Table 3.
Control phase | Study phase | Treatment effect (95% CI) | p value | Carry-over p value |
Period effect p value |
|
---|---|---|---|---|---|---|
Pro-inflammatory cytokines | ||||||
IL-1 (pg/ml) | 9.7 (8.9; 10.6) | 9.2 (8.4; 9.8) | −0.78 (−1,12 to −0.5) | <0.001 | 0.809 | 0.651 |
IL-6 (pg/ml) | 43.7 (36.7; 50.9) | 37.2 (34.7; 44) | −4.36 (−7.09 to −2.57) | <0.001 | 0.305 | 0.258 |
IL-8 (pg/ml) | 60.9 (49.4; 74.3) | 53.3 (45; 70.5) | −4.35 (−6.1 to −3.04) | <0.001 | 0.184 | 0.642 |
IL-12 (pg/ml) | 102.1 (74.3; 124.2) | 102.7 (76.3; 125.4) | −0.5 (−1.65 to 0.11) | 0.076 | 0.21 | 0.91 |
MCP-1 (pg/ml) | 78.8 (73.4; 83.1) | 76.3 (71.6; 81.9) | −1.84 (−2.45 to −1.4) | <0.001 | 1 | 0.539 |
TNF-a (pg/ml) | 108.8 (98.7; 128.8) | 97 (93.8; 113.1) | −7.26 (−11.88 to −4.08) | <0.001 | 0.752 | 0.696 |
SAA (ng/ml) | 5949.1 (3248.3; 10,000) | 2747.5 (2089.2; 3771.9) | −3491.2 (−4438.5 to−2132.4) | <0.001 | 0.867 | 0.445 |
C5a (ng/ml) | 96.2 (78.9; 121.4) | 60.3 (48.3; 88.2) | −29.27 (−53.64 to −18.87) | <0.001 | 0.724 | 0.402 |
Anti-inflammatory cytokines | ||||||
IL-1ra (pg/ml) | 251 (222.2; 295) | 255.3 (221.4; 296.4) | 5.12 (−0.4 to 10.62) | 0.061 | 0.926 | 0.616 |
IL-4 (pg/ml) | 14.2 (11; 17.5) | 16.2 (13.2; 18.4) | 1.35 (0.95 to 1.75) | <0.001 | 0.224 | 0.196 |
IL-10 (pg/ml) | 51.4 (45.3; 61.4) | 53.3 (50.1; 61.5) | 1.22 (−2.9 to 6.69) | 0.402 | 0.254 | 0.468 |
IL-13 (pg/ml) | 18.5 (15.7; 22.9) | 20 (17.6; 25.6) | 1.28 (0.69 to 1.89) | <0.001 | 0.128 | 0.956 |
IL-17 (pg/ml) | 178.6 (140; 215.1) | 183.3 (157.2; 222.8) | 3.57 (1.76 to 7.47) | <0.001 | 0.376 | 0.491 |
Numbers are median and 95% CI
CI confidence interval, IL interleukin, MCP monocyte chemoattractant protein, TNF tumor necrosis factor, SAA serum A-amyloid, C5a complement fraction 5