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
|
|