Baricitinib in patients with rheumatoid arthritis with inadequate response to methotrexate: results from a phase 3 study

This study evaluated the efficacy and safety of baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, in patients with moderately to severely active rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX) therapy. In this phase 3, double-blind, 52-week, placebo-controlled study, 2...

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Published in:Clinical and experimental rheumatology 2020-07, Vol.38 (4), p.732-741
Main Authors: Li, Zhanguo, Hu, Jiankang, Bao, Chunde, Li, Xingfu, Li, Xiangpei, Xu, Jianhua, Spindler, Alberto J, Zhang, Xiao, Xu, Jian, He, Dongyi, Li, Zhijun, Wang, Guochun, Yang, Yue, Wu, Hanjun, Ji, Fei, Tao, Haoxun, Zhan, Lujing, Bai, Fan, Rooney, Terence P, Zerbini, Cristiano A F
Format: Article
Language:English
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Summary:This study evaluated the efficacy and safety of baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, in patients with moderately to severely active rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX) therapy. In this phase 3, double-blind, 52-week, placebo-controlled study, 290 patients with moderately to severely active RA and inadequate response to MTX were randomly assigned 1:1 to placebo or baricitinib 4-mg once daily, stratified by country (China, Brazil, Argentina) and presence of joint erosions. Primary endpoint measures included American College of Rheumatology 20% response (ACR20) at week 12. Secondary endpoints included changes in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Disease Activity Score for 28-joint counts (DAS28)-high-sensitivity C-reactive protein (hsCRP), Simplified Disease Activity Index (SDAI) score ≤3.3, mean duration of morning joint stiffness, severity of morning joint stiffness numeric rating scale (NRS 0-10), worst tiredness NRS, and worst joint pain NRS at week 12. Most patients (approximately 80%) were from China. More patients achieved ACR20 response at week 12 with baricitinib than with placebo (58.6% vs. 28.3%; p
ISSN:0392-856X
1593-098X