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Predictors of disease flare after discontinuation of concomitant methotrexate in Japanese patients with rheumatoid arthritis treated with tocilizumab.

Abstract：

OBJECTIVE:To investigate predictors of disease flare after methotrexate discontinuation in Japanese rheumatoid arthritis (RA) patients with sustained low disease activity undergoing tocilizumab plus methotrexate combination therapy. METHODS:Participants of this multicenter, open-label, uncontrolled, prospective study were RA patients maintaining low disease activity (Clinical Disease Activity Index [CDAI]≤10) for≥12weeks with tocilizumab plus methotrexate. Methotrexate was discontinued after 12weeks of biweekly administration while continuing tocilizumab therapy. Disease flare was defined as either a CDAI score>10 or intervention with rescue treatments for any reason even if the CDAI score was≤10. The impact of baseline characteristics on disease flare at week 64 (52weeks after methotrexate discontinuation) was assessed with logistic regression models. RESULTS:Efficacy analyses were performed in 49 patients, of whom 15 had a disease flare by week 64. The proportion (95% confidence interval [CI]) of patients who maintained low disease activity without a flare at week 64 was 69.4% (54.6-81.8%). The dosing interval of tocilizumab was longer than that described on the drug label in Japan (i.e., intravenously every 4weeks, or subcutaneously every 2weeks) in 27% and 6% of patients with and without a flare, respectively. Multivariate analysis revealed that male sex (odds ratio [OR]: 18.00, 95% CI: 2.80-115.56) and extended dosing interval of tocilizumab (OR: 12.00, 95% CI: 1.72-83.80) were independent predictors of disease flare. CONCLUSION:Male patients and those receiving tocilizumab at an extended dosing interval are at high risk of disease flare after discontinuation of concomitant methotrexate. TRIAL REGISTRATION NUMBER:jRCTs041180071, UMIN000021247.

journal_name

Joint Bone Spine

journal_title

Joint bone spine

authors

Asai S,Takahashi N,Hayashi M,Hanabayashi M,Kanayama Y,Takemoto T,Yabe Y,Shioura T,Ishikawa H,Yoshioka Y,Kato T,Hirano Y,Fujibayashi T,Hattori Y,Kobayakawa T,Ando M,Kuwatsuka Y,Matsumoto T,Asai N,Sobue Y,Nishiume T

doi

10.1016/j.jbspin.2020.06.001

subject

Has Abstract

pub_date

2020-12-01 00:00:00

pages

596-602

issue

eissn

1297-319X

issn

1778-7254

pii

S1297-319X(20)30111-1

journal_volume

pub_type

杂志文章

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Predictors of disease flare after discontinuation of concomitant methotrexate in Japanese patients with rheumatoid arthritis treated with tocilizumab.