Frequency of real-world reported adverse drug reactions in rheumatoid arthritis patients

References

• Guo Q, Wang Y, Xu D, et al. Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone Res. 2018;6:15.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73(3):492–509.
   PubMed Web of Science ®Google Scholar
• Wilsdon TD, Hill CL. Managing the drug treatment of rheumatoid arthritis. Aust Prescr. 2017;40(2):51–58.
   PubMed Web of Science ®Google Scholar
• Guideline A. On Summary Of Product Characteristics (SmPC). 2009. (Directorate-General ECEAI, editor). p. 29.
   Google Scholar
• DREAM-RA registry. 2020. [cited 2020 May 1]. Available from: https://www.dreamregistry.nl
   Google Scholar
• Kievit W, Fransen J, Adang EM, et al. Long-term effectiveness and safety of TNF-blocking agents in daily clinical practice: results from the Dutch Rheumatoid Arthritis Monitoring register. Rheumatology (Oxford). 2011;50(1):196–203.
   PubMed Web of Science ®Google Scholar
• Ten Klooster PM, Versteeg LGA, Oude VMAH, et al. Radiographic progression can still occur in individual patients with low or moderate disease activity in the current treat-to-target paradigm: real-world data from the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry. Arthritis Res Ther. 2019;21(1):237.
   PubMed Web of Science ®Google Scholar
• van Dartel SA, Fransen J, Kievit W, et al. Predictors for the 5-year risk of serious infections in patients with rheumatoid arthritis treated with anti-tumour necrosis factor therapy: a cohort study in the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry. Rheumatology (Oxford). 2013;52(6):1052–1057.
   PubMed Web of Science ®Google Scholar
• van Dartel SA, Fransen J, Kievit W, et al. Difference in the risk of serious infections in patients with rheumatoid arthritis treated with adalimumab, infliximab and etanercept: results from the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry. Ann Rheum Dis. 2013;72(6):895–900.
   PubMed Web of Science ®Google Scholar
• mijnreumacentrum: transparency in healthcare. 2020. [cited 2020 May 1]. Available from: https://www.mijnreumacentrum.nl/reuma-en-behandeling
   Google Scholar
• Kievit W, Fransen J, Oerlemans AJ, et al. The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice. Ann Rheum Dis. 2007;66(11):1473–1478.
   PubMed Web of Science ®Google Scholar
• Vermeer M, Kuper HH, Bernelot Moens HJ, et al. Adherence to a treat-to-target strategy in early rheumatoid arthritis: results of the DREAM remission induction cohort. Arthritis Res Ther. 2012;14(6):R254.
   PubMed Web of Science ®Google Scholar
• Steunebrink LM, Vonkeman HE, Ten Klooster PM, et al. Recently diagnosed rheumatoid arthritis patients benefit from a treat-to-target strategy: results from the DREAM registry. Clin Rheumatol. 2016;35(3):609–615.
   PubMed Web of Science ®Google Scholar
• van de Laar CJ, Oude Voshaar MAH, Vonkeman HE. Cost-effectiveness of different treat-to-target strategies in rheumatoid arthritis: results from the DREAM registry. BMC Rheumatol. 2019;3:16.
   PubMedGoogle Scholar
• CBG. Geneesmiddeleninformatiebank College ter Beoordeling van Geneesmiddelen. 2020. [cited 2020 May 1]. Available from: https://www.geneesmiddeleninformatiebank.nl/nl/
   Google Scholar
• AbbVie. Samenvatting van de productkenmerken Humira oplossing voor injectie in een voorgevulde spuit. 2008.
   Google Scholar
• Accord. Samenvatting van de productkenmerken Methotrexaat Accord 20 mg. 2020. (tabletten).
   Google Scholar
• Accord. Samenvatting van de productkenmerken Injexate oplossing voor injectie in voorgevulde spuit. 2019.
   Google Scholar
• Centrafarm. Samenvatting van de productkenmerken Leflunomide CF. 2017. (filmomhulde tabletten).
