Blisibimod may improve disease activity, fatigue and other symptoms in patients with SLE
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.
Disclosure s : Petri reports she is a consultant for Anthera Pharmaceuticals. Please see the full study for a list of all other authors’ relevant financial disclosures.