{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T19:42:34Z","timestamp":1783539754405,"version":"3.55.0"},"reference-count":125,"publisher":"Springer Science and Business Media LLC","issue":"11","license":[{"start":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T00:00:00Z","timestamp":1721088000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T00:00:00Z","timestamp":1721088000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2024,11]]},"DOI":"10.1007\/s40264-024-01461-1","type":"journal-article","created":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T15:00:35Z","timestamp":1721142035000},"page":"1075-1093","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["A Systematic Overview of Contraindications and Special Warnings for Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs: Establishing a Framework to Create a \u201cSafety Checklist\u201d"],"prefix":"10.1007","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1408-0027","authenticated-orcid":false,"given":"Lykke","family":"Skaarup","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-9045-1037","authenticated-orcid":false,"given":"Elvina","family":"Ingrid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1954-0229","authenticated-orcid":false,"given":"Alexandre","family":"Sepriano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6847-3726","authenticated-orcid":false,"given":"Elena","family":"Nikiphorou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6124-8972","authenticated-orcid":false,"given":"Ren\u00e9","family":"\u00d8stg\u00e5rd","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4315-9009","authenticated-orcid":false,"given":"Kim","family":"Lauper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilona","family":"Grosse-Michaelis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9294-2307","authenticated-orcid":false,"given":"Margreet","family":"Kloppenburg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8931-8482","authenticated-orcid":false,"given":"Bente","family":"Glintborg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8451-8883","authenticated-orcid":false,"given":"David F. L.","family":"Liew","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6439-397X","authenticated-orcid":false,"given":"Tue W.","family":"Kragstrup","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,7,16]]},"reference":[{"issue":"1","key":"1461_CR1","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1136\/ard-2022-223356","volume":"82","author":"JS Smolen","year":"2023","unstructured":"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\u201318.","journal-title":"Ann Rheum Dis"},{"issue":"7","key":"1461_CR2","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1002\/acr.24596","volume":"73","author":"L Fraenkel","year":"2021","unstructured":"Fraenkel L, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924\u201339.","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"1461_CR3","unstructured":"Gossec L, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024."},{"issue":"1","key":"1461_CR4","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1002\/acr.23789","volume":"71","author":"JA Singh","year":"2019","unstructured":"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\u201329.","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"1461_CR5","doi-asserted-by":"crossref","unstructured":"Ramiro S, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2022.","DOI":"10.1136\/ard-2023-223937"},{"issue":"10","key":"1461_CR6","doi-asserted-by":"crossref","first-page":"1599","DOI":"10.1002\/art.41042","volume":"71","author":"MM Ward","year":"2019","unstructured":"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\u2013613.","journal-title":"Arthritis Rheumatol"},{"key":"1461_CR7","unstructured":"FDA. Homepage. Available from: https:\/\/www.fda.gov\/."},{"key":"1461_CR8","unstructured":"EMA. Homepage. Available from: https:\/\/www.ema.europa.eu\/en."},{"key":"1461_CR9","unstructured":"European Commission Enterprise and Industry Directorate-General. A guideline on summary of product characteristics (SmPC). 2009."},{"key":"1461_CR10","unstructured":"ACR Convergence Meeting. A label is worth a thousand words: exploring FDA communication methods 2021. 2021."},{"key":"1461_CR11","unstructured":"FDA. Guidance for industry warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products\u2014content 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."