RItA: The Italian severe/uncontrolled asthma registry

Maio, Sara; Baldacci, Sandra; Bresciani, M; Simoni, Marzia; Latorre, Manuela; Murgia, Nicola; Spinozzi, Fabrizio; Braschi, Mariachiara; Antonicelli, Leonardo; Brunetto, Barbara; Iacovacci, Patrizia; Roazzi, P.; Pini, Carlo; Pátá, M.; Grasta, L La; Paggiaro, Pierluigi; Viegi, Giovanni

doi:10.1111/all.13342

Cited by 60 publications

(61 citation statements)

References 35 publications

(73 reference statements)

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“…Thus, it is possible that pre‐existing ocular disorders and a dupilumab–AD disease‐specific interaction may be responsible for this increased incidence in dupilumab‐treated patients with AD, particularly as conjunctivitis was not associated with dupilumab in trials in other type 2 diseases . Allergic conjunctivitis is a common comorbidity in asthma and allergic rhinitis, as well as in AD . Both lesional and nonlesional skin in AD are characterized by epithelial barrier dysfunction, including abnormalities in keratinocyte terminal differentiation, keratinocyte lipid production and tight junctions, which all contribute to increased transepidermal water loss .…”

Section: Discussionmentioning

confidence: 99%

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Conjunctivitis in dupilumab clinical trials

et al. 2019

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Summary Background Dupilumab blocks the shared receptor component for interleukin (IL)‐4 and IL‐13. It is approved in the U.S.A. for patients aged ≥ 12 years with moderate‐to‐severe atopic dermatitis (AD) uncontrolled by topical prescription medicines or who cannot use topical medicines, for patients in Japan whose AD is uncontrolled with existing therapies, for patients with moderate‐to‐severe AD in Europe who are candidates for systemic therapy and for patients aged ≥ 12 years for maintenance treatment of moderate‐to‐severe asthma uncontrolled with their current medicines. AD trials have reported increased incidence of conjunctivitis for dupilumab vs. placebo. Objectives To characterize further the occurrence and risk factors of conjunctivitis in dupilumab clinical trials. Methods We evaluated randomized placebo‐controlled trials of dupilumab in AD (n = 2629), asthma (n = 2876), chronic rhinosinusitis with nasal polyps (CRSwNP) (n = 60) and eosinophilic oesophagitis (EoE) (n = 47). Results In most AD trials, dupilumab‐treated patients had higher conjunctivitis incidence than placebo controls. Higher baseline AD severity and previous history of conjunctivitis were associated with increased conjunctivitis incidence. Conjunctivitis was mostly mild to moderate. Most cases recovered or resolved during the treatment period; two patients permanently discontinued dupilumab due to conjunctivitis or keratitis. Common treatments included ophthalmic corticosteroids, antibiotics, and antihistamines or mast cell stabilizers. Most cases were diagnosed by the investigators. In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase the incidence compared with placebo. In the EoE trial, no patients had conjunctivitis. Conclusions Conjunctivitis was more frequent with dupilumab treatment in most AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, the incidence of conjunctivitis was associated with AD severity and prior history of conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab‐treated patients require further study. What's already known about this topic? Ocular disorders, including allergic conjunctivitis, are common in patients with atopic dermatitis (AD). In most dupilumab AD trials, dupilumab‐treated patients had higher conjunctivitis incidence than those receiving placebo. Most cases were mild to moderate and recovered or were recovering during study treatment; study treatment discontinuation due to conjunctivitis was rare. Conjunctivitis incidence was very low and similar for dupilumab and placebo in clinical trials in asthma, chronic rhinosinusitis with nasal polyps and eosinophilic oesophagitis. What does this study add? This analysis confirms and extends the results of the individual clinical trials. Baseline disease‐related factors, including AD severity, prior conjunctivitis history and certa...

