Newly Published Results from Anifrolumab’s Phase III Trial Affirm Drug’s Efficacy as Potential Lupus Treatment
Following AstraZeneca’s initial announcement shared earlier this year, the full phase III trial results of anifrolumab for the treatment of lupus have now been published in The New England Journal of Medicine. The study findings demonstrate the drug met its primary endpoint, showing that monthly administration of anifrolumab resulted in a higher percentage of patients who experienced a reduction in moderate-to-severe disease activity after 52 weeks compared to the placebo group.
Successful treatment response was defined by the British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA). Achieving BICLA response also requires no worsening in any of the nine organ systems included in the BILAG Index and no increase of 0.3 points or more in Physician Global Assessment scores of disease activity.
Trial participants receiving anifrolumab also benefited from greater reductions in glucocorticoid dose and the severity of skin disease. However, the study did not demonstrate that anifrolumab helped to reduce annual flare rates, or joint swelling and tenderness. Frequency of herpes zoster (the virus that causes shingles and chickenpox) was also higher in those receiving the trial drug.
The study’s findings are promising, and AstraZeneca plans to file the treatment for regulatory approval in the second half of 2020. Continue to follow the Lupus Foundation of America for updates on anifrolumab and learn more about medications used to treat lupus.