Table 2 Examples of composite responder endpoints used in IMID trials

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