Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disease where the current focus of drug development efforts is devoted to specific blockade of certain cytokine activities. It is therefore highly likely that IB monitoring will play an important role in RA disease prognosis and drug development programs. A brief review of the cytokine blockade strategies for RA starts with the inflammatory cytokine TNFa, a major therapeutic advancement in the treatment of RA 9 . There are now several TNFa biological...

Role Of Biomarkers In Phase Iii And Postmarketing Decisions

Traditional clinical trial endpoints, such as morbidity and mortality, often require extended time frames and may be difficult to evaluate. Fully validated surrogate markers can be used as primary endpoints for pivotal phase IIb and III safety and efficacy trials. Lowering blood pressure and lowering LDL cholesterol are both examples of surrogate biomarker endpoints upon which several drugs have been approved, because it has been demonstrated that effects on these markers directly affect...

Hiv

Rheumatoid arthritis Lipid metabolism Nucleotide metabolism Oxidative stress (diabetes, heart disease, arthritis, obesity, and cancer) Type 1 and 2 diabetes weight of evidence that demonstrates that changes in the biomarker correlate strongly with the desired clinical outcome. The best known physiologic surrogate marker is blood pressure reduction as an indicator of reduced incidence of stroke and myocardial infarction. This surrogate marker is now used as a clinical endpoint, because a strong...

References

Pharmacogenomics and its role in drug safety. FDA Drug Saf Newsl, 1 2 . 2. Nowell PC, Hungerford DAA 1960 . Chromosome studies on normal and leukemic leukocytes. J Nat Cancer Inst, 25 85-109. 3. Rowley JD 1973 . A new consistent chromosomal abnormality in chronic myelogenous leukemia identified by quinacrine fluorescence and Giemsa staining. Nature, 243 290-293. 4. Daley GQ, Van Etten RA , Baltimore D 1990 . Induction of chronic myelogenous leukemia in mice by the P210bcr abl gene...