Phase II randomized trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis
Annals of Rheumatic Diseases Feb 12, 2022
In this study, anifrolumab’s (type I interferon receptor antibody) efficacy and safety were examined in patients with active, biopsy-proven, Class III/IV lupus nephritis. Findings revealed that anifrolumab intensified regimen (IR) was linked with numerical improvements over placebo across endpoints, including complete renal response (CRR), although primary endpoint was not met.
In this phase II double-blinded study, 147 patients were randomized (1:1:1) to receive monthly intravenous anifrolumab basic regimen (BR, 300 mg; n=45), intensified regimen (IR, 900 mg ×3, 300 mg thereafter; n=51) or placebo (n=49), alongside standard therapy (oral glucocorticoids, mycophenolate mofetil).
Primary endpoint was defined as alteration in baseline 24-hour urine protein–creatinine ratio (UPCR) at week (W) 52 for combined anifrolumab vs placebo groups.
In the combined anifrolumab and placebo groups, 24-hour UPCR improved by 69% and 70%, respectively, at W52.
Serum levels were detected to be higher with anifrolumab IR vs anifrolumab BR, which offered suboptimal exposure.
In the anifrolumab IR group, numerically more patients achieved CRR (45.5% vs 31.1%), CRR with UPCR ≤0.5 mg/mg (40.9% vs 26.7%), CRR with inactive urinary sediment (40.9% vs 13.3%) and sustained glucocorticoid decreases (55.6% vs 33.3%), compared to placebo.
Combined anifrolumab was associated with higher incidence of herpes zoster vs placebo (16.7% vs 8.2%).
Across groups, a similar incidence of serious adverse events was observed.
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