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Section: Discussionmentioning

confidence: 99%

“…The incidence of ophthalmic complications increases with AD severity . Allergic conjunctivitis and other ocular surface disorders are also common comorbidities of other atopic disorders such as asthma and allergic rhinitis …”

mentioning

confidence: 99%

Conjunctivitis in dupilumab clinical trials

et al. 2019

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“…These conditions may complicate asthma in the obese and there is evidence that at least some of these co-morbidities may contribute to severe obese asthma. For example, GERD is very common in severe asthma (55, 56), especially in patients who are obese (27) and in SARP, subjects in the obese asthma clusters have more GERD than subjects in the other severe asthma clusters (35). Reflux can cause bronchoconstriction (57), and GERD is an important risk factor for asthma exacerbations in patients with severe asthma (58, 59).…”

Section: Obesity Increases the Severity Of Asthmamentioning

confidence: 99%

Obesity and severe asthma

Tashiro

Shore

2019

Allergology International

105

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Obesity is an important global health issue for both children and adults. Obesity increases the prevalence and incidence of asthma and also increases the risk for severe asthma. Here we describe the features of severe asthma phenotypes for which obesity is a defining characteristic, including steroid resistance, airway inflammation, and co-morbidities. We also review current concepts regarding the mechanistic basis for the impact of obesity in severe asthma, including possible roles for vitamin D deficiency, systemic inflammation, and the microbiome. Finally, we describe data indicating a role for diet, weight loss, and exercise in the treatment of severe asthma with obesity. Better understanding of the mechanistic basis for the role of obesity in severe asthma could lead to new therapeutic options for this population.

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“…Children with severe asthma that is nonresponsive to standard inhaled corticosteroids have a distinct pattern of transcription factors expressed in CD4 T cells compared with nonsevere asthma . The clinical data from the Italian Registry (RItA) from 493 severe/uncontrolled asthmatic patients across 27 clinical centres were analyzed and found to be similar to those obtained from other European and US studies . In a real‐life study, a large cohort of Japanese patients with severe or life‐threatening asthma were clustered into three groups according to the visual analogue scale scores obtained starting from 14 days prior to hospitalization, in order to identify patterns leading to severe or life‐threatening exacerbations .…”

Section: Asthma Treatmentmentioning

confidence: 94%

“…97 The clinical data from the Italian Registry (RItA) from 493 severe/uncontrolled asthmatic patients across 27 clinical centres were analyzed and found to be similar to those obtained from other European and US studies. 98 In a real-life study, a large cohort of Japanese patients with severe or life-threatening asthma were clustered into three groups according to the visual analogue scale scores obtained starting from 14 days prior to hospitalization, in order to identify patterns leading to severe or life-threatening exacerbations. 99 The findings highlight the need for personalized asthma management, and various asthma treatment options for patients in each cluster have been proposed.…”

Section: A S Thma Tre Atmentmentioning

confidence: 99%

Highlights and recent developments in airway diseases in EAACI journals (2018)

Bousquet

Akdiş

Grattan

et al. 2019

Allergy

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The European Academy of Allergy and Clinical Immunology (EAACI) supports three journals: Allergy, Pediatric Allergy and Immunology, and Clinical and Translational Allergy. EAACI's major goals include supporting the promotion of health, in which the prevention of allergy and asthma plays a critical role, and disseminating the knowledge of allergic disease to all stakeholders. In 2018, the remarkable progress in the identification of basic mechanisms of allergic and respiratory diseases as well as the translation of these findings into clinical practice were observed. Last year's highlights include publication of EAACI guidelines for allergen immunotherapy, many EAACI Position Papers covering important aspects for the specialty, better understanding of molecular and cellular mechanisms, identification of biomarkers for disease prediction and progress monitoring, novel prevention and intervention studies, elucidation of mechanisms of multimorbidities, introduction of new drugs to the clinics, recently completed phase three clinical studies, and publication of a large number of allergen immunotherapy studies and meta‐analyses.

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RItA: The Italian severe/uncontrolled asthma registry

Abstract: An international effort in the implementation of SUA patients' registries could help to better understand the clinical features and to manage severe asthma, representing a non-negligible socioeconomic burden for health services.

Cited by 60 publications

References 35 publications

Conjunctivitis in dupilumab clinical trials

Conjunctivitis in dupilumab clinical trials

Obesity and severe asthma

Highlights and recent developments in airway diseases in EAACI journals (2018)

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