizumab and Mepolizumab on Use of Oral Glucocorticoids in Patients with Eosinophilic Granulomatosis with Polyangiitis.","authors":"Parameswaran K Nair,Bernhard Hellmich,Arnaud Bourdin,David R W Jayne,Florence Roufosse,Nader Khalidi,Lena Börjesson Sjö,Ying Fan,Christopher McCrae,Sofia Necander,Eva Rodríguez-Suárez,Anat Shavit,Claire Walton,Peter A Merkel,Michael E Wechsler","doi":"10.1002/art.43398","DOIUrl":null,"url":null,"abstract":"OBJECTIVE\r\nThe Phase 3 MANDARA study demonstrated non-inferiority of benralizumab versus mepolizumab for remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA). More benralizumab-treated patients achieved complete withdrawal of oral glucocorticoids (OGCs). These post-hoc analyses further elucidate the efficacy of benralizumab and mepolizumab in facilitating reductions in OGCs.\r\n\r\nMETHODS\r\nAdults with EGPA requiring ≥7.5 mg/day OGC ±immunosuppressive therapy were randomized to benralizumab 30mg (n=70) or mepolizumab 300mg (n=70) subcutaneously every 4 weeks for 52 weeks. Investigators tapered OGCs for patients with stable EGPA based on clinical judgment. Reductions in OGC use (to ≤4mg/day, by ≥50%, or complete withdrawal) were considered sustained if achieved by Week 40 and maintained through Week 52.\r\n\r\nRESULTS\r\nThe 12-month cumulative dose of OGC was ~1,800 mg in both groups. At Weeks 49-52, the median (minimum-maximum) OGC dose was 1.16 (0.0-16.6) and 3.00 (0.0-25.7) mg/day for benralizumab and mepolizumab, respectively. Time to first or sustained OGC reduction to ≤4mg/day or by ≥50%, and accrued OGC-free duration, were similar between groups. More benralizumab- than mepolizumab-treated patients completely withdrew OGCs (33/70 vs 20/70; HR for time to first complete withdrawal 1.84 [95% CI, 1.06, 3.27], unstratified log-rank test p=0.0291) and sustained complete withdrawal (17/70 vs 7/70; HR for time to reduction 2.97 [95%CI: 1.26,7.77], unstratified log-rank test p=0.0268). In both groups, complete OGC withdrawal was similar across patient subgroups, including by ANCA status and immunosuppressive use.\r\n\r\nCONCLUSION\r\nTargeting the interleukin-5 receptor with benralizumab, or circulating interleukin-5 with mepolizumab, are effective OGC-sparing strategies in patients with EGPA.","PeriodicalId":129,"journal":{"name":"Arthritis & Rheumatology","volume":"39 1","pages":""},"PeriodicalIF":10.9000,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Arthritis & Rheumatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/art.43398","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
OBJECTIVE
The Phase 3 MANDARA study demonstrated non-inferiority of benralizumab versus mepolizumab for remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA). More benralizumab-treated patients achieved complete withdrawal of oral glucocorticoids (OGCs). These post-hoc analyses further elucidate the efficacy of benralizumab and mepolizumab in facilitating reductions in OGCs.
METHODS
Adults with EGPA requiring ≥7.5 mg/day OGC ±immunosuppressive therapy were randomized to benralizumab 30mg (n=70) or mepolizumab 300mg (n=70) subcutaneously every 4 weeks for 52 weeks. Investigators tapered OGCs for patients with stable EGPA based on clinical judgment. Reductions in OGC use (to ≤4mg/day, by ≥50%, or complete withdrawal) were considered sustained if achieved by Week 40 and maintained through Week 52.
RESULTS
The 12-month cumulative dose of OGC was ~1,800 mg in both groups. At Weeks 49-52, the median (minimum-maximum) OGC dose was 1.16 (0.0-16.6) and 3.00 (0.0-25.7) mg/day for benralizumab and mepolizumab, respectively. Time to first or sustained OGC reduction to ≤4mg/day or by ≥50%, and accrued OGC-free duration, were similar between groups. More benralizumab- than mepolizumab-treated patients completely withdrew OGCs (33/70 vs 20/70; HR for time to first complete withdrawal 1.84 [95% CI, 1.06, 3.27], unstratified log-rank test p=0.0291) and sustained complete withdrawal (17/70 vs 7/70; HR for time to reduction 2.97 [95%CI: 1.26,7.77], unstratified log-rank test p=0.0268). In both groups, complete OGC withdrawal was similar across patient subgroups, including by ANCA status and immunosuppressive use.
CONCLUSION
Targeting the interleukin-5 receptor with benralizumab, or circulating interleukin-5 with mepolizumab, are effective OGC-sparing strategies in patients with EGPA.
期刊介绍:
Arthritis & Rheumatology is the official journal of the American College of Rheumatology and focuses on the natural history, pathophysiology, treatment, and outcome of rheumatic diseases. It is a peer-reviewed publication that aims to provide the highest quality basic and clinical research in this field. The journal covers a wide range of investigative areas and also includes review articles, editorials, and educational material for researchers and clinicians. Being recognized as a leading research journal in rheumatology, Arthritis & Rheumatology serves the global community of rheumatology investigators and clinicians.