Biosimilars for Pediatric Patients With Inflammatory Bowel Disease: Pediatric Gastroenterology Clinical Practice Survey.
Journal
Journal of pediatric gastroenterology and nutrition
ISSN: 1536-4801
Titre abrégé: J Pediatr Gastroenterol Nutr
Pays: United States
ID NLM: 8211545
Informations de publication
Date de publication:
01 05 2023
01 05 2023
Historique:
medline:
25
4
2023
pubmed:
25
2
2023
entrez:
24
2
2023
Statut:
ppublish
Résumé
Biosimilars are biological agents that have been demonstrated to have similar safety and efficacy profiles as the originator. The objective of this study was to evaluate the perspectives of pediatric gastroenterologists in the United States (U.S.) toward biosimilar use and to explore factors that impact their comfort level with prescribing infliximab biosimilars. A cross-sectional survey was developed and distributed to pediatric gastroenterology physicians from the U.S. via a listserv (Pediatric gastroenterology Bulletin Board). Respondent's demographics were recorded. Using a 6-point Likert scale, the survey assessed the respondent's perceptions toward biosimilars and initiating switches from the originator to biosimilar agent along with factors impacting provider's comfort level. Fischer exact tests were used to detect statistically significant differences in responses for hypotheses of interest. One hundred thirty-nine pediatric gastroenterologists completed the online survey (response rate 5.4%). Eighty-seven percent of respondents reported being comfortable prescribing infliximab biosimilars to anti-tumor necrosis factor naive patients, and 69% reported being comfortable doing a one-time switch if the patient was in clinical remission. Factors that negatively impacted a respondent's comfort level included respondents not practicing at an ImproveCareNow (ICN) center and managing less than 50 patients with inflammatory bowel diseases (IBD). Nearly 90% of pediatric gastroenterologists felt comfortable prescribing an infliximab biosimilar, and 70% felt comfortable with a one-time switch to the biosimilar if the patient was in clinical remission. Involvement in ICN a learning health system and caring for higher numbers of patients with IBD was associated with increased provider comfort with biosimilar use.
Sections du résumé
BACKGROUND
Biosimilars are biological agents that have been demonstrated to have similar safety and efficacy profiles as the originator. The objective of this study was to evaluate the perspectives of pediatric gastroenterologists in the United States (U.S.) toward biosimilar use and to explore factors that impact their comfort level with prescribing infliximab biosimilars.
METHODS
A cross-sectional survey was developed and distributed to pediatric gastroenterology physicians from the U.S. via a listserv (Pediatric gastroenterology Bulletin Board). Respondent's demographics were recorded. Using a 6-point Likert scale, the survey assessed the respondent's perceptions toward biosimilars and initiating switches from the originator to biosimilar agent along with factors impacting provider's comfort level. Fischer exact tests were used to detect statistically significant differences in responses for hypotheses of interest.
RESULTS
One hundred thirty-nine pediatric gastroenterologists completed the online survey (response rate 5.4%). Eighty-seven percent of respondents reported being comfortable prescribing infliximab biosimilars to anti-tumor necrosis factor naive patients, and 69% reported being comfortable doing a one-time switch if the patient was in clinical remission. Factors that negatively impacted a respondent's comfort level included respondents not practicing at an ImproveCareNow (ICN) center and managing less than 50 patients with inflammatory bowel diseases (IBD).
CONCLUSIONS
Nearly 90% of pediatric gastroenterologists felt comfortable prescribing an infliximab biosimilar, and 70% felt comfortable with a one-time switch to the biosimilar if the patient was in clinical remission. Involvement in ICN a learning health system and caring for higher numbers of patients with IBD was associated with increased provider comfort with biosimilar use.
Identifiants
pubmed: 36827968
doi: 10.1097/MPG.0000000000003750
pii: 00005176-202305000-00011
doi:
Substances chimiques
Infliximab
B72HH48FLU
Biosimilar Pharmaceuticals
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
616-621Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2023 by European Society for European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest.
Références
Baert F, Moortgat L, Van Assche G, et al. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn’s disease. Gastroenterology 2010;138:463–8; quiz e10.
Holdam AS, Bager P, Dahlerup JF. Biological therapy increases the health-related quality of life in patients with inflammatory bowel disease in a clinical setting. Scand J Gastroenterol 2016;51:706–11.
