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2019-08-29

AstraZeneca: Anifrolumab Phase III trial meets primary endpoint in systemic lupus erythematosus

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
(https://www.astrazeneca.com/investor-relations/stock-exchange-announceme...).

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 (http://www.astrazeneca.com/) and follow us on
Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

Media Relations
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References

1. Mikdashi J, Nived O. Measuring disease activity in adults with
systemic lupus erythematosus: the challenges of administrative burden
and responsiveness to patient concerns in clinical research.
Arthritis Research & Therapy. 2015;17(1):183.

2. Furie, Khamashta M, Merrill J T, et al. Anifrolumab, an
Anti-Interferon-? Receptor Monoclonal Antibody, in Moderate-to-Severe
Systemic Lupus Erythematosus. Arthritis & Rheumatology.
2017;69(2);376-386.

3. Lauwerys BR, Ducreux J, Houssiau FA. Type I interferon blockade in
systemic lupus erythematosus: where do we stand?. Rheumatology.
2013;53(8);1369-1376.

4. Crow, M. K, Type I Interferon in the Pathogenesis of Lupus, The
Journal of Immunology. 2014;192(12);5459-5468.

5. Wallace D. et al. Evaluation of treatment success in systemic lupus
erythematosus clinical trials: development of the British Isles Lupus
Assessment Group-based composite lupus assessment endpoint [poster].
Presented at: ACR/ARHP 2011 Annual Scientific Sessions; November 5-9,
2011; Chicago, IL. Poster 2265.
https://acr.confex.com/acr/2011/webprogram/Paper23976.html. Accessed
July 8, 2019.

6. Thanou A, Chackravarty E, James J et al. Which outcome measures in
SLE clinical trials best reflect medical judgment? Lupus Science &
Medicine. 2014;1:e000005.

7. The Lupus Foundation of America. Available at
https://resources.lupus.org/entry/what-is-lupus?utm_source=lupusorg&utm_....
[Accessed June 2019]

8. 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.

9. Nossent J, Cikes N, Kiss E, et al. Current causes of death in
systemic lupus erythematosus in Europe, 2000-2004: relation to
disease activity and damage accrual. Lupus. 2007; 16:309-317.

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

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