AstraZeneca has reported that anifrolumab reduced disease activity in the Phase III TULIP 2 study involving patients with moderate to severe systemic lupus erythematosus (SLE).
Anifrolumab is a fully human monoclonal antibody designed to attach to subunit 1 of the type I interferon receptor and block the activity of type I interferons.
The majority of patients with SLE are known to have an elevated type I interferon gene signature, which is linked to disease activity. SLE is an autoimmune disorder that develops when the immune system attacks healthy tissue.
TULIP 2 investigated the safety and efficacy of a 300mg intravenous infusion of the drug in 365 patients on standard of care treatment.
The drug showed superiority across multiple efficacy endpoints compared to placebo.
Anifrolumab demonstrated a statistically significant and clinically meaningful decrease in disease activity at week 52, where 47.8% of patients treated with the drug experienced response versus 31.5% on placebo.
This is the primary endpoint of the trial and is determined using the British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) composite measure.
Also, 51.5% of patients in the treatment group receiving oral corticosteroids (OCS) greater than or equal to 10mg had a sustained decrease in OCS use compared to 30.2% in the placebo group.
Furthermore, 49% and 25% of patients with moderate to severe skin disease achieved improved skin manifestations at week 12 with anifrolumab and placebo, respectively.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “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.”
TULIP 2 is part of the Phase III TULIP programme, which also includes TULIP 1 trial.
TULIP 1 did not meet its primary endpoint on the SLE Responder Index 4 (SRI4) composite measure. The company said that the trial showed efficacy consistent with TULIP 2 on its secondary endpoints of BICLA response, reduction in OCS use and improvement in skin disease activity.
AstraZeneca acquired the rights to anifrolumab in 2004 as part of an exclusive licence and collaboration agreement with Medarex, which was acquired by Bristol-Myers Squibb in 2009.