Real-world safety and effectiveness of mepolizumab for patients with eosinophilic granulomatosis with polyangiitis in Japan: Long-term observation of the MARS study
Tomonori Ishii, Hideaki Kunishige, T Kobayashi, Etsuko Hayashi, Masaki Komatsubara, Rafael Alfonso-Cristancho, J Tamaoki, Peter Howarth
Abstract
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, and end of observation period), the proportion of patients with no clinical symptoms increased (from 6% to 27% to 32%, respectively), median oral glucocorticoid dose decreased (from 6.9 to 3.0 to 2.0 mg/day, respectively), and the proportion of oral glucocorticoid-free patients increased (from 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.