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. 2021 Feb 14;4(3):otab001.
doi: 10.1093/crocol/otab001. eCollection 2022 Jul.

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

Marieke J Pierik  1 , Andrea E van der Meulen  2 , Klaas Van der Linde  3 , Maurice Lutgens  4 , Johan P Kuijvenhoven  5 , Halil Akol  6 , Ids J Klompmaker  7 , Michelle S G Sikkens  8 , Yvonne J B van Megen  9 , Corinne M Stoop  9 , Joanne P J Bloemsaat-Minekus  9 , Gerard Dijkstra  10
Affiliations

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

Marieke J Pierik et al. Crohns Colitis 360. .

Abstract

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: biosimilar; inflammatory bowel disease; infliximab; quality of life.

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Figures

FIGURE 1.
FIGURE 1.
Trial flow diagram.
FIGURE 2.
FIGURE 2.
QoL measured with the IBDQ score during the study period for the intention to treat (ITT) population. The box represents the interquartile range. The line in the middle of the box represents the median. The asterisk represents the mean. The whiskers represent the maximum value (1.5 times higher than the 75th percentile) and minimum (1.5 times lower than the 25th percentile) values. The circles outside the whiskers represent outliers.
See this image and copyright information in PMC

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