{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T06:48:46Z","timestamp":1783406926738,"version":"3.54.6"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2023,10,17]],"date-time":"2023-10-17T00:00:00Z","timestamp":1697500800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Fundaci\u00f3n Piel Sana of the Academia Espa\u00f1ola de Dermatolog\u00eda y Venereolog\u00eda"},{"name":"Spanish Medicines and Health Products Agency"},{"DOI":"10.13039\/501100007761","name":"Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007761","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Abbott\/AbbVie"},{"DOI":"10.13039\/501100022606","name":"Almirall","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100022606","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005614","name":"Biogen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005614","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Bristol Myers Squibb"},{"DOI":"10.13039\/100005565","name":"Janssen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005565","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006978","name":"UCB","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006978","id-type":"DOI","asserted-by":"publisher"}]},{"name":"LeoPharma"},{"DOI":"10.13039\/100008792","name":"Novartis Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008792","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004312","name":"Lilly","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007054","name":"MSD","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007054","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"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,2,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Safety is an important consideration in decisions on treatment for patients with moderate-to-severe psoriasis and the study of drug safety is the main purpose of the BIOBADADERM registry. The combination of a biologic agent and a conventional systemic drug [generally methotrexate (MTX)] is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in the treatment of psoriasis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate-to-severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy using tumour necrosis factor (TNF), interleukin (IL)-17 and IL-23 inhibitors with the use of the same drugs in combination with MTX.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Using data from the BIOBADADERM registry, we compared biologic monotherapies with therapies that were combined with MTX. We estimated adjusted incidence rate ratios (aIRR) using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections and other AEs by system organ class.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We analysed data from 2829 patients and 5441 treatment cycles, a total of 12 853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a\u00a0TNF inhibitor combined with MTX was associated with an increase in the incidence of gastrointestinal AEs (aIRR 2.50, 95% CI 1.57\u20133.98; P &amp;lt; 0.002).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The risk of AEs and SAEs was not significantly increased in patients with moderate-to-severe psoriasis receiving different classes of biologic drugs combined with MTX compared with those on biologic monotherapy.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljad382","type":"journal-article","created":{"date-parts":[[2023,10,17]],"date-time":"2023-10-17T19:40:13Z","timestamp":1697571613000},"page":"355-363","source":"Crossref","is-referenced-by-count":9,"title":["Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry"],"prefix":"10.1093","volume":"190","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8373-4303","authenticated-orcid":false,"given":"Juan Jos\u00e9","family":"Lluch-Galcer\u00e1","sequence":"first","affiliation":[{"name":"Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Aut\u00f2noma de Barcelona, IGTP. Badalona, Barcelona,\u00a0Spain"},{"name":"Departament de Medicina, Universitat Autonoma de Barcelona (UAB) , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4266-0771","authenticated-orcid":false,"given":"Jose Manuel","family":"Carrascosa","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Aut\u00f2noma de Barcelona, IGTP. Badalona, Barcelona,\u00a0Spain"},{"name":"Departament de Medicina, Universitat Autonoma de Barcelona (UAB) , Barcelona , Spain"}],"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 , Islas Canarias , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4604-0724","authenticated-orcid":false,"given":"Raquel","family":"Rivera-D\u00edaz","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario 12 de Octubre, Universidad Complutense , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Sahuquillo-Torralba","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario y Polit\u00e9cnico La Fe , Valencia , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar","family":"Llamas-Velasco","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigaci\u00f3n Sanitaria de La Princesa (IIS-LP) , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco\u00a0Jos\u00e9","family":"G\u00f3mez-Garc\u00eda","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario Reina Sof\u00eda , C\u00f3rdoba , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"Herrera-Acosta","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario Virgen de la Victoria , M\u00e1laga , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"de la Cueva","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario Infanta Leonor , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ofelia","family":"Baniandr\u00e9s-Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"Department of Dermatology, CEIMI, Hospital General Universitario Gregorio Mara\u00f1\u00f3n , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Luis","family":"Lopez-Estebaranz","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario Fundaci\u00f3n Alcorc\u00f3n , Alcorc\u00f3n, Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"Belinch\u00f3n","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital General Universitario de Alicante-ISABIAL-UMH , Alicante , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Ferr\u00e1n","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital del Mar, Parc de Salut Mar , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Almudena","family":"Mateu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario Doctor Peset , Valencia , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lourdes","family":"Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Virgen del Roc\u00edo , Seville , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9265-1019","authenticated-orcid":false,"given":"Josep","family":"Riera-Monroig","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Clinic