The effect of mizoribine on rheumatoid arthritis / 대한내과학회지

ABSTRACT

BACKGROUND: This retrospective study was performed to investigate the clinical effects of mizoribine with using methotrexate (MTX) or mizoribine alone on those patients with rheumatoid arthritis (RA) who showed an ineffective response or intolerance to the MTX. METHODS: The patients were divided into two groups (1) combination therapy of mizoribine with MTX and (2) mizoribine alone. All the patients took 100 mg mizoribine daily for at least 16 weeks. Before and after administration of mizoribine for 16 weeks, we assessed the clinical variables such as the visual analogue pain scale (VAS), the tender joint counts (TJC), and the swollen joint counts (SJC). At each time, the laboratory parameters including the ESR, CRP, complete blood count (CBC), liver enzymes and creatinine were also measured. Disease activity scores (by the DAS28) and the adverse effects were determined at baseline and after 16 weeks. RESULTS: Fifty patients were recruited in this study (mizoribine plus MTX group n=35, mizoribine group n=15). There were no significant differences in the initial laboratory values between the two treatment groups. After treatment for 16 weeks, the DAS28 was decreased significantly in the mizoribine plus MTX group (4.7+/-1.14 vs. 3.9+/-0.97, respectively, p<0.05). Yet the mizoribine alone group did not showed any significant change of the DAS28 (4.3+/-0.56 vs. 3.9+/-0.37, respectively, p=0.076). Mild gastrointestinal disturbance was the most common adverse effect. The incidence of adverse effects was similar in both treatment groups (20% vs. 27%, respectively). CONCLUSIONS: Mizoribine in combination with MTX was effective for RA patients who showed an ineffective response or intolerance to MTX. Furthermore, this treatment can be considered to be relatively safe.