Patients with systemic lupus erythematosus who received blisibimod showed improvements in disease activity for up to 52 weeks in a phase 2B trial, according to results presented at the European League Against Rheumatism Annual European Congress of Rheumatology.
Researchers analyzed 547 patients with systemic lupus erythematosus (SLE) from the PEARL-SC study. Patients met the American College of Rheumatology criteria, had positive tests for anti-dsDNA antibodies or antinuclear antibodies, and had a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) of 6 or greater at baseline.
The patients were randomly assigned on a 1:1 basis to receive blisibimod, a B cell-activating factor (BAFF) inhibitor, at one of three dosing schedules or placebo. Dosage was either 100 mg every week, 200 mg every week or 200 mg every 4 weeks for up to 52 weeks, with a resulting median participation of 37 weeks. The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale was used to assess patient-reported outcomes (PRO), and disease activity was evaluated utilizing both SELENA-SLEDAI and British Isles Lupus Assessment Group (BILAG) assessments.
Results showed disease activity was significantly improved in patients who received steroids for severe disease, defined as a SELENA-SLEDAI score of 10 or greater. Patients who received the highest dose showed the greatest response, according to the researchers.
At baseline, 76% of participants had musculoskeletal involvement based on SELENA-SLEDAI and 89% had mucocutaneous organ involvement. After 24 weeks, about 12% of patients who received 200 mg blisibimod twice a week had musculoskeletal involvement and 39% of patients at the same dose had mucocutaneous organ involvement. Self-reported fatigue improved based on FACIT-Fatigue as early as week 8 in the group of patients who received 200 mg twice a week compared with placebo.
“Fatigue remains a debilitating manifestation of lupus,” the researchers wrote. “In this trial, blisibimod showed a tendency toward improved mucocutaneous and musculoskeletal disease activity as well as patient self-reported fatigue.” – by Shirley Pulawski
Petri MA, et al. Paper #THU0387. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.
: Petri reports she is a consultant for Anthera Pharmaceuticals. Please see the full study for a list of all other authors’ relevant financial disclosures.