PT  - JOURNAL ARTICLE
AU  - Lipani, J A
AU  - Strand, V
AU  - Johnson, K
AU  - Woodworth, T
AU  - Furst, D
AU  - Singh, G
AU  - Day, R
AU  - Brooks, P
AU - OMERACT Drug Safety Working Party
TI  - A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid arthritis. OMERACT Drug Safety Working Party.
DP  - 2001 May 01
TA  - The Journal of Rheumatology
PG  - 1170--1173
VI  - 28
IP  - 5
4099  - http://www.jrheum.org/content/28/5/1170.short
4100  - http://www.jrheum.org/content/28/5/1170.full
SO  - J Rheumatol2001 May 01; 28
AB  - This paper proposes the creation of an objectively acquired reference database to more accurately characterize the incidence and longterm risk of relatively infrequent, but serious, adverse events. Such a database would be maintained longitudinally to provide for ongoing comparison with new rheumatologic drug safety databases collecting the occurrences and treatments of rare events. We propose the establishment of product-specific registries to prospectively follow a cohort of patients with rheumatoid arthritis (RA) who receive newly approved therapies. In addition, a database is required of a much larger cohort of RA patients treated with multiple second line agents of sufficient size to enable case-controlled determinations of the relative incidence of rare but serious events in the treated (registry) versus the larger disease population. The number of patients necessary for agent-specific registries and a larger patient population adequate to supply a matched case-control cohort will depend upon estimates of the detectability of an increased incidence over background. We suggest a system to carry out this proposal that will involve an umbrella organization, responsible for establishment of this large patient cohort, envisioned to be drawn from around the world.