Mahmoud, K, Zayat, AS, Yusof, Y et al. (4 more authors) (2019) Responsiveness of clinical and ultrasound outcome measures in musculoskeletal systemic lupus erythematosus. Rheumatology, 58 (8). key422. pp. 1353-1360. ISSN 1462-0324
Abstract
Objective
To assess the responsiveness of clinical outcome measures in musculoskeletal SLE compared with ultrasound.
Methods
A prospective pilot study was conducted in consecutive SLE patients with inflammatory musculoskeletal symptoms. Clinical assessments including SLEDAI, BILAG, 28-tender and swollen joint counts, physician and patient VAS and ultrasound were performed at 0, 2 and 4 weeks following 120mg intramuscular methylprednisolone acetate. Responsiveness was analysed using changes and effect sizes using Cohen’s criteria.
Results
20 patients were recruited. 15/20 had clinical swelling at baseline. All clinical and US parameters were significantly improved at week 4 (all p≤0.01). Musculoskeletal-BILAG score improved in 16/20. Musculoskeletal-SLEDAI improved in 7/20. SRI-4 criteria were assessed in 19 patients with SLEDAI>= 4 at baseline met in 9/19 at 4 weeks. Effect sizes at 4 weeks were large (>0.5) for US, physician VAS and BILAG and medium (>0.3) for joint counts and SLEDAI. Large effect sizes for improvement in US GS and PD were observed in both SRI responders (r=-0.51 and -0.56 respectively) and non-responders (r=-0.62 and -0.59) at 4 weeks.
Conclusions
This is the first study to measure the responsiveness of clinical outcome measures in musculoskeletal SLE against an objective inflammation measure. BILAG and physician VAS were the most responsive clinical instruments. US was highly responsive in musculoskeletal SLE, while SLEDAI and joint counts appeared suboptimal for detection of improvement. These results suggest that clinical trials based on the SLEDAI and SRI-4 may underestimate the efficacy of therapy in SLE
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology. 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 non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
Keywords: | systematic lupus erythematosus; lupus arthritis; BILAG; SLEDAI; synovium; tendons and ligaments; outcome measures; ultrasonography |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Clinical Musculoskeletal Medicine (LIRMM) (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Inflammatory Arthritis (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Musculoskeletal Medicine & Imaging (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research CS-2013-13-032 Lupus UK USEFUL |
Depositing User: | Symplectic Publications |
Date Deposited: | 06 Nov 2018 13:06 |
Last Modified: | 25 Jun 2023 21:35 |
Status: | Published |
Publisher: | Oxford University Press |
Identification Number: | 10.1093/rheumatology/key422 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:138241 |