CDC achievers | Non-achievers | |
---|---|---|
N=200 | N=1267 | |
Demographics | ||
Age, mean±SD | 48.5±13.3 | 53.9±13.0 |
Female, n (%) | 123 (61.5) | 973 (76.8) |
Trial, n (%) | ||
OPTIMA | 58 (29.0) | 255 (20.1) |
PREMIER | 98 (49.0) | 563 (44.4) |
DE019 | 44 (22.0) | 449 (35.4) |
Study outcomes, mean±SD | ||
Continuous CDC components | ||
DAS28 | 5.2±1.3 | 5.8±1.1 |
HAQ-DI | 0.9±0.6 | 1.5±0.6 |
mTSS | 20.9±31.6 | 37.1±44.7 |
Patient-reported outcomes | ||
SF-36 physical component score*,† | 34.2±8.9 | 29.7±8.0 |
SF-36 mental component score*,† | 48.2±12.4 | 45.9±12.0 |
VAS-Pain* | 47.8±25.9 | 56.3±23.5 |
FACIT-Fatigue‡ | 35.3±10.8 | 29.0±11.2 |
Lab values | ||
Haemoglobin (g/dL) | 13.1±1.5 | 12.8±1.5 |
Creatine (mg/dL) | 0.8±0.2 | 0.7±0.2 |
Work-related outcomes in OPTIMA§ | ||
Absenteeism* | 9.6±23.1 | 17.3±30.9 |
Presenteeism* | 25.9±25.2 | 45.6±27.2 |
Activity impairment* | 26.9±24.2 | 47.8±23.9 |
Work impairment* | 29.4±26.5 | 49.9±30.9 |
Work instability scale | 6.7±6.6 | 11.7±7.2 |
Work-related outcomes in PREMIER/DE032¶ | ||
Number of work days missed among employed patients in the last 4 weeks | 3.2±6.1 | 5.2±8.6 |
Level work performance has been affected among employed patients in the last week* | 45.6±32.6 | 53.5±32.0 |
Number of work days missed among homemakers in the last 4 weeks | 4.7±8.3 | 7.2±10.1 |
Level work performance has been affected among homemakers in the last week* | 43.6±26.8 | 62.4±26.4 |
Additional measures | ||
Clinical characteristics, mean±SD | ||
RA duration (years) | 2.7±5.1 | 4.4±7.3 |
Swollen joint count (66) | 16.1±8.0 | 19.8±9.8 |
Tender joint count (68) | 21.1±10.2 | 29.0±13.7 |
C reactive protein (mg/L) | 20.1±23.7 | 27.7±33.6 |
Physician’s global assessment of disease activity* | 58.7±18.5 | 64.5±17.2 |
Patient’s global assessment of disease activity* | 55.0±25.6 | 60.6±23.3 |
Radiographic findings, mean±SD | ||
Erosion score | 12.6±18.5 | 20.9±25.0 |
Joint space narrowing | 8.3±14.3 | 16.3±21.4 |
Components of CDC achievement at week 26, n (%) | ||
Full achievement | 200 (100.0) | 0 (0.0) |
Achieved HAQ <0.5 and DAS <2.6 | 0 (0.0) | 58 (4.6) |
Achieved HAQ <0.5 and ΔmTSS ≤0.5 | 0 (0.0) | 216 (17.0) |
Achieved DAS <2.6 and ΔmTSS ≤0.5 | 0 (0.0) | 89 (7.0) |
Achieved HAQ <0.5 only | 0 (0.0) | 95 (7.5) |
Achieved DAS <2.6 only | 0 (0.0) | 33 (2.6) |
Achieved ΔmTSS ≤0.5 only | 0 (0.0) | 495 (39.1) |
Achieved none | 0 (0.0) | 281 (22.2) |
ACR-EULAR remission achievement at week 26, n (%) | ||
Yes | 65 (33.0) | 29 (2.3) |
*Measured from 0 to 100.
†Not measured in OPTIMA patients.
‡Measured from 0 to 52. Greater values indicate less fatigue.
§Among OPTIMA patients only.
¶Among PREMIER/DE032 patients only.
ACR-EULAR, American College of Rheumatology-European League Against Rheumatism; CDC, comprehensive disease control; DAS, Disease Activity Score; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire disability index; RA, rheumatoid arthritis; SF-36, Short Form 36; VAS, Visual Analogue Scale; mTSS, modified total Sharp score; ΔmTSS, change in modified total Sharp score.