THU0196 EFFICACY AND SAFETY UP TO 24 WEEKS OF BARICITINIB FOR JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL WORLD MULTICENTER CLINICAL DATA
Authors: Eiji Torikai, Daisuke Suzuki
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Baricitinib (bari) is approved for treating moderate–severe rheumatoid arthritis (RA) in many countries, including Japan. Bari is an oral Janus kinase (JAK1)/JAK2 selective inhibitor that has shown good efficacy in patients with RA and adequate response to conventional synthetic DMARDs in some clinical trials. However, there have been few reports about the efficacy and safety of bari in real-world clinical data. <h3>Objectives:</h3> We evaluated the efficacy and safety of bari for Japanese RA patients who have an inadequate response to DMARDs in real-world multicenter clinical data. <h3>Methods:</h3> We included 32 Japanese patients with RA who show an inadequate response to csDMARDs or bDMARDs (biologics-naïve (BN group): 19 cases and biologics-experience (BE group): 13 cases). Patients were scheduled to receive bari 4 or 2 mg once daily dose as a monotherapy or in combination with other csDMARDs. If the disease activity was not improved within 3 months in patients treated with bari 2 mg, the bari dose was increased to 4 mg. Patients were allowed to decrease their predonisolone treatment if their disease activity improved. First, we evaluated changes in the number of swollen joints and tender joints, CRP (mg/dL), visual analog scale of pain (0–100 mm), patient's global assessment (0–100 mm), Clinical Disease Activity Index, and HAQ-DI for 24 weeks. Second, we evaluated the proportion of patients with adverse events (AEs) and progress after these AEs. <h3>Results:</h3> Patients' backgrounds are provided Table 1. Many patients felt the early effect of bari. At 1 month after treatment, ACR20/50/70 were 84.2%/63.2%/21.1% in the BN group and 53.8%/23.1%/7.7% in the BE group, respectively. All measurement items of disease activity and patient-reported outcomes were significantly improved after treatment. This tendency continued until the final evaluation (Table 2). At 24 weeks, remission and low disease activity rates were 47.4% and 78.9% in the BN group and 15.4% and 61.5% in the BE group, respectively. One case in the BE group discontinued bari treatment due to no response. These data were better than clinical trial data (Japanese subpopulation data from RA-BEAM and RA-BUILD studies<sup>[1]</sup>). We determined that we could take an aggressive treatment course according to treat to target strategies in real-world clinics. Greater early improvements in HAQ-DI were seen. HAQ-DI was improved significantly at each evaluation time point after bari treatment (Table 2). We had two cases of mild pneumonia and one case of herpes zoster. These cases were improved after 1–2 weeks of antibiotic therapy or antiviral drug therapy. One case discontinued bari. Although the other two cases withdrew from bari treatment, we could restart it. We think that the most important reason why they did not advance in severe because we were able to diagnose and treat these cases earlier. No patient showed malignancies, cardiovascular events, or deep vein thrombosis. No patient discontinued bari treatment due to AEs. Also, increases in blood pressure and d-dimer were not observed during the follow-up period. Other mild AEs, including upper respiratory tract infection, nasopharyngitis, and laboratory data abnormalities occurred in 62.5% of patients (Table 3). A small increase in lymphocyte count and small decrease in neutrophil count were seen at 1 month after bari treatment. These either remained flat or improved 3 months after treatment. An increase from baseline in creatinine was also seen. These tendencies continued to the final observation. Moving forward, these items should be monitored for long-term evaluation. <h3>Conclusion:</h3> These data showed that bari has a favorable benefit–risk balance in a real-world clinic and thus may be considered as a good treatment option for Japanese RA patients who have an inadequate response to csDMARDs or bDMARDs. <h3>Reference:</h3> [1] Tanaka Y, et al. Mod Rheumatol2018;28:583-91 <h3>Disclosure of Interests:</h3> None declared