Anifrolumab Improves Skin and Joint Disease Activity in Patients With Systemic Lupus Erythematosus

In patients with moderate to severe systemic lupus erythematosus (SLE), anifrolumab vs placebo was found to be associated with improvements in skin rash and arthritis across 3 different measures, according to study data in a press release and consequently the European Alliance of Associations for Rheumatology (EULAR) 2021 Virtual Congress, held between June 2 and 5, 2021.

A post-hoc analysis of pooled data from the Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP) phase 3 program was conducted, which included 2 trials evaluating the efficacy and safety of anifrolumab, a type I interferon inhibitor, vs placebo in patients with moderate to severe autoantibody-positive SLE who were receiving standard care.

Improvements in skin rash were assessed using 3 different disease measures, the SLE Disease Activity Index (SLEDAI), the British Isles Lupus Assessment Group index (BILAG), and the modified Cutaneous Lupus Erythematosus Disease Area and Severity Index. The response rates at week 52 were 13.5%, 15.5%, and 15.6%, respectively (P <.001 for all). The response rates for arthritis at week 52 were measured using SLEDAI, BILAG, and joint response and the differences in response rates were 8.2% (P =.029), 11.8% (P =.002), and 12.6% (P =.016), respectively.

The most frequently reported adverse events in the TULIP-1 and -2 trials were upper respiratory tract infection, bronchitis, infusion-related reactions, and herpes zoster. Anifrolumab is currently not approved in any country; however, AstraZeneca’s application for anifrolumab in SLE is being reviewed in the US, European Union, and Japan.

According to John Merrill of the Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Research Program, US, noted, “Capturing multiple aspects of improvement increases confidence that anifrolumab may be an important option for patients.”

Executive Vice President of BioPharmaceuticals R&D Mene Pangalos added, “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 [SLE] treatments in over a decade, we’re working to make this new medicine available as soon as possible.”

Reference

Anifrolumab showed benefit across different measures of skin and joint disease activity in patients with systemic lupus erythematosus. News release. AstraZeneca. Published online June 2, 2021. Accessed June 5, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/anifrolumab-showed-benefit-across-different-measures-of-skin-and-joint-disease-activity-in-patients-with-systemic-lupus-erythematosus.html