Responsiveness of disease activity indices ESSPRI and ESSDAI in patients with primary Sjögren's syndrome treated with rituximab
- 17 January 2012
- journal article
- research article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 71 (8), 1297-1302
- https://doi.org/10.1136/annrheumdis-2011-200460
Abstract
Objective To evaluate the responsiveness of the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) and EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) in patients with primary Sjögren's syndrome (pSS) treated with rituximab. Methods Twenty-eight patients with pSS treated with rituximab (1000 mg) infusions on days 1 and 15 were included in the study. Data were collected prospectively at baseline and 16, 24, 36, 48 and 60 weeks after treatment. Internal responsiveness was assessed using standardised response means (SRM) and effect sizes (ES). SRM and ES 0.8 were interpreted as small, moderate and large, respectively. External responsiveness was assessed using Spearman correlation coefficients. Results Median (range) ESSPRI and ESSDAI scores at baseline were 6.7 (0.3–9.0) and 8 (2–18), respectively. Both indices improved significantly after treatment. SRM and ES values for ESSPRI and ESSDAI were ≥0.8 at week 16 and decreased afterwards, and were larger for ESSDAI than for ESSPRI. SRM and ES values for patient's and physician's global disease activity (GDA) and rheumatoid factor broadly followed the pattern of those of ESSPRI and ESSDAI. SRM and ES for stimulated whole salivary flow were small at all time points. At baseline and for most change scores, moderate to good correlations were found between ESSPRI and patient's GDA and between ESSDAI and physician's GDA. Poor association was found between ESSPRI and ESSDAI. Conclusions ESSPRI and ESSDAI are sensitive measures of change in disease activity after therapeutic intervention, which supports the usefulness of these indices for future clinical trials in patients with pSS. The responsiveness of ESSDAI was greater than that of ESSPRI.Keywords
This publication has 27 references indexed in Scilit:
- Current and Future Challenges in Primary Sjogren’s SyndromeCurrent Pharmaceutical Biotechnology, 2012
- What have we learned from clinical trials in primary Sjögren's syndrome about pathogenesis?Arthritis Research & Therapy, 2011
- Treatment of Primary Sjögren SyndromeJAMA, 2010
- Effectiveness of rituximab treatment in primary Sjögren's syndrome: A randomized, double‐blind, placebo‐controlled trialArthritis & Rheumatism, 2010
- Health-related quality of life, employment and disability in patients with Sjögren's syndromeRheumatology, 2009
- Reduction of fatigue in Sjogren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot studyAnnals Of The Rheumatic Diseases, 2008
- Tolerance and efficacy of rituximab and changes in serum B cell biomarkers in patients with systemic complications of primary Sjogren's syndromeAnnals Of The Rheumatic Diseases, 2007
- Improvement of Sjögren's syndrome after two infusions of rituximab (anti‐CD20)Arthritis Care & Research, 2007
- Rituximab treatment in patients with primary Sjögren's syndrome: An open‐label phase II studyArthritis & Rheumatism, 2005
- Immunopathogenesis of primary Sj??gren??s syndrome: implications for disease management and therapyCurrent Opinion in Rheumatology, 2005