Abstract

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 rheumatoid arthritis (RA) in clinical settings. A total of 113 consecutive RA patients who had been treated with baricitinib were registered in a Japanese multicenter registry and followed for at least 24 weeks. Mean age was 66.1 years, mean RA disease duration was 14.0 years, 71.1% had a history of use of biologics or JAK inhibitors (targeted DMARDs), and 48.3% and 40.0% were receiving concomitant methotrexate and oral prednisone, respectively. Mean DAS28-CRP significantly decreased from 3.55 at baseline to 2.32 at 24 weeks. At 24 weeks, 68.2% and 64.1% of patients achieved low disease activity (LDA) and moderate or good response, respectively. 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. While the effectiveness of baricitinib was similar regardless of whether patients had a history of only one or multiple targeted DMARDs use, patients with previous use of non-TNF inhibitors or JAK inhibitors showed lower rates of improvement in DAS28-CRP. 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. Baricitinib significantly improved RA disease activity in clinical practice. Baricitinib was significantly more effective when used as a first-line targeted DMARDs.

Highlights

  • 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 rheumatoid arthritis (RA) in clinical settings

  • While some multi-national randomized controlled trials (RCTs) have examined the clinical outcomes of Japanese patients with RA who were treated with ­baricitinib[13,14,15], clinical data for Japanese RA patients in routine clinical practice are scarce

  • We examined changes in lymphocyte count, which has been shown to decrease by treatment with tofacitinib, another Janus kinase (JAK) ­inhibitor[19], changes in hemoglobin levels, which is expected to decrease via inhibition of erythropoietin s­ ignaling[6], and the incidence of herpes zoster, as treatment with JAK inhibitors including baricitinib has been reported to increase the risk of herpes zoster in a Japanese sub-population[13]

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Summary

Introduction

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 rheumatoid arthritis (RA) in clinical settings. 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. While the effectiveness of baricitinib was similar regardless of whether patients had a history of only one or multiple targeted DMARDs use, patients with previous use of non-TNF inhibitors or JAK inhibitors showed lower rates of improvement in DAS28-CRP. Baricitinib significantly improved RA disease activity in clinical practice. Baricitinib was significantly more effective when used as a first-line targeted DMARDs. Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease characterized by persistent synovitis and joint destruction. Baricitinib had a significantly superior ACR20 response rate at 12 weeks compared to adalimumab, an anti-TNF agent, in RA patients who showed inadequate response to ­MTX12. While some multi-national RCTs have examined the clinical outcomes of Japanese patients with RA who were treated with ­baricitinib[13,14,15], clinical data for Japanese RA patients in routine clinical practice are scarce

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