Lupus Patients Show Improvement with Combo Therapy of Belimumab and Standard of Care, Study Shows

Patients with systemic lupus erythematosus (SLE) showed significant improvements and decreased disease severity when treated with a combined therapy of belimumab and standard of care measures for up to 24 months, according to results of a two-year study.

The study, “Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA,” was published in the journal Lupus Science & Medicine.

Belimumab, a human monoclonal antibody that inhibits B-lymphocyte stimulator, is used as a treatment for active, autoantibody-positive SLE patients receiving standard of care.

Reseachers investigated the disease activity and clinical efficacy of belimumab in a cohort of patients with SLE followed for 24 months in rheumatology practices in the United States. Adult patients who were receiving at least eight infusions of belimumab plus standard of care measures were enrolled in the study. Disease outcomes were measured every six months of treatment for up to 24 months.

Physicians assessed patient outcomes, including change in steroid use, laboratory tests, and use of healthcare resources.

Out of 501 patients studied (446 were female presenting moderate to severe disease activity at baseline, meaning at the first dose of belimumab), physicians analyzed data from 227 subjects who completed 24 months of belimumab treatment. From the initial patient population, 48.7 percent showed a 50 percent improvement in overall clinical response in the first six months, and patients continued to improve throughout the treatment when compared to the previous timepoint.

Notably, belimumab treatment decreased the percentage of patients suffering from moderate to severe disease. The use of steroids was also progressively decreasing in the treated population: prednisone equivalent dose of 19.9 mg/day was reduced to 8.4 mg/day at six months, and 6.1 mg/day at 24 months.

Laboratory test results for several parameters, usually abnormal in SLE patients, continuously improved throughout the 24 months of belimumab treatment, while patients’ use of healthcare facilities decreased.

The results of this single-arm observational study show that belimumab administered to SLE patients, together with standard of care (for up to 24 months) leads to a significant reduction in disease activity, accompanied by lower use of steroids and improved values of blood test parameters. As a result, patients did not use healthcare facilities as often.