Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Responsiveness of Disease Activity Indices (ESSPRI, ESSDAI) in Patients with Primary Sjgren's Syndrome Treated with Rituximab.
Meiners, Petra M., Arends, Suzanne, Brouwer, Elisabeth, Vissink, Arjan, Bootsma, Hendrika
To evaluate the responsiveness of the ESSPRI and ESSDAI in patients with primary Sjögren's syndrome (pSS) treated with rituximab.
Twenty-eight pSS patients who were treated with rituximab (1000 mg) infusions at days 1 and 15 were included. Clinical data, including ESSPRI and ESSDAI, were collected prospectively at baseline and 16, 24, 36, 48 and 60 weeks after treatment. Internal responsiveness was assessed using standardized response means (SRM) and effect sizes (ES). SRM and ES <0.5 were interpreted as small, between 0.5 and 0.8 as moderate and >0.8 as large. External responsiveness was assessed using Spearman's correlation coefficients.
Median (range) ESSPRI and ESSDAI at baseline were 6.7 (0.39.0) and 8 (218), respectively. Both indices improved significantly after treatment. SRM and ES for ESSPRI and ESSDAI were >=0.8 at week 16, decreased afterwards and were larger for ESSDAI than for ESSPRI. SRM and ES values for patient (patGDA) and physician (phyGDA) global disease activity, and rheumatoid factor (IgM-Rf) broadly followed the pattern of those of ESSPRI and ESSDAI. SRM and ES for stimulated whole salivary flow were small at all time-points. Furthermore, at baseline and form most change scores, moderate correlations were found between ESSPRI and patGDA and between ESSDAI and phyGDA. No significant correlation was found between ESSPRI and ESSDAI.
This is the first study to demonstrate that the recently developed ESSPRI and ESSDAI are sensitive to measure change in disease activity after therapeutic intervention. This supports the usefulness of these indices for future clinical trials in pSS patients. Responsiveness of ESSPRI was less prominent than for ESSDAI.
To cite this abstract, please use the following information:
Meiners, Petra M., Arends, Suzanne, Brouwer, Elisabeth, Vissink, Arjan, Bootsma, Hendrika; Responsiveness of Disease Activity Indices (ESSPRI, ESSDAI) in Patients with Primary Sjgren's Syndrome Treated with Rituximab. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :466