TABLE 8.
Changes in serum cytokines during treatment
| Treatment groupa | Group differenceb | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PLACEBO | RAPA | |||||||||
| Pre | Post | P value | Difference (95%CI) | Pre | Post | P value | Difference (95%CI) | P value | Difference (95%CI) | |
| Luminex | (n=14) | (n=11) | ||||||||
| EGF | 161.60 ± 96.32 | 160.30 ± 92.72 | 0.95 | −1.34 [−44.98, 42.30] | 91.53 ± 65.97 | 82.39 ± 49.52 | 0.62 | −9.14 [−49.31, 31.03] | 0.78 | −7.80 [−63.81, 48.21] |
| Eotaxin | 173.20 ± 140.60 | 175.00 ± 161.10 | 0.90 | 1.859 [−29.12, 32.84] | 172.90 ± 110.90 | 187.20 ± 144.90 | 0.61 | 14.35 [−45.79, 74.48] | 0.69 | 12.49 [−52.48, 77.45] |
| G−CSF | 13.41 ± 24.11 | 15.03 ± 29.74 | 0.40 | 1.62 [−2.43, 5.66] | 23.88 ± 42.16 | 27.65 ± 39.24 | 0.36 | 3.77 [−5.05, 12.59] | 0.63 | 2.15 [−7.22, 11.52] |
| GM-CSF | 4.95 ± 5.88 | 3.69 ± 5.27 | 0.35 | −1.26 [−4.07, 1.54] | 12.58 ± 24.26 | 13.47 ± 24.32 | 0.49 | 0.88 [−1.88, 3.65] | 0.24 | 2.15 [−1.57, 5.86] |
| INFα | 10.27 ± 29.30 | 11.42 ± 34.31 | 0.52 | 1.15 [−2.57, 4.87] | 1.97 ± 4.47 | 1.78 ± 5.82 | 0.85 | −0.20 [−2.51, 2.12] | 0.51 | −1.35 [−5.53, 2.836] |
| INFγ | 17.53 ± 33.50 | 13.49 ± 24.64 | 0.21 | −4.05 [−10.70, 2.60] | 8.55 ± 8.26 | 13.99 ± 20.93 | 0.23 | 5.44 [−4.00, 14.87] | 0.09 | 9.49 [−1.46, 20.43] |
| IL-1rα | 91.31 ± 200.10 | 96.22 ± 237.90 | 0.80 | 4.90 [−35.19, 44.99] | 6.35 ± 15.40 | 11.01 ± 26.49 | 0.21 | 4.66 [−3.10, 12.41] | 0.99 | −0.24 [−40.77, 40.28] |
| IL-1α | 45.88 ± 56.35 | 39.71 ± 53.53 | 0.57 | −6.17 [−29.18, 16.84] | 31.47 ± 61.12 | 32.57 ± 57.15 | 0.89 | 1.10 [−16.91, 19.11] | 0.59 | 7.27 [−20.42, 34.96] |
| IL-1β | 0.76 ± 2.85 | 0.18 ± 0.66 | 0.34 | −0.59 [−1.86, 0.68] | 0.47 ± 1.49 | 1.36 ± 4.23 | 0.31 | 0.89 [−0.95, 2.73] | 0.16 | 1.48 [−0.64, 3.60] |
| IL-2 | 0.00 ± 0.00 | 0.01 ± 0.04 | 0.34 | 0.01 [−0.01, 0.03] | Difference = 0; cannot calculate p value | 0.34 | −0.01 [−0.03, 0.01] | |||
| IL-3 | 1.11 ± 0.51 | 0.98 ± 0.30 | 0.31 | −0.13 [−0.40, 0.14] | 1.13 ± 0.37 | 1.22 ± 0.39 | 0.37 | 0.09 [−0.13, 0.31] | 0.17 | 0.23 [−0.10, 0.55] |
| IL-4 | 11.88 ± 17.04 | 7.05 ± 8.11 | 0.18 | −4.83 [−12.28, 2.62] | 6.84 ± 9.25 | 8.15 ± 9.54 | 0.63 | 1.31 [−4.60, 7.22] | 0.17 | 6.14 [−2.86, 15.15] |
| IL-5 | 7.38 ± 17.18 | 7.96 ± 19.93 | 0.66 | 0.58 [−2.21, 3.37] | 0.00 ± 0.00 | 0.08 ± 0.20 | 0.23 | 0.08 [−0.06, 0.21] | 0.70 | −0.51 [−3.30, 2.28] |
| IL-6 | 2.37 ± 8.87 | 0.41 ± 1.53 | 0.34 | −1.96 [−6.20, 2.28] | 0.56 ± 1.86 | 2.04 ± 4.02 | 0.32 | 1.47 [−1.69, 4.64] | 0.17 | 3.44 [−1.583, 8.454] |
| IL-7 | Difference = 0; cannot calculate p value | |||||||||
| IL-8 | 19.00 ± 16.09 | 14.34 ± 14.81 | 0.17 | −4.66 [−11.53, 2.21] | 8.86 ± 5.54 | 10.72 ± 6.57 | 0.10 | 1.86 [−0.40, 4.12] | 0.07 | 6.52 [−0.57, 13.61] |
| IL-10 | 4.45 ± 7.94 | 3.59 ± 6.07 | 0.18 | −0.86 [−2.17, 0.46] | 3.21 ± 4.74 | 1.86 ± 3.01 | 0.10 | −1.36 [−3.02, 0.31] | 0.61 | −0.50 [−2.50, 1.50] |
| IL-12p40 | 0.90 ± 3.38 | 2.49 ± 7.54 | 0.19 | 1.59 [−0.92, 4.10] | 2.09 ± 6.94 | 1.07 ± 3.56 | 0.34 | −1.02 [−3.29, 1.25] | 0.11 | −2.61 [−5.80, 0.59] |
