• Profile

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.

Go to Original
Only Doctors with an M3 India account can read this article. Sign up for free or login with your existing account.
4 reasons why Doctors love M3 India
  • Exclusive Write-ups & Webinars by KOLs

  • Nonloggedininfinity icon
    Daily Quiz by specialty
  • Nonloggedinlock icon
    Paid Market Research Surveys
  • Case discussions, News & Journals' summaries
Sign-up / Log In
M3 app logo
Choose easy access to M3 India from your mobile!

M3 instruc arrow
Add M3 India to your Home screen
Tap  Chrome menu  and select "Add to Home screen" to pin the M3 India App to your Home screen