The new AstraZeneca drug for lupus erythematosus has reached the clinical end of Phase 3

today, AstraZeneca announced that its use in the treatment of systemic lupus (systemic lupus erythematosus, SLE) in the study of mono-anti-drug anifrolumab, in the critical Phase 3 clinical trial TULIP 2, achieved a significant improvement in the main endpoint of the disease. Anifrolumab is a monoclonal antibody that inhibits the signaling path of type I interferon.SLE is an autoimmune disease with a prevalent rate of about 30 cases per 100,000 people in China. About 90% of SLE patients are women. The main symptoms of SLE are fatigue, arthritis, muscle pain, rash, hair loss, fever, etc. , in severe cases, heart, lung, kidney and other organ damage and life-threatening. The pathogenesis of SLE is still under study, including immune system disorders, as well as genetic susceptibility, environmental triggers and congenital and adaptive immune system activation. Current guidelines recommend the use of antimalarial drugs, glucoticoids, nonsteroidal anti-inflammatory drugs, and immunosuppressants to control lupus activity and prevent organ damage. In the past 60 years, only one new biological agent, belimumab, has been approved for the treatment of lupus erythematosus.Anifrolumab can be combined with sub-base 1 of the Type I interferon receptor to antagonly resist all type 1 interferon (IFN-α, IFN-β, and IFN-o) activities. Type I interferon is a class of cytokines involved in inflammatory responses. IFN-α promotes activation and differentiation of a variety of immune cells, including plasma cells that promote the differentiation of autoreactive B lymphocytes into immune globulins, promotes the maturation of degenerative cells and induces their expression of B-cell activation factors (BAFF) and proliferation-induced ligations (APRIL). Between 60% and 80% of SLE patients had high expression characteristics of type I interferon, while the concentration of type I interferon was positively associated with the disease activity index (SLEDAI) score of SLE patients.373 patients with moderate to severe SLE participated in the TULIP 2 trial, which was randomly divided into two groups and given 300 mg of anifrolumab, or placebo, every 4 weeks on the basis of standard therapy. The results showed that anifrolumab significantly improved the BILAG-based Lupus Comprehensive Evaluation Index (BICLA), bringing statistically significant and clinically significant relief to patients. Improvements in BICLA mean that disease activity improves in all organs and there are no new outbreaks."SLE is a debilitating autoimmune disease," said Dr. Mene Pangalos, Executive Vice President of Biopharmaceutical Research and Development at AstraZeneta. In the past 60 years, only one new treatment has been approved. The results of tuLIP tests are important. We will review the complete data set and work to bring this potential new treatment to patients. " (Drug Mingkangde)