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Psoriasis, MS, Lupus, and RA.
Science and technology have drastically improved how autoimmune diseases are managed, and there are more options than ever before to treat autoimmune diseases.
Chase Spurlock, PhD, professor at Vanderbilt University and CEO of IQuity, a Nashville-based analytics startup offering an autoimmune disease-focused data analytics platform, says for many autoimmune diseases the available treatments can effectively control disease, but there is no one-size-fits-all approach.
He adds that all too often, patients are wandering through the healthcare system trying to find answers and some patients receive the wrong diagnosis and are placed on medicines that are not only expensive but also carry a high level of risk. Receiving an accurate diagnosis as quickly as possible is vital to ensure for the best long-term outcomes.
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“Time is of the essence. If autoimmune diseases are allowed to progress without any therapeutic intervention, irreversible tissue damage and disability ensue,” he says. “We are very fortunate to live in an era where the therapies to treat many autoimmune diseases are highly effective, especially if they are prescribed early.”
Here are some of the latest advancements for autoimmune disease diagnoses and treatments.
Psoriasis is a common autoimmune disease that affects more than 8 million people in the United States and has a significant burden on patients’ quality of life. Patients are often faced with embarrassment because of the visible plaques on their skin and some patients isolate themselves for fear that others will think their disease is contagious.
In the summer months, this is especially important because clothing worn in warmer weather tends to expose more skin and therefore more unsightly plaque.
Fabrice Chouraqui, president of Novartis Pharmaceuticals Corp., says the treatment of psoriasis has been evolving over the years and there are now multiple therapeutic options.
“Cosentyx is the first and only fully human IL-17A antagonist which has demonstrated efficacy in moderate to severe plaque psoriasis, which may involve troublesome areas such as the nails, the scalp, hands and feet,” he says. “When these areas are involved, psoriasis has an even greater impact on a patient’s quality of life. Cosentyx has also shown efficacy in the joints and is approved for active psoriatic arthritis and active ankylosing spondylitis.”
Unlike some other therapies that have only shown efficacy in the skin, Cosentyx is also a proven therapy for psoriatic arthritis, which is a complication of psoriasis that can cause irreversible bone damage and disability.
The Institute for Clinical and Economic Review (ICER) recognized that IL-17 agents provide long-term value to insurers, patients, and the healthcare system. ICER’s 6/18 Psoriasis Update Evidence Report reviewed Cosentyx and other targeted immunomodulators for moderate to severe plaque psoriasis and concluded that first-line treatment with IL-17 drugs is a reasonable strategy due to their high efficacy and reasonable economic value, even in comparison to step therapy using a less effective and less expensive targeted drug first line.
Chouraqui said Cosentyx costs virtually nothing for a 30-day prescription with the Novartis $0 copay program for those with commercial or private insurance.
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In April, the FDA approved Duobrii (halobetasol propionate and tazarotene), a lotion developed by Bausch Health, which contains two medications for the treatment of plaque psoriasis in adults. The medicines work together to slow the growth of skin cells and reduce the symptoms of plaque psoriasis.
Additionally, the FDA recently approved Sorilux Foam (calcipotriene, Mayne Pharma), a topical treatment originally indicated for adult patients only, as being safe for pediatric patients 12 and older.
A study led by Dr. Mitchell T Wallin of the Department of Veterans Affairs MS Center of Excellence and Georgetown University, and supported by the National Multiple Sclerosis Society, revealed the prevalence of MS in the U.S. is nearly 1 million people, more than twice the previously-reported estimate. This suggests many more people are living with MS than previously thought, and in particular the number of people with a progressive form of the disease-where the greatest needs continue to exist-may be much higher as well.
“This study tells us many things, but one thing in particular-twice as many people need a cure,” says Cyndi Zagieboylo, president and CEO of the National Multiple Sclerosis Society. “We must do more.”
More than a dozen medicines for relapsing multiple sclerosis have been approved since the ’90s, but the first DMT for the primary progressive form of MS, Ocrevus, was not approved by the FDA until 2017.
