Assessment of structure-modifying drugs in osteoarthritis: surrogate or hard clinical end points?

in Future Rheumatology (2006), 1(2), 199-206

Current regulatory requirements for the development of disease-modifying drugs in osteoarthritis (OA) still consider the measurement of joint space narrowing (a change in joint space width over many years ... [more ▼]

Current regulatory requirements for the development of disease-modifying drugs in osteoarthritis (OA) still consider the measurement of joint space narrowing (a change in joint space width over many years) on plain x-rays as the appropriate primary end point for the demonstration of efficacy. However, other outcomes have recently been proposed. Among these, time to joint replacement appears to be an attractive option. Preliminary results are encouraging; however, more data are needed before recommending joint replacement as a primary outcome in disease-modifying OA drugs. It should be acknowledged that, owing to potential biases (e.g., absence of recommended guidelines, socio–economic and gender disparities in the rates of knee surgery, variability from country to country and willingness of patients to undergo the surgery), a recent expert consensus panel did not recommend this particular outcome as the primary end point for assessing the success or failure of a disease-modifying drug. Other tools, such as magnetic resonance imaging or biochemical markers, have potential as outcome measures but more studies are needed. [less ▲]

Osteoporosis and cardiovascular disease: in nonskeletal risk important in patients requiring an antiosteoporotic treatment?

in Future Rheumatology (2006), 1