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Lookup NU author(s): Dr Alexis Collins, Dr Dennis LendremORCiD, Professor James WasonORCiD, Dr Jessica Tarn, Dr Nadia Howard-Tripp, Professor Fai NgORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2021, The Author(s). To re-analyse the clinical outcomes and interferon (IFN) activity data from the JOQUER trial, a phase III trial investigating hydroxychloroquine (HCQ) in patients with primary Sjögren’s syndrome (pSS), after stratifying patients into putative pathobiological subgroups utilizing the Newcastle Sjögren’s Stratification Tool (NSST) based on patient-reported symptoms of dryness, pain, fatigue, anxiety and depression. 107 patients were assigned to one of four subgroups using NSST at baseline—the high symptom burden (HSB), pain dominant with fatigue (PDF), dryness dominant with fatigue (DDF) and low symptom burden (LSB). Endpoints were re-analysed after stratification, testing for treatment differences within subgroups and adjusting for baseline differences using a repeated measures covariate model. The HSB subgroup (n = 32) showed a relative improvement in ESSPRI of 1.49 points (95% CI 0.54–2.43; p = 0.002) within 12 weeks in patients taking HCQ compared to placebo, with no further changes after 24 weeks. For the LSB subgroup (n = 14), the ESSPRI worsened in the placebo but not the HCQ arm after 12 weeks (mean difference 1.44, 95% CI 0.05–2.83, p = 0.042). Neither the HSB nor the LSB patients showed significant changes in IFN activity at 24 weeks. There were no significant differences in ESSPRI in the PDF (n = 39) and DDF (n = 22) patients taking HCQ. However, significant reductions in overall IFN score at 24 weeks were seen in both PDF (difference at 24 weeks; 6.41, 95% CI, 2.48–10.34, p = 0.002) and DDF (difference at 24 weeks; 7.23, 95% CI, 1.85–12.6, p = 0.009) without improvement in ESSPRI. Although the JOQUER trial reported no overall benefit from HCQ in pSS patients, stratification suggests that both HSB and LSB subgroups may respond to HCQ. However, these patients may benefit through mechanisms other than the reduction of IFN activities.
Author(s): Collins A, Lendrem D, Wason J, Tarn J, Howard-Tripp N, Bodewes I, Versnel MA, Gottenberg J-E, Seror R, Mariette X, Ng W-F
Publication type: Article
Publication status: Published
Journal: Rheumatology International
Year: 2021
Volume: 41
Pages: 1593-1600
Print publication date: 01/09/2021
Online publication date: 24/06/2021
Acceptance date: 14/06/2021
Date deposited: 08/07/2021
ISSN (print): 0172-8172
ISSN (electronic): 1437-160X
Publisher: Springer Science and Business Media Deutschland GmbH
URL: https://doi.org/10.1007/s00296-021-04927-y
DOI: 10.1007/s00296-021-04927-y
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