XALOC-1: Clinical Remission Over 2 Years With Benralizumab in Severe Eosinophilic Asthma

Girolamo Pelaia; David J Jackson; Parameswaran Nair; Benjamin Emmanuel; Trung N Tran; Andrew Menzies-Gow; Michael Watt; Sheena Kayaniyil; Silvia Boarino; Javier Nuevo; Marisa Pardal; Anat Shavit; Vivian H Shih; David Cohen; Claudia Loureiro; Alicia Padilla-Galo

doi:10.1016/j.chest.2025.04.011

XALOC-1: Clinical Remission Over 2 Years With Benralizumab in Severe Eosinophilic Asthma

Chest. 2025 Apr 19:S0012-3692(25)00441-6. doi: 10.1016/j.chest.2025.04.011. Online ahead of print.

Authors

Girolamo Pelaia¹, David J Jackson², Parameswaran Nair³, Benjamin Emmanuel⁴, Trung N Tran⁴, Andrew Menzies-Gow⁵, Michael Watt⁶, Sheena Kayaniyil⁷, Silvia Boarino⁸, Javier Nuevo⁹, Marisa Pardal¹⁰, Anat Shavit⁵, Vivian H Shih⁴, David Cohen⁴, Claudia Loureiro¹¹, Alicia Padilla-Galo¹²

Affiliations

¹ Università Magna Graecia, Catanzaro, Italy. Electronic address: pelaia@unicz.it.
² Guy's Severe Asthma Centre, Guy's and St Thomas' NHS Trust, King's College London, London, England.
³ McMaster University, Hamilton, ON, Canada; McGill University, Montreal, QC, Canada; St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
⁴ AstraZeneca, Gaithersburg, MD.
⁵ AstraZeneca, Cambridge, England.
⁶ AstraZeneca, London, England.
⁷ AstraZeneca, Mississauga, ON, Canada.
⁸ AstraZeneca, Milan, Italy.
⁹ AstraZeneca, Madrid, Spain.
¹⁰ AstraZeneca, Lisbon, Portugal.
¹¹ Pneumology Unit, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
¹² Hospital Universitario Virgen de la Victoria, Málaga, Spain.

PMID: 40258512
DOI: 10.1016/j.chest.2025.04.011

Abstract

Background: Long-term real-world data on clinical remission in patients with severe eosinophilic asthma (SEA) receiving biologics are lacking. We describe clinical remission over 2 years in patients with SEA receiving benralizumab.

Research question: Is long-term clinical remission a viable goal for patients with SEA receiving benralizumab?

Study design and methods: XALOC-1 is a multinational, retrospective, real-world program in adults with SEA who received benralizumab for ≤ 96 weeks. Percentages of patients meeting the components and composite of clinical remission (no exacerbations, no maintenance oral corticosteroid use, and well-controlled asthma [Asthma Control Test score ≥ 20 or 6-item Asthma Control Questionnaire score ≤ 0.75]) were assessed at weeks 0, 48, and 96. The association between key baseline demographics, clinical characteristics, and clinical remission status was assessed at weeks 48 and 96 using multivariable logistic regression analysis.

Results: Of 1,070 patients, 0.4%, 39%, and 31% met the 3-component clinical remission criteria at weeks 0, 48, and 96, respectively. In biologic-naive and biologic-experienced patients, remission occurred in 43% and 32% (week 48), and 36% and 23% (week 96), of patients, respectively. Lower maintenance oral corticosteroid dose (OR, 0.51; 95% CI, 0.34-0.76), lower BMI (OR, 0.56; 95% CI, 0.36-0.86), and higher peak eosinophil count (OR, 1.68; 95% CI, 1.05-2.69) at baseline were positively associated with meeting criteria for clinical remission at week 96.

Interpretation: Our results indicate that clinical remission is a realistic goal, sustainable up to 2 years in around one-third of patients with SEA receiving benralizumab. In this study, remission was more likely in patients with lower baseline disease burden, suggesting that further research is warranted regarding whether earlier initiation of a biologic may be beneficial.

Keywords: benralizumab; biologics; clinical remission; real world; severe eosinophilic asthma.