Table 2.
Parameter at baseline | Subgroup | CZP+MTX | PBO+MTX | ||
---|---|---|---|---|---|
n | mTSS CFB mean±SD |
n | mTSS CFB mean±SD |
||
Anti-CCP antibody (U/mL) | <100 | 51 | −0.03±0.69 | 51 | 1.34±3.11 |
100–<300 | 57 | 0.11±1.99 | 56 | 1.52±3.79 | |
≥300 | 50 | 1.05±4.21 | 50 | 1.91±7.01 | |
RF (IU/mL) | <20 | 6 | −0.26±0.45 | 11 | 2.20±5.14 |
20–<60 | 33 | 0.06±1.09 | 29 | 0.82±3.07 | |
≥60 | 119 | 0.48±3.06 | 117 | 1.72±5.20 | |
CRP (mg/dL) | ≤0.5 | 75 | 0.13±0.74 | 69 | 0.39±2.12 |
>0.5–≤1.0 | 22 | 0.00±0.52 | 27 | 1.85±3.23 | |
>1.0 | 61 | 0.78±4.25 | 61 | 2.82±6.97 | |
MMP-3 (ng/mL) | <50 | 36 | 0.09±0.50 | 33 | 0.01±0.42 |
50–<100 | 59 | 0.31±0.97 | 50 | 1.44±3.17 | |
≥100 | 63 | 0.57±4.17 | 74 | 2.38±6.47 | |
HAQ-DI | ≤0.5 | 43 | 0.27±1.61 | 43 | 0.52±2.71 |
>0.5–≤1.0 | 44 | 0.10±0.98 | 41 | 1.60±4.09 | |
>1.0 | 71 | 0.58±3.76 | 73 | 2.21±6.04 | |
DAS28 (ESR) | <3.2 | 5 | 0.10±0.22 | 3 | 0.00±0.00 |
3.2–5.1 | 60 | 0.20±0.83 | 54 | 0.71±3.14 | |
>5.1 | 93 | 0.49±3.46 | 100 | 2.10±5.59 | |
mTSS | ≤0.5 | 55 | 0.20±0.64 | 56 | 0.42±0.99 |
>0.5 | 103 | 0.45±3.32 | 101 | 2.23±5.93 | |
Concomitant MTX—average dose (mg/week) | 0–8 | 18 | 0.07±0.88 | 21 | 0.61±2.37 |
8–≤12 | 64 | 0.38±4.01 | 59 | 1.40±2.98 | |
>12–16 | 76 | 0.42±1.27 | 77 | 1.99±6.31 |
CCP, cyclic citrullinated peptide; CFB, change from baseline; CRP, C reactive protein; CZP, certolizumab pegol; DAS28, Disease Activity Score 28-joint assessment; ESR, erythrocyte sedimentation rate; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire Disability Index; LINEAR, linear extrapolation; MMP-3, matrix metalloproteinase-3; mTSS, modified Total Sharp Score; MTX, methotrexate; PBO, placebo; RF, rheumatoid factor.