Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases

Helen R. Gosselt; Jette A. van Lint; Leanne J. Kosse; Phyllis I. Spuls; Harald E. Vonkeman; Sander W. Tas; Frank Hoentjen; Michael T. Nurmohamed; Bart J.F. van den Bemt; Martijn B.A. van Doorn; Naomi T. Jessurun

doi:10.1080/14740338.2023.2181340

Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases

Helen R. Gosselt^*, Jette A. van Lint, Leanne J. Kosse, Phyllis I. Spuls, Harald E. Vonkeman, Sander W. Tas, Frank Hoentjen, Michael T. Nurmohamed, Bart J.F. van den Bemt, Martijn B.A. van Doorn, Naomi T. Jessurun

^*Corresponding author for this work

Dermatology

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

1 Citation (Scopus)

Abstract

Background: We examine sex differences in relation to the nature, frequency, and burden of patient-reported adverse drug reactions (ADRs) in patients with inflammatory rheumatic diseases. Research design and methods: Rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis patients using etanercept or adalimumab from the Dutch Biologic Monitor were sent bimonthly questionnaires concerning experienced ADRs. Sex differences in the proportion and nature of reported ADRs were assessed. Additionally, 5-point Likert-type scales reported for the burden of ADRs, were compared between sexes. Results: In total 748 consecutive patients were included (59% female). From the women 55% reported ≥1 ADR, which was significantly higher than 38% of the men that reported ≥1 ADR (p < 0.001). A total of 882 ADRs were reported comprising 264 distinct ADRs. The nature of the reported ADRs differed significantly between both sexes (p = 0.02). Women in particular reported more injection site reactions than men. The burden of ADRs was similar between sexes. Conclusions: Sex differences in the frequency and nature of ADRs, but not in ADR burden, exist during treatment with adalimumab and etanercept in patients with inflammatory rheumatic diseases. This should be taken into consideration when investigating and reporting results on ADRs and when counseling patients in daily clinical practice.

Original language	English
Pages (from-to)	501-507
Number of pages	7
Journal	Expert Opinion on Drug Safety
Volume	22
Issue number	6
Early online date	1 Mar 2023
DOIs	https://doi.org/10.1080/14740338.2023.2181340
Publication status	Published - 2023

Bibliographical note

Funding Information:
The Dutch Biologic Monitor work was supported by the Netherlands Organisation for Health Research and Development (ZonMw) [36]. No specific funding was received from any bodies in the public, commercial, or not-for-profit sectors to carry out the work described in this article. We would like to thank all participants of the Dutch Biologic Monitor for their contribution to these patient-reported outcomes. This work has been presented in poster form at the Annual European Congress of Rheumatology (EULAR), Skin inflammation & psoriasis international network (SPIN) and the Lancet Summit: sex and gender in rheumatology.

Publisher Copyright:
© 2023 Informa UK Limited, trading as Taylor & Francis Group.

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Gosselt, H. R., van Lint, J. A., Kosse, L. J., Spuls, P. I., Vonkeman, H. E., Tas, S. W., Hoentjen, F., Nurmohamed, M. T., van den Bemt, B. J. F., van Doorn, M. B. A., & Jessurun, N. T. (2023). Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases. Expert Opinion on Drug Safety, 22(6), 501-507. https://doi.org/10.1080/14740338.2023.2181340

@article{ded233d747b1430488a53c9d87d47e17,

title = "Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases",

abstract = "Background: We examine sex differences in relation to the nature, frequency, and burden of patient-reported adverse drug reactions (ADRs) in patients with inflammatory rheumatic diseases. Research design and methods: Rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis patients using etanercept or adalimumab from the Dutch Biologic Monitor were sent bimonthly questionnaires concerning experienced ADRs. Sex differences in the proportion and nature of reported ADRs were assessed. Additionally, 5-point Likert-type scales reported for the burden of ADRs, were compared between sexes. Results: In total 748 consecutive patients were included (59% female). From the women 55% reported ≥1 ADR, which was significantly higher than 38% of the men that reported ≥1 ADR (p < 0.001). A total of 882 ADRs were reported comprising 264 distinct ADRs. The nature of the reported ADRs differed significantly between both sexes (p = 0.02). Women in particular reported more injection site reactions than men. The burden of ADRs was similar between sexes. Conclusions: Sex differences in the frequency and nature of ADRs, but not in ADR burden, exist during treatment with adalimumab and etanercept in patients with inflammatory rheumatic diseases. This should be taken into consideration when investigating and reporting results on ADRs and when counseling patients in daily clinical practice.",

author = "Gosselt, {Helen R.} and {van Lint}, {Jette A.} and Kosse, {Leanne J.} and Spuls, {Phyllis I.} and Vonkeman, {Harald E.} and Tas, {Sander W.} and Frank Hoentjen and Nurmohamed, {Michael T.} and {van den Bemt}, {Bart J.F.} and {van Doorn}, {Martijn B.A.} and Jessurun, {Naomi T.}",

