Table 2

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

STAR’s proposed designs	Binary/continuous	Major domain/weight	Definition of response
Design 1 (DAS-28-like)	Continuous	No 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)	Binary	2 major domains (systemic activity and PROs). 3 minor domains.	Improvement of one of the major domains and no worsening of the other domains.
Design 2 (SRI-like)	Binary	Only 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 3A	Binary	2 major domains (systemic activity and PROs). 3 minor domains.	Improvement in ≥3 of 5 domains with improvement in at least 1 major domain.
Design 3B	Binary or continuous	3 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)	Binary	2 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	Binary	None.	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.