Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)

Merel de Boer; Helen R. Gosselt; Jurriaan Jansen; Martijn B. A. van Doorn; Frank Hoentjen; Michael T. Nurmohamed; Phyllis Spuls; Sander W. Tas; Harald E. Vonkeman; Naomi T. Jessurun

doi:10.1080/14740338.2022.2110237

Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)

Merel de Boer^*
, Helen R. Gosselt
, Jurriaan Jansen
, Martijn B. A. van Doorn
, Frank Hoentjen
, Michael T. Nurmohamed
, Phyllis Spuls
, Sander W. Tas
, Harald E. Vonkeman
, Naomi T. Jessurun

^*Corresponding author for this work

Dermatology

Netherlands Pharmacovigilance Centre Lareb
University of Alberta
Amsterdam Rheumatology & Immunology Centre
Amsterdam UMC
Vrije Universiteit Amsterdam
Centre for eHealth and Wellbeing Research

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

3 Citations (Scopus)

5 Downloads (Pure)

Abstract

Background: We aimed to investigate course and burden over time of ADRs attributed to TNFα-inhibitors in IRD-patients, and whether Sankey diagrams and polar plots can visualize this. Research design and methods: Data on ADRs experienced during the Dutch Biologic Monitor (January 2017 till December 2022) were used in this study. We selected IRD-patients using a TNFα-inhibitor, reporting skin reactions/infections/injection site reactions and completing ≥3 questionnaires (i.e. the initial report and ≥2 follow-ups). Course was scored as worsening/improving/remaining stable/resolving and as (non-)recurrent. Patients scored burden from 1 (no burden) to 5 (very high burden). Sankey diagrams and polar plots visualized this. Results: 202 patients were included, reporting 353 ADRs. Most skin reactions were stable (25.0%). Most infections resolved (50.8%). Injection site reactions were mostly recurrent (72.3%). Skin reactions and infections tended to decrease in burden. Infections had highest burden at start, which mostly decreased over time. Injection site reactions had a low and stable burden. Conclusions: Skin reactions attributed to TNFα-inhibitors by IRD-patients are stable with a slightly decreasing burden over time. Infections have highest burden at start but resolved mostly. Injection site reactions have a low and stable burden. Sankey diagrams and polar plots are suitable to visualize this.

Original language	English
Pages (from-to)	195-202
Number of pages	8
Journal	Expert Opinion on Drug Safety
Volume	22
Issue number	3
Early online date	10 Aug 2022
DOIs	https://doi.org/10.1080/14740338.2022.2110237
Publication status	Published - 2023

Bibliographical note

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

Funding Information:
PI Spuls has done consultancies in the past for Sanofi 111017 and AbbVie 041217 (unpaid), receives departmental independent research grants for TREAT NL registry, for which she is Chief Investigator (CI), from pharma companies since December 2019, is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital. MBA van Doorn reports grants from Novartis; consulting fees or honorarium from Leopharma, Novartis, Abbvie, BMS, Celgene, Janssen-Cilag, Lilly, 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 has served on advisory boards or as speaker for Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk. He reports grants from Dr. Falk, Janssen-Cilag and Abbvie and consulting fees from Celgene, all outside the submitted work. MT Nurmohamed has received payment as a speaker or consultant of Abbvie, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Janssen, Roche and Sanofi, all outside the submitted work. He reports financial grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, Galapagos and Sanofi, all outside the submitted work. SW Tas has worked as a paid consultant for Gebro, GSK, AbbVie, Galvani, Arthrogen and Galapagos, all outside the submitted work. He reports financial grants from Pfizer, GSK, Celgene, BMS, Sanofi and AstraZeneca, all outside the submitted work. HE Vonkeman has worked as a paid consultant for AbbVie, Amgen, AstraZeneca, BMS, Celgene, Celltrion, Galapagos, Gilead, GSK, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche and Sanofi-Genzyme, all outside the submitted work. He reports financial grants from AbbVie and Sanofi, both 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Publisher Copyright:
© 2022 Informa UK Limited, trading as Taylor & Francis Group.

