<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2413-4341</journal-id>
<journal-title><![CDATA[Revista Paraguaya de Reumatología]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. parag. reumatol.]]></abbrev-journal-title>
<issn>2413-4341</issn>
<publisher>
<publisher-name><![CDATA[Sociedad Paraguaya de Reumatología]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2413-43412025000100003</article-id>
<article-id pub-id-type="doi">10.18004/rpr/2025.11.01.3</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Seguridad de terapias biológicas en una cohorte de pacientes paraguayos]]></article-title>
<article-title xml:lang="en"><![CDATA[Safety of biological therapies in a cohort of paraguayan patients]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Trigueros]]></surname>
<given-names><![CDATA[Paloma de Abreu]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Villalba]]></surname>
<given-names><![CDATA[Sonia Cabrera]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Román]]></surname>
<given-names><![CDATA[Lourdes]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Paniagua]]></surname>
<given-names><![CDATA[Patricia Melgarejo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cabrera]]></surname>
<given-names><![CDATA[Vannia Valinotti]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ortiz]]></surname>
<given-names><![CDATA[Angélica Amarilla]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pineda]]></surname>
<given-names><![CDATA[Alexis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pusineri]]></surname>
<given-names><![CDATA[Paola]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Torres]]></surname>
<given-names><![CDATA[Mariela Zarza]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Aranda]]></surname>
<given-names><![CDATA[Raquel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Parodi]]></surname>
<given-names><![CDATA[Clyde]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ríos]]></surname>
<given-names><![CDATA[Evelyn Leiva]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[Laura]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gómez]]></surname>
<given-names><![CDATA[Paola Jara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ayala]]></surname>
<given-names><![CDATA[Zoilo Morel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Campuzano]]></surname>
<given-names><![CDATA[Roger Rolón]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cavazzoni]]></surname>
<given-names><![CDATA[Magali Zanotti]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Balbuena]]></surname>
<given-names><![CDATA[Cynthia Vega]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Babak]]></surname>
<given-names><![CDATA[Pedro]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pedretti]]></surname>
<given-names><![CDATA[Gabriela Ávila]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Sociedad Paraguaya de Reumatología  ]]></institution>
<addr-line><![CDATA[Asunción ]]></addr-line>
<country>Paraguay</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad Nacional de Asunción Facultad de Ciencias Médicas Hospital de Clínicas, Departamento de Reumatología]]></institution>
<addr-line><![CDATA[San Lorenzo ]]></addr-line>
<country>Paraguay</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Universidad Católica Nuestra Señora de la Asunción Instituto de Previsión Social Hospital Central, Servicio de Reumatología]]></institution>
<addr-line><![CDATA[Asunción ]]></addr-line>
<country>Paraguay</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,Ministerio de Salud Pública y Bienestar Social Hospital de Villa Elisa ]]></institution>
<addr-line><![CDATA[Villa Elisa ]]></addr-line>
<country>Paraguay</country>
</aff>
<aff id="Af5">
<institution><![CDATA[,Ministerio de Salud Pública y Bienestar Social Hospital de Villarrica ]]></institution>
<addr-line><![CDATA[Villarrica ]]></addr-line>
<country>Paraguay</country>
</aff>
<aff id="Af6">
<institution><![CDATA[,Ministerio de Salud Pública y Bienestar Social Hospital Nacional de Itauguá ]]></institution>
<addr-line><![CDATA[Itauguá ]]></addr-line>
<country>Paraguay</country>
</aff>
<aff id="Af7">
<institution><![CDATA[,Ministerio de Salud Pública y Bienestar Social, Hospital Pediátrico Niños de Acosta Ñu ]]></institution>
