Strand V, Levy RA, Cervera R et al, for the BLISS-52 and -76 Study Groups. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. (2013) [Epub ahead of print] PMID: 23524886
The latest results from two late-stage, multicenter clinical trials of belimumab (Benlysta) show that, when given alongside standard therapy for systemic lupus erythematosus, the drug improves health-related quality of life (HRQOL) and fatigue.
Fatigue affects 81% of lupus patients, researchers note, impacting both overall HRQOL and the ability to keep a job.
These results are consistent with previously reported reductions in disease activity, severe flares, and prednisone use seen in the BLISS-52 and BLISS-76 trials among patients with active, autoantibody-positive SLE on standard therapy.
Belimumab inhibits activity of the inflammatory cytokine B-lymphocyte stimulator (BLyS) that is overexpressed in many SLE patients and those with other autoimmune diseases.
The patients had been on stable regimens of standard SLE therapies (including prednisone, nonsteroidal anti-inflammatory drugs, antimalarial, or immunosuppressive drugs) for 30 days prior to enrollment.
They were then randomly assigned to placebo or to either 1 mg/kg or 10 mg/kg of intravenous belimumab (1 or 10 mg/kg) for either 52 weeks (BLISS-52) or 76 weeks (BLISS-76).
The 819 patients in BLISS-76 had a longer duration of SLE and more damage; the 865 participants in the BLISS-52 trial were more serologically active. However, at 52 weeks patients in both BLISS trials taking either dose of belimumab plus other therapies reported clinically meaningful improvements in HRQOL – including physical functioning, body pain, general health, vitality, social functioning, and emotional health – as well as in fatigue scores, compared to patients on placebo and other therapies.
In the 76-week trial, improvements in some measures at the 1 mg/kg dose were sometimes similar to or greater than those seen at the higher dose. Outcome differences in both trials became apparent only after 24 weeks. The researchers attribute the delay to effects of the background therapies.