Real-world safety and effectiveness of mepolizumab for patients with eosinophilic granulomatosis with polyangiitis in Japan: long-term observation of the MARS study.

Autor:	Ishii T; Tohoku University Hospital, Clinical Research Innovation and Education Centre, Sendai, Japan.; Tohoku Medical and Pharmaceutical University, Division of Hematology and Rheumatology, Sendai, Japan., Kunishige H; Value Evidence & Outcomes, GSK, Tokyo, Japan., Kobayashi T; Clinical Statistics, GSK, Tokyo, Japan., Hayashi E; Respiratory/Immunology Medical Affairs, GSK, Tokyo, Japan., Komatsubara M; Value Evidence & Outcomes, GSK, Tokyo, Japan., Alfonso-Cristancho R; Value Evidence & Outcomes, GSK, Collegeville, PA, USA., Tamaoki J; Tokyo Women's Medical University, Tokyo, Japan., Howarth P; Global Medical Affairs, GSK, London, UK.
Jazyk:	angličtina
Zdroj:	Modern rheumatology [Mod Rheumatol] 2024 Nov 07. Date of Electronic Publication: 2024 Nov 07.
DOI:	10.1093/mr/roae100
Abstrakt:	Objectives: To provide long-term, real-world safety and effectiveness data for mepolizumab treatment in eosinophilic granulomatosis with polyangiitis in Japan. Methods: MARS (NCT04551989) was a real-world, observational study of patients who had previously completed the PMS study (NCT03557060; ≥96 weeks of mepolizumab treatment before study entry [baseline]) and continued receiving four-weekly mepolizumab 300 mg subcutaneously for a further 96 weeks. Safety outcomes were assessed from baseline to Week 96 (observation period); clinical outcomes were assessed pre-mepolizumab initiation (retrospective period) and during the observation period. Results: Of 118 patients enrolled in the study, 58% (69/118) experienced adverse events and 22% (26/118) experienced serious adverse events over the observation period; none were mepolizumab-related. Over the study (pre-mepolizumab period; baseline; end of observation period) the proportion of patients with no clinical symptoms increased (6%, to 27%, to 32%, respectively), median oral glucocorticoid dose decreased (6.9, to 3.0, to 2.0 mg/day, respectively) and the proportion of oral glucocorticoid-free patients increased (8%, to 31%, to 36%, respectively). Conclusions: Long-term MARS study data are consistent with the known safety profile of mepolizumab. Over 192 weeks (pre-mepolizumab-observation), mepolizumab was well tolerated, with improvements in eosinophilic granulomatosis with polyangiitis disease control and reductions in oral glucocorticoid use. (© Japan College of Rheumatology 2024. Published by Oxford University Press.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu