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Vol. 17. Issue 6.
Pages 329-334 (June - July 2021)
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Vol. 17. Issue 6.
Pages 329-334 (June - July 2021)
Original Article
DOI: 10.1016/j.reumae.2019.11.005
Effectiveness of intravenous tocilizumab in routine clinical practice in a cohort of Costa Rican patients with rheumatoid arthritis
Efectividad del tocilizumab intravenoso en la práctica clínica usual de una cohorte de pacientes costarricenses con artritis reumatoide
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Mauricio Cordero-Alfaroa,
Corresponding author
maucordero@gmail.com

Corresponding author.
, Carlos León-Céspedesa, Allan Ramos-Esquivelb
a Servicio de Reumatología, Hospital San Juan de Dios, San José, Costa Rica
b Departamento de Farmacología, Universidad de Costa Rica, San José, Costa Rica
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Figures (2)
Tables (3)
Table 1. Clinical characteristics of the patients included.
Table 2. Univariate analysis of potential predictors of remission (DAS28 < 2.6) at 3 months.
Table 3. Multivariate analysis of potential predictors of remission (DAS28 < 2.6) at 3 months.
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Abstract
Objective

To determine the effectiveness and the incidence of severe adverse events in a cohort of Costa Rican patients with Rheumatoid Arthritis (RA) treated with intravenous (IV) tocilizumab (TCZ).

Patients and methods

A retrospective analysis was carried out in 45 patients that were unresponsive to disease-modifying antirheumatic drugs (DMARDs). The study included patients who received IV TCZ every 4 weeks (4 mg/kg) along with methotrexate or leflunomide. Effectiveness was measured through the incidence of clinical remission according to a disease activity score – erythrocyte sedimentation rate (DAS28-ESR) less than 2.6. Safety was assessed by the incidence rate of serious adverse events. An univariate and multivariate logistic regression analysis was performed to assess the association of potential variables with the probability of achieving remission during the first 3 months of TCZ therapy.

Results

During the 3rd month of TCZ therapy, a total of 22 patients (48.9%; 95% Confidence Interval (CI) 34.3%–63.5%) achieved remission. The cumulative incidence of patients with remission at month 12 was 75.0% (n = 34) (95% CI: 62.3%–87.6%). A total of 18 patients (40%; 95% CI: 25.7%–54.3%) were switched to a 8 mg/kg dose due to the absence of remission. The incidence rate of serious adverse events was .98 per 100 patients/year, all of them due to infectious diseases with no fatal events reported. Only basal DAS28-ESR was associated with the probability of achieving remission at month 3.

Conclusions

IV TCZ (4 mg/kg) is an effective and safe treatment for RA patients in a clinical setting in Costa Rica.

Keywords:
Disease-modifying antirheumatic drugs
Rheumatoid arthritis
Effectiveness
Safety
Humanised monoclonal antibody
Optimisation
Tocilizumab
Resumen
Objetivo

Determinar la efectividad y la incidencia de eventos adversos graves del tocilizumab (TCZ) en una cohorte de pacientes costarricenses con artritis reumatoide (AR).

Pacientes y métodos

Se realizó un análisis retrospectivo de 45 pacientes con AR, refractarios al uso previo de fármacos modificadores de la enfermedad reumática (FAME), que utilizaron TCZ a una dosis inicial de 4 mg/kg intravenoso (IV) cada 4 semanas en asociación con metotrexato o leflunomida. La medida de efectividad fue la incidencia de remisión clínica, determinada cada 3 meses y definida por un puntaje de actividad de la enfermedad en 28 articulaciones con velocidad de sedimentación globular (DAS28-VSG) menor de 2,6. La seguridad del fármaco se evaluó mediante la tasa de incidencia de eventos adversos severos. Se realizó un modelo de regresión logística uni- y multivariado para determinar las variables asociadas con la probabilidad de remisión a los 3 meses de iniciado el tratamiento.

Resultados

A los 3 meses de tratamiento un total de 22 pacientes (48,9%; intervalo de Confianza [IC] del 95%: 34,3–63,5%) alcanzaron remisión, en tanto que a los 12 meses de terapia con TCZ el valor aumentó a 34 pacientes (75%; IC 95%: 62,3–87,6%). Un total de 18 pacientes (40%; IC 95%: 25,7–54,3%) requirieron aumento de dosis del TCZ de 4 a 8 mg/kg ante la ausencia de remisión. La tasa de incidencia de eventos adversos severos fue de 0,98 por 100 pacientes/año, correspondiendo todos ellos a cuadros infecciosos que resolvieron sin ningún desenlace fatal. Solo el DAS28-VSG inicial se asoció de forma independiente con la probabilidad de remisión a los 3 meses.

Conclusiones

El uso de TCZ IV a una dosis inicial de 4 mg/kg en pacientes costarricenses con AR es efectivo y seguro en la práctica clínica.

Palabras clave:
Anticuerpo monoclonal humanizado
Artritis reumatoide
Efectividad
Seguridad
Fármacos modificadores de la enfermedad reumática
Optimización
Tocilizumab

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