Table 2 Core outcomes proposed across inflammatory conditions

Disease activity

Patient global assessment of wellbeing

✓^†

✓*^†

✓*^†

✓*^†

✓*

5

Clinician global assessment of disease activity

✓^†

✓*

✓*

✓

✓*^†

✓*

6

Disease activity

✓*

✓

✓^†

✓*^†

✓*^†

✓*^†~

✓*^†

✓*

8

Low disease activity

✓*

1

Musculoskeletal (MSK) disease activity

Peripheral joints

✓*^†

✓*^†

2

Enthesitis

✓*^†

✓*^†

✓

3

Dactylitis

✓*^†

✓

2

Spine symptoms

✓*^†

1

Tender joints

✓*^†

✓

2

Swollen joints

✓*^†

✓*

2

Joint or structural damage

✓*^†

✓*^†

✓*

✓

✓^†

5

Organ damage

✓^†

✓*^†~

✓*

3

Systemic inflammation

✓*^†

1

Ocular surface damage

✓

1

Visual acuity

✓^†

1

Grade of cells in anterior chamber

✓^†

1

Grade of flare in anterior chamber

✓^†

1

Flares

✓*

1

Comorbidities

✓^†

1

Biomarkers

Auto-antibody status

✓^†

✓

✓^†

3

Anti-drug antibody

✓*

1

Acute phase reactants

✓*^†

✓*^†

✓*

✓*

✓*

✓*

6

Unspecified

✓

✓^†

2

Laboratory indices

✓*^†

1

MAS

✓

1

Skin disease activity

Skin

✓*^†

1

Nails

✓*^†

1

Itching

✓^†

1

Perianal disease activity

Dev of perianal abscess

✓

1

Dev of a new/recurrent fistula

✓

1

Unplanned surgical intervention

✓

1

Faecal diversion/ proctectomy

✓

1

Clinical endpoints

Mucosal healing (endoscopic)

✓*~

✓*

2

Histological evaluation of mucosal inflammation

✓*

1

Symptomatic remission

✓*

✓*

2

Clinical remission

✓*^†

✓*^†~

✓^†*

3

Remission without steroid

✓*~

✓*

2

Complete clinical response

✓~

1

Sustained clinical benefit

✓~

1

Radiological remission

✓~

1

Radiological response

✓~

1

Deep remission

✓~

1

Occlusive symptoms (absence)

✓~

1

Endoscopic remission

✓~

Bowel damage progression

✓~

1

Treatment and therapeutic failure

✓~

1

Long term efficacy

✓~

1

Steroid free

✓~

1

Clinical success/benefit

✓~

1

Fistula healing

✓*

1

Time to remission

✓*

✓*

2

Time to response

✓*

✓*

2

Clinical assessment of drainage

✓*

1

Salivary flow

✓

1

Ophthalmic outcome

✓

1

Symptom free survival

✓~

1

Overall survival

✓^†

✓^†

2

Colorectal cancer

✓^†

✓^†

2

Symptoms, QOL, function

Pain

✓*^†

✓*^†

✓*^†

✓^†

✓^†

✓*

6

Anaemia

✓^†

✓^†

2

Morning stiffness

✓*

1

Spinal stiffness and mobility

✓*^†

1

Fatigue

✓*

✓*^†

✓^†

✓

✓^†

✓^†

✓*

✓

8

Fever

✓

1

HRQOL (Generic)

✓^†

✓*

✓*^†

✓^†

✓

✓*^†~

✓*

✓

✓^†

9

HRQOL (Specific)

✓*

✓*^†

✓

✓*~

✓*

✓*~

6

Physical function/Disability

✓*^†

✓*^†

✓*^†

✓^†~

✓^†~

✓*

✓^†

7

Function (General)

✓*

✓^†

✓*

3

Psychosocial function

✓

✓

✓

3

Psychological health/emotional well being

✓

✓

✓^#

✓

4

Sexual activity

✓^#

1

Overall control

✓

✓

2

Work limitation/productivity

✓

✓

✓

✓^#

✓*

5

Sicca symptoms

Dry eyes

✓^†

1

Dry mouth

✓^†

1

Change in bowel symptoms

✓^†

✓^†

2

Rectal bleeding

✓*

1

Stool frequency

✓*

1

Stool consistency

✓

1

Impact of fistula

✓

✓

2

Global assessment of incontinence

✓

1

Healthcare utilisation

Surgery

✓

✓~

✓

✓

4

Reduction in surgical procedures

✓*

1

Time spent/number of hospital visits

✓^†

✓^†

✓^†

3

DMARD use

✓^†

✓

2

Steroid use

✓^†

✓^†

✓*^†

✓*~

✓

5

Non-drug treatments

✓

1

Others

SAE/safety outcomes

✓

✓*^†

✓^†~

✓

4

Toxicity

✓

✓^†

2

Death/cause of death

✓

✓

✓~

3

Cost/Cost-effectiveness

✓

1

Weight

✓^†

✓^†

✓^†

3

Nutritional status

✓

✓

2

Disease duration

✓^†

1

Smoking

✓^†

1

Paediatric-specific

Parent global assessment of disease activity

✓

✓^†

2

Growth

✓*

✓

✓^†

✓

4

Improved growth pattern

✓*

1

Normalised growth

✓*

1

School absence

✓^†

1

Extra-intestinal manifestations

✓*

1