TY - JOUR
T1 - Predictors of new bone erosion in rheumatoid arthritis patients receiving conventional synthetic disease-modifying antirheumatic drugs
T2 - Analysis of data from the DRIVE and DESIRABLE studies
AU - Takeuchi, Tsutomu
AU - Soen, Satoshi
AU - Ishiguro, Naoki
AU - Yamanaka, Hisashi
AU - Tanaka, Sakae
AU - Kobayashi, Makiko
AU - Okubo, Naoki
AU - Nitta, Takaya
AU - Tanaka, Yoshiya
N1 - Funding Information:
This work was supported by Daiichi Sankyo Co., Ltd. TT received grant/research support from Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Mitsubishi Tanabe Pharma Corporation, Pfizer, Eisai Co., Ltd., Ayumi Pharmaceutical Corporation, Nipponkayaku Co., Ltd., and Novartis Pharma; speakers’ bureau fees from AbbVie GK, Bristol–Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Pfizer, Astellas Pharma Inc., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Sanofi, Teijin Pharma Ltd., Takeda Pharmaceutical Co., Ltd., and Novartis Pharma; and consulting fees from AstraZeneca, Eli Lilly, Novartis Pharma, Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Nippon Kayaku Co., Ltd., Janssen, Astellas Pharma Inc., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co, Ltd., Taisho Toyama Pharmaceutical Co., Ltd., GlaxoSmithKline, and UCB. SS received grant/research support from Chugai Pharmaceutical Co., Ltd. and Daichi Sankyo Co., Ltd.; and speakers’ bureau fees from Asahi Kasei Pharma Corp., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly, Eisai Co., Ltd., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Pfizer. NI received grant/research support from Astellas Pharma Inc., AbbVie GK, Asahi Kasei Corporation, Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Kaken Pharmaceutical Co., Ltd., Medical Corporation Sanjikai, Medical Corporation Toukoukai, Mitsubishi Tanabe Pharma Corporation, Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Company Ltd., Zimmer Biomet G.K., Astellas Pharma Inc., Eli Lilly, Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Pfizer, and Bristol–Myers Squibb; speakers’ bureau fees from Astellas, Bristol–Myers Squibb, Daiichi Sankyo, Eli Lilly, Pfizer, and Taisho Toyama; and consulting fees or other remuneration from Ono Pharmaceutical Co., Ltd. HY received grant/research support from AbbVie, Eisai Co., Ltd., Bristol–Meyers Squibb, Novartis Pharma, Nippon Boehringer Ingelheim Co., Ltd., Astellas Pharma Inc., Kaken Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Pfizer, UCB, Ayumi Pharmaceutical Corporation, Ono Pharmaceutical Co., Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd, Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Chugai Pharmaceutical Co., Ltd., Teijin Pharma Limited, Torii Pharmaceutical Co., Ltd., and YL Biologics Ltd.; and speakers’ bureau fees from Pfizer, Takeda Pharmaceutical Co., Ltd., YL Biologics Ltd., Teijin Pharma Limited, Daiichi Sankyo Co., Ltd., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Bristol–Meyers Squibb, and Mitsubishi Tanabe Pharma Corporation. ST received grant/research support from KYOCERA Corporation and Asahi Kasei Corporation; consulting fees from Amgen Astellas BioPharma K.K., KYOCERA Corporation, Pfizer, and Daiichi Sankyo Co., Ltd.; and speakers’ bureau fees from Asahi Kasei Corporation, Astellas Pharma Inc., Ayumi Pharmaceutical Corporation, Eisai Co., Ltd., Ono Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd, Taisho Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Chugai Pharmaceutical Co., Ltd., Teijin Pharma Ltd., Eli Lilly, Hisamitsu Pharmaceutical Co., Inc., Pfizer, and Bristol–Myers Squibb. MK, NO, and TN are employees of Daiichi Sankyo Co., Ltd. YT received speaking fees and/or honoraria from Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-MyersSquibb, Takeda, Mitsubishi Tanabe, Novartis, Eisai, Janssen, Teijin and has received research grants from Asahi Kasei, Mitsubishi Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers Squibb, UCB, Daiichi-Sankyo, Eisai, Ono.
