Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry
Information regarding the safety of biological drugs prescribed to psoriasis patients on daily and long-term bases is insufficient. We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection d...
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creator | Dávila-Seijo, Paula Dauden, Esteban Descalzo, M.A. Carretero, Gregorio Carrascosa, José-Manuel Vanaclocha, Francisco Gómez-García, Francisco-José De la Cueva-Dobao, Pablo Herrera-Ceballos, Enrique Belinchón, Isabel López-Estebaranz, José-Luis Alsina, Merce Sánchez-Carazo, José-Luis Ferrán, Marta Torrado, Rosa Ferrandiz, Carlos Rivera, Raquel Llamas, Mar Jiménez-Puya, Rafael García-Doval, Ignacio Pérez Zafrilla, Beatriz Muñoz-Santos, Carlos Mendiola-Fernández, Victoria Sánchez Roldán, Cristina Ruiz-Genao, Diana Echeverría, Begoña Galiano Mejías, Sagrario |
description | Information regarding the safety of biological drugs prescribed to psoriasis patients on daily and long-term bases is insufficient. We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and nonbiological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RRs) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression. Our study included records of 2,153 patients (7,867.5 person-years). The adjusted RR of overall infection was significantly increased in the groups treated with adalimumab with methotrexate (adjusted RR = 2.13, 95% confidence interval [CI] = 1.2–3.7), infliximab (adjusted RR = 1.71, 95% CI = 1.1–2.65), cyclosporine (adjusted RR = 1.58, 95% CI = 1.17–2.15), ustekinumab with methotrexate (adjusted RR = 1.56, 95% CI = 1.08–2.25), and etanercept (adjusted RR = 1.34, 95% CI: 1.02–1.76) compared with methotrexate alone. Cyclosporine had a significant risk of serious infection (adjusted RR = 3.12, 95% CI = 1.1–8.8), followed by adalimumab combined with methotrexate (adjusted RR = 3.28, 95% CI = 0.8–13.5). Adalimumab in combination with methotrexate had the highest risk of infection recurrence (adjusted RR = 4.33, 95% CI = 2.27–8.24). |
doi_str_mv | 10.1016/j.jid.2016.08.034 |
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We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and nonbiological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RRs) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression. Our study included records of 2,153 patients (7,867.5 person-years). The adjusted RR of overall infection was significantly increased in the groups treated with adalimumab with methotrexate (adjusted RR = 2.13, 95% confidence interval [CI] = 1.2–3.7), infliximab (adjusted RR = 1.71, 95% CI = 1.1–2.65), cyclosporine (adjusted RR = 1.58, 95% CI = 1.17–2.15), ustekinumab with methotrexate (adjusted RR = 1.56, 95% CI = 1.08–2.25), and etanercept (adjusted RR = 1.34, 95% CI: 1.02–1.76) compared with methotrexate alone. Cyclosporine had a significant risk of serious infection (adjusted RR = 3.12, 95% CI = 1.1–8.8), followed by adalimumab combined with methotrexate (adjusted RR = 3.28, 95% CI = 0.8–13.5). Adalimumab in combination with methotrexate had the highest risk of infection recurrence (adjusted RR = 4.33, 95% CI = 2.27–8.24).</description><identifier>ISSN: 0022-202X</identifier><identifier>EISSN: 1523-1747</identifier><identifier>DOI: 10.1016/j.jid.2016.08.034</identifier><identifier>PMID: 27677836</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adalimumab - adverse effects ; Adalimumab - therapeutic use ; Adult ; Aged ; Bacterial Infections - etiology ; Biological Products - adverse effects ; Cyclosporine - adverse effects ; Cyclosporine - therapeutic use ; Drug Therapy, Combination ; Female ; Humans ; Male ; Methotrexate - adverse effects ; Methotrexate - therapeutic use ; Middle Aged ; Poisson Distribution ; Psoriasis - complications ; Psoriasis - drug therapy ; Registries</subject><ispartof>Journal of investigative dermatology, 2017-02, Vol.137 (2), p.313-321</ispartof><rights>2016 The Authors</rights><rights>Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c396t-d5d218b51090dfd95d811a1f0f8f32944b782d1bc25b3cf27a15584e25b672ee3</citedby><cites>FETCH-LOGICAL-c396t-d5d218b51090dfd95d811a1f0f8f32944b782d1bc25b3cf27a15584e25b672ee3</cites><orcidid>0000-0002-6881-5260</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27929,27930</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27677836$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dávila-Seijo, Paula</creatorcontrib><creatorcontrib>Dauden, Esteban</creatorcontrib><creatorcontrib>Descalzo, M.A.