A multi-center, open-label, randomized study to explore efficacy and safety of baricitinib in active primary Sjogren’s syndrome patients

Trials

Study Protocol

Yi Zhao¹  Wei Bai²  Xiaofeng Zeng²  Xiaomei Leng²  Fan Yang²  Huji Xu³  Yan Zhang⁴  Xiaofei Shi⁵  Wei Wei⁶  Hongbin Li⁷  Liyun Zhang⁸ 

[1] Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China;Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College; National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Ministry of Science & Technology; State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital; Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, 100730, Beijing, China;Department of Rheumatology and Immunology, Changzheng Hospital, Naval Medical University, 200003, Shanghai, China;Department of Rheumatology and Immunology, Tangdu Hospital, Fourth Military Medical University (Air Force Medical University), Xi’an, Shaanxi, China;Department of Rheumatology and Immunology, The First Affiliated Hospital and College of Clinical Medicine, Henan University of Science and Technology, Luoyang, Henan, China;Department of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China;Department of Rheumatology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, China;Department of Rheumatology, Third Hospital of Shanxi Medical University, Bethune Hospital Shanxi Academy of Medical Sciences, Taiyuan, Shanxi, China;

关键词: Primary Sjogren’s syndrome;    JAK/STAT;    Baricitinib;    Hydroxychloroquine;    ESSDAI;   

DOI  :  10.1186/s13063-023-07087-5

 received in 2022-03-09, accepted in 2023-01-10,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPrimary Sjogren’s syndrome (pSS) is a systemic autoimmune disease involving multiple organ systems. The Janus kinase/signal transduction and activator of transcription (JAK/STAT) signaling pathway is a key pathway involving the pathogenesis of pSS. Baricitinib, a selective JAK1 and JAK2 inhibitor, has been approved for treatment of active rheumatoid arthritis and reported in treatment of some other autoimmune diseases including systemic lupus erythematosus. We have found that baricitinib might be effective and safe in pSS in a pilot study. However, there is no published clinical evidence of baricitinib in pSS. Hence, we conducted this randomized study to further explore the efficacy and safety of baricitinib in pSS.MethodsThis is a multi-center, prospective, open-label, randomized study to compare the efficacy of baricitinib + hydroxychloroquine (HCQ) with HCQ alone in pSS patients. We plan to involve 87 active pSS patients with European League Against Rheumatism pSS disease activity index (ESSDAI) ≥ 5 from eight different tertiary centers in China. Patients will be randomized (2:1) to receive baricitinib 4 mg per day + HCQ 400 mg per day or HCQ 400 mg per day alone. We will switch HCQ to baricitinib + HCQ if the patient in the latter group has no ESSDAI response at week 12. The final evaluation will be at week 24. The primary endpoint is the percentage of ESSDAI response, or minimal clinically important improvement (MCII), which was defined as an improvement of ESSDAI at least three points at week 12. The secondary endpoints include EULAR pSS patient-reported index (ESSPRI) response, change of Physician’s Global Assessment (PGA) score, serological activity parameters, salivary gland function test, and focus score on labial salivary gland biopsy.DiscussionThis is the first randomized controlled study to evaluate the clinical efficacy and safety of baricitinib in pSS. We hope that the result of this study can provide more reliable evidence of the efficacy and safety of baricitinib in pSS.Trial registrationClinicalTrials.gov NCT05016297. Registered on 19 Aug 2021.

【 授权许可】

CC BY   
© The Author(s) 2023. corrected publication 2023