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TABLE X-26 Evidence for CRSwNP management with biologic therapy Study Year LOE(1-5) Study Design Study Groups Clinical Endpoint Conclusions Gevaert 1645 2020 2 Two replicate randomized, double blind, placebo controlled added to intranasal corticosteroids Omalizumab or placebo and intranasal mometasone for 24 weeks Change in nasal polyp score and nasal congestion score Omalizumab groups with reduced nasal polyp score and reduced nasal congestion score compared to placebo. Bachert 60a 2019 2 Randomized, double blind, placebo controlled added to INCS Dupilumab 300 mg Q 2 weeks x 52 weeks; Dupilumab 300 mg Q 2 weeks x 24 weeks then Q 4weeks × 28weeks; Placebo Change in nasal polyp score; Change in nasal congestion symptom score Dupilumab groups with reduced nasal polyp score and reduced nasal congestion score compared to placebo.

Dupilumab group with reduced nasal polyp score.

Dupilumab group with reduced nasal polyp score and reduced nasal congestion

score compared to placebo.

Mepolizumab group with higher

percentage of people no longer requiring surgery.

Change in nasal polyp score

Change in nasal polyp score

Change in nasal congestion

symptom score

Number of patients requiring sinus surgery at 25 weeks

Dupilumab 600 mg loading then 300 mg weekly for total of 16 weeks; Placebo

Dupilumab 300 mg Q 2 weeks x 24 weeks; Placebo

Mepolizumab 750 IV every 4 weeks for 24 weeks; placebo

Bachert 56 2016 2 Randomized, double blind, placebo

controlled added to INCS

Bachert 60b 2019 2 Randomized, double blind, placebo

controlled added to INCS

Bachert 57 2017 3 Randomized, double blind, placebo

controlled added to INCS