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Patients With SLE on Baseline Steroids may Benefit More From Belimumab
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Patients with systemic lupus erythematosus who received steroids at baseline were more likely to benefit from additional treatment with belimumab vs. patients who did not, according to recently published data.
Researchers conducted a post-hoc analysis of the BLISS-52 and BLISS-76 randomized controlled studies of patients with systemic lupus erythematosus (SLE) who received placebo (n = 562) or belimumab (Benlysta, GlaxoSmithKline) at a dose of IV 10 mg/kg or 1 mg/kg of body weight in addition to steroid plus antimalarials (n = 346) or steroids plus antimalarials and immunosuppressants (n = 272) or antimalarials only (n = 77).
The primary endpoint of the studies was an SLE Responder Index of at least 4.
The proportion of patients with SLE who met the primary endpoint at week 52 were more likely to have received 10 mg/kg belimumab compared with placebo, with the highest response rate observed in the group that also received steroids and antimalarials. A significant response rate was also seen with the group that received belimumab and steroids only, followed by the group that received antimalarials and immunosuppressants. Patients who received belimumab and antimalarials only had the lowest response rate.
At week 52, patients who received only steroids in addition to belimumab were more likely to experience a flare vs. other treatment arms of the study.
Overall, the mean dose of antimalarials was stable through the study periods, whereas the use of steroids tended to increase with time.
At week 52, 94 patients who received placebo and 78 patients who received belimumab withdrew from the studies. Reasons for withdrawal included lack of efficacy, protocol violations or adverse events. The incidence of adverse events and serious adverse events was similar across treatment arms, and included. – by Shirley Pulawski
Disclosure: The researchers report the study was funded by GlaxoSmithKline.
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