Phase 2 TULIP-LN Trial: Anifrolumab shows efficacy in treating lupus nephritis
The Phase 2 randomized, double-blind TULIP-LN trial evaluating the safety and efficacy of anifrolumab in treating active lupus nephritis (LN) has shown promising results through the second year of the study, according to a study.
Patients received intravenous anifrolumab doses, with the initial 3 doses at 900 mg followed by either a 300 mg intensified regimen (IR) or a basic regimen (BR) dosing every four weeks. Patients were eligible to continue into the second year of the trial if they achieved at least a partial renal response and were able to taper their glucocorticoid use.
Results from the trial demonstrated that out of the 147 patients initially randomized, 101 completed the first year of the study, and 75 of those patients (74%) continued into the second year. During the second year, adverse events (AEs) were reported in 72% of patients, with serious AEs reported in 6.9% of the anifrolumab IR group, 8.7% of the anifrolumab BR group, and 8.7% of the placebo group. The incidence of treatment discontinuation due to AEs was low, with 3 patients discontinuing (2 from the anifrolumab IR group and 1 from the placebo group). Notably, herpes zoster was reported in 2 patients, 1 from each anifrolumab dosing group.
In terms of efficacy, the study found that more patients on the intensified dosing regimen achieved complete renal response at Week 104 compared to the basic regimen or placebo (27.3% vs 18.6% and 17.8% respectively). Additionally, the groups on anifrolumab simultaneously achieved sustained tapering of glucocorticoid use (IR: 25.0%; BR: 18.6%; placebo: 17.8%).
Improvements in estimated glomerular filtration rate (a measure of kidney function) were larger in both anifrolumab groups compared to the placebo group.
Reference
Jayne D, Rovin B, Mysler E, et al. Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Lupus Sci Med. 2023;10(2):e000910. doi: 10.1136/lupus-2023-000910. PMID: 37607780; PMCID: PMC10445374.
