Disease activity guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis: a prospective, randomized, open-label, multicentric study

Therapeutic Advances in Musculoskeletal Disease
Ting ZhangHuaxiang Wu

Abstract

The aim of this study was to evaluate disease-activity-guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis (AS) in a prospective, randomized, open-label, multicentric study. Active AS patients with AS disease activity score (ASDAS) ⩾2.1 recruited from 10 hospitals were treated with rhTNFR:Fc 50 mg weekly for 12 weeks, and further randomized into different tapering or discontinuation groups according to ASDAS at week 12. Patients who achieved clinical remission (ASDAS < 1.3) were assigned randomly to stepwise tapering group or discontinuation group. Patients who achieved low disease activity (LDA, 1.3⩽ASDAS < 2.1) were assigned randomly to stepwise tapering, delayed tapering, or discontinuation group. All patients were evaluated every 12 weeks until week 48. The primary endpoint was cumulative flare rates in different groups at week 48. A total of 311 patients were enrolled with an average ASDAS of 3.6 ± 1.0, and 259 completed 12 weeks of rhTNFR:Fc induction therapy, with 148 patients (57.1%) achieved clinical remission, 100 (38.6%) achieved LDA, and 11 (4.3%) remained as high disease activity (ASDAS⩾2.1). In patients who achieved clinical remission at week ...Continue Reading

References

Nov 12, 2010·Annals of the Rheumatic Diseases·Pedro MachadoUNKNOWN Assessment of SpondyloArthritis international Society
Mar 5, 2011·Clinical Rheumatology·Victoria Navarro-CompánFederico Navarro-Sarabia
Oct 8, 2014·Experimental and Therapeutic Medicine·Ya-Fei LiuYong-Hong Hu
Jun 30, 2016·The New England Journal of Medicine·Joel D TaurogRobert A Colbert
Jan 15, 2017·Annals of the Rheumatic Diseases·Désirée van der HeijdeJürgen Braun
Mar 25, 2017·Rheumatology·Christopher J EdwardsKlaus Kruger
Apr 25, 2017·International Journal of Technology Assessment in Health Care·Heeyoung LeeEunyoung Kim
Feb 18, 2018·Annals of the Rheumatic Diseases·Pedro M MachadoUNKNOWN Assessment of SpondyloArthritis international Society (ASAS)

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Methods Mentioned

BETA
ESR

Clinical Trials Mentioned

NCT03880968

Software Mentioned

R
ASDAS

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