},{"key":"1461_CR12","unstructured":"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."},{"key":"1461_CR13","unstructured":"EMA. Guideline on good pharmacovigilance practices (GVP) module VII\u2014periodic 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."},{"key":"1461_CR14","unstructured":"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."},{"key":"1461_CR15","unstructured":"FDA. Drug label. Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm."},{"issue":"2","key":"1461_CR16","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1007\/s40801-020-00187-7","volume":"7","author":"A Thoenes","year":"2020","unstructured":"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\u20139.","journal-title":"Drugs Real World Outcomes"},{"key":"1461_CR17","unstructured":"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."},{"issue":"9","key":"1461_CR18","doi-asserted-by":"crossref","first-page":"1693","DOI":"10.1093\/rheumatology\/kev404","volume":"55","author":"J Flint","year":"2016","unstructured":"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\u20137.","journal-title":"Rheumatology (Oxford)"},{"issue":"3","key":"1461_CR19","doi-asserted-by":"crossref","first-page":"725","DOI":"10.1016\/j.rdc.2022.03.007","volume":"48","author":"EA Ogbu","year":"2022","unstructured":"Ogbu EA, Brunner HI. Treatment guidelines in pediatric rheumatic diseases. Rheum Dis Clin North Am. 2022;48(3):725\u201346.","journal-title":"Rheum Dis Clin North Am"},{"key":"1461_CR20","unstructured":"EMA. Rituximab. Sept 2023 [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/mabthera#product-information-section."},{"key":"1461_CR21","unstructured":"FDA. Rituximab. Jun 2021 [27.11.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/103705s5464lbl.pdf."},{"key":"1461_CR22","unstructured":"EMA. Adalimumab. Okt 2022 [27.11.22]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/humira."},{"key":"1461_CR23","unstructured":"FDA. Adalimumab. Feb 2021 [27.11.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/125057s417lbl.pdf."},{"key":"1461_CR24","unstructured":"EMA. Infliximab. Sept 2022 [27.11.22]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/remicade#product-information-section."},{"key":"1461_CR25","unstructured":"FDA. Infliximab. Okt 2021 [27.11.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/103772s5401lbl.pdf."},{"key":"1461_CR26","unstructured":"EMA. Golimumab. Jul 2023 [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/simponi#product-information-section."},{"key":"1461_CR27","unstructured":"FDA. Golimumab. Feb 2021 [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/125433s032lbl.pdf."},{"key":"1461_CR28","unstructured":"EMA. Certolizumab Pegol. Apr 2023 [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/cimzia-0."},{"key":"1461_CR29","unstructured":"FDA. Certolizumab Pegol. Dec 2022 [18.09.23]; Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/125160s305lbl.pdf."},{"key":"1461_CR30","unstructured":"EMA. Etanercept. Aug 2023 [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/enbrel."},{"key":"1461_CR31","unstructured":"FDA. Etanercept. Jun 2023 [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/103795s5594lbl.pdf."},{"key":"1461_CR32","unstructured":"EMA. Anakinra. Jul 2023 [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/kineret#product-information-section."},{"key":"1461_CR33","unstructured":"FDA. Anakinra. Dec 2020 [01.12.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/103950s5189lbl.pdf."},{"key":"1461_CR34","unstructured":"EMA. Canakinumab. Aug 2023 [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/ilaris#product-information-section."},{"key":"1461_CR35","unstructured":"FDA. Canakinumab. Aug 2023. [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/125319s107lbl.pdf."},{"key":"1461_CR36","unstructured":"EMA. Abatacept. Jun 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/orencia."},{"key":"1461_CR37","unstructured":"FDA. Abatacept. Dec 2021. [01.12.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/125118s240lbl.pdf."},{"key":"1461_CR38","unstructured":"EMA. Ustekinumab. Jul 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/stelara#product-information-section."},{"key":"1461_CR39","unstructured":"FDA. Ustekinumab. Jul 2022. [01.12.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/125261s161lbl.pdf."},{"key":"1461_CR40","unstructured":"EMA. Tocilizumab. Apr 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/roactemra#product-information-section."