Biologic Dupilumab (anti IL-4R⍺)1 Dupilumab (anti IL-4R⍺)1 Omalizumab (anti IgE)2 Omalizumab (anti IgE)2 Mepolizumab (anti IL-5)3 Benralizumab (anti IL-5R⍺)*
Study Name (Total numbers) Treatment Duration SINUS-24 (N=276) 24 weeks SINUS-52 (N=448) 52 weeks POLYP 1 (N=138) 24 weeks POLYP 2 (N=127) 24 weeks SYNAPSE (N=407) 52 weeks OSTRO (N=413) 56 weeks
Co-Primary Outcomes
LS mean difference in NPS vs placebo (scale 0-8) 95% CI (P value) LS mean difference in NPS vs placebo (scale 0-8) 95% CI (P value) Treatment arm difference in NPS vs placebo (scale 0-8) 95% Cl (P value) Treatment arm difference in NPS vs placebo (scale 0-8) 95% Cl (P value)
Difference in median change from baseline for NPS (scale 0-8) 95% Cl (P value)
NPS
−2.06 −2.43, −1.69 (P<0.0001) −1.80 −2.10, −1.51 (P<0.0001) −1.14 −1.59, −0.69 (P<0.0001) −0.59 −1.05, −0.12 (P=0.0140) −0.73 −1.11, −0.34 (P<0.001)
Met primary endpoint
LS mean difference in NCS vs placebo (scale 0-3) 95% Cl (P value) LS mean difference in NCS vs placebo (scale 0-3) 95% Cl (P value) Treatment arm difference in NCS vs placebo (scale 0-3) 95% Cl (P value) Treatment arm difference in NCS vs placebo (scale 0-3) 95% Cl (P value)
Difference in median change from baseline in nasal obstruction VAS score 95% Cl (P value)
Nasal blockage score
−0.89 −1.07, −0.71 (P<0.0001) −0.87 −1.03, −0.71 (P<0.0001) −0.55 −0.84, −0.25 (P=0.0004) −0.50 −0.80, −0.19 (P=0.0017) −3.14 −4.09, −2.18 (P<0.001)
Met primary endpoint
Secondary Outcomes
Significant improvement with dupilumab vs placebo (week 24)
Significant improvement with dupilumab vs placebo (week 24)
Significant improvement with omalizumab vs placebo (week 24) Significant improvement with omalizumab vs placebo (week 24)
Significant improvement with mepolizumab vs placebo (week 52)
NOT PUBLISHED
Quality of life (SNOT-22) Total symptom score Sense of smell (UPSIT) and loss of smell score Radiographic assessment (Lund-Mackay score) Increased time to oral corticosteroids or surgery Quality of life (SNOT-22) Total symptom score Sense of smell (UPSIT) and loss of smell score Radiographic assessment (Lund-Mackay score) Increased time to oral corticosteroids or surgery UPSIT and loss of smell score SNOT-22 score UPSIT score TNSS UPSIT and loss of smell score SNOT-22 score UPSIT score TNSS SNOT-22 VAS score Loss of smell Reduced need for surgery Reduced need for systemic corticosteroid use
Adverse reactions with active drug
Injection site reaction, transient eosinophilia, conjunctivitis (7 cases), EGPA (1 case), eosinophilia with arthralgia (1 case)
Injection site reaction, transient eosinophilia, conjunctivitis (7 cases), EGPA (1 case), eosinophilia with arthralgia (1 case)
Headache, injection site reaction, dizziness, upper abdominal pain
Headache, injection site reaction, dizziness, upper abdominal pain
Nasopharyngitis