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Multicenter Study
. 2025 Jul;168(1):19-32.
doi: 10.1016/j.chest.2025.04.011. Epub 2025 Apr 19.

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

Girolamo Pelaia  1 , David J Jackson  2 , Parameswaran Nair  3 , Benjamin Emmanuel  4 , Trung N Tran  4 , Andrew Menzies-Gow  5 , Michael Watt  6 , Sheena Kayaniyil  7 , Silvia Boarino  8 , Javier Nuevo  9 , Marisa Pardal  10 , Anat Shavit  5 , Vivian H Shih  4 , David Cohen  4 , Claudia Loureiro  11 , Alicia Padilla-Galo  12
Affiliations
Free article
Multicenter Study

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

Girolamo Pelaia et al. Chest. 2025 Jul.
Free article

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.

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Conflict of interest statement

Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: G. P. has received lecture fees and advisory board fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Guidotti, Insmed, Lusofarmaco, Menarini, Neopharmed Gentili, Novartis, Sanofi, and Zambon. D. J. J. has received consultancy fees and speakers’ fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, and Sanofi Regeneron; and research grants from AstraZeneca. P. N. reports that in the past 2 years, his institution received grant support from AstraZeneca, Cyclomedica, Equillium, Foresee, Genentech, Sanofi, and Teva; and has received honoraria from Arrowhead, AstraZeneca, CSL Behring, GSK, and Sanofi. B. E., T. N. T., D. C., A. S., S. K., A. M. -G., and M. P. are employees of, and own stock in, AstraZeneca. M. W., S. B., and J. N. are employees of AstraZeneca. V. H. S. is a previous employee of, and owned stock in, AstraZeneca. C. L. has received consultancy fees and speakers’ fees from AstraZeneca, GSK, Sanofi Regeneron, and Teva; and research grants from GSK. A. P.-G. reports grants, personal fees and nonfinancial support from AstraZeneca and Sanofi; and personal fees and nonfinancial support from Chiesi, GSK, Novartis, and Teva.

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