},{"key":"1461_CR41","unstructured":"FDA. Tocilizumab. Dec 2023. [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/125276s138lbl.pdf."},{"key":"1461_CR42","unstructured":"EMA. Sarilumab. Jul 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/kevzara#product-information-section."},{"key":"1461_CR43","unstructured":"FDA. Sarilumab. Feb 2023. [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/761037s013lbl.pdf."},{"key":"1461_CR44","unstructured":"EMA. Tofacitinib. Jun 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/xeljanz."},{"key":"1461_CR45","unstructured":"FDA. Tofacitinib. Dec 2021. [01.12.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/203214s028,208246s013,213082s003lbl.pdf."},{"key":"1461_CR46","unstructured":"EMA. Baricitinib. Aug 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/olumiant."},{"key":"1461_CR47","unstructured":"FDA. Baricitinib. Jun 2022. [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/207924s007lbl.pdf."},{"key":"1461_CR48","unstructured":"EMA. Filgotinib. May 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/jyseleca."},{"key":"1461_CR49","unstructured":"EMA. Upadacitinib. Aug 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/rinvoq."},{"key":"1461_CR50","unstructured":"FDA. Upadacitinib. Jun 2023. [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/211675s017lbl.pdf."},{"key":"1461_CR51","unstructured":"EMA. JAK. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/janus-kinase-inhibitors-jaki."},{"key":"1461_CR52","unstructured":"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."},{"key":"1461_CR53","unstructured":"EMA. Apremilast. Jul 2022. [01.12.22]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/otezla."},{"key":"1461_CR54","unstructured":"FDA. Apremilast. Jul 2023. [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/205437s012lbl.pdf."},{"key":"1461_CR55","unstructured":"EMA. Secukinumab. Aug 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/cosentyx#product-information-section."},{"key":"1461_CR56","unstructured":"FDA. Secukinumab. Jul 2023. [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/125504Orig1s054s055s067lbl.pdf."},{"key":"1461_CR57","unstructured":"EMA. Ixekizumab. Feb 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/taltz."},{"key":"1461_CR58","unstructured":"FDA. Ixekizumab. Jul 2022. [18.09.23]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/125521s024lbl.pdf."},{"key":"1461_CR59","unstructured":"EMA. Bimekizumab. Jun 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/bimzelx."},{"key":"1461_CR60","unstructured":"EMA. Guselkumab. Jul 2022. [01.12.22]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/tremfya."},{"key":"1461_CR61","unstructured":"FDA. Guselkumab. Jul 2020. [01.12.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761061s007lbl.pdf."},{"key":"1461_CR62","unstructured":"EMA. Risankizumab. Sep 2023. [18.09.23]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/skyrizi."},{"key":"1461_CR63","unstructured":"FDA. Risankizumab. Jan 2022. [01.12.22]. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761105s014lbl.pdf."},{"issue":"1","key":"1461_CR64","first-page":"e14","volume":"8","author":"J Lexchin","year":"2014","unstructured":"Lexchin J. How safe are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009. Open Med. 2014;8(1):e14\u20139.","journal-title":"Open Med"},{"key":"1461_CR65","doi-asserted-by":"crossref","unstructured":"Riley TR, George MD. Risk for infections with glucocorticoids and DMARDs in patients with rheumatoid arthritis. RMD Open. 2021;7(1).","DOI":"10.1136\/rmdopen-2020-001235"},{"key":"1461_CR66","doi-asserted-by":"crossref","unstructured":"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).","DOI":"10.1136\/rmdopen-2022-002621"},{"issue":"4","key":"1461_CR67","doi-asserted-by":"crossref","first-page":"316","DOI":"10.1056\/NEJMoa2109927","volume":"386","author":"SR Ytterberg","year":"2022","unstructured":"Ytterberg SR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386(4):316\u201326.","journal-title":"N Engl J Med"},{"issue":"2","key":"1461_CR68","doi-asserted-by":"crossref","first-page":"285","DOI":"10.1136\/annrheumdis-2019-216102","volume":"79","author":"X Li","year":"2020","unstructured":"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\u201391.","journal-title":"Ann Rheum Dis"},{"key":"1461_CR69","doi-asserted-by":"crossref","first-page":"1759720x2093011","DOI":"10.1177\/1759720X20930116","volume":"12","author":"G