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Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases

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Abstract

Introduction

Although the burden of adverse drug reactions (ADRs) has a significant impact on patients’ quality of life, thorough knowledge about patients’ perspectives on the burden of ADRs attributed to biologics is lacking.

Objectives

This study was conducted to gain insight into the patient burden of ADRs experienced with biologic use.

Methods

The Dutch Biologic Monitor is a prospective, multicentre, event monitoring cohort system including information collected by web-based questionnaires from patients using biologics, mainly for immune-mediated inflammatory diseases (IMIDs). Patients were asked to complete bimonthly questionnaires on biologics used, indication for the biologic, experienced ADRs, consequences of ADRs and burden on a five-point Likert-type scale, ranging from 1 (no burden) to 5 (very high burden). We assessed potential factors associated with patient-reported burden of ADRs.

Results

A total of 1355 patients completed 6293 questionnaires between 1 January 2017 and 1 May 2019. Almost half of the patients (665 patients, 49%), 69% with rheumatic diseases and 31% with other diseases, collectively reported 1720 unique ADRs. Infections and musculoskeletal complaints were the most burdensome ADRs and injection-site reactions were the least burdensome. ADRs leading to healthcare professional contact were more burdensome than ADRs without healthcare professional contact. Smoking, respiratory and psychiatric comorbidities were associated with higher burden of ADRs. Crohn’s disease, use of adalimumab and use of sulfasalazine as combination therapy were associated with lower burden of ADRs.

Conclusions

The patient perspective gives important insights into the burden of ADRs experienced with biologics. This information could be used by healthcare professionals to optimise treatment with biologics.

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Acknowledgements

We would like to thank all patients for participating in the Dutch Biologic Monitor and all centres for inviting patients to participate: Academic Medical Center, Amsterdam; Sint Maartenskliniek, Nijmegen; Radboud University Medical Centre, Nijmegen; Reade Rheumatology, Amsterdam; Jeroen Bosch Hospital, ‘s-Hertogenbosch; Medisch Spectrum Twente, Enschede; Ziekenhuisgroep Twente, Almelo/Hengelo; Franciscus Gasthuis & Vlietland, Rotterdam; Haga Hospital, Den Haag.

Author information

Authors and Affiliations

  1. Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch, The Netherlands

    Jette A. van Lint, Naomi T. Jessurun & Eugene P. van Puijenbroek

  2. Department of Rheumatology, Amsterdam Rheumatology and Immunology Center | Reade, Amsterdam, The Netherlands

    Renske C. F. Hebing & Michael T. Nurmohamed

  3. Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands

    Frank Hoentjen

  4. Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, AMC/University of Amsterdam, Amsterdam, The Netherlands

    Sander W. Tas

  5. Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, The Netherlands

    Harald E. Vonkeman

  6. University of Twente, Enschede, The Netherlands

    Harald E. Vonkeman

  7. Department of Dermatology, Erasmus Medical Center, Rotterdam, The Netherlands

    Martijn B. A. van Doorn

  8. Department of Hospital Pharmacy, Haga Hospital, The Hague, The Netherlands

    Annemieke Sobels

  9. Department of Dermatology, Public Health and Epidemiology; Immunity and Infections, Amsterdam University Medical Centers, Location Academic Medical Center, Amsterdam, The Netherlands

    Phyllis I. Spuls

  10. Pharmacotherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy University of Groningen, Groningen, The Netherlands

    Eugene P. van Puijenbroek

  11. Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, The Netherlands

    Michael T. Nurmohamed

  12. Department of Pharmacy, Sint Maartenskliniek, Nijmegen, The Netherlands

    Bart J. F. van den Bemt

  13. Department of Pharmacy, RadboudUMC, Nijmegen, The Netherlands

    Bart J. F. van den Bemt

Authors
  1. Jette A. van Lint
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  2. Naomi T. Jessurun
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  3. Renske C. F. Hebing
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  4. Frank Hoentjen
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  5. Sander W. Tas
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  6. Harald E. Vonkeman
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  7. Martijn B. A. van Doorn
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  8. Annemieke Sobels
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  9. Phyllis I. Spuls
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  10. Eugene P. van Puijenbroek
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  11. Michael T. Nurmohamed
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  12. Bart J. F. van den Bemt
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Corresponding author

Correspondence to Jette A. van Lint.

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Funding

The Dutch Biologic Monitor work was supported by the Netherlands Organisation for Health Research and Development (ZonMw) [grant number 848050005]. No funding was received for this study.

Conflicts of interest

JA van Lint, NT Jessurun, RCF Hebing, SW Tas, HE Vonkeman, A Sobels, EP van Puijenbroek, MT Nurmohamed and BJF van den Bemt declare that they have no conflicts of interest. PI Spuls reports unpaid consultancies for Sanofi and Abbvie in the past, a departmental independent research grant for the TREAT NL registry from Leopharma, financial compensation from pharmaceutical industries to her department/hospital for involvement in performing clinical trials and she is chief investigator in the Netherlands national systemic and phototherapy atopic eczema registry (TREAT NL). MBA van Doorn reports grants from Novartis; consulting fees or honorarium from Leopharma, Novartis, Abbvie, BMS, Celgene, Janssen-Cilag, Lily, MSD, Pfizer and Sanofi-Genzyme; support for travel, manuscript preparation or other purposes from Sanofi-Genzyme, Novartis and Pfizer; payment for lectures from Leopharma, Novartis, Janssen-Cilag and Pfizer, all outside the submitted work. F Hoentjen reports received grants, consulting fees or honorarium and payment for lectures, all outside the submitted work.

Ethics approval

Ethical approval was waived for the Dutch Medical Research Involving Human Subjects Act (WMO) by the Medical Research Ethical Committee of Brabant, the Netherlands (file number: NW2016-66). The Dutch Biologic Monitor was approved by the medical ethics committees of the participating hospitals. All participants received information about the Dutch Biologic Monitor prior to participation and signed a digital informed consent form.

Data availability

The dataset analysed during the current study is available from the corresponding author on reasonable request.

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van Lint, J.A., Jessurun, N.T., Hebing, R.C.F. et al. Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases. Drug Saf 43, 917–925 (2020). https://doi.org/10.1007/s40264-020-00946-z

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  • DOI: https://doi.org/10.1007/s40264-020-00946-z

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