PMID- 38100679
OWN - NLM
STAT- Publisher
LR  - 20231215
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
DP  - 2023 Dec 8
TI  - Real-world safety and effectiveness of mepolizumab for patients with eosinophilic 
      granulomatosis with polyangiitis (EGPA) in Japan: 48-week interim analysis of the 
      MARS study.
LID - road109 [pii]
LID - 10.1093/mr/road109 [doi]
AB  - OBJECTIVES: : Assess real-world, long-term safety/effectiveness of mepolizumab 
      for eosinophilic granulomatosis with polyangiitis (EGPA) in Japan. METHODS: : 
      MARS (GSK ID:213684/NCT04551989) is an ongoing 96-week study of patients with 
      EGPA who received 4-weekly mepolizumab 300 mg subcutaneously for >/=96 weeks before 
      study entry (baseline) and continued treatment. This interim analysis included 
      safety from baseline to Week 48 (observation period) and clinical outcomes before 
      mepolizumab and during the observation period. RESULTS: : Of 118 patients 
      enrolled, 29% (34/118) experienced adverse events (AEs) of which 13% (15/118) 
      experienced serious AEs; none were considered mepolizumab-related. Median oral 
      corticosteroid (OCS) dose decreased from 6.9 (pre-mepolizumab) to 3.0 (baseline) 
      and 2.0 mg/day (Weeks 45-48); the proportion of patients receiving no OCS 
      increased from 8% to 32% and 38%, respectively. Patients experiencing clinical 
      symptoms decreased from 94% (pre-mepolizumab) to 73% (baseline) and 67% (Week 
      48). During the observation period, 5% of patients experienced EGPA relapse; 
      rates of EGPA-related hospitalisations, EGPA-related emergency room/unscheduled 
      visits and asthma exacerbations were 0.05, 0.09 and 0.08 event/person-year, 
      respectively. CONCLUSIONS: : Results of mepolizumab treatment for >/=144 weeks 
      (before baseline plus observation) were consistent with the known safety profile 
      and allowed OCS dose reduction while improving disease control versus 
      pre-treatment among patients with EGPA.
CI  - (c) Japan College of Rheumatology 2023. Published by Oxford University Press.
FAU - Ishii, Tomonori
AU  - Ishii T
AD  - Tohoku University Hospital, Clinical Research, Innovation and Education Center, 
      Sendai, Japan.
FAU - Kunishige, Hideaki
AU  - Kunishige H
AD  - Value Evidence & Outcomes, GSK, Tokyo, Japan.
FAU - Kobayashi, Tamami
AU  - Kobayashi T
AD  - Clinical Statistics, GSK, Tokyo Japan.
FAU - Hayashi, Etsuko
AU  - Hayashi E
AD  - Respiratory Medical & Development, GSK, Tokyo, Japan.
FAU - Komatsubara, Masaki
AU  - Komatsubara M
AD  - Respiratory Medical & Development, GSK, Tokyo, Japan.
FAU - Ishii, Takeo
AU  - Ishii T
AD  - Value Evidence & Outcomes, GSK, Tokyo, Japan.
FAU - Alfonso-Cristancho, Rafael
AU  - Alfonso-Cristancho R
AD  - Value Evidence & Outcomes, GSK, Collegeville, PA, USA.
FAU - Tamaoki, Jun
AU  - Tamaoki J
AD  - Respiratory Medical & Development, GSK, Tokyo, Japan.
FAU - Howarth, Peter
AU  - Howarth P
AD  - Global Medical Affairs, GSK, London, UK.
LA  - eng
PT  - Journal Article
DEP - 20231208
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
SB  - IM
OTO - NOTNLM
OT  - ANCA-associated vasculitis
OT  - Churg-Strauss syndrome
OT  - biologic
OT  - corticosteroid-sparing
OT  - interleukin-5
EDAT- 2023/12/15 18:41
MHDA- 2023/12/15 18:41
CRDT- 2023/12/15 15:33
PHST- 2023/05/31 00:00 [received]
PHST- 2023/10/02 00:00 [revised]
PHST- 2023/12/04 00:00 [accepted]
PHST- 2023/12/15 18:41 [medline]
PHST- 2023/12/15 18:41 [pubmed]
PHST- 2023/12/15 15:33 [entrez]
AID - 7473722 [pii]
AID - 10.1093/mr/road109 [doi]
PST - aheadofprint
SO  - Mod Rheumatol. 2023 Dec 8:road109. doi: 10.1093/mr/road109.