Clinical evaluation of novel anti-rheumatic drugs

New methodology is required to evaluate new drugs. Trials designs and measurements developed for conventional anti-inflammatory therapy will fail to demonstrate the properties of a group of novel anti-rheumatic agents including gold, penicillamine and levamisole. These compounds act slowly, producing their maximum effect after 6 months of treatment. Trials must therefore be of at least this duration and it is useful to document the time course of the action. Measurements of rheumatoid arthritis must include not only conventional indices of disease activity (pain, morning stiffness, articular index, swelling) but also extra-articular features such as nodules, E.S.R., and rheumatoid factor titre. Reduction in technetium index is a feature of the action of drugs of this type. Changes in immunoglobulins and in some other immunological measurements may also be useful. Future trials must look increasingly at modes of action of drugs and the factors which determine the presence or absence of a response in an individual patient.