Table 2.
Poor prognostic factors used as inclusion criteria in randomized controlled trials
| Trial | Inclusion criteria | Primary endpoint | Secondary endpoints |
|---|---|---|---|
| AGREE [45] | RA (1987) ≤2 years, MTX-naïve Poor prognosis: RF/ACPA-positive, SJC ≥10, TJC ≥12, CRP ≥4.5 mg/l, erosions |
Remission (DAS28-CRP <2.6) Joint damage (TSS) at 1 year |
ACR response DAS28-CRP HAQ-DI, HRQoL improvement Radiologic nonprogression |
| TEAR [42] | RA (1987) <3 years, biologic DMARD-naïve Poor prognosis: RF/ACPA positive or radiologic erosions Active: SJC ≥4, TJC ≥4 (28 joints), DAS28-ESR >3.2 |
DAS28-ESR at week 48 and 102 | ACR response Modified HAQ Joint damage |
| C-EARLY [40] | RA (2010) ≤1 year, DMARD-naïve poor prognosis (RF/ACPA-positive) Active RA: SJC ≥4, TJC ≥4, DAS28-ESR >3.2, ESR ≥28 or CRP ≥10 mg/l |
Sustained remission (DAS28-ESR <2.6) or low disease activity (<3.2) at week 40 and 52 | ACR response HAQ-DI TSS (change from baseline) At week 52 |
| C-OPERA [6] | RA (2010) ≤1 year, MTX-naïve Poor prognosis (ACPA ≥3× upper limit of normal and RF-positive and/or erosions Active RA: DAS28-ESR ≥3.2 |
Non-progression (defined: mTSS ≤0.5 change from baseline to 12 months) | SDAI, Boolean and DAS28-ESR HAQ-DI ACR response |
| FUNCTION [41] | RA (1987) ≤2 years, MTX-naïve Poor prognosis: RF/ACPA-positive or radiologic erosions Active RA: DAS28-ESR >3.2, SJC ≥4 (66 joints), TJC ≥6 (68 joints), ESR ≥28 or CRP ≥10 mg/l |
Remission (DAS28-ESR <2.6 at week 24 | ACR response Modified TSS SF-36 |
| CareRA [46] | RA (1987) ≤1 year, DMARD-naïve Lack of poor prognosis: no erosions, DAS ≤3.2, seronegative |
Remission (DAS28-CRP ≤3.2) at week 16 | EULAR response HAQ response Cumulative disease activity |
ACPA anti-citrullinated protein-peptide antibodies, ACR American College of Rheumatology, CRP C-reactive protein, ESR erythrocyte sedimentation rate, EULAR European League Against Rheumatism, HAQ-DI Health Assessment Questionnaire Damage Index, HRQoL health-related quality of life, MTX methotrexate, DAS disease activity score, DMARD disease-modifying antirheumatic drug, TSS Total Sharp Score, RA rheumatoid arthritis, RF rheumatoid factor, SDAI Simple Disease Activity Index, SF-36 Short Form-36, SJC swollen joint count, TJC tender joint count