The Severe Asthma Network in Italy: Findings and Perspectives

doi:10.1016/j.jaip.2018.10.016

The Journal of Allergy and Clinical Immunology: In Practice

Volume 7, Issue 5, May–June 2019, Pages 1462-1468

https://doi.org/10.1016/j.jaip.2018.10.016 Get rights and content

Background

Severe Asthma Network in Italy (SANI) is a registry of patients recruited by accredited centers on severe asthma.

Objective

To analyze epidemiological, clinical, inflammatory, functional, and treatment characteristics of severe asthmatics from the SANI registry.

Methods

All consecutive patients with severe asthma were included into the registry, without exclusion criteria to have real-life data on demographics, asthma control, treatments (including biologics), inflammatory biomarkers, and comorbidities.

Results

A total of 437 patients (mean age: 54.1 years, 57.2% females, 70.7% atopics, 94.5% in Global Initiative for Asthma severity step V) were enrolled into the study. The mean annual exacerbation rate was 3.75. The mean blood eosinophil level was 536.7 cells/mcL, and the average serum total IgE was 470.3 kU/L. Approximately 64% of patients were on regular oral corticosteroid treatment, 57% with omalizumab and 11.2% with mepolizumab. Most common comorbidities were rhinitis, nasal polyposis, and bronchiectasis. Patients with nasal polyposis had higher age of disease onset, higher blood eosinophil count, and lower frequency of atopy and atopic eczema. Bronchiectasis was associated with more frequent severe exacerbations, higher blood eosinophils, and total IgE. Stratifying patients, those with late-onset asthma were less frequently atopic (with less frequent allergic rhinitis and food allergy), and more frequently with nasal polyposis and higher serum total IgE levels.

Conclusions

This study revealed a high frequency of relevant comorbidities and that a substantial proportion of patients have late-onset asthma; all these features define specific different disease phenotypes. Severe asthma complexity and comorbidities require multidisciplinary approaches, led by specifically trained pulmonologists and allergists.

Section snippets

SANI and data collection

The Italian asthma network SANI is a web-based observatory collecting demographic, clinical, functional, and inflammatory data of patients with SA, recruited in Italian reference centers for SA, according to the ERS/ATS classification.¹

Each reference center (Allergy and/or Respiratory Disease Units) was accredited based on the following criteria: enough trained personnel dedicated to asthma (at least 1 specialist and 1 nurse), population of treated asthmatic patients per year (at least 1000

Demographic data

The data of 437 eligible patients were analyzed: almost all the patients (413, 94.5%) can be classified as GINA therapeutic step V.¹⁷ In the study population, more than half of patients were females (57.2%) and the mean age was 54.1 years (Table I). Approximately 70% of patients were sensitized to at least 1 airborne allergen and were defined as “atopic.” Forty-five percent (45.1%) of patients had a normal BMI value, whereas 35% and 19.9% of patients were overweight and obese, respectively.

Discussion

This study is the report of the first available data collected in the context of the SANI registry of patients with SA. The great majority of patients had clinical, functional, and therapy-related features consistent with GINA V step severity classification. In fact, by definition according to ERS/ATS recommendations,¹ all of them were taking high dose of ICS plus another controller agent and, despite that, more than one-third of them had suboptimal ACT values, 73% had the FEV₁ value below the

Acknowledgments

We sincerely thank Dr Piero Zucchi (Medical Writer) and Dr Concetta Sirena (SANI Project Manager).

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: The Severe Asthma Network in Italy Project was supported by Global Initiative for Asthma Italy/Federasma/Italian Society of Allergy, Asthma and Clinical Immunology/Italian Respiratory Society through unrestricted support from AstraZeneca, GlaxoSmithKline, Novartis, Sanofi, and Teva.

: Conflicts of interest: The authors declare that they have no relevant conflicts of interest.

^∗: SANI Network contributors include: Sarah Barbuto (Catanzaro, Italy), Matteo Bradicich (Pisa, Italy), Gianna Camiciottoli (Florence, Italy), Marco Caminati (Verona, Italy), Giselda Colombo (Milan, Italy), Maria Teresa Costantino (Mantua, Italy), Nunzio Crimi (Catania, Italy), Mariangiola Crivellaro (Padua, Italy), Alice D'Adda (Milan, Italy), Mariella D'Amato (Naples, Italy), Elisabetta Favero (Conegliano, Italy), Maria Pia Foschino (Foggia, Italy), Carla Galeone (Reggio Emilia, Italy), Gabriella Guarnieri (Padua, Italy), Carlo Lombardi (Brescia, Italy), Roberta Parente (Salerno, Italy), Giovanni Passalacqua (Genoa, Italy), Vincenzo Patella (Battipaglia, Italy), Francesca Puggioni (Milan, Italy), Erminia Ridolo (Parma, Italy), Giovanni Rolla (Turin, Italy), Eleonora Savi (Piacenza, Italy), Nicola Scichilone (Palermo, Italy), Paolo Solidoro (Turin, Italy), Giuseppe Spadaro (Naples, Italy).

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Original ArticleThe Severe Asthma Network in Italy: Findings and Perspectives

Background

Objective

Methods

Results

Conclusions

Section snippets

SANI and data collection

Demographic data

Discussion

Acknowledgments

Resp Med

Pulm Pharmacol Ther

J Allergy Clin Immunol Pract

Respir Med

Value Health

J Clin Epidemiol

Value Health

International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma

Eur Resp J

Therapy and Health Economics Working Group of the European Community Respiratory Health Survey II. The socio-economic burden of asthma is substantial in Europe

Allergy

Severe asthma

Omalizumab therapy in severe asthma: experience from the Spanish Registry—some new approaches

J Asthma

Effects of omalizumab in non atopic asthma: results from a Spanish Multicentre Registry

J Asthma

The at risk registers in severe asthma (ARRISA) study: a cluster-randomized controlled trial examining effectiveness and costs in primary care

Thorax

Clinical management and outcome of refractory asthma in the UK from the British Thoracic Society Difficult Asthma Registry

Thorax

Statistical cluster analysis of the British Thoracic Society Severe Refractory Asthma Registry: clinical outcome and phenotype stability

PloS One

Original Article
The Severe Asthma Network in Italy: Findings and Perspectives