Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months
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 o...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Aran Ediciones
2018-09-01
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| Series: | Revista Espanola de Enfermedades Digestivas |
| Subjects: | |
| Online Access: | http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082018000900006&tlng=en |
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| author | Maria-Fernanda Guerra-Veloz Juan-María Vázquez-Morón María Belvis-Jiménez Héctor Pallarés-Manrique Teresa Valdés-Delgado Luisa Castro-Laria Belén Maldonado-Pérez Antonio Benítez-Roldán Raúl Perea-Amarillo Vicente Merino Ángel Caunedo-Álvarez Ángel Vilches-Arenas Federico Argüelles-Arias |
| author_facet | Maria-Fernanda Guerra-Veloz Juan-María Vázquez-Morón María Belvis-Jiménez Héctor Pallarés-Manrique Teresa Valdés-Delgado Luisa Castro-Laria Belén Maldonado-Pérez Antonio Benítez-Roldán Raúl Perea-Amarillo Vicente Merino Ángel Caunedo-Álvarez Ángel Vilches-Arenas Federico Argüelles-Arias |
| author_sort | Maria-Fernanda Guerra-Veloz |
| collection | DOAJ |
| description | 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%. |
| first_indexed | 2024-12-20T16:18:05Z |
| format | Article |
| id | doaj.art-0e6345d5ab5d4913be382ed841c819f6 |
| institution | Directory Open Access Journal |
| issn | 1130-0108 |
| language | English |
| last_indexed | 2024-12-20T16:18:05Z |
| publishDate | 2018-09-01 |
| publisher | Aran Ediciones |
| record_format | Article |
| series | Revista Espanola de Enfermedades Digestivas |
| spelling | doaj.art-0e6345d5ab5d4913be382ed841c819f62022-12-21T19:33:43ZengAran EdicionesRevista Espanola de Enfermedades Digestivas1130-01082018-09-01110956457010.17235/reed.2018.5368/2017Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 monthsMaria-Fernanda Guerra-VelozJuan-María Vázquez-MorónMaría Belvis-JiménezHéctor Pallarés-ManriqueTeresa Valdés-DelgadoLuisa Castro-LariaBelén Maldonado-PérezAntonio Benítez-RoldánRaúl Perea-AmarilloVicente MerinoÁngel Caunedo-ÁlvarezÁngel Vilches-ArenasFederico Argüelles-AriasABSTRACT 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%.http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082018000900006&tlng=enCrohn's diseaseUlcerative colitisInflammatory bowel diseaseBiosimilar agentCT-P13Infliximab |
| spellingShingle | Maria-Fernanda Guerra-Veloz Juan-María Vázquez-Morón María Belvis-Jiménez Héctor Pallarés-Manrique Teresa Valdés-Delgado Luisa Castro-Laria Belén Maldonado-Pérez Antonio Benítez-Roldán Raúl Perea-Amarillo Vicente Merino Ángel Caunedo-Álvarez Ángel Vilches-Arenas Federico Argüelles-Arias Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months Revista Espanola de Enfermedades Digestivas Crohn's disease Ulcerative colitis Inflammatory bowel disease Biosimilar agent CT-P13 Infliximab |
| title | Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months |
| title_full | Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months |
| title_fullStr | Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months |
| title_full_unstemmed | Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months |
| title_short | Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months |
| title_sort | switching from reference infliximab to ct p13 in patients with inflammatory bowel disease results of a multicenter study after 12 months |
| topic | Crohn's disease Ulcerative colitis Inflammatory bowel disease Biosimilar agent CT-P13 Infliximab |
| url | http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082018000900006&tlng=en |
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