Anifrolumab (AstraZeneca) demonstrated a statistically significant and clinically meaningful reduction in disease activity based on composite lupus assessment.
Anifrolumab (AstraZeneca), an investigational medicine for the treatment of systemic lupus erythematosus (SLE), reduced disease activity in patients in a phase 3 study, according to a press release.
There has been only 1 new treatment approved for the treatment of SLE in the last 60 years, according to AstraZeneca.
The clinical trial program known as the Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP) phase 3 studies assessed the efficacy and safety of anifrolumab versus placebo in patients with moderately-to-severely active autoantibody-positive SLE who received standard of care treatment. The program also includes a phase 3 long-term extension trial in SLE and a phase 3 trial in lupus nephritis.
Anifrolumab, a fully human monoclonal antibody that binds to subunit 1 of the type I interferon, is designed to block the activity of all type I interferons, including IFN-alpha, IFN-beta, and IFN-omega. Between 60% and 80% of adults with SLE have an increased type I gene signature, which has been shown to correlate with disease activity, according to AstraZeneca.
In the TULIP 2 study, 373 patients received either a fixed-dose intravenous infusion of 300 mg anifrolumab or placebo every 4 weeks. The primary endpoint was the effect of anifrolumab in reducing disease activity, as measured by the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52.
The study met its primary endpoint of achieving a statistically significant and clinically meaningful reduction in disease activity versus placebo, with both arms receiving standard of care, according to the results.
“As clinicians we need new medicines for this complex and difficult-to-treat disease,” principal TULIP 2 study investigator Eric F. Morand, MBBS, PhD, Monash University, said in a statement. “These exciting results from the TULIP 2 trial demonstrate that, by targeting the type I interferon receptor, anifrolumab reduced disease activity in patients with systemic lupus erythematosus.”
The positive BICLA response in TULIP 2 was consistent with a pre-specified analysis of the previous TULIP 1 trial, according to the findings. Additionally, the safety profile of anifrolumab was consistent with previous trials.
Results from the TULIP 1 trial were previously announced in August 2018. In TULIP 1, 460 patients were randomized to receive either a fixed-dose intravenous infusion of 150 mg anifrolumab, 300 mg anifrolumab, or a placebo every 4 weeks. The trial did not meet its primary endpoint of a statistically significant reduction in disease activity as measured by the SLE Responder Index 4 at 12 months.
Anifrolumab Phase 3 trial meets primary endpoint in systemic lupus erythematosus [news release]. AstraZeneca. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/anifrolumab-phase-iii-trial-meets-primary-endpoint-in-systemic-lupus-erythematosus-29082019.html. Accessed September 3, 2019.