</creatorcontrib><creatorcontrib>Carretero, Gregorio</creatorcontrib><creatorcontrib>Carrascosa, José-Manuel</creatorcontrib><creatorcontrib>Vanaclocha, Francisco</creatorcontrib><creatorcontrib>Gómez-García, Francisco-José</creatorcontrib><creatorcontrib>De la Cueva-Dobao, Pablo</creatorcontrib><creatorcontrib>Herrera-Ceballos, Enrique</creatorcontrib><creatorcontrib>Belinchón, Isabel</creatorcontrib><creatorcontrib>López-Estebaranz, José-Luis</creatorcontrib><creatorcontrib>Alsina, Merce</creatorcontrib><creatorcontrib>Sánchez-Carazo, José-Luis</creatorcontrib><creatorcontrib>Ferrán, Marta</creatorcontrib><creatorcontrib>Torrado, Rosa</creatorcontrib><creatorcontrib>Ferrandiz, Carlos</creatorcontrib><creatorcontrib>Rivera, Raquel</creatorcontrib><creatorcontrib>Llamas, Mar</creatorcontrib><creatorcontrib>Jiménez-Puya, Rafael</creatorcontrib><creatorcontrib>García-Doval, Ignacio</creatorcontrib><creatorcontrib>Pérez Zafrilla, Beatriz</creatorcontrib><creatorcontrib>Muñoz-Santos, Carlos</creatorcontrib><creatorcontrib>Mendiola-Fernández, Victoria</creatorcontrib><creatorcontrib>Sánchez Roldán, Cristina</creatorcontrib><creatorcontrib>Ruiz-Genao, Diana</creatorcontrib><creatorcontrib>Echeverría, Begoña</creatorcontrib><creatorcontrib>Galiano Mejías, Sagrario</creatorcontrib><creatorcontrib>BIOBADADERM Study Group</creatorcontrib><title>Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry</title><title>Journal of investigative dermatology</title><addtitle>J Invest Dermatol</addtitle><description>Information regarding the safety of biological drugs prescribed to psoriasis patients on daily and long-term bases is insufficient. We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and nonbiological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RRs) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression. Our study included records of 2,153 patients (7,867.5 person-years). The adjusted RR of overall infection was significantly increased in the groups treated with adalimumab with methotrexate (adjusted RR = 2.13, 95% confidence interval [CI] = 1.2–3.7), infliximab (adjusted RR = 1.71, 95% CI = 1.1–2.65), cyclosporine (adjusted RR = 1.58, 95% CI = 1.17–2.15), ustekinumab with methotrexate (adjusted RR = 1.56, 95% CI = 1.08–2.25), and etanercept (adjusted RR = 1.34, 95% CI: 1.02–1.76) compared with methotrexate alone. Cyclosporine had a significant risk of serious infection (adjusted RR = 3.12, 95% CI = 1.1–8.8), followed by adalimumab combined with methotrexate (adjusted RR = 3.28, 95% CI = 0.8–13.5). Adalimumab in combination with methotrexate had the highest risk of infection recurrence (adjusted RR = 4.33, 95% CI = 2.27–8.24).</description><subject>Adalimumab - adverse effects</subject><subject>Adalimumab - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Bacterial Infections - etiology</subject><subject>Biological Products - adverse effects</subject><subject>Cyclosporine - adverse effects</subject><subject>Cyclosporine - therapeutic use</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Methotrexate - adverse effects</subject><subject>Methotrexate - therapeutic use</subject><subject>Middle Aged</subject><subject>Poisson Distribution</subject><subject>Psoriasis - complications</subject><subject>Psoriasis - drug therapy</subject><subject>Registries</subject><issn>0022-202X</issn><issn>1523-1747</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU1v1DAQhi0EokvhB3BBPnJJsJ0vB0770cJKrVq1ReJmOfZk61USbz3eov0v_FhctnDk5LHmmVeaeQh5z1nOGa8_bfOts7lIZc5kzoryBZnxShQZb8rmJZkxJkQmmPhxQt4gblkCy0q-JieiqZtGFvWM_FpPPZjo_ITUTfTSWwg6Ao2e3sIjBKDX6IPT6JBe6-hgikjvAiTG0p8u3tOF84PfOKMHugr7DdKlH3c6pHbKWA4a0Rl6e8AIYyr-IJ_puZusmxLcBz_SeA90sb5azFfz1dnNJb2BjcMYDm_Jq14PCO-e31Py_fzsbvktu7j6ul7OLzJTtHXMbGUFl13FWctsb9vKSs4171kv-0K0Zdk1UljeGVF1helFo3lVyRLSt24EQHFKPh5zd8E_7AGjGh0aGAY9gd-j4rLkTVsUXCaUH1ETPGKAXu2CG3U4KM7UkxS1VUmKepKimFRJSpr58By_70aw_yb-WkjAlyMAaclHB0GhSZc2YF1IcpT17j_xvwGfRZ4F</recordid><startdate>201702</startdate><enddate>201702</enddate><creator>Dávila-Seijo, Paula</creator><creator>Dauden, Esteban</creator><creator>Descalzo, M.A.