Abstract
Background and Objective: Therapeutic effects of methotrexate (MTX) and azathioprine (AZA) in rheumatoid arthritis (RA) patients have been compared in a few double blind studies and there is only one in study Iran which showed different results. We conducted a double – blind, clinical trial.
Materials and Methods: From Jun 2003 to Jul 2004, 76 patient with active RA were entered into a 24-week, prospective, double – blind, clinical trial and were randomly assigned to two treatment groups (41 in MTX and 35 in AZA). In the course of study patients received MTX 7.5 mg weekly or AZA 100 mg daily. All patients were evaluated for clinical (tender and swollen joint counts, Ritchie arthicular index, duration of morning stiffness, pain score (VAS), grip test and laboratory variables (Hemoglobin, platelet, WBC, ESR, CRP, RF) at the beginning of study and every 8 weeks thereafter.
Results: sixty nine Patients completed the trial. There were no statistically significant differences among the treatment groups in the time of onset of response, clinical improvement, overall physician assessment and laboratory variables at 8th and 24th weeks except higher decrease in RF titer in MTX group.
Adverse drug reactions were slightly more common in AZA group and withdrawals because of side effects was 2 in AZA because of neutropenia and 1 in MTX because of elevation of SGPT.
Conclusion: No significant difference in the therapeutic results of AZA and MTX on RA patients was noted. but adverse events were higher in AZA group.