<addr-line><![CDATA[San Lorenzo ]]></addr-line>
<country>Paraguay</country>
</aff>
<aff id="Af8">
<institution><![CDATA[,Ministerio de Salud Pública y Bienestar Social, Hospital Regional de Encarnación ]]></institution>
<addr-line><![CDATA[Encarnación ]]></addr-line>
<country>Paraguay</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>06</month>
<year>2025</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>06</month>
<year>2025</year>
</pub-date>
<volume>11</volume>
<numero>1</numero>
<fpage>3</fpage>
<lpage>9</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_arttext&amp;pid=S2413-43412025000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_abstract&amp;pid=S2413-43412025000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_pdf&amp;pid=S2413-43412025000100003&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN   Objetivos: analizar la seguridad de las terapias biológicas (FAME-b) en la cohorte de pacientes paraguayos del registro BIOBADAGUAY (registro paraguayo-uruguayo de acontecimientos adversos (AA) en pacientes con enfermedades reumáticas inflamatorias).  Material y Método: BIOBADAGUAY es un registro para evaluar prospectivamente la eficacia y seguridad de los FAME-b. La metodología completa está disponible en https://biobadaguay.ser.es. Para el presente estudio se utilizaron variables asociadas a la seguridad de las terapias. La incidencia de AA se calculó como tasa de incidencia (IR) por 1000 pacientes-año, con intervalos de confianza (IC) del 95% y la regresión de Poisson para la razón de tasa de incidencia (IRR).  Resultados: Se analizaron 696 pacientes (71,3% mujeres) con 1077 AA predominantemente leves (88,6%). La incidencia global fue 323,8 por 1000 pacientes año. Las infecciones fueron el AA más frecuente (55,3%). El tratamiento con anti-TNF se asoció a una menor incidencia de AA, mientras que segundas y posteriores líneas de tratamiento se asociaron con más AA.  Conclusiones : Este estudio ha proporcionado datos valiosos sobre la seguridad de los FAME-b en una cohorte de pacientes paraguayos con enfermedades reumáticas inflamatorias. La mayoría de AA fueron leves y los procesos infecciosos fueron el AA más frecuente. Es importante continuar con estos registros para contribuir a un control riguroso y permanente de esta población de pacientes.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Objectives:  to analyze the safety of biologic therapies (FAME-b) in the Paraguayan patient cohort of the BIOBADAGUAY registry (Paraguayan-Uruguayan registry of adverse events (AE) in patients with inflammatory rheumatic diseases.  Material and Methods : BIOBADAGUAY is a registry to prospectively evaluate the efficacy and safety of b-DMARDs. The complete methodology is available at https://biobadaguay.ser.es. Variables associated with the safety of therapies were used for the present study. The incidence of EA was calculated as incidence rate (IR) per 1000 patient-years, with 95% confidence intervals (CI) and Poisson regression for the incidence rate ratio (IRR).  Results:  We analyzed 696 patients (71.3% women) with 1077 predominantly mild AE (88.6%). The overall incidence was 323.8 per 1000 patient-years. Infections were the most frequent AA (55.3%). Anti-TNF treatment was associated with a lower incidence of EA, while second and subsequent lines of treatment were associated with more AE.  Conclusions: This study has provided valuable data on the safety of FAME-b in a cohort of Paraguayan patients with inflammatory rheumatic diseases. Most of AEs were mild and infectious processes were the most frequent AE. It is important to continue with these registries to contribute to a rigorous and permanent control of this patient population.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[terapia biológica]]></kwd>
<kwd lng="es"><![CDATA[registro]]></kwd>
<kwd lng="es"><![CDATA[seguridad]]></kwd>
<kwd lng="es"><![CDATA[enfermedades reumáticas inflamatorias.]]></kwd>
<kwd lng="en"><![CDATA[biologic therapy]]></kwd>
<kwd lng="en"><![CDATA[registry]]></kwd>
<kwd lng="en"><![CDATA[safety]]></kwd>
<kwd lng="en"><![CDATA[inflammatory rheumatic diseases.]]></kwd>
</kwd-group>
</article-meta>
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