Clinical Remission in Oral Corticosteroid (OCS)-dependent Patients with Severe Asthma: An Analysis of the ANDHI-IP and PONENTE Trials

The ANDHI-In Practice (AIP) and PONENTE trials evaluated benralizumab, a monoclonal antibody directed at theinterleukin-5 receptor α, in patients with severe eosinophilic asthma (SEA). We evaluated data from these trials to describe thecharacteristics of oral corticosteroid (OCS)-dependent (defined as a daily OCS dose ≥5 mg for ≥3 months) patients withuncontrolled SEA receiving benralizumab who met a proposed composite definition of clinical remission (CR). Methods: Weanalyzed data from ANDHI and PONENTE to characterize patients who met CR outcomes of interest. AIP was a 56-week open-label extension of ANDHI (NCT03170271) during which OCS and other asthma therapies were tapered in patients who achievedasthma control on benralizumab. PONENTE (NCT03557307) was a phase 3b, open-label, multicenter trial designed to evaluaterapid OCS tapering in patients with SEA on benralizumab. Eligible patients were ≥18 years of age with blood eosinophil (bEOS)counts ≥150 cells/μL or a historical bEOS counts ≥300 cells/μL in the last 12 months who were receiving high-dose inhaledcorticosteroids and long-term OCS at baseline. Patients who received placebo in ANDHI were excluded. Components of CR forthis analysis were zero exacerbations, zero OCS, and ACQ-6 score <1.5; patients who achieved all three components at 12months (PONENTE)/18 months (AIP) were defined as in CR. We compared baseline patient characteristics (ANDHI andPONENTE) for patients who achieved CR with patients who did not achieve remission (non-remission). Results: Among 66patients from AIP, 28.8% achieved CR; among 312 patients from PONENTE, 26.0% achieved CR. Patients who achieved CRhad a shorter mean [SD] time since diagnosis (AIP, 17.2 [11.42] years; PONENTE, 17.6 [13.97] years) than non-remissionpatients (AIP, 25.5 [20.93] years; PONENTE, 23.1 [15.92] years) (Table). Mean [SD] age at asthma onset was higher for CRpatients (AIP, 40.7 [15.26] years; PONENTE, 35.2 [18.59] years) than for non-remission patients (AIP, 28.3 [18.07] years;PONENTE, 28.6 [18.93] years). Median OCS dosages were similar between groups. Mean [SD] baseline ACQ-6 scores werelower for CR patients (AIP, 2.8 [0.70]; PONENTE, 1.6 [1.19]) than for non-remission patients (AIP, 3.2 [0.86]; PONENTE, 2.3[1.21]). Conclusions: Our analysis of OCS-dependent patients in AIP and PONENTE showed that those who achieved CR had ashorter time since asthma diagnosis, an older age at asthma diagnosis, and a lower ACQ-6 score, highlighting a need todiagnose and appropriately treat SEA as early as possible.