Abstract

BackgroundSevere asthma is a complex heterogeneous disease typically requiring advanced therapies. Underlying the treatment of all asthma, however, is the consistent recommendation across international guidelines to ensure that adherence to therapy is adequate. Currently, there is no consensus on an objective marker of adherence.MethodsWe performed a prospective observational study of 17 participants taking oral prednisolone using serum prednisolone levels as a marker of adherence, and sputum eosinophilia as a marker of control of type 2 airway inflammation. Based on these biomarkers, we classified participants into a non-adherent and an adherent cohort, and further stratified by the presence of ongoing sputum eosinophilia.ResultsWe identified 3 non-adherent participants and 14 who were adherent, based on their serum prednisolone levels. Stratification using sputum eosinophil counts identified one participant as having ongoing sputum eosinophilia in the setting of non-adherence, while six were identified as steroid resistant with ongoing sputum eosinophilia despite adherence to oral prednisolone therapy.ConclusionSerum prednisolone can be used an objective marker of adherence in those patients with severe asthma taking daily oral prednisolone. In combination with sputum eosinophil counts, a steroid resistant cohort can be distinguished from one with ongoing inflammation in the setting of non-adherence. This information can then be used by clinicians to differentiate the optimal next steps for treatment in these specific populations.Trial registrationParticipants were recruited as part of the Markers of Inflammation in the Management of Severe Asthma (MIMOSA) study, trial registration ACTRN12616001015437, 02 August 2016.

Highlights

  • Severe asthma is a complex heterogeneous disease typically requiring advanced therapies

  • There were no significant differences in the populations between those that were adherent compared to non-adherent with respect to sex distribution, age, BMI, prednisolone dose, inhaled corticosteroid dose, exacerbation frequency, ACQ score, FEV1, cortisol levels, ex-smoker status, or markers of type 2 inflammation

  • There was higher selfreported adherence in the group defined as adherent based on serum prednisolone levels. (p = 0.03)

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Summary

Introduction

Severe asthma is a complex heterogeneous disease typically requiring advanced therapies. Asthma is estimated to affect approximately 300 million people worldwide, with an ever increasing incidence [1] Within this staggering figure, 5–10% of this population is estimated to have severe asthma, requiring Global Initiative for Asthma (GINA) Step 4 or 5 therapy [2]. Ensuring adherence to existing therapy is essential to ensure that costly novel therapies are applied to a truly severe asthma population. Many of these options are fraught with potential sources of error These include them being subjective, open to recall bias, as well as there being an inability to differentiate if medication is taken, absorbed, or administered appropriately. The aim of this study was to examine serum prednisolone levels as a marker of oral corticosteroid adherence in patients with severe asthma and the combination of serum prednisolone levels and sputum eosinophil counts to identify corticosteroid resistant severe asthma

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