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        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To compare&#44; in the Spanish setting&#44; 2 drugs for adults with rheumatoid artritis &#40;RA&#41;&#58; leflunomide and subcutaneous methotrexate &#40;SC&#41;&#46; The high price of methotrexate SC compared with traditional presentations of methotrexate justifies conducting an economic evaluation comparing it with leflunomide&#46;</p> <span class="elsevierStyleSectionTitle">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The analysis considered the annual costs of the drugs and their effectiveness&#44; measured with a number needed to treat &#40;NNT&#41; approach&#44; considering both the ACR20 and ACR50 criteria for effectiveness&#46; Data about efficacy and dosage were derived from the clinical trial US310&#44; a randomized&#44; doble-blinded controlled trial&#44; which compared efficacy and safety of leflunomide &#40;20<span class="elsevierStyleHsp" style=""></span>mg&#47;daily&#41; versus placebo versus methotrexate &#40;7&#46;5&#8211;15<span class="elsevierStyleHsp" style=""></span>mg&#47;weekly&#41; in 482 patients with active RA&#46; Data about use of medical resources for drug monitoring &#40;visits to rheumatologists and diagnostic procedures&#41; were derived from the manufacturers¿ summary of product characteristics&#46; Direct costs &#40;drugs and monitoring&#41; were obtained from 2 Spanish databases&#46; The analysis has been performed under the Spanish National Health System perspective&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Using the ACR20 criteria&#44; the NNT with leflunomide and methotrexate are 4 &#40;95&#37; CI&#44; 2&#46;56&#8211;7&#46;71&#41; and 5 &#40;95&#37; CI&#44; 3&#46;03&#8211;14&#46;3&#41; respectively&#46; Using the ACR50 criteria&#44; NNT are 4 &#40;95&#37; CI&#44; 2&#46;72-6&#46;54&#41; and 7 &#40;95&#37; CI&#44; 4&#46;03&#8211;19&#46;3&#41;&#46; In the case of leflunomide&#44; annual treatment costs per patient-year equals &#8364;1793&#46;30&#59; in the case of methotrexate total treatment costs amounts to &#8364;2149&#46;20</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Combining these results the cost of a controlled patient according to ACR20 would amount &#8364;7173 for leflunomide and &#8364;10 746 for methotrexate SC&#46; Results considering ACR50 are &#8364;7173 and &#8364;15 044 for leflunomide and methotrexate respectively&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Comparar 2 farmacos para la artritis reumatoide &#40;AR&#41;&#58; leflunomida y metotrexato subcutaneo &#40;s&#46;c&#46;&#41; &#40;jeringas precargadas&#41;&#44; considerando tanto costes anuales de tratamiento como la efectividad medida a traves del numero de pacientes que es necesario tratar &#40;NNT&#41;&#46;</p> <span class="elsevierStyleSectionTitle">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Los datos de eficacia y dosis fueron extraidos del ensayo clinico US310&#44; ensayo aleatorizado y doble ciego&#44; que tuvo por objetivo comparar la eficacia y la seguridad del tratamiento a 12 meses con leflunomida &#40;20<span class="elsevierStyleHsp" style=""></span>mg&#47;dia&#41; frente a placebo y metotrexato &#40;7&#44;5&#8211;15<span class="elsevierStyleHsp" style=""></span>mg&#47;semana&#41; en 482 pacientes con AR activa&#46; La informacion sobre los actos medicos para los seguimientos de control se obtuvo de la ficha tecnica del producto&#46; El estudio de costes se ha realizado con la perspectiva del Sistema Nacional de Salud espanol&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Considerando el criterio de ACR20&#44; el NNT de leflunomida es 4 &#40;intervalo de confianza &#91;IC&#93; del 95&#37;&#44; 2&#44;56-7&#44;71&#41; y el de metotrexato s&#46;c&#46;&#44; 5 &#40;IC del 95&#37;&#44; 3&#44;03&#8211;14&#44;3&#41;&#59; para el criterio de ACR50&#44; el NNT de leflunomida es 4 &#40;IC del 95&#37;&#44; 2&#44;72&#8211;6&#44;54&#41; y el de metotrexato s&#46;c&#46;&#44; 7 &#40;IC del 95&#37;&#44; 4&#44;03&#8211;19&#44;3&#41;&#46; El coste anual del farmaco fue 1&#46;112&#44;52 euros para la leflunomida y 1&#46;438&#44;91 euros para el metotrexato s&#46;c&#46; Los costes anuales de monitorizacion fueron 680&#44;76 euros para la leflunomida y 710&#44;26 euros para el metotrexato s&#46;c&#46;</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Combinando la informacion&#44; el coste de un paciente respondedor segun ACR20 seria de 7&#46;173 euros con leflunomida y 10&#46;746 euros con metotrexato s&#46;c&#46;&#59; los resultados considerando ACR50 oscilarian entre los 7&#46;173 euros para la leflunomida y 15&#46;044 euros para el metotrexato s&#46;c&#46;</p>"
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A comparison of leflunomide and subcutaneous methotrexate in the treatment of rheumatoid arthritis: an approximation based on the number needed to treat
Comparación de leflunomida y metrotrexato subcutáneo en el tratamiento de la artritis reumatoide: una aproximación basada en el número de pacientes que es necesario tratar
Antonio J. Garcia Ruiza,
Corresponding author
ajgr@uma.es

Corresponding author.
