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AstraZeneca: Update on TULIP 1 Phase III trial for anifrolumab in systemic lupus erythematosus

Trial did not meet the primary endpoint of a reduction of disease
activity as measured by the SLE Responder Index

AstraZeneca and MedImmune, its global biologics research and
development arm, today announced top-line results from the TULIP 1
Phase III trial for anifrolumab in adult patients with
moderate-to-severe systemic lupus erythematosus (SLE).

The trial did not meet the primary endpoint of a
statistically-significant reduction in disease activity in patients
with SLE as measured by the SLE Responder Index 4 (SRI4) at 12

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "SLE is a debilitating autoimmune
disease with significant unmet need among patients who struggle to
achieve meaningful disease control. The result of this trial is
disappointing for patients and the lupus community."

The pivotal Phase III TULIP 1 trial was a randomised, double-blinded,
52-week placebo-controlled, multi-centre trial assessing the safety
and efficacy of anifrolumab as a treatment for adult patients with
moderate-to-severe SLE. A full evaluation of the data will be
conducted when TULIP 2 data are available later this year. TULIP 1
data will be presented at a future medical meeting.

About Anifrolumab

Anifrolumab (formerly MEDI-546) is a fully human monoclonal antibody
and potential new medicine that binds to subunit 1 of the type I
interferon receptor, blocking the activity of all type I interferons
including IFN-?, IFN-? and IFN-?.1 Type I interferons are cytokines
involved in the inflammatory pathways.2 60% - 80% of adult lupus
patients have an increased type I interferon gene signature, which
has been shown to correlate with disease activity.2, 3

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, that are evaluating the efficacy and safety of
anifrolumab versus placebo in patients with moderately-to-severely
active autoantibody-positive SLE who are receiving standard of care
treatment. TULIP 1 randomised 460 eligible patients (1:2:2) to
receive a fixed-dose intravenous infusion of 150mg anifrolumab, 300mg
anifrolumab, or placebo every 4 weeks. TULIP 2 randomised 373
eligible patients (1:1) to receive a fixed-dose intravenous infusion
of 300mg anifrolumab or placebo every 4 weeks.

The programme assesses the effect of anifrolumab in reducing disease
activity, as measured by the SRI4, decreasing use of oral
corticosteroids, improving skin manifestations, as measured by
Cutaneous Lupus Erythematosus Disease Area and Severity Index
(CLASI)4, and reducing flares. In addition to the pivotal trials,
anifrolumab is also being tested in a Phase III SLE long-term
extension trial, a Phase II trial using subcutaneous delivery in SLE
and a Phase II trial for lupus nephritis.

About SLE

SLE is an autoimmune disease in which the immune system attacks
healthy tissue in the body instead of primarily targeting viruses or
other foreign invaders.5 Lupus can cause a range of symptoms,
including pain, rashes, fatigue, swelling in joints and fevers.6 It
is associated with a greater risk of death from causes such as
infection and cardiovascular disease.7 There has been only one new
medicine approved for lupus in the last 60 years.8

About MedImmune

MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology, Respiratory, Cardiovascular, Renal and Metabolic Diseases,
and Infection and Vaccines. The MedImmune headquarters is located in
Gaithersburg, Md., one of AstraZeneca's three global R&D centres,
with additional sites in Cambridge, UK and South San Francisco,
Calif. For more information, please visit

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, Cardiovascular, Renal & Metabolism
and Respiratory. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.

For more information, please visit and follow us
on Twitter @AstraZeneca.

Media Relations
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Investor Relations
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1. Furie, R, et al. Anifrolumab, an Anti-Interferon-? Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus. Arthritis & Rheumatology. 2017;69(2);376-386.

2. Lauwerys, Bernard R, et al. Type I interferon blockade in systemic lupus erythematosus: where do we stand?. Rheumatology. 2013;53(8);1369-1376.

3. Crow, M. K, Type I Interferon in the Pathogenesis of Lupus, J Immunol. 2014;192(12);5459-5468.

4. Albrecht, Joerg et al. The CLASI (Cutaneous LE Disease Area and Severity Index): An Outcome Instrument for Cutaneous Lupus Erythematosus. The Journal of Investigative Dermatology. 2005;125(5);889-894.

5. The Lupus Foundation of America. Available at [Accessed August 2018]

6. ACR. Guidelines for referral and management of systemic lupus erythematosus in adults. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines, Arthritis & Rheumatism. 1999; 42; 1785-1796.

7. Nossent, J., et al. Current causes of death in systemic lupus erythematosus in Europe, 2000-2004: relation to disease activity and damage accrual. Lupus. 2007;16(5);309-317.

8. Mahieu, M. A. et al. A critical review of clinical trials in systemic lupus erythematosus. Lupus. 2016;25(10);1122-1140.


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