Declines of tender and swollen joint counts between 1985 and 2001 in patients with rheumatoid arthritis seen in standard care: Possible considerations for revision of inclusion criteria for clinical trials

Theodore Pincus ^1*, Tuulikki Sokka ¹, Cecilia Chung ¹ and Gail Cawkwell ²

¹ Vanderbilt University, United States
² Pfizer Inc., United States

^* To whom correspondence should be addressed. E-mail: t.pincus{at}vanderbilt.edu.

Accepted 9 November 2005

Abstract

Objective: To analyze the proportions of patients in 3 cohorts with rheumatoid arthritis (RA) seen in standard clinical care in 1985, 2000 and 2001, who had fewer than 6-12 tender or swollen joints, to provide possible evidence-based information toward more generalizable inclusion criteria for future RA clinical trials.

Methods: Tender and swollen joint counts were analyzed in 3 RA patient cohorts: 125 seen in 1985, 152 in 2000, and 232 with early RA seen in a different setting in 2001.

Results: A 28 tender joint count was >12, >6, >4, and >3 in 47%, 80%, 85% and 90% of patients in 1985, versus 20%, 37%, 44% and 49% in 2000, and 17%, 37%, 50% and 58% in 2001. A 28 swollen joint count was >12, >6, >4, and >3 in 51%, 78%, 85% and 90% of patients in 1985, versus 20%, 50%, 64% and 67% in 2000, and 14%, 46%, 58% and 72% in 2001. The median number of tender joints was 11 in 1985, versus 2 in 2000 and 4 in 2001, while the median number of swollen joints was 12 in 1985, versus 5 in 2000 and 8 in 2001. More patients had >6 tender joints in 1985 (80%) than >3 tender joints in 2000 (49%) and 2001 (58%), or >6 swollen joints in 1985 (78%) than >3 swollen joints in 2000 (67%) and 2001 (72%).

Conclusion: Revision in numbers of tender and swollen joints might be considered to improve generalizability of inclusion criteria for contemporary RA clinical trials.

Keywords: Clinical trials, inclusion criteria, joint count, rheumatoid arthritis, standard care

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