medwireNews: The addition of intravenous belimumab to standard care is associated with improvements in disease activity and a reduction in corticosteroid use among North East Asian patients with active, autoantibody-positive systemic lupus erythematosus (SLE), phase III trial results suggest.
“These results are consistent with those from the BLISS-52 and BLISS-76 trials of intravenous belimumab, and the BLISS-SC trial of subcutaneous belimumab, performed across several worldwide locations,” write the researchers, noting that “numbers of patients from North East Asia were low in previous studies.”
As reported in the Annals of the Rheumatic Diseases, Fengchun Zhang (Peking Union Medical College Hospital, Beijing, China) and co-investigators randomly assigned patients from 49 centers across China, Japan, and South Korea to receive intravenous belimumab 10 mg/kg or placebo at baseline, week 2, week 4, and every 4 weeks until week 48, alongside standard care. Approximately 98% of patients in both groups were receiving concomitant steroid treatment.
At the 1-year follow-up, 53.8% of 446 patients in the belimumab group achieved an SLE Responder Index 4 (SRI4) response, defined as an improvement from baseline in Safety of Estrogens in Lupus Erythematosus National Assessment–SLE Disease Activity Index (SELENA–SLEDAI) score of at least 4 points with no disease worsening.
By comparison, 40.1% of 217 participants in the placebo group achieved an SRI4 response at 1 year, giving a significant odds ratio of 1.99 in favor of belimumab.
The researchers note that significant differences in SRI4 response rates between the treatment groups were observed from week 12, and were maintained until 1 year.
Furthermore, patients receiving belimumab had a significantly lower cumulative dose of prednisone or equivalent corticosteroid over the 1-year period than those in the placebo group (4190.0 vs 4758.1 mg), and a numerically higher proportion of patients given belimumab had at least a 25% reduction from baseline in prednisone dose to 7.5 mg/day or less at weeks 40–52 (15.6 vs 10.9%).
Zhang and colleagues report that the safety profile of belimumab was “consistent with previous studies,” and the overall incidence of adverse events was comparable between the belimumab and placebo groups, at 74.9% and 75.7%, respectively.
And the team concludes: “This study provides evidence that supports the use of intravenous belimumab 10 mg/kg, in addition to SoC [standard of care], as a viable treatment option for patients with SLE in North East Asia who present with disease activity despite SoC treatment.”
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