A research study has shown the efficacy and safety of the Benlysta (belimumab), used in combination with other standard of care lupus treatments, such as antimalarials (AM), immunosuppressants (IS) and steroids. The findings may contribute to a better understanding of how Benlysta works as an add-on therapy for systemic lupus erythematosus (SLE).
The study “Impact of concomitant medication use on belimumab efficacy and safety in patients with systemic lupus erythematosus,” published in the journal Lupus, intended to find possible interactions between Benlysta — an approved add-on therapy — and AM, IS, and steroids, the standard care protocols. Such information, the researchers said, was of interest to physicians.
This study, an ad-hoc analysis, drew on data from two previous Phase 3 clinical trials, BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384), conducted in patients with active SLE who were receiving standard care, and had autoantibody positive results confirming autoimmune disease. The authors analyzed information collected on 834 patients who received 10 mg/kg of Benlysta or placebo, together with standard of care, for 52 weeks.
Results showed that patients undergoing Benlysta treatment had improved (59%) SLE Responder Index (SRI) scores — a measure of disease activity — compared to placebo (44%). More specifially, patients who received AM plus steroids had the best treatment responses with Benlysta, based on SRI scores, whereas those treated with AM only showed the least benefit from the addition of Benlysta. Benlysta also induced a 36% reduction in SLE flares in steroid-treated patients compared to the placebo group.
The safety profile of the combination of Benlysta with standard care was similar across the different medications, with the exception of the group that was receiving steroids plus antimalarials. In this group, 16% of the patients had severe side-effects after Benlysta treatment, compared to 8% in the placebo group.
Besides the positive results observed by the use of Benlysta, the study had some limitations based on the trials’ design, particularly concerning the number of patients included in each study group, and changes in standard of care medications patients used during the trials, which moved them among treatment groups.
Still, “the efficacy of belimumab in combination with SoC [standard of care] was demonstrated for steroids, alone and in combination with AM [antimalarials] and IS [immunosuppressants],” the researchers concluded. “These findings may be helpful in understanding current prescribing practice trends and may improve the understanding of the safety and efficacy of adding belimumab to various treatments.”
SLE is a chronic autoimmune disease that affects several organs and tissues in the body, such as the kidneys, skin, muscles and bones. The immune responses responsible for SLE are quite complex, but they ultimately lead to the accumulation of antibodies, produced by the immune system, that attack the body and result in tissue damage. There is no cure, so available treatments focus on symptom flares and reducing their severity and duration.