- AstraZeneca Plc AZN has announced a new posthoc analysis of pooled data from the TULIP Phase 3 clinical trials evaluating anifrolumab in patients with moderate to severe systemic lupus erythematosus (SLE).
- Data were presented at the annual European Congress of Rheumatology (EULAR 2021).
- Systemic lupus erythematosus is an autoimmune disease in which the immune system attacks healthy tissue in the body.
- The analysis showed anifrolumab was consistently associated with improvements in skin rash and arthritis across three different disease measures, compared to placebo, in SLE patients.
- For skin rash, the difference in response rates for anifrolumab versus placebo at week 52 was 13.5% SLE disease activity index (SLEDAI), 15.5% British Isles Lupus Assessment Group index (BILAG), and 15.6% modified Cutaneous Lupus Erythematosus severity index (mCLASI).
- For arthritis, differences in response rates were 8.2% SLEDAI, 11.8% BILAG, and 12.6% joint response.
- 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 U.S., E.U., and Japan, with decisions anticipated in the second half of 2021.
- Price Action: AZN shares are down 0.5% at $55.98 during the premarket session on the last check Wednesday.
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