Sustained clinical remission rates with 2-years of benralizumab treatment among SEA patients in XALOC-1 trial

17 Nov 2023


Despite high-dose inhalation therapies, disease control of severe eosinophilic asthma (SEA) has always been suboptimal, leading to frequent exacerbations and swift deterioration in lung function, requiring supplementation with high dose oral corticosteroids (OCS).1 With the emergence of biologic therapies such as benralizumab, clinical remission has become a realistic goal for patients with SEA.1 To understand the long-term effects of biologics treatment for SEA, the XALOC-1 study was conducted to analyze the 2-year efficacy of benralizumab in patients with SEA, regardless of prior experience with biologics.1

The XALOC-1 study was a retrospective, multinational program that recruited 1,070 adult patients with SEA, of which 61.9% of patients reported having no prior biologics treatment.1

During the 12-month baseline study period, the mean frequency of exacerbations in the study population was 3.8 times, with 54.7% of patients dependent on maintenance OCS (mOCS) and only 26.3% of patients retaining control over asthma symptoms [defined as having an Asthma Control Test (ACT) score ≥16 or 6-item Asthma Control Questionnaire (ACQ-6) score <1.5].1

The study population was then given benralizumab 30mg for every 8 weeks (Q8W) and was followed-up for 96 weeks.1 The primary clinical outcome of this study was a 3-component clinical remission rate assessed at weeks 48 and 96.1 The 3 components included being exacerbation-free, no mOCS use, and maintaining symptomatic control of their asthma (ACT score ≥16 or ACQ-6 score <1.5).1

Primary endpoint:
  • The primary endpoint of this study was a 3-component clinical remission rate at weeks 48 and 961
  • Overall, 45.1% and 37.6% of patients in the study population fulfilled the criteria of a 3-component clinical remission at weeks 48 and 96 respectively1
  • Similar rates of 3-component clinical remission were observed in the biologic-naïve cohort (50.4% at week 48; 42.0% at week 96) and the biologic-experienced cohort (36.2% at week 48; 30.6% at week 96)1
  • In addition, 59.3% of patients who achieved sustained remission at week 96 had reached the remission criteria from week 481
  • 68.4% and 61.5% of patients remained exacerbation-free from baseline to weeks 48 and 96 respectively1
  • 75.7% and 76.2% of patients did not require mOCS administration at weeks 48 and 96 respectively1
  • 65.2% and 69.6% of patients achieved asthma symptom control (ACT score ≥16 or ACQ-6 score <1.5) at weeks 48 and 96 respectively1


"Clinical remission is a realistic, sustainable goal up to 2 years for patients with SEA receiving benralizumab, and can be achieved regardless of prior biologic experience"

Dr. Girolamo Pelaia
Università Magna Graecia,

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