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Osteoarthritis, a serious disease

Dr. Josep Vergés, President and CEO of the Osteoarthritis Foundation International (OAFI)

X-Ray severe osteoarthritis in both knees

 

It is considered a disease associated with old age and with very little glamor, if any disease has it. However, osteoarthritis is a very complex pathology and affects notonly older people but other at-risk groups. Especially women in post-menopausal age, athletes and also young people. It affects more than 242 million people worldwide and is a figure that continues to grow due to increased life expectancy, but also to poor eating habits, obesity, sedentary lifestyle or making exercise without medical control.

It not only causes pain, but is associated with other pathologies such as diabetes, cardiovascular diseases, or hypertension among others. A poor evolution of osteoarthritis can lead to lack of mobility and disability, thus incapacitating patients to perform the most daily tasks. In addition, people with osteoarthritis, especially women, are at greater risk of suffering from other conditions such as anxiety or depression than those who do not [EMARTRO study].

In this context, the International Society for Osteoarthritis Research (OARSI) has asked the American Medicines Agency (FDA) to consider osteoarthritis as a serious disease through the white paper Osteoarthritis, a serious disease [OARSI white paper. Osteoarthritis: A serious disease].

There are currently drugs to treat osteoarthritis symptomatically. Analgesics and NSAIDs are recommended against pain, although they may present problems of toxicity and SYSADOAS (Chondroitin Sulfate, Glucosamine, Hyaluronic Acid Intra-articular) that have been shown to be effective at the symptomatic level and above all very safe, providing therapeutic advantages.

However, according to the OARSI document, presently there are no drugs approved that can prevent, stop, or even restrain progression of OA. There is no proven remedy to prevent the need to surgically replace the knee affected by osteoarthritis that ends up being the final solution for millions of people around the world.

There is an urgent need for clinical studies with new or existing agents that may be involved in the pathophysiology and progression of osteoarthritis. Consideration of osteoarthritis as a serious disease by the FDA would imply greater speed in the approval process of a drug that “treats a serious condition and generally provides a meaningful advantage over available therapies and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (IMM) that is reasonably likely to predict an effect on IMM or other clinical benefit (i.e., an intermediate clinical endpoint)” [FDA Guidance for Industry Expedited Programs for Serious Conditions, 2014].

The term serious disease has been defined by the FDA as “a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible if it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.”

In this sense, from the Osteoarthritis Foundation International (OAFI) we consider that osteoarthritis is a serious disease too, and, in addition, constitutes the greatest challenge for 21st century healthcare systems worldwide.

We are committed – through our knowledge and disease prevention projects, as well as our innovation and development projects and also leading the OA Task Force with the Arthritis Foundation, it is the United States-, to carry out actions that improve the quality of life of patients with osteoarthritis and to make the health system more sustainable.