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Vol. 12. Issue 3.
Pages 139-145 (May - June 2016)
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Vol. 12. Issue 3.
Pages 139-145 (May - June 2016)
Original Article
DOI: 10.1016/j.reumae.2015.07.002
Eficiency of Different Doses of Rituximab in Rheumatoid Arthritis
Eficiencia de diferentes dosis de rituximab en la artritis reumatoide
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Natalia Mena-Vázquez, Sara Manrique-Arija, Inmaculada Ureña-Garnica, Carmen M. Romero-Barco, Francisco G. Jiménez-Núñez, Virginia Coret, María Victoria Irigoyen-Oyarzábal, Antonio Fernández-Nebro
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afernandezn@uma.es

Corresponding author.
Unidad de Gestión Clínica de Reumatología, Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Regional Universitario de Málaga, Universidad de Málaga, Málaga, Spain
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Figures (1)
Tables (5)
Table 1. Baseline Clinical Characteristics According to Treatment Group.
Table 2. Sequence of Rituximab Use and Previous Biological Agents According to Treatment Group.
Table 3. Retention Time and Rate of Rituximab Retreatment According to Treatment Group.
Table 4. Causes for Discontinuation and Adverse Effects of Rituximab According to Treatment Group.
Table 5. Costs in Euros per Treatment Group.
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Abstract
Objective

Evaluate the effectiveness, cost and safety of rituximab in patients with rheumatoid arthritis (RA) depending on the dose used.

Material and methods

Retrospective observational study conducted on 52 patients with RA treated with at least one dose of rituximab for 135.3 patient-years were included. Three treatment groups were obtained: (G1) First course and following two 1g infusions separated by 15 days; (G2) First course 2 infusions of 1g followed by 2 infusions of 500mg; (G3) First course and followed by 2 infusions of 500mg separated by 15 days. Re-treatments were administered on-demand according to the clinical activity. The retention time (Log-Rank), retreats and adverse events rates (incidence rate ratio) and treatment costs per patient-month of rituximab were analyzed by groups.

Results

Group 2 showed a better cost-effectiveness ratio than group 1, as it was associated with a longer retention of rituximab (mean [95% CI] 65.7 [60.8–70.7] months vs 33.5 [22.7–44.3]; P<.001) and a lower rate of severe adverse events with only a slight increase in the rate of retreatment (courses/patient-year [95% CI] 1.66 [1.39–1.93] vs 1.01 [0.69–1.34]; P=.005), and in the costs (median/patient-month, €484.89 vs €473.45). Although group 3 was €41.20/patient-month cheaper than group 2, it was associated with a higher rate of re-treatments and shorter retention of rituximab (P<.001).

Conclusions

The use of full-dose rituximab at onset, followed by reduced doses in successive courses administered on-demand retreatment may be the most cost-effective option.

Keywords:
Adult
Antibodies, monoclonal/administration and dosage
Antibodies, monoclonal/adverse effects
Antibodies, monoclonal/therapeutic use
Antibodies, monoclonal, murine-derived
Antirheumatic agents/administration and dosage
Antirheumatic agents/adverse effects
Antirheumatic agents/therapeutic use
Arthritis, rheumatoid/drug therapy
Arthritis, rheumatoid/immunology
Dose-response relationship, drug
Drug administration schedule
Humans
Rituximab
Treatment outcome
Resumen
Objetivo

Evaluar la efectividad, seguridad y coste de rituximab en pacientes con artritis reumatoide (AR) dependiendo de la dosis utilizada.

Material y métodos

Estudio observacional retrospectivo. Se incluyó a 52 pacientes con AR tratados al menos con una dosis de rituximab durante 135,3 pacientes-año. Se obtuvieron 3 grupos de tratamiento: G1, primer curso y siguientes de 2 infusiones de 1g separadas 15 días; G2, primer curso de 2 infusiones de 1g seguido por cursos de 2 infusiones de 500mg, y G3, primer curso y siguientes de 2 infusiones de 500mg separadas por 15 días. Los retratamientos fueron a demanda según la clínica. Se analizaron por grupos: el tiempo retención (Log-Rank), las tasas de retratamientos y de eventos adversos (razón de tasas de incidencia) y los costes del tratamiento por paciente-mes de rituximab.

Resultados

El grupo 2 mostró una mejor relación coste-efectividad que el grupo 1 ya que se asoció a una mayor retención de rituximab (media [IC del 95%] 65,7 [60,8-70,7] meses vs 33,5 [22,7-44,3]; p<0,001) y una menor tasa de eventos adversos graves, con solo un ligero incremento de la tasa de retratamientos (cursos/paciente-año [IC del 95%] 1,66 [1,39-1,93] vs 1,01 [0,69.-1,34]; p=0,005) y del coste (mediana/paciente-mes, 484,89 € vs 473,45 €). Aunque el grupo 3 fue 41,20 €/paciente-mes más económico que el grupo 2, se asoció a una mayor tasa de retratamientos y una menor retención de rituximab (p<0,001).

Conclusiones

El uso de rituximab a dosis completa al inicio seguido de dosis reducida en los sucesivos cursos administrados a demanda parece la opción más coste-efectiva.

Palabras clave:
Adulto
Anticuerpos, monoclonal/administración y dosis
Anticuerpos, monoclonal/efectos adversos
Anticuerpos, monoclonal/uso terapéutico
Anticuerpos, monoclonal, derivado-murino
Agentes antirreumáticos/administración y dosis
Agentes antirreumáticos/efectos adversos
Agentes antirreumáticos/uso terapéutico
Artritis, reumatoide/terapia farmacológica
Artritis, reumatoide/inmunología
Relación dosis-respuesta, fármaco
Pauta administración fármaco
Humanos
Rituximab
Tratamiento desenlace

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