Quantification of Longitudinal Patient-Reported Burden of Adverse Drug Reactions Attributed to the Use of TNF-α Inhibitors in inflammatory rheumatic diseases: an observational prospective cohort study

ABSTRACT

Background

There is a lack of knowledge on patient perspectives on adverse drug reactions (ADRs) attributed to the use of biologics. The aim of this study is to quantify the burden over time of ADRs attributed to TNF-α inhibitors in patients with inflammatory rheumatic diseases (IRDs) and investigate whether the burden over time differs between different types of ADRs.

Research design and methods

Data were used from the Dutch Biologic Monitor (DBM), an observational prospective cohort study for patient-reported ADRs attributed to biologics. Patients with an IRD using a TNF-α inhibitor reporting an ADR, lasting for three consecutive questionnaires, were included. Questionnaires were sent every two months and burden was scored on a 5-point Likert-type scale. Burden scores were analyzed using linear mixed models.

Results

Data from 166 unique patients reporting 274 ADRs were included. The burden score decreased every month by 0.29 points (95% CI -0.34 – -0.24) on average on a 5-point Likert-type scale. The burden score for infections and infestations decreased significantly faster than the burden score for injection site reactions.

Conclusions

Patient-reported burden of ADRs attributed to the use of a TNF-α inhibitor in patients with IRDs decreased significantly over time, especially for infections and infestations.

KEYWORDS:

• Biologics
• Adverse drug reactions
• Inflammatory rheumatism
• Longitudinal study

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Declaration of interests

H.E. Vonkeman declares having received grants, consulting fees or honorarium from AbbVie, Boehringer Ingelheim, Novartis, Pfizer, UCB, Janssen and Galapagos; all outside the submitted work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

We would like to thank the patients for participating in the DBM.

Data availability statement

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

Author contribution statement

NJ, HG and BK were involved in the conception and design of the study. BK analyzed the data. BK, NJ, HG and PtK interpreted the data. All authors critically reviewed and revised the paper for intellectual content, provided detailed feedback, read an approved the final manuscript and agreed to be accountable for all aspects of the work.

Ethics statement

Ethical approval of the Dutch Biologic Monitor was waived for the Dutch Medical Research Involving Human Subjects Act (WMO) by the Medical Research Ethical Committee of Brabant, the Netherlands.

Informed consent

All participants received information about the Dutch Biologic Monitor prior to participation and signed a digital informed consent form.

Additional information

Funding

The Dutch Biologic Monitor work was supported by the Netherlands Organisation for Health Research and Development (ZonMw) [grant number 848050005]. 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.