Anifrolumab for SLE shows favourable benefit–risk profile in extension study

Patients with moderate-to-severe systemic lupus erythematosus (SLE) appear to fare well with anifrolumab, with a recent study showing that the drug has an acceptable long-term safety profile and helps maintain reductions in disease activity and glucocorticoid usage.

In the study, SLE patients who completed a Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP) trial were enrolled in the placebo-controlled 3-year long-term extension (LTE) study. These patients continued treatment with anifrolumab 300 mg, switched from anifrolumab 150 mg to 300 mg, or were rerandomized from placebo to receive either anifrolumab 300 mg or to continue placebo. Treatment was administered every 4 weeks.

Results showed that the exposure-adjusted incidence rates (EAIRs) of serious adverse events (AEs) were lower in the anifrolumab group than in the placebo group (8.5 vs 11.2 per 100 patient-years). the same was true for EAIRs of AEs leading to treatment discontinuation (2.5 vs 3.2 per 100 patient-years).

Meanwhile, there was no significant difference in EAIRs of nonopportunistic serious infections (3.7 per 100 patient-years with anifrolumab vs 3.6 per 100 patient-years with placebo). Exposure-adjusted event rates of COVID-related AEs, including asymptomatic infections, were 15.5 and 9.8 per 100 patient-years, respectively. None of the fully vaccinated patients developed COVID-related AEs.

The two treatment groups had similar EAIRs of malignancy and major acute cardiovascular events. Compared with placebo, anifrolumab use was associated with lower cumulative glucocorticoid use and greater mean improvement in the SLE Disease Activity Index 2000, compared with placebo.