Connelly, Kathryn and Kandane-Rathnayake, Rangi and Hoi, Alberta and Louthrenoo, Worawit and Hamijoyo, Laniyati and Cho, Jiacai and Lateef, Aisha and Luo, Shue Fen and Wu, Yeong-Jian J. and Li, Zhanguo and Navarra, Sandra and Zamora, Leonid and Sockalingam, Sargunan and Hao, Yanjie and Zhang, Zhuoli and Katsumata, Yasuhiro and Harigai, Masayoshi and Oon, Shereen and Chan, Madelynn and Chen, Yi-Hsing and Bae, Sang-Cheol and O'Neill, Sean and Goldblatt, Fiona and Kikuchi, Jun and Takeuchi, Tsutomu and Ng, Kristine Pek Ling and Tugnet, Nicola and Basnayake, B. M. D. B. and Ohkubo, Naoaki and Tanaka, Yoshiya and Lau, Chak Sing and Nikpour, Mandana and Golder, Vera and Morand, Eric F. and Collaboration, Asia-Pacific Lupus (2022) Associations of improvement in laboratory tests with clinical outcomes in patients with active systemic lupus erythematosus: A multinational longitudinal cohort study. LANCET RHEUMATOLOGY, 4 (12). E831-E841. ISSN 2665-9913, DOI https://doi.org/10.1016/S2665-9913(22)00307-1.
Full text not available from this repository.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.
| Item Type: | Article |
|---|---|
| Funders: | Ministry of Education, Culture, Sports, Science and Technology, Japan (MEXT) Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (KAKENHI) [20H03720] |
| Uncontrolled Keywords: | DISEASE-ACTIVITY INDEX; C-REACTIVE PROTEIN; INITIAL VALIDATION; CLASSIFICATION; DEFINITION; TRIAL; ANIFROLUMAB; BELIMUMAB; CRITERIA; SLE |
| Subjects: | R Medicine > RA Public aspects of medicine |
| Divisions: | Faculty of Medicine > Medicine Department |
| Depositing User: | Ms Koh Ai Peng |
| Date Deposited: | 28 Oct 2024 07:50 |
| Last Modified: | 28 Oct 2024 07:50 |
| URI: | http://eprints.um.edu.my/id/eprint/46158 |
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