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Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry
Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to se...
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| Published in: | Journal of the American Academy of Dermatology 2020-07, Vol.83 (1), p.139-150 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Article |
| Language: | English |
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| cited_by | cdi_FETCH-LOGICAL-c422t-72d14b6d088bb50b685b5c48bc177d4b1277c85df0025c0722ef5a711497ec8a3 |
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| cites | cdi_FETCH-LOGICAL-c422t-72d14b6d088bb50b685b5c48bc177d4b1277c85df0025c0722ef5a711497ec8a3 |
| container_end_page | 150 |
| container_issue | 1 |
| container_start_page | 139 |
| container_title | Journal of the American Academy of Dermatology |
| container_volume | 83 |
| creator | Daudén, Esteban Carretero, Gregorio Rivera, Raquel Ferrándiz, Carlos Llamas-Velasco, Mar de la Cueva, Pablo Belinchón, Isabel Gómez-García, Francisco José Herrera-Acosta, Enrique Ruiz-Genao, Diana Patricia Ferrán-Farrés, Marta Alsina, Mercè Baniandrés-Rodríguez, Ofelia Sánchez-Carazo, José Luis Sahuquillo-Torralba, Antonio Fernández-Freire, Lourdes Rodriguez Vilar-Alejo, Jaime García-Donoso, Carmen Carrascosa, José Manuel Herrera-Ceballos, Enrique López-Estebaranz, José Luis Botella-Estrada, Rafael Segovia-Muñoz, Eva Descalzo, Miguel Angel García-Doval, Ignacio Daudén, Esteban Llamas-Velasco, Mar Carretero, Gregorio Vilar-Alejo, Jaime Rivera, Raquel García-Donoso, Carmen Ferrándiz, Carlos Carrascosa, José Manuel Ballescá, Ferrán Cueva, Pablo de la Belinchón, Isabel Gómez-García, Fran J. Jiménez, Rafael Herrera-Ceballos, Enrique Herrera-Acosta, Enrique López-Estebaranz, José Luis Ruiz-Genao, Diana Patricia Farrés, Marta Ferrán Alsina, Mercè Baniandrés, Ofelia Nieto, Lula Sánchez-Carazo, José Luis Sahuquillo-Torralba, Antonio Botella-Estrada, Rafael Marco, Conrad Pujol Fernández-Freire, Lourdes Rodríguez Puchades, Almudena Mateu Menéndez, Ángeles Flórez Salgado, Laura Sixto, Beatriz González Eiris, Noemí García-Doval, Ignacio Descalzo Gallego, Miguel Ángel de Vega Martínez, Marina |
| description | Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.
To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.
The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.
Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of |
| doi_str_mv | 10.1016/j.jaad.2020.03.033 |
| format | article |
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To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.
The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.
Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5).
Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.
Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.</description><identifier>ISSN: 0190-9622</identifier><identifier>EISSN: 1097-6787</identifier><identifier>DOI: 10.1016/j.jaad.2020.03.033</identifier><identifier>PMID: 32213306</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; adverse effects ; Aged ; anti-inflammatory agents ; anti-TNF ; biologic agents ; Biological Therapy - adverse effects ; Cohort Studies ; Female ; Humans ; immunosuppressive agents ; long-term follow-up ; Male ; Middle Aged ; pharmacovigilance ; prospective cohort ; Psoriasis - drug therapy ; Registries ; safety ; Spain ; Time Factors</subject><ispartof>Journal of the American Academy of Dermatology, 2020-07, Vol.83 (1), p.139-150</ispartof><rights>2020 American Academy of Dermatology, Inc.