| Title | Associations of improvement in laboratory tests with clinical outcomes in patients with active systemic lupus erythematosus: a multinational longitudinal cohort study |
| Authors | Connelly, Kathryn Kandane-Rathnayake, Rangi Hoi, Alberta Louthrenoo, Worawit Hamijoyo, Laniyati Cho, Jiacai Lateef, Aisha Luo, Shue Fen Wu, Yeong-Jian J. Li, Zhanguo Navarra, Sandra Zamora, Leonid Sockalingam, Sargunan Hao, Yanjie Zhang, Zhuoli Katsumata, Yasuhiro Harigai, Masayoshi Oon, Shereen Chan, Madelynn Chen, Yi-Hsing Bae, Sang-Cheol O'Neill, Sean Goldblatt, Fiona Kikuchi, Jun Takeuchi, Tsutomu Ng, Kristine Pek Ling Tugnet, Nicola Basnayake, B. M. D. B. Ohkubo, Naoaki Tanaka, Yoshiya Lau, Chak Sing Nikpour, Mandana Golder, Vera Morand, Eric F. Asia-Pacific Lupus Collaboration |
| Affiliation | Monash Univ, Sch Clin Sci Monash Hlth, Clayton, VIC, Australia Chiang Mai Univ Hosp, Div Rheumatol, Dept Internal Med, Chiang Mai, Thailand Padjadjaran State Univ, Div Rheumatol, Dept Internal Med, Bandung, Indonesia Univ Med Cluster, Rheumatol Div, Natl Univ Hosp, Singapore, Singapore Chang Gung Mem Hosp, Dept Rheumatol Allergy & Immunol, Taoyuan, Taiwan Peking Univ, Hlth Sci Ctr, Peoples Hosp, Dept Rheumatol & Immunol, Beijing, Peoples R China Univ St Tomas Hosp, Bone & Joint Ctr, Manila, Philippines Univ Malaya, Dept Med, Kuala Lumpur, Malaysia Peking Univ First Hosp, Dept Rheumatol & Immunol, Beijing, Peoples R China Tokyo Womens Med Univ, Inst Rheumatol, Hosp Rheumat Dis, Tokyo, Japan St Vincents Hosp, Dept Rheumatol, Melbourne, Vic, Australia Tan Tock Seng Hosp, Dept Rheumatol Allergy & Immunol, Singapore, Singapore Taichung Vet Gen Hosp, Div Allergy Immunol & Rheumatol, Taichung, Taiwan Liverpool Hosp, Rheumatol Dept, Liverpool, NSW, Australia Royal Adelaide Hosp, Dept Rheumatol, Flinders Med Ctr, Bedford Pk, SA, Australia Royal Adelaide Hosp, Bedford Pk, SA, Australia Keio Univ, Div Rheumatol, Dept Internal Med, Tokyo, Japan North Shore Hosp, Dept Med, Auckland, New Zealand Greenlane Clin Ctr, Dept Rheumatol, Auckland, New Zealand Teaching Hosp Kandy, Div Nephrol, Kandy, Sri Lanka Univ Occupat & Environm Hlth, Dept Internal Med 1, Fukuoka, Japan Univ Hong Kong, Div Rheumatol & Clin Immunol, Dept Med, Hong Kong Special Adm Reg, Hong Kong, Peoples R China Monash Univ, Sch Clin Sci Monash Hlth, Monash Med Ctr, Clayton, Vic 3168, Australia |
| Keywords | DISEASE-ACTIVITY INDEX C-REACTIVE PROTEIN INITIAL VALIDATION CLASSIFICATION DEFINITION TRIAL ANIFROLUMAB BELIMUMAB CRITERIA SLE |
| Issue Date | Dec-2022 |
| Publisher | LANCET RHEUMATOLOGY |
| Abstract | Background The selection and categorisation of laboratory tests in disease activity measures used within systemic lupus erythematosus (SLE) trial endpoints lack strong evidence. We aimed to determine whether longitudinal improvements in routinely measured laboratory tests are associated with measures of clinical improvement in patients with baseline active SLE. Methods We included patients from a multicentre longitudinal cohort (recruited between May 1, 2013, and Dec 31, 2019) with active SLE (SLEDAI-2K >= 6) coinciding with an abnormality in at least one of 13 routine laboratory tests, at a visit designated as baseline. At 12 months, we analysed associations between thresholds of improvement in individual laboratory test results, measured as continuous variables, and five clinical outcomes using logistic regression. Primary outcomes were damage accrual and lupus low disease activity state (LLDAS), and secondary outcomes were modified SLE responder index (mSRI), physician global assessment (PGA) improvement of at least 0middot3, and flare. Findings We included 1525 patients (1415 [93%] women and 110 [7%] men, 1328 [87%] Asian ethnicity) in separate subsets for each laboratory test. The strongest associations with LLDAS and damage protection were seen with improvements in proteinuria (complete response: adjusted odds ratio [OR] 62middot48, 95% CI 18middot79-208middot31 for LLDAS, OR 0middot22, 95% CI 0middot10-0middot49 for damage accrual), albumin (complete response: adjusted OR 6middot46, 95% CI 2middot20-18middot98 for LLDAS, OR 0middot42, 95% CI 0middot20-1middot22 for damage accrual), haemoglobin (complete response: adjusted OR 1middot97, 95% CI 1middot09-3middot53 for LLDAS, OR 0middot33, 95% CI 0middot15-0middot71 for damage accrual), erythrocyte sedimentation rate (complete response: adjusted OR 1middot71, 95% CI 1middot10-2middot67 for LLDAS, OR 0middot53, 95% CI 0middot30-0middot94 for damage accrual), and platelets (complete response: adjusted OR 4middot82, 95% CI 1middot54-15middot07 for LLDAS, OR 0middot49, 95% CI 0middot20-1middot19 for damage accrual). Improvement in serological tests were mainly associated with PGA and mSRI. White cell and lymphocyte count improvements were least predictive. Interpretation Improvements in several routine laboratory tests correspond with clinical outcomes in SLE over 12 months. Tests with the strongest associations were discrepant with laboratory tests included in current trial endpoints, and associations were observed across a range of improvement thresholds including incomplete resolution. These findings suggest the need to revise the use of laboratory test results in SLE trial endpoints. Copyright (c) 2022 Published by Elsevier Ltd. All rights reserved. |
| URI | http://hdl.handle.net/20.500.11897/672060 |
| ISSN | 2665-9913 |
| DOI | 10.1016/S2665-9913(22)00307-1 |
| Indexed | SCI(E) |
| Appears in Collections: | 第一医院 |
