Objective: To determine the proportion of 2 cohorts of patients with rheumatoid arthritis (RA) in Nashville, Tennessee, who met 4 common criteria for inclusion in clinical trials: > or = 6 swollen joints, > or = 6 tender joints, erythrocyte sedimentation rate > or = 28 mm/h, and/or morning stiffness > or = 45 min.
Methods: Two cohorts of patients with RA, all of whom had met American Rheumatism Association (ARA) [now American College of Rheumatology (ACR)] criteria for RA at some time, were studied. Cohort L (late) included 146 consecutive patients whose mean disease duration was 14.0 years and who had been under care at a weekly academic rheumatology clinic for a mean of 6.2 years when seen in 1998-2001. Cohort E (early) included 232 patients of 5 private practice rheumatologists whose symptoms began in 1998 or later and whose mean disease duration was 1.8 years when seen in 2001. Patients were reviewed for the 4 inclusion criteria as well as 6 ARA remission criteria.
Results: In Cohort L, on a 28 joint count, 42.5% of patients had > or = 6 swollen joints, 25.3% had > or = 6 tender joints, 19.9% had both > or = 6 swollen and > or = 6 tender joints, 25.0% had ESR > or = 28, and 45.9% had morning stiffness > or = 45 min. In Cohort E, on a 42 joint count, 63.4% of patients had > or = 6 swollen joints, 50.4% had > or = 6 tender joints, 38.8% had both > or = 6 swollen and > or = 6 tender joints, 49.3% had ESR > or = 28, and 50.9% had morning stiffness > or = 45 min. Overall, 15.3% of Cohort L and 34.1% of Cohort E patients had > or = 6 swollen and tender joints, as well as an ESR > or = 28 or morning stiffness > or = 45 min. Only 4.1% of Cohort L and no patient in Cohort E met ARA criteria for remission.
Conclusion: The majority of patients seen in routine care in these 2 cohorts did not meet criteria for inclusion in most contemporary RA clinical trials, including clinical trials sponsored by pharmaceutical companies to introduce new drugs or biological agents. Few of these patients met ARA criteria for remission. Controlled trial data are not available concerning results of treatment with new biological agents or disease modifying antirheumatic drugs in a large proportion, if not a majority, of patients with RA at this time.