ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1676

Safety of Baricitinib in Japanese Patients with Rheumatoid Arthritis (RA): The 2020 Interim Report from All-case Post Marketing Surveillance in Clinical Practice

Takao Fujii1, Tatsuya Atsumi2, Nami Okamoto3, Nobunori Takahashi4, Naoto Tamura5, Atsuo Nakajima6, Ayako Nakajima7, Hiroaki Matsuno8, Naoto Tsujimoto9, Atsushi Nishikawa10, Taeko Ishii10, Tsutomu Takeuchi11, Masataka Kuwana12 and Michiaki Takagi13, 1Department of Rheumatology and Clinical Immunology, Wakayama Medical University, Wakayama, Japan, 2Hokkaido University, Sapporo, Japan, 3Osaka Medical College, Takatsuki-city, Japan, 4Nagoya University Graduate School of Medicine, Nagoya, Japan, 5Department of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine, Tokyo, Japan, 6Ueno Touseki Clinic, Fukuoka, Japan, 7Center for Rheumatic Diseases, Mie University Hospital, Mie, Japan, 8Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, 9Eli Lilly Japan K.K.,, Kobe, Japan, 10Eli Lilly Japan K.K., Kobe, Japan, 11Div. Rheumatology, Keio University, Tokyo, Japan, 12Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan, 13Department of Orthopaedic Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan

Meeting: ACR Convergence 2021

Keywords:

Session Information

Date: Tuesday, November 9, 2021

Title: RA – Treatments Poster III: RA Treatments & Their Safety (1674–1710)

Session Type: Poster Session D

Session Time: 8:30AM-10:30AM

Background/Purpose: An all-case post marketing surveillance (PMS) of baricitinib, that started in Sep 2017, collects safety and effectiveness for the first 24 weeks of treatment and continues to collect serious adverse events (SAEs) for 3 years. The objective of this analysis was to evaluate safety of baricitinib in RA patients in clinical practice.

Methods: We report patient baseline demographics and adverse events (AEs) up to 24 weeks for patients whose case report files for 24-week data were completed as of Jun 2020.

Results: Data from 3445 patients were analyzed (females=80%, mean age=64 years, mean RA duration=12 years). Baricitinib dose regimen was as follows: 4mg, 60%, 2mg, 27%, 4mgà2mg, 5%, 2mgà4mg, 5%, and others, 2%. Concomitant use of MTX and glucocorticoid was 65% and 48%, respectively. Overall, 74% continued treatment for 24 weeks. AE and SAE were recognized in 887 (26%) and 122 patients (4%), respectively. Six patients died of pneumonia, aspiration pneumonia, bacterial pneumonia, cerebral infarction/interstitial lung disease (ILD)/aspiration pneumonia, adenocarcinoma, and colorectal cancer. Major AEs were as follows: herpes zoster=3%, liver dysfunction=3%, serious infection=1%, anemia=1%, hyperlipidemia=1%, malignancy=0.3%, interstitial pneumonia=0.2%, major adverse cardiovascular event (MACE)=0.1%, and venous thromboembolism (VTE)=0.1%.

Conclusion: Data do not show new safety concerns and encourage guideline-compliant use of Baricitinib.

