ABSTRACT
Introduction
The role of biologic treatments in severe asthma continues to expand, with five agents now approved. Selection of biologic treatment has become increasingly complex in the setting of overlapping indications and in the absence of head-to-head trials. Long-term safety data are still limited for more recently approved agents.
Areas covered
We review the evidence supporting the choice of biologic and predicting treatment response utilizing existing widely available biomarkers. In addition, we provide a digest of the long-term safety data currently available for agents approved since 2015. Data sources were identified by using PubMed in 2021.
Expert opinion
We generally favor omalizumab in the first instance for those severe asthma patients also eligible for other biologics, due to the greater long-term safety data available for this agent. Clinical characteristics predicting response, treatment priorities, and comorbidities must also be considered.
Article highlights
GINA guidelines recommend that biologics be considered at Step 5 as add-on therapy, i.e. in patients who despite high dose ICS-LABA, suffer exacerbations requiring systemic corticosteroids or who require maintenance OCS.
The five biologic agents currently available for severe asthma target TH2-type inflammation and treatment effect is principally seen in reduction of exacerbations and systemic corticosteroid requirement; effects on symptoms and lung function are generally more modest.
Interval evaluation for response to biologic treatment is recommended, as a proportion of individuals with severe asthma will not respond to an agent for which they are eligible. Factors predicting response remain poorly understood.
We offer a decision-support tool for the selection of biologic agent in severe asthma, which considers currently available biomarkers, clinical characteristics which may predict response, clinical priorities in the individual patient and comorbidities which may benefit from certain biologic agents in making treatment decisions.
Long-term safety data is limited on more recently approved agents – we provide a digest of the long-term safety data currently available for agents approved since 2015.
Abbreviations
ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AE: adverse effect; AER: annualized exacerbation rate; AQLQ: Asthma Quality of Life Questionnaire; FeNO: fractional exhaled nitric oxide; FEV1: forced expiratory volume in 1 second; ICS: inhaled corticosteroid; Ig: immunoglobulin; LABA: long-acting beta agonist; OCS: oral corticosteroid; RAST: radioallergosorbent test; RCT: randomised controlled trial(s); SEA: severe eosinophilic asthma.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.