Abstract | OBJECTIVE: METHODS: All 64 patients enrolled in the original randomized double blind study were invited for an open extension of followup to 4 years including 4-monthly clinical and laboratory assessments and radiographs of hands, wrists, and feet at 2 and 4 years. RESULTS: After 4 years, 18 patients (58%) from the MTX group and 7 patients (21%) from the AZA group continued the initial study drug. During followup more patients (n = 21) switched from AZA to MTX than vice versa (n = 5). In an intention-to-treat analysis improvement of clinical and laboratory variables at 4 years was more pronounced in the MTX group. Mean radiologic scores increased in both treatment groups during followup. According to an intention-to-treat analysis increase in erosion score at one and 2 years in the MTX group was significantly lower than in the AZA group: after one year MTX group 1.8 versus AZA group 5.3 (p = 0.002); after 2 years MTX 3.5 versus AZA 6.5 (p = 0.05). After 4 years there was a trend toward less progression in the MTX group: MTX 6.8 versus AZA 10.8 (p = 0.09). For the total score, progression in the MTX group was less after one and 2 years. After 4 years marked radiologic progression was observed more often in the AZA group. CONCLUSION: Drug continuation after 4 years of followup was better for MTX than for AZA. In an intention-to-treat analysis the beneficial effect of MTX on radiologic progression compared with AZA was sustained after 2 years of followup. Thereafter differences between treatment groups leveled off, probably mainly due to the greater number of switches from AZA to MTX than vice versa.
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Authors | P J Kerstens, A M Boerbooms, M E Jeurissen, R de Graaf, J Mulder, L B van de Putte |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 27
Issue 5
Pg. 1148-55
(May 2000)
ISSN: 0315-162X [Print] Canada |
PMID | 10813280
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Azathioprine
- Methotrexate
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Topics |
- Anti-Inflammatory Agents, Non-Steroidal
(adverse effects, therapeutic use)
- Arthritis, Rheumatoid
(diagnostic imaging, drug therapy, surgery)
- Azathioprine
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Follow-Up Studies
- Humans
- Male
- Methotrexate
(adverse effects, therapeutic use)
- Middle Aged
- Radiography
- Treatment Outcome
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