Seeking structural endpoints for OA

Companies turn to imaging-based endpoints for first wave of disease-modifying OA therapies

As the first disease-modifying therapies for osteoarthritis enter late-stage development, companies are testing new endpoints that can capture effects on joint structure instead of relying on traditional pain-related readouts. Most are converging on MRI imaging for its superior sensitivity to X-ray.

Readouts this year will help determine whether either method can demonstrate a slowing of already slow disease progression in osteoarthritis (OA) patients.

Despite being the most common joint disorder, OA remains one of the few rheumatic diseases without an available disease-modifying therapy.

While NSAIDs and steroids are approved to help manage OA’s most troublesome symptom -- pain -- there’s been little progress in addressing the joint destruction itself.

Part of the challenge has been that OA develops slowly, and often unnoticed, over years. The condition was once widely viewed as a normal part of aging rather than a disease, but new biological insights and increased recognition from FDA as a serious unmet need has helped change perception (see “New Targets in Osteoarthritis”).

Now, at least four potentially disease-modifying therapies for OA are in Phase II or Phase III development, and companies want to show they affect more than just pain.

FDA issued draft guidance last year on disease-modifying endpoints for OA, but it offered little direction, instead calling on industry

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