A two-year phase II TULIP-LN trial (NCT02547922) demonstrated the safety and efficacy of anifrolumab in treating active lupus nephritis, with the intensified dosing regimen showing particularly encouraging results. The findings were published in Lupus Science & Medicine.
The trial enrolled 147 patients who were randomly assigned to receive one of two anifrolumab dosing regimens or a placebo. Patients in the intensified regimen (IR) group received intravenous anifrolumab 900 mg for the first three doses, followed by 300 mg of anifrolumab every four weeks. The basic regimen (BR) group received 300 mg of anifrolumab, and the placebo group followed a similar dosing schedule. To continue into Year 2 of the trial, patients had to achieve at least a partial renal response and meet a glucocorticoid tapering target.
Out of the 101 patients who completed Year 1 of the study, 75 continued into Year 2, with 29 in the anifrolumab IR group, 23 in the BR group, and 23 in the placebo group. During Year 2, 72% of patients reported at least one adverse event (AE). Serious AEs were reported in 6.9% of the anifrolumab IR group, 8.7% of the BR group, and 8.7% of the placebo group. Three patients discontinued treatment due to an AE, and herpes zoster was reported in two patients.
Importantly, no COVID-19 cases were reported despite the trial overlapping with the start of the pandemic. More patients in the anifrolumab IR group achieved a complete renal response at Week 104 compared to those on BR or placebo (27.3% vs. 18.6% and 17.8%, respectively) while simultaneously sustaining glucocorticoid tapering (25.0% in the IR group, 18.6% in the BR group, and 17.8% in the placebo group). Additionally, estimated glomerular filtration rate improvements were numerically larger in both anifrolumab groups compared to the placebo group.
The results suggest that anifrolumab, particularly when administered using an intensified dosing regimen, exhibits a promising safety profile and improved efficacy in treating active proliferative LN. These findings provide a strong foundation for further investigations and may offer new hope for patients with this challenging autoimmune disease.
Reference:
Jayne, D., Rovin, B., Mysler, E., Furie, R., Houssiau, F., Trasieva, T., Knagenhjelm, J., Schwetje, E., Tang, W., Tummala, R., & Lindholm, C. (2023). Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. In Lupus Science & Medicine (Vol. 10, Issue 2, p. e000910). BMJ. https://doi.org/10.1136/lupus-2023-000910
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