The first new treatment for generalised SLE in more than a decade, anifrolumab (Saphnelo), has been approved by the US Food and Drug Administration (FDA) and is now being evaluated by the TGA for licensing in Australia.
Anifrolumab, a first-in-class type I interferon receptor antagonist, has been approved in the US for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.
According to sponsor AstraZeneca, the approval was based on trials such as the Australian-led TULIP 2 study, which showed that addition of anifrolumab to usual lupus treatment reduced overall disease activity across organ systems, including skin and joints, and also achieved sustained reduction in oral corticosteroid compared to placebo in adult patients with moderate to severely active SLE.
Led by Professor Eric Morand from the Centre for Inflammatory Disease at Monash University, the TULIP2 study found monthly IV anifrolumab for 48 weeks resulted in a statistically significant improvement in the British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA) response at one-year compared to placebo (47.8% v 31.5%; p=0.001).
Professor Morand said the FDA approval was a milestone for SLE treatment, coming 10 years after the FDA approval of belimumab, and vindicating the focus on type 1interferon in the pathophysiology of lupus.
As a proud supporter of @LupusResearch and proud recipient of their support, I am so excited to be a small part of this very big story for #lupus patients around the world. Can’t wait to see the RWE and how this treatment fits into standard of care – and hopefully changes lives. https://t.co/iK3DRS6eda
— Eric Morand (@EricFMorand) August 3, 2021
In a statement released by the Lupous Research Alliance (LRA) he noted that 60-80% of adults with SLE had high levels of type I interferons and increased type I interferon signalling was associated with increased SLE disease activity and severity.
“The role of interferon in lupus has been supported by the science for years but has long awaited this formal proof of benefit in a clinical trial,” said Professor Morand.
“The FDA approval of anifrolumab-fnia potentially allows thousands of lupus patients to benefit. Decreased disease activity along with reduced steroid use form the pillars of treatment goals in lupus, and anifrolumab-fnia has shown these effects.
“As an LRA investigator, I am extremely proud to have been involved in this landmark journey to improve the lives of people with lupus.”
The former chair of the Lupus Research Alliance Scientific Advisory Board, Dr Mary Crow described the approval as “a critical milestone for lupus research and an exciting new therapeutic option for patients with lupus.”
“It is personally gratifying to have discovered the activation of the type I interferon pathway as a significant mechanism in lupus disease and to see the fruition of interferon research and the related drug development program,” said Dr Crow, a rheumatologist and Co-Director of the Mary Kirkland Center for Lupus Research at the HSS Research Institute, New York.
According to the TGA, anifrolumab was accepted for evaluation in February 2021.