Systemic lupus erythematosus (SLE) patients treated Benlysta (belimumab) together with standard of care showed significantly lesser evidence of long-term organ damage than those given standard of care alone, a review study reports.
The research, “Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis,” compared five-year outcomes in almost 100 SLE patients given the combination treatment as part of a Phase 3 long-term extension study in the U.S. with an equal number given standard care as part of a Canadian patient registry.
It was published in Annals of the Rheumatic Diseases.
Benlysta, by GlaxoSmithKline, is approved to treat adults with active SLE who are also using standard lupus medicines. It targets B lymphocyte stimulator (BLyS), a protein that stimulates B-cells to develop into antibody-producing cells, suppressing the production of lupus-causing antibodies.
Four Phase 3 trials have demonstrated that Benlysta plus standard therapy is clinically more effective than placebo plus standard of care treatment — like corticosteroids — in preventing accrued organ damage. Studies also support Benlysta’s use as generally safe, well-tolerated, and clinically effective.
Long-term extension studies, however, involved patients using the investigative or active treatment plus standard of care. No data exist to compare the combination’s benefits over years to standard care alone.
Investigators looked a rates of organ damage progression in SLE patients treated with Benlysta over five years. As secondary measures, they also assessed the time to organ damage and the magnitude of total damage.
Using data from the BLISS Phase 3 extension study (NCT00724867) and data on patients in the Toronto Lupus Cohort registry, scientists applied a statistical technique called propensity score matching. The approach “is often used in observational studies to compare treatments, clinical techniques or subgroups or to adjust for confounding in two groups of patients with different observed outcomes, to examine the effect of the treatment,” the researchers wrote.
They looked rates of organ damage progression from study start (baseline) to five years in the two groups of patients — 99 from each group matched for similar characteristics and long-term data collection.
The BLISS extension trial included 268 SLE patients given standard of care treatment plus Benlysta (1 mg/kg, daily for five years), while those in the Toronto Lupus Cohort received standard of care.
A primary goal was an assessment of organ damage progression over five years, using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score. A higher SDI score indicates greater damage.
Five-year results in published literature showed that those given Benlysta as an add-on treatment had significantly lower organ damage compared with patients on standard of care therapy alone.
“The results indicated that patients treated with belimumab plus SoC [standard of care] were 60% less likely than patients from the TLC [Toronto Lupus Cohort] … to have a 5 year change in total SDI score,” the study reported. “If patients treated with belimumab did experience a change, they were 60% less likely to have seen a change of more than 1 unit.”
Researchers also sought to compare the time to organ damage progression and the magnitude of such damage. Such analysis required at least a one-year follow-up, so they looked at the original data again. For this analysis, 179 patients from each study were matched.
Results here showed that lupus patients given Benlysta plus standard care were 61% less likely to experience a worsening of organ damage over any given year (up to five years) compared to those on standard of care.
A higher proportion of standard treatment patients also saw their SDI scores increase of two or more points (30.6%) compared with patients also using Benlysta (6.1%).
“Patients receiving belimumab had significantly less SLE-related organ damage progression over 5 years compared with patients in the TLC receiving SoC only,” the researchers concluded. “Similarly, the study found significantly slower organ damage progression, and a smaller magnitude of progression, in patients treated with belimumab compared with SoC.”
They added that propensity score matching enabled an effective and credible comparison of patients from distinct studies, and that “future studies may use [the approach] to reinforce conclusions that can be drawn from long-term, open-label studies.”