Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma

Prior treatment

• use of systemic corticosteroids at any dose within the 6 weeks prior to enrollment;
• use of immunosuppressive therapies;
• receipt of live attenuated vaccines within 30 days prior to enrollment;
• upper or lower respiratory tract infections within 30 days prior to signing informed consent or during the screening/run-in period;
• concurrent treatment with other biologics for asthma or other conditions (except for stable allergen immunotherapy, defined as an unchanged dose and regimen at screening); prior biologic therapy for asthma within 6 months before starting mepolizumab; planned surgical procedures during the study period;

Other illness

• diagnosis of other chronic pulmonary diseases;
• current or recent history (within the last 5 years) of malignancy, except in cases of complete remission;

Other

• current smoking;
• coexisting chronic rhinosinusitis with nasal polyps;
• diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA);
• any clinically significant abnormalities identified during screening through physical examination, vital signs assessment, hematology, or clinical chemistry, which, in the opinion of the investigator, could pose a risk to patient safety or interfere with study outcomes or compliance.
• known immunodeficiency (primary or secondary);
• pregnancy;
• participation in another interventional or post-authorization safety study.

• Eligibility for mepolizumab treatment according to clinical practice;
• age between 18 and 75 years;
• diagnosis of severe eosinophilic refractory asthma, defined as peripheral blood eosinophil count (BEC) \> 300 cells/μL and at least two documented exacerbations within the previous 12 months;
• ongoing treatment with high daily doses of inhaled corticosteroids (ICS) combined with long-acting β2-agonists (LABA), plus at least one additional controller medication for a minimum of 12 months.