Pjsm. Kerstens et al., Radiological and clinical results of longterm treatment of rheumatoid arthritis with methotrexate and azathioprine, J RHEUMATOL, 27(5), 2000, pp. 1148-1155
Objective. To study whether the reported superior effect of methotrexate (M
TX) compared to azathioprine (AZA) in retarding radiologic progression afte
r one year in rheumatoid arthritis was sustained at 2 and 4 years.
Methods. All 64 patients enrolled in the original randomized double blind s
tudy were invited for an open extension of followup to 4 years including 4-
monthly clinical and laboratory assessments and radiographs of hands, wrist
s, 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 verse (n = 5), I
n an intention-to-treat analysis improvement of clinical and laboratory var
iables at 4 years was more pronounced in the MTX group. Mean radiologic sco
res increased in both treatment groups during followup, According to an int
ention-to-treat analysis increase in erosion score at one and 2 years in th
e MTX group was significantly lower than in the AZA group. after one year M
TX 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 3 years there was a trend toward less progressio
n 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 year
s 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 MT
X on radiologic progression compared with AZA was sustained after 2 years o
f followup. Thereafter differences between treatment groups leveled off, pr
obably mainly due to the greater number of switches from AZA to MTX than vi
ce versa.