Evangelatos","year":"2020","unstructured":"Evangelatos G, et al. Tuberculosis and targeted synthetic or biologic DMARDs, beyond tumor necrosis factor inhibitors. Ther Adv Musculoskelet Dis. 2020;12:1759720x20930116.","journal-title":"Ther Adv Musculoskelet Dis"},{"issue":"1","key":"1461_CR70","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1136\/annrheumdis-2021-220651","volume":"81","author":"I Redeker","year":"2022","unstructured":"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\u20137.","journal-title":"Ann Rheum Dis"},{"issue":"4","key":"1461_CR71","doi-asserted-by":"crossref","first-page":"359","DOI":"10.1080\/09546634.2019.1597246","volume":"31","author":"KK Wu","year":"2020","unstructured":"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\u201365.","journal-title":"J Dermatolog Treat"},{"key":"1461_CR72","volume":"13","author":"A Vassilopoulos","year":"2022","unstructured":"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.","journal-title":"Front Pharmacol"},{"issue":"1","key":"1461_CR73","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1016\/j.jaad.2019.03.017","volume":"81","author":"E Baumrin","year":"2019","unstructured":"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\u201310.","journal-title":"J Am Acad Dermatol"},{"issue":"5","key":"1461_CR74","doi-asserted-by":"crossref","first-page":"724","DOI":"10.1002\/acr.23346","volume":"70","author":"TC Lin","year":"2018","unstructured":"Lin TC, et al. Risk of hepatitis B virus reactivation in patients with inflammatory arthritis receiving disease-modifying antirheumatic drugs: a systematic review and meta-analysis. Arthritis Care Res (Hoboken). 2018;70(5):724\u201331.","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"1461_CR75","doi-asserted-by":"crossref","unstructured":"Fragoulis GE, et al. 2022 EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in adults with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2022.","DOI":"10.1136\/rmdopen-2022-002726"},{"key":"1461_CR76","volume":"13","author":"L Davidson","year":"2022","unstructured":"Davidson L, et al. Risk of candidiasis associated with interleukin-17 inhibitors: a real-world observational study of multiple independent sources. Lancet Reg Health Eur. 2022;13: 100266.","journal-title":"Lancet Reg Health Eur"},{"issue":"1","key":"1461_CR77","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1136\/annrheumdis-2019-215882","volume":"79","author":"V Furer","year":"2020","unstructured":"Furer V, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020;79(1):39\u201352.","journal-title":"Ann Rheum Dis"},{"key":"1461_CR78","unstructured":"ACR. Vaccination guideline. 2024."},{"issue":"10","key":"1461_CR79","doi-asserted-by":"crossref","first-page":"1255","DOI":"10.1136\/annrheumdis-2021-221244","volume":"80","author":"MA Friedman","year":"2021","unstructured":"Friedman MA, Curtis JR, Winthrop KL. Impact of disease-modifying antirheumatic drugs on vaccine immunogenicity in patients with inflammatory rheumatic and musculoskeletal diseases. Ann Rheum Dis. 2021;80(10):1255\u201365.","journal-title":"Ann Rheum Dis"},{"key":"1461_CR80","unstructured":"EULAR, OP0045. EULAR points to consider on the initiation of targeted therapies in patients with inflammatory arthritides and a history of cancer. 2023."},{"issue":"3","key":"1461_CR81","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1002\/acr.23865","volume":"72","author":"MA Lopez-Olivo","year":"2020","unstructured":"Lopez-Olivo MA, et al. Systematic review of recommendations on the use of disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and cancer. Arthritis Care Res (Hoboken). 2020;72(3):309\u201318.","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"1461_CR82","doi-asserted-by":"crossref","unstructured":"Wetzman A, et al. Risk of cancer after initiation of targeted therapies in patients with rheumatoid arthritis and a prior cancer: systematic review with meta-analysis. Arthritis Care Res (Hoboken). 2021.","DOI":"10.1002\/acr.24784"},{"issue":"5","key":"1461_CR83","doi-asserted-by":"crossref","first-page":"1810","DOI":"10.1093\/rheumatology\/keab570","volume":"61","author":"V Huss","year":"2022","unstructured":"Huss V, et al. Short- and longer-term cancer risks with biologic and targeted synthetic disease-modifying antirheumatic drugs as used against rheumatoid arthritis in clinical practice. Rheumatology (Oxford). 