RT Journal Article
SR Electronic
T1 A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid arthritis. OMERACT Drug Safety Working Party.
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1170
OP 1173
VO 28
IS 5
A1 Lipani, J A
A1 Strand, V
A1 Johnson, K
A1 Woodworth, T
A1 Furst, D
A1 Singh, G
A1 Day, R
A1 Brooks, P
A1 OMERACT Drug Safety Working Party
YR 2001
UL http://www.jrheum.org/content/28/5/1170.abstract
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.