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PERFUSE: Non-interventional cohort study of patients receiving infliximab biosimilar SB2 [...]

Martinez-Vinson, Christine MD; Lemoine, Anaïs MD; Bouhnik, Yoram MD, PhD; Braithwaite, Ben M. Sc. A., M. Ing.; Fohlen-Weill, Audrey PharmD; Addison, Janet MSc


Journal of Pediatric Gastroenterology and Nutrition, December 16, 2022.

Voir la publication : DOI: 10.1097/MPG.0000000000003683


Abstract

Objectives:

PERFUSE s a non-interventional study of 1233 patients (inflammatory rheumatic disease, n=496; inflammatory bowel disease [IBD], n=737) receiving infliximab (IFX) biosimilar SB2 therapy. This analysis describes response to treatment and persistence on SB2 for up to 12 months in paediatric IBD patients (n=126).

Methods:

Paediatric IBD patients with Crohn's disease (CD) or ulcerative colitis (UC), either naïve or switched from originator infliximab, who started SB2 in routine practice after September 2017 were eligible. Data were captured for 12 months following SB2 initiation. Disease activity was measured using C-Reactive Protein (CRP) levels and the Harvey-Bradshaw Index (HBI) or Paediatric Ulcerative Colitis Activity Index (PUCAI) for CD and UC patients respectively. Body Mass Index (BMI) and height z-scores were used to assess patient growth between initiation (M0) and month 12 (M12).

Results:

126 paediatric IBD patients were included (102 CD patients, 51 naïve and 51 switched; 24 UC patients, 9 naïve and 15 switched). Naive patients’ disease scores decreased between M0 and M12. CRP measurements also decreased in naïve CD patients. Switched patients’ disease scores and CRP levels remained stable between M0 and M12. Height z-scores improved significantly over the course of the treatment for all groups except for naïve UC patients.

Conclusions:

SB2 provides effective disease control for naïve and switched paediatric patients. Clinical remission rates improved in naïve patients and no loss of control was observed in switched patients after 1 year. Growth failure is not observed in IBD patients under SB2 treatment.


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Copyright © 2022 The Author(s). Published by Wolters Kluwer on behalf of European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.


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