Anifrolumab, a potential new treatment for systemic lupus erythematosus (SLE), just successfully completed a phase three clinical trial in which patients demonstrated reduced disease activity by significant margins, according to a statement issued by the drug’s maker AstraZeneca.
The trial, called Treatment of Uncontrolled Lupus via the Interferon IFN Pathway 2 (TULIP 2), was the second phase three trial of anifrolumab for moderate to severe SLE. Success, or the trial's primary endpoint, was determined by the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) measure taken at week 52. An acceptable BICLA measure was defined as improvement in disease activity in all organs with no new flares. The first phase three trial, called TULIP 1, did not meet the primary endpoint which was defined by Responder Index 4 (SRI4).
"The positive BICLA response in TULIP 2 was consistent with a pre-specified analysis of the previous phase III TULIP 1 trial, which did not meet its primary endpoint of SLE Responder Index 4 (SRI4)," AstraZeneca stated.
The Lupus Research Alliance has been watching the results of the TULIP trial very closely.
"These positive results from a pivotal phase III trial are very hopeful for people with lupus who have waited years for desperately needed new treatment options. We look forward to seeing the full results of the study and further progress in evaluating anifrolumab as a potential therapy," said Kenneth M. Farber the president of the Lupus Research Alliance which issued a statement in response to the trial's results.
Anifrolumab has been assessed in nine SEL trials, one systemic sclerosis trial and one rheumatoid arthritis clinical trial to date, according a study published in May 2019 in the journal Drug Design Development and Therapy. In one phase IIb randomized controlled trial (called MUSE) of adults with SLE, there were positive results in which patients with the high baseline IFN gene signature, responded better to the treatment as compared to those with the low baseline IFN gene signature. The treatment also showed benefits in cutaneous and arthritic manifestations, especially among patients with a high IFN gene signature.