Page 82 - Portuguese Journal - SPORL - Vol 61. Nº1

Table 1
Inclusion criteria and main characteristics of the randomized clinical trials included in the systematic
review and meta-analysis
DUPILUMAB

Studie BACHERT 2016
Population under study CRSwNP
Inclusion criteria Refractoriness to treatment Intranasal glucocorticoids for at least 8 weeks prior to screening, with refractoriness to treatment;
Age (y)
18-65
with glucocorticoids, and/or
53.3%: ≥ 1 previous surgery for nasal polyps in the intervention group;
previous surgery for nasal
63.3%: ≥ 1 previous surgery for nasal polyps in the control group.
polyps with relapse
NPS Bilateral NPS ≥5 (≥ 2 in each nostril)
Duration 16 weeks
The intervention group received 600 mg subcutaneous dupilumab as a loading dose, followed
by 300 mg every week for 15 weeks; The control group received subcutaneous placebo every
Intervention Protocol week for 16 weeks; All groups received 100 μg of mometasone furoate nasal spray in each nostril
twice daily for the 4 weeks of preparation and continued with stable doses for the remainder
of the study.
Total number of participants 60
at the start of each trial
Studie LIBERTY SINUS 24
Population under study CRSwNP
Inclusion criteria Refractoriness to treatment Systemic glucocorticoids within the past 2 years (if not contraindicated);
Age (y)
≥18
with glucocorticoids, and/or
previous surgery for nasal
Previous surgery for nasal polyps.
polyps with relapse
NPS Bilateral NPS ≥5 (≥ 2 in each nostril)

Duration 24 weeks treatment and 24 weeks follow-up
The intervention group received 300 mg of dupilumab subcutaneously every 2 weeks for
Intervention Protocol 24 weeks; The control group received subcutaneous placebo every 2 weeks for 24 weeks;
All groups received 100 μg of mometasone furoate nasal spray in each nostril twice daily
during the 4-week preparation period, which was continued for the remainder of the study.
Total number of participants 276
at the start of each trial
Studie LIBERTY SINUS 52

Population under study CRSwNP
Inclusion criteria Refractoriness to treatment Systemic glucocorticoids within the past 2 years (if not contraindicated);
Age (y)
≥18
with glucocorticoids, and/or
Previous surgery for nasal polyps.
previous surgery for nasal
polyps with relapse
NPS Bilateral NPS ≥5 (≥ 2 in each nostril)
Duration 52 weeks
The intervention group received 300 mg of dupilumab subcutaneously every 2 weeks for 24
weeks and then every 4 weeks thereafter until a total of 52 weeks OR 300 mg of dupilumab
subcutaneously every 2 weeks for 52 weeks; The control group received placebo subcutaneously
Intervention Protocol
every 2 weeks for 52 weeks; All groups received 100 μg of mometasone furoate nasal spray in
each nostril twice daily during the 4-week preparation period, which was continued for the
remainder of the study.
Total number of participants 276
at the start of each trial

82 Portuguese Journal of Otorhinolaryngology - Head and Neck Surgery