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Epratuzumab Seen as Well-tolerated, Steroid-sparing Treatment for SLE patients
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Treatment of moderate to severe systemic lupus erythematosus with epratuzumab infusions was well tolerated and associated with sustained improvements in disease activity and health-related quality of life. The treatment was also associated with reduced steroid use, according to an analysis of data from an open-label extension trial.
Patients with systemic lupus erythematosus who completed a randomized controlled trial and received one of five epratuzumab-dosing regimens were invited to participate in an open-label extension trial with repeating 12-week treatment cycles of a 1,200-mg infusion at weeks 0 and 2 plus standard of care. Of the 203 patients who participated, 113 patients completed the treatment protocol. Overall, 90 patients withdrew from the study, including 23 due to lack of efficacy and seven due to pregnancy. One death occurred and was not considered to be related to treatment.
Concomitant medications included corticosteroids in 94.1% of patients, immunosuppressive medication by 44.3% of patients and antimalarial treatment by 43.3% of patients.
The median corticosteroid use at baseline was 10 mg per day and was decreased to 5 mg per day by patients enrolled at 108 weeks. Patients who required at least 17.5-mg corticosteroid doses decreased to 12.1% at week 108 compared with 21.2% to 28.6% at baseline from two different groups. The proportion of patients who received no corticosteroids increased from 2% to 5.9% to 12.1% at week 108. The number of patients who had improvements in British Isled Lupus Group (BILAG) scores increased from 34.5% at screening to 63.8% at week 108, and 48.3% had no worsening of BILAG scores. – by Shirley Pulawski
Disclosure: The researchers report the research was supported by UCB Pharma.
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