| IL-12p70 | 5.41 ± 7.72 | 3.73 ± 3.36 | 0.36 | −1.68 [−5.55, 2.18] | 4.63 ± 5.50 | 6.77 ± 11.99 | 0.32 | 2.14 [−2.44, 6.72] | 0.17 | 3.82 [−1.84to 9.48] |
| IL-13 | 75.71 ± 154.00 | 71.32 ± 169.80 | 0.62 | −4.39 [−23.23, 14.45] | 0.44 ± 1.31 | 0.55 ± 1.82 | 0.88 | 0.11 [−1.47, 1.70] | 0.62 | 4.51 [−14.37, 23.39] |
| IL-15 | 3.81 ± 1.22 | 3.70 ± 1.70 | 0.61 | −0.11 [−0.53, 0.32] | 4.10 ± 2.12 | 4.46 ± 2.13 | 0.17 | 0.35 [−0.18, 0.89] | 0.16 | 0.46 [−0.19, 1.11] |
| IL-17A | 4.07 ± 6.02 | 2.83 ± 6.62 | 0.24 | −1.24 [−3.41, 0.93] | 1.75 ± 4.04 | 3.04 ± 8.47 | 0.36 | 1.29 [−1.74, 4.32] | 0.15 | 2.54 [−1.00, 6.07] |
| IP−10 | 480.20 ± 177.10 | 504.40 ± 241.10 | 0.64 | 24.20 [−84.89, 133.30] | 418.00 ± 164.00 | 445.30 ± 201.30 | 0.56 | 27.30 [−74.66, 129.30] | 0.96 | 3.09 [−137.9, 144.1] |
| MCP-1 | 689.40 ± 270.60 | 674.50 ± 344.90 | 0.75 | −14.92 [−113.10, 83.24] | 717.80 ± 285.40 | 696.10 ± 274.70 | 0.73 | −21.72 [−157.80, 114.30] | 0.93 | −6.81 [−165.8, 152.2] |
| MIP-1α | 12.44 ± 10.01 | 10.71 ± 6.90 | 0.28 | −1.73 [−5.08, 1.61] | 8.63 ± 3.12 | 8.44 ± 2.85 | 0.53 | −0.19 [−0.83, 0.46] | 0.34 | 1.54 [−1.84, 4.92] |
| MIP-1β | 41.47 ± 25.68 | 35.73 ± 16.88 | 0.16 | −5.74 [−14.09, 2.62] | 28.33 ± 20.57 | 24.97 ± 21.12 | 0.06 | −3.37 [−6.97, 0.24] | 0.58 | 2.37 [−6.46, 11.2] |
| TNFα | 14.07 ± 5.66 | 12.45 ± 4.84 | 0.11 | −1.63 [−3.68, 0.43] | 12.08 ± 6.80 | 14.00 ± 6.59 | 0.10 | 1.91 [−0.41, 4.23] | 0.02 | 3.54 [0.62, 6.47] |
| TNFβ | 65.94 ± 154.50 | 69.62 ± 177.00 | 0.72 | 3.68 [−17.71, 25.07] | 3.03 ± 10.06 | 2.03 ± 6.72 | 0.34 | −1.01 [−3.25, 1.24] | 0.65 | −4.69 [−26.14, 16.77] |
| VEGF | 151.80 ± 153.40 | 138.90 ± 147.60 | 0.47 | −12.90 [−50.32, 24.53] | 90.65 ± 113.70 | 100.10 ± 112.40 | 0.40 | 9.47 [−14.74, 33.69] | 0.29 | 22.37 [−20.16, 64.89] |
| ELISA | (n=8) | (n=7) | ||||||||
| IL6 | 1.79 ± 0.56 | 1.92 ± 1.61 | 0.80 | 0.13 [−1.08, 1.34] | 3.56 ± 4.00 | 4.33 ± 3.94 | 0.64 | 0.76 [−3.02, 4.55] | 0.71 | 0.63 [−3.12, 4.45] |
. Changes in serum cytokine levels were assessed either by Luminex-based array assays or by high sensitivity ELISA, as indicated. Values that were “OOR<” (out of range low) were converted to 0 (zero) for the statistical analysis. Values below 16 pg/ml (the concentration of the lowest standard) were extrapolated. The differences between pre-treatment values and those seen at 6 weeks of treatment are shown for both the RAPA and placebo groups. “Differences” due to treatment were assessed by paired t-tests to identify any statistically significant changes in either group and the p-values are shown. The direction of the change is indicated in the “Difference column” where a positive number indicates a higher mean value after treatment and a negative value reflects a decrease in that cell population. The 95% confidence interval is shown in brackets.
. To determine whether there was a difference in the RAPA vs. the placebo group, the mean “difference” values were compared using a Welch’s t-test. The resulting p-values are shown; the mean differences and 95% confidence interval are shown.