AstraZeneca has reported positive results from a post-hoc analysis of the Phase III TULIP clinical trials that assessed anifrolumab in moderate to severe systemic lupus erythematosus (SLE) patients.
A fully human monoclonal antibody, anifrolumab attaches to subunit 1 of the type I interferon receptor and inhibits type I interferons activity.
AstraZeneca obtained worldwide rights to the drug in 2004 as part of an exclusive licence and collaboration agreement with Medarex, which was later purchased by Bristol-Myers Squibb in 2009.
The Phase III TULIP programme assessed the drug’s safety and efficacy in TULIP-1 and TULIP-2 trials that enrolled 457 and 362 SLE patients, respectively.
In TULIP-1, which failed to meet its primary endpoint, participants received 150mg, 300mg anifrolumab, or placebo every four weeks, plus standard of care.
TULIP-2 participants were given a 300mg dose of the drug or placebo every four weeks, in addition to standard treatment. This trial showed superiority on various efficacy endpoints compared to placebo.
According to the new post-hoc analysis data, anifrolumab demonstrated consistent improvements in skin rash and arthritis across three separate disease measures each, versus placebo.
When anifrolumab was compared to placebo, differences in response rates for skin rash at week 52 were 13.5% SLE Disease Activity Index (SLEDAI) and 15.5% British Isles Lupus Assessment Group index (BILAG).
In addition, the difference was 15.6% modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI).
For arthritis measures, differences in response rates were 8.2% SLEDAI, 11.8% BILAG, and 12.6% joint response.
In both TULIP-1 and TULIP-2 studies, the most frequent anifrolumab-related adverse events were infection of the upper respiratory tract, bronchitis, reactions due to infusion, and herpes zoster.
The company will present these latest results at the annual European Congress of Rheumatology (EULAR 2021), which is being held from 2 June 2021.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “The data being presented at EULAR add to the growing body of evidence for anifrolumab that demonstrate a compelling clinical profile with the potential to address significant unmet medical needs in this debilitating disease.
“With no new systemic lupus erythematosus treatments in over a decade, we’re working to make this new medicine available as soon as possible.”
Regulators in the US, EU and Japan are currently reviewing an application for anifrolumab in SLE. AstraZeneca expects decisions in the coming months.