Omalizumab management beyond clinical trials: The added value of a network model

Caminati, Marco; Senna, Gianenrico; Bianchi, Fulvia Chieco; Marchi, Maria Rita; Vianello, Andrea; Micheletto, Claudio; Pomari, Carlo; Tognella, Silvia; Savoia, Francesca; Mirisola, Valentina; Rossi, Andrea

doi:10.1016/j.pupt.2014.01.007

Cited by 20 publications

(30 citation statements)

References 23 publications

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“…Recently a prospective real-life study involving six patients with severe atopic asthma provided similar results [54]. However, besides experimental settings and "off-label" indications, very few data are available concerning the impact of omalizumab on rhinitis and the other comorbidities in patients suffering from severe allergic asthma with perennial sensitizations [46]. Table 6 highlights how R-L studies provided a follow-up duration significantly longer than RCTs (18.29 vs 8.57 months), which certainly better reflects what happens in routine clinical practice, being asthma a chronic disease.…”

Section: Discordant and Missing Datamentioning

confidence: 89%

Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address

Caminati

Senna

Guerriero

et al. 2015

Pulmonary Pharmacology & Therapeutics

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Section: Discordant and Missing Datamentioning

confidence: 89%

Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address

Caminati

Senna

Guerriero

et al. 2015

Pulmonary Pharmacology & Therapeutics

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“…However, non-responders have also been described among patients matching all the EMA prescription criteria [17, 28], and the efficacy of omalizumab in non-atopic asthma is also supported by the literature [53]. Patient selection, particularly in the field of biological drugs for asthma, still represents a challenge [54, 55].…”

Section: Discussionmentioning

confidence: 99%

“…However drop-out rates due to lack of efficacy and adverse events do not significantly differ between NEONet and published Real-life studies. The population sample was smaller in comparison with other real-life studies, however it is quite homogeneous, as the patients live in the same geographical area, and the centers share the same diagnostic work-up and patient selection criteria [17]. In the NEONet population, patient decision was the most common reason for dropping out.…”

Section: Discussionmentioning

confidence: 99%

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Drop-out rate among patients treated with omalizumab for severe asthma: Literature review and real-life experience

et al. 2016

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BackgroundIn patients with asthma, particularly severe asthma, poor adherence to inhaled drugs negatively affects the achievement of disease control. A better adherence rate is expected in the case of injected drugs, such as omalizumab, as they are administered only in a hospital setting. However, adherence to omalizumab has never been systematically investigated. The aim of this study was to review the omalizumab drop-out rate in randomized controlled trials (RCTs) and real-life studies. A comparative analysis was performed between published data and the Italian North East Omalizumab Network (NEONet) database.ResultsIn RCTs the drop-out rate ranged from 7.1 to 19.4 %. Although the reasons for withdrawal were only occasionally reported, patient decision and adverse events were the most frequently reported causes. In real-life studies the drop-out rate ranged from 0 to 45.5 %. In most cases lack of efficacy was responsible for treatment discontinuation. According to NEONet data, 32 % of treated patients dropped out, with an increasing number of drop outs observed over time. Patient decision and lack of efficacy accounted for most treatment withdrawals.ConclusionsTreatment adherence is particularly crucial in patients with severe asthma considering the clinical impact of the disease and the cost of non-adherence. The risk of treatment discontinuation has to be carefully considered both in the experimental and real-life settings. Increased knowledge regarding the main reasons for patient withdrawal is important to improve adherence in clinical practice.

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“…After the American TENOR cohort study [10, 11], subsequently in Europe similar registries were also developed in Belgium [12], in Spain [13, 14] and also in Italy, though limited to the North–East territory or related to specific research studies [15–17]. Possibly the most well organized registry on refractory asthma has been create in the United Kingdom by the British Thoracic Society [18–22].…”

Section: Introductionmentioning

confidence: 99%

SANI-Severe Asthma Network in Italy: a way forward to monitor severe asthma

et al. 2017

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Even if severe asthma (SA) accounts for 5–10% of all cases of the disease, it is currently a crucial unmet need, owing its difficult clinical management and its high social costs. For this reason several networks, focused on SA have been organized in some countries, in order to select these patients, to recognize their clinical features, to evaluate their adherence, to classify their biological/clinical phenotypes, to identify their eligibility to the new biologic therapies and to quantify the costs of the disease. Aim of the present paper is to describe the ongoing Italian Severe Asthma Network (SANI). Up today 49 centres have been selected, widespread on the national territory. Sharing the same diagnostic protocol, data regarding patients with SA will be collected and processed in a web platform. After their recruitment, SA patients will be followed in the long term in order to investigate the natural history of the disease. Besides clinical data, the cost/benefit evaluation of the new biologics will be verified as well as the search of peculiar biomarker(s) of the disease.

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Omalizumab management beyond clinical trials: The added value of a network model

Cited by 20 publications

References 23 publications

Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address

Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address

Drop-out rate among patients treated with omalizumab for severe asthma: Literature review and real-life experience

SANI-Severe Asthma Network in Italy: a way forward to monitor severe asthma

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