Table 1.
Placebo + MTX (n = 45) | Sarilumab 150 mg q2w + MTX (n = 46) | Sarilumab 200 mg q2w + MTX (n = 45) | Totala (n = 136) | |
---|---|---|---|---|
Baseline demographic and disease parameters | ||||
Age, mean ± SD, years | 54.7 ± 13.1 | 49.8 ± 12.7 | 48.4 ± 12.8 | 51.0 ± 13.1 |
Sex, female, % | 75.6 | 84.8 | 80.0 | 80.1 |
Duration of RA, mean ± SD, years | 8.0 ± 8.6 | 7.1 ± 6.7 | 6.4 ± 6.4 | 7.2 ± 7.3 |
Anti-CCP antibody positive, %b | 73.7 | 95.0 | 90.0 | 86.4 |
Rheumatoid factor positive, % | 66.7 | 87.0 | 88.9 | 80.9 |
Tender joint count, mean ± SD | 27.9 ± 17.0 | 28.1 ± 17.2 | 26.9 ± 14.6 | 27.7 ± 16.2 |
Swollen joint count, mean ± SD | 17.6 ± 12.3 | 18.3 ± 10.9 | 17.2 ± 9.3 | 17.7 ± 10.8 |
CRP, mean ± SD, mg/dL | 2.8 ± 2.8 | 2.6 ± 2.8 | 3.4 ± 4.4 | 3.0 ± 3.4 |
Baseline biomarker serum concentrations, median (quartile 1/quartile 3) | ||||
C1M, ng/mL | 198.1 (132.0/263.4) | 179.6 (140.2/235.8) | 172.3 (132.4/273.0) | 179.6 (133.5/259.3) |
C2M, ng/mL | 0.2 (0.2/0.3) | 0.3 (0.2/0.3) | 0.2 (0.2/0.4) | 0.2 (0.2/0.3) |
C3M, ng/mL | 45.6 (38.9/58.1) | 47.6 (38.3/60.2) | 47.9 (37.9/59.3) | 47.5 (38.3/59.0) |
CRPM, ng/mL | 17.3 (12.1/21.7) | 16.5 (14.1/21.4) | 16.3 (13.9/22.3) | 16.7 (13.1/21.7) |
aAll patients receiving placebo, sarilumab 150 mg q2w, or sarilumab 200 mg q2w. bResults not available for the entire biomarker population. C1M collagen type I MMP-cleaved fragment, C2M collagen type II MMP-cleaved fragment, C3M collagen type III MMP-cleaved fragment, CCP cyclic citrullinated peptide, CRPM C-reactive protein MMP-derived fragment, MMP matrix metalloproteinase, MTX methotrexate, q2w every 2 weeks, RA rheumatoid arthritis, SD standard deviation