Zhanguo Li1, Jiankang Hu2, Chunde Bao3, Xingfu Li4, Xiangpei Li5, Jianhua Xu6, Alberto J Spindler7, Xiao Zhang8, Jian Xu9, Dongyi He10, Zhijun Li11, Guochun Wang12, Yue Yang13, Hanjun Wu14, Fei Ji14, Haoxun Tao14, Lujing Zhan14, Fan Bai14, Terence P Rooney15, Cristiano A F Zerbini16. 1. Peking University People's Hospital, Beijing, China. li99@bjmu.edu.cn. 2. Jiangxi Pingxiang People's Hospital, Pingxiang, China. 3. Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China. 4. Qilu Hospital of Shandong University, Jinan, China. 5. Anhui Provincial Hospital, Hefei, China. 6. The First Affiliated Hospital of Anhui Medical University, Hefei, China. 7. Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Argentina. 8. Guangdong General Hospital, Guangzhou, China. 9. First Affiliated Hospital of Kunming Medical University, Kunming, China. 10. GuangHua Hospital, Shanghai, China. 11. Affiliated Hospital of Bengbu Medical College, Bengbu, China. 12. China-Japan Friendship Hospital, Beijing, China. 13. Peking University People's Hospital, Beijing, China. 14. Eli Lilly and Company, Shanghai, China. 15. Eli Lilly and Company, Indianapolis, USA. 16. CEPIC - Centro Paulista de Investigação Clinica e Serviços Médicos, Ipiranga São Paulo, Brazil.
Abstract
OBJECTIVES: 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. METHODS: 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. RESULTS: 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<0.001). Statistically significant improvements were also seen in HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain in the baricitinib group compared to placebo at week 12. Through week 24, rates of treatment-emergent adverse events, including infections, were higher for baricitinib compared to placebo, while serious adverse event rates were similar between baricitinib and placebo. CONCLUSIONS: In patients with RA who had an inadequate response to MTX, baricitinib was associated with significant clinical improvements as compared with placebo.
RCT Entities:
OBJECTIVES: 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. METHODS: 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 painNRS at week 12. RESULTS: 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<0.001). Statistically significant improvements were also seen in HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain in the baricitinib group compared to placebo at week 12. Through week 24, rates of treatment-emergent adverse events, including infections, were higher for baricitinib compared to placebo, while serious adverse event rates were similar between baricitinib and placebo. CONCLUSIONS: In patients with RA who had an inadequate response to MTX, baricitinib was associated with significant clinical improvements as compared with placebo.
Authors: Gonzalo Villapalos-García; Pablo Zubiaur; Rebeca Rivas-Durán; Pilar Campos-Norte; Cristina Arévalo-Román; Marta Fernández-Rico; Lucio García-Fraile Fraile; Paula Fernández-Campos; Paula Soria-Chacartegui; Sara Fernández de Córdoba-Oñate; Pablo Delgado-Wicke; Elena Fernández-Ruiz; Isidoro González-Álvaro; Jesús Sanz; Francisco Abad-Santos; Ignacio de Los Santos Journal: Life Sci Alliance Date: 2022-05-30
Authors: Lilla Tóth; Márk F Juhász; László Szabó; Alan Abada; Fruzsina Kiss; Péter Hegyi; Nelli Farkas; György Nagy; Zsuzsanna Helyes Journal: Int J Mol Sci Date: 2022-01-23 Impact factor: 5.923
Authors: Thomas Bieber; Eugen Feist; Alan D Irvine; Masayoshi Harigai; Ewa Haladyj; Susan Ball; Walter Deberdt; Maher Issa; Susanne Grond; Peter C Taylor Journal: Adv Ther Date: 2022-09-05 Impact factor: 4.070