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Table 4 Evidence summary table

From: Anti-IgE monoclonal antibody therapy for the treatment of chronic rhinosinusitis: a systematic review

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   
  1. CI confidence interval, IQR interquartile range, SF-36 36-Item Short Form Health Survey, AQLQ Asthma Quality of Life Questionnaire, RSOM-31 Rhinosinusitis Outcome Measure 31, TNSS Total Nasal Symptom Severity, SNOT-20 Sinonasal Outcome Test 20, PNIF peak nasal inspiratory flow, UPSIT University of Pennsylvania Smell Identification Test, N/A not available
  2. ar = 0.25 used