PMID- 36036179
OWN - NLM
STAT- MEDLINE
DCOM- 20230411
LR  - 20230411
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 22
IP  - 3
DP  - 2023 Mar
TI  - Disease-specific ADRs of TNF-alpha inhibitors as reported by patients with 
      inflammatory rheumatic diseases: a registry-based prospective multicenter cohort 
      study.
PG  - 203-211
LID - 10.1080/14740338.2022.2115479 [doi]
AB  - BACKGROUND: The extent to which adverse drug reactions (ADRs) of biologics differ 
      per immune-mediated inflammatory disease (IMID), and the relevance of tailoring 
      ADR information per IMID is not fully investigated. We aimed to compare 
      patient-reported ADRs attributed to adalimumab and etanercept between different 
      inflammatory rheumatic diseases (IRDs). RESEARCH DESIGN AND METHODS: ADR reports 
      from IRD patients were extracted from the Dutch Biologic Monitor. ADR frequencies 
      were compared using Fischer-Freeman-Halton exact test and the influence of 
      covariates was assessed using binomial logistic regression. A total, of 729 
      participants were included, of which 354 participants reported 887 unique ADRs. 
      ADR frequencies were not significantly different between the IRDs. Rheumatoid 
      arthritis and ankylosing spondylitis including axial spondyloarthritis patients 
      had an increased risk of ADRs related to 'Respiratory, thoracic and mediastinal 
      disorders' and as compared to psoriatic arthritis patients. Etanercept use, 
      combination therapy with methotrexate and/or corticosteroids, and age also 
      influenced the risk of reporting specific ADRs. CONCLUSIONS: There were no 
      differences in frequencies and nature of patient-reported ADRs attributed to 
      adalimumab and etanercept between different IRDs. However, more research is 
      needed to align patients' and health-care professionals' perspectives to improve 
      knowledge on disease-specific ADRs.
FAU - Roest, Lieke H
AU  - Roest LH
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
FAU - Kosse, Leanne J
AU  - Kosse LJ
AUID- ORCID: 0000-0002-9358-2286
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
AD  - Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University 
      Medical Center, Nijmegen, The Netherlands.
FAU - van Lint, Jette A
AU  - van Lint JA
AUID- ORCID: 0000-0003-2303-6199
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
AD  - Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University 
      Medical Center, Nijmegen, The Netherlands.
FAU - Gosselt, Helen R
AU  - Gosselt HR
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
FAU - Scholl, Joep H G
AU  - Scholl JHG
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
FAU - van Puijenbroek, Eugene
AU  - van Puijenbroek E
AUID- ORCID: 0000-0002-2236-1398
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
AD  - Groningen Research Institute of Pharmacy, PharmacoTherapy, Epidemiology & 
      -Economics, University of Groningen, Groningen, The Netherlands.
FAU - Vonkeman, Harald E
AU  - Vonkeman HE
AUID- ORCID: 0000-0003-3792-7718
AD  - Department of Psychology, Health and Technology, University of Twente, Enschede, 
      The Netherlands.
AD  - Department of Rheumatology & Clinical Immunology, Medisch Spectrum Twente, 
      Enschede, The Netherlands.
FAU - Tas, Sander W
AU  - Tas SW
AD  - Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location AMC, 
      University of Amsterdam and Amsterdam Rheumatology & Immunology Center (ARC), 
      Amsterdam, The Netherlands.
FAU - Nurmohamed, Michael T
AU  - Nurmohamed MT
AUID- ORCID: 0000-0002-6274-1934
AD  - Amsterdam Rheumatology & immunology Center | Reade, Amsterdam, The Netherlands.
FAU - van den Bemt, Bart J F
AU  - van den Bemt BJF
AD  - Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University 
      Medical Center, Nijmegen, The Netherlands.
AD  - Department of Pharmacy, Sint Maartenskliniek, Nijmegen, The Netherlands.
FAU - Jessurun, Naomi T
AU  - Jessurun NT
AUID- ORCID: 0000-0002-8267-1259
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
AD  - Unit of Pharmacotherapy, Epidemiology & -Economics, Faculty of Science and 
      Engineering, University of Groningen, Groningen, The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220828
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - FYS6T7F842 (Adalimumab)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Humans
MH  - Tumor Necrosis Factor Inhibitors
MH  - Tumor Necrosis Factor-alpha
MH  - Adalimumab/adverse effects
MH  - Etanercept/adverse effects
MH  - Prospective Studies
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Registries
OTO - NOTNLM
OT  - Adverse drug reactions
OT  - anti-TNF therapy
OT  - bDMARD
OT  - inflammatory rheumatic diseases
OT  - patient perspective
EDAT- 2022/08/30 06:00
MHDA- 2023/04/11 06:41
CRDT- 2022/08/29 05:40
PHST- 2023/04/11 06:41 [medline]
PHST- 2022/08/30 06:00 [pubmed]
PHST- 2022/08/29 05:40 [entrez]
AID - 10.1080/14740338.2022.2115479 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2023 Mar;22(3):203-211. doi: 10.1080/14740338.2022.2115479. 
      Epub 2022 Aug 28.