Page 83 - Portuguese Journal - SPORL - Vol 61. Nº1

MEPOLIZUMAB

Studie GEVAERT 2011
Population under study CRSwNP

≥18
Age (y)
Inclusion criteria Refractoriness to treatment Failure of conventional medical treatment;
with glucocorticoids, and/or
75% - ≥ 1 previous surgery for nasal polyps in the intervention group;
previous surgery for nasal
80% - ≥ 1 previous surgery for nasal polyps in the control group.
polyps with relapse
Bilateral NPS:
NPS Mean - 5.2 in the intervention group;
Mean - 5.5 in the control group.
Duration 8 weeks of treatment and 40 weeks of follow-up

The intervention group received 2 doses of 750 mg intravenous mepolizumab administered
Intervention Protocol 28 days apart;
The control group received 2 doses of intravenous placebo administered 28 days apart.

Total number of participants 30
at the start of each trial

Studie BACHERT 2017
Population under study CRSwNP
Inclusion criteria Refractoriness to treatment Intranasal glucocorticoids for at least 3 months and/or a short regimen of oral corticosteroids;
18-70
Age (y)
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 24 weeks

The intervention group received 750 mg of mepolizumab intravenously every 4 weeks for
24 weeks; The control group received placebo intravenously every 4 weeks for 24 weeks;
Intervention Protocol
All groups received 100 μg of fluticasone propionate nasal spray daily in each nostril for 10
to 14 days in preparation, which was continued for the remainder of the study
Total number of participants 105
at the start of each trial

Studie SYNAPSE
Population under study CRSwNP
Inclusion criteria Refractoriness to treatment Intranasal glucocorticoids for at least 8 weeks prior to screening;
Age (y)
≥18
with glucocorticoids, and/or
previous surgery for nasal
Previous surgery for nasal polyps within the past 10 years.
polyps with relapse
NPS Bilateral NPS ≥5 (≥ 2 in each nostril)

Duration 52 weeks
The intervention group received 100 mg of mepolizumab subcutaneously in the thigh, abdomen,
Intervention Protocol or arm every 4 weeks for 52 weeks. The control group received placebo subcutaneously in the
thigh, abdomen or arm every 4 weeks for 52 weeks; All groups received mometasone furoate
nasal spray.
Total number of participants 407
at the start of each trial

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