Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis

In a recent phase III trial (NCT02020889) 53% of mepolizumab-treated versus 19% of placebo-treated patients with eosinophilic granulomatosis with polyangiitis (EGPA) achieved protocol-defined remission. We sought to investigate post hoc the clinical benefit of mepolizumab in patients with EGPA using...

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Bibliographic Details
Published in:Journal of allergy and clinical immunology 2019-06, Vol.143 (6), p.2170-2177
Main Authors: Steinfeld, Jonathan, Bradford, Eric S., Brown, Judith, Mallett, Stephen, Yancey, Steven W., Akuthota, Praveen, Cid, Maria C., Gleich, Gerald J., Jayne, David, Khoury, Paneez, Langford, Carol A., Merkel, Peter A., Moosig, Frank, Specks, Ulrich, Weller, Peter F., Wechsler, Michael E.
Format: Article
Language:English
Subjects:
Adult
Antibodies, Monoclonal, Humanized - therapeutic use
Asthma
Blood
Churg-Strauss syndrome
Clinical trials
Dosage
Double-Blind Method
Eosinophilic Granuloma - drug therapy
Eosinophilic granulomatosis with polyangiitis
eosinophils
Eosinophils - immunology
Female
Glucocorticoids
Granulomatosis
Granulomatosis with Polyangiitis - drug therapy
Humans
IL-5
Inflammatory diseases
Interleukin-5 - antagonists & inhibitors
Leukocyte Count
Leukocytes (eosinophilic)
Male
mepolizumab
Middle Aged
Monoclonal antibodies
Patients
Placebos
Prednisolone
Prednisolone - therapeutic use
Prednisone
Randomization
Remission
Studies
Treatment Outcome
Vasculitis
Vein & artery diseases
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Summary:In a recent phase III trial (NCT02020889) 53% of mepolizumab-treated versus 19% of placebo-treated patients with eosinophilic granulomatosis with polyangiitis (EGPA) achieved protocol-defined remission. We sought to investigate post hoc the clinical benefit of mepolizumab in patients with EGPA using a comprehensive definition of benefit encompassing remission, oral glucocorticoid (OGC) dose reduction, and EGPA relapses. The randomized, placebo-controlled, double-blind, parallel-group trial recruited patients with relapsing/refractory EGPA receiving stable OGCs (prednisolone/prednisone, ≥7.5–50 mg/d) for 4 or more weeks. Patients received 300 mg of subcutaneous mepolizumab or placebo every 4 weeks for 52 weeks. Clinical benefit was defined post hoc as follows: remission at any time (2 definitions used), 50% or greater OGC dose reduction during weeks 48 to 52, or no EGPA relapses. The 2 remission definitions were Birmingham Vasculitis Activity Score of 0 plus OGC dose of 4 mg/d or less (remission 1/clinical benefit 1) or 7.5 mg/d or less (remission 2/clinical benefit 2). Clinical benefit was assessed in all patients and among subgroups with a baseline blood eosinophil count of less than 150 cells/μL, baseline OGC dosage of greater than 20 mg/d, or weight of greater than 85 kg. With mepolizumab versus placebo, 78% versus 32% of patients experienced clinical benefit 1, and 87% versus 53% of patients experienced clinical benefit 2 (both P 
ISSN:0091-6749
1097-6825
DOI:10.1016/j.jaci.2018.11.041