Real-life effects of dupilumab in patients with severe type 2 asthma, according to atopic trait and presence of chronic rhinosinusitis with nasal polyps

Pelaia, Corrado; Benfante, Alida; Busceti, Maria Teresa; Caiaffa, Maria Filomena; Campisi, Raffaele; Carpagnano, Giovanna Elisiana; Crimi, Nunzio; D’Amato, Maria; Barbaro, Maria Pia Foschino; Maglio, Angelantonio; Minenna, Elena; Nolasco, Santi; Paglino, Giuseppe; Papia, Francesco; Pelaia, Girolamo; Portacci, Andrea; Ricciardi, Luisa; Scichilone, Nicola; Scioscia, Giulia; Triggiani, Massimo; Valenti, Giuseppe; Vatrella, Alessandro; Crimi, Claudia

doi:10.3389/fimmu.2023.1121237

Cited by 24 publications

(11 citation statements)

References 47 publications

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“…In addition, objective and patient-reported outcomes related to CRSwNP followed the trend of asthma outcomes in our population (Figure 3), demonstrating a rapid and significant direct effect of dupilumab on upper airways. Our results are in line with a recently published real-life study [14], although limited to a 6 months follow-up, and with the work by Al-Ahmad et al [15]. The authors explored as a secondary objective the effect of dupilumab on asthma symptom control.…”

Section: Discussionsupporting

confidence: 91%

“…A limited number of studies in a real-life setting have focused on severe asthma outcomes as the primary objective, most of them following up with patients for 6 months or less [10,11,13,14,16]. or including a small sample size (64 patients in a French cohort [9], 18 patients in an Italian study [18]).…”

Section: Discussionmentioning

confidence: 99%

“…So far, few studies have specifically reported on dupilumab efficacy on asthma outcomes in a real-life setting, most of them including a small sample size and a limited follow-up time frame [9][10][11][12][13][14][15][16][17][18]. In addition, despite the fact that the coexistence of CRSwNP and asthma does represent a well-known factor for worse and more difficult asthma control [19], whether such comorbidity limits the effect of dupilumab on asthma outcomes in treated patients has been poorly investigated in real life [14,15]. Furthermore, the available data are mostly limited to severe asthma patients [12].…”

Section: Introductionmentioning

confidence: 99%

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Dupilumab Efficacy on Asthma Functional, Inflammatory, and Patient-Reported Outcomes across Different Disease Phenotypes and Severity: A Real-Life Perspective

Caminati,

Maule,

Benoni

et al. 2024

Biomedicines

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Dupilumab is currently approved for the treatment of Type 2 severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies have specifically reported on dupilumab efficacy on asthma outcomes as a primary objective in a real-life setting, in patients with and without CRSwNP. Our study aimed to explore the efficacy of dupilumab on functional, inflammatory, and patient-reported outcomes in asthma patients across different disease phenotypes and severity, including mild-to-moderate asthma coexisting with CRSwNP. Data from 3, 6, and 12 months follow-up were analyzed. Asthma (FEV1%, Tiffeneau%, ACT, FeNO, oral steroid use, exacerbation rate, and blood eosinophilia) and polyposis (SNOT22, VAS, NPS) outcomes showed a rapid (3 months) and sustained (6 and 12 months) significant change from baseline, despite most of the patients achieving oral steroid withdrawal. According to the sensitivity analysis, the improvement was not conditioned by either the presence of polyposis or severity of asthma at baseline. Of note, even in the case of milder asthma forms, a significant further improvement was recorded during dupilumab treatment course. Our report provides short-, medium-, and long-term follow-up data on asthma outcomes across different diseases phenotypes and severity, contributing to the real-world evidence related to dupilumab efficacy on upper and lower airways T2 inflammation.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Dupilumab Efficacy on Asthma Functional, Inflammatory, and Patient-Reported Outcomes across Different Disease Phenotypes and Severity: A Real-Life Perspective

Caminati,

Maule,

Benoni

et al. 2024

Biomedicines

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“…We believe comorbidities and patient burden should be integrated into the assessment and management of atopic dermatitis, optimizing therapeutic decision-making and improving patient outcomes. Furthermore, this therapeutic opportunity offers the possibility of simplifying the treatment approach by employing a drug that can effectively treat multiple type 2 inflammatory diseases at the same time ( 33 ).…”

Section: Discussionmentioning

confidence: 99%

Asthma improvement in patients treated with dupilumab for severe atopic dermatitis

