Initially they responded that “we are not interested in supporting studies of MTX in rheumatoid arthritis but would keep the protocol on file.” Approximately 6 months later I was called by the clinical development team at Lederle to attend a meeting in Pearl River, New York to discuss MTX in RA. In 1982, I submitted a 35-patient double-blind crossover study to Lederle Laboratories, the manufacturer of MTX, for support of this study. I was influenced by the reports from Hoffmeister and Willkens and my own experience with MTX in psoriatic arthritis. Upon completion of my fellowship in 1980, I became interested in studying MTX as a treatment for RA. New drug development for RA was essentially non-existent with the only drug under development being oral gold (auranofin), which proved to have limited efficacy and gastrointestinal intolerance. The therapeutic landscape was bleak with failures using total nodal radiation and plasmapheresis. Treatment regimens also included joint injections, short-term hospitalization, physical therapy, and joint replacement surgery. During my fellowship training (1978 to 1980) the pyramid approach to treatment was used, which included high dose aspirin, the newer non-steroidal anti-inflammatory drug such as ibuprofen, corticosteroids, and slow-acting anti-rheumatic therapy, i.e., gold salts, hydroxychloroquine, d-penicillamine, and immuno-suppressive drugs, including azathioprine and cyclophosphamide. That was the landscape of RA in the 1980s. For rheumatologists who have recently completed training, one could not imagine the clinical picture 40 years ago in which many of our patients were disabled, unable to work, in wheel chairs, and had significant pain and deformity.
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