Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS)

Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune... BioDrugs (2018) 32:377–390 https://doi.org/10.1007/s40259-018-0285-2 OR IGINAL RESEARCH ARTIC L E Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS) 1 1 1 • • • Ariane G. S. Araujo Helena H. L. Borba Fernanda S. Tonin 1 2 1 1 • • • Luana Lenzi Rafael Venson Roberto Pontarolo Astrid Wiens Published online: 5 June 2018 Springer International Publishing AG, part of Springer Nature 2018 Abstract Objective The aim of this study was to identify signals of Introduction The molecular and pharmacological com- disproportionate reporting (SDR) of clinical relevance plexity of biologic disease-modifying antirheumatic drugs related to the use of biologic drugs approved for RA and used for the management of rheumatoid arthritis (RA) other autoimmune diseases. favors the occurrence of adverse drug reactions (ADRs), Methods All suspected ADRs registered in the FDA which should be constantly monitored in post-marketing Adverse Event Reporting System between January 2003 safety studies. and June 2016 were collected. The reporting odds ratio was used as a measure of disproportionality to identify possible SDRs related to biologics. Those involving important medical events and designated medical events (DME) were http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BioDrugs Springer Journals

Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS)

14 pages
Read Article

Loading next page...
 
/lp/springer_journal/safety-of-biologics-approved-for-the-treatment-of-rheumatoid-arthritis-RZ8KFvgEg0
Publisher site
See Article on Publisher Site

Abstract

BioDrugs (2018) 32:377–390 https://doi.org/10.1007/s40259-018-0285-2 OR IGINAL RESEARCH ARTIC L E Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS) 1 1 1 • • • Ariane G. S. Araujo Helena H. L. Borba Fernanda S. Tonin 1 2 1 1 • • • Luana Lenzi Rafael Venson Roberto Pontarolo Astrid Wiens Published online: 5 June 2018 Springer International Publishing AG, part of Springer Nature 2018 Abstract Objective The aim of this study was to identify signals of Introduction The molecular and pharmacological com- disproportionate reporting (SDR) of clinical relevance plexity of biologic disease-modifying antirheumatic drugs related to the use of biologic drugs approved for RA and used for the management of rheumatoid arthritis (RA) other autoimmune diseases. favors the occurrence of adverse drug reactions (ADRs), Methods All suspected ADRs registered in the FDA which should be constantly monitored in post-marketing Adverse Event Reporting System between January 2003 safety studies. and June 2016 were collected. The reporting odds ratio was used as a measure of disproportionality to identify possible SDRs related to biologics. Those involving important medical events and designated medical events (DME) were

