Anifrolumab Phase III trial meets primary endpoint in systemic lupus erythematosus

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Anifrolumab Phase III trial meets primary endpoint in systemic lupus erythematosus

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, co-director of the Lupus Center of Excellence and chair of the Department of Medicine of West Penn Allegheny Health System in Pittsburgh 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 endpoints. 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.”

PUBLISHED 29 August 2019
This announcement contains inside information

29 August 2019 07:00 BST

Positive top-line results from TULIP 2 trial demonstrate a statistically-significant and clinically-meaningful reduction in disease activity based on composite lupus assessment

AstraZeneca today announced that the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care.

The reduction was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. The BICLA requires improvement in all organs with disease activity at baseline with no new flares.1 The safety profile of anifrolumab was consistent with previous trials.

TULIP 2 was the second Phase III trial designed to assess the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE. 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).

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “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.”

Professor Eric F. Morand, Monash University, Australia, and Principal Investigator on the TULIP 2 trial said: “As clinicians we need new medicines for this complex and difficult-to-treat disease. These exciting results from the TULIP 2 trial demonstrate that, by targeting the type I interferon receptor, anifrolumab reduced disease activity in patients with systemic lupus erythematosus.”

Data from TULIP 1 and TULIP 2 will be submitted for presentation at a forthcoming medical meeting.

About anifrolumab

Anifrolumab is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon receptor, blocking the activity of all type I interferons including IFN-alpha, IFN-beta and IFN-omega.2 Type I interferons are cytokines involved in the inflammatory pathways.3 Between 60% and 80% of adults with SLE have an increased type I interferon gene signature, which has been shown to correlate with disease activity.3,4

About the Phase III TULIP programme

The pivotal TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) programme includes two Phase III clinical trials, TULIP 1 and TULIP 2, which evaluated the efficacy and safety of anifrolumab versus placebo in patients with moderately-to-severely active autoantibody-positive SLE who were receiving standard of care treatment. Results from TULIP 1 were announced in August 2018.

TULIP 2 randomised 373 eligible patients (1:1) to receive a fixed-dose intravenous infusion of 300mg anifrolumab or placebo every four weeks. TULIP 2 assessed the effect of anifrolumab in reducing disease activity, as measured by the BICLA. The BICLA was chosen as the primary endpoint for TULIP 2 following a full evaluation of TULIP 1 and is an established measurement for disease activity in adults with SLE.5,6

TULIP 1 randomised 460 eligible patients (1:2:2) to receive a fixed-dose intravenous infusion of 150mg anifrolumab, 300mg anifrolumab or placebo every four weeks. TULIP 1 assessed the effect of anifrolumab in reducing disease activity, as measured by the SRI4.

In addition, the TULIP programme includes a Phase III long-term extension trial in SLE and a Phase II trial in lupus nephritis.

About systemic lupus erythematosus

SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body.7 It is a chronic and complex disease with a variety of clinical manifestations that can impact many organs and cause a range of symptoms including pain, rashes, fatigue, swelling in joints and fevers.8 It is associated with a greater risk of death from causes such as infection and cardiovascular disease.9 There has been only one new medicine approved for SLE in the last 60 years.10

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, CVRM and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.com and follow us on Twitter @AstraZeneca.