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Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting

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Title: Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting
Authors: Atsumi, Tatsuya Browse this author →KAKEN DB
Fujio, Keishi Browse this author →KAKEN DB
Yamaoka, Kunihiro Browse this author
Tomobe, Minako Browse this author
Kuroyanagi, Kazuyuki Browse this author
Kameda, Hideto Browse this author
Keywords: Rheumatoid arthritis
tocilizumab
interleukin 6
postmarketing surveillance
subcutaneous
Issue Date: 2018
Publisher: Taylor & Francis
Journal Title: Modern rheumatology
Volume: 28
Issue: 5
Start Page: 780
End Page: 788
Publisher DOI: 10.1080/14397595.2017.1416760
PMID: 29251032
Abstract: Objectives: The objective of this study is to evaluate the safety and effectiveness of subcutaneous tocilizumab (TCZ-SC) in a real-world clinical setting in Japan.Methods: This single arm, 26-week prospective observational study enrolled patients with RA who were either TCZ naive or switched from TCZ-IV to TCZ-SC (TCZ-IV-SC group) (UMIN Clinical Trials Registry UMIN000011102). All patients received TCZ-SC 162mg every 2 weeks and data were collected until week 26 or discontinuation.Results: Overall 784 (78.1%) were TCZ naive and 219 (21.8%) were in the TCZ-IV-SC group. 70.9% received disease-modifying antirheumatic drugs at baseline. Adverse events (AEs) and serious AEs occurred in 28.2% and 4.9% of patients, respectively (TCZ-naive: 29.5% and 5.2%; TCZ-IV-SC: 23.2% and 4.1%). Infections and infestations were the most common AEs (7.4%) and serious AEs (1.7%). Two TCZ-naive patients died. TCZ-naive patients had an improvement in median Clinical Disease Activity Index (CDAI) score and mean Disease Activity Score in 28 joints as measured by erythrocyte sedimentation rate (DAS28-ESR) from baseline to week 26. The TCZ-IV-SC group had similar median CDAI scores and mean DAS28-ESR over 26 weeks.Conclusions: There were no unexpected safety signals with TCZ-SC. TCZ-SC was effective in reducing disease activity in TCZ-naive patients and maintaining remission in TCZ-IV-SC patients.
Rights: http://creativecommons.org/licenses/by-nc-nd/4.0/
Type: article
URI: http://hdl.handle.net/2115/72030
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 渥美 達也

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