Long-term results confirm sustained benefits of belimumab in SLE patients
medwireNews: Results of the BLISS-76 continuation study suggest that long-term treatment with belimumab alongside standard care is associated with sustained efficacy and a stable adverse event profile among patients with systemic lupus erythematosus (SLE).
In the original phase III BLISS-76 study, patients from Europe and America with autoantibody-positive, active SLE were randomly assigned to receive 76 weeks of treatment with intravenous belimumab at a dose of 1 or 10 mg/kg, or placebo, in addition to standard care, say Richard Furie (Hofstra Northwell School of Medicine, Great Neck, New York, USA) and study co-authors.
This study demonstrated that belimumab had favorable efficacy and safety profiles, and patients from the USA who completed the trial entered the 7-year continuation study, they add.
As reported in Arthritis & Rheumatology, belimumab-treated patients continued to receive the same dose of the drug during the extension phase, while those given placebo switched to the 10 mg/kg drug dose. Following a protocol amendment in 2011, all patients received belimumab 10 mg/kg for the remainder of the study.
Patients experienced an overall decrease in disease activity with continued belimumab treatment. At the 7-year follow-up, 75.6% of 119 patients achieved an SLE Responder Index (SRI) response, a marked increase from the 41.9% rate after 1 year of belimumab treatment.
The proportion of patients who experienced at least a 4-point improvement from baseline in Safety of Estrogens in Lupus Erythematosus National Assessment–SLE Disease Activity Index (SELENA–SLEDAI) score increased from 44.4% at the 1-year follow-up to 78.2% after 7 years. Organ damage accrual over the continuation study was “low,” with 98.4% of participants having no new British Isles Lupus Assessment Group 1A/2B organ domain scores.
Furthermore, patients who were treated with prednisone had a 31.4% decrease in the mean percentage dose from baseline to the 7-year follow-up, and approximately one in eight patients were able to discontinue prednisone.
“One of the major goals of SLE therapy is to reduce corticosteroid exposure,” emphasize the investigators.
Furie and team also report a “stable or decreased incidence” of adverse events (AEs) with continued belimumab treatment over the course of the study.
Indeed, the proportion of patients experiencing at least one treatment-related AE decreased from 33.2% in years 0–1 to 10.0% in years 6–7, and the corresponding rates of serious AEs were 12.3% and 10.0%. The most commonly occurring AEs were arthralgia, nausea, headache, and infections.
Taken together, “[t]hese long-term exposure results confirm the previously observed safety and efficacy profiles of belimumab in patients with SLE,” conclude the researchers.
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