</rights><rights>Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c422t-72d14b6d088bb50b685b5c48bc177d4b1277c85df0025c0722ef5a711497ec8a3</citedby><cites>FETCH-LOGICAL-c422t-72d14b6d088bb50b685b5c48bc177d4b1277c85df0025c0722ef5a711497ec8a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32213306$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Daudén, Esteban</creatorcontrib><creatorcontrib>Carretero, Gregorio</creatorcontrib><creatorcontrib>Rivera, Raquel</creatorcontrib><creatorcontrib>Ferrándiz, Carlos</creatorcontrib><creatorcontrib>Llamas-Velasco, Mar</creatorcontrib><creatorcontrib>de la Cueva, Pablo</creatorcontrib><creatorcontrib>Belinchón, Isabel</creatorcontrib><creatorcontrib>Gómez-García, Francisco José</creatorcontrib><creatorcontrib>Herrera-Acosta, Enrique</creatorcontrib><creatorcontrib>Ruiz-Genao, Diana Patricia</creatorcontrib><creatorcontrib>Ferrán-Farrés, Marta</creatorcontrib><creatorcontrib>Alsina, Mercè</creatorcontrib><creatorcontrib>Baniandrés-Rodríguez, Ofelia</creatorcontrib><creatorcontrib>Sánchez-Carazo, José Luis</creatorcontrib><creatorcontrib>Sahuquillo-Torralba, Antonio</creatorcontrib><creatorcontrib>Fernández-Freire, Lourdes Rodriguez</creatorcontrib><creatorcontrib>Vilar-Alejo, Jaime</creatorcontrib><creatorcontrib>García-Donoso, Carmen</creatorcontrib><creatorcontrib>Carrascosa, José Manuel</creatorcontrib><creatorcontrib>Herrera-Ceballos, Enrique</creatorcontrib><creatorcontrib>López-Estebaranz, José Luis</creatorcontrib><creatorcontrib>Botella-Estrada, Rafael</creatorcontrib><creatorcontrib>Segovia-Muñoz, Eva</creatorcontrib><creatorcontrib>Descalzo, Miguel Angel</creatorcontrib><creatorcontrib>García-Doval, Ignacio</creatorcontrib><creatorcontrib>Daudén, Esteban</creatorcontrib><creatorcontrib>Llamas-Velasco, Mar</creatorcontrib><creatorcontrib>Carretero, Gregorio</creatorcontrib><creatorcontrib>Vilar-Alejo, Jaime</creatorcontrib><creatorcontrib>Rivera, Raquel</creatorcontrib><creatorcontrib>García-Donoso, Carmen</creatorcontrib><creatorcontrib>Ferrándiz, Carlos</creatorcontrib><creatorcontrib>Carrascosa, José Manuel</creatorcontrib><creatorcontrib>Ballescá, Ferrán</creatorcontrib><creatorcontrib>Cueva, Pablo de la</creatorcontrib><creatorcontrib>Belinchón, Isabel</creatorcontrib><creatorcontrib>Gómez-García, Fran J.</creatorcontrib><creatorcontrib>Jiménez, Rafael</creatorcontrib><creatorcontrib>Herrera-Ceballos, Enrique</creatorcontrib><creatorcontrib>Herrera-Acosta, Enrique</creatorcontrib><creatorcontrib>López-Estebaranz, José Luis</creatorcontrib><creatorcontrib>Ruiz-Genao, Diana Patricia</creatorcontrib><creatorcontrib>Farrés, Marta Ferrán</creatorcontrib><creatorcontrib>Alsina, Mercè</creatorcontrib><creatorcontrib>Baniandrés, Ofelia</creatorcontrib><creatorcontrib>Nieto, Lula</creatorcontrib><creatorcontrib>Sánchez-Carazo, José Luis</creatorcontrib><creatorcontrib>Sahuquillo-Torralba, Antonio</creatorcontrib><creatorcontrib>Botella-Estrada, Rafael</creatorcontrib><creatorcontrib>Marco, Conrad Pujol</creatorcontrib><creatorcontrib>Fernández-Freire, Lourdes Rodríguez</creatorcontrib><creatorcontrib>Puchades, Almudena Mateu</creatorcontrib><creatorcontrib>Menéndez, Ángeles Flórez</creatorcontrib><creatorcontrib>Salgado, Laura</creatorcontrib><creatorcontrib>Sixto, Beatriz González</creatorcontrib><creatorcontrib>Eiris, Noemí</creatorcontrib><creatorcontrib>García-Doval, Ignacio</creatorcontrib><creatorcontrib>Descalzo Gallego, Miguel Ángel</creatorcontrib><creatorcontrib>de Vega Martínez, Marina</creatorcontrib><creatorcontrib>the BIOBADADERM Study Group</creatorcontrib><creatorcontrib>BIOBADADERM Study Group</creatorcontrib><title>Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry</title><title>Journal of the American Academy of Dermatology</title><addtitle>J Am Acad Dermatol</addtitle><description>Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.
To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.
The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.
Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5).
Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.
Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.</description><subject>Adult</subject><subject>adverse effects</subject><subject>Aged</subject><subject>anti-inflammatory agents</subject><subject>anti-TNF</subject><subject>biologic agents</subject><subject>Biological Therapy - adverse effects</subject><subject>Cohort Studies</subject><subject>Female</subject><subject>Humans</subject><subject>immunosuppressive agents</subject><subject>long-term follow-up</subject><subject>Male</subject><subject>Middle Aged</subject><subject>pharmacovigilance</subject><subject>prospective cohort</subject><subject>Psoriasis - drug therapy</subject><subject>Registries</subject><subject>safety</subject><subject>Spain</subject><subject>Time 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Ignacio ; Descalzo Gallego, Miguel Ángel ; de Vega Martínez, Marina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c422t-72d14b6d088bb50b685b5c48bc177d4b1277c85df0025c0722ef5a711497ec8a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>adverse effects</topic><topic>Aged</topic><topic>anti-inflammatory agents</topic><topic>anti-TNF</topic><topic>biologic agents</topic><topic>Biological Therapy - adverse effects</topic><topic>Cohort Studies</topic><topic>Female</topic><topic>Humans</topic><topic>immunosuppressive agents</topic><topic>long-term follow-up</topic><topic>Male</topic><topic>Middle Aged</topic><topic>pharmacovigilance</topic><topic>prospective cohort</topic><topic>Psoriasis - drug therapy</topic><topic>Registries</topic><topic>safety</topic><topic>Spain</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Daudén, Esteban</creatorcontrib><creatorcontrib>Carretero, Gregorio</creatorcontrib><creatorcontrib>Rivera, Raquel</creatorcontrib><creatorcontrib>Ferrándiz, Carlos</creatorcontrib><creatorcontrib>Llamas-Velasco, Mar</creatorcontrib><creatorcontrib>de la Cueva, Pablo</creatorcontrib><creatorcontrib>Belinchón, Isabel</creatorcontrib><creatorcontrib>Gómez-García, Francisco José</creatorcontrib><creatorcontrib>Herrera-Acosta, Enrique</creatorcontrib><creatorcontrib>Ruiz-Genao, Diana Patricia</creatorcontrib><creatorcontrib>Ferrán-Farrés, Marta</creatorcontrib><creatorcontrib>Alsina, Mercè</creatorcontrib><creatorcontrib>Baniandrés-Rodríguez, Ofelia</creatorcontrib><creatorcontrib>Sánchez-Carazo, José Luis</creatorcontrib><creatorcontrib>Sahuquillo-Torralba, Antonio</creatorcontrib><creatorcontrib>Fernández-Freire, Lourdes Rodriguez</creatorcontrib><creatorcontrib>Vilar-Alejo, Jaime</creatorcontrib><creatorcontrib>García-Donoso, Carmen</creatorcontrib><creatorcontrib>Carrascosa, José Manuel</creatorcontrib><creatorcontrib>Herrera-Ceballos, Enrique</creatorcontrib><creatorcontrib>López-Estebaranz, José Luis</creatorcontrib><creatorcontrib>Botella-Estrada, Rafael</creatorcontrib><creatorcontrib>Segovia-Muñoz, Eva</creatorcontrib><creatorcontrib>Descalzo, Miguel Angel</creatorcontrib><creatorcontrib>García-Doval, Ignacio</creatorcontrib><creatorcontrib>Daudén, Esteban</creatorcontrib><creatorcontrib>Llamas-Velasco, Mar</creatorcontrib><creatorcontrib>Carretero, Gregorio</creatorcontrib><creatorcontrib>Vilar-Alejo, Jaime</creatorcontrib><creatorcontrib>Rivera, Raquel</creatorcontrib><creatorcontrib>García-Donoso, Carmen</creatorcontrib><creatorcontrib>Ferrándiz, Carlos</creatorcontrib><creatorcontrib>Carrascosa, José Manuel</creatorcontrib><creatorcontrib>Ballescá, Ferrán</creatorcontrib><creatorcontrib>Cueva, Pablo de la</creatorcontrib><creatorcontrib>Belinchón, Isabel</creatorcontrib><creatorcontrib>Gómez-García, Fran J.</creatorcontrib><creatorcontrib>Jiménez, Rafael</creatorcontrib><creatorcontrib>Herrera-Ceballos, Enrique</creatorcontrib><creatorcontrib>Herrera-Acosta, Enrique</creatorcontrib><creatorcontrib>López-Estebaranz, José Luis</creatorcontrib><creatorcontrib>Ruiz-Genao, Diana Patricia</creatorcontrib><creatorcontrib>Farrés, Marta Ferrán</creatorcontrib><creatorcontrib>Alsina, Mercè</creatorcontrib><creatorcontrib>Baniandrés, Ofelia</creatorcontrib><creatorcontrib>Nieto, Lula</creatorcontrib><creatorcontrib>Sánchez-Carazo, José Luis</creatorcontrib><creatorcontrib>Sahuquillo-Torralba, Antonio</creatorcontrib><creatorcontrib>Botella-Estrada, Rafael</creatorcontrib><creatorcontrib>Marco, Conrad