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Vol. 14. Num. 2.March - April 2018
Pages 65-124
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Vol. 14. Num. 2.March - April 2018
Pages 65-124
Original Article
DOI: 10.1016/j.reumae.2016.10.005
Biologic Disease-modifying Antirheumatic Drug Attributes in the First Lines of Treatment of Rheumatoid Arthritis. 2015 ACORDAR Project
Atributos del fármaco antirreumático modificador de la enfermedad biológico en las primeras líneas de tratamiento de la artritis reumatoide. Proyecto ACORDAR 2015
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Santiago Muñoz-Fernándeza,
Corresponding author
santiago.munoz@salud.madrid.org

Corresponding author.
, María Sagrario Bustabad Reyesb, Jaime Calvo Alénc, Manuel Castaño Sánchezd, Eugenio Chamizo Carmonae, Héctor Corominasf, Nagore Fernández-Llanio Comellag, María Cristina Hidalgo Callejah, José Javier Pérez Venegasi, José Manuel Rodríguez Herediaj, Susana María Romero Yustek, Virginia Ruiz-Esquide Torinol, ACORDAR 2015 Working Group
a Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, Madrid, Spain
b Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain
c Hospital Universitario Araba, Vitoria, Álava, Spain
d Hospital Universitario Virgen de la Arrixaca, Murcia, Spain
e Hospital de Mérida, Mérida, Badajoz, Spain
f Hospital Moisés Broggi, Sant Joan Despí, Barcelona, Spain
g Hospital Arnau de Vilanova, Valencia, Spain
h Hospital Clínico de Salamanca, Salamanca, Spain
i Hospital de Jerez de la Frontera, Jerez de la Frontera, Cádiz, Spain
j Hospital Universitario de Getafe, Getafe, Madrid, Spain
k Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain
l Hospital Clínic i Provincial, Barcelona, Spain
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Statistics
Figures (1)
Tables (3)
Table 1. Analysis of the Attributes of Biological Disease-modifying Antirheumatic Drugs and Results of the 2 Delphi Rounds.
Table 2. Spearman Correlation Coefficients and Cronbach Alpha.
Table 3. Attributes With an Agreement of 100% in the 2 Delphi Rounds of the Study.
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Abstract
Objective

To date, between 17% and 35% of patients with rheumatoid arthritis (RA) do not respond as expected to the initial biological therapy. The objective of this project is to recognize and weigh the attributes of biologic DMARD (bDMARD) to identify the most appropriate for each case, in the first lines of treatment of RA (after inadequate response to at least one synthetic DMARD or previous bDMARD).

Methods

To recognize the possible attributes that could define the bDMARD, we performed a systematic search of the literature that recognized the possible attributes involving general aspects, pharmacology, efficacy, safety, management, and cost. Then a Delphi process was conducted with two rounds among a group of selected expert rheumatologists in the management of RA indicating the degree of agreement with the attributes identified in the literature. The project was completed between February and September 2015, indicating the degree of importance that was ascribed to each attribute. Two criteria were applied to determine the consistency of results: (1) based on the median and interquartile range; and (2) on the simultaneous compliance with mean, median, standard deviation, interquartile range and coefficient of variation. The agreement and final ratification of the expert panel were also determined.

Results

Eighty-three Spanish rheumatologists participated and completed both rounds of the Delphi process. In no case was the importance of the 77 attributes identified considered to be low; 75 of 77 (97.4%) were considered highly important and 76 of 77 (98.7%) were ratified. Fifteen attributes had the support of 100% of the working group.

Conclusions

There was a high degree of agreement concerning the selected attributes. Fifteen of them had the support of 100% of the working group and could be considered the definition of the ideal bDMARD in the first lines of RA treatment.

Keywords:
Characteristic
Arthritis
Biologic
Disease-modifying antirheumatic drug
Selection
Resumen
Objetivo

Existen pacientes con artritis reumatoide (AR) que no responden de la forma deseada a la terapia biológica. Nuestro objetivo fue reconocer los atributos del FAME biológico (FAMEb) que podrían identificar al más adecuado en las primeras líneas de tratamiento de la AR.

Métodos

Para reconocer los atributos que podrían definir el FAMEb, se realizó una búsqueda sistemática de la literatura acerca de aspectos generales, farmacología, eficacia, seguridad, administración y coste. A continuación, se realizó un proceso Delphi a 2 rondas entre un grupo de reumatólogos expertos en el manejo de la AR para determinar el grado de acuerdo con los atributos identificados, indicando el grado de importancia que se le daba a cada atributo. Se aplicaron 2 criterios para determinar la consistencia de los resultados: 1) sobre la base de la mediana y el rango intercuartílico, y 2) el cumplimiento simultáneo de media, mediana, desviación estándar, rango intercuartílico y coeficiente de variación. Se determinaron también la concordancia y la ratificación final del panel de expertos.

Resultados

Ochenta y tres reumatólogos españoles completaron las 2 circulaciones del proceso Delphi. Ninguno de los 77 atributos identificados se consideró de baja importancia, 75 de los 77 (97,4%) se consideraron de alta importancia y 76 de los 77 (98,7%) fueron ratificados. Quince tuvieron el apoyo del 100% del grupo de trabajo.

Conclusiones

Quince atributos tuvieron el apoyo del 100% del grupo de trabajo y podrían considerarse los que definirían el FAMEb ideal en las primeras líneas de tratamiento de la AR.

Palabras clave:
Características
Artritis
Biológico
Fármaco antirreumático modificador de la enfermedad
Selección

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