Characterization of patients in the international severe asthma registry with high steroid exposure who did or did not initiate biologic therapy

Wenjia Chen, Mohsen Sadatsafavi, Trung N Tran, Ruth B Murray, Chong Boon Nigel Wong, Nasloon Ali, Cono Ariti, Esther Garcia Gil, Anthony Newell, Marianna Alacqua, Mona Al-Ahmad, Alan Altraja, Riyad Al-Lehebi, Mohit Bhutani, Leif Bjermer, Anne Sofie Bjerrum, Arnaud Bourdin, Lakmini Bulathsinhala, Anna von Bülow, John BusbyGiorgio Walter Canonica, Victoria Carter, George C Christoff, Borja G Cosio, Richard W Costello, J Mark FitzGerald, João A Fonseca, Kwang Ha Yoo, Liam G. Heaney, Enrico Heffler, Mark Hew, Ole Hilberg, Flavia Hoyte, Takashi Iwanaga, David J Jackson, Rupert C Jones, Mariko Siyue Koh, Piotr Kuna, Désirée Larenas-Linnemann, Sverre Lehmann, Lauri A Lehtimäki, Juntao Lyu, Bassam Mahboub, Jorge Maspero, Andrew N Menzies-Gow, Concetta Sirena, Nikolaos Papadopoulos, Andriana I Papaioannou, Luis Pérez de Llano, Diahn-Warng Perng

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Background: Many severe asthma patients with high oral corticosteroid exposure (HOCS) often do not initiate biologics despite being eligible. This study aimed to compare the characteristics of severe asthma patients with HOCS who did and did not initiate biologics.

Methods: Baseline characteristics of patients with HOCS (long-term maintenance OCS therapy for at least 1 year, or ≥4 courses of steroid bursts in a year) from the International Severe Asthma Registry (ISAR;, who initiated or did not initiate biologics (anti-lgE, anti-IL5/5R or anti-IL4R), were described at the time of biologic initiation or registry enrolment. Statistical relationships were tested using Pearson's chi-squared tests for categorical variables, and t-tests for continuous variables, adjusting for potential errors in multiple comparisons.

Results: Between January 2015 and February 2021, we identified 1412 adult patients with severe asthma from 19 countries that met our inclusion criteria of HOCS, of whom 996 (70.5%) initiated a biologic and 416 (29.5%) did not. The frequency of biologic initiation varied across geographical regions. Those who initiated a biologic were more likely to have higher blood eosinophil count (483 vs 399 cells/µL, p=0.003), serious infections (49.0% vs 13.3%, p<0.001), nasal polyps (35.2% vs 23.6%, p<0.001), airflow limitation (56.8% vs 51.8%, p=0.013), and uncontrolled asthma (80.8% vs 73.2%, p=0.004) despite greater conventional treatment adherence than those who did not start a biologic. Both groups had similar annual asthma exacerbation rates in the previous 12 months (5.7 vs 5.3, p=0.147).

Conclusion: Around one third of severe HOCS asthma patients did not receive biologics despite a similar high burden of asthma exacerbations as those who initiated a biologic therapy. Other disease characteristics such as eosinophilic phenotype, serious infectious events, nasal polyps, airflow limitation and lack of asthma control appear to dictate biologic use.

Original languageEnglish
Pages (from-to)1491-1510
JournalJournal of Asthma and Allergy
Publication statusPublished - 21 Oct 2022


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