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

Abstract

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.

Real-life effectiveness of asthma treatment with a fixed-dose fluticasone/formoterol pressurised metered-dose inhaler – Results from a non-interventional study

“…A further feature was the emphasis on having few exclusion criteria, which may have allowed unmeasured confounding factors to influence the outcome in some patients. The dropout rate of 30.2% during the study is only a bit higher than in two other non-interventional asthma studies over 12 months (18.0%, 26.7%) [45,46] and lies within the range reported in 12-month non-interventional omalizumab studies [44]. The dropout rate should be taken into account when interpreting the data, as patients with less treatment benefit and more adverse events are often more likely to drop out than patients with improvement of disease control.…”

"Real-life" Efficacy and Safety Aspects of 4-Year Omalizumab Treatment for Asthma

“…In this study, the 15.3% incidence of mild adverse reactions, including pain at the injection site, headache, tiredness, and hair loss, was higher than incidence rates reported in other studies (7-12.6%) [29,30].…”

Uncontrolled severe asthma: starting from the unmet needs

“…In fact, Th2 high phenotype accounts for the biggest proportion of severe asthma, but still the Th2 low phenotype is not negligible, also because it is usually characterized by a reduced response to ICS and OCS 9 . Second, a proportion of patients, ranging from 20-30%, do not respond to the treatment, despite the eligibility criteria being fully matched 10 . In the era of "Precision Medicine", the issue of "non-responders" is crucial for the biologic treatments sustainability, under a clinical and economic perspective 3 .…”