Risk of Self-Harm and the Use of Leukotriene Receptor Antagonists and Inhaled Corticosteroids: a Population-Based Study

Boqing Chen; Andrew S.C. Yuen; Kenneth K.C. Man; Joseph F. Hayes; David P.J. Osborn; Ian C.K. Wong; Adrienne Y.L. Chan; Lok Yin Cheng; Yogini H. Jani; Wallis C.Y. Lau

doi:10.1016/j.jaip.2025.09.025

Risk of Self-Harm and the Use of Leukotriene Receptor Antagonists and Inhaled Corticosteroids: a Population-Based Study

Boqing Chen
, Andrew S.C. Yuen
, Kenneth K.C. Man
, Joseph F. Hayes
, David P.J. Osborn
, Ian C.K. Wong
, Adrienne Y.L. Chan
, Lok Yin Cheng
, Yogini H. Jani
, Wallis C.Y. Lau^*

^*Corresponding author for this work

Centre for Medicines Optimisation Research and Education, University College London Hospitals NHS Foundation Trust, London, United Kingdom
Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Camden and Islington NHS Foundation Trust, London, United Kingdom
Respiratory Medicine, University Hospitals Birmingham NHS Foundation Trust, United Kingdom

Research output: Contribution to journal › Article › peer-review

2 Citations (SciVal)

1 Downloads (Pure)

Abstract

Background: Whether leukotriene receptor antagonist (LTRA) or inhaled corticosteroid (ICS) use can increase the risk of self-harm remains unclear. Objective: To evaluate the association between self-harm and use of LTRAs and ICSs among patients with asthma. Methods: This self-controlled case series study used data from the UK Clinical Practice Research Datalink linked to hospital and mortality records. We included patients with asthma aged 10 years or more who had at least 1 prescription of LTRA, 1 prescription of ICS, and an incident self-harm during the period 2005 to 2020. Incidence rate ratios (IRRs) of self-harm during periods of (presented in order of precedence if they overlapped) pre-LTRA, pre-ICS, LTRA-alone, ICS-alone, and combination use of LTRA and ICS, versus nonuse, were calculated using conditional Poisson regression model. Additional analyses using self-controlled case series extension, case-case-time-control, and cohort study designs were used to examine robustness of results. Results: Among 313,943 individuals prescribed LTRAs and ICSs, 2900 had incident self-harm. IRRs were 0.77 (95% CI, 0.58-1.01) during pre-LTRA, 0.68 (95% CI, 0.57-0.82) during LTRA-alone, and 0.70 (95% CI, 0.56-0.86) during combination use. Further analysis suggested that the self-harm incidence was lower during the first 90 days of LTRA use (IRR, 0.74; 95% CI, 0.58-0.95), before returning to nonuse level (IRR, 0.93; 95% CI, 0.74-1.17). Comparable incidence to nonuse was observed during pre-ICS (IRR, 0.99; 95% CI, 0.71-1.39) and ICS-alone (IRR, 0.88; 95% CI, 0.75-1.04). The results were robust across sensitivity analyses and study designs, which did not suggest increased risk of self-harm with LTRA/ICS use. Conclusions: Using the self-controlled case series design, which was based on comparisons within a population with both the outcome and exposure of interest, our study does not support an association between self-harm and LTRA or ICS use in patients with asthma.

Original language	English
Pages (from-to)	166-175
Number of pages	10
Journal	Journal of Allergy and Clinical Immunology: In Practice
Volume	14
Issue number	1
Early online date	27 Sept 2025
DOIs	https://doi.org/10.1016/j.jaip.2025.09.025
Publication status	Published - Jan 2026

Bibliographical note

Copyright © 2025 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/).

Data Access Statement

Electronic health records are, by definition, considered to be sensitive data in the UK by the Data Protection Act and cannot be shared via public deposition because of information governance restriction in place to protect patient confidentiality. Access to data is available only once approval has been obtained through the individual constituent entities controlling access to the data. The data in this study was obtained from Clinical Practice Research Datalink. Datasets may be requested from Clinical Practice Research Datalink upon reasonable request and with formal approval procedures.

Funding

This study received no direct funding.

