{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T20:39:14Z","timestamp":1793047154904,"version":"4.5.0"},"reference-count":23,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2023,7,14]],"date-time":"2023-07-14T00:00:00Z","timestamp":1689292800000},"content-version":"unspecified","delay-in-days":13,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene"},{"name":"Amgen, Arena, Astellas"},{"DOI":"10.13039\/100011110","name":"UCB","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011110","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Leo"},{"name":"Janssen, Lilly"},{"DOI":"10.13039\/100006436","name":"Celgene","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006436","id-type":"DOI","asserted-by":"publisher"}]},{"name":"GSK, Janssen, Lilly, Leo, Novartis, Pfizer, Sanofi, Sun Pharma, UCB"},{"name":"The BAD"},{"DOI":"10.13039\/501100000545","name":"British Association of Dermatologists","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000545","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000770","name":"University of Manchester","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000770","id-type":"DOI","asserted-by":"publisher"}]},{"name":"The British Association of Dermatologists"},{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100014653","name":"NIHR Manchester Biomedical Research Centre","doi-asserted-by":"crossref","award":["NIHR203308"],"award-info":[{"award-number":["NIHR203308"]}],"id":[{"id":"10.13039\/100014653","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100013126","name":"Psoriasis Association","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013126","id-type":"DOI","asserted-by":"publisher"}]},{"name":"BAD"},{"DOI":"10.13039\/100015661","name":"UCB Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015661","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011218","name":"Sandoz","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011218","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Amgen, Celgene, Janssen, LEO Pharma, Lilly, Novartis, Samsung"},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,7,3]]},"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Psoriasis is a chronic inflammatory skin disease. Adalimumab is an effective but previously expensive biological treatment for psoriasis. The introduction of biosimilars following the patent expiry of the originator adalimumab Humira has reduced the unit cost of treatment. However, the long-term effectiveness and safety of adalimumab biosimilars for treating psoriasis in real-world settings are uncertain and may be a barrier to widespread usage.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This study aims to compare the drug survival and safety of adalimumab biosimilars to adalimumab originator for the treatment of psoriasis. We will use both routinely collected healthcare databases and dedicated pharmacovigilance registries from the PsoNet initiative, including data from the UK, France and Spain. We will conduct a cohort study using a prevalent new user design. We will match patients on previous adalimumab exposure time to create two equal-sized cohorts of biosimilar and originator users. The coprimary outcomes are drug survival, defined by the time from cohort entry to discontinuation of the drug of interest; and risk of serious adverse events, defined by adverse events leading to hospitalisation or death. Cox proportional hazards models will be fitted to calculate HRs as the effect estimate for the outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The participating registries agree with the Declaration of Helsinki and received approval from local ethics committees. The results of the study will be published in scientific journals and presented at international dermatology conferences by the end of 2023.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-075197","type":"journal-article","created":{"date-parts":[[2023,7,14]],"date-time":"2023-07-14T11:19:53Z","timestamp":1689333593000},"page":"e075197","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Drug survival and safety of biosimilars and originator adalimumab in the treatment of psoriasis: a multinational cohort study"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8916-9093","authenticated-orcid":false,"given":"Duc Binh","family":"Phan","sequence":"first","affiliation":[{"name":"Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugo","family":"Jourdain","sequence":"additional","affiliation":[{"name":"EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), Saint-Denis, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Gonz\u00e1lez-Quesada","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario de Gran Canaria Dr Negr\u00edn, Las Palmas de Gran Canaria, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8393-4217","authenticated-orcid":false,"given":"Mahmoud","family":"Zureik","sequence":"additional","affiliation":[{"name":"EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), Saint-Denis, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raquel","family":"Rivera-D\u00edaz","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario 12 de Octubre, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Sahuquillo-Torralba","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario y Politecnico La Fe, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel Angel","family":"Descalzo-Gallego","sequence":"additional","affiliation":[{"name":", Research Unit, Fundacion Piel Sana AEDV, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Lunt","sequence":"additional","affiliation":[{"name":"Versus Arthritis Epidemiology Unit, The University of Manchester, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ignacio","family":"Garcia-Doval","sequence":"additional","affiliation":[{"name":", Research Unit, Fundacion Piel Sana AEDV, Madrid, Spain"},{"name":"Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilie","family":"Sbidian","sequence":"additional","affiliation":[{"name":"EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), Saint-Denis, France"},{"name":"EpiDermE Epidemiology in Dermatology and Evaluation of Therapeutics, Assistance Publique-H\u00f4pitaux de Paris (AP-HP), Paris Est Cr\u00e9teil University, Cr\u00e9teil, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R B","family":"Warren","sequence":"additional","affiliation":[{"name":"Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1831-074X","authenticated-orcid":false,"given":"Zenas Z N","family":"Yiu","sequence":"additional","affiliation":[{"name":"Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,7,14]]},"reference":[{"key":"2025121512330850000_13.7.e075197.1","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m1590","article-title":"National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling 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A retrospective cohort study","volume":"37","author":"Grau-P\u00e9rez","year":"2023","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2025121512330850000_13.7.e075197.10","doi-asserted-by":"crossref","DOI":"10.3390\/biomedicines10102522","article-title":"Adalimumab originator vs. biosimilar in hidradenitis suppurativa: a multicentric retrospective study","volume":"10","author":"Burlando","year":"2022","journal-title":"Biomedicines"},{"key":"2025121512330850000_13.7.e075197.11","doi-asserted-by":"crossref","unstructured":"Phan DB , Elyoussfi S , Stevenson M , et al . Biosimilars for the treatment of psoriasis: a systematic review of clinical trials and observational studies. 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