Declines in number of tender and swollen joints in patients with rheumatoid arthritis seen in standard care in 1985 versus 2001: possible considerations for revision of inclusion criteria for clinical trials

Objective: To analyse tender and swollen joint counts in three cohorts of patients with rheumatoid arthritis (RA), with a focus on the proportions of patients who had fewer than 6 - 12 tender or swollen joints, as possible evidence based information toward more generalisable inclusion criteria for current and future RA clinical trials. Methods: Tender and swollen joint counts were analysed in three cohorts of patients with RA: 125 in 1985, 138 in 2000, and 232 with early RA in 2001. Results: The median numbers of tender joints were 11, 2, and 4 in 1985, 2000, and in early RA in 2001, respectively. The median numbers of swollen joints were 12, 6, and 5 in 1985, 2000, and 2001, respectively. The numbers of tender joints among 28 assessed were >= 12, >= 6, >= 4, and >= 3 in 47%, 80%, 85%, and 90% of patients in 1985; 20%, 37%, 44%, and 49% in 2000; and 17%, 37%, 50%, and 58% in early RA in 2001. The numbers of swollen joints among 28 assessed were >= 12, >= 6, >= 4, and >= 3 in 51%, 78%, 86%, and 90% of patients in 1985; 20%, 50%, 64%, and 67% in 2000; and 14%, 46%, 58%, and 72% in 2001. The number of patients with >= 6 tender or swollen joints in 1985 was greater than the number with >= 3 joints in 2000 and in early RA in 2001. Conclusion: Contemporary cohorts of patients seen in standard care have smaller numbers of tender and swollen joints than in previous times. These findings suggest that revision of inclusion criteria for numbers of tender and swollen joints in contemporary RA clinical trials might improve generalisability.