Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: A randomized, placebo-controlled trial

Bachert, Claus; Han, Joseph K.; Desrosiers, Martin; Gevaert, Philippe; Heffler, Enrico; Hopkins, Claire; Tversky, Jody; Barker, Peter; Cohen, David E.; Emson, Claire; Martin, Ubaldo J.; Shih, Vivian H.; Necander, Sofia; Kreindler, James L.; Jison, Maria; Werkström, Viktoría

doi:10.1016/j.jaci.2021.08.030

Cited by 178 publications

(180 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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“…A phase 3 trial examining the efficacy of benralizumab in CRwNP (OSTRO) has recently been published and reported a reduction in nasal blockage score (patient reported) and nasal polyp score (determined by nasoendoscopy). There was also an improvement in disease-specific quality of life (SNOT-22) versus placebo, but this did not reach statistical significance [ 73 ]. OSTRO did not require evidence of eosinophilic disease for enrolment, and a further trial of benralizumab in eosinophilic CRwNP (ORCHID, ClinicalTrials.gov identifier: NCT04157335) is currently recruiting.…”

Section: Benralizumabmentioning

confidence: 99%

A pragmatic guide to choosing biologic therapies in severe asthma

Kavanagh

Hearn

Jackson

2021

Breathe

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There are now several monoclonal antibody (mAb) therapies (“biologics”) available to treat severe asthma. Omalizumab is an anti-IgE mAb and is licensed in severe allergic asthma. Current evidence suggests it may decrease exacerbations by augmenting deficient antiviral immune responses in asthma. Like all other biologics, clinical efficacy is greatest in those with elevated T2 biomarkers. Three biologics target the interleukin (IL)-5–eosinophil pathway, including mepolizumab and reslizumab that target IL-5 itself, and benralizumab that targets the IL-5 receptor (IL-5R-α). These drugs all reduce the exacerbation rate in those with raised blood eosinophil counts. Mepolizumab and benralizumab have also demonstrated steroid-sparing efficacy. Reslizumab is the only biologic that is given intravenously rather than by the subcutaneous route. Dupilumab targets the IL-4 receptor and like mepolizumab and benralizumab is effective at reducing exacerbation rate as well as oral corticosteroid requirements. It is also effective for the treatment of nasal polyposis and atopic dermatitis. Tezepelumab is an anti-TSLP (thymic stromal lymphopoietin) mAb that has recently completed phase 3 trials demonstrating significant reductions in exacerbation rate even at lower T2 biomarker thresholds.Many patients with severe asthma qualify for more than one biologic. To date, there are no head-to-head trials to aid physicians in this choice. However, post-hoc analyses have identified certain clinical characteristics that are associated with superior responses to some therapies. The presence of allergic and/or eosinophilic comorbidities, such as atopic dermatitis, nasal polyposis or eosinophilic granulomatosis with polyangiitis, that may additionally benefit by the choice of biologic should also be taken into consideration, as should patient preferences which may include dosing frequency. To date, all biologics have been shown to have excellent safety profiles.

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“…All authors declare that they have no conflicts of interest to disclose. José Laerte Boechat 1,2,3 Diana Silva 2,4 Bernardo Sousa-Pinto 3,5 Luís Delgado…”

Section: Lettersmentioning

confidence: 99%

“…(NMA) providing indirect comparisons between different biologicals, and updating it with three additional randomized controlled trials (RCTs). [2][3][4] We included all RCTs evaluated in the SR by Agache We performed NMA, calculating pooled risk ratios for binary outcomes and mean differences for continuous outcomes. As, for every comparison, evidence was either direct or indirect, we were not able to assess inconsistency.…”

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confidence: 99%

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Comparing biologicals for severe chronic rhinosinusitis with nasal polyps: A network meta‐analysis

Boechat

Silva

Sousa‐Pinto

et al. 2022

Allergy

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To the Editor, We read with special interest the systematic review (SR) by Agache et al. 1 on the efficacy and safety of biologicals in patients with severe chronic rhinosinusitis with nasal polyposis (CRSwNP).Meta-analytical results were presented for the comparison between each biologic versus placebo, but indirect comparisons between different biologicals were not performed. Therefore, we aimed to complement this SR 1 with a network meta-analysis

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Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: A randomized, placebo-controlled trial

Cited by 178 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

A pragmatic guide to choosing biologic therapies in severe asthma

Comparing biologicals for severe chronic rhinosinusitis with nasal polyps: A network meta‐analysis

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