AstraZeneca Plc (NASDAQ: 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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