Development and testing of an alternative responder definition for EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI).

ABSTRACT:

Objectives

Dryness, fatigue and joint/muscle pain are typically assessed in Sjögren's trials using European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI). A Patient Acceptable Symptom State of <5 and a Minimal Clinically Important Improvement (MCII)/responder definition (RD) of ≥1 point or 15% on ESSPRI have previously been defined. This study explored alternative RDs to better discriminate between active treatment and placebo in trials.

Methods

Anchor-based and distribution-based methods were used to derive RD thresholds in blinded phase IIb trial data (N=190) and confirm these in blinded data pooled from three early phase II trials (N=126). The populations consisted of individuals with moderate-to-severe systemic primary Sjögr

SUBMITTER: Wratten S 

PROVIDER: S-EPMC10030922 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature