Rev. OFIL 2017, 27;3:280-284
Fecha de recepción: 04/08/2016 – Fecha de aceptación: 20/12/2016
González de la Fuente GA, Gutiérrez Nicolás F, Nazco Casariego GJ, González García J, García Gil S, González Perera I
Servicio de Farmacia. Complejo Hospitalario Universitario de Canarias. Tenerife (España)
____
Correspondencia:
Guillermo A. González de la Fuente
Complejo Hospitalario Universitario de Canarias
(Servicio de Farmacia)
Carretera Ofra, s/n
38320 San Cristóbal de La Laguna, Santa Cruz de Tenerife
Correo electrónico: ggonzalezdlf@gmail.com
____
SUMMARY
Purpose: To compare the results of effectiveness and safety of original infliximab (PR) and biosimilar infliximab (CT-P13).
Methods: Two-year long descriptive and retrospective study, which included all adult patients who were prescribed PR or CT-P13. To evaluate the effectiveness, the corresponding disease activity indexes were recorded for each of the pathologies before entering the study and when leaving the study. To evaluate safety, the appearance of infusion reactions and / or drug side effects were registered.
Results: A total of 39 patients were included in the study:
– 21 in the PR group: 66.67% men, mean age: 46 years old [24-64].
– 18 in the CT-P13 group: 61.1% men, mean age: 41 years old [19-66]
On the whole, lack of effectiveness was observed in 3 patients in the PR group and in 2 patients in the CT-P13 group (p=0.78). In both groups, an infusion reaction occurred. As far as treatment interruptions because of side effects are concerned, 3 patients in the PR group had to discontinue therapy. Any interruption for this reason was observed in the CT-P13 (p=0.116).
Conclusions: According to our data, PR and CT-P13 don’t show significant differences in effectiveness and safety neither in adults nor in pediatric population.
Key Words: Infliximab, biosimilar, effectiveness, safety.
____
Download PDF: Análisis comparativo de efectividad y seguridad entre infliximab marca de referencia e infliximab biosimilar