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Vol. 18. Issue 10.
Pages 567-573 (December 2022)
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Vol. 18. Issue 10.
Pages 567-573 (December 2022)
Original Article
Effectiveness and safety of tocilizumab in monotherapy in biologic-naïve and non-naïve patients with rheumatoid arthritis in a real-world setting
Eficacia y seguridad de tocilizumab en monoterapia en pacientes con artritis reumatoide naive y no naive a biológicos en un entorno del mundo real
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Sara Marsal Barrila, Mª Auxiliadora Martin-Martinezb,
Corresponding author
xily_mm@yahoo.com

Corresponding author.
, Francisco Javier Blanco-Garciac, Antonio Fernández-Nebrod, Rosario García de Vicuñae, Jesús Tornero-Molinaf,g, Fernando Sánchez-Alonsob, Marta Novella-Navarroh, Alejandro Escudero-Contrerasi, Juan José Alegre-Sanchoj, Ana Urruticoechea-Aranak, Maria Sagrario Bustabad-Reyesl, Pilar Trenor-Larrazm, Trinidad Pérez-Sandovaln, Maria Isabel Tevar-Sánchezo, Jesús T. Sánchez-Costab, Enrique Raya-Álvarezp
a Rheumatology Department, Hospital Universitario Vall d’Hebron, Passeig de la Vall d’Hebron, 119, 129, 08035 Barcelona, Spain
b Research Unit of Spanish Society of Rheumatology, Calle Marqués del Duero, 5 Primero A, 28001 Madrid, Spain
c Rheumatology Department, Complejo Hospitalario Universitario A Coruña, As Xubias, 84, 15006 A Coruña, Spain
d Rheumatology Department, Biomedical Research Institute of Málaga (IBIMA), Hospital Universitario Regional de Málaga, Av. de Carlos Haya, 84, 29010 Málaga, Spain
e Rheumatology Department, Hospital Universitario La Princesa, Calle de Diego de León, 62, 28006, Madrid, Spain
f Rheumatology Department, Hospital Universitario de Guadalajara, Calle Donante de Sangre, S/N, 19002 Guadalajara, Spain
g Medicine and Medical Specialties Departament, University of Alcalá, Campus Universitario - C/ 19, Av. de Madrid, Km 33,600, 28871 Alcalá de Henares, Madrid, Spain
h Rheumatology Department, Hospital Universitario de Torrejón, Calle Mateo Inurria, s/n, 28850 Torrejón de Ardoz, Madrid, Spain
i Rheumatology Department, Hospital Universitario Reina Sofia, Córdoba. Av. Menéndez Pidal, s/n, 14004, Córdoba, Spain
j Rheumatology Department, Hospital Universitario Doctor Peset, Valencia, Av. de Gaspar Aguilar, 90, 46017 Valencia, Spain
k Rheumatology Department, Hospital Can Misses, Carrer de Corona, s/n, 07800 Ibiza, Islas Baleares, Spain
l Rheumatology Department, Hospital Universitario de Canarias, Carretera Cuesta Taco, 0, 38320 Santa Cruz de Tenerife, Islas Canarias, Spain
m Rheumatology Department, Hospital Clínico Universitario de Valencia, Av. de Blasco Ibáñez, 17, 46010 Valencia, Spain
n Rheumatoloy Department, Complejo Asistencial Universitario de León, Calle Altos de nava, s/n, 24001 León, Spain
o Rheumatoloy Department, Hospital Vega Baja, Ctra. Orihuela – Almoradí S/N, 03314 San Bartolomé, Orihuela, Spain
p Rheumatoloy Department, Hospital Universitario San Cecilio, Av. de la Investigación, s/n, 18016 Granada, Spain
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Abstract
Objective

To evaluate the effectiveness and safety of tocilizumab (TCZ) monotherapy in biologic-naïve patients with rheumatoid arthritis (RA) versus patients with previous biologic exposure in a real-world setting.

Materials and methods

Non-controlled clinical-trial, 32-week prospective multicenter study including RA patients with moderate-severe disease activity starting TCZ in monotherapy who had a prior inadequate response or were intolerant to methotrexate (MTX). Effectiveness according to EULAR response evaluated at 24-week and safety at 32-weekwere assessed.

Results

Of the 93 were enrolled of whom 84 (90%) were eligible for the effectiveness analysis. Biologic-naïve patients (n=46, 54.8%) were younger (51.5 versus 57.9) with shorter disease duration (6.4 versus 13.3) but presented similar comorbidities in comparison with non-naïve patients. DAS28 remission was achieved in a higher percentage in the group of patients with prior biological treatment. 89 adverse events (AE) were recorded in 50 patients, most of them non-serious AE (non-SAE) (86.3%).

Conclusions

In a real world setting, TCZ exhibit similar effectiveness and safety in monotherapy in patients with RA regardless previous exposure to other biologic therapies. This study provides additional and valuable real-world findings on the use of TCZ in patients with RA.

Keywords:
Rheumatoid arthritis
Tocilizumab
Remission
Methotrexate
Biologic therapy
Resumen
Objetivo

Evaluar la efectividad y seguridad de la monoterapia con tocilizumab (TCZ) en pacientes con artritis reumatoide (AR) sin tratamiento biológico en comparación con pacientes con exposición previa a biológico en un entorno real.

Materiales y métodos

Ensayo clínico no controlado, estudio multicéntrico prospectivo de 32 semanas que incluyó pacientes con AR con actividad de la enfermedad moderada-grave que comenzaron con TCZ en monoterapia y que tuvieron una respuesta inadecuada previa o fueron intolerantes al metotrexato. La eficacia de acuerdo con la respuesta EULAR fue evaluada a las 24 semanas y la seguridad a las 32 semanas.

Resultados

De los 93 pacientes seleccionados, 84 (90%) fueron elegibles para el análisis de efectividad. Los pacientes sin tratamiento biológico previo (n=46, 54,8%) eran más jóvenes (51,5 frente a 57,9 años), con una duración más corta de la enfermedad (6,4 frente a 13,3 años), pero presentaban comorbilidades similares en comparación con los pacientes con tratamiento previo. La remisión de DAS28 se logró en un mayor porcentaje en el grupo de pacientes con tratamiento biológico previo. Se registraron 89 eventos adversos en 50 pacientes, la mayoría de ellos no graves (86,3%).

Conclusiones

En un entorno del mundo real, TCZ exhibe una eficacia y seguridad similares en monoterapia en pacientes con AR, independientemente de la exposición previa a otras terapias biológicas. Este estudio proporciona hallazgos adicionales y valiosos en el contexto del mundo real sobre el uso de TCZ en pacientes con AR.

Palabras clave:
Artritis reumatoide
Tocilizumab
Remisión
Metotrexato
Terapia biológica

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