Real-world Omalizumab and Mepolizumab treated Difficult Asthma Phenotypes and their Clinical Outcomes

Abstract

Background: Omalizumab (OMA) and Mepolizumab (MEPO) have proven efficacy in clinical trials. However, a better understanding of their real-world effectiveness in severe asthma (SA) is needed.

Methods: Using real-world data, we retrospectively phenotyped biologic naïve patients from the Wessex AsThma CoHort of difficult asthma (N=478) commenced on OMA (N=105) or MEPO (N=62) compared to SA patients not receiving biologics (SNB, N=178). We also assessed multiple clinical endpoints and identified features associated with response.

Results: Compared to SNB, OMA patients were younger, diagnosed with asthma earlier, and more likely to have rhinitis. MEPO patients were predominantly older males, diagnosed with asthma later, and more likely to have nasal polyposis. Both drugs reduced exacerbations, Acute Healthcare Encounters [AHE] (emergency department or hospital admissions), maintenance oral corticosteroid dose, and improved Asthma Control Questionnaire 6 (ACQ6) scores. OMA response was independently associated with more baseline exacerbations (P=0.024) but fewer AHE (P=0.050) and absence of anxiety (P=0.008). Lower baseline ACQ6 was independently associated with MEPO response (P=0.007). A composite group of non-responders had significantly more psychopathologies and worse baseline subjective disease compared to responder groups.

Conclusion: In a difficult asthma cohort, OMA and MEPO were used in distinct clinical phenotypes but had multidimensional efficacy. Certain baseline features were associated with poorer biologic responses, such as psychopathologies, which may assist clinicians in biologic selection and emphasize the need for comprehensive approaches to support these patients.