A white paper has been submitted to the US Food and Drug Administration (FDA) as evidence that future osteoarthritis applications should be considered under one of their expedited programs for serious conditions.
Osteoarthritis: A Serious Disease, auspiced by the Osteoarthritis Research Society International (OARSI) with substantial contributions from Australian experts, was submitted to the FDA late last year.
The white paper spearheads an international effort to accelerate approvals for novel, disease-modifying therapies for osteoarthritis and help reduce the global burden of progressive disability.
Professor Lyn March, a member of the white paper executive committee and writing group, told the limbic the FDA set a high bar for disease-modifying agents for osteoarthritis – expecting evidence of both symptom and structure modification.
“We need large, well controlled, and long duration studies. Drug developers are looking at trials of about 10 years in order to say they can reduce the need for joint replacements.”
She said an additional complexity in osteoarthritis trials was the high rate of placebo response – about 30% for oral and 50% for injectable interventions.
”Our immediate strategy is to get enough evidence via early outcome measures such as MRI change or change in serum or urine markers for bone turnover.”
She said other diseases for which drugs had been fast tracked fulfilled the definition of seriousness as outlined in a FDA guidance.
The white paper said the global prevalence of hip and knee osteoarthritis was approaching 5% and projected to rise with an ageing population and higher levels of obesity.
It provided evidence of the high rates of comorbidities and increased mortality associated with osteoarthritis in addition to pain, loss of function, reduced physical activity and work limitations.
“The trends in osteoarthritis years lived with disability (YLD) from 1990 to 2013 showed a 75% increase, the third most rapidly rising condition associated with disability, just behind diabetes at 135% and dementia at 84%,” it said.
The paper noted that most estimates of the osteoarthritis burden were also likely to be underestimates given they rarely considered sites other than the knee and hip.
It called for global and national health policies to urgently address the rising burden of osteoarthritis.
“The onus is on us to identify, based on phenotype and biomarkers, the people who are at high risk of progression,” Professor March said.
She said the white paper was one of several advocacy efforts highlighting the urgent need to acknowledge the burden of osteoarthritis, find solutions to disease progression and avoid joint replacement surgery.