Table 1.
Baseline characteristics and clinical responses in the biopsy subgroup
| Baseline and change from baseline at Week 16 | ||||||
|---|---|---|---|---|---|---|
| Placebo + MFNS (n = 4) | Dupilumab + MFNS (n = 8) | Absolute difference from baseline vs placebo, LS mean (95% CI) | P value vs placebo | |||
| Baseline, mean (SD) | Change from baseline at Week 16, LS mean (SE) | Baseline, mean (SD) | Change from baseline at Week 16, LS mean (SE) | |||
| Bilateral endoscopic NPS | 6.25 (0.50) | −0.77 (0.85) | 5.63 (1.19) | −1.83 (0.59) | −1.06 (−3.43, 1.31) | 0.3391 |
| Lund–Mackay total score | 18.25 (3.95) | 1.10 (1.49) | 18.13 (4.76) | −9.52 (1.01) | −10.62 (−14.70, −6.54) | 0.0005 |
| Percentage of maxillary sinus volume occupied by disease | 72.20 (24.50) | 6.46 (9.03) | 61.54 (25.30) | −33.43 (5.98) | −39.89 (−64.38, −15.39) | 0.0063 |
| PNIF (AM) | 108.21 (88.57) | 0.11 (21.35) | 108.38 (66.18) | 57.36 (15.28) | 57.25 (−2.05, 116.54) | 0.0568 |
| SNOT‐22 score | 42.50 (25.89) | −0.60 (7.49) | 45.50 (13.61) | −32.11 (5.68) | −31.52 (−55.12, −7.91) | 0.0177 |
| Sinusitis symptom severity assessed on VAS, cm | 6.20 (1.84) | 1.13 (1.41) | 5.46 (3.02) | −3.65 (0.77) | −4.78 (−8.99, −0.58) | 0.0332 |
| Sense of smell assessed by UPSIT | 12.00 (2.16) | −2.27 (3.58) | 14.38 (8.60) | 9.84 (2.61) | 12.11 (1.74, 22.48) | 0.0277 |
| Nasal congestion or obstruction (AM) | 1.61 (0.66) | −0.11 (0.38) | 1.82 (0.57) | −0.93 (0.29) | −0.81 (−1.90, 0.27) | 0.1220 |
| Posterior rhinorrhea (AM) | 2.32 (0.47) | −0.03 (0.31) | 1.20 (1.03) | −0.64 (0.21) | −0.61 (−1.52, 0.30) | 0.1650 |
| Serum total IgE, IU/mL | 151.75 (125.84) | 10.47 (17.04) | 142.50 (119.29) | −61.17 (13.92) | −71.63 (−124.94, −18.33) | 0.0163 |
| Serum TARC, pg/mL | 425.09 (305.46) | 36.12 (108.45) | 441.94 (256.06) | 4.94 (97.00) | −31.18 (−387.31, 324.96) | 0.8375 |
| Plasma eotaxin‐3,a pg/mL | 56.75 (14.78) | 7.86 (6.24) | 65.70 (30.70) | −20.26 (5.24) | −28.12 (−48.03, −8.21) | 0.0131 |
| Blood eosinophil count, × 109/L | 0.29 (0.18) | 0.03 (0.08) | 0.32 (0.20) | −0.04 (0.06) | −0.07 (−0.38, 0.24) | 0.5199 |
AM, in the morning; CI, confidence interval; IgE, immunoglobulin E; IU, international units; LS, least squares; MFNS, mometasone furoate nasal spray; NPS, nasal polyp score; PNIF, peak nasal inspiratory flow; SD, standard deviation; SE, standard error; SNOT‐22, 22‐item Sino‐Nasal Outcome Test; TARC, thymus and activation‐regulated chemokine; UPSIT, University of Pennsylvania Smell Identification Test; VAS, visual analog scale.
a
For plasma eotaxin‐3 data, heterogeneous compound symmetry covariance structure was used instead of unstructured covariance structure, as the model with unstructured covariance structure does not converge.