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10.1080/14740338.2022.2110237

Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)Final published version, 2.4 MBLicence: Article 25fa Dutch Copyright Act

https://ris.utwente.nl/ws/files/286339551/De_boer_2022_Analysis_and_visualization_of_the_c.pdf

Cite this

de Boer, M., Gosselt, H. R., Jansen, J., van Doorn, M. B. A., Hoentjen, F., Nurmohamed, M. T., Spuls, P., Tas, S. W., Vonkeman, H. E., & Jessurun, N. T. (2023). Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs). Expert Opinion on Drug Safety, 22(3), 195-202. https://doi.org/10.1080/14740338.2022.2110237

@article{b461092d985d4d179adc836f2f538d5e,

title = "Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)",

abstract = "Background: We aimed to investigate course and burden over time of ADRs attributed to TNFα-inhibitors in IRD-patients, and whether Sankey diagrams and polar plots can visualize this. Research design and methods: Data on ADRs experienced during the Dutch Biologic Monitor (January 2017 till December 2022) were used in this study. We selected IRD-patients using a TNFα-inhibitor, reporting skin reactions/infections/injection site reactions and completing ≥3 questionnaires (i.e. the initial report and ≥2 follow-ups). Course was scored as worsening/improving/remaining stable/resolving and as (non-)recurrent. Patients scored burden from 1 (no burden) to 5 (very high burden). Sankey diagrams and polar plots visualized this. Results: 202 patients were included, reporting 353 ADRs. Most skin reactions were stable (25.0\%). Most infections resolved (50.8\%). Injection site reactions were mostly recurrent (72.3\%). Skin reactions and infections tended to decrease in burden. Infections had highest burden at start, which mostly decreased over time. Injection site reactions had a low and stable burden. Conclusions: Skin reactions attributed to TNFα-inhibitors by IRD-patients are stable with a slightly decreasing burden over time. Infections have highest burden at start but resolved mostly. Injection site reactions have a low and stable burden. Sankey diagrams and polar plots are suitable to visualize this.",

author = "\{de Boer\}, Merel and Gosselt, \{Helen R.\} and Jurriaan Jansen and \{van Doorn\}, \{Martijn B. A.\} and Frank Hoentjen and Nurmohamed, \{Michael T.\} and Phyllis Spuls and Tas, \{Sander W.\} and Vonkeman, \{Harald E.\} and Jessurun, \{Naomi T.\}",

note = "Funding Information: The Dutch Biologic Monitor work was supported by the Netherlands Organization for Health Research and Development (ZonMw) [grant number 848050005]. No funding was received for this study. Funding Information: PI Spuls has done consultancies in the past for Sanofi 111017 and AbbVie 041217 (unpaid), receives departmental independent research grants for TREAT NL registry, for which she is Chief Investigator (CI), from pharma companies since December 2019, is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital. MBA van Doorn reports grants from Novartis; consulting fees or honorarium from Leopharma, Novartis, Abbvie, BMS, Celgene, Janssen-Cilag, Lilly, 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 has served on advisory boards or as speaker for Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk. He reports grants from Dr. Falk, Janssen-Cilag and Abbvie and consulting fees from Celgene, all outside the submitted work. MT Nurmohamed has received payment as a speaker or consultant of Abbvie, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Janssen, Roche and Sanofi, all outside the submitted work. He reports financial grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, Galapagos and Sanofi, all outside the submitted work. SW Tas has worked as a paid consultant for Gebro, GSK, AbbVie, Galvani, Arthrogen and Galapagos, all outside the submitted work. He reports financial grants from Pfizer, GSK, Celgene, BMS, Sanofi and AstraZeneca, all outside the submitted work. HE Vonkeman has worked as a paid consultant for AbbVie, Amgen, AstraZeneca, BMS, Celgene, Celltrion, Galapagos, Gilead, GSK, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche and Sanofi-Genzyme, all outside the submitted work. He reports financial grants from AbbVie and Sanofi, both 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Publisher Copyright: {\textcopyright} 2022 Informa UK Limited, trading as Taylor \& Francis Group.",

year = "2023",

doi = "10.1080/14740338.2022.2110237",

language = "English",

volume = "22",

pages = "195--202",

journal = "Expert Opinion on Drug Safety",

issn = "1474-0338",

publisher = "Taylor \& Francis Ltd (UK)",

number = "3",

}

de Boer, M, Gosselt, HR, Jansen, J, van Doorn, MBA, Hoentjen, F, Nurmohamed, MT, Spuls, P, Tas, SW, Vonkeman, HE & Jessurun, NT 2023, 'Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)', Expert Opinion on Drug Safety, vol. 22, no. 3, pp. 195-202. https://doi.org/10.1080/14740338.2022.2110237

Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs). / de Boer, Merel; Gosselt, Helen R.; Jansen, Jurriaan et al.
In: Expert Opinion on Drug Safety, Vol. 22, No. 3, 2023, p. 195-202.

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

TY - JOUR

T1 - Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)

AU - de Boer, Merel

AU - Gosselt, Helen R.

AU - Jansen, Jurriaan

AU - van Doorn, Martijn B. A.

AU - Hoentjen, Frank

AU - Nurmohamed, Michael T.

AU - Spuls, Phyllis

AU - Tas, Sander W.

