Results from two Phase 3 trials revealed that patients with systemic lupus erythematosus (SLE) can benefit from the recombinant human monoclonal antibody Benlysta (belimumab) when it is used with steroids.
The study, “Impact of concomitant medication use on belimumab efficacy and safety in patients with systemic lupus erythematosus,” published in Lupus, was developed by researchers at Germany’s University Hospital Mainz and colleagues.
Until recently, the standard of care for SLE patients included treatment with antimalarials, immunosuppressants, and steroids, either as single agents or in combination therapies. Benlysta was licenced for autoantibody-positive SLE patients in combination with those treatments in 2011.
Benlysta targets a molecule that stimulates B cells and impairs the production of autoantibodies. The result had been proven effective in two large randomized and controlled trials: BLISS-52 (A Study of Belimumab in Subjects with Systemic Lupus Erythomatosus) and BLISS-76, which included auto-antibody positive SLE adult patients receiving standard of care therapy. Primary endpoints for both studies was SLE Responder Index response rate at week 52.
Researchers conducted a pooled analysis of the studies to assess the effectiveness and safety of Benlysta in combination with different standard-of-care therapies. The trials included 562 patients who received placebo; 78 who received Belynsta with steroids only; 77 who were given Benlysta in combination with antimalarials; 272 who were given Benlysta, antimalarials, and antisuppressants; and 346 subjects on Benlysta plus steroids and antimalarials.
Results revealed that patients on Benlysta 10 mg/kg were more likely to meet the primary endpoint at week 52 than those on a placebo. However, the highest response rate was observed in those who received steroids and antimalarials.
Patients on the steroids-only group also showed a significant response rate compared to placebo, followed by the combination of steroids, antimalarials, and immunosuppressants group. Patients on Benlysta and antimalarials only displayed lower response rates. Patients on Belynsta plus standard-of-care therapy with steroids displayed a reduced probability of experiencing an SLE flare compared to those on placebo or in the other study groups.
The researchers report that those who received antimalarials and immunosuppressants had little or no changes in doses needed over time, but that steroid doses tended to decrease over time in 25 percent to 33 percent of patients.
Study results indicated that patients in all treatment groups had similar safety profiles, with the exception of those receiving steroids plus antimalarials. These patients experienced twice the number of adverse events as patients on placebo.
These findings suggest that Benlysta is effective and safe when combined with standard of care therapies for SLE patients, the researchers concluded.