2022;61(5):1810\u20138.","journal-title":"Rheumatology (Oxford)"},{"key":"1461_CR84","doi-asserted-by":"crossref","unstructured":"Kragstrup TW, et al. Waiting for JAK inhibitor safety data. RMD Open. 2022;8(1).","DOI":"10.1136\/rmdopen-2022-002236"},{"issue":"8","key":"1461_CR85","doi-asserted-by":"crossref","first-page":"937","DOI":"10.1001\/jamaneurol.2020.1162","volume":"77","author":"A Kunchok","year":"2020","unstructured":"Kunchok A, et al. Association between tumor necrosis factor inhibitor exposure and inflammatory central nervous system events. JAMA Neurol. 2020;77(8):937\u201346.","journal-title":"JAMA Neurol"},{"issue":"2","key":"1461_CR86","doi-asserted-by":"crossref","first-page":"220","DOI":"10.2174\/18756190MTA2cMjAm1","volume":"19","author":"I Lotan","year":"2021","unstructured":"Lotan I, McGowan R, Levy M. Anti-IL-6 therapies for neuromyelitis Optica spectrum disorders: a systematic review of safety and efficacy. Curr Neuropharmacol. 2021;19(2):220\u201332.","journal-title":"Curr Neuropharmacol"},{"issue":"5","key":"1461_CR87","doi-asserted-by":"crossref","first-page":"686","DOI":"10.1177\/1352458516662727","volume":"23","author":"SJ Khoury","year":"2017","unstructured":"Khoury SJ, et al. ACCLAIM: a randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis. Mult Scler. 2017;23(5):686\u201395.","journal-title":"Mult Scler"},{"key":"1461_CR88","doi-asserted-by":"crossref","unstructured":"Yang V, et al. Managing cardiovascular and cancer risk associated with JAK inhibitors. Drug Saf. 2023.","DOI":"10.1007\/s40264-023-01333-0"},{"issue":"6","key":"1461_CR89","doi-asserted-by":"crossref","first-page":"789","DOI":"10.1136\/annrheumdis-2021-221996","volume":"81","author":"B Delcoigne","year":"2022","unstructured":"Delcoigne B, et al. Short-term, intermediate-term and long-term risks of acute coronary syndrome in cohorts of patients with RA starting biologic DMARDs: results from four Nordic countries. Ann Rheum Dis. 2022;81(6):789\u201397.","journal-title":"Ann Rheum Dis"},{"issue":"1","key":"1461_CR90","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1002\/art.41095","volume":"72","author":"JT Giles","year":"2020","unstructured":"Giles JT, et al. Cardiovascular safety of tocilizumab versus etanercept in rheumatoid arthritis: a randomized controlled trial. Arthritis Rheumatol. 2020;72(1):31\u201340.","journal-title":"Arthritis Rheumatol"},{"issue":"2","key":"1461_CR91","doi-asserted-by":"crossref","first-page":"325","DOI":"10.1136\/ard.2009.113696","volume":"69","author":"MJ Peters","year":"2010","unstructured":"Peters MJ, et al. EULAR evidence-based recommendations for cardiovascular risk management in patients with rheumatoid arthritis and other forms of inflammatory arthritis. Ann Rheum Dis. 2010;69(2):325\u201331.","journal-title":"Ann Rheum Dis"},{"issue":"1","key":"1461_CR92","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1136\/annrheumdis-2020-218398","volume":"80","author":"P Nash","year":"2021","unstructured":"Nash P, et al. Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement. Ann Rheum Dis. 2021;80(1):71\u201387.","journal-title":"Ann Rheum Dis"},{"issue":"4","key":"1461_CR93","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1007\/s00281-017-0632-2","volume":"39","author":"K Lauper","year":"2017","unstructured":"Lauper K, Gabay C. Cardiovascular risk in patients with rheumatoid arthritis. Semin Immunopathol. 2017;39(4):447\u201359.","journal-title":"Semin Immunopathol"},{"issue":"6","key":"1461_CR94","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1007\/s40264-021-01065-z","volume":"44","author":"R Bissonnette","year":"2021","unstructured":"Bissonnette R, et al. Signal detection and methodological limitations in a Real-World Registry: learnings from the evaluation of long-term safety analyses in PSOLAR. Drug Saf. 2021;44(6):699\u2013709.","journal-title":"Drug Saf"},{"key":"1461_CR95","doi-asserted-by":"crossref","unstructured":"Kotyla PJ. Bimodal function of anti-TNF treatment: shall we be concerned about anti-TNF treatment in patients with rheumatoid arthritis and heart failure? Int J Mol Sci. 2018;19(6).","DOI":"10.3390\/ijms19061739"},{"issue":"13","key":"1461_CR96","doi-asserted-by":"crossref","first-page":"1594","DOI":"10.1161\/01.CIR.0000124490.27666.B2","volume":"109","author":"DL Mann","year":"2004","unstructured":"Mann DL, et al. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL). Circulation. 