The following is a summary of “Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial,” published in the August 2023 issue of Nephrology by Jayne et al.
Researchers performed a retrospective study to characterize the safety and efficacy of anifrolumab in active lupus nephritis (LN) through year 2 of the Treatment of Uncontrolled Lupus via the Interferon Pathway TULIP-LN trial.
They gave intravenous anifrolumab 900 mg for the first 3 doses, followed by 300 mg anifrolumab (intensified regimen (IR)), 300 mg anifrolumab (basic regimen (BR)), or placebo every 4 weeks. To continue into Year 2, achieving at least a partial renal response and meeting a glucocorticoid tapering target were required.
The results showed 147 patients, 101 completed Year 1 of the study treatment, 75 (74%) continued into Year 2 (anifrolumab IR: n=29, BR: n=23, and placebo: n=23). In Year 2, 72% of patients reported at least one adverse event (AE), with serious AEs reported 6.9%, 8.7%, and 8.7% (anifrolumab IR, BR, and placebo, respectively). Three patients discontinued treatment due to AEs (anifrolumab IR: n=2, and placebo: n=1), and herpes zoster was reported in 2 patients (anifrolumab IR: n=1, and BR: n=1). Among 145 patients in treatment, more in the IR group achieved complete renal response at Week 104 than in the BR or placebo groups. (27.3% vs. 18.6% and 17.8%), along with sustained glucocorticoid tapering (IR: 25.0%; BR: 18.6%; and placebo: 17.8%). Both anifrolumab groups had better estimated glomerular filtration rate improvements than the placebo group.
They concluded the safety and efficacy of anifrolumab IR regimen in patients with active proliferative LN warrants further investigation.