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2016 ; 25
(4
): 346-54
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Elevated BLyS levels in patients with systemic lupus erythematosus: Associated
factors and responses to belimumab
#MMPMID26385220
Roth DA
; Thompson A
; Tang Y
; Hammer AE
; Molta CT
; Gordon D
Lupus
2016[Apr]; 25
(4
): 346-54
PMID26385220
show ga
INTRODUCTION: Patients with systemic lupus erythematosus (SLE) with B-lymphocyte
stimulator (BLyS) levels???2?ng/mL are at increased risk of flare. A regression
analysis was undertaken to identify routine clinical measures that correlate with
BLyS???2?ng/mL. Efficacy and safety of belimumab 10?mg/kg were examined in
patients with BLyS???2?ng/mL and 2?ng/mL. METHODS: Data from BLISS-52 and -76
(N?=?1684) were pooled post hoc. A univariate logistic regression was employed to
identify factors predictive of baseline BLyS???2?ng/mL. Factors significant at
the 0.05 level then entered a stepwise logistic regression as covariates.
Efficacy endpoints included SLE responder index (SRI), ??4-point reduction in
Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus
Disease Activity Index (SELENA-SLEDAI) and risk of severe flare over 52 weeks.
Adverse events (AEs) were analyzed for each treatment arm and BLyS subgroup.
RESULTS: Baseline predictors of BLyS???2?ng/mL included positive anti-Smith (??15
U/mL), low complement (C) 3 (900?mg/L), anti-double-stranded DNA (anti-dsDNA)
80-200 and ??200?IU/mL, immunosuppressant usage, proteinuria, elevated C-reactive
protein (CRP), and low total lymphocyte count for all patients. Belimumab
10?mg/kg led to significantly greater SRI responses over 52 weeks versus placebo
in both BLyS subgroups, though treatment differences were numerically greater at
Week 52 in the BLyS???2?ng/mL group (24.1%, p?0.0001) compared with
BLyS?2?ng/mL (8.2%, p?=?0.0158). Results were similar for???4-point reduction
in SELENA-SLEDAI. Risk of severe flare over 52 weeks was significantly reduced
with belimumab 10?mg/kg versus placebo in the BLyS???2?ng/mL group (p?=?0.0002).
AEs were similar across treatment arms and BLyS subgroups. CONCLUSIONS: Positive
anti-Smith, low C3, anti-dsDNA???80?IU/mL, immunosuppressant usage, proteinuria,
elevated CRP, and low total lymphocyte count were predictors of BLyS???2?ng/mL.
Monitoring these factors could identify patients with BLyS???2?ng/mL who are at
risk of flare.
|Adult
[MESH]
|Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
[MESH]