AU - Vonkeman, Harald E.

AU - Jessurun, Naomi T.

N1 - Funding Information: The Dutch Biologic Monitor work was supported by the Netherlands Organization for Health Research and Development (ZonMw) [grant number 848050005]. No funding was received for this study. Funding Information: PI Spuls has done consultancies in the past for Sanofi 111017 and AbbVie 041217 (unpaid), receives departmental independent research grants for TREAT NL registry, for which she is Chief Investigator (CI), from pharma companies since December 2019, is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital. MBA van Doorn reports grants from Novartis; consulting fees or honorarium from Leopharma, Novartis, Abbvie, BMS, Celgene, Janssen-Cilag, Lilly, 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 has served on advisory boards or as speaker for Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk. He reports grants from Dr. Falk, Janssen-Cilag and Abbvie and consulting fees from Celgene, all outside the submitted work. MT Nurmohamed has received payment as a speaker or consultant of Abbvie, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Janssen, Roche and Sanofi, all outside the submitted work. He reports financial grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, Galapagos and Sanofi, all outside the submitted work. SW Tas has worked as a paid consultant for Gebro, GSK, AbbVie, Galvani, Arthrogen and Galapagos, all outside the submitted work. He reports financial grants from Pfizer, GSK, Celgene, BMS, Sanofi and AstraZeneca, all outside the submitted work. HE Vonkeman has worked as a paid consultant for AbbVie, Amgen, AstraZeneca, BMS, Celgene, Celltrion, Galapagos, Gilead, GSK, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche and Sanofi-Genzyme, all outside the submitted work. He reports financial grants from AbbVie and Sanofi, both 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Publisher Copyright: © 2022 Informa UK Limited, trading as Taylor & Francis Group.

PY - 2023

Y1 - 2023

N2 - Background: We aimed to investigate course and burden over time of ADRs attributed to TNFα-inhibitors in IRD-patients, and whether Sankey diagrams and polar plots can visualize this. Research design and methods: Data on ADRs experienced during the Dutch Biologic Monitor (January 2017 till December 2022) were used in this study. We selected IRD-patients using a TNFα-inhibitor, reporting skin reactions/infections/injection site reactions and completing ≥3 questionnaires (i.e. the initial report and ≥2 follow-ups). Course was scored as worsening/improving/remaining stable/resolving and as (non-)recurrent. Patients scored burden from 1 (no burden) to 5 (very high burden). Sankey diagrams and polar plots visualized this. Results: 202 patients were included, reporting 353 ADRs. Most skin reactions were stable (25.0%). Most infections resolved (50.8%). Injection site reactions were mostly recurrent (72.3%). Skin reactions and infections tended to decrease in burden. Infections had highest burden at start, which mostly decreased over time. Injection site reactions had a low and stable burden. Conclusions: Skin reactions attributed to TNFα-inhibitors by IRD-patients are stable with a slightly decreasing burden over time. Infections have highest burden at start but resolved mostly. Injection site reactions have a low and stable burden. Sankey diagrams and polar plots are suitable to visualize this.

AB - Background: We aimed to investigate course and burden over time of ADRs attributed to TNFα-inhibitors in IRD-patients, and whether Sankey diagrams and polar plots can visualize this. Research design and methods: Data on ADRs experienced during the Dutch Biologic Monitor (January 2017 till December 2022) were used in this study. We selected IRD-patients using a TNFα-inhibitor, reporting skin reactions/infections/injection site reactions and completing ≥3 questionnaires (i.e. the initial report and ≥2 follow-ups). Course was scored as worsening/improving/remaining stable/resolving and as (non-)recurrent. Patients scored burden from 1 (no burden) to 5 (very high burden). Sankey diagrams and polar plots visualized this. Results: 202 patients were included, reporting 353 ADRs. Most skin reactions were stable (25.0%). Most infections resolved (50.8%). Injection site reactions were mostly recurrent (72.3%). Skin reactions and infections tended to decrease in burden. Infections had highest burden at start, which mostly decreased over time. Injection site reactions had a low and stable burden. Conclusions: Skin reactions attributed to TNFα-inhibitors by IRD-patients are stable with a slightly decreasing burden over time. Infections have highest burden at start but resolved mostly. Injection site reactions have a low and stable burden. Sankey diagrams and polar plots are suitable to visualize this.

UR - https://www.scopus.com/pages/publications/85135775570

U2 - 10.1080/14740338.2022.2110237

DO - 10.1080/14740338.2022.2110237

M3 - Article

C2 - 35946722

SN - 1474-0338

VL - 22

SP - 195

EP - 202

JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

IS - 3

ER -

Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)

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