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Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis


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Title: Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis
Authors: Iwamoto, Naoki / Tsuji, Sosuke / Takatani, Ayuko / Shimizu, Toshimasa / Fukui, Shoichi / Umeda, Masataka / Nishino, Ayako / Horai, Yoshiro / Koga, Tomohiro / Kawashiri, Shin-ya / Aramaki, Toshiyuki / Ichinose, Kunihiro / Hirai, Yasuko / Tamai, Mami / Nakamura, Hideki / Terada, Kaoru / Origuchi, Tomoki / Eguchi, Katsumi / Ueki, Yukitaka / Kawakami, Atsushi
Issue Date: 4-May-2017
Publisher: Public Library of Science
Citation: PLOS ONE, 12(5), e0177057; 2017
Abstract: Objective We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA) in a real-world setting. Methods Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS)28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs) were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks. Results Fifty-eight patients (82.9%) continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (P<0.0001, vs. baseline). 15 AEs including 5 herpes zoster infection occurred during tofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX) or patients whose treatment with tocilizumab (TCZ) failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs) previously used was independently associated with achievement of DAS-low disease activity. Conclusions Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.
URI: http://hdl.handle.net/10069/37558
DOI: 10.1371/journal.pone.0177057
Rights: © 2017 Iwamoto et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/37558

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