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 |