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A pivotal phase III, randomised, placebo-controlled study of belimumab in
patients with systemic lupus erythematosus located in China, Japan and South
Korea
#MMPMID29295825
Zhang F
; Bae SC
; Bass D
; Chu M
; Egginton S
; Gordon D
; Roth DA
; Zheng J
; Tanaka Y
Ann Rheum Dis
2018[Mar]; 77
(3
): 355-363
PMID29295825
show ga
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: This 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: The 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.
|Administration, Intravenous
[MESH]
|Adult
[MESH]
|Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
[MESH]
|China
[MESH]
|Double-Blind Method
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Immunosuppressive Agents/adverse effects/*therapeutic use
[MESH]
free
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