, Ana C. Montesinos Galveza, Lucia Perez Costillasa, Pablo Rebollob
a Unit of Pharmacoeconomics and Health Results Research, Universidad de Málaga, Málaga, Spain
b BAP Health Outcomes, Oviedo, Spain
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    "titulo" => "A comparison of leflunomide and subcutaneous methotrexate in the treatment of rheumatoid arthritis&#58; an approximation based on the number needed to treat"
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        "titulo" => "Comparaci&#243;n de leflunomida y metrotrexato subcut&#225;neo en el tratamiento de la artritis reumatoide&#58; una aproximaci&#243;n basada en el n&#250;mero de pacientes que es necesario tratar"
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        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To compare&#44; in the Spanish setting&#44; 2 drugs for adults with rheumatoid artritis &#40;RA&#41;&#58; leflunomide and subcutaneous methotrexate &#40;SC&#41;&#46; The high price of methotrexate SC compared with traditional presentations of methotrexate justifies conducting an economic evaluation comparing it with leflunomide&#46;</p> <span class="elsevierStyleSectionTitle">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The analysis considered the annual costs of the drugs and their effectiveness&#44; measured with a number needed to treat &#40;NNT&#41; approach&#44; considering both the ACR20 and ACR50 criteria for effectiveness&#46; Data about efficacy and dosage were derived from the clinical trial US310&#44; a randomized&#44; doble-blinded controlled trial&#44; which compared efficacy and safety of leflunomide &#40;20<span class="elsevierStyleHsp" style=""></span>mg&#47;daily&#41; versus placebo versus methotrexate &#40;7&#46;5&#8211;15<span class="elsevierStyleHsp" style=""></span>mg&#47;weekly&#41; in 482 patients with active RA&#46; Data about use of medical resources for drug monitoring &#40;visits to rheumatologists and diagnostic procedures&#41; were derived from the manufacturers¿ summary of product characteristics&#46; Direct costs &#40;drugs and monitoring&#41; were obtained from 2 Spanish databases&#46; The analysis has been performed under the Spanish National Health System perspective&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Using the ACR20 criteria&#44; the NNT with leflunomide and methotrexate are 4 &#40;95&#37; CI&#44; 2&#46;56&#8211;7&#46;71&#41; and 5 &#40;95&#37; CI&#44; 3&#46;03&#8211;14&#46;3&#41; respectively&#46; Using the ACR50 criteria&#44; NNT are 4 &#40;95&#37; CI&#44; 2&#46;72-6&#46;54&#41; and 7 &#40;95&#37; CI&#44; 4&#46;03&#8211;19&#46;3&#41;&#46; In the case of leflunomide&#44; annual treatment costs per patient-year equals &#8364;1793&#46;30&#59; in the case of methotrexate total treatment costs amounts to &#8364;2149&#46;20</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Combining these results the cost of a controlled patient according to ACR20 would amount &#8364;7173 for leflunomide and &#8364;10 746 for methotrexate SC&#46; Results considering ACR50 are &#8364;7173 and &#8364;15 044 for leflunomide and methotrexate respectively&#46;</p>"
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        "titulo" => "Resumen"
        "resumen" => "<span class="elsevierStyleSectionTitle">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Comparar 2 farmacos para la artritis reumatoide &#40;AR&#41;&#58; leflunomida y metotrexato subcutaneo &#40;s&#46;c&#46;&#41; &#40;jeringas precargadas&#41;&#44; considerando tanto costes anuales de tratamiento como la efectividad medida a traves del numero de pacientes que es necesario tratar &#40;NNT&#41;&#46;</p> <span class="elsevierStyleSectionTitle">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Los datos de eficacia y dosis fueron extraidos del ensayo clinico US310&#44; ensayo aleatorizado y doble ciego&#44; que tuvo por objetivo comparar la eficacia y la seguridad del tratamiento a 12 meses con leflunomida &#40;20<span class="elsevierStyleHsp" style=""></span>mg&#47;dia&#41; frente a placebo y metotrexato &#40;7&#44;5&#8211;15<span class="elsevierStyleHsp" style=""></span>mg&#47;semana&#41; en 482 pacientes con AR activa&#46; La informacion sobre los actos medicos para los seguimientos de control se obtuvo de la ficha tecnica del producto&#46; El estudio de costes se ha realizado con la perspectiva del Sistema Nacional de Salud espanol&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Considerando el criterio de ACR20&#44; el NNT de leflunomida es 4 &#40;intervalo de confianza &#91;IC&#93; del 95&#37;&#44; 2&#44;56-7&#44;71&#41; y el de metotrexato s&#46;c&#46;&#44; 5 &#40;IC del 95&#37;&#44; 3&#44;03&#8211;14&#44;3&#41;&#59; para el criterio de ACR50&#44; el NNT de leflunomida es 4 &#40;IC del 95&#37;&#44; 2&#44;72&#8211;6&#44;54&#41; y el de metotrexato s&#46;c&#46;&#44; 7 &#40;IC del 95&#37;&#44; 4&#44;03&#8211;19&#44;3&#41;&#46; El coste anual del farmaco fue 1&#46;112&#44;52 euros para la leflunomida y 1&#46;438&#44;91 euros para el metotrexato s&#46;c&#46; Los costes anuales de monitorizacion fueron 680&#44;76 euros para la leflunomida y 710&#44;26 euros para el metotrexato s&#46;c&#46;</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Combinando la informacion&#44; el coste de un paciente respondedor segun ACR20 seria de 7&#46;173 euros con leflunomida y 10&#46;746 euros con metotrexato s&#46;c&#46;&#59; los resultados considerando ACR50 oscilarian entre los 7&#46;173 euros para la leflunomida y 15&#46;044 euros para el metotrexato s&#46;c&#46;</p>"
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