2016 年 35 巻 4 号 p. 465-473
Objective: Iguratimod (IGU) was newly approved in Japan in 2012. In this retrospective study, we have investigated the efficacy and safety of IGU in patients with rheumatoid arthritis (RA).
Methods: One hundred thirty nine patients were treated with IGU at our institution during the period of 2012-2014. Among those patients, 109 who were able to continue using IGU for over 12 months were divided into three groups. M−: 44 patients who started IGU due to intolerance to methotrexate (MTX), M+: 25 patients in whom IGU was added because treatment with MTX was unable to control the disease, and B+: 40 patients in whom IGU was added because treatment with biological agents was unable to control the disease. The results were assessed by disease activity index, inflammatory reaction, and autoantibody values.
Results: Adverse reactions including exanthema and abdominal pain were observed in 25 patients (18.9%). Nine patients who experienced adverse reactions such as liver damage were able to continue the treatments by reducing the amount of IGU to 25 mg/day. DAS28-ESR (4) showed a significant improvement, on average from 5.03 at baseline, to 3.62 at six months. C-reactive protein levels decreased from on average from 2.4 mg/dl to 1.0 mg/dl, respectively. This trend continued for 30 months and was maintained. Matrix metalloproteinase-3 and rheumatoid factor (RF) IgM values also showed significant decreases. At one year, there were obvious improvement rates in the DAS, which was observed in M−, B+and M+groups, respectively. Patients with high RF values showed clearer improvements than those with lower values.
Conclusions: Though there is significant value of using methotrexate and biological agents in the treatment of RA, some patients have to discontinue such drugs due to intolerance, lack of efficacy, and adverse reactions. Under these circumstances, IGU should be considered as an additonal treatment option.
