Table 4.
Biomarker Analysis at Week 17
| Placebo (n = 25) | Dupilumab (n = 26) | SCIT (n = 26) | SCIT+dupilumab (n = 26) | SCIT+dupilumab vs SCIT Median Difference (95% CI), P value | Dupilumab vs Placebo Median Difference (95% CI), P value | |
|---|---|---|---|---|---|---|
| sIgE | ||||||
| Median % change (LOCF) | −37.2 | −16.9 | 81.3 | −56.4 | −134.6 (−205.51, −94.98), <0.0001 | 4.6 (−15.89, 29.59), 0.7314 |
| Median absolute change (LOCF) | −1.110 | −0.585 | 6.460 | −2.990 | −13.325 (−23.9400, −8.3600), <0.0001 | 0.740 (−0.9200, 3.3100), 0.3288 |
| sIgG4 | ||||||
| Median % change (LOCF) | 19.0 | 0.0 | 1444.5 | 1896.3 | 335.3 (−551.47, 1746.55), 0.1231 | 0.0 (−30.77, 0.00), 0.4024 |
| Median absolute change (LOCF) | 0.050 | 0.000 | 1.705 | 3.550 | 0.665 (−0.7700, 3.2100), 0.1449 | 0.000 (−0.0800, 0.0000), 0.2734 |
| sIgG | ||||||
| Median % change (LOCF) | 0.0 | 0.0 | 216.1 | 454.6 | 159.5 (−43.94, 434.21), 0.0079 | 0.1 (−19.13, 23.81), 0.7295 |
| Median absolute change (LOCF) | 0.000 | 0.000 | 6.150 | 10.350 | 3.800 (−0.6000, 8.9000), 0.0112 | 0.050 (−0.5000, 0.8000), 0.7653 |
| Log (sIgG4/sIgE) | ||||||
| Median change (LOCF) | 0.310 | 0.235 | 0.745 | 1.720 | 0.840 (0.4500, 1.2700), <0.0001 | −0.060 (−0.2300, 0.1200), 0.9551 |
| Log (sIgG/sIgE) | ||||||
| Median change (LOCF) | 0.190 | 0.130 | 0.180 | 1.105 | 0.830 (0.5400, 1.1300), <0.0001 | −0.005 (−0.1900, 0.1800), 0.6032 |
Note: All P values reported are nominal.
Abbreviations: CI, confidence interval; LOCF, last observation carried forward; SCIT, subcutaneous immunotherapy; sIgE, timothy grass–specific immunoglobulin E; sIgG, timothy grass–specific immunoglobulin G: sIgG4: serum timothy grass–specific IgG4.