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Radiographic progression based on baseline characteristics from TNF inhibitor biosimilar studies in patients with rheumatoid arthritis

Authors :
Josef S. Smolen
Young Mo Kang
Wan-Hee Yoo
Paul Emery
Michael E. Weinblatt
Edward C. Keystone
Mark C. Genovese
Gihyun Myung
Inyoung Baek
Jeehoon Ghil
Source :
Arthritis Research & Therapy, Vol 22, Iss 1, Pp 1-9 (2020)
Publication Year :
2020
Publisher :
BMC, 2020.

Abstract

Abstract Objective Phase III clinical trials of the tumour necrosis factor inhibitors SB4, SB2, and SB5 (biosimilars to etanercept, infliximab, and adalimumab, respectively) have demonstrated efficacy in moderate-to-severe rheumatoid arthritis (RA). Data from these trials were used to identify baseline characteristics associated with radiographic progression and to build a matrix risk model for its prediction. Methods Patients with radiographic progression and baseline demographic and disease characteristic data were pooled across the 3 phase III studies of each biosimilar and its reference product. Baseline demographics and disease characteristics were evaluated for their relationship with radiographic progression (1-year mean change in mTSS > 0); 3 factors were selected based on strongest Pearson’s correlation coefficient with the change in modified Total Sharp Score. Univariate logistic regression was performed to assess the association between each baseline factor and the rate of radiographic progression, with subsequent matrix model development performed using multivariate logistic regression. Results A total of 1371 patients were included in the analysis, with a radiographic progression rate of 27.4%. The 3 baseline predictors of radiographic progression, based on Pearson’s correlation coefficient, were 28 swollen joint count (SJC28), C-reactive protein (CRP), and physician global assessment (PhGA). A matrix model showed that the predicted risk of radiographic progression was higher with the increased level of SJC28, CRP, and PhGA (P

Details

Language :
English
ISSN :
14786362
Volume :
22
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Arthritis Research & Therapy
Publication Type :
Academic Journal
Accession number :
edsdoj.078e3fc0c86e4ce59dfa6b3cf0caed92
Document Type :
article
Full Text :
https://doi.org/10.1186/s13075-020-02267-z