Lydia Ho-Pui Tam1,2, Qing Shang1,2, Edmund Kwok-Ming Li1,2, Priscilla Ching-Han Wong1,2, Kitty Yan Kwok1,2, Emily Wai-Lin Kun1,2, Isaac Cheuk-Wan Yim1,2, Violet Ka-Lai Lee1,2, Ronald Man-Lung Yip1,2, Steve Hin-Ting Pang1,2, Virginia Weng-Nga Lao1,2, Queenie Wah-Yan Mak1,2, Isaac Tsz-Ho Cheng1,2, Xerox Sze-Lok Lau1,2, Tena Ka-Yan Li1,2, Tracy Yaner Zhu1,2, Alex Pui-Wai Lee1,2, Lai-Shan Tam3,4. 1. From the Department of Medicine and Therapeutics, and Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong; Department of Medicine, Queen Elizabeth Hospital; Department of Medicine, Tai Po Hospital; Department of Medicine, Tseung Kwan O Hospital; Department of Medicine, Pamela Youde Nethersole Eastern Hospital; Department of Medicine, Kwong Wah Hospital, Hong Kong. 2. L.H. Tam, MBChB, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; Q. Shang, Research Assistant Professor, PhD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; E.K. Li, Professor, MD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; P.C. Wong, Associate Consultant, FHKAM, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; K.Y. Kwok, Associate Consultant, FHKAM, Department of Medicine, Queen Elizabeth Hospital; E.W. Kun, Consultant, FRCP, Department of Medicine, Tai Po Hospital; I.C. Yim, Associate Consultant, FRCP, Department of Medicine, Tseung Kwan O Hospital; V.K. Lee, Associate Consultant, FHKAM, Department of Medicine, Pamela Youde Nethersole Eastern Hospital; R.M. Yip, Associate Consultant, FRCP, Department of Medicine, Kwong Wah Hospital; S.H. Pang, Associate Consultant, FHKAM, Department of Medicine, Kwong Wah Hospital; V.W. Lao, Associate Consultant, FHKAM, Department of Medicine, Kwong Wah Hospital; Q.W. Mak, Research Assistant, PgD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; I.T. Cheng, Research Assistant, MSc, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; X.S. Lau, Research Assistant, MPH, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; T.K. Li, Nursing Officer, BN, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; T.Y. Zhu, scientific officer, PhD, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong; A.P. Lee, Assistant Professor, MD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; L.S. Tam, Professor, MD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong. 3. From the Department of Medicine and Therapeutics, and Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong; Department of Medicine, Queen Elizabeth Hospital; Department of Medicine, Tai Po Hospital; Department of Medicine, Tseung Kwan O Hospital; Department of Medicine, Pamela Youde Nethersole Eastern Hospital; Department of Medicine, Kwong Wah Hospital, Hong Kong. lstam@cuhk.edu.hk. 4. L.H. Tam, MBChB, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; Q. Shang, Research Assistant Professor, PhD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; E.K. Li, Professor, MD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; P.C. Wong, Associate Consultant, FHKAM, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; K.Y. Kwok, Associate Consultant, FHKAM, Department of Medicine, Queen Elizabeth Hospital; E.W. Kun, Consultant, FRCP, Department of Medicine, Tai Po Hospital; I.C. Yim, Associate Consultant, FRCP, Department of Medicine, Tseung Kwan O Hospital; V.K. Lee, Associate Consultant, FHKAM, Department of Medicine, Pamela Youde Nethersole Eastern Hospital; R.M. Yip, Associate Consultant, FRCP, Department of Medicine, Kwong Wah Hospital; S.H. Pang, Associate Consultant, FHKAM, Department of Medicine, Kwong Wah Hospital; V.W. Lao, Associate Consultant, FHKAM, Department of Medicine, Kwong Wah Hospital; Q.W. Mak, Research Assistant, PgD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; I.T. Cheng, Research Assistant, MSc, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; X.S. Lau, Research Assistant, MPH, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; T.K. Li, Nursing Officer, BN, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; T.Y. Zhu, scientific officer, PhD, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong; A.P. Lee, Assistant Professor, MD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong; L.S. Tam, Professor, MD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong. lstam@cuhk.edu.hk.
Abstract
OBJECTIVE: To determine the efficacy of 2 tight control treatment strategies aiming at Simplified Disease Activity Score (SDAI) remission (SDAI ≤ 3.3) compared to 28-joint count Disease Activity Score (DAS28) remission (DAS28 < 2.6) in the prevention of arterial stiffness in patients with early rheumatoid arthritis (RA). METHODS: This was an open-label study in which 120 patients with early RA were randomized to receive 1 year of tight control treatment. Group 1 (n = 60) aimed to achieve SDAI ≤ 3.3 and Group 2 (n = 60), DAS28 < 2.6. Pulse wave velocity (PWV) and augmentation index (AIx) were measured at baseline and 12 months. A posthoc analysis was also performed to ascertain whether achieving sustained remission could prevent progression in arterial stiffness. RESULTS: The proportions of patients receiving methotrexate monotherapy were significantly lower in Group 1 throughout the study period. At 12 months, the proportions of patients achieving DAS28 and SDAI remission, and the change in PWV and AIx, were comparable between the 2 groups. In view of the lack of differences between the 2 groups, a posthoc analysis was performed at Month 12, including all 110 patients with PWV, to elucidate the independent predictors associated with the change in PWV. Multivariate analysis revealed that achieving sustained DAS28 remission at months 6, 9, and 12 and a shorter disease duration were independent explanatory variables associated with less progression of PWV. CONCLUSION: With limited access to biologic disease-modifying antirheumatic drugs, treatment efforts toward DAS28 and SDAI remission had similar effects in preventing the progression of arterial stiffness at 1 year. However, achieving sustained DAS28 remission was associated with a significantly greater improvement in PWV. [Clinical Trial registration: Clinicaltrial.gov NCT01768923.].
RCT Entities:
OBJECTIVE: To determine the efficacy of 2 tight control treatment strategies aiming at Simplified Disease Activity Score (SDAI) remission (SDAI ≤ 3.3) compared to 28-joint count Disease Activity Score (DAS28) remission (DAS28 < 2.6) in the prevention of arterial stiffness in patients with early rheumatoid arthritis (RA). METHODS: This was an open-label study in which 120 patients with early RA were randomized to receive 1 year of tight control treatment. Group 1 (n = 60) aimed to achieve SDAI ≤ 3.3 and Group 2 (n = 60), DAS28 < 2.6. Pulse wave velocity (PWV) and augmentation index (AIx) were measured at baseline and 12 months. A posthoc analysis was also performed to ascertain whether achieving sustained remission could prevent progression in arterial stiffness. RESULTS: The proportions of patients receiving methotrexate monotherapy were significantly lower in Group 1 throughout the study period. At 12 months, the proportions of patients achieving DAS28 and SDAI remission, and the change in PWV and AIx, were comparable between the 2 groups. In view of the lack of differences between the 2 groups, a posthoc analysis was performed at Month 12, including all 110 patients with PWV, to elucidate the independent predictors associated with the change in PWV. Multivariate analysis revealed that achieving sustained DAS28 remission at months 6, 9, and 12 and a shorter disease duration were independent explanatory variables associated with less progression of PWV. CONCLUSION: With limited access to biologic disease-modifying antirheumatic drugs, treatment efforts toward DAS28 and SDAI remission had similar effects in preventing the progression of arterial stiffness at 1 year. However, achieving sustained DAS28 remission was associated with a significantly greater improvement in PWV. [Clinical Trial registration: Clinicaltrial.gov NCT01768923.].