WASHINGTON, DC--(Marketwired - August 22, 2016) - Lupus is an autoimmune disease that can impact any part of the body. This prototypical autoimmune disease, affecting millions of people worldwide, causes a wide range of serious and life-threatening consequences that are challenging to bring under control because of a lack of adequate treatments.
Over the years, pioneering physicians, using therapies borrowed from other diseases, have painstakingly developed treatment regimens that have helped to reduce mortality associated with lupus. Unfortunately, people suffering from certain forms of lupus, such as lupus-related kidney disease (known as lupus nephritis or LN), cardiovascular disease and other complications, remain at a very high risk for premature death. Lupus nephritis is associated with a six-fold increase in mortality compared with the general population, and there is now strong evidence that people with lupus have at least a two to three fold risk of heart disease and stroke, compared to those without lupus.
Rarely, however, do we hear much about lupus mortality because these deaths usually are attributed to the consequences of lupus, such as kidney failure, heart attacks, strokes or infections. The root cause, lupus, is seldom listed as the primary cause of death, making it difficult to determine the true mortality of the disease.
The history of lupus drug development has been filled with challenges. These hurdles include the way clinical trials are designed and conducted and the requirement that new medications be tested against potent therapies that patients are already taking when they enter a trial. These therapies include chemotherapies (yes, chemotherapies are used to treat very sick lupus patients) and high doses of steroids. This requirement sets a very high, almost insurmountable bar to meet in order to get new lupus drugs through the review and approval process.
Only one therapy, Benlysta, has been approved for the treatment of some forms of lupus. That occurred back in 2011 after a more than 50 year drought. Presently, most of the therapies used to treat lupus patients are off-label and have never been researched specifically for lupus.
On August 15, 2016, Aurinia Pharmaceutical Company announced positive top-line results of a Phase IIB clinical study of voclosporin, a potential new therapy option for people with active lupus nephritis. This was the first-ever study for a medication to treat active lupus nephritis that successfully reached its primary endpoint of demonstrating greater complete remission.
The announcement should have been viewed by all as a big win for this medically underserved disease. Amazingly, however, articles written about this trial instead focused on the number of deaths associated with this trial, failing to recognize that the trial was conducted among a group of already very seriously ill patients who have very few options. The truth is people around the world are dying every day from the complications of lupus. A review of the scientific literature would have revealed that many active lupus nephritis trials had a similar number of mortalities. The history of this disease was overlooked, even diminished, when the results of a successful trial were misinterpreted.
So what is the solution? First and foremost, we need accurate statistics on the incidence and prevalence of lupus and its associated rate of mortality. Next, we must have a much more robust lupus research effort at the National Institutes of Health (NIH) and in the private sector to better understand the biology of the disease and establish additional targets for drug development. Moreover, the FDA, working with key lupus experts, must figure out better ways to design clinical trials so they can be shorter, smaller and less expensive. Additionally, the public and our policy makers must understand that lupus is a devastating disease that can have life-threatening and life-altering consequences.
The Lupus Foundation of America stands ready to launch a global movement to achieve the goals outlined above. Will you help? If so, please contact me at firstname.lastname@example.org.
Lupus is an unpredictable and misunderstood autoimmune disease that ravages different parts of the body. It is difficult to diagnose, hard to live with and a challenge to treat. Lupus is a cruel mystery because it is hidden from view and undefined, has a range of symptoms, strikes without warning, and has no known cause and no known cure. Its health effects can range from a skin rash to a heart attack. Lupus is debilitating and destructive and can be fatal, yet research on lupus remains underfunded relative to diseases of similar scope and devastation.
About the Lupus Foundation of America
The Lupus Foundation of America is the only national force devoted to solving the mystery of lupus, one of the world's cruelest, most unpredictable and devastating diseases, while giving caring support to those who suffer from its brutal impact. Through a comprehensive program of research, education, and advocacy, the Foundation leads the fight to improve the quality of life for all people affected by lupus. Learn more about lupus, Lupus Science & Medicine Journal and the Lupus Foundation of America at lupus.org. For the latest news and updates, follow us on Twitter and Facebook.