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]
Summary
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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