Funding Information:
The authors thank Ingrid de Ruiter, MBChB, PhD, and Clare Cox, PhD, of Edanz Medical Writing for providing medical writing support. The authors also thank Takeshi Ohira of Daiichi Sankyo Co., Ltd., for his advice.
Publisher Copyright:
© 2020 Japan College of Rheumatology Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2021
Y1 - 2021
N2 - Objective: To investigate new bone erosion and cartilage destruction predictors in rheumatoid arthritis (RA) patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Methods: Placebo-treated patient data from two 12-month, randomized, double-blind, phase 2 (DRIVE) and 3 (DESIRABLE) trials that evaluated denosumab efficacy in csDMARD-treated RA patients were used. Change from baseline in erosion score (ES) of ≥1.0 at 12 months was considered new bone erosion; predictors were identified using a multivariate model. Results: Among 306 patients, mean ± standard deviation disease activity score 28–C-reactive protein (CRP) at baseline was 3.58 ± 1.03. New bone erosion was observed in 90 patients (29.4%). Univariate analysis identified female sex, anti-cyclic citrullinated peptide (CCP) antibody positivity, rheumatoid factor (RF) positivity, tender joint count ≥6, CRP ≥0.3 mg/dL, erythrocyte sedimentation rate (ESR) ≥28 mm/h, and baseline ES ≥3 as significant predictors for new bone erosion. In multivariate analysis, predictors were anti-CCP antibody positivity, CRP ≥0.3 mg/dL, and baseline ES ≥3; RF and ESR were excluded as they strongly correlated with anti-CCP antibody and CRP, respectively. Conclusion: In RA patients treated with csDMARDs, new bone erosion predictors were seropositivity, elevated inflammatory markers, and baseline ES ≥3. Trial registration number: DRIVE, JapicCTI-101263; DESIRABLE, NCT01973569.
AB - Objective: To investigate new bone erosion and cartilage destruction predictors in rheumatoid arthritis (RA) patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Methods: Placebo-treated patient data from two 12-month, randomized, double-blind, phase 2 (DRIVE) and 3 (DESIRABLE) trials that evaluated denosumab efficacy in csDMARD-treated RA patients were used. Change from baseline in erosion score (ES) of ≥1.0 at 12 months was considered new bone erosion; predictors were identified using a multivariate model. Results: Among 306 patients, mean ± standard deviation disease activity score 28–C-reactive protein (CRP) at baseline was 3.58 ± 1.03. New bone erosion was observed in 90 patients (29.4%). Univariate analysis identified female sex, anti-cyclic citrullinated peptide (CCP) antibody positivity, rheumatoid factor (RF) positivity, tender joint count ≥6, CRP ≥0.3 mg/dL, erythrocyte sedimentation rate (ESR) ≥28 mm/h, and baseline ES ≥3 as significant predictors for new bone erosion. In multivariate analysis, predictors were anti-CCP antibody positivity, CRP ≥0.3 mg/dL, and baseline ES ≥3; RF and ESR were excluded as they strongly correlated with anti-CCP antibody and CRP, respectively. Conclusion: In RA patients treated with csDMARDs, new bone erosion predictors were seropositivity, elevated inflammatory markers, and baseline ES ≥3. Trial registration number: DRIVE, JapicCTI-101263; DESIRABLE, NCT01973569.
KW - Anti-cyclic citrullinated peptide
KW - bone erosion
KW - predictors
KW - rheumatoid arthritis
KW - tender joint count
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U2 - 10.1080/14397595.2019.1703484
DO - 10.1080/14397595.2019.1703484
M3 - Article
C2 - 31826682
AN - SCOPUS:85078590129
SN - 1439-7595
VL - 31
SP - 34
EP - 41
JO - Modern rheumatology
JF - Modern rheumatology
IS - 1
ER -