Shah SC, Colombel JF, Sands BE, Narula N. Mucosal healing is associated with improved long-term outcomes of patients with ulcerative colitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2016;14:1245–1255.e8.
Vogelaar L, Spijker AV, van der Woude CJ. The impact of biologics on health-related quality of life in patients with inflammatory bowel disease. Clin Exp Gastroenterol 2009;2:101–9.
Yzet C, Diouf M, Le Mouel JP, et al. Complete endoscopic healing associated with better outcomes than partial endoscopic healing in patients with Crohn’s disease. Clin Gastroenterol Hepatol 2020;18:2256–61.
Leonard E, Wascovich M, Oskouei S, Gurz P, Carpenter D. Factors affecting health care provider knowledge and acceptance of biosimilar medicines: a systematic review. J Manag Care Spec Pharm 2019;25:102–12.
Dipasquale V, Romano C. Biosimilar infliximab in paediatric inflammatory bowel disease: efficacy, immunogenicity and safety. J Clin Pharm Ther 2020;45:1228–34.
Farkas K, Rutka M, Golovics PA, et al. Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. J Crohns Colitis 2016;10:1273–8.
Fiorino G, Manetti N, Armuzzi A, et al. The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar. Inflamm Bowel Dis 2017;23:233–43.
Morris GA, McNicol M, Boyle B, et al. Increasing biosimilar utilization at a pediatric inflammatory bowel disease center and associated cost savings: show me the money. Inflamm Bowel Dis 2022;28:531–8.
Ratnakumaran R, To N, Gracie DJ, et al. Efficacy and tolerability of initiating, or switching to, infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD): a large single-centre experience. Scand J Gastroenterol 2018;53:700–7.
Ye BD, Pesegova M, Alexeeva O, et al. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn’s disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet 2019;393:1699–707.
Barbier L, Simoens S, Vulto AG, Huys I. European stakeholder learnings regarding biosimilars: Part I-improving biosimilar understanding and adoption. BioDrugs 2020;34:783–96.
Dalpoas SE, Socal M, Proctor C, Shermock KM. Barriers to biosimilar utilization in the United States. Am J Health Syst Pharm 2020;77:2006–14.
Malter L, Jain A, Cohen BL, et al. Identifying IBD providers’ knowledge gaps using a prospective web-based survey. Inflamm Bowel Dis 2020;26:1445–50.
Egberg MD, Kappelman MD, Gulati AS. Improving care in pediatric inflammatory bowel disease. Gastroenterol Clin North Am 2018;47:909–19.
Hartley DM, Keck C, Havens M, Margolis PA, Seid M. Measuring engagement in a collaborative learning health system: the case of ImproveCareNow. Learn Health Syst 2021;5:e10225.
Kandavel P, Eder SJ, Adler J, et al. Reduced systemic corticosteroid use among pediatric patients with inflammatory bowel disease in a large learning health system. J Pediatr Gastroenterol Nutr 2021;73:345–51.
Prendaj E, Thomas S, Tomer G. Population management: a tool to improve timely care in pediatric and young adult patients with inflammatory bowel disease. Gastroenterol Res Pract 2019;2019:4702969.
Petit J, Antignac M, Poilverd RM, et al. Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar. RMD Open 2021;7:e001396.
Pouillon L, Socha M, Demore B, et al. The nocebo effect: a clinical challenge in the era of biosimilars. Expert Rev Clin Immunol 2018;14:739–49.
Ilias A, Szanto K, Gonczi L, et al. Outcomes of patients with inflammatory bowel diseases switched from maintenance therapy with a biosimilar to remicade. Clin Gastroenterol Hepatol 2019;17:2506–2513.e2.
Accelerating Progress Toward Continuous Learning: A National Academy of Medicine Meeting Summary. National Academy of Medicine; June 29, 2017.
Carlo WF, Cnota JF, Dabal RJ, Anderson JB. Practice trends over time in the care of infants with hypoplastic left heart syndrome: a report from the National Pediatric Cardiology Quality Improvement Collaborative. Congenit Heart Dis 2017;12:315–21.
Walsh MC, Crowley M, Wexelblatt S, et al. Ohio perinatal quality collaborative improves care of neonatal narcotic abstinence syndrome. