Safety and Effectiveness of Baricitinib in Chinese Patients with Moderate-to-Severe Rheumatoid Arthritis: 24-Week Results from a Post-Marketing Safety Study

Chan-Yuan Wu; Qian Wang; Jian Shi; Xiu-Ying Zhang; Rong Du; Jie-Ruo Gu; Qi-Huan Liu; Jiao Yu; Jia-Wei Xu; Yan-Jie Zhang; Hao Zhu; Meng-Tao Li; Xiao-Feng Zeng

doi:10.1007/s40744-023-00596-4

Safety and Effectiveness of Baricitinib in Chinese Patients with Moderate-to-Severe Rheumatoid Arthritis: 24-Week Results from a Post-Marketing Safety Study

Rheumatol Ther. 2023 Dec;10(6):1609-1622. doi: 10.1007/s40744-023-00596-4. Epub 2023 Sep 28.

Authors

Chan-Yuan Wu¹, Qian Wang¹, Jian Shi², Xiu-Ying Zhang³, Rong Du⁴, Jie-Ruo Gu⁵, Qi-Huan Liu⁶, Jiao Yu⁷, Jia-Wei Xu⁷, Yan-Jie Zhang⁷, Hao Zhu⁷, Meng-Tao Li¹, Xiao-Feng Zeng⁸

Affiliations

¹ Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences and Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Ministry of Science and Technology, State Key Laboratory of Complex Severe and Rare Diseases, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.
² Department of Rheumatology and Immunology, Yiyang Central Hospital, Central South University, Hunan, China.
³ Department of Rheumatology and Immunology, Zibo Central Hospital, Shandong, China.
⁴ Department of Rheumatology and Immunology, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei, China.
⁵ Department of Rheumatology and Immunology, The Third Affiliated Hospital, Sun Yat-Sen University, Guangdong, China.
⁶ Department of Rheumatology and Immunology, Sinopharm Dongfeng General Hospital, Hubei University of Medicine, Hubei, China.
⁷ Eli Lilly and Company, Shanghai, China.
⁸ Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences and Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Ministry of Science and Technology, State Key Laboratory of Complex Severe and Rare Diseases, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China. xiaofeng.zeng@cstar.org.cn.

Abstract

Introduction: Baricitinib, a JAK1/JAK2 inhibitor, is approved for treatment of moderate-to-severe rheumatoid arthritis (RA) in China. This single-arm, prospective, multi-center, post-marketing safety study (PMSS) evaluated the safety and effectiveness of baricitinib in Chinese patients.

Methods: This study included adult patients with moderate-to-severe active RA who received baricitinib over periods of approximately 12 and 24 weeks. The primary endpoint was safety, defined as week 12 adverse event (AE)/serious AE incidence. Secondary endpoints were week 24 safety and effectiveness (disease activity score with 28 joints/C-reactive protein [DAS28-CRP] and simplified/Clinical Disease Activity Index [SDAI/CDAI]).

Results: Safety analyses included 667 patients (female, 82.3%; mean age, 53.3 years; mean RA duration, 86.9 months); 106/667 (15.9%) were 65-74 years old and 19/667 (2.8%) were ≥ 75 years old; 87.0% received baricitinib 2 mg QD. Total exposure was 262.1 patient-years (PY). At week 12, AEs had occurred in 214 (32.1%; exposure-adjusted incidence rate [EAIR], 172.5 per 100 PY) patients (serious AEs: 22 [3.3%; EAIR, 15.0]). At week 24, AEs had occurred in 250 (37.5%; EAIR, 125.9) patients (serious AEs: 28 [4.2%; EAIR, 10.9]). Two patients (0.3%) died (of pneumonia and unknown cause); EAIR for death, 0.77. Serious infection occurred in 1.2% of patients (EAIR, 3.1). Hepatotoxicity occurred in 3.4% of patients (EAIR, 9.0). No patients met potential Hy's law laboratory criteria (alanine/aspartate aminotransferases ≥ 3 × upper limit of normal (ULN) and total bilirubin ≥ 2 × ULN). Malignancy occurred in one patient. No patients experienced venous thromboembolism (VTE) or major adverse cardiovascular events (MACE). At week 24, 52.4%, 27.5%, and 27.6% of patients achieved remission per DAS28-CRP, SDAI, and CDAI, respectively.

Conclusions: This PMSS investigated the safety and effectiveness of baricitinib in clinical practice in China. No VTE/MACE or new safety signals were reported and there was promising effectiveness, supporting the use of baricitinib in Chinese patients with moderate-to-severe active RA.

Trial registration: EU PAS Register: EUPAS34213.

Keywords: Baricitinib; Effectiveness; Janus kinase (JAK) inhibitor; Pharmacovigilance; Rheumatoid arthritis (RA).