BIIB059 improves active total joint count in systemic lupus erythematosus
medwireNews: BIIB059, a monoclonal antibody that binds blood dendritic cell antigen 2 and inhibits interferon 1, improves total active joint count at 24 weeks in patients with systemic lupus erythematosus (SLE), findings from the LILAC trial show.
Reporting the findings at the ACR Convergence 2020 virtual meeting, Richard Furie (Northwell Health, Great Neck, New York, USA) explained that blood dendritic cell antigen 2 is “a protein unique to plasmacytoid dendritic cells,” which produce large amounts of interferon 1 and accumulate in the skin and other tissues of SLE patients.
For the phase 2 trial, 132 patients with SLE were randomly assigned to receive subcutaneous BIIB059 450 mg or placebo every 4 weeks for 20 weeks (with an extra dose at week 2) in addition to standard care.
The participants had stable disease and were taking oral corticosteroid doses below 20 mg/day of prednisone (or equivalent), which were tapered to 10 mg/day or below between weeks 4 and 12 and maintained for the duration of the study.
The patients were also required to have active skin disease and at least four tender joints and at least four swollen joints. They were also all positive for antinuclear antibodies or elevated anti-dsDNA antibodies.
At baseline, approximately 80% of patients had high interferon gene signature and the average swollen and tender joint counts were around 8 and 10, respectively.
At week 24, the primary efficacy endpoint was met. The 56 patients taking BIIB059 achieved an average least-squares absolute reduction in total joint count (sum of tender and swollen joints) from baseline of 15.0 points, which was a significant 3.4-point improvement on the 11.6-point reduction seen among the 46 patients taking placebo, said Furie, noting that “the separation occurred starting at week 8.”
He also reported a significant improvement in the SRI-4 response rate with BIIB059, which was achieved by 57% of patients, compared with 30% of those in the placebo group, at an odds ratio of 3.49.
“Like almost all other trials the driver of this statistically significant and robust SRI response was [a] 4-point reduction in SLEDAI,” he commented.
The number of patients achieving a 50% improvement in Cutaneous Lupus Erythematosus Disease Area and Severity Index response was also higher among the patients taking BIIB059 compared with placebo, but not significantly so.
Adverse events occurred in 59.2% of patients taking BIIB059 and 67.9% of those taking placebo. In most cases, these were mild to moderate in severity. The incidence of serious adverse events was comparable, at 5.3% and 10.7%, respectively, as was the incidence of infection, at a corresponding 35.5% and 39.3%.
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