Safety of baricitinib in Japanese patients with rheumatoid arthritis in clinical use: 3-year data of all-case post-marketing surveillance study

Nami Okamoto; Tatsuya Atsumi; Michiaki Takagi; Nobunori Takahashi; Tsutomu Takeuchi; Naoto Tamura; Atsuo Nakajima; Ayako Nakajima; Takao Fujii; Hiroaki Matsuno; Taeko Ishii; Naoto Tsujimoto; Atsushi Nishikawa; Machiko Minatoya; Yoshiya Tanaka; Masataka Kuwana

doi:10.1093/mr/roae064

Safety of baricitinib in Japanese patients with rheumatoid arthritis in clinical use: 3-year data of all-case post-marketing surveillance study

Mod Rheumatol. 2024 Aug 9:roae064. doi: 10.1093/mr/roae064. Online ahead of print.

Authors

Nami Okamoto¹, Tatsuya Atsumi², Michiaki Takagi³, Nobunori Takahashi⁴, Tsutomu Takeuchi^{5

6}, Naoto Tamura⁷, Atsuo Nakajima⁸, Ayako Nakajima⁹, Takao Fujii¹⁰, Hiroaki Matsuno¹¹, Taeko Ishii¹², Naoto Tsujimoto¹², Atsushi Nishikawa¹², Machiko Minatoya¹², Yoshiya Tanaka¹³, Masataka Kuwana¹⁴

Affiliations

¹ Department of Paediatrics, Osaka Rosai Hospital, Osaka, Japan.
² Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Hokkaido, Japan.
³ Department of Orthopaedic Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan.
⁴ Department of Orthopedic Surgery, Aichi Medical University, Aichi, Japan.
⁵ Saitama Medical University, Saitama, Japan.
⁶ Keio University School of Medicine, Tokyo, Japan.
⁷ Department of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine, Tokyo, Japan.
⁸ Department of Rheumatology, Ueno Dialysis Clinic, Tokyo, Japan.
⁹ Center for Rheumatic Diseases, Mie University Hospital, Mie, Japan.
¹⁰ Department of Rheumatology and Clinical Immunology, Wakayama Medical University, Wakayama, Japan.
¹¹ Matsuno Clinic for Rheumatic Diseases, Toyama City, Japan.
¹² Japan Drug Development & Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.
¹³ The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
¹⁴ Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.

PMID: 39119689
DOI: 10.1093/mr/roae064

Abstract

Objective: To assess safety of baricitinib in Japanese patients with rheumatoid arthritis in real-world clinical practice.

Methods: This all-case post-marketing surveillance study included patients initiating baricitinib for rheumatoid arthritis from September 2017 to April 2019. Treatment duration was recorded. Safety data were collected for up to 3 years from baricitinib initiation (up to 4 weeks post discontinuation in discontinuing patients).

Results: Safety analyses included 4720 patients; 2580 (54.7%) were ≥65 years old. Baricitinib persistence rate was 45.4% (3 year Kaplan-Meier analysis); the most common discontinuation reason was insufficient effectiveness (n = 1005, 21.3%). Serious adverse events occurred in 600 patients (incidence rate 10.42/100 patient-years; 95% confidence interval, 9.76-11.09). There were 39 deaths (incidence rate 0.43 [0.30-0.57]/100 patient-years). Incidence rate per 100 patient-years for adverse events of special interest were herpes zoster 4.68 (4.22-5.14), serious infection 3.05 (2.68-3.41), malignancy 1.09 (0.87-1.30), major adverse cardiovascular events 0.35 (0.23-0.48) and venous thromboembolism 0.25 (0.15-0.36). Incidence rates did not increase with prolonged exposure.

Conclusions: No new safety concerns were identified during this 3 year post-marketing surveillance study of baricitinib in Japanese patients with rheumatoid arthritis. Patients and clinicians should be cognizant of herpes zoster and other serious infection risks during baricitinib treatment, especially in the first 6 months.

Keywords: Arthritis; baricitinib; janus kinase inhibitors; post-marketing safety and effectiveness study; rheumatoid; safety.