SAT0147 EFFICACY AND SAFETY OF IGURATIMOD AS FIRST-LINE DISEASE-MODIFYING ANTIRHEUMATIC DRUG THERAPY FOR PATIENTS WITH RHEUMATOID ARTHRITIS
Authors: D. Kobayashi, E. Hasegawa, Y. Wada, S. Ito, A. Abe, K. Nakazono, A. Murasawa, I. Narita, H. Ishikawa
Journal: Annals of the Rheumatic Diseases (2020)

Background: Although methotrexate is the anchor drug, it took some days to check contraindications, such as interstitial pneumonia, hepatitis B virus infection, and latent tuberculosis infection. Therefore, we sometimes start rheumatoid arthritis (RA) treatment with other disease-modifying antirheumatic drug (DMARD) in daily clinical setting. Iguratimod (IGU) is a newly developed DMARD approved in Japan in September 2012, and the efficacy of IGU for DMARD naïve patients has not been thoroughly evaluated. Objectives: The aim of this prospective single-center study was to demonstrate the efficacy and safety of IGU when used as a first-line daily DMARD for patients with RA in a clinical setting. Methods: Enrolled patients included those diagnosed with RA according to the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) classification criteria who took IGU as a first-line DMARD at Niigata Rheumatic Center between April 2016 and December 2018 (IGU group). There were no constraints regarding the addition or withdrawal of other DMARDs. Details of the patients’ background, clinical parameters, and laboratory findings were obtained, including C-reactive protein (CRP) level, erythrocyte sedimentation rate (ESR), matrix metalloprotease-3 (MMP-3), rheumatoid factor (RF), Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]), Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire Disability Index (HAQ-DI). The efficacy of IGU was evaluated at week 24. The IGU group’s data were then compared with 64 patients who took salazosulfapyridine or bucillamine as first-line DMARD in our hospital (other DMARD group). The data were expressed as median values. Comparisons between the parameters were performed using nonparametric method. Results: Forty-three patients (15 males, 28 females) received IGU as a first-line DMARD for RA. The age was 69.0 years and the duration of disease was 2.0 months. Twenty patients received prednisolone (PSL) concomitantly at a median dose of 5.0 mg/day. At 24 weeks medications were utilized in patients as follows: IGU in 36 (83.7 %), methotrexate in 18 (41.2%), PSL in 17 (39.5%), BUC in 10 (23.2 %), and biological DMARD in 7 (15.2 %) patients. Although 7 patients discontinued taking IGU due to liver enzyme elevation (n=4), nausea (n=1), creatinine elevation (n=1), and skin rash (n=1) during the 24-week period, serious adverse events requiring hospitalization were not observed. Clinical parameters that improved from baseline after 24 weeks of treatment included: ESR from 42.0 mm/h to 16.0 mm/h with p &lt; 0.001; CRP from 0.70 mg/dL to 0.10 mg/dL with p&lt; 0.001; MMP-3 from 136 ng/mL to 91.5 ng/mL with a p value of 0.11; RF went from 18.0 IU/mL to 8.00 IU/mL with p &lt; 0.001; DAS28(4)-ESR dropped from 5.13 to 2.73 with p&lt; 0.001; CDAI dropped from 20.0 to 5.00 with p&lt; 0.001, and HAQ-DI decreased from 0.55 to 0.00 with p&lt; 0.001. Patients who achieved a good or moderate response based on EULAR response at 24 weeks, included 90.7% in the IGU group versus 70.5% in the other DMARD group (Fisher`s exact test, p=0.046). The retention rate of the IGU group was 81.4 %, roughly equivalent to the 81.2% retention rate in the other DMARD group (Log-rank test, p=0.733). Conclusion: Our study indicates IGU is safe and effective for DMARD naïve RA patients. Starting treatment with IGU might be a new and effective strategy for RA patients without previous use of a DMARD. Disclosure of Interests: Daisuke Kobayashi: None declared, Eriko Hasegawa: None declared, Yoko Wada: None declared, Satoshi Ito Speakers bureau: Abbvie,Eisai, Asami Abe: None declared, Kiyoshi Nakazono: None declared, Akira Murasawa: None declared, Ichiei Narita: None declared, Hajime Ishikawa: None declared