Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial

investigators, Synapse study

doi:10.1016/s2213-2600(21)00097-7

Cited by 353 publications

(303 citation statements)

References 38 publications

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“…Biologics currently indicated for CRSwNP include dupilumab, omalizumab, and mepolizumab [ 6 , 7 , [9] , [12] , 13 , 28 ]. Results from the OSTRO (benralizumab) and SYNAPSE (mepolizumab) Phase 3 trials in CRSwNP have demonstrated improvements in nasal polyp score and nasal blockage/obstruction following biologic treatment [ 29 , 30 ]. These findings are supported by studies that found a reduction in nasal polyp size, symptoms, and/or quality of life in the overlap population of patients with severe eosinophilic asthma and CRSwNP treated with benralizumab [ [31] , [32] , [33] ].…”

Section: Discussionmentioning

confidence: 99%

Effect of benralizumab in a patient with uncontrolled severe eosinophilic asthma and comorbid chronic rhinosinusitis with nasal polyps refractory to mepolizumab treatment

Mansur

2022

Respiratory Medicine Case Reports

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Severe eosinophilic asthma is associated with a high corticosteroid burden, particularly in patients with comorbid chronic sinusitis/nasal polyps. This case study reports a 33-year-old woman who presented to the severe asthma center with uncontrolled severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Despite maximized asthma treatment, including maintenance oral corticosteroids (OCS) for 7 years, the patient experienced one to two hospitalizations per year, had daily symptoms that substantially impacted her quality of life, and elevated type 2 inflammatory markers (blood eosinophils, 0.72 × 10 9 /L; fractional exhaled nitric oxide, 134 to 300 parts per billion). Her asthma worsened during her first pregnancy, in which she required five hospital admissions despite treatment with maintenance OCS. Mepolizumab treatment was commenced after pregnancy but showed limited efficacy (blood eosinophil levels up to 0.94 × 10 9 /L); treatment was discontinued because of a second pregnancy. The patient's asthma worsened and resulted in four hospitalizations and an increase in monthly OCS dose. Mepolizumab was recommenced after pregnancy, but her asthma remained uncontrolled, symptoms persisted, and one hospitalization and nine OCS courses were required. The patient was switched to benralizumab treatment when it became available. Although her CRSwNP symptoms remained, benralizumab treatment resulted in a marked improvement in asthma control, zero hospitalizations, and suppressed blood eosinophil levels. Notably, the patient was successfully weaned off maintenance OCS after >11 years of treatment. In summary, these findings support the use of benralizumab as a corticosteroid-sparing treatment option in difficult-to-treat severe eosinophilic asthma refractory to mepolizumab treatment.

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Section: Discussionmentioning

confidence: 99%

Effect of benralizumab in a patient with uncontrolled severe eosinophilic asthma and comorbid chronic rhinosinusitis with nasal polyps refractory to mepolizumab treatment

Mansur

2022

Respiratory Medicine Case Reports

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“…Biological therapies, namely IgE-, IL-5/IL-5Rα -and IL-4Rα -antibodies have revolutionized the treatment of severe asthma and were recently also found to be effective in severe CRSwNP. [2][3][4] Here, we investigated the real-life effectiveness of different biologics on symptoms in patients with severe asthma and comorbid CRSwNP.…”

Section: To the Editormentioning

confidence: 99%

“…of dupilumab, 2 omalizumab 3 and mepolizumab4 reporting improvements in objective outcome measures like endoscopic nasal polyp score (NPS) as well as subjective measures, including SNOT-22. In our study, the different treatment groups varied in baseline characteristics reflecting the different target molecules and licensing criteria of the antibodies in severe asthma and this limits comparability between groups.…”

mentioning

confidence: 99%

Real‐life effectiveness of biological therapies on symptoms in severe asthma with comorbid CRSwNP

Mümmler

Dünzelmann

Kneidinger

et al. 2021

Clinical & Translational All

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Background:We aimed to evaluate the effectiveness of different antibody therapies on nasal polyp symptoms in patients treated for severe asthma. Methods:We performed a retrospective analysis of patients with severe asthma and comorbid CRSwNP who were treated with anti-IgE, anti-IL-5/R or anti-IL-4R. CRSwNP symptom burden was evaluated before and after 6 months of therapy.Results: Fifty patients were included hereof treated with anti-IgE: 9, anti-IL-5/R: 26 and anti-IL-4R: 15 patients. At baseline median SNOT-20 was similar among groups (anti-IgE: 55, anti-IL-5/R: 52 and anti-IL-4R: 56, p = 0.76), median visual analogue scale (VAS) for nasal symptoms was 4, 7 and 8 (p = 0.14) and VAS for total symptoms was higher in the anti-IL-4R group (4, 5 and 8, p = 0.002). After 6 months SNOT-20 improved significantly in all patient groups with median improvement of anti-IgE: −8 (p < 0.01), anti-IL-5/R: −13 (p < 0.001) and anti-IL-4R: −18 (p < 0.001), with larger improvement in the anti-IL-4R group than in anti-IgE (p < 0.001) and anti-IL-5/R (p < 0.001) groups. VAS nasal symptoms improved by median anti-IgE: 0 (n.s.), anti-IL-5/R: −1 (p < 0.01) and anti-IL-4R: −3 (p < 0.001), VAS total symptoms by anti-IgE: −1 (n.s.), anti-IL-5/R: −2 (p < 0.001) and anti-IL-4R: −2 (p < 0.001). Conclusions:Treatment by all antibodies showed effectiveness in reducing symptoms of CRSwNP in patients with severe asthma, with the largest reduction observed in anti-IL-4R-treated patients.

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“…Patients with SEA and concomitant NP had a phenotype that showed greater benefit with mepolizumab compared with patients with SEA in the absence of NP. The phase 3 SYNAPSE study54 was a 52-week, randomised, double-blind, placebo-controlled, parallel group study of subcutaneous mepolizumab 100 mg in 407 adult patients with highly symptomatic CRSwNP uncontrolled by previous surgery and treated with INCS. Eligible patients had at least 1 prior surgery in the past 10 years, recurrent nasal polyps despite treatment with standard of care and in need of nasal polyp surgery (overall VAS > 7 and an NPS of at least 5 with a minimum score of 2 in each side).…”

mentioning

confidence: 99%

Biologics for severe uncontrolled chronic rhinosinusitis with nasal polyps: a change management approach. Consensus of the Joint Committee of Italian Society of Otorhinolaryngology on biologics in rhinology

Corso

Bellocchi

Benedetto

et al. 2022

Acta Otorhinolaryngol Ital

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Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial

Cited by 353 publications

References 38 publications

Effect of benralizumab in a patient with uncontrolled severe eosinophilic asthma and comorbid chronic rhinosinusitis with nasal polyps refractory to mepolizumab treatment

Effect of benralizumab in a patient with uncontrolled severe eosinophilic asthma and comorbid chronic rhinosinusitis with nasal polyps refractory to mepolizumab treatment

Real‐life effectiveness of biological therapies on symptoms in severe asthma with comorbid CRSwNP

Biologics for severe uncontrolled chronic rhinosinusitis with nasal polyps: a change management approach. Consensus of the Joint Committee of Italian Society of Otorhinolaryngology on biologics in rhinology

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