Real-World Effectiveness of Dupilumab for Patients with Severe Asthma: A Retrospective Study

Abstract

Background

Treatment with dupilumab, an anti-interleukin (IL)-4 receptor α monoclonal antibody that blocks both the IL-4 and IL-13 pathways, has demonstrated efficacy for the treatment of severe asthma (SA) with type 2 inflammation. However, few studies have focused on the efficacy of this biologic for the treatment of SA in a real-world setting.

Methods

From April 2019 to December 2021, 26 Japanese patients with SA received dupilumab at Jikei University Hospital. We retrospectively evaluated the number of moderate-to-severe exacerbations, pulmonary function, maintenance dose of corticosteroids, biomarkers, and adverse events.

Results

During a mean follow-up period of 12.6 months, 10 patients received dupilumab as the first biologic, and 16 switched to dupilumab from other biologics. Dupilumab treatment significantly reduced the number of annual exacerbations from 3.4 ± 4.1 to 1.6 ± 2.7 (/person-year, p < 0.01) at the last follow-up regardless of previous biologic use. The Asthma Control Test score significantly improved in all patients by six months after administration but tended to worsen by 24 months in patients with previous biologic use. On the other hand, blood eosinophil counts (BECs) transiently increased and peaked three to six months after administration. The peak timing can be affected by previous biologic use. Adverse events included wheezing immediately after injection, hypereosinophilia, mild conjunctivitis, and relapse of chronic eosinophilic pneumonia in the patient switched from benralizumab.

Conclusion

Dupilumab treatment was useful for patients with SA in a real-world setting. However, the BEC should be monitored carefully, especially in patients who previously received anti-IL-5/IL-5 receptor antibody.

Keywords:

• dupilumab
• severe asthma
• exacerbation
• transient eosinophilia
• real-world

Abbreviations

ACT, Asthma Control Test; BEC, blood eosinophil count; CRSwNPs, chronic rhinosinusitis with nasal polyps; ECRS, eosinophilic chronic rhinosinusitis; FeNO, fractional exhaled nitric oxide; ICS, inhaled corticosteroid; IL, interleukin; LABA, long-acting β-2 agonist; LAMA, long-acting muscarinic antagonist; LTRA, leukotriene receptor antagonist; MCID, minimal clinically important difference; OCS, oral corticosteroids; SA, severe asthma.

Data Sharing Statement

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Ethics Approval and Consent to Participate

Due to the retrospective nature of this study, we provided an opt-out consent on the website of our hospital. This study was approved by the Ethical Committee of the Jikei University School of Medicine [33-075(10687)] on Oct 1, 2021. The director/administer of Jikei University Hospital granted us permission to access the medical records. The data used in this study were anonymized before use.

Author Contributions

All authors made significant contributions to the work reported, whether to the study conception, design, and execution; data acquisition, analysis, and interpretation; or all these areas. All authors contributed to drafting, revising or critically reviewing the article; gave final approval of the version to be published; agreed on the journal to which the article has been submitted; and agreed to be accountable for all aspects of the work.

Disclosure

The authors declare that they have no competing interests in this work.

Additional information

Funding

There is no funding to report.