Keywords

asthma
leukotriene receptor antagonists
inhaled corticosteroids
self-harm

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10.1016/j.jaip.2025.09.025Licence: CC BY 4.0

Risk of Self-Harm and the Use of Leukotriene Receptor Antagonists and Inhaled Corticosteroids_VoR
Copyright © 2025 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/).
Final published version, 2.42 MBLicence: CC BY 4.0

Cite this

Chen, B., Yuen, A. S. C., Man, K. K. C., Hayes, J. F., Osborn, D. P. J., Wong, I. C. K., Chan, A. Y. L., Cheng, L. Y., Jani, Y. H., & Lau, W. C. Y. (2026). Risk of Self-Harm and the Use of Leukotriene Receptor Antagonists and Inhaled Corticosteroids: a Population-Based Study. Journal of Allergy and Clinical Immunology: In Practice, 14(1), 166-175. https://doi.org/10.1016/j.jaip.2025.09.025

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title = "Risk of Self-Harm and the Use of Leukotriene Receptor Antagonists and Inhaled Corticosteroids: a Population-Based Study",

abstract = "Background: Whether leukotriene receptor antagonist (LTRA) or inhaled corticosteroid (ICS) use can increase the risk of self-harm remains unclear. Objective: To evaluate the association between self-harm and use of LTRAs and ICSs among patients with asthma. Methods: This self-controlled case series study used data from the UK Clinical Practice Research Datalink linked to hospital and mortality records. We included patients with asthma aged 10 years or more who had at least 1 prescription of LTRA, 1 prescription of ICS, and an incident self-harm during the period 2005 to 2020. Incidence rate ratios (IRRs) of self-harm during periods of (presented in order of precedence if they overlapped) pre-LTRA, pre-ICS, LTRA-alone, ICS-alone, and combination use of LTRA and ICS, versus nonuse, were calculated using conditional Poisson regression model. Additional analyses using self-controlled case series extension, case-case-time-control, and cohort study designs were used to examine robustness of results. Results: Among 313,943 individuals prescribed LTRAs and ICSs, 2900 had incident self-harm. IRRs were 0.77 (95\% CI, 0.58-1.01) during pre-LTRA, 0.68 (95\% CI, 0.57-0.82) during LTRA-alone, and 0.70 (95\% CI, 0.56-0.86) during combination use. Further analysis suggested that the self-harm incidence was lower during the first 90 days of LTRA use (IRR, 0.74; 95\% CI, 0.58-0.95), before returning to nonuse level (IRR, 0.93; 95\% CI, 0.74-1.17). Comparable incidence to nonuse was observed during pre-ICS (IRR, 0.99; 95\% CI, 0.71-1.39) and ICS-alone (IRR, 0.88; 95\% CI, 0.75-1.04). The results were robust across sensitivity analyses and study designs, which did not suggest increased risk of self-harm with LTRA/ICS use. Conclusions: Using the self-controlled case series design, which was based on comparisons within a population with both the outcome and exposure of interest, our study does not support an association between self-harm and LTRA or ICS use in patients with asthma.",

keywords = "asthma, leukotriene receptor antagonists, inhaled corticosteroids, self-harm",

author = "Boqing Chen and Yuen, \{Andrew S.C.\} and Man, \{Kenneth K.C.\} and Hayes, \{Joseph F.\} and Osborn, \{David P.J.\} and Wong, \{Ian C.K.\} and Chan, \{Adrienne Y.L.\} and Cheng, \{Lok Yin\} and Jani, \{Yogini H.\} and Lau, \{Wallis C.Y.\}",

note = "Copyright {\textcopyright} 2025 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma \& Immunology. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/).",

year = "2026",

month = jan,

doi = "10.1016/j.jaip.2025.09.025",

language = "English",

volume = "14",

pages = "166--175",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2201",

publisher = "Elsevier",

number = "1",

}

TY - JOUR

T1 - Risk of Self-Harm and the Use of Leukotriene Receptor Antagonists and Inhaled Corticosteroids: a Population-Based Study

AU - Chen, Boqing

AU - Yuen, Andrew S.C.

AU - Man, Kenneth K.C.

AU - Hayes, Joseph F.

AU - Osborn, David P.J.

AU - Wong, Ian C.K.

AU - Chan, Adrienne Y.L.

AU - Cheng, Lok Yin

AU - Jani, Yogini H.

AU - Lau, Wallis C.Y.

N1 - Copyright © 2025 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/).

