A Systematic Overview of Contraindications and Special Warnings for Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs: Establishing a Framework to Create a “Safety Checklist”

Smolen JS, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3–18.

Article  CAS  PubMed  Google Scholar 

Fraenkel L, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924–39.

Article  PubMed  Google Scholar 

Gossec L, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024.

Singh JA, et al. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Care Res (Hoboken). 2019;71(1):2–29.

Article  PubMed  Google Scholar 

Ramiro S, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2022.

Ward MM, et al. 2019 update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599–613.

Article  PubMed  PubMed Central  Google Scholar 

FDA. Homepage. Available from: https://www.fda.gov/.

EMA. Homepage. Available from: https://www.ema.europa.eu/en.

European Commission Enterprise and Industry Directorate-General. A guideline on summary of product characteristics (SmPC). 2009.

ACR Convergence Meeting. A label is worth a thousand words: exploring FDA communication methods 2021. 2021.

FDA. Guidance for industry warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format. 2011. Available from: https://www.fda.gov/files/drugs/published/Warnings-and-Precautions--Contraindications--and-Boxed-Warning-Sections-of-Labeling-for-Human-Prescription-Drug-and-Biological-Products-%E2%80%94-Content-and-Format.pdf.

EMA. Periodic safety update reports 2023. [09.01.23]. Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/periodic-safety-update-reports-psurs.

EMA. Guideline on good pharmacovigilance practices (GVP) module VII—periodic safety update report (Rev 1). 2013. [09.01.23]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-report_en.pdf.

EMA. EMA pharmacovigilance system manual Version 1.3. 2021. [09.01.23]. Available from: https://www.ema.europa.eu/en/documents/other/european-medicines-agency-pharmacovigilance-system-manual_en.pdf.

FDA. Drug label. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.

Thoenes A, et al. Discrepancies between the labels of originator and generic pharmaceutical products: implications for patient safety. Drugs Real World Outcomes. 2020;7(2):131–9.

Article  PubMed  PubMed Central  Google Scholar 

MEDDRA. Medical dictionary for regulatory activities. [05.10.22]. Available from: https://admin.meddra.org/sites/default/files/page/documents_insert/essentials_on_meddra.pdf.

Flint J, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016;55(9):1693–7.

Article  CAS  PubMed  Google Scholar 

Ogbu EA, Brunner HI. Treatment guidelines in pediatric rheumatic diseases. Rheum Dis Clin North Am. 2022;48(3):725–46.

Article  PubMed  Google Scholar 

EMA. Rituximab. Sept 2023 [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera#product-information-section.

FDA. Rituximab. Jun 2021 [27.11.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5464lbl.pdf.

EMA. Adalimumab. Okt 2022 [27.11.22]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/humira.

FDA. Adalimumab. Feb 2021 [27.11.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf.

EMA. Infliximab. Sept 2022 [27.11.22]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/remicade#product-information-section.

FDA. Infliximab. Okt 2021 [27.11.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf.

EMA. Golimumab. Jul 2023 [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/simponi#product-information-section.

FDA. Golimumab. Feb 2021 [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf.

EMA. Certolizumab Pegol. Apr 2023 [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/cimzia-0.

FDA. Certolizumab Pegol. Dec 2022 [18.09.23]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125160s305lbl.pdf.

EMA. Etanercept. Aug 2023 [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/enbrel.

FDA. Etanercept. Jun 2023 [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5594lbl.pdf.

EMA. Anakinra. Jul 2023 [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/kineret#product-information-section.

FDA. Anakinra. Dec 2020 [01.12.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103950s5189lbl.pdf.

EMA. Canakinumab. Aug 2023 [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/ilaris#product-information-section.

FDA. Canakinumab. Aug 2023. [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125319s107lbl.pdf.

EMA. Abatacept. Jun 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/orencia.

FDA. Abatacept. Dec 2021. [01.12.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125118s240lbl.pdf.

EMA. Ustekinumab. Jul 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/stelara#product-information-section.

FDA. Ustekinumab. Jul 2022. [01.12.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125261s161lbl.pdf.

EMA. Tocilizumab. Apr 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/roactemra#product-information-section.

FDA. Tocilizumab. Dec 2023. [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s138lbl.pdf.

EMA. Sarilumab. Jul 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/kevzara#product-information-section.

FDA. Sarilumab. Feb 2023. [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761037s013lbl.pdf.

EMA. Tofacitinib. Jun 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/xeljanz.

FDA. Tofacitinib. Dec 2021. [01.12.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf.

EMA. Baricitinib. Aug 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/olumiant.

FDA. Baricitinib. Jun 2022. [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s007lbl.pdf.

EMA. Filgotinib. May 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca.

EMA. Upadacitinib. Aug 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq.

FDA. Upadacitinib. Jun 2023. [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s017lbl.pdf.

EMA. JAK. Available from: https://www.ema.europa.eu/en/medicines/human/referrals/janus-kinase-inhibitors-jaki.

FDA. JAK. Available from: https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death.

EMA. Apremilast. Jul 2022. [01.12.22]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/otezla.

FDA. Apremilast. Jul 2023. [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205437s012lbl.pdf.

EMA. Secukinumab. Aug 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx#product-information-section.

FDA. Secukinumab. Jul 2023. [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf.

EMA. Ixekizumab. Feb 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/taltz.

FDA. Ixekizumab. Jul 2022. [18.09.23]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf.

EMA. Bimekizumab. Jun 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/bimzelx.

EMA. Guselkumab. Jul 2022. [01.12.22]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya.

FDA. Guselkumab. Jul 2020. [01.12.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf.

EMA. Risankizumab. Sep 2023. [18.09.23]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/skyrizi.

FDA. Risankizumab. Jan 2022. [01.12.22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf.

Lexchin J. How safe are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009. Open Med. 2014;8(1):e14–9.

PubMed  PubMed Central  Google Scholar 

Riley TR, George MD. Risk for infections with glucocorticoids and DMARDs in patients with rheumatoid arthritis. RMD Open. 2021;7(1).

Dey M, et al. Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic data. RMD Open. 2022;8(2).

Ytterberg SR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386(4):316–26.

Article  CAS  PubMed  Google Scholar 

Li X, et al. Comparative risk of serious infections among real-world users of biologics for psoriasis or psoriatic arthritis. Ann Rheum Dis. 2020;79(2):285–91.

Article  CAS  PubMed  Google Scholar 

Evangelatos G, et al. Tuberculosis and targeted synthetic or biologic DMARDs, beyond tumor necrosis factor inhibitors. Ther Adv Musculoskelet Dis. 2020;12:1759720x20930116.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Redeker I, et al. Risk of herpes zoster (shingles) in patients with rheumatoid arthritis under biologic, targeted synthetic and conventional synthetic DMARD treatment: data from the German RABBIT register. Ann Rheum Dis. 2022;81(1):41–7.

Article  CAS  PubMed  Google Scholar 

Wu KK, et al. Risk of herpes zoster with IL-17 inhibitor therapy for psoriasis and other inflammatory conditions. J Dermatolog Treat. 2020;31(4):359–65.

Article  CAS  PubMed  Google Scholar 

Vassilopoulos A, et al. The incidence of opportunistic infections in patients with psoriatic arthritis treated with biologic and targeted synthetic agents: a systematic review and meta-analysis. Front Pharmacol. 2022;13: 992713.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Baumrin E, et al. A systematic review of herpes zoster incidence and consensus recommendations on vaccination in adult patients on systemic therapy for psoriasis or psoriatic arthritis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2019;81(1):102–10.

Article  PubMed 

留言 (0)

沒有登入
gif