The experimental drug, if approved, will compete with GlaxoSmithKline’s Benlysta, which is the only new drug approved for lupus in the last 60 years.
AstraZeneca announced positive results from its Phase III TULIP 2 trial of anifrolumab in moderate to severe systemic lupus erythematosus (SLE). The experimental drug, if approved, will compete with GlaxoSmithKline‘s Benlysta, which is the only new drug approved for lupus in the last 60 years. In 2018, Benlysta brought in $607.2 million (U.S.).
SLE is an autoimmune disease where the immune system attacks healthy tissue. Both chronic and complex, it can affect many different organs with a range of symptoms including pain, rash, fatigue, joint swelling and fever. It is associated with higher risk of death from infection and cardiovascular diseases.
“There has only been one new medicine approved for systemic lupus erythematosus in the last 60 years, which is why we are so excited to see the positive TULIP 2 results,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D of AstraZeneca. “There is now a strong body of evidence demonstrating the benefit of anifrolumab, and we look forward to bringing this potential new medicine to patients with systemic lupus erythematosus as soon as possible.”
The TULIP program includes two Phase III clinical trials, TULIP 1 and TULIP 2. TULIP 2 randomized 365 eligible patients 1:1 to receive a fixed-dose intravenous infusion of 300mg anifrolumab or placebo every four weeks. The trial evaluated the effect of the drug in reducing disease activity as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) composite measure.
The drug showed superiority across multiple efficacy endpoints compared to placebo, with both arms receiving standard of care. The primary endpoint was statistically significant and clinically meaningful decrease in disease activity at week 52. In that group, 47.8% of the patients receiving anifrolumab responded compared to 31.5% of patients on placebo.
Statistically significant differences were also observed in multiple secondary endpoints. For example, 51.5% of anifrolumab patients receiving oral corticosteroids (OCS) showed a sustained reduction in OCS use compared to 30.2% of placebo group patients, and 49% receiving anifrolumab with moderate to severe skin disease showed improved skin symptoms at week 12 compared to 25% receiving placebo.
“Systemic lupus erythematosus is often difficult to treat, and innovative new therapies are urgently needed,” said Eric F. Morand, principal investigator of the TULIP 2 trial and professor at Monash University in Australia. “The TULIP 2 results demonstrated that, by targeting the type I interferon receptor, anifrolumab reduces overall disease activity, reduces corticosteroid use and improves skin manifestations.”
The TULIP data are being presented at the American College of Rheumatology (ACR) Annual Meeting 2019 held in Atlanta. The TULIP 1 data were published simultaneously in The Lancet Rheumatology.
TULIP 1 did not meet its primary endpoint of the SLE Responder Index 4 (SRI4) composite measure, but analysis showed efficacy consistent with TULIP 2 on BICLA response, decrease in OCS use and improved skin disease activity.
Anifrolumab is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon receptor. Type 1 interferons are involved in inflammation.
“The results across the MUSE and TULIP trials are very important because they support anifrolumab’s potential to address systemic lupus erythematosus, an often devastating disease that can impact almost any organ and even lead to long-term organ damage and death,” said Richard Furie, chief of the Division of Rheumatology at Northwell Health, New York and principal investigator on the TULIP 1 and Phase II MUSE trial.
