PMID- 28472115 OWN - NLM STAT- MEDLINE DCOM- 20170915 LR - 20220321 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 12 IP - 5 DP - 2017 TI - Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis. PG - e0177057 LID - 10.1371/journal.pone.0177057 [doi] LID - e0177057 AB - 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. FAU - Iwamoto, Naoki AU - Iwamoto N AUID- ORCID: 0000-0002-2197-0757 AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Tsuji, Sosuke AU - Tsuji S AD - Department of Rheumatology, Sasebo Chuo Hospital, Sasebo, Japan. FAU - Takatani, Ayuko AU - Takatani A AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Shimizu, Toshimasa AU - Shimizu T AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Fukui, Shoichi AU - Fukui S AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Umeda, Masataka AU - Umeda M AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Nishino, Ayako AU - Nishino A AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Horai, Yoshiro AU - Horai Y AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Koga, Tomohiro AU - Koga T AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Kawashiri, Shin-Ya AU - Kawashiri SY AD - Departments of Community Medicine, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Aramaki, Toshiyuki AU - Aramaki T AD - Department of Rheumatology, Sasebo Chuo Hospital, Sasebo, Japan. FAU - Ichinose, Kunihiro AU - Ichinose K AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Hirai, Yasuko AU - Hirai Y AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Tamai, Mami AU - Tamai M AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Nakamura, Hideki AU - Nakamura H AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Terada, Kaoru AU - Terada K AD - Department of Rheumatology, Sasebo Chuo Hospital, Sasebo, Japan. FAU - Origuchi, Tomoki AU - Origuchi T AD - Department of Physical Therapy, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. FAU - Eguchi, Katsumi AU - Eguchi K AD - Department of Rheumatology, Sasebo Chuo Hospital, Sasebo, Japan. FAU - Ueki, Yukitaka AU - Ueki Y AD - Department of Rheumatology, Sasebo Chuo Hospital, Sasebo, Japan. FAU - Kawakami, Atsushi AU - Kawakami A AD - Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. LA - eng PT - Journal Article DEP - 20170504 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Antirheumatic Agents) RN - 0 (Piperidines) RN - 0 (Pyrimidines) RN - 0 (Pyrroles) RN - 87LA6FU830 (tofacitinib) SB - IM MH - Aged MH - Antirheumatic Agents/adverse effects/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Female MH - Humans MH - Male MH - Middle Aged MH - Piperidines/adverse effects/*therapeutic use MH - Pyrimidines/adverse effects/*therapeutic use MH - Pyrroles/adverse effects/*therapeutic use PMC - PMC5417647 COIS- Competing Interests: The authors declare that there are no conflicts of interest. EDAT- 2017/05/05 06:00 MHDA- 2017/09/16 06:00 PMCR- 2017/05/04 CRDT- 2017/05/05 06:00 PHST- 2017/03/09 00:00 [received] PHST- 2017/04/23 00:00 [accepted] PHST- 2017/05/05 06:00 [entrez] PHST- 2017/05/05 06:00 [pubmed] PHST- 2017/09/16 06:00 [medline] PHST- 2017/05/04 00:00 [pmc-release] AID - PONE-D-17-09353 [pii] AID - 10.1371/journal.pone.0177057 [doi] PST - epublish SO - PLoS One. 2017 May 4;12(5):e0177057. doi: 10.1371/journal.pone.0177057. eCollection 2017.