Dubini,

Benzecry,

Rivolta

et al. 2023

Front. Allergy

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IntroductionAtopic dermatitis (AD) is considered a systemic type 2 immune driven disease, and it is associated to many atopic comorbidities including asthma. The aim of our study was to prospectively evaluate the respiratory outcomes in patients with persistent allergic asthma treated with dupilumab due to severe AD (sAD).MethodsWe enrolled eligible patients with sAD for dupilumab treatment from September 2018 to December 2020. We then selected the subgroup of patients sensitized to perennial allergens. Dupilumab's efficacy and safety on AD and comorbid asthma were assessed at baseline, one month, four months, and then every 4 months up to one year.ResultsA total of 437 patients with sAD were enrolled for dupilumab treatment due to sAD, and 273 reached 48 weeks of therapy. Respiratory outcomes were evaluated in the 85 asthmatic patients with positivity only to perennial allergens. Our patients showed statistically and clinically significant improvement in asthma control (Asthma Control Test and Asthma Control Questionnaire) and airway obstruction parameters (FEV1), in addition to the expected AD-related skin outcomes. Specifically, a significant improvement was achieved at the fourth month of dupilumab therapy, and this trend was maintained up to twelve months, regardless of asthma severity.ConclusionsOur results showed the overall improvement of the clinical picture that dupilumab offers for patients with severe AD and persistent allergic asthma of any severity, highlighting the importance of a global multidisciplinary approach of type 2 driven disease.

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“…Biologics have been introduced as a treatment option for severe T2 high asthma owing to their efficacy and OCS-sparing benefits [9]. Dupilumab is a fully human VelocImmune ® -derived monoclonal antibody directed against the IL-4Rα subunit, thereby inhibiting both IL-4 and IL-13 signaling pathways and hence T2 inflammation [10][11][12][13][14]. Dupilumab demonstrated efficacy in improving clinical outcomes and an adequate safety profile through randomized controlled trials (RCTs) in patients with T2 asthma [10][11][12]15].…”

Section: Introductionmentioning

confidence: 99%

Real-World Characteristics of Patients with Severe Asthma prior to Starting Dupilumab: The ProVENT Study

Korn,

Schmidt,

Timmermann

et al. 2023

Respiration

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Introduction: Dupilumab is approved for the treatment of severe type 2 (T2) asthma; however, the characteristics of patients receiving dupilumab in routine clinical practice are incompletely understood. This study describes the characteristics of patients with severe asthma before dupilumab treatment in a real-world setting. Methods: This interim analysis of an ongoing real-life study of dupilumab assessed baseline characteristics of the first patient cohort enrolled in the ProVENT study. Results: A total of 99 patients (59% females) were analyzed (17% received another biologic before dupilumab treatment and 15% were on maintenance oral corticosteroid treatment). Adult-onset asthma (>18 years) and an allergic phenotype were documented in 58% and 48% of patients, respectively. Median (interquartile range) age was 54 (40–61) years; the median number of exacerbations in the last 24 months was 1 (0–3); median fractional exhaled nitric oxide (FeNO) value was 38 (23–64) ppb; and median blood eosinophils (bEOS) count was 184 (8–505) cells/µL. According to the United Kingdom Severe Asthma Registry classification, 53% of patients had T2 intermediate asthma (bEOS ≥150 cells/µL or FeNO ≥25 ppb), 17% had T2 high asthma (bEOS ≥150 cells/µL and FeNO ≥25 ppb), and 4% had T2 low asthma (bEOS <150 cells/µL and FeNO <25 ppb). At least one GINA criterion for T2 airway inflammation was documented in 70% of patients. T2 comorbidities were observed in 64% of patients. Conclusions: This analysis suggests that patients eligible for dupilumab treatment display various clinical and biochemical characteristics rather than one clear-cut phenotype.

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Real-life effects of dupilumab in patients with severe type 2 asthma, according to atopic trait and presence of chronic rhinosinusitis with nasal polyps

Cited by 24 publications

References 47 publications

Dupilumab Efficacy on Asthma Functional, Inflammatory, and Patient-Reported Outcomes across Different Disease Phenotypes and Severity: A Real-Life Perspective

Dupilumab Efficacy on Asthma Functional, Inflammatory, and Patient-Reported Outcomes across Different Disease Phenotypes and Severity: A Real-Life Perspective

Asthma improvement in patients treated with dupilumab for severe atopic dermatitis

Real-World Characteristics of Patients with Severe Asthma prior to Starting Dupilumab: The ProVENT Study

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