배상철
2019-12-06T07:39:11Z
2019-12-06T07:39:11Z
2018-03
ANNALS OF THE RHEUMATIC DISEASES, v. 77, no. 3, page. 355-363
0003-4967
1468-2060
https://ard.bmj.com/content/77/3/355
https://repository.hanyang.ac.kr/handle/20.500.11754/118001
Background Intravenous belimumab plus standard of care (SoC) is approved in the USA and Europe for treatment of active, autoantibody-positive systemic lupus erythematosus (SLE).Methods T his phase III, multicentre, randomised, double-blind, placebo-controlled study (BEL113750; NCT01345253) was conducted in 49 centres across China, Japan and South Korea (May 2011-September 2015). Patients with SLE were randomised 2: 1 to intravenous belimumab 10 mg/ kg or placebo, plus SoC, every 4 weeks until Week 48. The primary endpoint was the SLE Responder Index (SRI) 4 response rate at Week 52. Secondary endpoints were the percentage of patients with >= 4 point reduction in Safety of Oestrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI), SRI7, time to first severe flare and number of days prednisone (or equivalent) dose >= 7.5 mg/day and/or reduced by 50% from baseline. Safety was assessed.Results T he modified intent-to-treat population included 677 patients (belimumab n= 451, placebo n= 226). At Week 52, the SRI4 response rate was higher with belimumab versus placebo (53.8% vs 40.1%; OR: 1.99 (95% CI: 1.40, 2.82; P= 0.0001)). The percentages of patients with a = 4 point reduction in SELENA-SLEDAI and an SRI7 response were significantly greater for belimumab versus placebo. Patients in the belimumab group had a 50% lower risk of experiencing a severe flare than those receiving placebo (P= 0.0004). In patients with baseline prednisone dose > 7.5 mg/day, there was a significant reduction in steroid use favouring belimumab (P= 0.0228). The incidence of adverse events was similar between groups.Conclusions In patients with SLE from North East Asia, belimumab significantly improved disease activity, while reducing prednisone use, with no new safety issues.
This study was funded by GSK.
en_US
BMJ PUBLISHING GROUP
B-LYMPHOCYTE STIMULATOR
MONOCLONAL-ANTIBODY
MORTALITY
RECOMMENDATIONS
CLASSIFICATION
SURVIVAL
DISEASE
DAMAGE
A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea
Article
3
77
10.1136/annrheumdis-2017-211631
355-363
ANNALS OF THE RHEUMATIC DISEASES
Zhang, Fengchun
Bae, Sang-Cheol
Bass, Damon
Chu, Myron
Egginton, Sally
Gordon, David
Roth, David A.
Zheng, Jie
Tanaka, Yoshiya
2018001383
S
COLLEGE OF MEDICINE[S]
DEPARTMENT OF MEDICINE
scbae
http://orcid.org/0000-0003-4658-1093