Mepolizumab in CRSwNP/ECRS and NP: the phase III randomised MERIT trial in Japan, China, and Russia.
Rhinology
; 62(5): 576-589, 2024 Oct 01.
Article
en En
| MEDLINE
| ID: mdl-39058315
ABSTRACT
BACKGROUND:
This randomised, double-blind, placebo-controlled, parallel-group, 52-week Phase III study (MERIT; NCT04607005) assessed mepolizumab efficacy and safety in patients with chronic rhinosinusitis with nasal polyps (CRSwNP)/eosinophilic CRS (ECRS) in Japan, Russia, and China, for which data are limited.METHODOLOGY:
Eligible patients (enrolled at 60 centres) had blood eosinophil count >2%, endoscopic bilateral NP score ≥5, nasal obstruction visual analogue scale (VAS) score >5, ≥2 sinonasal symptoms, and either previous sinus surgery or systemic corticosteroid use/intolerance. Patients were randomised (11) to receive mepolizumab 100 mg subcutaneously or placebo every 4 weeks, plus standard of care. Co-primary endpoints change from baseline in total endoscopic NP score (ENPS) (Week 52) and nasal obstruction VAS score (Weeks 49-52). Post hoc analyses conducted in a modified intent-to-treat (mITT) population excluded patients from two study sites, related to Good Clinical Practice violations by the Site Management Organisation overseeing these sites. These were considered the primary efficacy analyses.RESULTS:
In the mITT population, mepolizumab (n=80) versus placebo (n=83) significantly improved nasal obstruction VAS score from baseline to Week 49-52 and was associated with a trend of total ENPS improvements at Week 52. Mepolizumab/placebo on-treatment adverse events (AEs) occurred in 68/84 and 65/85 patients in the safety population (treatment-related AEs 2/84 and 5/85, respectively), and on-treatment serious AEs in 0/84 and 4/85 patients, respectively (no fatalities reported).CONCLUSIONS:
Mepolizumab was effective and well-tolerated in patients with CRSwNP/ECRS from Japan, Russia, and China.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Sinusitis
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Pólipos Nasales
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Anticuerpos Monoclonales Humanizados
Límite:
Adult
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Female
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Humans
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Male
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Middle aged
País como asunto:
Asia
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Europa
Idioma:
En
Año:
2024
Tipo del documento:
Article