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Table 1 Results of biologic trials for CRSwNP

From: Canadian Rhinology Working Group consensus statement: biologic therapies for chronic rhinosinusitis

Study Treatment Study sample size Diagnosis Comorbidities Study Outcomes Results
Nasal IL5 levels determine the response to
anti-IL-5 treatment in patients with nasal polyps.
Gevaert et al.
(2006) [11]
Reslizumab
(anti-IL-5)
n = 24
(Placebo
n = 8 /
1 mg/kg Treatment
n = 8 /
3 mg/kg Treatment
n = 8)
CRSwNP Asthma: n = 18 Nasal polyp score, adverse events, NPIF, disease symptoms score, blood and serum markers - Total nasal polyp score was only significantly decreased in the 1 mg/kg group at week 12
- No significant difference in NPIF or disease symptoms score at any time point in treatment groups compared to placebo.
- Significant decrease in blood eosinophil counts groups sustained until week 8 and Serum ECP and Secreted IL-5Rα until week 4 in both treatment groups
A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis.
Pinto et al. (2010) [12]
Omalizumab (anti-IgE) N = 14
(Placebo
n = 7 /
Treatment n = 7)
CRSwNP/ Crisp Asthma: All patients Snot-22, SF-36, nasal polyp size, CT scan opacification percentage, adverse events, NPIF, eosinophil count, UPSIT No significant differences in polyp size, CT scan opacification percentage, SNOT-22 score, NPIF in the omalizumab group compared to placebo
Improvement in UPSIT smell test score but not statistically significant and no significant differences in SF-36 except for the one domain, Vitality, between omalizumab and placebo group
Mepolizumab, a humanized anti-IL-5 mAb, as
a treatment option for severe nasal polyposis.
Gevaert et al.
(2011) [13]
Mepolizumab
(anti-IL-5)
n = 30
(Placebo
n = 10 / Treatment
n = 20)
CRSwNP refractory to corticosteroid therapy Asthma: n = 23
Allergies: n = 14
Aspirin intolerance: n = 5
Disease symptom scores, Adverse events, nasal polyp score, CT scan score, NPIF, blood and serum markers - Significant improvement in total polyp score and CT scan scores from baseline in the mepolizumab group compared to placebo
- No significant difference in disease symptoms scores or NPIF
- Significant reduction of blood eosinophil counts and serum ECP and serum IL-5Rα levels at week 8 in mepolizumab group
- Nasal IL-5Rα, IL-6, IL-1β, and MPO levels were significantly reduced in the mepolizumab group
Omalizumab is effective in allergic and nonallergic
patients with nasal polyps and asthma.
Gevaert et al.
(2013) [14]
Omalizumab
(anti-IgE)
n = 24
(Placebo
n = 8 / Treatment
n = 15)
CRSwNP with asthma Asthma: All patients
Allergies: n = 13
Aspirin intolerance:
n = 12
Disease symptom scores, adverse events, RSOM-31, AQLQ, SF-36, polyp size and total overall polyp score, LMK Score, FEV1 and PEF, and blood and serum markers - Significant reduction in polyp size, improvement in LMK scores in Omalizumab group after 16 weeks
Significant decrease in symptom scores for Omalizumab group: nasal congestion, anterior rhinorrhea, loss of sense of smell, dyspnea
Significant improvement in SF-36 of physical health, RSOM-31 of sleep and general symptoms and AQLQ after Omalizumab treatment
No significant changes in blood and serum markers
Effect of Subcutaneous Dupilumab on Nasal
Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized
Clinical Trial.
Bachert et al.
(2016) [15]
Dupilumab
(anti-IL-4/IL-13)
n = 60
(Placebo
n = 30 / Treatment
n = 30)
CRSwNP refractory to intranasal corticosteroid therapy Asthma: n = 35
Allergies: n = 38
Aspirin intolerance:
n = 12
SNOT-22, VAS, adverse events, Endoscopic polyp score, LMK Score, UPSIT, NPIF, FEV1, ACQ-5, patient-rated disease severity symptoms - Statistically significant improvement in SNOT-22 and UPSIT in the dupilumab group vs placebo
- Statistically significant difference of least squares mean change in bilateral endoscopic nasal polyp score and LMK CT total scores between the treatment and placebo group
- Statistically significant reduction of IgE, and plasma eotaxin-3 with dupilumab vs placebo
Reduced need for surgery in severe nasal polyposis
with mepolizumab: randomized trial.
