Table 2

Description of the STAR design proposed (step 2) and tested for sensitivity to change (step 3)

STAR’s proposed designsBinary/continuousMajor domain/weightDefinition of response
Design 1 (DAS-28-like)ContinuousNo major domain.
Need to define a weight for each component (using PatGA or PhGA as gold standard).
Total score will be the sum of the weighted domains.
Threshold of response to be further defined.
Design 2 (SRI-like)Binary2 major domains (systemic activity and PROs).
3 minor domains.
Improvement of one of the major domains and no worsening of the other domains.
BinaryOnly 1 major domain (systemic activity or PROs depending on the primary objective of the study/drug).
4 minor domains.
Improvement of the target major domain and no worsening of the other domains.
Design 3ABinary2 major domains (systemic activity and PROs).
3 minor domains.
Improvement in ≥3 of 5 domains with improvement in at least 1 major domain.
Design 3BBinary or continuous3 points for major domains (systemic activity and PROs).
1 point for minor domain.
The score is the sum of the domains.
For binary option: response is defined by a threshold of response (tested from 4 to 9).
For continuous options: the total score is compared between groups.
Design 4
(ACR-like)
Binary2 major domains (systemic activity and PROs).
3 minor domains.
Improvement (of xx%, from 10% to 70%) in ≥3 of 5 domains, including at least 1 major domain.
CRESS22 BinaryNone.Improvement in ≥3 of 5 domains.
  • ACR, American College of Rheumatology; CRESS, Composite of Relevant Endpoints for Sjögren's Syndrome; DAS-28, Disease Activity Score 28; PatGA, patient global assessment; PhGA, physician global assessment; PRO, patient-reported outcome; SRI, Systemic Lupus Responder Index; STAR, Sjögren’s Tool for Assessing Response.