A Randomized Phase 3 Study, Sinus-52, Evaluating the Efficacy and Safety of Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps

Bachert, Claus; Desrosiers, Martin; Mullol, Joaquim; Hellings, Peter; Cervin, Anders; Sher, Lawrence; Bosso, John V.; Lee, Stella E.; Máspero, Jorge; Fujieda, Shigeharu; Matsune, Shoji; Lu, Xin; Fan, Chunpeng; Draikiwicz, Steven; Amin, Nikhil; Kamat, Siddhesh; Khan, Asif; Pirozzi, Gianluca; Graham, Neil M.H.; Ruddy, Marcella; Staudinger, Heribert; Mannent, Leda

doi:10.1016/j.jaci.2018.12.980

Cited by 19 publications

(21 citation statements)

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“…At 52 weeks, dupilumab reduced rescue treatment (systemic corticosteroids) or NP surgery by 76% versus placebo (p < .0001) 88 . Also at 52 weeks, dupilumab significantly improved both ACQ-6 scores (p < .0001) and FEV 1 (p < .0001) versus placebo for patients with severe CRSwNP plus comorbid asthma 86 . The Phase II trial (NCT01920893) demonstrated that dupilumab significantly improved endoscopic nasal congestion and NP, Lund-Mackay, UPSIT, and SNOT-22 scores compared with placebo for patients with CRSwNP refractory to intranasal corticosteroids 87 .…”

Section: Results For Biologicsmentioning

confidence: 94%

“…Also at 24 weeks, dupilumab significantly improved Asthma Control Questionnaire (ACQ)-6 scores (p < .0001) and forced expiratory volume in 1 second (FEV 1 ) (p < .001) versus placebo for patients with severe CRSwNP plus comorbid asthma 85 . In the SINUS-52 trial, dupilumab significantly improved endoscopic nasal congestion and NP, Lund-Mackay, UPSIT, and SNOT-22 scores relative to placebo for patients with severe CRSwNP (Figure 4(B)) 86 . 95 Omalizumab prospective cohort study N/A N/A 37 CRSwNP patients with severe allergic asthma a Only biologics RCTs with results available at the time of the literature search are listed in this table.…”

Section: Results For Biologicsmentioning

confidence: 99%

“…Three RCT studies for dupilumab, the Phase III SINUS-24 85 and SINUS-52 86 studies, and a Phase II study 87 were retrieved. No RWE studies were found for dupilumab.…”

Section: Results For Biologicsmentioning

confidence: 99%

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Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis

Chen

Zhou

Emmanuel

et al. 2020

Current Medical Research and Opinion

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Objectives: We conducted a systematic literature review (SLR) to determine the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyps (CRSwNP) and to describe how the addition of biologics has affected outcomes for patients with CRSwNP. Methods: The SLR adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Embase, MEDLINE, and Evidence-Based Medicine Reviews databases were searched using OVID. Relevant studies published between 1

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Section: Results For Biologicsmentioning

confidence: 94%

Section: Results For Biologicsmentioning

confidence: 99%

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Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis

Chen

Zhou

Emmanuel

et al. 2020

Current Medical Research and Opinion

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“…The second study had 448 subjects randomized to 300 mg of dupilumab every other week for 52 weeks, 300 mg of dupilumab every other week for 24 weeks, followed by every four weeks until week 52, or placebo. 13,15 The nasal polyp endoscopic score, nasal congestion symptom score, and need for systemic steroids or polyp surgery were all reduced. Patients with asthma again had improved FEV 1 and asthma control.…”

Section: Chronic Rhinosinusitis With Nasal Polyposismentioning

confidence: 97%

<p>Updated Evaluation of Dupilumab in the Treatment of Asthma: Patient Selection and Reported Outcomes</p>

Gd¹

2020

TCRM

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Uncontrolled asthma continues to be a problem for many patients with moderateto-severe allergic asthma. Dupilumab, which blocks the receptors for interleukin-4 and interleukin-13, has been effective in reducing asthma exacerbations, improving forced expiratory volume in one second (FEV 1), and reducing oral corticosteroid use. When selecting patients for dupilumab, it is important to consider entry criteria for the original studies, subgroups that have responded best, and the presence of comorbid diseases that may also respond to dupilumab. Factors that were considered when selecting patients likely to respond to dupilumab in asthma studies include: failure of moderate or high dose inhaled steroids in combination with an additional controller medication, baseline FEV 1 reversibility of 12% or greater, and Asthma Control Questionnaire > 1.5. The baseline characteristics that predicted a better response to dupilumab included blood eosinophils > 150 cells/mm 3 and fractional exhaled nitric oxide > 25 parts per billion. Comorbidities that may also respond to treatment with dupilumab include atopic dermatitis, chronic rhinosinusitis, and allergic rhinitis. A combination of these factors should be considered when selecting the patients most likely to benefit from dupilumab.

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“…It is approved in the European Union, USA, Japan and other countries for treatment of inadequately controlled moderate‐to‐severe atopic dermatitis in adults . Dupilumab is recently approved by the United States Food and Drug Administration (FDA) since June 2019 for the treatment of inadequately controlled CRSwNP based on two pivotal trials, the 24‐week SINUS‐24 and 52‐week SINUS‐52, that are part of the Phase 3 LIBERTY clinical trial programme . These trials evaluated dupilumab 300 mg every 2 weeks for the duration of the trial with standard‐of‐care mometasone furoate nasal spray compared to placebo injection plus mometasone furoate nasal spray.…”

Section: Precision Medicine In Crsmentioning

confidence: 99%

Novel findings in immunopathophysiology of chronic rhinosinusitis and their role in a model of precision medicine

Ong

Wang

2019

Allergy

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Our understanding of the pathophysiology of chronic rhinosinusitis (CRS) is continuously evolving. The traditional description of CRS in terms of two phenotypes based on the presence or absence of nasal polyps belies the underlying intricate immunopathophysiological processes responsible for this condition. CRS is being increasingly recognized as a disease spectrum encompassing a range of inflammatory states in the sinonasal cavity, with non-type 2 inflammatory disease on one end, type 2 inflammatory, eosinophil-heavy disease on the other and an overlap of both in different proportions in between. Abundance in research on the immune mechanisms of CRS has revealed various new endotypes that hold promise as biomarkers for the development of targeted therapies in severe, uncontrolled CRS. The introduction of precision medicine to manage this chronic, complex condition is a step forward in providing individualized care for all patients with CRS. In this review, the latest research on the pathophysiology of CRS with a focus on potential novel biomarkers and treatment options over the last 2 years are summarized and integrated into a suggested model of precision medicine in CRS. K E Y W O R D S biomarkers, chronic rhinosinusitis, endotypes, immunopathophysiology, precision medicine

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A Randomized Phase 3 Study, Sinus-52, Evaluating the Efficacy and Safety of Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps

Cited by 19 publications

References 0 publications

Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis

Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis

<p>Updated Evaluation of Dupilumab in the Treatment of Asthma: Patient Selection and Reported Outcomes</p>

Novel findings in immunopathophysiology of chronic rhinosinusitis and their role in a model of precision medicine

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