Patients with systemic lupus erythematosus (SLE) who received long-term treatment with belimumab in addition to standard of care showed improvements in fatigue and health-related quality of life measures, according to study results published in Arthritis Care & Research.
Researchers conducted a multicenter continuation study and enrolled 268 patients from the parent BLISS-76 trial. Of the patients included in the study, 140 completed the continuation trial (ClinicalTrials.gov identifier: NCT00724867), while 128 discontinued their participation for various reasons, including patient request (n=31), adverse events (n=25), and lack of efficacy (n=14). Patients in the treatment group continued to receive belimumab 1 mg/ kg or 10 mg/ kg intravenously every 28 days plus standard of care, while patients who received placebo in the BLISS-76 trial were switched to belimumab 10 mg/kg intravenously every 28 days with standard of care. The Short Form-36 (SF-36) and Health Survey and Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) scale were used to measure improvements in outcomes.
After analysis, the investigators found that following 6 study years (48-weeks per study year), mean physical component summary SF-36 scores improved from a baseline score of 37.0 (n=267) to 41.7 (n=185) and mean mental component summary scores from 44.3 (n=267) to 47.0 (n=185) over the continuation study. In addition, the mean change in FACIT-F score was 3.7 (n=184) over 6 study years.
“Overall, the data reported here indicate that early and long-term control of disease activity, with belimumab plus [standard of care], translates into meaningful and sustained benefits in patient-reported fatigue and [health-related quality of life],” the researchers wrote.
Strand V, Berry P, Lin X, Asukai Y, Punwaney R, Ramachandran S. Long-term impact of belimumab on health-related quality of life and fatigue in patients with systemic lupus erythematosus: 6 years of treatment [published online October 15, 2018]. Arthritis Care Res. doi:10.1002/acr.23788