A new post-hoc analysis of pooled data from the TULIP Phase III clinical trials being presented at the annual European Congress of Rheumatology (EULAR 2021) showed anifrolumab was consistently associated with improvements in both skin rash and arthritis across three different disease measures each, compared to placebo, in patients with moderate to severe systemic lupus erythematosus (SLE).1
The analysis examined disease manifestations in the two most commonly impacted organ domains in SLE. Anifrolumab is a potential first-in-class type I interferon inhibitor.
For skin rash, the difference in response rates for anifrolumab versus placebo at week 52 were 13.5% SLE Disease Activity Index (SLEDAI), 15.5% British Isles Lupus Assessment Group index (BILAG) and 15.6% modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI). For arthritis, differences in response rates were 8.2% SLEDAI, 11.8% BILAG and 12.6% joint response.
Joan Merrill, Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Research Program, US, said: “Arthritis and rash are the most common and persistent problems in lupus and often have a significant impact on a person’s life. The strength of the data from this analysis is that anifrolumab was found to be consistently effective using three different ways of looking at rash and three different approaches to arthritis. Capturing multiple aspects of improvement increases confidence that anifrolumab may be an important option for patients.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, 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.”
The most frequently reported adverse events for anifrolumab in the TULIP-1 and TULIP-2 trials were upper respiratory tract infection, bronchitis, infusion-related reactions and herpes zoster.
AstraZeneca’s application for anifrolumab in SLE is under review by regulatory authorities in the US, EU and Japan, with decisions anticipated in the second half of 2021. Anifrolumab is not currently approved in any country.