2004;109(13):1594\u2013602.","journal-title":"Circulation"},{"issue":"3","key":"1461_CR97","doi-asserted-by":"crossref","first-page":"667","DOI":"10.1002\/art.23281","volume":"58","author":"J Listing","year":"2008","unstructured":"Listing J, et al. Does tumor necrosis factor alpha inhibition promote or prevent heart failure in patients with rheumatoid arthritis? Arthritis Rheum. 2008;58(3):667\u201377.","journal-title":"Arthritis Rheum"},{"issue":"4","key":"1461_CR98","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1093\/ehjcr\/ytz227","volume":"3","author":"A Aimo","year":"2019","unstructured":"Aimo A, et al. Rituximab as a novel treatment for heart failure: evidence from a case series. Eur Heart J Case Rep. 2019;3(4):1\u20132.","journal-title":"Eur Heart J Case Rep"},{"key":"1461_CR99","doi-asserted-by":"crossref","unstructured":"Molander V, et al. Venous thromboembolism with JAK inhibitors and other immune-modulatory drugs: a Swedish comparative safety study among patients with rheumatoid arthritis. Ann Rheum Dis. 2022.","DOI":"10.1136\/ard-2022-223050"},{"issue":"9","key":"1461_CR100","doi-asserted-by":"crossref","first-page":"1628","DOI":"10.1093\/rheumatology\/kex221","volume":"56","author":"F Anger","year":"2017","unstructured":"Anger F, et al. Toxic drug-induced liver failure during therapy of rheumatoid arthritis with tocilizumab subcutaneously: a case report. Rheumatology (Oxford). 2017;56(9):1628\u20139.","journal-title":"Rheumatology (Oxford)"},{"issue":"4","key":"1461_CR101","doi-asserted-by":"crossref","first-page":"458","DOI":"10.1016\/j.semarthrit.2013.08.001","volume":"43","author":"G Navarro","year":"2014","unstructured":"Navarro G, et al. Tocilizumab in rheumatoid arthritis: a meta-analysis of efficacy and selected clinical conundrums. Semin Arthritis Rheum. 2014;43(4):458\u201369.","journal-title":"Semin Arthritis Rheum"},{"issue":"3","key":"1461_CR102","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1007\/s40264-015-0366-9","volume":"39","author":"JB French","year":"2016","unstructured":"French JB, et al. Hepatotoxicity associated with the use of anti-TNF-\u03b1 agents. Drug Saf. 2016;39(3):199\u2013208.","journal-title":"Drug Saf"},{"issue":"9","key":"1461_CR103","doi-asserted-by":"crossref","first-page":"1132","DOI":"10.1136\/annrheumdis-2020-217927","volume":"79","author":"M Fauny","year":"2020","unstructured":"Fauny M, et al. Paradoxical gastrointestinal effects of interleukin-17 blockers. Ann Rheum Dis. 2020;79(9):1132\u20138.","journal-title":"Ann Rheum Dis"},{"issue":"5","key":"1461_CR104","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0233781","volume":"15","author":"J Burisch","year":"2020","unstructured":"Burisch J, et al. Risk for development of inflammatory bowel disease under inhibition of interleukin 17: a systematic review and meta-analysis. PLoS ONE. 2020;15(5): e0233781.","journal-title":"PLoS ONE"},{"issue":"3","key":"1461_CR105","doi-asserted-by":"crossref","first-page":"953","DOI":"10.1093\/rheumatology\/keab438","volume":"61","author":"C Rempenault","year":"2022","unstructured":"Rempenault C, et al. Risk of diverticulitis and gastrointestinal perforation in rheumatoid arthritis treated with tocilizumab compared to rituximab or abatacept. Rheumatology (Oxford). 2022;61(3):953\u201362.","journal-title":"Rheumatology (Oxford)"},{"issue":"Suppl 1","key":"1461_CR106","doi-asserted-by":"crossref","first-page":"i34","DOI":"10.1093\/rheumatology\/key287","volume":"58","author":"M Harigai","year":"2019","unstructured":"Harigai M. Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019;58(Suppl 1):i34\u201342.","journal-title":"Rheumatology (Oxford)"},{"key":"1461_CR107","unstructured":"Torre Alonso JC, et al. Expert recommendations for the use of apremilast in psoriatic arthritis. Reumatol Clin (Engl Ed). 2022."},{"issue":"1","key":"1461_CR108","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1186\/s42358-022-00249-0","volume":"62","author":"M de Souza","year":"2022","unstructured":"de Souza M, et al. Effect of biological disease-modifying antirheumatic drugs on body composition in patients with rheumatoid arthritis: a systematic review and meta-analysis. Adv Rheumatol. 