Outcome | Rating scale 1–9a (importance of the outcome for decision-making) | Type of outcome |
---|---|---|
Disease activity/clinical response | ||
CDAI | 9 (critical) | Continuous or binary |
DAS-28 ESR | 8.5 (critical) | Continuous or binary |
SDAI | 8.5 (critical) | Continuous or binary |
ACR 20 | 8 (critical) | Binary |
ACR 50 | 8 (critical) | Binary |
DAS-28 CRP | 8 (critical) | Continuous or binary |
ACR-N | 7.5 (critical) | Continuous |
ACR 70 | 6 (important but not critical) | Binary |
EULAR response | 5 (important but not critical) | Binary |
Safety | ||
TEAE | 9 (critical) | Binary |
Serious TEAE | 9 (critical) | Binary |
Death related to treatment | 9 (critical) | Binary |
IRRs | 9 (critical) | Binary |
Hypersensitivity | 9 (critical) | Binary |
Active tuberculosis | 9 (critical) | Binary |
Serious infections | 9 (critical) | Binary |
Death all causes | 8 (critical) | Binary |
Overall discontinuation rate | 8.5 (critical) | Binary |
Malignancies | 8 (critical) | Binary |
Fatigue | 7 (critical) | Binary |
Function capacity/quality of life | ||
HAQ-DI | 8.5 (critical) | Continuous |
SF-36 score—physical component summary | 8 (critical) | Continuous |
SF-36 score- mental component summary | 8 (critical) | Continuous |
Structural damage progression | ||
mTRSS or Sharp/van der Heijde score | 5.5 (important but not critical) | Continuous |
Immunogenicity | ||
Incidence of ADAs | 5 (important but not critical) | Binary |
NABs—positive | 5 (important but not critical) | Binary |