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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Veröffentlicht in:Journal of investigative dermatology 2017-02, Vol.137 (2), p.313-321
Hauptverfasser: 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
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container_issue 2
container_start_page 313
container_title Journal of investigative dermatology
container_volume 137
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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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). 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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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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
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