Disease modification in osteoarthritis; pathways to drug approval.

OBJECTIVE: To summarize proceedings of a workshop convened to discuss advances in disease modifying osteoarthritis (OA) drugs and regulatory challenges in bringing these drugs to market. DESIGN: Summary of a one day workshop held in Washington, DC in May 2019. RESULTS: Attendees presented data documenting the prevalence, cost and disability burden of OA; recent documentation of disease modification without concomitant clinical benefit in trials of disease modifying drugs; regulatory considerations pertinent to disease modifying therapy; and methodologic approaches to addressing these regulatory considerations. CONCLUSIONS: The research, pharmaceutical and regulatory communities must continue to collaborate on defining pathways for approval of disease modifying osteoarthritis drugs that document effects on clinical endpoints (such as pain, function or joint replacement) as well as on bone, cartilage and other structures.

Duke Scholars

Author Virginia Byers Kraus Medicine, Rheumatology and Immunology