FRI0167 DOES BARICITINIB HAVE A SPECIFIC EFFECT PATIENT'S REPORTED OUTCOME? ∼ COMPARISON OF EFFECTS ON PAIN AND PATIENT GLOBAL ASSESSMENT WITH TNF INHIBITORS ∼

Abstract

Background: 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 and has shown good efficacy in RA and an adequate response to conventional synthetic DMARDs in some clinical trials. Pain and patient global assessment (PGA) are common symptoms for patients with RA. Some trials suggest that bari may have a supplementary benefit on patients' reported outcomes (PRO). Our goal was to determine the impact of each treatment on pain and PGA. Objectives: We evaluated and compared the impact of bari and TNF inhibitors (TNFi) on pain and PGA and correlation with PRO and clinical assessments for Japanese RA patients who have an inadequate response to csDMARDs in real world multicenter clinical data. Methods: We included 60 Japanese RA patients with an inadequate response to csDMARDs. We classified patients into two groups, one treated with bari (B group; 24 females and 8 males) and the other with TNFi (TNFi group; 22 females and 6 males). Patients were scheduled to receive TNFi (GLM 50 mg/month or ETN 50 mg/week) in TNFi group or bari 4 or 2 mg/day in B group as a monotherapy or in combination with csDMARDs. We evaluated swollen joint counts on 28 joints (SJC), tender joint counts on 28 joints (TJC), visual analog scale of pain (VAS pain) (0-100 mm), PGA (0-100 mm), and Clinical Disease Activity Index (CDAI) at baseline, 4 weeks, and 12 weeks. First, we compared the changes in SJC, TJC, CDAI, VAS pain, and PGA at 4 and 12 weeks after treatments between the two groups. Second, we evaluated the correlation between PROs (VAS pain or PGA) and variations in clinical evaluation items (SJC, TJC, and CDAI). Results: There were no significant differences in background at baseline between the two groups (Table 1). Baseline SJC, TJC, and CDAI scores VAS pain; and PGA were 6.67 ± 3.81, 7.93 ± 3.69, 26.35 ± 8.77, 61.2 ± 21.8, and 62.2 ± 18.4 in the bari group, respectively, and 6.13 ± 3.21, 7.27 ± 3.56, 24.65 ± 9.72, 63.9 ± 22.7, and 64.2 ± 18.4 in the TNFi group, respectively. SLC, TJC, CDAI scores, VAS pain, and PGA in both groups were significantly improved 1 month after treatment. This tendency continued for 3 months after treatment. There were no significant differences in the improvement rate of SJC, TJC, CDAI scores, VAS pain, and PGA between the two groups at each follow-up time point after treatment. VAS pain scores were significantly correlated with SJC and CDAI scores in both groups (B group; r = 0.651, p