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Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis : Text mining of the Japanese postmarketing adverse event-reporting database
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| Title: | Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis : Text mining of the Japanese postmarketing adverse event-reporting database |
| Authors: | Atsumi, Tatsuya Browse this author →KAKEN DB | | Ando, Yoshiaki Browse this author | | Matsuda, Shinichi Browse this author | | Tomizawa, Shiho Browse this author | | Tanaka, Riwa Browse this author | | Takagi, Nobuhiro Browse this author | | Nakasone, Ayako Browse this author |
| Keywords: | Adverse events | | infections | | rheumatoid arthritis | | text mining | | tocilizumab |
| Issue Date: | 2018 |
| Publisher: | Taylor & Francis |
| Journal Title: | Modern rheumatology |
| Volume: | 28 |
| Issue: | 3 |
| Start Page: | 435 |
| End Page: | 443 |
| Publisher DOI: | 10.1080/14397595.2017.1366007 |
| PMID: | 28880689 |
| Abstract: | 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. |
| Rights: | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Type: | article |
| URI: | http://hdl.handle.net/2115/71491 |
| 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)
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Submitter: 渥美 達也
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