Page 84 - Portuguese Journal - SPORL - Vol 61. Nº1

OMALIZUMAB

Studie GEVAERT 2013
Population under study CRSwNP
Age (y)
≥18
Inclusion criteria Refractoriness to treatment Chronic rhinosinusitis and comorbid asthma for more than 2 years;
with glucocorticoids, and/or
87% - ≥ 1 previous surgery for nasal polyps in the intervention group;
previous surgery for nasal
75% - ≥ 1 previous surgery for nasal polyps in the control group.
polyps with relapse
NPS Bilateral NPS:
Mean - 6 in the intervention group;
Mean - 6 in the control group.
Duration 6 weeks treatment and 4 weeks follow-up
The intervention group received subcutaneous omalizumab. The dose and dosing frequency
Intervention Protocol (every 2 weeks or every 4 weeks) of omalizumab were based on total serum IgE levels and
body weight, with a maximum dose of 375 mg; The control group received subcutaneous
placebo, with the same instructions as the intervention group.
Total number of participants 23
at the start of each trial
Studie POLYP 1
Population under study CRSwNP
Inclusion criteria Refractoriness to treatment CRSwNP with inadequate response to conventional medical treatment;
Age (y)
18-75
with glucocorticoids, and/or
54.2% - ≥ 1 previous surgery for nasal polyps in the intervention group;
previous surgery for nasal
60.6% - ≥ 1 previous surgery for nasal polyps in the control group.
polyps with relapse
NPS Bilateral NPS ≥5 (≥ 2 in each nostril)
Duration 24 weeks treatment and 4 weeks follow-up

The intervention group received 75 mg to 600 mg omalizumab subcutaneously every 2 to 4
weeks (with dose and frequency determined by the total serum IgE level and body weight) for
Intervention Protocol 24 weeks; The control group received subcutaneous placebo every 2 to 4 weeks (with dose and
frequency determined by the total serum IgE level and body weight) for 24 weeks;All groups
received 200 μg of mometasone furoate nasal spray twice daily (or once daily if intolerant to a
twice daily regimen) during the preparation and treatment periods.
Total number of participants 138
at the start of each trial

Studie POLYP 2
Population under study CRSwNP
Inclusion criteria Refractoriness to treatment CRSwNP with inadequate response to conventional medical treatment;
Age (y)
18-75
with glucocorticoids, and/or
62.9% - ≥ 1 previous surgery for nasal polyps in the intervention
previous surgery for nasal
61.5% - ≥ 1 previous surgery for nasal polyps in the control group.
polyps with relapse
NPS Bilateral NPS ≥5 (≥ 2 in each nostril)
Duration 24 weeks treatment and 4 weeks follow-up

The intervention group received 75 mg to 600 mg omalizumab subcutaneously every 2 to 4
weeks (with dose and frequency determined by the total serum IgE level and body weight) for
24 weeks; The control group received subcutaneous placebo every 2 to 4 weeks (with dose and
Intervention Protocol
frequency determined by the total serum IgE level and body weight) for 24 weeks; All groups
received 200 μg of mometasone furoate nasal spray twice daily (or once daily if intolerant to a
twice daily regimen) during the preparation and treatment periods.
Total number of participants 127
at the start of each trial

84 Portuguese Journal of Otorhinolaryngology - Head and Neck Surgery