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2016 ; 25
(14
): 1587-1596
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Impact of concomitant medication use on belimumab efficacy and safety in patients
with systemic lupus erythematosus
#MMPMID27488472
Schwarting A
; Dooley MA
; Roth DA
; Edwards L
; Thompson A
; Wilson B
Lupus
2016[Dec]; 25
(14
): 1587-1596
PMID27488472
show ga
Practicing physicians have requested efficacy and safety data for belimumab, when
used with specific systemic lupus erythematosus (SLE) medications. This was a
post hoc analysis of pooled efficacy and safety data from patients who received
belimumab 10?mg/kg plus standard of care (SoC) or placebo (SoC) in two Phase III,
randomized trials, BLISS-52 and BLISS-76. Patients were categorized into four
groups based on baseline concomitant medication usage: steroids only;
antimalarials (AM) only; steroids?+?AM; or steroids?+?AM?+?immunosuppressants
(IS). The primary endpoint was the SLE Responder Index (SRI) at Week 52. SRI over
time and individual SRI components were secondary endpoints. Time to first flare
and changes in concomitant medications were exploratory endpoints. Safety was
assessed using adverse event (AE) reporting. Across 834 patients, steroids?+?AM
was the largest group (n?=?346, 41.5%) and AM only was the smallest (n?=?77,
9.2%). Disease duration was shortest in the steroids?+?AM group (5.7 years vs
6.4-7.1 years); SELENA-SLEDAI scores were similar across groups. At Week 52, the
percentage of SRI responders was greatest in the steroids?+?AM group for
belimumab 10?mg/kg (59%) compared with placebo (44%); treatment response and SRI
component improvements were also observed across other groups. The probability of
experiencing an SLE flare was reduced in the steroids-only group for patients who
received belimumab 10?mg/kg compared with placebo (64.3% vs 78.1%; hazard ratio
0.64; 95% confidence interval: 0.42-0.96). There was little or no change in daily
AM or IS dose in any group. For all groups, there was a general decrease in
steroid dose over time; a quarter to a third of patients experienced decreased
steroid doses at Week 52. The overall safety profile was similar across treatment
arms and concomitant medication groups, with the exception of serious AEs in the
steroids?+?AM group (belimumab 10?mg/kg 16%, placebo 8%). The efficacy and safety
of belimumab in combination with SoC was demonstrated for various groupings of
steroids, AM and IS. These findings may improve the understanding of the safety
and efficacy of adding belimumab to different treatments.
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