Disclosures: T. Fujii, Chugai Pharmaceutical Co. Ltd, 5, 6, Eisai Co. Ltd, 6, Eli Lilly Japan K.K., 5, 6, Janssen Pharmaceutical K.K., 6, Ono Pharmaceutical Co. Ltd., 5, 6, Asahikasei Pharma Corp, 2, 5, AbbVie Japan GK, 5, Mitsubishi-Tanabe Pharma Co., 5; T. Atsumi, AbbVie Japan GK, 2, 6, Astellas Pharma Inc., 5, 6, Bristol-Myers Squibb Co. Ltd, 6, Chugai Pharmaceutical Co. Ltd, 5, 6, Daiichi Sankyo Co. Ltd, 5, 6, Eisai Co. Ltd., 6, Eli Lilly Japan K.K, 6, Mitsubishi Tanabe Pharma Co.;, 5, 6, Pfizer Japan Inc, 2, 5, 6, Takeda Pharmaceutical Co. Ltd, 5, 6, UCB Japan Co. Ltd, 6, AstraZeneca plc, 2, Boehringer Ingelheim Co. Ltd, 2, Medical & Biological Laboratories Co. Ltd, 2, Novartis Pharma K.K, 2, Ono Pharmaceutical Co. Ltd, 2, Alexion Inc, 5, Otsuka Pharmaceutical Co., Ltd, 5, Gilead Sciences, Inc., 5, 6; N. Okamoto, AbbVie Japan GK, 6, Asahikasei Pharma Co., 6, AYUMI Pharmaceutical Co, 6, Eisai Co. Ltd, 6, Bristol-Myers Squibb Co. Ltd, 6, Eli Lilly Japan K.K, 6, Mitsubishi Tanabe Pharma Co.;, 6, Pfizer Japan Inc, 6, Chugai Pharmaceutical Co. Ltd, 6, Novartis Pharma K.K, 6, Teijin Pharma Ltd, 6, Torii Pharmaceutical Co., Ltd., 6; N. Takahashi, AbbVie Japan GK, 6, Eisai Co. Ltd, 6, Mitsubishi Tanabe Pharma Co.;, 6, Pfizer Japan Inc, 6, Chugai Pharmaceutical Co. Ltd, 6, Eli Lilly Japan K.K, 6, Janssen Pharmaceutical K.K., 6, UCB Japan Co. Ltd, 6, Astellas Pharma Inc., 6, Bristol-Myers Squibb Co. Ltd, 5, 6; N. Tamura, AbbVie Japan GK, 6, Bristol-Myers Squibb Co. Ltd, 6, Chugai Pharmaceutical Co. Ltd, 6, Eisai Co. Ltd, 6, Eli Lilly Japan K.K, 6, Glaxo Smith Kline K.K., 6, Janssen Pharmaceutical K.K., 6, Mitsubishi-Tanabe Pharma Co., 6, Novartis Pharma K.K, 6; A. Nakajima, None; A. Nakajima, AbbVie Japan GK, 6, Actelion Pharmaceuticals Japan Ltd, 6, Asahikasei Pharma Corp, 6, AYUMI Pharmaceutical Co, 6, Bristol-Myers Squibb Co. Ltd, 6, Chugai Pharmaceutical Co. Ltd, 5, 6, Eisai Co. Ltd, 6, Eli Lilly Japan K.K, 6, Glaxo Smith Kline K.K., 6, Hisamitsu Pharmaceutical Co. Inc, 6, Kyorin Pharmaceutical Co. Ltd, 6, Mitsubishi Tanabe Pharma Co.;, 5, 6, Otsuka Pharmaceutical Co., Ltd, 6, Pfizer Japan Inc, 5, 6, Teijin Pharma Ltd, 6; H. Matsuno, Chugai Pharmaceutical Co. Ltd, 6, Daiichi Sankyo Co. Ltd, 6, Eli Lilly Japan K.K, 5, 6, Astellas Pharma Inc., 5, Janssen Pharmaceutical K.K., 5, Mochida Pharmaceutical Co., Ltd., 5; N. Tsujimoto, Eli Lilly Japan K.K, 3; A. Nishikawa, Eli Lilly Japan K.K., 3; T. Ishii, Eli Lilly Japan K.K, 3; T. Takeuchi, Astellas Pharma, 2, 5, 6, Chugai Pharmaceutical, 2, 5, 6, Asahi Kasei Pharma, 5, Mitsubishi Tanabe, 2, 5, 6, AbbVie, 5, 6, Daiichi Sankyo, 5, 6, Eisai, 5, 6, Shionogi, 5, Takeda, 5, UCB Japan, 5, Eli Lilly Japan, 2, 6, AYUMI, 6, Bristol-Myers Squibb, 6, Gilead Sciences, Inc., 6, Novartis, 6, Pfizer Japan, 6, Sanofi, 6, Dainippon Sumitomo, 6; M. Kuwana, Boehringer Ingelheim, 5, 6, One Pharmaceuticals, 5, 6, Chugai, 6, Janssen, 6, Astellas, 6, Tanabe Mitsubishi, 6, Pfizer, 6, Nippon Shinyaku, 6, Corbus, 2, Mochida, 2, Kissei, 2, MBL, 9; M. Takagi, None.

To cite this abstract in AMA style:

Fujii T, Atsumi T, Okamoto N, Takahashi N, Tamura N, Nakajima A, Nakajima A, Matsuno H, Tsujimoto N, Nishikawa A, Ishii T, Takeuchi T, Kuwana M, Takagi M. Safety of Baricitinib in Japanese Patients with Rheumatoid Arthritis (RA): The 2020 Interim Report from All-case Post Marketing Surveillance in Clinical Practice [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/safety-of-baricitinib-in-japanese-patients-with-rheumatoid-arthritis-ra-the-2020-interim-report-from-all-case-post-marketing-surveillance-in-clinical-practice/. Accessed .

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