Takeaways for Clinicians
The three-year PROGRESS OA Project launched in early August. The $2.5 million study includes funding from the Arthritis Foundation, Kolon TissueGene Inc., Merck KGaA, Pfizer/Eli Lilly and Co. and Samumed. The scientific efforts are led by the University of Sydney and Duke University, with strategic input and alignment provided by NIAMS and the U.S. Food and Drug Administration (FDA). When the study concludes in 2021, results will, hopefully, yield a regulatory package that will be submitted to both the FDA and the European Medicines Agency. Pending acceptance of biomarkers predictive of treatment response, researchers and pharmaceutical companies can use these as study endpoints to advance treatment options for patients with knee OA.
“None of this is fast,” Dr. Menetski pointed out, “but it is on the radar of most researchers in the biopharmaceutical industry. The major stumbling block is running the trials. If there is a better way to run shorter and less expensive trials with qualified endpoints, we will see accelerated [drug development] activity.”
Dr. Hunter adds that the key message for clinicians is awareness. “I think it’s important for clinicians to be aware that there’s promise here. There is a lot of activity in the osteoarthritis disease modification space, both in terms of what we’re doing with method enhancement and improving clinical trial efficiency; and the number of companies with activity in Phase 3 trials. There will be agents that become available to rheumatologists and orthopedists hopefully in the very near future.”
Dr. Kraus seconds that opinion. “I think the prevalent nihilism that OA is an inevitable part of aging is going to change with these successes. Everyone will now recognize the acute need to tackle the disease at its foundation and in its early stages.”
Gretchen Henkel is a health and medical journalist based in California.
References
- Wallace IJ, Worthington S, Felson DT, et al. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332–9336.
- Roemer FW, Guermazi A, Collins JE, et al. Semi-quantitative MRI biomarkers of knee osteoarthritis progression in the FNIH biomarkers consortium cohort—Methodologic aspects and definition of change. BMC Musculoskelet Disord. 2016 Nov 10;17(1):466.
