Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

M.J. Pierik; A.E. Van der Meulen; K. Van der Linde; M. Lutgens; J.P. Kuijvenhoven; H. Akol; I.J. Klompmaker; M.S.G. Sikkens; Y.J.B. Van Megen; C.M. Stoop; J.P.J. Bloemsaat-Minekus; G. Dijkstra

doi:10.1093/crocol/otab001

Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

M.J. Pierik, A.E. Van der Meulen, K. Van der Linde, M. Lutgens, J.P. Kuijvenhoven, H. Akol, I.J. Klompmaker, M.S.G. Sikkens, Y.J.B. Van Megen, C.M. Stoop, J.P.J. Bloemsaat-Minekus^*, G. Dijkstra

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Lay Summary Patients with inflammatory bowel disease were switched from the originator infliximab to the biosimilar CT-P13. Before and after switching they filled in questionnaires. The study showed that switching did not reduce the quality of life and efficacy of the treatment.Background Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching. Methods OoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions. Results One hundred seventy-eight patients were included. Noninferiority was established for QoL [ratio 97.95% (95% confidence interval 95.93 to 100.01)] and efficacy [difference -0.02 (95% confidence interval -0.68 to 0.64)]. Five patients reported 6 nonrelated, serious adverse events. Conclusions Switching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated.

Original language	English
Article number	001
Number of pages	8
Journal	Crohn's & Colitis 360
Volume	4
Issue number	3
DOIs	https://doi.org/10.1093/crocol/otab001
Publication status	Published - 1 Jul 2022

Keywords

quality of life
infliximab
biosimilar
inflammatory bowel disease
CROHNS-DISEASE
END-POINTS
THERAPY
INHIBITORS
EFFICACY

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10.1093/crocol/otab001Licence: CC BY-NC

Cite this

Pierik, M. J., Van der Meulen, A. E., Van der Linde, K., Lutgens, M., Kuijvenhoven, J. P., Akol, H., Klompmaker, I. J., Sikkens, M. S. G., Van Megen, Y. J. B., Stoop, C. M., Bloemsaat-Minekus, J. P. J., & Dijkstra, G. (2022). Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients. Crohn's & Colitis 360, 4(3), Article 001. https://doi.org/10.1093/crocol/otab001

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title = "Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients",

abstract = "Lay Summary Patients with inflammatory bowel disease were switched from the originator infliximab to the biosimilar CT-P13. Before and after switching they filled in questionnaires. The study showed that switching did not reduce the quality of life and efficacy of the treatment.Background Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching. Methods OoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions. Results One hundred seventy-eight patients were included. Noninferiority was established for QoL [ratio 97.95% (95% confidence interval 95.93 to 100.01)] and efficacy [difference -0.02 (95% confidence interval -0.68 to 0.64)]. Five patients reported 6 nonrelated, serious adverse events. Conclusions Switching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated.",

keywords = "quality of life, infliximab, biosimilar, inflammatory bowel disease, CROHNS-DISEASE, END-POINTS, THERAPY, INHIBITORS, EFFICACY",

author = "M.J. Pierik and {Van der Meulen}, A.E. and {Van der Linde}, K. and M. Lutgens and J.P. Kuijvenhoven and H. Akol and I.J. Klompmaker and M.S.G. Sikkens and {Van Megen}, Y.J.B. and C.M. Stoop and J.P.J. Bloemsaat-Minekus and G. Dijkstra",

year = "2022",

month = jul,

day = "1",

doi = "10.1093/crocol/otab001",

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Pierik, MJ, Van der Meulen, AE, Van der Linde, K, Lutgens, M, Kuijvenhoven, JP, Akol, H, Klompmaker, IJ, Sikkens, MSG, Van Megen, YJB, Stoop, CM, Bloemsaat-Minekus, JPJ & Dijkstra, G 2022, 'Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients', Crohn's & Colitis 360, vol. 4, no. 3, 001. https://doi.org/10.1093/crocol/otab001

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T1 - Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

AU - Pierik, M.J.

AU - Van der Meulen, A.E.

AU - Van der Linde, K.

AU - Lutgens, M.

AU - Kuijvenhoven, J.P.

AU - Akol, H.

AU - Klompmaker, I.J.

AU - Sikkens, M.S.G.

AU - Van Megen, Y.J.B.

AU - Stoop, C.M.

AU - Bloemsaat-Minekus, J.P.J.

AU - Dijkstra, G.

PY - 2022/7/1

Y1 - 2022/7/1

N2 - Lay Summary Patients with inflammatory bowel disease were switched from the originator infliximab to the biosimilar CT-P13. Before and after switching they filled in questionnaires. The study showed that switching did not reduce the quality of life and efficacy of the treatment.Background Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching. Methods OoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions. Results One hundred seventy-eight patients were included. Noninferiority was established for QoL [ratio 97.95% (95% confidence interval 95.93 to 100.01)] and efficacy [difference -0.02 (95% confidence interval -0.68 to 0.64)]. Five patients reported 6 nonrelated, serious adverse events. Conclusions Switching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated.

AB - Lay Summary Patients with inflammatory bowel disease were switched from the originator infliximab to the biosimilar CT-P13. Before and after switching they filled in questionnaires. The study showed that switching did not reduce the quality of life and efficacy of the treatment.Background Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching. Methods OoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions. Results One hundred seventy-eight patients were included. Noninferiority was established for QoL [ratio 97.95% (95% confidence interval 95.93 to 100.01)] and efficacy [difference -0.02 (95% confidence interval -0.68 to 0.64)]. Five patients reported 6 nonrelated, serious adverse events. Conclusions Switching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated.

KW - quality of life

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KW - inflammatory bowel disease

KW - CROHNS-DISEASE

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KW - THERAPY

KW - INHIBITORS

KW - EFFICACY

U2 - 10.1093/crocol/otab001

DO - 10.1093/crocol/otab001

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VL - 4

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