Outcome | Study | Study data: anti-IgE vs. placebo | Effect estimate (95 % CI) | Studies (people) | Overall quality of evidence | Comments |
---|---|---|---|---|---|---|
Primary outcomes | ||||||
Change in CT score | ||||||
Lund-McKay Score (change in score from baseline) | Gevaert | Mean (no CI), 4.0 vs. −0.5 (improvement at 16 weeks); p = 0.04 | See comment | 1 (23) | Low | Authors state that scores improved with treatment over control at 16 weeks. |
Percent opacification on CT (median change in % inflammation from baseline) | Pinto | Median (IQR), 13.1 % (4.7 to 29.9) vs. 5.9 % (−11.6 to 23.0) | Not estimable | 1 (14) | Low | (−) median value means reduced inflammation at 6 months. |
Change in clinical polyp score | ||||||
Total nasal endoscopic polyp score (change in score from baseline; score 0 to 4, 4 = largest) | Gevaert; Pinto | Mean (SDa), −2.67 (2.09) vs. −0.12 (0.99) (smaller polyp size at 16 weeks); see comment | MD −2.55 (−3.81 to −1.29); MD could not be calculated in Pinto et al. trial due to ambiguity in data handling | 1 (23); 1 (14) | Low | Pinto et al. trial provided mean data despite nonparametric statistical test. (−) value for MD means greater decrease in polyp size from baseline with anti-IgE monoclonal antibody therapy. |
Change in quality of life | ||||||
SF-36 (change in score from baseline; physical health, mental health) | Gevaert | Not provided | Not estimable | 1 (23) | Low | Authors did not compare change from baseline between groups. |
AQLQ (change in score from baseline) | Gevaert | Mean (no CI), 0.81 vs. 0.27 (improvement at 16 weeks) | See comment | 1 (23) | Low | Data poorly reported; unclear whether p = 0.003 refers to difference in treatment arm from baseline or a comparison from baseline between groups. |
RSOM-31 (change in score from baseline) | Gevaert | Not provided | Not estimable | 1 (23) | Low | Authors did not compare change from baseline between groups. |
TNSS | Pinto | Median, −1 vs. 0; p < 0.21 | Not estimable | 1 (14) | Low | (−) median value means reduced nasal symptoms at 6 months. |
SNOT-20 (change in mean from baseline) | Pinto | Mean (SDa), 0.98 (1.15) vs. 0.75 (1.76) (improvement at 16 weeks); p < 0.60 | MD 0.23 (−1.33 to 1.79) | 1 (14) | Low | (+) value for MD means greater control of nasal symptoms from baseline with anti-IgE monoclonal antibody therapy. |
Secondary outcomes | ||||||
Change in cellular inflammation | ||||||
Eosinophil count (nasal lavage; median change from baseline) | Pinto | Median (IQR), 2 (−11.75 to 9.25) vs. 9 (−2.75 to 26.5); p < 0.47 | Not estimable | 1 (8) | Low | (+) median value means increased eosinophil count at 6 months. |
Change in nasal airflow | ||||||
PNIF (median change from baseline) | Pinto | Median (IQR), −0.9 (−20.0 to 40.0) vs. −7.5 (−30.0 to 13.3); p < 0.31 | Not estimable | 1 (12) | Low | (−) median value means reduced nasal airflow at 6 months. |
Change in olfaction | ||||||
UPSIT | Pinto | Median (IQR), 3 (2 to 14) vs. −4 (−5 to −2); p < 0.31 | Not estimable | 1 (14) | Low | (+) median value means increased smell identification at 6 months. |
Adverse events | Gevaert; Pinto | Treatment (4—frontal headache, 3—nasal obstruction, 2—shortness of breath, 1—allergy, 8—common cold, 1—gastroenteritis, 1—shoulder pain, 2—otitis media, 1—left ulnar hypoesthesia, 1—general myalgia) vs. placebo (1—asthma exacerbation, 1—frontal headache, 3—nasal obstruction, 1—shortness of breath, 1—jaundice, 1—acute sinusitis); no adverse events occurred in Pinto et al. trial | See comment | 1 (23); 1 (14) | Low | Common cold was the only adverse event to occur more frequently with treatment (p = 0.02). |
Change in systemic IgE levels | ||||||
Not reported in any studies | N/A | N/A | ||||
Change in spirometric results | ||||||
Not reported in any studies | N/A | N/A |