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- Title
Anti-IL-5 Pathway Agents in Eosinophilic-Associated Disorders Across the Lifespan.
- Authors
Lombardi, Carlo; Comberiati, Pasquale; Ridolo, Erminia; Cottini, Marcello; Yacoub, Mona Rita; Casagrande, Silvia; Riccò, Matteo; Bottazzoli, Marco; Berti, Alvise
- Abstract
Monoclonal antibodies targeting interleukin (IL)-5 pathways have revolutionized the treatment expectations for eosinophilic-associated conditions, particularly in patients with respiratory involvement. Mepolizumab (IL-5 antagonist monoclonal antibody), benralizumab (IL-5 receptor blocker monoclonal antibody), and reslizumab (IL-5 antagonist monoclonal antibody) have collectively contributed to the overall improvement of the disease burden in various conditions. Eosinophilic asthma currently boasts the most robust evidence across all age groups: all three biologics are approved for adults (aged ≥18 years); mepolizumab is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) also in children (aged ≥ 6 years), while bernalizumab was recently approved by the FDA for patients aged ≥6 years in the USA. In chronic rhinosinusitis with nasal polyps, subcutaneous mepolizumab is the only anti-IL-5 therapy approved so far and can be used in adult patients (aged ≥18 years). For eosinophilic esophagitis, conflicting evidence surrounds both mepolizumab, reslizumab, and benralizumab, leading to non-approval of these agents by the FDA/EMA. Recently, mepolizumab was approved for eosinophilic granulomatosis with polyangiitis patients aged ≥6 years or older and for hypereosinophilic syndrome adult patients. A phase III trial proving noninferiority of benralizumab versus mepolizumab in eosinophilic granulomatosis with polyangiitis has been recently published, while evidence on reslizumab is scant. Overall, current evidence on anti-IL-5 biologics for eosinophilic-associated disorders is mostly focused on adults, whereas data for individuals aged under 18 years and over 65 years are scarce, resulting in a lack of evidence, particularly regarding efficacy, for the use of anti-IL-5 agents in these specific patient populations. This review addresses high-quality evidence from randomized controlled trials and real-world post-marketing studies regarding the use of anti-IL-5 therapies for eosinophilic-associated disorders across all age groups, spanning childhood, adulthood, and older age.
- Subjects
THERAPEUTIC use of monoclonal antibodies; DRUG therapy for asthma; EOSINOPHILIC esophagitis; UNITED States. Food &; Drug Administration; RHINITIS; GRANULOMATOSIS with polyangiitis; DRUG approval; EOSINOPHILIA; DRUG efficacy; HYPEREOSINOPHILIC syndrome; EVIDENCE-based medicine; INTERLEUKINS; CHEMICAL inhibitors; DISEASE complications
- Publication
Drugs, 2024, Vol 84, Issue 6, p661
- ISSN
0012-6667
- Publication type
Article
- DOI
10.1007/s40265-024-02037-0