TY - JOUR
T1 - Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis
T2 - A multicentre, observational study
AU - Kubo, Satoshi
AU - Yamaoka, Kunihiro
AU - Amano, Koichi
AU - Nagano, Shuji
AU - Tohma, Shigeto
AU - Suematsu, Eiichi
AU - Nagasawa, Hayato
AU - Iwata, Kanako
AU - Tanaka, Yoshiya
N1 - Funding Information:
Disclosure statement: S.T. was supported by research grants from AbbVie, Chugai Pharmaceutical, Santen Pharmaceutical and Takeda Pharmaceutical and received honoraria from AbbVie, Astellas Pharma, AYUMI Pharmaceutical, Chugai Pharmaceutical, Ono Pharmaceutical, Mitsubishi-Tanabe Pharma and Pfizer Japan. Y.T. has received speaking fees from AbbVie, Daiichi-Sankyo, Chugai, Takeda, Mitsubishi-Tanabe Pharma, Bristol-Myers Squibb, Astellas Pharma, Eisai Pharma, Janssen, Pfizer, Asahi-kasei, Eli Lilly, GlaxoSmithKline, UCB, Teijin, MSD and Santen and received research grants from Mitsubishi-Tanabe, Takeda, Chugai, Astellas, Eisai, Taisho-Toyama, Kyowa-Kirin, AbbVie and Bristol-Myers Squibb. S.K. has received speaking fees from BMS. K.A has received honoraria from Pfizer Japan, and Mitsubishi-Tanabe Pharma. K.Y. received consultant fees from Pfizer, Chugai Pharma, Mitsubishi-Tanabe Pharma and AbbVie; received honoraria from Pfizer, Chugai Pharma, Mitsubishi-Tanabe Pharma, Bristol-Myers Squibb, Takeda Industrial Pharma, GlaxoSmithKline, Nippon Shinyaku, Eli Lilly, Janssen Pharma, Eisai Pharma, Astellas Pharma, Actelion Pharmaceuticals and received research support from Chugai Pharma and Mitsubishi-Tanabe Pharma. All other authors have declared no conflicts of interest.
Funding Information:
Funding: This work was supported in part by Grants-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan; the Ministry of Education, Culture, Sports, Science and Technology of Japan and the University of Occupational and Environmental Health, Japan, through a University of Occupational and Environmental Health Grant for Advanced Research.
Publisher Copyright:
© The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved.
PY - 2017/8/1
Y1 - 2017/8/1
N2 - Objective. To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA).Methods. RA patients with LDA after tofacitinib treatment in a phase III and long-term extension study were enrolled in this multicentre, non-randomized, open, prospective, observational study. The decision of discontinuation or continuation of tofacitinib was determined based on patient-physician decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib-free at post-treatment week 52. Clinical outcome was compared between those who continued and those who discontinued tofacitinib. The last observation carried forward method was used for patients who could not discontinue tofacitinib before week 52.Results. Of 64 patients, 54 discontinued and 10 continued tofacitinib therapy. At post-treatment week 52, 20 of the 54 patients (37%) of the discontinuation group remained tofacitinib-free without disease flare. Disease activity at post-treatment week 52 was higher in the discontinuation group than the continuation group. Among the discontinuation group, the RF titre at baseline was significantly lower in patients who remained tofacitinib-free than those who did not (40 vs 113 U/ml). In fact, a higher proportion of patients with lower RF remained tofacitinib-free at week 52 compared with those with higher RF at baseline. In patients who could not achieve tofacitinib-free status, re-initiation of tofacitinib or other biologics improved disease activity. Conclusion. It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib.
AB - Objective. To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA).Methods. RA patients with LDA after tofacitinib treatment in a phase III and long-term extension study were enrolled in this multicentre, non-randomized, open, prospective, observational study. The decision of discontinuation or continuation of tofacitinib was determined based on patient-physician decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib-free at post-treatment week 52. Clinical outcome was compared between those who continued and those who discontinued tofacitinib. The last observation carried forward method was used for patients who could not discontinue tofacitinib before week 52.Results. Of 64 patients, 54 discontinued and 10 continued tofacitinib therapy. At post-treatment week 52, 20 of the 54 patients (37%) of the discontinuation group remained tofacitinib-free without disease flare. Disease activity at post-treatment week 52 was higher in the discontinuation group than the continuation group. Among the discontinuation group, the RF titre at baseline was significantly lower in patients who remained tofacitinib-free than those who did not (40 vs 113 U/ml). In fact, a higher proportion of patients with lower RF remained tofacitinib-free at week 52 compared with those with higher RF at baseline. In patients who could not achieve tofacitinib-free status, re-initiation of tofacitinib or other biologics improved disease activity. Conclusion. It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib.
KW - Discontinuation
KW - Rheumatoid arthritis
KW - Rheumatoid factor
KW - Tofacitinib
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U2 - 10.1093/rheumatology/kex068
DO - 10.1093/rheumatology/kex068
M3 - Article
C2 - 28407099
AN - SCOPUS:85028325720
SN - 1462-0324
VL - 56
SP - 1293
EP - 1301
JO - Rheumatology (United Kingdom)
JF - Rheumatology (United Kingdom)
IS - 8
ER -