To obtain preliminary evidence on the safety and efficacy of low dose hydroxyurea as a treatment for rheumatoid arthritis (RA).
Five patients with active RA unresponsive to conventional therapy were entered into a 12 week, open label trial of hydroxyurea followed by a one month postdrug evaluation.
Three of the 4 patients completing the study had a decrease in morning stiffness and number of swollen and tender joints. All 4 patients had a decrease in pain and an increase in function as measured by a modified health assessment questionnaire. No patient had improvement in sedimentation rate, C-reactive protein, or subjective measures of global well being. However, 3 of the 4 patients had disease flare after the drug was withdrawn, demonstrated by increased number of swollen and tender joints.
Low dose hydroxyurea may be effective in the treatment of RA, but confirmation will require further testing by a randomized double blind placebo controlled trial of patients with a broader spectrum of disease severity over a longer period of therapeutic intervention.