March is Multiple Sclerosis (MS) Awareness month, and PAREXEL Insights sat down with two members of our team who are also Neurologists, Kemi Olugemo, MD and Olena Rudnyeva, MD, to discuss the current state of drug development in MS and how we can work to improve the outlook for patients with this condition.
Dr. Olugemo is a Board-Certified Neurologist and Senior Medical Director at PAREXEL. She completed subspecialty training in Neuroimmunology and Multiple Sclerosis (MS) at the University of Maryland School of Medicine, Baltimore, USA. She has extensive experience treating patients with MS and has been a Principal Investigator and medical monitor on several MS clinical trials. Dr. Olugemo is passionate about MS research, advocacy, and patient education. Her role currently involves medical monitoring, and providing medical and scientific support for new MS therapies in various stages of drug discovery.
Dr. Rudnyeva is a Neurologist and Associate Medical Director at PAREXEL. She obtained her medical degree from Kharkiv State Medical University, Ukraine, as well as a diploma in Clinical Research from the University of Liverpool, UK. Dr. Rudnyeva has experience treating MS patients and multifaceted MS clinical trial experience; including roles as a clinical research associate and medical monitor. She has been a regular contributor to a key industry journal in Ukraine on the topics of clinical trials and multiple sclerosis management.
PAREXEL Insights: How widespread is Multiple Sclerosis (MS) today?
Dr. Olugemo: Multiple Sclerosis is a chronic inflammatory demyelinating disease that affects over 2 million individuals globally. It is the most common cause of neurologic disability in young adults in Western Europe and North America. Patients with MS either have a relapsing or progressive form of the disease, both of which can be active or inactive. The incidence of MS has been relatively stable over the past few decades in Caucasians, whereas, it has increased in other racial and ethnic groups, such as African Americans.
According to The Global Burden of Diseases, Injuries, and Risk Factors Study, MS prevalence has increased substantially in many regions since 1990. This increase may be partially attributed to increased survival. The regions with the highest prevalence of MS include North America, Western Europe, and Australasia.
PAREXEL Insights: What is PAREXEL’s experience and expertise working in MS?
Dr. Olugemo: Central nervous system (i.e., Neurology & Psychiatry) disorders represent PAREXEL’s second largest therapeutic area in terms of experience. Our experts have collective clinical, medical, scientific, genomic, regulatory and operational experience that is instrumental to companies developing therapies for MS patients. As a service provider and trusted partner, we provide innovative ways to optimize and accelerate the execution of clinical trials, with the goal of helping to get safe and effective medicines to patients. We also provide practical solutions based on our vast experience in all phases of development, including first-in-human, proof of concept, Phase II-III, and post-marketing studies.
PAREXEL Insights: What are the main challenges for patients with MS?
Dr. Olugemo: As you can imagine, the challenge for MS patients will vary depending on whether the patient has active relapses and how fast the disease is progressing. One of the first symptoms MS patients experience is vision loss from optic neuritis. Many patients also have difficulty walking, a symptom that can be caused by muscle weakness, impaired coordination, muscle spasms, and numbness. Fatigue is a prominent complaint for many patients, and again, the cause for this tends to be multifactorial. In many cases patients develop bladder dysfunction, which may negatively influence quality of life. After exposure to very warm temperatures, symptoms can worsen considerably, and this can affect exercise, certain work environments, and even leisure activities.
Dr. Rudnyeva: MS patients are often well-educated about their disease and options for treatment. For those patients on disease modifying therapy, issues such as access to certain treatments, cost and medication side effects are common.
PAREXEL Insights: Tell us a little about the current treatment landscape for MS.
Dr. Olugemo: Treatment options for MS patients have improved significantly in the past two decades. Medications are categorized by their effect on relapse reduction and delaying progression (disease modifying), or solely as symptomatic in nature.
Disease modifying medications work either by suppressing the immune system or by modulating it. As of February 2019, there are 8 injectable, 3 oral, and 4 intravenous medications approved for disease modification. Beginning in 2017, we also now have disease modifying treatment for patients with the Primary Progressive form of MS, which represents a breakthrough in research.
In addition to medications, complementary and alternative medicine approaches are utilized to improve quality of life, as well as exercise and rehabilitation.
PAREXEL Insights: What is the most exciting thing happening in research today for MS?
Dr. Olugemo: Companies are now looking at “neuroprotective” treatments that can stave off damage from MS and potentially halt the progression completely. We now have prognostic biomarkers such as neurofilament light protein (NfL) that aid in predicting the disease course as well as response to treatment.
No evidence of disease activity (NEDA), also referred to as freedom from relapses, new or contrast enhancing lesions on Brain MRI, and from disability worsening, is the new goal that is emerging in MS treatment. In patients with Primary Progressive MS, a goal of no evidence of disease progression or active disease (NEPAD) has been proposed.
Ongoing cell-based therapy studies are targeting some of the known causes of MS. These trials are promising in terms of achieving NEDA and NEPAD. Although primarily at the preclinical stage, gene therapy approaches show either prevention of disease onset or near complete remission in mouse models of MS. If translated to patients, future treatments would potentially be curative.
PAREXEL Insights: What stakeholders need to get involved to improve the outlook for patients with MS?
Dr. Rudnyeva: The outlook for patients with MS changed dramatically over last decade and will improve further when new medications discussed above are available on the market. Development of one or more drugs that reverse damage or even cure MS will make the future bright for every patient.
Availability of currently approved treatments for patients with MS differs from region to region, due to the prohibitive price for some of them. It’s in payors hands to include all drugs in their programs and ensure every patient gets access to what is the best option for them.
Generics and biosimilars will be emerging on the market in the future, as patents for many drugs will be expiring in the coming years. Patients with MS will expect balanced decisions from regulatory agencies in establishing that safety and efficacy profiles of these medications are indeed comparable to originals.
GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Mar;18(3):269-285
Reich DS, Lucchinetti CF, Calabresi PA. Multiple Sclerosis. N Engl J Med. 2018 Jan 11;378(2):169-180