Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Apr 1;76(4):451-459.
doi: 10.1097/MPG.0000000000003683. Epub 2022 Dec 16.

PERFUSE: Non-Interventional Cohort Study of Patients Receiving Infliximab Biosimilar SB2: Results in Pediatric Patients

Christine Martinez-Vinson  1 , Anaïs Lemoine  2 , Yoram Bouhnik  3 , Ben Braithwaite  4 , Audrey Fohlen-Weill  5 , Janet Addison  6
Affiliations

PERFUSE: Non-Interventional Cohort Study of Patients Receiving Infliximab Biosimilar SB2: Results in Pediatric Patients

Christine Martinez-Vinson et al. J Pediatr Gastroenterol Nutr. .

Abstract

Objectives: PERFUSE is 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 pediatric IBD patients (n = 126).

Methods: Pediatric IBD patients with Crohn disease (CD) or ulcerative colitis (UC), either naïve or switched from originator IFX, 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 or Pediatric Ulcerative Colitis Activity Index for CD and UC patients, respectively. Body mass index and height z scores were used to assess patient growth between initiation (M0) and month 12 (M12).

Results: One hundred twenty-six pediatric 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 pediatric 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.

Trial registration: ClinicalTrials.gov NCT03662919.

PubMed Disclaimer

Conflict of interest statement

C.M-Z. received consulting and/or speaker fees from AbbVie, MSD, Nestle, Biogen. A.L. received consulting and/or speaker fees from Mead Johnson, Modilac, Nestle, Nutricia. Y.B. received consulting and/or speaker fees from AbbVie, Biogaran, Biogen, Boehringer Ingelheim, CTMA, Ferring, Gilead, Hospira, ICON, Inception IBD, Janssen, Lilly, Mayoly Spindler, Merck, Merck Sharp & Dohme, Norgine, Pfizer, Robarts Clinical Trials, Roche, Sanofi, Shire, Takeda, UCB, Vifor Pharma. B.B. provided medical writing services for Biogen on behalf of Sanoïa e-Health Services. J.A. and A.F-W. are employees of and may hold options and/or stock in Biogen.

Figures

None
Graphical abstract
FIGURE 1.
FIGURE 1.
Evolution of disease scores and biological assays. (A and B) The evolution of disease activity scores for patients with CD (HBI ranging from 0 to 18) and UC (PUCAI ranging from 0 to 85), respectively. (C and D) The evolution of measured CRP concentrations in mg/L for CD and UC patients, respectively. (E and F) The evolution of trough levels in µg/L for CD and UC patients, respectively. Values at baseline (M0), 6 months (M6), and 12 months (M12) are provided for naïve (blue) and switched (orange) patients. Data is presented using the mean and 95% CI for CD patients and median with IQR for UC patients. A colored star indicates a significant difference between baseline and M12 (P < 0.05). CD = Crohn disease; CI = confidence interval; CRP = C-reactive protein; HBI = Harvey-Bradshaw Index; IQR = interquartile range; PUCAI = Pediatric Ulcerative Colitis Activity Index; UC = ulcerative colitis.
FIGURE 2.
FIGURE 2.
Patient growth metrics: growth was measured using the height z score and ponderal growth was measured using BMI. (A and B) Distributions of height z scores for naïve (blue) and switched (orange) CD and UC patients at baseline and at 12 months. (C and D) Distributions of BMI for naïve (blue) and switched (orange) CD and UC patients at baseline and at 12 months. Significant differences (P < 0.05) between baseline and M12 are indicated with a star. BMI = body mass index; CD = Crohn disease; UC = ulcerative colitis.
FIGURE 3.
FIGURE 3.
Survival curves for participants based on a Kaplan Meier approach. (A) The survival curve for CD patients’ persistence on SB2 treatment. (B) The survival curve for UC patients’ persistence on SB2 treatment. Each step represents a patient who left the study and stopped SB2 treatment. Each star represents a censored patient for whom we have no data beyond that point. CD = Crohn disease; UC = ulcerative colitis.
See this image and copyright information in PMC

References

    1. Ghione S, Sarter H, Fumery M, et al. . Dramatic increase in incidence of ulcerative colitis and Crohn’s disease (1988–2011): a population-based study of French adolescents. Am J Gastroenterol 2018;113:265–72. - PubMed
    1. Alatab S, Sepanlou SG, Ikuta K, et al. . The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol 2020;5:17–30. - PMC - PubMed
    1. Däbritz J, Gerner P, Enninger A, Claßen M, Radke M. Inflammatory bowel disease in childhood and adolescence. Dtsch Arztebl Int 2017;114:331–8. - PMC - PubMed
    1. Kuenzig ME, Fung SG, Marderfeld L, et al. . Twenty-first century trends in the global epidemiology of pediatric-onset inflammatory bowel disease: systematic review. Gastroenterology 2022;162:1147–1159.e4. - PubMed
    1. Lev-Tzion R, Turner D. Is pediatric IBD treatment different than in adults? Minerva Gastroenterol Dietol 2012;58:137–50. - PubMed

Publication types

MeSH terms

Associated data