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Revisiting the JOQUER trial: stratification of primary Sjögren’s syndrome and the clinical and interferon response to hydroxychloroquine
- Source :
- Rheumatology International, Rheumatology International, 2021, 41 (9), pp.1593-1600. ⟨10.1007/s00296-021-04927-y⟩, Rheumatology International, 41(9), 1593-1600. Springer-Verlag
- Publication Year :
- 2021
- Publisher :
- Springer Berlin Heidelberg, 2021.
-
Abstract
- 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.
- Subjects :
- medicine.medical_specialty
[SDV]Life Sciences [q-bio]
Immunology
Placebo
03 medical and health sciences
0302 clinical medicine
Rheumatology
Interferon
Internal medicine
medicine
Immunology and Allergy
Clinical Trials
030212 general & internal medicine
Depression (differential diagnoses)
030203 arthritis & rheumatology
business.industry
Repeated measures design
Hydroxychloroquine
[SDV] Life Sciences [q-bio]
Sjögren’s syndrome
Anxiety
Sjögren's syndrome
Sjogren s
medicine.symptom
business
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 1437160X and 01728172
- Volume :
- 41
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Rheumatology International
- Accession number :
- edsair.doi.dedup.....88c86ea804fcea67c47e0ad5df1a4d7d