ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0203

Safety of Baricitinib in Patients with Rheumatoid Arthritis: Interim Report from All-Case Post‑Marketing Study in Clinical Use

Tatsuya Atsumi1, Nami Okamoto2, Nobunori Takahashi3, Naoto Tamura4, Atsuo Nakajima5, Ayako Nakajima6, Takao Fujii7, Hiroaki Matsuno8, Yuko Takahashi9, Fumie Inui9, Naoto Tsujimoto9, Atsushi Nishikawa9, Taeko Ishii9, Tsutomu Takeuchi10, Masataka Kuwana11 and Michiaki Takagi12, 1Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapparo, Hokkaido, Japan, 2Department of Rheumatology and Allergy of Pediatrics, Osaka Medical College, Takatsuki, Osaka, Japan, 3Department of Orthopaedics/Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan, 4Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Bunkyō, Tokyo, Japan, 5Ueno Touseki Clinic, Kitasaku District, Nagano, Japan, 6Center for Rheumatic Diseases, Mie University Hospital, Tsu, Mie, Japan, 7Department of Rheumatology and Clinical Immunology, Wakayama Medical University, Wakayama, Wakayama, Japan, 8Matsuno Clinic for Rheumatic Diseases, Toyama, Toyama, Japan, 9Eli Lilly, Kobe, Hyogo, Japan, 10Division of Rheumatology, Department of internal Medicine, School of Medicine, Keio University, Tokyo, Japan, 11Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Tokyo, Japan, 12Department of Orthopaedic Surgery, Yamagata University Faculty of Medicine, Yamagata, Yamagata, Japan

Meeting: ACR Convergence 2020

Keywords:

Session Information

Date: Friday, November 6, 2020

Title: RA – Treatments Poster I: RA Treatments & Their Safety

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: To evaluate the safety of baricitinib in rheumatoid arthritis (RA) patients in clinical use.

Methods: An all-case post-marketing study of baricitinib, started in September 2017, collects safety and effectiveness for the first 24 weeks of treatment and continues to collect serious adverse events (SAEs) for 3 years. We report patients baseline demographics and adverse events (AEs) for patients completing the 24 weeks case report or discontinued before 24 weeks, as of December 2019.

Results: Data from 1992 patients were collected (females 80%). At dosing, the mean age was 64 years (median: 66 years), >65 years 54%; the mean RA duration was 11 years (median: 9 years), baricitinib dose regimen 4 mg 62%, 2 mg 27%, 4 mg → 2 mg 5%, 2 mg → 4 mg 4%, and others 3%. Pre-use of biologic DMARDs was 75% and targeted synthetic DMARDs was 21%; concomitant use of MTX was 55% and corticosteroid was 43%. 73% continued treatment for 24 weeks.

Totally, 536 patients (27%) had AEs. 4 patients died of adenocarcinoma, aspiration pneumonia, bacterial pneumonia, and pulmonary hypertension. The SAEs were 79 patients (4%): pneumonia (9), herpes zoster (5), bacterial pneumonia (4), osteonecrosis (3), anemia (3), aspiration pneumonia (3), fall (3), and femur fracture (3). The major adverse event of special interests were herpes zoster (58), serious infections (29), low hemoglobin or anemia (26), liver dysfunction (68), high lipid or hyperlipidemia (27), cardiovascular event (15), interstitial pneumonia (5), malignancy (7), and venous thromboembolism (2).

Conclusion: No new safety concern has been indicated. Encourage guideline-compliant use of baricitinib, as SAEs, including infections, have been reported.

Disclosure: T. Atsumi, AbbVie Inc., 5, 8, 9, UCB Japan Co.,Ltd., 5, 8, Eisai Co., Ltd., 8, Gilead Sciences, Inc., 5, 8, Bristol Myers Squibb Co., 2, 8, Chugai Pharmaceutical Co., Ltd., 2, 8, 9, Mitsubishi Tanabe Pharma Corporation, 8, 9, Eli Lilly Japan K.K., 2, 5, 8, Astellas Pharma Inc., 8, 9, Pfizer Inc., 2, 8, 9, Daiichi Sankyo Company, Limited, 5, 8, 9; N. Okamoto, None; N. Takahashi, Eli Lilly and Company, 8; N. Tamura, GlaxoSmithKline plc, 2, 8, Eli Lilly Japan K.K., 8, Chugai Pharmaceutical Co.Ltd., 8, Novartis Pharma K.K., 8, AbbVie GK., 8, Eisai Co., Ltd., 8, Mitsubishi Tanabe Pharma Corporation, 8, Janssen Pharmaceutical K.K., 8, Bristol Myers Squibb Co.Ltd., 8; A. Nakajima, None; A. Nakajima, Eli Lilly, 8; T. Fujii, None; H. Matsuno, Chugai Pharmaceutical Co., Ltd., 8, Daiichi Sankyo Company, Limited, 8, Mochida Pharmaceutical Co Ltd,, 8, Ayumi Pharmaceutical Co, 8, Nichi-Iko Pharmaceutical Co Ltd, 8; Y. Takahashi, Eli Lilly Japan K.K., 3; F. Inui, Eli Lilly Japan K.K., 3; N. Tsujimoto, Eli Lilly Japan K.K., 3, Eli Lilly and Company, 4; A. Nishikawa, Eli Lilly Japan K.K., 3, Eli Lilly and Company, 4; T. Ishii, Eli Lilly Japan K.K., 3, Eli Lilly and Company, 4; T. Takeuchi, Astellas Pharma Inc., 2, 5, 8, Daiichi Sankyo Company, Limited, 2, 5, 8, Takeda Pharmaceutical Company Limited, 2, 5, 8, AbbVie GK., 2, 5, 8, Asahi Kasei Pharma Corporation, 2, 5, 8, Mitsubishi Tanabe Pharma Corporation, 2, 5, 8, Eisai Co., Ltd., 2, 5, 8, Nippon Kayaku Co., Ltd., 2, 5, 8, Chugai Pharmaceutical Co., Ltd., 2, 5, 8, Eli Lily Japan K.K, 2, 5, 8, Gilead Sciences, Inc., 2, 5, 8, Pfizer Japan, Inc., 2, 5, 8, Bristol-Myers Squibb, 2, 5, 8, AYUMI Pharmaceutical Corporation, 2, 5, 8, Novartis Pharma K.K., 2, 5, 8, UCB, 2, 5, 8, Dainippon Sumitomo Co., 2, 5, 8, Shionogi & Co., Ltd., 2, 5, 8; M. Kuwana, Ono Pharmaceutical, 2, 8, Chugai, 2, 8, Astellas, 8, Mitsubishi Tanabe Pharma Corporation, 2, 8, AbbVie Inc., 8, Eisai Co., Ltd., 8; M. Takagi, None.

To cite this abstract in AMA style:

Atsumi T, Okamoto N, Takahashi N, Tamura N, Nakajima A, Nakajima A, Fujii T, Matsuno H, Takahashi Y, Inui F, Tsujimoto N, Nishikawa A, Ishii T, Takeuchi T, Kuwana M, Takagi M. Safety of Baricitinib in Patients with Rheumatoid Arthritis: Interim Report from All-Case Post‑Marketing Study in Clinical Use [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/safety-of-baricitinib-in-patients-with-rheumatoid-arthritis-interim-report-from-all-case-post%e2%80%91marketing-study-in-clinical-use/. Accessed .

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