“Our work with Ocrevus has provided an earlier treatment option with a favorable benefit-risk profile,” says Hideki Garren, MD, PhD, global head of multiple sclerosis and neuroimmunology at Genentech, developers of Ocrevus. “This is because we know treatment with a high-efficacy medicine that impacts MS disability progression, not just relapses, is important to preserve patient function and ultimately quality of life.”
Ocrevus is the first and only therapy approved for all relapsing forms of MS, which includes relapsing-remitting and active or relapsing, secondary-progressive MS as well as primary progressive MS.
“Ocrevus has fundamentally changed our understanding of MS pathology and how to treat the disease,” Garren says. “By uncovering the role of B cells in MS (when it was previously thought to be primarily a T-cell driven disease) we have created a high-efficacy medicine that can be used earlier because of its favorable benefit-risk profile and the ability to slow the progression of disease.”
Genentech set the price to allow people to have the easiest path to access, and today Ocrevus is widely covered both in the U.S. and abroad. The manufacturer has not increased the price since launch and is committed to fair, reasonable pricing over the life cycle of Ocrevus.
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“We are committed to helping people access the medicines they are prescribed and offer comprehensive services for people prescribed Ocrevus to help minimize barriers to access and reimbursement,” Garren says.
Until 2011 and the FDA approval of belimumab, there were no new treatments approved for lupus. This biologic treatment interferes with a specific protein that supports the activation and survival of B cells, which play a pivotal role in lupus pathology.
Taken together, the more than 30 treatments that have failed in clinical trials for lupus since the early 1990s represent well over $1 billion in lost research and development funding and have left lupus as one of the most underserved diseases.
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“It is now 2019 and every treatment that has gotten into late-stage development for lupus since belimumab has failed,” says Joan T. Merrill, MD, chief advisor for clinical development at the Lupus Foundation of America, and Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation. “The good news is that there is no slowdown in development for lupus, and new agents are coming into early phase trials each year.”
She explains that more and more has been learned about the pitfalls in the clinical trials for this complicated disease and improvements have been made in trial design, patient selection, and a better biologic understanding of the patient subsets that may or may not respond to a given targeted treatment.
“There have been some recent successful phase 2 trials and we are waiting to see if any of these new agents break through at the end,” Merrill says. “Current treatments in development include agents that target proteins that lie at various points along the type I interferon pathway, agents that are similar (but not identical to belimumab), and agents that affect other regulators of the immune system.”
In 2019, belimumab was approved for children for the first time.
Rheumatoid arthritis (RA) affects multiple joints, including in the hands and feet and can cause irreversible damage to these joints resulting in pain and loss of functionality.
Alla Rudinskaya, MD, section chief of rheumatology at Danbury Hospital and medical director of Western Connecticut Medical Group Rheumatology, says the main goals of treatment for RA and other autoimmune diseases are to improve symptoms (pain, functionality), and prevent joint damage from occurring.
In 1998, the first biologic agents (infliximab and etanercept) were approved for treatment of RA. Over the past 20 years, options for RA treatment have grown exponentially and there are now several classes of biologic agents available to treat RA.
“The use of biologics has greatly improved the treatment and prognosis of RA. Biologics are made by using biotechnology and work by interrupting or blocking immune system signals causing inflammation and joint destruction,” Rudinskaya says. “The availability of more medications is great news for people with RA because if they don’t respond to one treatment, they can try another one to effectively manage the disease. Also with these newer medications, there is a greater chance for the disease to go into remission.”
Most medications to treat RA are covered by commercial health insurance plans, Medicare, and state health insurance. For example, the first line of treatment for RA, methotrexate (which is a DMARD-disease-modifying antirheumatic drug), is a medication that has been around for decades. It’s an effective medication and is relatively inexpensive.
“However, the newer medications, like biologics, are usually quite expensive,” Rudinskaya says. “Most health insurance plans may cover different biologics but may have restrictions or prefer some medications over others. Patients who cannot get their medications through their insurance may sometimes be eligible for patient assistance programs.”