</creator><creator>Carretero, Gregorio</creator><creator>Carrascosa, José-Manuel</creator><creator>Vanaclocha, Francisco</creator><creator>Gómez-García, Francisco-José</creator><creator>De la Cueva-Dobao, Pablo</creator><creator>Herrera-Ceballos, Enrique</creator><creator>Belinchón, Isabel</creator><creator>López-Estebaranz, José-Luis</creator><creator>Alsina, Merce</creator><creator>Sánchez-Carazo, José-Luis</creator><creator>Ferrán, Marta</creator><creator>Torrado, Rosa</creator><creator>Ferrandiz, Carlos</creator><creator>Rivera, Raquel</creator><creator>Llamas, Mar</creator><creator>Jiménez-Puya, Rafael</creator><creator>García-Doval, Ignacio</creator><creator>Pérez Zafrilla, Beatriz</creator><creator>Muñoz-Santos, Carlos</creator><creator>Mendiola-Fernández, Victoria</creator><creator>Sánchez Roldán, Cristina</creator><creator>Ruiz-Genao, Diana</creator><creator>Echeverría, Begoña</creator><creator>Galiano Mejías, Sagrario</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-6881-5260</orcidid></search><sort><creationdate>201702</creationdate><title>Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry</title><author>Dávila-Seijo, Paula ; Dauden, Esteban ; Descalzo, M.A. ; Carretero, Gregorio ; Carrascosa, José-Manuel ; Vanaclocha, Francisco ; Gómez-García, Francisco-José ; De la Cueva-Dobao, Pablo ; Herrera-Ceballos, Enrique ; Belinchón, Isabel ; López-Estebaranz, José-Luis ; Alsina, Merce ; Sánchez-Carazo, José-Luis ; Ferrán, Marta ; Torrado, Rosa ; Ferrandiz, Carlos ; Rivera, Raquel ; Llamas, Mar ; Jiménez-Puya, Rafael ; García-Doval, Ignacio ; Pérez Zafrilla, Beatriz ; Muñoz-Santos, Carlos ; Mendiola-Fernández, Victoria ; Sánchez Roldán, Cristina ; Ruiz-Genao, Diana ; Echeverría, Begoña ; Galiano Mejías, Sagrario</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c396t-d5d218b51090dfd95d811a1f0f8f32944b782d1bc25b3cf27a15584e25b672ee3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adalimumab - 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We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and nonbiological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RRs) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression. Our study included records of 2,153 patients (7,867.5 person-years). The adjusted RR of overall infection was significantly increased in the groups treated with adalimumab with methotrexate (adjusted RR = 2.13, 95% confidence interval [CI] = 1.2–3.7), infliximab (adjusted RR = 1.71, 95% CI = 1.1–2.65), cyclosporine (adjusted RR = 1.58, 95% CI = 1.17–2.15), ustekinumab with methotrexate (adjusted RR = 1.56, 95% CI = 1.08–2.25), and etanercept (adjusted RR = 1.34, 95% CI: 1.02–1.76) compared with methotrexate alone. Cyclosporine had a significant risk of serious infection (adjusted RR = 3.12, 95% CI = 1.1–8.8), followed by adalimumab combined with methotrexate (adjusted RR = 3.28, 95% CI = 0.8–13.5). Adalimumab in combination with methotrexate had the highest risk of infection recurrence (adjusted RR = 4.33, 95% CI = 2.27–8.24).</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>27677836</pmid><doi>10.1016/j.jid.2016.08.034</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-6881-5260</orcidid><oa>free_for_read</oa></addata></record> |
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language | eng |
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source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
subjects | Adalimumab - adverse effects Adalimumab - therapeutic use Adult Aged Bacterial Infections - etiology Biological Products - adverse effects Cyclosporine - adverse effects Cyclosporine - therapeutic use Drug Therapy, Combination Female Humans Male Methotrexate - adverse effects Methotrexate - therapeutic use Middle Aged Poisson Distribution Psoriasis - complications Psoriasis - drug therapy Registries |
title | Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-13T02%3A15%3A31IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Infections%20in%20Moderate%20to%20Severe%20Psoriasis%20Patients%20Treated%20with%20Biological%20Drugs%20Compared%20to%20Classic%20Systemic%20Drugs:%20Findings%20from%20the%20BIOBADADERM%20Registry&rft.jtitle=Journal%20of%20investigative%20dermatology&rft.au=D%C3%A1vila-Seijo,%20Paula&rft.aucorp=BIOBADADERM%20Study%20Group&rft.date=2017-02&rft.volume=137&rft.issue=2&rft.spage=313&rft.epage=321&rft.pages=313-321&rft.issn=0022-202X&rft.eissn=1523-1747&rft_id=info:doi/10.1016/j.jid.2016.08.034&rft_dat=%3Cproquest_cross%3E1841793318%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1841793318&rft_id=info:pmid/27677836&rft_els_id=S0022202X16324599&rfr_iscdi=true |