Breakthrough science provides hope for disease that affects 1.5 million people in US

December 18, 2019

Today the prestigious New England Journal of Medicine (NEJM) publishes research led by Monash University Professor Eric Morand that offers the first real hope for the treatment of lupus, a disease which affects 1.5 million people in the US and more than 5 million globally, 90% women and for which there is no cure.

The results are of an international, three-year, Phase 3 trial of a potential new drug that treats this autoimmune disease (also known as systemic lupus erythematosus (SLE)).

Lupus is an autoimmune disease in which the immune system attacks healthy parts of the body. It is particularly insidious disease as it has a ten-year mortality of 10%, "which if you are diagnosed in your early twenties is a terrible outcome," according to Professor Morand, who oversaw the global trial in over 360 people with SLE.

The trial, called TULIP 2, evaluated AstraZeneca's anifrolumab and achieved a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care.

Professor Morand has also been key in developing new lupus assessment criteria - which because the disease involves a number of organs in the body - can be difficult to both diagnose and monitor.

According to Professor Morand, there has only been one new treatment approved for the disease in the last 60 years, which is not available on the Pharmaceutical Benefits Scheme in Australia.

Between 60% and 80% of adults with SLE show increased interferon-induced genes, which reflect overproduction of the immune protein Type 1 interferon. While previous attempts to block this protein in lupus have failed, the potential new treatment, anifrolumab, works by blocking the receptor on all cells in the body, aiming to reverse the triggering of lupus symptoms.

Professor Morand said that interferon is associated with other autoimmune diseases such as Scleroderma and Sjogren's disease "so there may be potential for using anifrolumab in the treatment of other interferon related diseases as well."

In the TULIP 2 trial, eligible patients received a fixed-dose intravenous infusion of anifrolumab or placebo every four weeks. TULIP 2 assessed the effect of anifrolumab in reducing disease activity - noting a significant effect in global disease activity measures.

The trial, from 2015 to 2018, involved 362 patients receiving either 300 mg of the drug or a placebo intravenously once every four weeks for 48 weeks. Benefit was measured using a defined clinical assessment of improvement in all organs as well as the number of flare ups (which see the patient experiencing fever, painful or swollen joints, fatigue, rashes or sores or ulcers in the mouth or nose). The volunteers were aged between 18 and 70 and had moderate to severe disease despite standard treatments. Patients with SLE typically die of organ failure.

The study found that - 52 weeks after the trial started - significantly more patients on the drug than the placebo had:The TULIP 2 trial followed on from the TULIP 1 trial which failed to meet its primary outcome. The second trial, published in the NEJM, used a different endpoint. "Measurement of treatment response in SLE has been very problematic and this represents a kind of second breakthrough of this trial," Professor Morand said.

AstraZeneca will now work with regulators, to bring anifrolumab, a potential new medicine, to patients. The study was done in collaboration with colleagues in Japan, the UK, the US, France and South Korea.
-end-


Monash University

Related Lupus Articles from Brightsurf:

Systemic lupus erythematosus (SLE)
If renal remission is achieved therapeutically in cases of lupus nephritis (LN), the 10-year survival rate increases significantly.

Race-specific lupus nephritis biomarkers
A University of Houston biomedical researcher has discovered a difference in urinary biomarker proteins of lupus nephritis in patients according to race.

Lupus patients who take their medications lower their diabetes risk
Patients with lupus who take their medications as prescribed have much lower odds of developing type 2 diabetes, a common complication of the disease, finds a new study from the University of British Columbia.

Nearly 1 in 3 patients with lupus use prescription opioids for pain
A new study finds nearly one in three adults with lupus use prescription opioids to manage pain, despite a lack of evidence that opioids are effective for reducing pain from rheumatic diseases.

Developing therapeutic strategies for pregnant women with lupus
A highly gender-biased disease, lupus afflicts females some nine times more than males.

Lupus antibody target identified
Researchers have identified a specific target of antibodies that are implicated in the neuropsychiatric symptoms of lupus, according to human research published in JNeurosci.

B cells off rails early in lupus
Emory scientists could discern that in people with SLE, signals driving expansion and activation are present at an earlier stage of B cell differentiation than previously appreciated.

Can adverse childhood experiences worsen lupus symptoms?
Adverse childhood experiences (ACEs) encompass traumas such as abuse, neglect, and household challenges.

Unlocking the female bias in lupus
The majority of lupus patients are female, and new findings from the University of Pennsylvania shed light on why.

How a single faulty gene can lead to lupus
IBS-AIM (Academy of Immunology and Microbiology) research team at Pohang University of Science and Technology (POSTECH) in South Korea has discovered the role of a key gene involved in the autoimmune disease systemic lupus erythematosus (SLE) or lupus for short.

Read More: Lupus News and Lupus Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.