Table II.
Effect of intradermal immunotherapy on primary and secondary outcomes (intention-to-treat analysis)
| Clinical outcome | Control subjects (n = 47), median (IQR) | Subjects receiving intradermal immunotherapy (n = 46), median (IQR) | Difference (95% CI) | P value |
|---|---|---|---|---|
| Primary outcome | ||||
| CSMS during entire season | 487 (365-717) | 502 (333-841) | 14 (−172.5 to 215.1) | .80 |
| Secondary outcomes | ||||
| Symptom score during entire season | 264 (156-398) | 335 (183-503) | 59 (−1.3 to 110.9) | .24 |
| Medication score during entire season | 263 (129-482) | 242 (116-405) | −19 (−153.0 to 100.2) | .44 |
| CSMS during peak season | 365 (278-508) | 356 (232-521) | −8 (−75.8 to 66.3) | .90 |
| Nasal symptom score during entire season | 121 (81-200) | 174 (120-207) | 35 (4.0 to 67.5) | .03 |
| Mouth symptom score during entire season | 14 (5-45) | 34 (8-90) | 10 (3.8 to 24) | .05 |
| Eye symptom score during entire season | 78 (52-180) | 79 (41-153) | −7 (−18.5 to 2.9) | .54 |
| Lung symptom score during entire season | 12 (0-34) | 17 (3-32) | 4 (−1 to 15) | .17 |
| Nasal allergic symptoms measured by VAS | 122 (54-184) | 156 (104-275) | 53 (−11.6 to 125.2) | .05 |
| Eye allergic symptoms measured by VAS | 144 (41-176) | 84 (32-197) | −3 (−46.0 to 35.8) | .40 |
| Global evaluation of symptom scores | 3 (1-4) | 3 (2-4) | 0 (0 to 1) | .48 |
| Symptom-free days | 41 (23-61) | 35 (19-53) | −6 (−17 to 3) | .15 |
| No. of days prednisone used during entire season | 0 (0-0) | 0 (0-0) | 0 (0 to 0) | .36 |
| Medication-free days | 76 (65-94) | 81 (65-93) | 4 (−11 to 21) | .22 |
| Mini-RQLQ | 18 (10-25) | 16 (13-23) | −0.3 (−4.2 to 3.7) | .89 |
| EQ-5D-5L | 88 (81-94) | 87 (83-94) | 9 (−24.8 to 43.6) | .59 |
Median difference between groups was calculated by using stratified Hodges-Lehmann estimation. P values were based on the stratified Mann-Whitney U (Van Elteren) test adjusted for stratification factors. P values for mini-RQLQ and EQ-5D-5L scores were based on linear mixed model adjusted for stratification factor. The entire grass pollen season was from May 13-August 31, 2013; the peak season was from June 12-July 26, 2013.
CSMS, Combined symptom and medication score; EQ-5D-5L, EuroQoL instrument.