Patients with systemic lupus erythematosus (SLE) showed clinically significant improvement and a significant decrease in their use of anti-inflammatory glucocorticoids after six months of treatment with Benlysta (belimumab), the Canadian OBSErve study showed. The study results also highlight a care gap in real-world clinical settings, as more than 40 percent of physicians did not routinely use disease assessment tools.
The study “Belimumab use, clinical outcomes and glucocorticoid reduction in patients with systemic lupus erythematosus receiving belimumab in clinical practice settings: results from the OBSErve Canada Study” was published in the journal Rheumatology International.
Benlysta is a human monoclonal antibody that targets the B lymphocyte stimulator (BLyS) in B-cells, and inhibits the production of autoantibodies. It was the first FDA-approved drug among biologics for the treatment of SLE.
However, “while the clinical efficacy of belimumab has been demonstrated in randomized controlled trials, utilization patterns and clinical benefit in real-world clinical practice have not been studied in Canada,” researchers wrote.
The OBSErve (evaluation Of use of Belimumab in clinical practice SEttings) Canada study (GSK Study 117300) is part of a series of studies established to describe the patterns of SLE care and clinical outcomes following treatment with Benlysta therapy in a real-world setting in different countries.
The Canadian OBSErve study included SLE patients who were prescribed Benlysta and received at least eight infusions or went through six months of treatment. The study primary endpoints included physician-determined overall clinical improvement from baseline, glucocorticoid use, and physician-determined SLE disease severity at six months. A total of 52 patients were included in the study.
Researchers observed that following six months of Benlysta therapy, SLE patients decreased their use of glucocorticoids: 59.4% of patients reduced their daily glucocorticoid dose and 11.4% of them stopped using glucocorticoid completely. At month six, researchers observed an 80.8% of physician-determined clinical improvement in more than 20% of the patients.
Overall, the observed results provide “the first real-world insights into belimumab use in Canada. It demonstrates significant reduction or discontinuation of glucocorticoid dose in 70.5% of patients and clinically significant improvement following 6 months’ belimumab therapy,” the researchers wrote.
However, as previously described in the OBSErve study in the United States, researchers found that rheumatologists did not routinely use any disease activity instrument, an absence found in 42.3% of study patients.
Since, “regular assessment of disease activity in SLE is vital for effective treatment management, as well as to prevent the long-term consequences of persistent disease activity (e.g., organ damage, mortality, high-dose glucocorticoid use),” this study also highlights a key care gap in the treatment of SLE in real-world settings.