Abstract
IntroductionBaricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2, which has demonstrated significant efficacy in patients with moderately to severely active rheumatoid arthritis (RA). This analysis aims to describe the efficacy and safety of baricitinib in Chinese RA patients with an inadequate response to methotrexate (MTX-IR), and to analyze the effects of baseline characteristics on the efficacy of baricitinib treatment.MethodsIn this 52-week, randomized, double-blind, placebo-controlled study, 231 Chinese patients with moderately to severely active RA who had MTX-IR were randomly assigned to placebo (n = 115) or baricitinib 4 mg once daily (n = 116). The primary endpoint was American College of Rheumatology 20% (ACR20) response at week 12. Other efficacy measures included ACR50, ACR70, Physician’s Global Assessment of Disease Activity, Patient’s Global Assessment of Disease Activity, patient’s assessment of pain, Disease Activity Score in 28 joints using high-sensitivity C-reactive protein, remission and low disease activity rates according to Simplified Disease Activity Index or Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, and mean duration and severity of morning joint stiffness, worst tiredness and worst joint pain were analyzed. Additionally, subgroup analyses were performed across baseline characteristics.ResultsStatistically significant improvement in ACR20 response was achieved with baricitinib at week 12 (53.4 vs. 22.6%, p = 0.001) in Chinese patients, compared to placebo. Most of the secondary objectives were met with statistically significant improvements. Efficacy of baricitinib was irrespective of patient demographics and baseline characteristics. Safety events were similar between the baricitinib and placebo groups.ConclusionsThe efficacy of baricitinib 4 mg in Chinese patients with moderately to severely active RA and prior MTX-IR was clinically significant compared to placebo regardless of baseline characteristics. Baricitinib was well tolerated with an acceptable safety profile during the full study period.Trial RegistrationNCT02265705Electronic Supplementary MaterialThe online version of this article (10.1007/s40744-020-00231-6) contains supplementary material, which is available to authorized users.
Highlights
Baricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2, which has demonstrated significant efficacy in patients with moderately to severely active rheumatoid arthritis (RA)
Statistically significant improvement in American College of Rheumatology 20% (ACR20) response was achieved with baricitinib at week 12 (53.4 vs. 22.6%, p = 0.001) in Chinese patients, compared to placebo
Patients were eligible for participation if they were adults with a diagnosis of adult-onset Rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 Criteria for Classification of Rheumatoid Arthritis [21], had at least six tender joints and six swollen joints, had an hsCRP measurement C 6 mg/l and had received at least 12 weeks of MTX therapy before study entry with 8 weeks on a stable dose (7.5 to 25 mg/week)
Summary
Baricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2, which has demonstrated significant efficacy in patients with moderately to severely active rheumatoid arthritis (RA). The current goal of RA treatment is to achieve disease remission or low disease activity with the ultimate goal of controlling the disease, reducing the disability rate, and improving quality of life [6, 7]. Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), such as methotrexate (MTX), are generally used as first-line treatment in China due to their low costs and established efficacy. Available DMARDs (csDMARDs or bDMARDs) do not always prevent progressive joint damage nor do they always significantly improve quality of life [9]
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