de Barcelona , UB, Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M Teresa","family":"Abalde-Pintos","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Complejo Hospitalario Universitario de Pontevedra , Pontevedra , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregorio","family":"Carretero","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario de Gran Canaria Dr. Negr\u00edn, Las Palmas de Gran Canaria , Islas Canarias , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Garc\u00eda-Donoso","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario 12 de Octubre, Universidad Complutense , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Conrad","family":"Pujol-Marco","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario y Polit\u00e9cnico La Fe , Valencia , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Del Alc\u00e1zar","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Aut\u00f2noma de Barcelona, IGTP. Badalona, Barcelona,\u00a0Spain"},{"name":"Departament de Medicina, Universitat Autonoma de Barcelona (UAB) , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Santamar\u00eda-Dom\u00ednguez","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigaci\u00f3n Sanitaria de La Princesa (IIS-LP) , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge Alonso","family":"Su\u00e1rez-P\u00e9rez","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario Virgen de la Victoria , M\u00e1laga , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lula Mar\u00eda","family":"Nieto-Benito","sequence":"additional","affiliation":[{"name":"Department of Dermatology, CEIMI, Hospital General Universitario Gregorio Mara\u00f1\u00f3n , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana\u00a0Patricia","family":"Ruiz-Genao","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital Universitario Fundaci\u00f3n Alcorc\u00f3n , Alcorc\u00f3n, Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Salgado-Boquete","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Complejo Hospitalario Universitario de Pontevedra , Pontevedra , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel \u00c1ngel","family":"Descalzo","sequence":"additional","affiliation":[{"name":"Research Unit, Spanish Academy of Dermatology and Venereology , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ignacio","family":"Garc\u00eda-Doval","sequence":"additional","affiliation":[{"name":"Research Unit, Spanish Academy of Dermatology and Venereology , Madrid , Spain"},{"name":"Department of Dermatology, Complexo Hospitalario Universitario de Vigo , Vigo, Pontevedra , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,10,17]]},"reference":[{"key":"2024090210033172500_ljad382-B1","doi-asserted-by":"crossref","first-page":"m1590","DOI":"10.1136\/bmj.m1590","article-title":"National, regional, and worldwide epidemiology of psoriasis: Systematic analysis and modelling study","volume":"369","author":"Parisi","year":"2020","journal-title":"BMJ"},{"key":"2024090210033172500_ljad382-B2","doi-asserted-by":"crossref","first-page":"2058","DOI":"10.1111\/jdv.15177","article-title":"Position statement for the management of comorbidities in psoriasis","volume":"32","author":"Dauden","year":"2018","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2024090210033172500_ljad382-B3","doi-asserted-by":"crossref","first-page":"2461","DOI":"10.1111\/jdv.16915","article-title":"EuroGuiDerm Guideline on the systemic 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Dermatol"},{"key":"2024090210033172500_ljad382-B6","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1111\/jdv.14583","article-title":"Biologics combined with conventional systemic agents or phototherapy for the treatment of psoriasis: real-life data from PSONET registries","volume":"32","author":"Busard","year":"2018","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2024090210033172500_ljad382-B7","doi-asserted-by":"crossref","first-page":"1056","DOI":"10.1001\/jamadermatol.2021.2599","article-title":"Association between biologics use and risk of serious infection in patients with psoriasis","volume":"157","author":"Penso","year":"2021","journal-title":"JAMA Dermatol"},{"key":"2024090210033172500_ljad382-B8","doi-asserted-by":"crossref","first-page":"696597","DOI":"10.3389\/fmed.2021.696597","article-title":"Systematic review and recommendations to combine newer therapies with conventional therapy in psoriatic 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Rates of serious adverse events in the prospective rheumatoid arthritis BIOBADASER and psoriasis BIOBADADERM cohorts","volume":"176","author":"Garc\u00eda-Doval","year":"2017","journal-title":"Br J Dermatol"},{"key":"2024090210033172500_ljad382-B10","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1016\/j.jid.2016.08.034","article-title":"Infections in moderate to severe psoriasis patients treated with biological drugs compared to classic systemic drugs: Findings from the BIOBADADERM registry","volume":"137","author":"D\u00e1vila-Seijo","year":"2017","journal-title":"J Invest Dermatol"},{"key":"2024090210033172500_ljad382-B11","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1016\/j.ad.2010.10.016","article-title":"[BIOBADADERM: registro espa\u00f1ol de acontecimientos adversos de terapias biol\u00f3gicas en dermatolog\u00eda. 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Datos obtenidos del registro espa\u00f1ol Biobadaderm]","volume":"111","author":"Ruiz-Genao","year":"2020","journal-title":"Actas Dermosifiliogr"},{"key":"2024090210033172500_ljad382-B29","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1007\/s40257-014-0097-1","article-title":"Use of biologic agents in combination with other therapies for the treatment of psoriasis","volume":"15","author":"Cather","year":"2014","journal-title":"Am J Clin Dermatol"}],"container-title":["British Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/bjd\/advance-article-pdf\/doi\/10.1093\/bjd\/ljad382\/54041642\/ljad382.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/190\/3\/355\/58992384\/ljad382.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/190\/3\/355\/58992384\/ljad382.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,9,2]],"date-time":"2024-09-02T12:41:12Z","timestamp":1725280872000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/bjd\/article\/190\/3\/355\/7319598"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,17]]},"references-count":29,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,10,17]]},"published-print":{"date-parts":[[2024,2,16]]}},"URL":"https:\/\/doi.org\/10.1093\/bjd\/ljad382","relation":{},"ISSN":["0007-0963","1365-2133"],"issn-type":[{"value":"0007-0963","type":"print"},{"value":"1365-2133","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,3]]},"published":{"date-parts":[[2023,10,17]]}}}