Exposure-adjusted incidence rates of serious adverse events 8.5 versus 11.2 per 100 patient-years for anifrolumab versus placebo
MONDAY, Nov. 21, 2022 (HealthDay News) — For patients with systemic lupus erythematosus (SLE), anifrolumab is safe in the long term, according to a study published online Nov. 11 in Arthritis & Rheumatology to coincide with the annual meeting of the American College of Rheumatology, held from Nov. 10 to 14 in Philadelphia.
Kenneth C. Kalunian, M.D., from the University of California San Diego School of Medicine in La Jolla, and colleagues examined the long-term safety and tolerability of anifrolumab versus placebo in patients with SLE who completed a trial and were enrolled in a three-year long-term extension (LTE) study. In the LTE study, patients continued anifrolumab 300 mg, switched from anifrolumab 150 mg to 300 mg, or were randomly reassigned from placebo to anifrolumab 300 mg or to continue placebo.
The researchers found that exposure-adjusted incidence rates (EAIRs) of serious adverse events (AEs) were 8.5 and 11.2 per 100 patient-years for anifrolumab and placebo, respectively; AEs leading to treatment discontinuation were 2.5 and 3.2, respectively. The groups had comparable EAIRs of nonopportunistic serious infections (3.7 and 3.6 with anifrolumab and placebo, respectively). Exposure-adjusted event rates of COVID-19-related AEs were 15.5 and 9.8 for anifrolumab and placebo, respectively. There were no COVID-19-related AEs noted in fully vaccinated individuals. Low EAIRs of malignancy and major acute cardiovascular events occurred and were comparable between the groups. Lower cumulative glucocorticoid use and greater mean improvement in the SLE Disease Activity Index 2000 were seen in association with anifrolumab versus placebo.
“The findings support the favorable benefit-risk profile of long-term anifrolumab as a treatment option for patients with moderate-to-severe SLE,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including AstraZeneca, which manufactures anifrolumab and funded the study.
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