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Tsetsos et al.

TABLE1. Characteristics of the RCTs included in the systematic review

Total patients, total TRG, CRG (n)

Study population

Monoclonal antibody

Duration (weeks)

Study

Country

Design

Intervention protocol

Pinto et al (2010)

USA

RCT

14, 7, 7

CRSwNP or CRSsNP

Omalizumab (anti-IgE MAb)

0.016 mg/kg per IU total serum IgE/mL subcutaneously at enrollment and every 4 weeks for 24 weeks vs placebo Two single intravenous injury of 750 mg of mepolizumab or Maximum dose of 375 mg subcutaneously (every 2 weeks/8 inj in total or every months/4 inj in total) of omalizumab vs placebo A 600-mg loading dose of dupilumab subcutaneously followed by 15 weekly doses of 300 mg plus MFNS100 µ g in each nostril twice daily or matched placebo for 16 weeks A total of 6 doses (1 every 4weeks) of mepolizumab 750 mg by intravenous infusion or matched placebo plus intranasal steroids (2 sprays of 1 mg/mL fluticasone propionate daily) placebo (28 days apart) subcutaneously every 2 weeks or matched placebo plus MFNS 100 µ g in each nostril twice daily for 24 weeks subcutaneously 300 mg every 2 weeks for 52 weeks; dupilumab every 2 weeks for 24 weeks, then every 4 weeks for 28 weeks; or placebo every 2 weeks for 52 weeks plus MFNS100 µ g in each nostril twice daily Dupilumab 300 mg Either dupilumab

24

Gevaert et al (2011)

Belgium

RCT

30, 20, 10

CRSwNP

Mepolizumab (anti–IL-5 MAb)

48

Gevaert et al (2013)

Belgium

RCT

24, 16, 8

CRSwNP

Omalizumab (anti-IgE MAb)

20

Bachert et al (2016)

USA, Belgium, Spain, Sweden

RCT

60, 30, 30

CRSwNP

Dupilumab

16

(anti–IL-4Ra MAb)

Bachert et al (2017)

Belgium, The

RCT

105, 54, 51

CRSwNP

Mepolizumab (anti–IL-5 MAb)

25

Netherlands, UK

Bachert et al (2019):

Bulgaria, Czech

RCT

276, 143, 133

CRSwNP

Dupilumab

24

Republic, France, Germany, Hungary, Italy, The Netherlands, Poland, Romania, Ukraine, Russia, UK, USA

(anti–IL-4Ra MAb)

LIBERTYNP SINUS-24

Bachert et al (2019):

Argentina, Australia, Belgium, Canada, Chile, Israel, Mexico, Portugal, Russia, Spain, Sweden, Turkey, Japan, USA

RCT

448, 295, 153

CRSwNP

Dupilumab

52

(anti–IL-4Ra MAb)

LIBERTYNP SINUS-52

CRG = control group; CRSsNP = chronic rhinosinusitis without nasal polyposis; CRSwNP = chronic rhinosinusitis with nasal polyposis; IgE = immunoglobulin E; IL = interleukin; IL-4R α = interleukin-4 receptor α subunit; inj = injections; IU = international unit; MAb = monoclonal antibody; MFNS = mometasonefuroate nasal spray; TRG = treatment group.

International Forum of Allergy & Rhinology, Vol. 10, No. 7, July 2020

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