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Development of the Sjögren's Syndrome Responder Index, a data-driven composite endpoint for assessing treatment efficacy
- Source :
- Rheumatology, Rheumatology, Oxford University Press (OUP), 2015, 54 (9), pp.1699--1708. ⟨10.1093/rheumatology/kev114⟩, Rheumatology, Oxford University Press (OUP), 2015, 54 (9), pp.1699-708. ⟨10.1093/rheumatology/kev114⟩, Rheumatology, Oxford University Press (OUP), 2015, 54 (9), pp.1699-708. 〈10.1093/rheumatology/kev114〉, Rheumatology, 54(9), 1699-1708. Oxford University Press, Rheumatology, 2015, 54 (9), pp.1699-708. ⟨10.1093/rheumatology/kev114⟩, Rheumatology, Oxford University Press (OUP), 2015, 54 (9), pp.1699--1708, Rheumatology, 2015, 54 (9), pp.1699--1708. ⟨10.1093/rheumatology/kev114⟩
- Publication Year :
- 2014
-
Abstract
- International audience; Objectives. To determine which outcome measures detected rituximab efficacy in the Tolerance and Efficacy of Rituximab in Sjo¨gren's Disease (TEARS) trial and to create a composite endpoint for future trials in primary SS (pSS). Methods. Post hoc analysis of the multicentre randomized placebo-controlled double-blind TEARS trial. The results were validated using data from two other randomized controlled trials in pSS, assessing rituximab (single-centre trial in the Netherlands) and infliximab, respectively. Results. Five outcome measures were improved by rituximab in the TEARS trial: patient-assessed visual analogue scale scores for fatigue, oral dryness and ocular dryness, unstimulated whole salivary flow and ESR. We combined these measures into a composite endpoint, the SS Responder Index (SSRI), and we defined an SSRI-30 response as a 530% improvement in at least two of five outcome measures. In TEARS, the proportions of patients with an SSRI-30 response in the rituximab and placebo groups at 6, 16 and 24 weeks were 47% vs 21%, 50% vs 7% and 55% vs 20%, respectively (P < 0.01 for all comparisons). SSRI-30 response rates after 12 and 24 weeks in the single-centre rituximab trial were 68% (13/19) vs 40% (4/10) and 74% (14/19) vs 40% (4/10), respectively. No significant differences in SSRI-30 response rates were found between infliximab and placebo at any of the time points in the infliximab trial. Conclusion. A core set of outcome measures used in combination suggests that rituximab could be effective and infliximab ineffective in pSS. The SSRI might prove useful as the primary outcome measure for future therapeutic trials in pSS.
- Subjects :
- Male
[SDV]Life Sciences [q-bio]
efficacy
primary Sjogren's syndrome
DISEASE
law.invention
DOUBLE-BLIND
0302 clinical medicine
Randomized controlled trial
law
Outcome Assessment, Health Care
Medicine
Pharmacology (medical)
Fatigue
Netherlands
0303 health sciences
Incidence
Middle Aged
primary Sjo¨gren's syndrome
3. Good health
Sjogren's Syndrome
Treatment Outcome
[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system
Rheumatoid arthritis
Antirheumatic Agents
Rituximab
Female
CLINICAL-TRIALS
medicine.drug
Adult
medicine.medical_specialty
Visual analogue scale
Endpoint Determination
ESSPRI
primary Sjögren’s syndrome
IMPROVEMENT
Blood Sedimentation
CONTROLLED-TRIAL
Placebo
Xerostomia
[ SDV.MHEP.RSOA ] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system
outcome measures
03 medical and health sciences
Rheumatology
[ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology
Internal medicine
Post-hoc analysis
Humans
030304 developmental biology
Aged
030203 arthritis & rheumatology
[ SDV ] Life Sciences [q-bio]
business.industry
RITUXIMAB TREATMENT
Reproducibility of Results
medicine.disease
eye diseases
Infliximab
RHEUMATOID-ARTHRITIS
Surgery
Clinical trial
stomatognathic diseases
business
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
ESSDAI
Subjects
Details
- ISSN :
- 14620332, 14620324, and 14602172
- Volume :
- 54
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Rheumatology (Oxford, England)
- Accession number :
- edsair.doi.dedup.....bd9995ef152b9732b67bcb32128ea80e