Weekly subcutaneous belimumab, standard of care yielded positive results in patients with active SLE

SAN FRANCISCO — In BLISS-SC, a phase 3 study, patients with active autoantibody-positive systemic lupus erythematosus had significantly greater reductions in disease activity when administered belimumab 200 mg weekly via subcutaneous injection plus the standard of care, such as glucocorticosteroids and immunosuppressants, compared with placebo plus the standard of care, according to a GlaxoSmithKline press release distributed at the American College of Rheumatology Annual Meeting.

At 52 weeks, significantly more patients treated with IV belimumab (Benlysta, GlaxoSmithKline) plus the standard of care (SoC) showed reduced disease compared with placebo plus the SoC (60.8% vs. 48.5%) using the Systemic Lupus Erythematosus Responder Index (SRI), according to the press release. The SRI components measure reduction in disease activity defined as clinical improvement with no significant worsening in any organ system and no worsening in overall patient condition. Of the 836 patients in the trial, 556 were randomized to receive belimumab plus the SoC and 280 received placebo plus the SoC. Of the patients, 94% were women.

For the two pre-specified secondary efficacy endpoints, the study showed the time to severe flare was significantly delayed in patients who received belimumab subcutaneously plus the SoC compared with patients who received placebo plus the SoC (170 days vs. 116.5 days). In addition, in patients who received more than 7.5 mg/day of prednisone (n = 503), 18.2% of patients who received subcutaneous belimumab plus the SoC were able to reduce their steroid dose by 25% during weeks 40 to 52 compared with 11.9% of patients who received placebo plus SoC. However, this finding was not statistically significant, according to the press release.

A serious adverse event was reported in 15.7% of patients in the placebo group and 10.8% of patients in the belimumab group. Most notable of the adverse events were five deaths – in the placebo group, one was hematologic and one was vascular; in the belimumab group, the three deaths were due to infection. The overall incidence of death for all randomized controlled studies that investigated this medication for lupus was 0.7% for belimumab and 0.5% for placebo, according to the press release.

Study authors concluded the safety of belimumab plus the SoC was similar to placebo plus the SoC, according to the meeting abstract. – by Joan-Marie Stiglich, ELS

Reference:

Stohl W, et al. Paper #3218. Presented at: American College of Rheumatology Annual Meeting; Nov. 7-11, 2015; San Francisco.

Disclosures: Stohl reports financial arrangements with Eli Lilly and Company and Janssen. Please see the full study for a list of all other authors’ relevant financial disclosures. GlaxoSmithKline and Human Genome Sciences sponsored and conducted this clinical trial.