Safety of Baricitinib Under Clinical Settings in Patients with Rheumatoid Arthritis, Using Data from All-Case Post-marketing Surveillance and Spontaneous Reports

Hiroaki Matsuno ¹, Tatsuya Atsumi ², Shuji Takei ³, Naoto Tamura ⁴, Masayoshi Harigai ⁵, Takao Fujii ⁶, Shigeki Momohara ⁷, Yuko Takahashi ⁸, Nobuhiro Narii ⁸, Naoto Tsujimoto ⁸, Atsushi Nishikawa ⁸, Taeko Ishii⁸, Kazuhiko Yamamoto ⁹, Masataka Kuwana ¹⁰ and Michiaki Takagi ¹¹, ¹Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, ²Hokkaido University, Sapporo, Japan, ³Kagoshima University, Kagoshima, Japan, ⁴Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan, ⁵Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Shinjuku-ku, Tokyo, Japan, ⁶Wakayama Medical University, Wakayama, Japan, ⁷Hakkeikai Incorporated Medical Institution, Shizuoka, Japan, ⁸Eli Lilly Japan K.K., Kobe, Japan, ⁹Riken Center for Integrative Medical Sciences, Kanagawa, Japan, ¹⁰Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan, Bunkyo-ku, Tokyo, Japan, ¹¹Yamagata University Faculty of Medicine, Yamagata-shi, Japan

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Janus kinase (JAK) and safety, Rheumatoid arthritis (RA)

Session Information

Date: Tuesday, November 12, 2019

Title: RA – Treatments Poster III: Safety and Outcomes

Session Type: Poster Session (Tuesday)

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

Background/Purpose: Baricitinib (bari), is an oral, selective inhibitor of Janus kinase (JAK) 1/ and JAK 2, is used to treat moderately to severely active RA in adults. The objective of the study was to evaluate Bari’s safety under clinical settings in RA patients.

Methods: All-case post-marketing surveillance of Bari (except patients in clinical studies) collects safety and efficacy data for the first 24 weeks starting in September 2017; collection of safety data like serious adverse events (SAEs) continues for 3 years. This interim report summarizes registration data including pretreatment test rates and adverse events (AEs) collected in the surveillance and spontaneous reports.

Results: As of August 2018, 1288 patients had been enrolled. Registration data are as follows: women, 81%; mean age, 64 years old; mean RA duration, 12 years; Steinbrocker stage II, 32%; stage III or IV, 52%; Bari 4 mg, 68%; Bari 2 mg 32%; methotrexate (MTX) use, 57%; corticosteroid use, 51%; pretreatment test for tuberculosis (TB), 93%; HBV, 95%; HCV, 93%; and estimated glomerular filtration rate (eGFR), 96%. Of 299 AEs collected, 53 were SAEs. SAEs reported in 2 or more patients were pneumonia (8), fall (4), osteonecrosis (3), Herpes zoster (2) and interstitial lung disease (2). Pulmonary TB (1), lymph node TB (1) and deep vein thrombosis (1) were also reported as SAEs.

Conclusion: Care is needed to ensure that all pretreatment tests be conducted in all patients; although most patients underwent all tests, some tests were not conducted in some patients. In these preliminary data, consistently with bari’s known safety profile, SAEs including infections were reported. Careful monitoring of patients receiving bari is recommended.

