Phase III TULIP 2 Trial of Anifrolumab Demonstrates Meaningful Reduction in Lupus Disease Activity
Today, AstraZeneca announced that the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for treatment in adults with moderate-to-severe lupus, met its primary endpoint of achieving a reduction in disease activity versus the placebo.
Susan Manzi, MD, MPH, Lupus Foundation of America board chair, chair of Allegheny Health Network Medicine Institute and director of its Lupus Center of Excellence said, “The positive trial results released today are encouraging as the top line data suggests anifrolumab achieved clinically significant disease activity reductions across multiple organ systems. Lupus can affect any organ system in the body and people with the disease frequently have multiple organs involved. The news today provides hope that another therapy may soon be added to the many treatments required to manage this devastating and potentially fatal autoimmune disease.”
The TULIP 2 trial involved administering a 300mg dose of anifrolumab or placebo, whereas the TULIP 1 trial, which reported results a year ago, had groups of patients receiving 150mg, 300mg or placebo. The TULIP 1 trial did not meet its primary endpoint. TULIP 2 also employed a different assessment tool, which measured results across all organ systems.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D for AstraZeneca, in the company announcement noted that: “Systemic lupus erythematosus is a debilitating autoimmune disease, but only one new treatment has been approved in the last 60 years. These are important results and we will now review the full data set and explore pathways to bring this potential new treatment to patients.”
For the full announcement from AstraZeneca, click here.