RECOMMENDATIONS FOR THE REGISTRATION OF DRUGS USED IN THE TREATMENT OF RHEUMATOID-ARTHRITIS

Rheumatoid arthritis (RA) is the commonest form of chronic inflammator y joint disease and a major target for symptom-modifying and disease-m odifying drug therapy. New approaches to the treatment of RA using bio logical agents targeted to cellular receptors, cytokines and other med iators of inflammation, together with the availability of new methods of outcome assessment, make it timely to reconsider the classification of anti-rheumatic drugs and the requirements for the registration of new drug entities. Under the auspices of GREES (Group for the Respect of Ethics and Excellence in Science), a European Working Group of clin icians with experience in rheumatology, scientists and representatives from industry and national drug licensing authorities have formulated recommendations for the requirements for registration of anti-rheumat ic drugs designed for symptom modification, structural modification an d the suppression of inflammation, with particular emphasis placed on quality of life assessment by generic and disease-specific validated m ethods. This paper outlines the group's advice for pre clinical testin g, and Phase I, Phase II and Phase III trials to allow licences to be granted for each indication, while recognizing that a single drug may have reason to be approved under several headings.