The general objective of this study is to evaluate whether elderly patients with rheumatoid arthritis experience the same benefit and toxicity when treated with second line drugs as younger more frequently studied patients. Specifically, we will perform a secondary data analysis on the raw data from rheumatoid arthritis clinical trials. Focusing on commonly used drugs, we will evaluate whether elderly subjects have similar responses to drugs and similar rates of toxicity and toxicity induced dropout as do younger subjects. This projects is important because the prevalence of rheumatoid arthritis is highest among elderly persons yet most clinical trials have focused on those in middle age. While there is strong biological and pharmacologic evidence to suggest that elderly people might experience different benefits and risks from these drugs than younger subjects, there is little clinical evidence evaluating whether these drugs have different toxicity or efficacy in the elderly. To evaluate this issue, we will assemble raw data from clinical trials from patients with rheumatoid arthritis in which second line drugs including injectable gold, auranofin, penicillamine, antimalarials, sulfasalazine, and methotrexate have been used. The project will be divided into several stages. These will include identifying the trials, obtaining trial data, analyzing data from each data set to confirm reported trial results, merging data sets, studying efficacy across trials and studying toxicity across trials. Many investigators who hold data from large clinical trails have already agreed to participate. Efficacy analysis will focus on whether older subjects differ from younger subjects with respect to drug efficacy. We will also look at whether the dose required for response is different in elderly patients. The toxicity analysis will focus on whether elderly subjects have different toxicity rates than younger subjects both with respect to overall toxicity causing withdrawal to the drugs and organ specific toxicity. We hope that ultimately this project will suggest guidelines about using these popular drugs for older rheumatoid arthritis patients.
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| Chernoff, M C; Wang, M; Anderson, J J et al. (1995) Problems and suggested solutions in creating an archive of clinical trials data to permit later meta-analysis: an example of methotrexate trials in rheumatoid arthritis. Control Clin Trials 16:342-55 |
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| Anderson, J J; Chernoff, M C (1993) Sensitivity to change of rheumatoid arthritis clinical trial outcome measures. J Rheumatol 20:535-7 |
