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J Crohns Colitis. 2019 Apr 12. pii: jjz070. doi: 10.1093/ecco-jcc/jjz070. [Epub ahead of print]

Effectiveness and safety of the switch from Remicade to CT-P13 in patients with inflammatory bowel disease.

Author information

1
Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid.
2
Hospital Universitario Virgen Macarena, Sevilla.
3
Hospital Juan Ramón Jiménez, Huelva.
4
Complejo Hospitalario Universitario de Vigo, Vigo.
5
Hospital Universitario Virgen del Rocío, Sevilla.
6
Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife.
7
Hospital Universitario Río Hortega, Valladolid.
8
Hospital Universitario Central de Asturias, Asturias.
9
Hospital de Galdakao-Usansolo, Vizcaya.
10
Consorcí Corporació Sanitària Parc Tauli de Sabadell and CIBERehd, Barcelona.
11
Instituto Biodonostia, Universidad del País Vasco (UPV/EHU) and CIBERehd, San Sebastián.
12
Hospital Universitario Marqués de Valdecilla and IDIVAL, Santander.
13
Hospital Clínico Universitario Lozano Blesa and CIBERehd, Zaragoza.
14
Hospital Universitario Reina Sofía, Córdoba.
15
Hospital Universitario de Fuenlabrada, Madrid.
16
Hospital Clínico Universitario de Valladolid, Valladolid.
17
Hospital General Universitario de Alicante, Alicante.
18
Hospital Germans Trials i Pujol and CIBERehd, Barcelona.
19
Hospital Universitario y Politécnico de La Fe, Valencia, Spain. and CIBERehd.
20
Hospital General Universitario de Ciudad Real, Ciudad Real.
21
Hospital Universitario Nuestra Señora de Valme, Sevilla.
22
Hospital Clínico Universitario de Santiago, Santiago de Compostela.
23
Hospital General de La Palma, La Palma.
24
Hospital Universitario de Torrejón, Madrid.
25
Hospital Regional Universitario de Málaga, Málaga. Spain.
26
Pharmacy Unit, Hospital Universitario de La Princesa, IIS-IP. Spain.

Abstract

AIMS:

To evaluate the clinical outcomes in patients with IBD after switching from Remicade to CT-P13 in comparison with patients who maintain Remicade .

METHODS:

Patients under Remicade who were in clinical remission with standard dosage at study entry were included. The switch cohort (SC) comprised patients who made the switch from Remicade to CT-P13, and the "non-switch" cohort (NC) patients kept under Remicade .

RESULTS:

Four hundred seventy-six patients were included: 199 (42%) in the SC and 277 (58%) in the NC. Median follow-up was 18 months in the SC and 23 months in the NC (p<0.01). Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR=3.5, 95%CI=2-6). Thirteen percent of patients had adverse events in the NC and 6% in the SC (p<0.05).

CONCLUSIONS:

Switching from Remicade to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. Nocebo effect might have influenced this result. Switching from Remicade to CT-P13 was safe.

KEYWORDS:

CT-P13; Crohn’s disease; Inflammatory bowel disease; Remicade; switch; ulcerative colitis

PMID:
30976785
DOI:
10.1093/ecco-jcc/jjz070

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