EMA Publishes New Guidance on Rheumatoid Arthritis Drug Trials

The European Medicines Agency updated guidance on clinical investigations of rheumatoid arthritis drugs to add new endpoints and distinguish between patient subgroups in trials.

Drug therapy for rheumatoid arthritis has made major advances since 2003 when the EMA issued a Points to Consider document, including more intensive early-disease intervention, with many combining biologic and non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

As a result of the advances, endpoints for treatment targets of remission have also changed to reflect earlier interventions than the previous six-month primary endpoint, the agency said.

The new guidance distinguishes between trials involving DMARD-naïve patients, those who have had an inadequate response to one prior DMARD treatment and those who have had an inadequate response to multiple treatments. For studies involving treatment-naïve patients, remission levels at three to six months are the ideal endpoint, whereas for those who have inadequately responded to previous treatment, low disease activity at three to six months is a preferable endpoint.