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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