AstraZeneca (LON:AZN) has announced that a new posthoc analysis of data from the TULIP Phase 3 clinical trials of anifrolumab showed promise in patients with systemic lupus erythematosus (SLE), the most common type of lupus. Anifrolumab is a monoclonal antibody that blocks the activity of interferons such as interferon-α and interferon-β. If approved, anifrolumab would be a first-in-class type I interferon inhibitor.
The most recent clinical trial data demonstrated that anifrolumab led to consistent skin rash and arthritis improvements in patients with moderate to severe SLE compared to placebo.
“Arthritis and rash are the most common and persistent problems in lupus and often have a significant impact on a person’s life,” said Joan Merrill, Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Research Program, U.S., in a statement. The data from the recent analysis indicate that anifrolumab was “consistently effective using three different ways of looking at rash and three different approaches to arthritis,” Merrill said.
The first Phase 3 trial of anifrolumab, however, failed to demonstrate a significant improvement on the primary endpoint related to the Systemic Lupus Erythematosus Responder Index.
Subsequent data have, however, been more promising. Clinical trial investigators have associated anifrolumab with durable improvements in skin-related SLE symptoms using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI).
The most recent data compares skin rash response rates for anifrolumab compared to placebo at 52 weeks. The group receiving anifrolumab had a 13.5% improvement in the SLE Disease Activity Index (SLEDAI), a 15.5% increase in the British Isles Lupus Assessment Group index (BILAG) and 15.6% improvement in the modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI). Arthritis symptoms also improved.
AstraZeneca acquired rights to anifrolumab through a license with Medarex in 2004. Bristol-Myers Squibb would go on to purchase Medarex in 2009.