Biologicals for severe asthma: what we can learn from real-life experiences?

Abstract

Purpose of review Severe asthma is a serious disease affecting about 5–10% of asthmatic patients. Often patients with this kind of asthma requires periodical courses or daily intake of oral corticosteroids, to control symptoms. In the last few years several biological drugs have been developed with the aim to decrease exacerbations and reduce or suspend intake of systemic steroids in severe asthmatic patients. Clinical trials demonstrated the efficacy and the safety of biological antibodies in asthma, but it is already known that randomized controlled trials alone are not sufficient to provide complete information on a drug. Recent findings After marketing of monoclonal antibodies has been developed several real-life studies with the aim to observe how drugs, tested only on trial patients, are able to provide adequate effectiveness even on ‘real’ patients; indeed, it is well known that the latter differ in some characteristics from the patients of the trials. Summary The results of this analysis confirm the good efficacy of the biologics similarly in real-life patients, also ensuring a promising safety even in periods of observation longer than those of the randomized controlled trials.

Evaluation of Real-Life Investigational Use of Enoximone in Asthma, the Third Step in Drug Repurposing: A Preliminary Report

“…We acknowledge that real-life investigation has its limitations, but it is a meaningful and valuable addition to randomised controlled trials [36]; they each provide equivalent and complementary answers to the same question [37]. is investigation showed that most asthma patients are already familiar with various traditional medications for their condition and can assess quite adequately their need for less/more medication.…”

“…Real-life investigations represent the shift towards personalized medication, based, in this case, primarily on decrease of asthma symptoms and improvement in quality of life [36]. is is also demonstrated from biologicals such as omalizumab (anti-IL-5 in severe asthma); variability in biologic levels has been shown to impact efficacy when also used in other applications of biologicals, e.g., in Inflammatory Bowel Disease [38]: an adapted personalized protocol was needed for more asthma-related benefit [39,40].…”

Biologics and severe asthma in children

“…As a result, free IgE and receptor expression are reduced, which leads to less release of Th2 mediators [3 & ,10,13,20]. Clinical trials on omalizumab have been previously discussed in this journal [5,6,39,40]. Based on a recent meta-analysis of six pediatric randomized controlled trials on omalizumab and severe asthma including a total of 2168 children, omalizumab reduces the risk of exacerbations as early as 12 weeks of therapy (risk ratio 0.52, 95% CI 0.31À0.89) [41 && ].…”

Specific Therapy for T2 Asthma

“…RCTs criteria drive health authorities to decide protocol for drug administration, shown in Table 1. The selectivity of the criteria for inclusion and exclusion of patients from trials is a well-known problem in the health sector where, generally, the sample examined in clinical studies is not very comparable to those who will then use the drug in "real life" once marketed [17]. The collection of data in real life has allowed us to observe the efficacy and efficiency of biological drugs and how these drugs manage to maintain long-term disease control [18].…”