抄録
Objective: It is known that tacrolimus is effective in patients with rheumatoid arthritis (RA) that is poorly controlled by methotrexate (MTX) . However, there is no clear evidence as to whether tacrolimus when combined with MTX is more effective than tacrolimus alone. We studied retrospectively the efficacy of tacrolimus alone and in combination with MTX in an attempt to determine when therapy with tacrolimus should be changed because of lack of efficacy.
Methods: Seventy three RA patients treated with tacrolimus were analyzed retrospectively; 37 of 73 patients had received MTX concomitantly. Disease activity and clinical response were assessed by disease activity score 28/C-reactive protein (DAS28-CRP) and EULAR response criteria, respectively. The ratios of DAS28-CRP remission at 1, 3, 6, and 12 months from administration of tacrolimus were examined. Furthermore, the clinical response and CRP levels at 1 and 3 months were evaluated for prediction of remission at 12 months. We assessed CRP by calculating the ratio of the CRP level at the evaluation point to that at administration.
Results: At 12 months, DAS28-CRP remission was observed in 29.4% of patients in the MTX group and in 19.4% of the non-MTX group. In patients with high disease activity, no patients achieved remission at 1 month; however, at 3 months 19.2% of patients in the MTX group and 0% of the non-MTX group were in remission, and at 12 months, the results were 30.8% for the MTX group and 14.3% for the non-MTX group. Patients who had achieved moderate or good responses at 3 months made up 88.9% of patients in remission at 12 months and 42.9% of patients not in remission at 12 months. The CRP ratio at 3 months was 0.36 in patients in remission at 12 months and 0.86 in patients not in remission at 12 months. Patients whose CRP ratio at 3 months was less than 0.4 were significantly more likely to achieve remission at 12 months than those with a CRP ratio greater than 0.4 (odds ratio 23.1, p<0.0001) .
Conclusion: These data suggest that tacrolimus therapy combined with MTX is more effective than tacrolimus therapy alone, and that alternative treatment should be considered when the CRP ratio is greater than 0.4 at 3 months.
