FRI0135 PREDICTORS FOR SHORT-TERM CLINICAL EFFECTIVENESS OF BARICITINIB IN RHEUMATOID ARTHRITIS PATIENTS IN ROUTINE CLINICAL PRACTICE: DATA FROM A JAPANESE MULTICENTER REGISTRY

Abstract

Background:Baricitinib is considered as a specific JAK1/2 inhibitor. While a number of randomized controlled trials have reported on the clinical efficacy and safety profile of baricitinib in rheumatoid arthritis (RA) patients, clinical data for RA patients in routine clinical practice are scarce.Objectives:This study aimed to evaluate the short-term effectiveness and safety profiles of baricitinib and explore factors associated with improved short-term effectiveness in patients with RA in clinical settings.Methods:A total of 113 consecutive RA patients who had been treated with baricitinib were registered in the TBCR, a Japanese multicenter registry for RA patients treated with biologics or JAK inhibitors (targeted DMARDs) [3], and followed for at least 24 weeks. Univariate and multivariate logistic regression analysis was used to study predictive factors for achievement of low disease activity (LDA) at 24 weeks.Results:Mean age was 66.1 years, mean RA disease duration was 14.0 years, 71.1% had a history of use targeted DMARDs, and 48.3% and 40.0% were receiving concomitant methotrexate (MTX) and oral prednisone, respectively. Mean DAS28-CRP significantly decreased from 3.55 at baseline to 2.32 at 24 weeks (Figure 1A). At 24 weeks, 68.2% and 64.1% of patients achieved LDA and moderate or good response, respectively (Figure 1B). Multivariate logistic regression analysis revealed that no previous targeted DMARD use and lower DAS28-CRP score at baseline were independently associated with achievement of LDA at 24 weeks (Table). While the percent change in DAS28-CRP was similar regardless of whether patients used concomitant MTX (Figure 2A), patietns with previous use of targeted DMARDs (Switch group) showed lower percent improvement in DAS28-CRP compared to targeted DMARDs-naïve patients (Naïve group) (Figure 2B). The overall retention rate for baricitinib was 86.5% at 24 weeks, as estimated by Kaplan-Meier analysis. The discontinuation rate due to adverse events was 6.5% at 24 weeks. In the present study cohort, seven patients developed herpes zoster, with an incidence rate of 8.4 per 100 patient-years. All seven patients were treated with antiviral agents for herpes zoster and restarted baricitinib treatment.TableUnivariateMultivariatevariablesOR (95%CI)p-valueadjusted OR (95%CI)p-valueMale1.17 (0.43-3.16)0.755Age, <65 years1.46 (0.62-3.44)0.388Disease duration, <10 years1.41 (0.61-3.23)0.419ACPA positive1.56 (0.51-4.80)0.433no previous biological DMARDs4.67 (1.49-14.66)0.00833.4 (2.53-442.62)0.008concomitant MTX0.860 (0.40-2.02)0.789concomitant PSL0.24 (0.10-0.56)0.001DAS28-CRP@baseline0.55 (0.38-0.80)0.0020.28 (0.13-0.62)0.002mHAQ@baseline0.27 (0.09-0.77)0.015Bold italic, p<0.05Conclusion:In this study, we demonstrated the short-term clinical effectiveness and safety profile of baricitinib in Japanese RA patients in the ‘real-world’ setting. To the best of our knowledge, this study is the first to report the clinical outcomes of baricitinib in routine clinical practice in Japan. Baricitinib significantly improved disease activity, with an expected safety profile. We observed some interesting features regarding the effectiveness of baricitinib. Baricitinib was significantly more effective when used as a first-line targeted DMARD and may play a key role in the modern treatment strategy for RA, although careful observation is necessary for possible complications and AEs including herpes zoster.