2022;62(1):16.","journal-title":"Adv Rheumatol"},{"issue":"8","key":"1461_CR109","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1007\/s40264-020-00938-z","volume":"43","author":"V Veeravalli","year":"2020","unstructured":"Veeravalli V, et al. Critical assessment of pharmacokinetic drug-drug interaction potential of tofacitinib, baricitinib and upadacitinib, the three approved janus kinase inhibitors for rheumatoid arthritis treatment. Drug Saf. 2020;43(8):711\u201325.","journal-title":"Drug Saf"},{"issue":"6","key":"1461_CR110","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1002\/cpdd.256","volume":"5","author":"Y Liu","year":"2016","unstructured":"Liu Y, et al. Impact of renal impairment on the pharmacokinetics of apremilast and metabolite M12. Clin Pharmacol Drug Dev. 2016;5(6):469\u201379.","journal-title":"Clin Pharmacol Drug Dev"},{"issue":"1","key":"1461_CR111","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/S0009-9236(03)00094-8","volume":"74","author":"BB Yang","year":"2003","unstructured":"Yang BB, Baughman S, Sullivan JT. Pharmacokinetics of anakinra in subjects with different levels of renal function. Clin Pharmacol Ther. 2003;74(1):85\u201394.","journal-title":"Clin Pharmacol Ther"},{"key":"1461_CR112","volume":"371","author":"ML Hetland","year":"2020","unstructured":"Hetland ML, et al. Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial. BMJ. 2020;371: m4328.","journal-title":"BMJ"},{"issue":"6","key":"1461_CR113","doi-asserted-by":"crossref","first-page":"844","DOI":"10.3899\/jrheum.150457","volume":"44","author":"F Espinoza","year":"2017","unstructured":"Espinoza F, Le Blay P, Combe B. Biologic disease-modifying antirheumatic drug (bDMARD)-induced neutropenia: a registry from a retrospective cohort of patients with rheumatic diseases treated with 3 classes of intravenous bDMARD. J Rheumatol. 2017;44(6):844\u20139.","journal-title":"J Rheumatol"},{"issue":"1","key":"1461_CR114","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1002\/art.38894","volume":"67","author":"A Souto","year":"2015","unstructured":"Souto A, et al. Lipid profile changes in patients with chronic inflammatory arthritis treated with biologic agents and tofacitinib in randomized clinical trials: a systematic review and meta-analysis. Arthritis Rheumatol. 2015;67(1):117\u201327.","journal-title":"Arthritis Rheumatol"},{"key":"1461_CR115","unstructured":"Astra Zenica. Roflumilast. Available from: https:\/\/www.medicines.org.uk\/emc\/files\/pil.9162.pdf."},{"issue":"2","key":"1461_CR116","doi-asserted-by":"crossref","first-page":"335","DOI":"10.1038\/mp.2016.167","volume":"23","author":"N Kappelmann","year":"2018","unstructured":"Kappelmann N, et al. Antidepressant activity of anti-cytokine treatment: a systematic review and meta-analysis of clinical trials of chronic inflammatory conditions. Mol Psychiatry. 2018;23(2):335\u201343.","journal-title":"Mol Psychiatry"},{"issue":"8","key":"1461_CR117","doi-asserted-by":"crossref","first-page":"459","DOI":"10.1002\/acr2.11156","volume":"2","author":"PJ Mease","year":"2020","unstructured":"Mease PJ, et al. Long-Term safety and tolerability of apremilast versus placebo in psoriatic arthritis: a pooled safety analysis of three phase III, randomized controlled trials. ACR Open Rheumatol. 2020;2(8):459\u201370.","journal-title":"ACR Open Rheumatol"},{"key":"1461_CR118","unstructured":"EMA. Brodalumab. Jul 2020. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/kyntheum#product-information-section."},{"issue":"1","key":"1461_CR119","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1016\/j.jaad.2017.08.024","volume":"78","author":"MG Lebwohl","year":"2018","unstructured":"Lebwohl MG, et al. Psychiatric adverse events during treatment with brodalumab: analysis of psoriasis clinical trials. J Am Acad Dermatol. 2018;78(1):81-89.e5.","journal-title":"J Am Acad Dermatol"},{"issue":"2","key":"1461_CR120","doi-asserted-by":"crossref","first-page":"e3","DOI":"10.1093\/rheumatology\/key208","volume":"58","author":"CR Holroyd","year":"2019","unstructured":"Holroyd CR, et al. The British Society for Rheumatology biologic DMARD safety guidelines in inflammatory arthritis. Rheumatology (Oxford). 2019;58(2):e3\u201342.","journal-title":"Rheumatology (Oxford)"},{"key":"1461_CR121","unstructured":"EMA. Section 4.4: special warnings and precautions for use. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/presentation\/presentation-section-44-special-warnings-precautions-use_en.pdf."},{"key":"1461_CR122","unstructured":"Lis Y. A comparison of US Food and Drug Administration and European Medicines Agency Regulations for pharmaceutical risk management: report of the International Society for Pharmacoeconomic and Outcomes Research Risk Management Working Group. ISPOR Connections; 2011."