On-line First

J Rheum Dis

Published online January 29, 2024

© Korean College of Rheumatology

Real-world effectiveness of a single conventional disease-modifying anti-rheumatic drug (cDMARD) plus an anti-TNF agent versus multiple cDMARDs in rheumatoid arthritis: a prospective observational study

Min Wook So, M.D., Ph.D.1 , Sang-Hyon Kim, M.D., Ph.D.2 , Dong Wook Kim, M.D., Ph.D.3 , Yoon-Kyoung Sung, M.D., Ph.D., MPH4 , Jung-Yoon Choe, M.D., Ph.D.5 , Sang-Il Lee, M.D., Ph.D.6 , Jin-Wuk Hur, M.D., Ph.D.7 , Hye-Soon Lee, M.D., Ph.D.8 , Sang-Heon Lee, M.D., Ph.D.9 , Jin Ran Kim, PharmD10

1Division of Rheumatology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, 2Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, 3Division of Rheumatology, Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, 4Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 5Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, 6Department of Internal Medicine and Institute of Health Science, Gyeongsang National University School of Medicine and Hospital, Jinju, 7Department of Internal Medicine, Eulji University College of Medicine, Seoul, 8Division of Rheumatology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, 9Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, 10Medical Department, MSL, Eisai Korea Inc., Seoul, Korea

Correspondence to : Sang-Heon Lee, https://orcid.org/0000-0002-7539-9330
Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, 120-1 Neungdong-ro, Gwangjin-gu, Seoul 05030, Korea. E-mail: shlee@kuh.ac.kr

Received: August 9, 2023; Revised: November 15, 2023; Accepted: December 6, 2023

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective: The objective of this prospective, observational multicenter study (NCT03264703) was to compare the effectiveness of single conventional disease-modifying anti-rheumatic drug (cDMARD) plus anti-tumor necrosis factor (TNF) therapy versus multiple cDMARD treatments in patients with moderate-to-severe rheumatoid arthritis (RA) following cDMARD failure in the real-world setting in South Korea.
Methods: At the treating physicians’ discretion, patients received single cDMARD plus anti-TNF therapy or multiple cDMARDs. Changes from baseline in disease activity score 28-joint count with erythrocyte sedimentation rate (DAS28-ESR), corticosteroid use, and Korean Health Assessment Questionnaire (KHAQ-20) scores were evaluated at 3, 6, and 12 months.
Results: Of 207 enrollees, the final analysis included 45 of 73 cDMARD plus anti-TNF and 91 of 134 multiple-cDMARD recipients. There were no significant between-group differences (BGDs) in ANCOVA-adjusted changes from baseline in DAS28-ESR at 3, 6 (primary endpoint), and 12 months (BGDs −0.18, −0.38, and −0.03, respectively). More cDMARD plus anti-TNF than multiple-cDMARD recipients achieved a >50% reduction from baseline in corticosteroid dosage at 12 months (35.7% vs 14.6%; p=0.007). Changes from baseline in KHAQ-20 scores at 3, 6, and 12 months were significantly better with cDMARD plus anti-TNF therapy than with multiple cDMARDs (BGD −0.18, −0.19, and −0.19 points, respectively; all p≤ 0.024).
Conclusion: In the real-world setting, relative to multiple cDMARDs, single cDMARD plus anti-TNF therapy significantly improved quality-of-life scores and reduced corticosteroid use, with no significant BGD in disease activity, in RA patients in whom previous cDMARD therapy had failed.

Keywords Rheumatoid arthritis, Disease-modifying anti-rheumatic drugs, Tumor necrosis factor inhibitors

Article

On-line First

J Rheum Dis

Published online January 29, 2024

Copyright © Korean College of Rheumatology.

