Skip to main content
MJH Life Sciences
  • Login
  • Register
  • Login
  • Register
Home
  • News
  • Topics
  • Image IQs
  • Treatment Guidelines
  • Conferences
  • Slideshows
  • Contribute to Site
  • Job Board
MJH Life Sciences

SUBSCRIBE: eNewsletter

Anifrolumab Shows Efficiency in Systemic Lupus

Anifrolumab Shows Efficiency in Systemic Lupus

(©ProstockStudio,AdobeStock)

  • Katie Robinson
November 13, 2019
  • ACR, Lupus, News, Rheumatology

In patients with moderate to severe systemic lupus erythematosus, anifrolumab (AstraZeneca) was superior to placebo for overall disease activity, skin disease and oral corticosteroid tapering, among other efficacy endpoints, according to a study presented at the annual meeting of the American College of Rheumatology in Atlanta on November 12.

In an interview with Rheumatology Network, Professor Eric Morand, head of the School of Clinical Sciences at Monash Health, Monash University, Australia, said, “here we have improved disease activity and lower steroid use - a clinical outcome everyone wants.”

Anifrolumab, a human monoclonal antibody to the type I interferon receptor subunit 1, showed efficacy in a phase 2 study of patients with active SLE. While the first phase 3 trial, TULIP-1, did not meet its primary endpoint, multiple other endpoints suggested clinical benefit.

This second phase 3 trial, TULIP-2, which included 362 patients with moderate to severe SLE despite standard-of-care treatment, evaluated efficacy and safety of intravenous anifrolumab 300 mg versus placebo every four weeks for 48 weeks. The primary endpoint was BILAG–based Composite Lupus Assessment (BICLA) response at week 52. Standard-of-care treatment was stable except for mandatory attempts at oral corticosteroid tapering to prednisone equivalent ≤7.5 mg/day for patients receiving ≥10 mg/day at baseline. Participants were randomized to receive anifrolumab (n=180, mean age 43.1 years, 93.3 percent female) or placebo (n=182, mean age 41.1 years, 93.4 percent female). Treatment completion was 85 percent for anifrolumab and 71.4 percent for placebo.

Anifrolumab was superior to placebo for BICLA response (47.8 percent vs 31.5 percent, respectively, P=0.001) and key secondary endpoints: oral corticosteroid reduction (51.5 percent vs 30.2 percent; P=0.014) and Cutaneous Lupus Erythematosus Disease Area and Severity Index response (49 percent vs 25 percent; P=0.039); annualized flare rate was numerically lower in the anifrolumab  group (0.43 vs 0.64; rate ratio 0.67 [95% CI: 0.48, 0.94]; P=0.081). 

Meanwhile,  numeric differences favored anifrolumab in several other secondary endpoints, including Systemic Lupus Erythematosus Responder Index-4 (SRI4) response (55.5 percent vs 37.3 percent; nominal P< 0.001) and higher thresholds of SRI(5–8), time to onset of BICLA response sustained to week 52 (hazard ratio [HR], 1.55; 95% CI: 1.11, 2.18; nominal P=0.011), and time to first flare (HR, 0.65; 95% CI: 0.46, 0.91; nominal P=0.013). In patients with high baseline interferon gene signature, anifrolumab induced neutralization of interferon gene signatures by week 12 (median suppression 88 percent) that was maintained through week 52. Serum anti-double stranded DNA trended toward normalization with anifrolumab.

The safety profile of anifrolumab was similar to that of previous trials. Herpes zoster occurred in 7.2 percent of the anifrolumab group and in 1.1 percent of the placebo group. The serious adverse event rates were 8.3 percent and 17 percent, respectively, and the rate of adverse events leading to treatment discontinuation was 2.8 percent and 7.1 percent, respectively.  One death occurred in the anifrolumab group due to pneumonia and 0.6 percent of patients taking the drug developed antidrug antibodies.

“There are three major takeaways from these data. Firstly, the interferon hypothesis for lupus pathogenesis is proven definitively by these human data. Secondly, understanding of how to measure treatment response in lupus trials, which has been a huge issue, is helped by these positive results, Professor Morand said. “Thirdly, pending regulatory approval, we could have a long awaited new and powerful treatment for lupus - the steroid sparing effects are compelling.”


REFERENCE

“L17 - Efficacy and Safety of Anifrolumab in Patients with Moderate to Severe Systemic Lupus Erythematosus: Results of the Second Phase 3 Randomized Controlled Trial.” Eric Morand, M.B.B.S., F.R.A.C.P., Ph.D., 4 p.m., Tuesday, Nov. 12. 2019 ACR/ARP Annual Meeting, Atlanta

DISCLOSURES

The authors disclosed several pharmaceutical industry associations.

Related Articles

Resource Topics rightRail

  • Resource Topics
  • Partner Content
  • Lupus
  • Rheumatoid Arthritis
  • Psoriatic Arthritis Quiz
  • Spondyloarthritis
  • Psoriatic Arthritis
JAK Inhibitors for Rheumatoid Arthritis: Historical Perspectives and Postmarketing Clinical Reports
Connect with Us
  • Column 1
    • Home
    • About Us
    • Contact Us
  • Column 2
    • Editorial Info
  • Column 3
    • Advertising Info
    • Reprints
    • Advertising Terms
  • Column 4
    • Terms of Use
    • Privacy Policy
Modern Medicine Network
© UBM 2019, All rights reserved.
Reproduction in whole or in part is prohibited.

We've noticed that you're using an ad blocker

Our content is brought to you free of charge because of the support of our advertisers. To continue enjoying our content, please turn off your ad blocker.

It's off now Dismiss How do I disable my ad blocker?
❌

How to disable your ad blocker for our site:

Adblock / Adblock Plus
  • Click on the AdBlock / AdBlock Plus icon on the top right of your browser.
  • Click “Don’t run on pages on this domain.” OR “Enabled on this site.”
  • Close this help box and click "It's off now".
Firefox Tracking Prevention
  • If you are Private Browsing in Firefox, "Tracking Protection" may casue the adblock notice to show. It can be temporarily disabled by clicking the "shield" icon in the address bar.
  • Close this help box and click "It's off now".
Ghostery
  • Click the Ghostery icon on your browser.
  • In Ghostery versions < 6.0 click “Whitelist site.” in version 6.0 click “Trust site.”
  • Close this help box and click "It's off now".
uBlock / uBlock Origin
  • Click the uBlock / uBlock Origin icon on your browser.
  • Click the “power” button in the menu that appears to whitelist the current website
  • Close this help box and click "It's off now".