Journal

BioDrugs – Springer Journals

Published: Jun 5, 2018

References

  • EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update
    Smolen, JS
  • Rheumatoid arthritis
    Smolen, JS; Aletaha, D; McInnes, IB
  • Indicators of suboptimal biologic therapy over time in patients with ulcerative colitis and Crohn’s disease in the United States
    Patel, H; Lissoos, T; Rubin, DT
  • Quantitative evaluation of biologic therapy options for psoriasis: a systematic review and network meta-analysis
    Jabbar-Lopez, ZK
  • Treatment patterns and costs for anti-TNFalpha biologic therapy in patients with psoriatic arthritis
    Palmer, JB
  • Adverse effects of biologics: a network meta-analysis and Cochrane overview
    Singh, JA
  • bDMARD dose reduction in rheumatoid arthritis: a narrative review with systematic literature search
    Verhoef, LM
  • Safety of biologic therapy in rheumatoid arthritis
    Woodrick, RS; Ruderman, EM
  • Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database, VigiBase
    Giezen, TJ
  • Postmarketing safety surveillance : where does signal detection using electronic healthcare records fit into the big picture?
    Coloma, PM
  • Defining ‘signal’ and its subtypes in pharmacovigilance based on a systematic review of previous definitions
    Hauben, M; Aronson, JK
  • The role of data mining in pharmacovigilance
    Hauben, M
  • 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis
    Singh, JA
  • Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force
    Smolen, JS
  • Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants
    Wong, CK
  • Medication prescribing in frail older people
    Hubbard, RE; O’Mahony, MS; Woodhouse, KW
  • Adverse drug reactions in the elderly and their prevention
    Cunningham, G
  • Safety profile of biological medicines as compared with non-biologicals: an analysis of the italian spontaneous reporting system database
    Cutroneo, PM
  • Lesiones cutáneas y terapia biológica con antagonistas del factor de necrosis tumoral
    Hernández, MV; Meineri, M; Sanmartí, R
  • Good signal detection practices: evidence from IMI PROTECT
    Wisniewski, AF
  • Performance of stratified and subgrouped disproportionality analyses in spontaneous databases
    Seabroke, S
  • A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions
    Puijenbroek, EP
  • Safety profiles of adalimumab, etanercept and infliximab: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events
    Mendes, D; Alves, C; Batel-Marques, F
  • Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval
    Giezen, TJ
  • Data mining applications in engineering and medicine
    Poluzzi, E
  • Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries
    Codreanu, C; Damjanov, N
  • Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models
    Dixit, R
  • Pharmacovigilance of biopharmaceuticals: challenges remain
    Giezen, TJ; Mantel-Teeuwisse, AK; Leufkens, HG
  • Safety-related regulatory actions for biologicals approved in the United States and the European Union
    Giezen, TJ
  • Segurança do uso de terapias biológicas para o tratamento de artrite reumatoide e espondiloartrites
    Mota, LMHD
  • Tumor necrosis factor blockade: mechanism of action
    Gottlieb, AB
  • Anti-TNF-alpha agents in the treatment of immune-mediated inflammatory diseases: mechanisms of action and pitfalls
    Silva, LC; Ortigosa, LC; Benard, G
  • Molecular mechanisms of action of anti-TNF-alpha agents—comparison among therapeutic TNF-alpha antagonists
    Mitoma, H
  • Granulomatous infectious diseases associated with tumor necrosis factor antagonists
    Wallis, RS
  • Rheumatoid arthritis, anti-tumour necrosis factor treatment, and risk of squamous cell and basal cell skin cancer: cohort study based on nationwide prospectively recorded data from Sweden
    Raaschou, P
  • Biologic treatment of rheumatoid arthritis and the risk of malignancy: analyses from a large US observational study
    Wolfe, F; Michaud, K
  • Pharmacoepidemiology studies: what levels of evidence and how can they be reached?
    Lapeyre-Mestre, M
  • Longterm safety of rituximab: final report of the rheumatoid arthritis global clinical trial program over 11 years
    Vollenhoven, RF
  • Clinical review: serious adverse events associated with the use of rituximab—a critical care perspective
    Kasi, PM
  • Factors affecting the development of adverse drug reactions (Review article)
    Alomar, MJ
  • Progressive multifocal leukoencephalopathy and monoclonal antibodies: a review
    Bohra, C; Sokol, L; Dalia, S
  • Quantitative signal detection using spontaneous ADR reporting
    Bate, A; Evans, SJ
  • Can disproportionality analysis of post-marketing case reports be used for comparison of drug safety profiles?
    Michel, C
  • Serious infection during etanercept, infliximab and adalimumab therapy for rheumatoid arthritis: a literature review
    Downey, C
  • Malignancies and anti-TNF therapy in rheumatoid arthritis: a single-center observational cohort study
    Berghen, N
  • TNF-alpha inhibitors: are they carcinogenic?
    Raval, G; Mehta, P
  • Observational studies on the risk of cancer associated with tumor necrosis factor inhibitors in rheumatoid arthritis: a review of their methodologies and results
    Solomon, DH; Mercer, E; Kavanaugh, A
  • Rituximab for the treatment of rheumatoid arthritis: an update
    Mok, CC
  • Autoimmune hepatitis triggered by anti-TNF-alpha therapy
    Nakayama, S
  • Autoimmune hepatitis and anti-tumor necrosis factor alpha therapy: a single center report of 8 cases
    Rodrigues, S
  • Adverse reactions to infliximab and the outcome of desensitization
    Mourad, AA
  • Tocilizumab-induced pancreatitis: case report and review of data from the FDA adverse event reporting system
    Flaig, T
  • Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs
    Strangfeld, A
  • Interstitial lung diseases induced or exacerbated by DMARDS and biologic agents in rheumatoid arthritis: a systematic literature review
    Roubille, C; Haraoui, B
  • Database size and power to detect safety signals in pharmacovigilance
    Hammond, IW
  • On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios
    Heijden, PG
  • Patient reporting of suspected adverse drug reactions: a review of published literature and international experience
    Blenkinsopp, A
  • Pharmacists’ role in reporting adverse drug reactions in an international perspective
    Grootheest, K
  • Pharmacovigilance: pharmacists’ perspective on spontaneous adverse drug reaction reporting
    Hadi, MA
  • Spontaneous adverse drug reaction reporting vs event monitoring: a comparison
    Fletcher, AP
  • Under-reporting of adverse drug reactions : a systematic review
    Hazell, L; Shakir, SA
  • Is reporting rate a good predictor of risks associated with drugs?
    Pierfitte, C
  • Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration
    Hartnell, NR; Wilson, JP
  • The Weber effect and the United States Food and Drug Administration’s adverse event reporting system (FAERS): analysis of sixty-two drugs approved from 2006 to 2010
    Hoffman, KB
  • Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias
    Pariente, A

You’re reading a free preview. Subscribe to read the entire article.

Try 2 weeks free now

DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

or browse the journals available

Search

Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly

Organize

Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.

Access

Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve

Freelancer

DeepDyve

Pro

Price

FREE

$49/month
$360/year

Save searches from
Google Scholar,
PubMed

Create folders to
organize your research

Export folders, citations

Read DeepDyve articles

Abstract access only

Unlimited access to over
18 million full-text articles

Print

20 pages / month

PDF Discount

20% off

Sign up
for free
Start 14 day
Free Trial