Real-world effectiveness of a single conventional disease-modifying anti-rheumatic drug (cDMARD) plus an anti-TNF agent versus multiple cDMARDs in rheumatoid arthritis: a prospective observational study

Min Wook So, M.D., Ph.D.1 , Sang-Hyon Kim, M.D., Ph.D.2 , Dong Wook Kim, M.D., Ph.D.3 , Yoon-Kyoung Sung, M.D., Ph.D., MPH4 , Jung-Yoon Choe, M.D., Ph.D.5 , Sang-Il Lee, M.D., Ph.D.6 , Jin-Wuk Hur, M.D., Ph.D.7 , Hye-Soon Lee, M.D., Ph.D.8 , Sang-Heon Lee, M.D., Ph.D.9 , Jin Ran Kim, PharmD10

1Division of Rheumatology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, 2Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, 3Division of Rheumatology, Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, 4Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 5Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, 6Department of Internal Medicine and Institute of Health Science, Gyeongsang National University School of Medicine and Hospital, Jinju, 7Department of Internal Medicine, Eulji University College of Medicine, Seoul, 8Division of Rheumatology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, 9Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, 10Medical Department, MSL, Eisai Korea Inc., Seoul, Korea

Correspondence to:Sang-Heon Lee, https://orcid.org/0000-0002-7539-9330
Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, 120-1 Neungdong-ro, Gwangjin-gu, Seoul 05030, Korea. E-mail: shlee@kuh.ac.kr

Received: August 9, 2023; Revised: November 15, 2023; Accepted: December 6, 2023

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective: The objective of this prospective, observational multicenter study (NCT03264703) was to compare the effectiveness of single conventional disease-modifying anti-rheumatic drug (cDMARD) plus anti-tumor necrosis factor (TNF) therapy versus multiple cDMARD treatments in patients with moderate-to-severe rheumatoid arthritis (RA) following cDMARD failure in the real-world setting in South Korea.
Methods: At the treating physicians’ discretion, patients received single cDMARD plus anti-TNF therapy or multiple cDMARDs. Changes from baseline in disease activity score 28-joint count with erythrocyte sedimentation rate (DAS28-ESR), corticosteroid use, and Korean Health Assessment Questionnaire (KHAQ-20) scores were evaluated at 3, 6, and 12 months.
Results: Of 207 enrollees, the final analysis included 45 of 73 cDMARD plus anti-TNF and 91 of 134 multiple-cDMARD recipients. There were no significant between-group differences (BGDs) in ANCOVA-adjusted changes from baseline in DAS28-ESR at 3, 6 (primary endpoint), and 12 months (BGDs −0.18, −0.38, and −0.03, respectively). More cDMARD plus anti-TNF than multiple-cDMARD recipients achieved a >50% reduction from baseline in corticosteroid dosage at 12 months (35.7% vs 14.6%; p=0.007). Changes from baseline in KHAQ-20 scores at 3, 6, and 12 months were significantly better with cDMARD plus anti-TNF therapy than with multiple cDMARDs (BGD −0.18, −0.19, and −0.19 points, respectively; all p≤ 0.024).
Conclusion: In the real-world setting, relative to multiple cDMARDs, single cDMARD plus anti-TNF therapy significantly improved quality-of-life scores and reduced corticosteroid use, with no significant BGD in disease activity, in RA patients in whom previous cDMARD therapy had failed.

Keywords: Rheumatoid arthritis, Disease-modifying anti-rheumatic drugs, Tumor necrosis factor inhibitors

JRD
Jan 01, 2024 Vol.31 No.1, pp. 1~63
COVER PICTURE
Characteristic findings in interstitial lung disease (ILD) detected by lung ultrasound. Lung ultrasound can reveal characteristic findings in ILD. However, the definitive diagnosis of ILD typically requires a combination of clinical assessment, imaging studies (such as high-resuloution computed tomography [HRCT]), and sometimes a lung biopsy. (A) Traction bronchiectasis and parenchymal changes of upper lung in HRCT (arrows). (B) Corresponding changes of lung ultrasound presented by B-lines (arrows). (J Rheum Dis 2024;31:3-14)

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