Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis : Text mining of the Japanese postmarketing adverse event-reporting database

Atsumi, Tatsuya; Ando, Yoshiaki; Matsuda, Shinichi; Tomizawa, Shiho; Tanaka, Riwa; Takagi, Nobuhiro; Nakasone, Ayako

Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis : Text mining of the Japanese postmarketing adverse event-reporting database

Atsumi, Tatsuya; Ando, Yoshiaki; Matsuda, Shinichi et al.

Modern rheumatology, 2018, 28(3), 435-443

Permalink : https://hdl.handle.net/2115/71491

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論文情報

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アクセス権	open access
URI	https://hdl.handle.net/2115/71491
タイトル	Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis : Text mining of the Japanese postmarketing adverse event-reporting database
著者	Atsumi, Tatsuya ; Ando, Yoshiaki ; Matsuda, Shinichi ; Tomizawa, Shiho ; Tanaka, Riwa ; Takagi, Nobuhiro ; Nakasone, Ayako
e-Rad_Researcher 20301905 著者名 Atsumi, Tatsuya
著者名 Ando, Yoshiaki
著者名 Matsuda, Shinichi
著者名 Tomizawa, Shiho
著者名 Tanaka, Riwa
著者名 Takagi, Nobuhiro
著者名 Nakasone, Ayako
言語	英語
キーワード	Adverse events
	infections
	rheumatoid arthritis
	text mining
	tocilizumab
発行日	2018
出版者	Taylor & Francis
収録物名	Modern rheumatology
巻(号)	28(3)
ページ	435-443
抄録	Objective: To search for signs and symptoms before serious infection (SI) occurs in tocilizumab (TCZ)-treated rheumatoid arthritis (RA) patients. Methods: Individual case safety reports, including structured (age, sex, adverse event [AE]) and unstructured (clinical narratives) data, were analyzed by automated text mining from a Japanese post-marketing AE-reporting database (16 April 2008-10 April 2015) assuming the following: treated in Japan; TCZ RA treatment; ≥1 SI; unable to exclude causality between TCZ and SIs. Results: The database included 7653 RA patients; 1221 reports met four criteria, encompassing 1591 SIs. Frequent SIs were pneumonia (15.9%), cellulitis (9.9%), and sepsis (5.0%). Reports for 782 patients included SI onset date; 60.7% of patients had signs/symptoms ≤28 days before SI diagnosis, 32.7% had signs/symptoms with date unidentified, 1.7% were asymptomatic, and 4.9% had unknown signs/symptoms. The most frequent signs/symptoms were for skin (swelling and pain) and respiratory (cough and pyrexia) infections. Among 68 patients who had normal laboratory results for C-reactive protein, body temperature, and white blood cell count, 94.1% had signs or symptoms of infection. Conclusion: This study identified prodromal signs and symptoms of SIs in RA patients receiving TCZ. Data mining clinical narratives from post-marketing AE databases may be beneficial in characterizing SIs.
資源タイプ	学術雑誌論文
出版タイプ	Version of Record
権利情報	Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
PISSN	1439-7595
関連情報	PMID 28880689
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.1080/14397595.2017.1366007