note = "Funding Information: The Dutch Biologic Monitor work was supported by the Netherlands Organisation for Health Research and Development (ZonMw) [36]. No specific funding was received from any bodies in the public, commercial, or not-for-profit sectors to carry out the work described in this article. We would like to thank all participants of the Dutch Biologic Monitor for their contribution to these patient-reported outcomes. This work has been presented in poster form at the Annual European Congress of Rheumatology (EULAR), Skin inflammation & psoriasis international network (SPIN) and the Lancet Summit: sex and gender in rheumatology. Publisher Copyright: {\textcopyright} 2023 Informa UK Limited, trading as Taylor & Francis Group.",

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Gosselt, HR, van Lint, JA, Kosse, LJ, Spuls, PI, Vonkeman, HE, Tas, SW, Hoentjen, F, Nurmohamed, MT, van den Bemt, BJF, van Doorn, MBA & Jessurun, NT 2023, 'Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases', Expert Opinion on Drug Safety, vol. 22, no. 6, pp. 501-507. https://doi.org/10.1080/14740338.2023.2181340

TY - JOUR

T1 - Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases

AU - Gosselt, Helen R.

AU - van Lint, Jette A.

AU - Kosse, Leanne J.

AU - Spuls, Phyllis I.

AU - Vonkeman, Harald E.

AU - Tas, Sander W.

AU - Hoentjen, Frank

AU - Nurmohamed, Michael T.

AU - van den Bemt, Bart J.F.

AU - van Doorn, Martijn B.A.

AU - Jessurun, Naomi T.

N1 - Funding Information: The Dutch Biologic Monitor work was supported by the Netherlands Organisation for Health Research and Development (ZonMw) [36]. No specific funding was received from any bodies in the public, commercial, or not-for-profit sectors to carry out the work described in this article. We would like to thank all participants of the Dutch Biologic Monitor for their contribution to these patient-reported outcomes. This work has been presented in poster form at the Annual European Congress of Rheumatology (EULAR), Skin inflammation & psoriasis international network (SPIN) and the Lancet Summit: sex and gender in rheumatology. Publisher Copyright: © 2023 Informa UK Limited, trading as Taylor & Francis Group.

PY - 2023

Y1 - 2023

N2 - Background: We examine sex differences in relation to the nature, frequency, and burden of patient-reported adverse drug reactions (ADRs) in patients with inflammatory rheumatic diseases. Research design and methods: Rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis patients using etanercept or adalimumab from the Dutch Biologic Monitor were sent bimonthly questionnaires concerning experienced ADRs. Sex differences in the proportion and nature of reported ADRs were assessed. Additionally, 5-point Likert-type scales reported for the burden of ADRs, were compared between sexes. Results: In total 748 consecutive patients were included (59% female). From the women 55% reported ≥1 ADR, which was significantly higher than 38% of the men that reported ≥1 ADR (p < 0.001). A total of 882 ADRs were reported comprising 264 distinct ADRs. The nature of the reported ADRs differed significantly between both sexes (p = 0.02). Women in particular reported more injection site reactions than men. The burden of ADRs was similar between sexes. Conclusions: Sex differences in the frequency and nature of ADRs, but not in ADR burden, exist during treatment with adalimumab and etanercept in patients with inflammatory rheumatic diseases. This should be taken into consideration when investigating and reporting results on ADRs and when counseling patients in daily clinical practice.

AB - Background: We examine sex differences in relation to the nature, frequency, and burden of patient-reported adverse drug reactions (ADRs) in patients with inflammatory rheumatic diseases. Research design and methods: Rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis patients using etanercept or adalimumab from the Dutch Biologic Monitor were sent bimonthly questionnaires concerning experienced ADRs. Sex differences in the proportion and nature of reported ADRs were assessed. Additionally, 5-point Likert-type scales reported for the burden of ADRs, were compared between sexes. Results: In total 748 consecutive patients were included (59% female). From the women 55% reported ≥1 ADR, which was significantly higher than 38% of the men that reported ≥1 ADR (p < 0.001). A total of 882 ADRs were reported comprising 264 distinct ADRs. The nature of the reported ADRs differed significantly between both sexes (p = 0.02). Women in particular reported more injection site reactions than men. The burden of ADRs was similar between sexes. Conclusions: Sex differences in the frequency and nature of ADRs, but not in ADR burden, exist during treatment with adalimumab and etanercept in patients with inflammatory rheumatic diseases. This should be taken into consideration when investigating and reporting results on ADRs and when counseling patients in daily clinical practice.

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U2 - 10.1080/14740338.2023.2181340

DO - 10.1080/14740338.2023.2181340

M3 - Article

C2 - 36794307

AN - SCOPUS:85149457936

SN - 1474-0338

VL - 22

SP - 501

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JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

IS - 6

ER -

Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases

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