Baseline Characteristics of Patients Enrolled in Clinical Trials of Biologics for Severe Asthma as Potential Predictors of Outcomes

Abstract

(1) Background: Over the past 20 years, monoclonal antibodies have been developed for the treatment of severe asthma, with numerous randomised controlled trials (RCTs) conducted to define their safety and efficacy. The growing availability of biologics, which until now have only been available for T2-high asthma, has been further enriched by the arrival of tezepelumab. (2) Methods: This review aims to evaluate the baseline characteristics of patients enrolled in RCTs of biologics for severe asthma to understand how they could potentially predict outcomes and how they can help differentiate between available options. (3) Results: The studies reviewed demonstrated that all biologic agents are effective in improving asthma control, especially with regard to reducing exacerbation rates and OCS use. As we have seen, in this regard, there are few data on omalizumab and none yet on tezepelumab. In analysing exacerbations and average doses of OCSs, pivotal studies on benralizumab have enrolled more seriously ill patients. Secondary outcomes, such as improvement in lung function and quality of life, showed better results—especially for dupilumab and tezepelumab. (4) Conclusion: Biologics are all effective, albeit with important differences. What fundamentally guides the choice is the patient’s clinical history, the endotype represented by biomarkers (especially blood eosinophils), and comorbidities (especially nasal polyposis).

Tezepelumab: patient selection and place in therapy in severe asthma

“…Such studies should be conducted considering the outcomes emerging from pivotal studies of other biologics. 84 …”

Severe Asthma in the Era of Biologics: Continuous Challenges

“…Furthermore, the steroid-sparing effect was one of the primary outcomes, which was addressed in pilot authorization studies. As secondary outcomes, RCTs were used to analyze several aspects, such as lung function, quality of life, and control of the disease [4].…”

“…What fundamentally guides the selection process is a multi-factorial approach, which involves a patient's clinical history, predominant endotype, comorbidities, and disease onset. Focusing on blood eosinophils, it is important to clarify that are both selective parameters but also predictive ones [4].…”