Bachert et al. (2017) [16]
Mepolizumab
(anti-IL-5)
n = 105
(Placebo
n = 51 / Treatment
n = 54)
CRSwNP Asthma: n = 82 VAS, SNOT-22, adverse events, avoidance of surgery, endoscopic nasal polyp score, EQ-5D, Sniffin Sticks Screening-12, and lung function assessments. - Significant improvement endoscopic nasal polyp score, all individual VAS symptom scores, and SNOT-22 score in the mepolizumab compared with placebo group
- The was no statistically signification difference in olfaction via Sniffin Sticks Screening-12, and lung function tests
-A reduction in blood eosinophil counts in the mepolizumab but not in the placebo
Efficacy and
safety of dupilumab in patients with chronic rhinosinusitis with nasal polyps: results from
the randomized phase 3 sinus-24 study.
Han et al. (2019) [17]
Dupilumab
(anti-IL-4/IL-13)
n = 276
(Placebo
n = 133 / Treatment
n = 143)
CRSwNP   VAS, SNOT-22, adverse events, patient-reported outcomes, ACQ-6, total nasal polyp score, UPSIT, FEV1, LMK Score, blood and serum markers Dupilumab significantly improved nasal polyp score, LMK score, Snot-22 score, patient reported nasal congestion, and UPSIT scores from baseline compared to placebo.
Asthma patients on dupilumab had improved lung function (FEV1) and ACQ-6 scores
A randomized
phase 3 study, sinus-52, evaluating the efficacy and safety of dupilumab in patients with
severe chronic rhinosinusitis with nasal polyps.
Bachert et al. (2019) [18]
Dupilumab
(anti-IL-4/IL-13)
n = 448
(Placebo n = 153 / Treatment Q2W/Q4W n = 145
Treatment Q2W
n = 150)
CRSwNP   VAS, SNOT-22, adverse events, patient-reported outcomes, ACQ-6, total nasal polyp score, UPSIT, FEV1, LMK score, blood and serum markers Dupilumab significantly improved nasal polyp score, LMK score, Snot-22 score, patient reported nasal congestion, and UPSIT scores from baseline compared to placebo.
Asthma patients on dupilumab had improved lung function (FEV1) and ACQ-6 scores
Dupilumab reduces opacification across all sinuses and related symptoms in patients with CRSwNP
Bachert et al. (2020) [19]
Dupilumab
(anti-IL-4/IL-13)
n = 60
(Placebo
n = 30 / Treatment
n = 30)
CRSwNP Asthma:
Placebo n = 19
Treatment
n = 16
zLMK, LMK Score, bilateral endoscopic nasal polyp score,
UPSIT, SNOT-22, VAS, patient reported symptoms of nasal congestion and/or obstruction
After 16 weeks, Dupilumab significantly decreased opacification across all sinuses measured using the LMK and zLMK scoring systems, and significantly improved nasal polyp score, SNOT-22 score, VAS score, and UPSIT score
At baseline opacification measured by
total LMK score correlated with other assessed outcomes but not at 16 weeks
  1. CRSwNP Chronic Rhinosinusitis with Nasal Polyposis, CRSsNP Chronic Rhinosinusitis without Nasal Polyposis, NPIF Nasal peak inspiratory flow, Serum ECP Serum Eosinophil cationic protein, IL-5Rα Interleukin- 5 receptor α, IL Interleukin, MPO myeloperoxidase, SNOT-22 Sino-Nasal Outcome Test-22, SF-36 36-Item Short Form Survey, UPSIT The University of Pennsylvania Smell Identification Test, RSOM-31 31-item Rhinosinusitis Outcome Measure, AQLQ Asthma Quality of Life Questionnaire, FEV1 Forced Expiratory Volume, PEF Peak Expiratory Flow, VAS Visual Analogue Scale, EQ-5D Generic health-related quality of life questionnaire, ACQ-6 6-question Asthma Control Questionnaire, ACQ-5 5-question Asthma Control Questionnaire, LMK Lund-Mackay Score, zLMK Zinreich-modified Lund–Mackay Score