Your browser doesn't support javascript.
loading
Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months
Guerra Veloz, María Fernanda; Vázquez Morón, Juan María; Belvis Jiménez, María; Pallarés Manrique, Héctor; Valdés Delgado, Teresa; Castro Laria, Luisa; Maldonado Pérez, Belén; Benítez Roldán, Antonio; Perea Amarillo, Raúl; Merino, Vicente; Caunedo Álvarez, Ángel; Vilches-Arenas, Ángel; Argüelles Arias, Federico.
Afiliação
  • Guerra Veloz, María Fernanda; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
  • Vázquez Morón, Juan María; Hospital Juan Ramón Jiménez. Gastroenterology Service. Huelva. Spain
  • Belvis Jiménez, María; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
  • Pallarés Manrique, Héctor; Hospital Juan Ramón Jiménez. Gastroenterology Service. Huelva. Spain
  • Valdés Delgado, Teresa; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
  • Castro Laria, Luisa; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
  • Maldonado Pérez, Belén; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
  • Benítez Roldán, Antonio; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
  • Perea Amarillo, Raúl; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
  • Merino, Vicente; Hospital Universitario Virgen Macarena. Pharmacy Unit. Sevilla. Spain
  • Caunedo Álvarez, Ángel; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
  • Vilches-Arenas, Ángel; Hospital Universitario Virgen Macarena. Department of Preventive Medicine and Public Health. Sevilla. Spain
  • Argüelles Arias, Federico; Hospital Universitario Virgen Macarena. Gastroenterology Service. Sevilla. Spain
Rev. esp. enferm. dig ; 110(9): 564-570, sept. 2018. tab, graf
Article em En | IBECS | ID: ibc-177777
Biblioteca responsável: ES1.1
Localização: BNCS
ABSTRACT
Background and aims: infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. Methods: this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC). All patients had switched from infliximab RP (Remicade(R)) to CT-P13 treatment and were followed up for 12 months. The efficacy endpoint was the change in clinical remission assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. Adverse events were monitored and recorded throughout the study. Results: a total of 167 patients (116 CD/51 UC) were included; 88.8% (103/116) of patients with CD were in remission at the time of the drug switch and 69.7% were in remission at 12 months. The Harvey-Bradshaw (HB) score significantly changed at 12 months (p = 0.001); 84.3% (43/51) of patients with UC were in remission at the time of the drug switch and 76.7% were in remission at 12 months. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Serious adverse events related to medication were reported in 12/167 (7.2%) cases. Conclusion: switching from infliximab RP to CT-P13 is safe and effective at 12 months. The loss of efficacy at 12 months was 15.7%
RESUMEN
No disponible
Assuntos

Texto completo: 1 Coleções: 06-national / ES Base de dados: IBECS Assunto principal: Colite Ulcerativa / Doença de Crohn / Síndrome do Intestino Irritável / Infliximab Limite: Humans Idioma: En Revista: Rev. esp. enferm. dig Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Coleções: 06-national / ES Base de dados: IBECS Assunto principal: Colite Ulcerativa / Doença de Crohn / Síndrome do Intestino Irritável / Infliximab Limite: Humans Idioma: En Revista: Rev. esp. enferm. dig Ano de publicação: 2018 Tipo de documento: Article