Page 85 - Portuguese Journal - SPORL - Vol 61. Nº1
P. 85
BENRALIZUMAB
Studie NCT03450083
Population under study CRSwNP
18-75
Age (y)
Inclusion criteria Refractoriness to treatment At least 1000 mg of oral prednisone (or equivalent) during the 12 months prior
with glucocorticoids, and/or
to symptom control;
previous surgery for nasal
At least one previous surgery for nasal polyps.
polyps with relapse
NPS Severe bilateral nasal polyps with bilateral NPS ≥5
Duration 20 weeks
Intervention Protocol The intervention group received 30 mg of benralizumab subcutaneously;
The control group received subcutaneous placebo.
Total number of participants 24
at the start of each trial
Studie OSTRO
Population under study CRSwNP
18-75
Age (y)
Inclusion criteria Refractoriness to treatment At least 1000 mg of oral prednisone (or equivalent) during the 12 months prior
with glucocorticoids, and/or
to symptom control;
previous surgery for nasal
At least one previous surgery for nasal polyps.
polyps with relapse
NPS Severe bilateral nasal polyps with bilateral NPS ≥5
Duration 56 weeks
The intervention group received 30 mg of benralizumab subcutaneously every 4 weeks for
the first 3 doses and every 8 weeks for the last 5 doses; The control group received subcutaneous
Intervention Protocol placebo every 4 weeks for the first 3 doses and every 8 weeks for the last 5 doses;
All groups received 200 μg of mometasone furoate nasal spray twice daily in each
nostril for a minimum of 4 weeks prior to randomization and throughout the remainder
of the study.
Total number of participants 410
at the start of each trial
CRSwNP – chronic rhinosinusitis with nasal polyps; NPS – Nasal Polyp Score
Volume 61 . Nº1 . March 2023 85
