DC-ART CLASSIFICATION - REVIEW OF RELEVANT CLINICAL-STUDIES

The proposed disease controlling antirheumatic therapy (DC-ART) defini tion requires that the therapy change the course of rheumatoid arthrit is (RA) for at least 1 year, evidenced by (1) sustained improvement in physical function, (2) decreased inflammatory synovitis, and (3) slow ing or prevention of structural joint damage. Selected studies are rev iewed. All studies were at least 1 year in duration, but most did not include all 3 of the DC-ART requirements. In these studies, patients t reated with placebo generally had no improvement in inflammatory synov itis and progressive structural joint damage, judged by serial joint r adiographs. A minority of studies significantly favored one or another of the available agents (gold injections, D-penicillamine, auranofin, antimalarials, azathioprine, sulfasalazine, methotrexate), but the ev idence for any one agent is not convincing. For future DC-ART clinical trials patients with early RA should be studied. A hybrid study desig n may be useful, combining an initial double blind randomized controll ed clinical trial with continuing longterm observation of all withdraw als using specified clinical, radiographic, and self report assessment s at regular intervals, and an intent-to-treat analysis comparing long term response rates of the original control and experimental therapy g roups. Responsive subgroups should be sought, their characteristics id entified, and their responsiveness confirmed in additional trials limi ted to the identified subgroup.