Disclosure: H. Matsuno, Chugai Pharmaceutical Co Ltd, 8, Daiichi Sankyo Co Ltd, 8, Mochida Pharmaceutical Co Ltd, 8, Ayumi Pharmaceutical Co, 8, Nichi-Iko Pharmaceutical Co Ltd, 8; T. Atsumi, AbbVie, 5, 8, Abbvie, 5, 8, Asahi Kasei Pharma Corporation, 8, Astellas Pharma, 8, 9, Astellas Pharma Inc, 8, AstraZeneca, 5, AstraZeneca plc, 5, 8, Bayer Yakuhin, 8, Bayer Yakuhin, Ltd., 8, Bristol-Myers Squibb, 8, 9, Chugai Pharmaceutical Co Ltd, 8, Chugai Pharmaceutical Co., 8, 9, Daiichi Sankyo, 8, 9, Daiichi Sankyo Co Ltd, 8, Eisai Co., Ltd, 8, Eli Lilly and Company, 8, 9, Eli Lilly Japan KK, 8, Elsai Co Ltd, 8, Gilead Sciences, 8, Gilead Sciences, Inc., 8, MEDICAL & BIOLOGICAL LABORATORIES CO., 5, Medical and Biological Laboratories Co Ltd, 5, Mitsubishi Tanabe Pharma, 8, 9, Nippon Shinyaku Co., 8, Novartis, 5, Novartis Pharma KK, 5, Ono Pharmaceutical, 5, ONO Pharmaceutical Co Ltd, 5, Otsuka Pharmaceutical, 8, Pfizer, 5, 9, Pfizer Inc, 5, 8, Sanofi, 9, Takeda Pharmaceutical Company, 8, Takeda Pharmaceuticals, 8; S. Takei, None; N. Tamura, AbbVie GK, 8, AbbVie pharma, 8, ASAHI KASEI MEDICAL, 2, ASAHI KASEI PHARMA, 2, astellas pharma, 2, 8, Astellas Pharma Inc., 2, 8, AYUMI PHARMA, 2, AYUMI Pharmaceutical Corporation, 2, bristol myers, 8, Bristol-Myers Squibb, 8, Chugai Phamaceutical Co. Ltd., 2, Chugai Pharma, 2, Eisai Co., Ltd., 2, Eisai Pharama, 2, Janssen Pharma, 8, Janssen Pharmaceutical K.K., 8, Mitsubishi Tanabe Pharma Corporation, 2, 8, Mitsubishi-Tanabe Pharma, 2, 8, Sanofi K.K., 8, Sanofi Pharma, 8, Takeda Pharma, 2, Takeda Pharmaceutical Company Ltd., 2; M. Harigai, AbbVie Japan GK, 2, 8, Ayumi Pharmaceutical Co. Ltd., 2, Bristol Meyers Squib, 2, 5, 8, Bristol-Myers Squibb Co. Ltd, 2, 5, 8, Chugai Pharmaceutical Co. Ltd., 2, 5, 8, Chugai Pharmaceutical Co., Ltd., 2, 5, 8, Eisai Co. Ltd., 2, Eisai Co., Ltd., 2, Eli Lilly, 5, 8, Mitsubishi Tanabe Pharma Co., 2, Mitsubishi Tanabe Pharma Corp., 2, Nippon Kayaku Co. Ltd., 2, Taisho Toyama Pharmaceutical Co. Ltd., 2, Takeda Pharmaceutical Co., 2, Takeda Pharmaceutical Co., Ltd., 2, Teijin Pharma Ltd., 2, 8, Teijin Pharma, Ltd., 2, 8; T. Fujii, None; S. Momohara, Mitsubishi Tanabe Pharma, 8, ONO Pharmaceutical Co Ltd, 8, Pfizer Pharmaceutical Co Ltd, 8, Eli Lilly Japan KK, 8; Y. Takahashi, Eli Lilly Japan KK, 1, 3; N. Narii, Eli Lilly Japan KK, 1, 3; N. Tsujimoto, Eli Lilly Japan KK, 1, 3; A. Nishikawa, Eli Lilly Japan KK, 1, 3; T. Ishii, Eli Lilly Japan KK, 1, 3; K. Yamamoto, AbbVie GK, 8, Astellas Pharma Inc, 8, AYUMI Pharma Corporation, 8, Bristol-Myers Squibb, 8, Chugai Pharmaceutical Co. Ltd, 2, Eisai Co., Ltd, 8, Janssen Pharmaceutical K.K, 8, Mitsubishi Tanabe Pharma Corporation, 8, Ono Pharmaceutical Co., Ltd, 8, UCB Japan Co. Ltd, 8; M. Kuwana, Abbvie, 2, 8, Actelion, 2, 8, Actelion Pharmaceuticals, 2, 8, Astellas, 2, 8, Bayer, 5, Boehringer Ingelheim, 5, Boehringer-Ingelheim, 5, Chugai, 2, 5, 8, Corbus, 5, CSL Behring, 5, CSL Berling, 5, Eisai, 2, 8, Eli Lilly, 2, Janssen, 8, Japan Blood Products Organization, 8, MBL, 7, 8, Ono, 2, 8, Pfizer, 2, Reata, 5, Tanabe-Mitsubishi, 2, 8; M. Takagi, None.

To cite this abstract in AMA style:

Matsuno H, Atsumi T, Takei S, Tamura N, Harigai M, Fujii T, Momohara S, Takahashi Y, Narii N, Tsujimoto N, Nishikawa A, Ishii T, Yamamoto K, Kuwana M, Takagi M. Safety of Baricitinib Under Clinical Settings in Patients with Rheumatoid Arthritis, Using Data from All-Case Post-marketing Surveillance and Spontaneous Reports [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/safety-of-baricitinib-under-clinical-settings-in-patients-with-rheumatoid-arthritis-using-data-from-all-case-post-marketing-surveillance-and-spontaneous-reports/. Accessed .

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