EVERY-OTHER-WEEK METHOTREXATE IN PATIENTS WITH RHEUMATOID-ARTHRITIS -A DOUBLE-BLIND, PLACEBO-CONTROLLED PROSPECTIVE-STUDY

Objective. To determine if patients with rheumatoid arthritis (RA) tha t is stable with weekly methotrexate (MTX) therapy could be switched t o an every-other-week regimen of MTX, Methods. Forty-seven patients wi th classic or definite RA who had received MTX for at least 8 months w ere studied, Clinical measurements consisted of the number of tender a nd swollen joints, physician and patient global evaluation of disease activity on a 5-point scale, grip strength, patient evaluation of pain , morning stiffness, and the interval to onset of fatigue from time of awakening, Laboratory measures included the erythrocyte sedimentation sate (ESR), rheumatoid factor, C-reactive protein (CRP), and baseline serum folate levels, Uptake of MTX was measured with tritiated thymid ine from peripheral blood mononuclear cells (PBMC) from patients ex vi vo. Serum measures of interleukin-1 beta (IL-1 beta), IL-6, and tumor necrosis factor alpha (TNF alpha) were performed in sera, and TNF alph a was also measured on PBMC supernatants, Results, Twelve of the 23 pa tients receiving every-other-week MTX (52%) were able to complete 6 mo nths of this treatment without experiencing a disease flare, Eleven of the 23 patients receiving every-other-week MTX (48%) withdrew from th e study before completing 6 months of treatment, because of a hare, No significant differences in clinical or laboratory parameters were see n when the 24 patients receiving weekly MTX were compared with the 12 patients in the every-other-week MTX group who successfully completed 6 months of the study, None of the changes in serum cytokine levels we re significantly different between the patients receiving MTX weekly v ersus those receiving it every other week, and changes in ESR and CRP did not differ between groups, Age, sex, RA disease duration, MTX week ly dose or duration, baseline joint counts, or serum folate status did not predict a flare, Tritiated MTX uptake did not differ between grou ps, Conclusion. Some patients with RA that is stable on weekly dosing are able to change to every-other-week dosing without experiencing a f lare in their disease activity.