   Google Scholar
• Mylan. Samenvatting van de productkenmerken Sulfasalazine Mylan. 2019. (maagsapresistente tabletten).
   Google Scholar
• Pfizer. Samenvatting van de productkenmerken Enbrel 25 mg poeder voor oplossing voor injectie. 2010.
   Google Scholar
• Sanofi-aventis. Samenvatting van de productkenmerken Plaquenil. 2020. (filmomhulde tabletten).
   Google Scholar
• Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20(2):109–117.
   PubMed Web of Science ®Google Scholar
• ICH. MedDRA maintenance and support services organization. 2010. (Introductory Guide to MedDRA Version 13.1).
   Google Scholar
• Patil P, Parker RA, Rawcliffe C, et al. Methotrexate-induced nausea and vomiting in adolescent and young adult patients. Clin Rheumatol. 2014;33(3):403–407.
   PubMed Web of Science ®Google Scholar
• Ma SN, Zaman Huri H, Yahya F. Drug-related problems in patients with rheumatoid arthritis. Ther Clin Risk Manag. 2019;15:505–524.
   PubMed Web of Science ®Google Scholar
• Dhir V, Aggarwal A. Methotrexate-related minor adverse effects in rheumatoid arthritis: more than a nuisance. J Clin Rheumatol. 2012;18(1):44–46.
   PubMed Web of Science ®Google Scholar
• Minozzi S, Bonovas S, Lytras T, et al. Risk of infections using anti-TNF agents in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: a systematic review and meta-analysis. Expert Opin Drug Saf. 2016;15(sup1):11–34.
   PubMed Web of Science ®Google Scholar
• Murdaca G, Spanò F, Contatore M, et al. Pharmacogenetics of etanercept: role of TNF-α gene polymorphisms in improving its efficacy. Expert Opin Drug Metab Toxicol. 2014;10:12.
   Web of Science ®Google Scholar
• Detert J, Klaus P, Listing J, et al. Hydroxychloroquine in patients with inflammatory and erosive osteoarthritis of the hands (OA TREAT): study protocol for a randomized controlled trial. Trials. 2014;15:412.
   PubMed Web of Science ®Google Scholar
• Patient information on hydroxychloroquine. Australian Rheumatology Association; 2016.
   Google Scholar
• Browning DJ. Hydroxychloroquine and chloroquine retinopathy: screening for drug toxicity. Am J Ophthalmol. 2002;133(5):649–656.
   PubMed Web of Science ®Google Scholar
• Grierson DJ. Hydroxychloroquine and visual screening in a rheumatology outpatient clinic. Ann Rheum Dis. 1997;56(3):188–190.
   PubMed Web of Science ®Google Scholar
• Sharma AN, Mesinkovska NA, Paravar T. Characterizing the adverse dermatologic effects of hydroxychloroquine: a systematic review. J Am Acad Dermatol. 2020;83(2):563–578.
   Web of Science ®Google Scholar
• Okubo S, Nakatani K, Nishiya K. Gastrointestinal symptoms associated with enteric-coated sulfasalazine (Azulfidine EN tablets). Mod Rheumatol. 2002;12(3):226–229.
   PubMedGoogle Scholar
• Kvien TK, Uhlig T, Odegard S, et al. Epidemiological aspects of rheumatoid arthritis: the sex ratio. Ann N Y Acad Sci. 2006;1069:212–222.
   PubMed Web of Science ®Google Scholar
• Zopf Y, Rabe C, Neubert A, et al. Women encounter ADRs more often than do men. Eur J Clin Pharmacol. 2008;64(10):999–1004.
   PubMed Web of Science ®Google Scholar
• Watson S, Caster O, Rochon PA, et al. Reported adverse drug reactions in women and men: aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine. 2019;17:100188.
   PubMedGoogle Scholar
• Holm L, Ekman E, Jorsater Blomgren K. Influence of age, sex and seriousness on reporting of adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf. 2017;26(3):335–343.
   PubMed Web of Science ®Google Scholar