PY - 2026/1

Y1 - 2026/1

N2 - Background: Whether leukotriene receptor antagonist (LTRA) or inhaled corticosteroid (ICS) use can increase the risk of self-harm remains unclear. Objective: To evaluate the association between self-harm and use of LTRAs and ICSs among patients with asthma. Methods: This self-controlled case series study used data from the UK Clinical Practice Research Datalink linked to hospital and mortality records. We included patients with asthma aged 10 years or more who had at least 1 prescription of LTRA, 1 prescription of ICS, and an incident self-harm during the period 2005 to 2020. Incidence rate ratios (IRRs) of self-harm during periods of (presented in order of precedence if they overlapped) pre-LTRA, pre-ICS, LTRA-alone, ICS-alone, and combination use of LTRA and ICS, versus nonuse, were calculated using conditional Poisson regression model. Additional analyses using self-controlled case series extension, case-case-time-control, and cohort study designs were used to examine robustness of results. Results: Among 313,943 individuals prescribed LTRAs and ICSs, 2900 had incident self-harm. IRRs were 0.77 (95% CI, 0.58-1.01) during pre-LTRA, 0.68 (95% CI, 0.57-0.82) during LTRA-alone, and 0.70 (95% CI, 0.56-0.86) during combination use. Further analysis suggested that the self-harm incidence was lower during the first 90 days of LTRA use (IRR, 0.74; 95% CI, 0.58-0.95), before returning to nonuse level (IRR, 0.93; 95% CI, 0.74-1.17). Comparable incidence to nonuse was observed during pre-ICS (IRR, 0.99; 95% CI, 0.71-1.39) and ICS-alone (IRR, 0.88; 95% CI, 0.75-1.04). The results were robust across sensitivity analyses and study designs, which did not suggest increased risk of self-harm with LTRA/ICS use. Conclusions: Using the self-controlled case series design, which was based on comparisons within a population with both the outcome and exposure of interest, our study does not support an association between self-harm and LTRA or ICS use in patients with asthma.

AB - Background: Whether leukotriene receptor antagonist (LTRA) or inhaled corticosteroid (ICS) use can increase the risk of self-harm remains unclear. Objective: To evaluate the association between self-harm and use of LTRAs and ICSs among patients with asthma. Methods: This self-controlled case series study used data from the UK Clinical Practice Research Datalink linked to hospital and mortality records. We included patients with asthma aged 10 years or more who had at least 1 prescription of LTRA, 1 prescription of ICS, and an incident self-harm during the period 2005 to 2020. Incidence rate ratios (IRRs) of self-harm during periods of (presented in order of precedence if they overlapped) pre-LTRA, pre-ICS, LTRA-alone, ICS-alone, and combination use of LTRA and ICS, versus nonuse, were calculated using conditional Poisson regression model. Additional analyses using self-controlled case series extension, case-case-time-control, and cohort study designs were used to examine robustness of results. Results: Among 313,943 individuals prescribed LTRAs and ICSs, 2900 had incident self-harm. IRRs were 0.77 (95% CI, 0.58-1.01) during pre-LTRA, 0.68 (95% CI, 0.57-0.82) during LTRA-alone, and 0.70 (95% CI, 0.56-0.86) during combination use. Further analysis suggested that the self-harm incidence was lower during the first 90 days of LTRA use (IRR, 0.74; 95% CI, 0.58-0.95), before returning to nonuse level (IRR, 0.93; 95% CI, 0.74-1.17). Comparable incidence to nonuse was observed during pre-ICS (IRR, 0.99; 95% CI, 0.71-1.39) and ICS-alone (IRR, 0.88; 95% CI, 0.75-1.04). The results were robust across sensitivity analyses and study designs, which did not suggest increased risk of self-harm with LTRA/ICS use. Conclusions: Using the self-controlled case series design, which was based on comparisons within a population with both the outcome and exposure of interest, our study does not support an association between self-harm and LTRA or ICS use in patients with asthma.

KW - asthma

KW - leukotriene receptor antagonists

KW - inhaled corticosteroids

KW - self-harm

UR - https://www.sciencedirect.com/science/article/pii/S2213219825009195

UR - https://www.scopus.com/pages/publications/105018883727

U2 - 10.1016/j.jaip.2025.09.025

DO - 10.1016/j.jaip.2025.09.025

M3 - Article

SN - 2213-2201

VL - 14

SP - 166

EP - 175

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

IS - 1

ER -

Risk of Self-Harm and the Use of Leukotriene Receptor Antagonists and Inhaled Corticosteroids: a Population-Based Study

Abstract

Bibliographical note

Data Access Statement

Funding

Keywords

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