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Table 2 Examples of composite responder endpoints used in IMID trials

From: Innovative trial approaches in immune-mediated inflammatory diseases: current use and future potential

IMID Endpoint Definition
Ankylosing spondylitis ASAS20 response • 20% improvement and ≥ 10 units of change (on a 0–100 scale) in each of 3 domains
• No worsening of a similar amount in the fourth domain
• (Components are physical function, pain, inflammation and patient’s global assessment)
Crohn’s disease Clinical remission • Crohn’s Disease Activity Index below a threshold (e.g., 150)
• No use of steroids or rescue treatment
Idiopathic arthritis-associated uveitis Best corrected visual acuity above threshold and no light perception • Best-corrected visual acuity, thresholds ≤20/50, ≤20/200
• No light perception
•Contribution of amblyopia, yes/no
Juvenile arthritis Response Improvement by 30% in at least 3 of:
• MD global assessment
• parent or patient global assessment
• functional ability
• number of joints with active arthritis
• number of joints with limited range of motion
• Erthrocyte Sedimentation Rate
Juvenile dermatomyositis Responder index • ≥4 point reduction from baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score
• No worsening (increase of < 0.30 points from baseline) in physician’s global assessment (PGA)
• No new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline
Nonalcoholic steatohepatitis Resolution of steatohepatitis without fibrosis • Improvement in NAS of two points
• No worsening of fibrosis
Sjogren’s syndrome Response • > 30% reduction in analog scales evaluating dryness, pain and fatigue