},{"issue":"8","key":"1461_CR123","doi-asserted-by":"crossref","first-page":"1108","DOI":"10.1016\/j.jval.2012.06.019","volume":"15","author":"Y Lis","year":"2012","unstructured":"Lis Y, et al. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group. Value Health. 2012;15(8):1108\u201318.","journal-title":"Value Health"},{"issue":"9","key":"1461_CR124","doi-asserted-by":"crossref","first-page":"1673","DOI":"10.1016\/j.cgh.2018.10.032","volume":"17","author":"W Reinisch","year":"2019","unstructured":"Reinisch W, et al. Comparison of the EMA and FDA guidelines on ulcerative colitis drug development. Clin Gastroenterol Hepatol. 2019;17(9):1673-1679.e1.","journal-title":"Clin Gastroenterol Hepatol"},{"key":"1461_CR125","unstructured":"WHO. WHO surgical checklist. Available from: WHO Surgical Safety Checklist."}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-024-01461-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-024-01461-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-024-01461-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T23:08:23Z","timestamp":1729120103000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-024-01461-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,16]]},"references-count":125,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["1461"],"URL":"https:\/\/doi.org\/10.1007\/s40264-024-01461-1","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,16]]},"assertion":[{"value":"12 June 2024","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 July 2024","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"T.W.K. was supported by a grant from Independent Research Fund Denmark (9039-00015B). The Kragstrup lab has recieved funding from Gigtforeningen, Axel Muusfeldts Fond, Beckett Fonden, Bjarne Jensens Fond, Danielsens Fond, H\u00f8rslev Fonden, Kong Christian den Tiendes Fond, Fonden til L\u00e6gevidenskabens Fremme, Direkt\u00f8r Michael Hermann Nielsens Mindelegat, Civilingeni\u00f8r Frode V.\u00a0Nyegaard\u00a0og Hustru's\u00a0Fond, and Oda og Hans Svenningsens Fond. This study did not receive direct funding from any of these funding sources.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"T.W.K. has engaged in educational activities receiving speaking fees from Pfizer, Bristol-Myers Squibb, Eli Lilly, Novartis, and UCB and has been consultant and advisor for Bristol-Myers Squibb, Lilly, and Gilead. T.W.K. is co-owner and clinical developer in Aptol Pharma. D.F.L.L. is a member of the Drug Utilisation Subcommittee of the Pharmaceutical Benefits Advisory Committee of the Australian Government. A.S. received speaker\/consulting fees from UCB, AbbVie, Novartis, and Lilly. K.L.received speaker\/consulting fees from Pfizer, Celltrion, AbbVie, Eli Lilly, Viatris, and Galapagos paid to the institution. B.G. received research grants (paid to institution) from Pfizer, AbbVie, and Sandoz. R.O. has engaged in educational activities receiving speaking fees from Janssen, Pfizer, Bristol-Myers Squibb, Eli Lilly, Novartis, and UCB and has been consultant and advisor for Bristol-Myers Squibb, Pfizer, Novartis, Lilly, and Gilead. E.N. has received speaker honoraria\/participated in advisory boards and\/or received research grants from: UCB, Pfizer, Gilead, Galapagos, AbbVie, Eli Lilly, Fresenius, and Pfizer. M.K. has contributed to consultancy\/advisory boards by Pfizer, Galapagos, CHDR, Novartis, UCB, GSK, and IMI-APPROACH (paid to institution) and received honoraria for presentations from Galapagos and Jansen (paid to institution). L.S., E.I., I.G., and M.K. have no disclosures. D.F.L.L. is an editorial board member of Drug Safety. D.F.L.L. was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All data is available via references or on the relevant websites","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not applicable","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"L.S. and T.W.K. established the project. All authors were involved in the conception and scope of the manuscript. L.S. and E.I. extracted data from the FDA and EMA documents and wrote the result section. L.S. and T.W.K. made the first draft of the manuscript. All authors were involved in analysis and interpretation of data and critically revising the manuscript for intellectual content. All authors approved the final version of the manuscript and agree to be accountable for the work.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"Not applicable","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}}]}}