Abstract
Introduction
Baricitinib is an oral, selective inhibitor of Janus kinase which demonstrates clinical efficacy in patients with rheumatoid arthritis (RA). This report aims to analyze the onset time of baricitinib in Chinese patients with moderately to severely active RA who had an inadequate response to methotrexate.
Methods
This post hoc analysis evaluated clinical improvements of Chinese patients treated with baricitinib 4 mg once daily compared with placebo, based on data from a phase 3 study RA-BALANCE. Efficacy measures including American College of Rheumatology 20% (ACR20) response, ACR core set values, Disease Activity Score modified to include the 28 diarthrodial joint count (DAS28) using high-sensitivity C-reactive protein (hsCRP), DAS28-erythrocyte sedimentation rate, Simplified Disease Activity Index, Clinical Disease Activity Index, DAS28-hsCRP ≤ 3.2 response (low disease activity), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated at weeks 1, 2, 4, 8, 12, 14, 16, 20, and 24 (except for FACIT-F evaluated every 4 weeks). A logistic regression model and an analysis of covariance model were used to analyze treatment comparisons of categorical and continuous measures, respectively.
Results
Statistically significant (p ≤ 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures. For other outcomes including 66 swollen joint count, 68 tender joint count, FACIT-F, and DAS28-hsCRP ≤ 3.2 response rate, differences were evident (p ≤ 0.05) by week 4 in the baricitinib group compared with placebo. Significant improvements in all efficacy measures were sustained through 24 weeks.
Conclusions
Baricitinib demonstrated a rapid onset of efficacy on ACR20 response, ACR core set values, disease activity, and patient-reported outcome improvements in Chinese patients from RA-BALANCE.
Trial Registration
ClinicalTrials.gov identifier, NCT02265705.
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Acknowledgements
We thank the participants of the study.
Funding
Sponsorship for this study and Rapid Service Fee were funded by Eli Lilly and Company.
Additional Assistance
This study was supported by Eli Lilly and Company, who was responsible for designing, conducting and monitoring the study, and for verification and analysis of the data. The authors would like to thank Bin Zhang of Eli Lilly and Company for statistical review, and Yu Mao of Icon Clinical Research (Beijing No.2) Co., Ltd for quality review of the paper.
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Disclosures
The authors Chun-De Bao and Guo-Chun Wang have served as advisory board members for baricitinib and have received consulting and/or speaking fees from Eli Lilly and Company. Fei Ji is a full-time employee of Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China and own stock in Eli Lilly and Company. Meng-Ru Liu and Chen-Ge Li are full-time employees of Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China. All other authors have no affiliations with or involvement in any organization or entity with any financial interest, or nonfinancial interest in the subject matter or materials discussed in this manuscript.
Compliance with Ethics Guidelines
This study complied with the 1964 Declaration of Helsinki and its later amendments, and ethics committee approval was obtained from each study center. Each enrolled patient provided written informed consent.
Data Availability
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Li, ZG., Hu, JK., Li, XP. et al. Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE. Adv Ther 38, 772–781 (2021). https://doi.org/10.1007/s12325-020-01572-y
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DOI: https://doi.org/10.1007/s12325-020-01572-y