Mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline EGPA characteristics
Background The Mepolizumab in Relapsing or Refractory EGPA (MIRRA) trial (GSK ID: 115921/NCT02020889) demonstrated that mepolizumab increased remission time and reduced oral corticosteroid (OCS) use compared with placebo in patients with relapsing or refractory eosinophilic granulomatosis with polya...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
European Respiratory Society
2024-01-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/10/1/00509-2023.full |
| _version_ | 1797278878186602496 |
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| author | David R.W. Jayne Benjamin Terrier Bernhard Hellmich Paneez Khoury Lee Baylis Jane H. Bentley Jonathan Steinfeld Steven W. Yancey Namhee Kwon Michael E. Wechsler Praveen Akuthota |
| author_facet | David R.W. Jayne Benjamin Terrier Bernhard Hellmich Paneez Khoury Lee Baylis Jane H. Bentley Jonathan Steinfeld Steven W. Yancey Namhee Kwon Michael E. Wechsler Praveen Akuthota |
| author_sort | David R.W. Jayne |
| collection | DOAJ |
| description | Background
The Mepolizumab in Relapsing or Refractory EGPA (MIRRA) trial (GSK ID: 115921/NCT02020889) demonstrated that mepolizumab increased remission time and reduced oral corticosteroid (OCS) use compared with placebo in patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The present analysis investigated the impact of baseline characteristics on clinical outcomes and characterised the OCS-sparing effect of mepolizumab.
Methods
In a phase 3, randomised controlled trial for patients with EGPA (MIRRA), patients received standard of care plus mepolizumab 300 mg or placebo every 4 weeks for 52 weeks. The accrued duration of remission, the proportion of patients in remission at weeks 36 and 48, and the proportion of patients with clinical benefit (remission, OCS or relapse-related) were assessed according to baseline EGPA characteristic subgroups (post hoc). Mepolizumab-related OCS-sparing benefits were also quantified.
Results
Accrued duration of remission and the proportion of patients in remission at weeks 36 and 48 were greater with mepolizumab than placebo across the baseline subgroups of refractory disease, immunosuppressant use, EGPA duration, relapse number and OCS use ≤20 mg·day−1. The proportion of patients with clinical benefit was greater with mepolizumab versus placebo (range 76–81% versus 25–39%), irrespective of immunosuppressant use or EGPA duration. Patients treated with mepolizumab versus placebo accrued significantly more weeks on OCS ≤4 mg·day−1 (OR 5.06, 95% CI 2.47–10.38) and had a mean of 1423.1 mg less per-patient OCS exposure over 52 weeks.
Conclusions
Mepolizumab treatment provided benefits to patients with EGPA across varying baseline clinical characteristics and can be considered an OCS-sparing treatment in EGPA. |
| first_indexed | 2024-03-07T16:15:27Z |
| format | Article |
| id | doaj.art-f5791a79712a421aaf3c5bd1a5f14a81 |
| institution | Directory Open Access Journal |
| issn | 2312-0541 |
| language | English |
| last_indexed | 2024-03-07T16:15:27Z |
| publishDate | 2024-01-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj.art-f5791a79712a421aaf3c5bd1a5f14a812024-03-04T11:29:59ZengEuropean Respiratory SocietyERJ Open Research2312-05412024-01-0110110.1183/23120541.00509-202300509-2023Mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline EGPA characteristicsDavid R.W. Jayne0Benjamin Terrier1Bernhard Hellmich2Paneez Khoury3Lee Baylis4Jane H. Bentley5Jonathan Steinfeld6Steven W. Yancey7Namhee Kwon8Michael E. Wechsler9Praveen Akuthota10 Department of Medicine, University of Cambridge, Cambridge, UK Service de Médecine Interne, Hôpital Cochin, Paris, France Klinik für Innere Medizin, Rheumatologie und Immunologie, Medius Kliniken, Universität Tübingen, Kirchheim-Teck, Germany Human Eosinophil Section, Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA Global Medical Affairs, GSK, Durham, NC, USA Clinical Statistics, GSK, Brentford, UK Respiratory Therapy Area Unit and Flexible Discovery Unit, GSK, Philadelphia, PA, USA Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA Clinical Sciences, Respiratory, GSK, Brentford, Middlesex, UK Department of Medicine, National Jewish Health, Denver, CO, USA Division of Pulmonary, Critical Care, and Sleep Medicine, University of California San Diego, La Jolla, CA, USA Background The Mepolizumab in Relapsing or Refractory EGPA (MIRRA) trial (GSK ID: 115921/NCT02020889) demonstrated that mepolizumab increased remission time and reduced oral corticosteroid (OCS) use compared with placebo in patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The present analysis investigated the impact of baseline characteristics on clinical outcomes and characterised the OCS-sparing effect of mepolizumab. Methods In a phase 3, randomised controlled trial for patients with EGPA (MIRRA), patients received standard of care plus mepolizumab 300 mg or placebo every 4 weeks for 52 weeks. The accrued duration of remission, the proportion of patients in remission at weeks 36 and 48, and the proportion of patients with clinical benefit (remission, OCS or relapse-related) were assessed according to baseline EGPA characteristic subgroups (post hoc). Mepolizumab-related OCS-sparing benefits were also quantified. Results Accrued duration of remission and the proportion of patients in remission at weeks 36 and 48 were greater with mepolizumab than placebo across the baseline subgroups of refractory disease, immunosuppressant use, EGPA duration, relapse number and OCS use ≤20 mg·day−1. The proportion of patients with clinical benefit was greater with mepolizumab versus placebo (range 76–81% versus 25–39%), irrespective of immunosuppressant use or EGPA duration. Patients treated with mepolizumab versus placebo accrued significantly more weeks on OCS ≤4 mg·day−1 (OR 5.06, 95% CI 2.47–10.38) and had a mean of 1423.1 mg less per-patient OCS exposure over 52 weeks. Conclusions Mepolizumab treatment provided benefits to patients with EGPA across varying baseline clinical characteristics and can be considered an OCS-sparing treatment in EGPA.http://openres.ersjournals.com/content/10/1/00509-2023.full |
| spellingShingle | David R.W. Jayne Benjamin Terrier Bernhard Hellmich Paneez Khoury Lee Baylis Jane H. Bentley Jonathan Steinfeld Steven W. Yancey Namhee Kwon Michael E. Wechsler Praveen Akuthota Mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline EGPA characteristics ERJ Open Research |
| title | Mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline EGPA characteristics |
| title_full | Mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline EGPA characteristics |
| title_fullStr | Mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline EGPA characteristics |
| title_full_unstemmed | Mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline EGPA characteristics |
| title_short | Mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline EGPA characteristics |
| title_sort | mepolizumab has clinical benefits including oral corticosteroid sparing irrespective of baseline egpa characteristics |
| url | http://openres.ersjournals.com/content/10/1/00509-2023.full |
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