Pujol</creatorcontrib><creatorcontrib>Fernández-Freire, Lourdes Rodríguez</creatorcontrib><creatorcontrib>Puchades, Almudena Mateu</creatorcontrib><creatorcontrib>Menéndez, Ángeles Flórez</creatorcontrib><creatorcontrib>Salgado, Laura</creatorcontrib><creatorcontrib>Sixto, Beatriz González</creatorcontrib><creatorcontrib>Eiris, Noemí</creatorcontrib><creatorcontrib>García-Doval, Ignacio</creatorcontrib><creatorcontrib>Descalzo Gallego, Miguel Ángel</creatorcontrib><creatorcontrib>de Vega Martínez, Marina</creatorcontrib><creatorcontrib>the BIOBADADERM Study Group</creatorcontrib><creatorcontrib>BIOBADADERM Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American Academy of Dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Daudén, Esteban</au><au>Carretero, Gregorio</au><au>Rivera, Raquel</au><au>Ferrándiz, Carlos</au><au>Llamas-Velasco, Mar</au><au>de la Cueva, Pablo</au><au>Belinchón, Isabel</au><au>Gómez-García, Francisco José</au><au>Herrera-Acosta, Enrique</au><au>Ruiz-Genao, Diana Patricia</au><au>Ferrán-Farrés, Marta</au><au>Alsina, Mercè</au><au>Baniandrés-Rodríguez, Ofelia</au><au>Sánchez-Carazo, José Luis</au><au>Sahuquillo-Torralba, Antonio</au><au>Fernández-Freire, Lourdes Rodriguez</au><au>Vilar-Alejo, Jaime</au><au>García-Donoso, Carmen</au><au>Carrascosa, José Manuel</au><au>Herrera-Ceballos, Enrique</au><au>López-Estebaranz, José Luis</au><au>Botella-Estrada, Rafael</au><au>Segovia-Muñoz, Eva</au><au>Descalzo, Miguel Angel</au><au>García-Doval, Ignacio</au><au>Daudén, Esteban</au><au>Llamas-Velasco, Mar</au><au>Carretero, Gregorio</au><au>Vilar-Alejo, Jaime</au><au>Rivera, Raquel</au><au>García-Donoso, Carmen</au><au>Ferrándiz, Carlos</au><au>Carrascosa, José Manuel</au><au>Ballescá, Ferrán</au><au>Cueva, Pablo de la</au><au>Belinchón, Isabel</au><au>Gómez-García, Fran J.</au><au>Jiménez, Rafael</au><au>Herrera-Ceballos, Enrique</au><au>Herrera-Acosta, Enrique</au><au>López-Estebaranz, José Luis</au><au>Ruiz-Genao, Diana Patricia</au><au>Farrés, Marta Ferrán</au><au>Alsina, Mercè</au><au>Baniandrés, Ofelia</au><au>Nieto, Lula</au><au>Sánchez-Carazo, José Luis</au><au>Sahuquillo-Torralba, Antonio</au><au>Botella-Estrada, Rafael</au><au>Marco, Conrad Pujol</au><au>Fernández-Freire, Lourdes Rodríguez</au><au>Puchades, Almudena Mateu</au><au>Menéndez, Ángeles Flórez</au><au>Salgado, Laura</au><au>Sixto, Beatriz González</au><au>Eiris, Noemí</au><au>García-Doval, Ignacio</au><au>Descalzo Gallego, Miguel Ángel</au><au>de Vega Martínez, Marina</au><aucorp>the BIOBADADERM Study Group</aucorp><aucorp>BIOBADADERM Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry</atitle><jtitle>Journal of the American Academy of Dermatology</jtitle><addtitle>J Am Acad Dermatol</addtitle><date>2020-07</date><risdate>2020</risdate><volume>83</volume><issue>1</issue><spage>139</spage><epage>150</epage><pages>139-150</pages><issn>0190-9622</issn><eissn>1097-6787</eissn><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Undefined-1</notes><notes>ObjectType-Feature-3</notes><notes>content type line 23</notes><abstract>Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.
To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.
The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.
Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5).
Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.
Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>32213306</pmid><doi>10.1016/j.jaad.2020.03.033</doi><tpages>12</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0190-9622 |
| ispartof | Journal of the American Academy of Dermatology, 2020-07, Vol.83 (1), p.139-150 |
| issn | 0190-9622 1097-6787 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2384202763 |
| source | ScienceDirect Freedom Collection |
| subjects | Adult adverse effects Aged anti-inflammatory agents anti-TNF biologic agents Biological Therapy - adverse effects Cohort Studies Female Humans immunosuppressive agents long-term follow-up Male Middle Aged pharmacovigilance prospective cohort Psoriasis - drug therapy Registries safety Spain Time Factors |
| title | Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry |
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