Is Structural Damage Evaluation by Traditional Radiographs Still Relevant in Rheumatoid Arthritis Clinical Trials?

Abstract

To the Editor: Suppression of progression of radiographic damage in rheumatoid arthritis (RA) is the hallmark of an effective disease-modifying antirheumatic drug (DMARD), whether a biologic or nonbiologic drug. Its assessment has been part of all pivotal clinical trials, to obtain such a claim in the product monograph. In the original US Food and Drug Administration guidance document, placebo-controlled trials of 2–5 years were suggested as the method to demonstrate inhibition of radiographic progression. Recently a draft guidance document, not yet implemented, has suggested using alternative study designs because patients cannot be maintained on placebo for more than about 12 weeks1; however, it is mentioned that newer imaging techniques such as magnetic resonance imaging (MRI) and ultrasound are not yet validated. The European Medicines Agency still requires 1-year trials, or in exceptional cases 6 months can be … Address correspondence Dr. B. Haraoui, 1551 Ontario est, Montreal, Quebec H2L 1S6, Canada. E-mail: bharaoui{at}videotron.ca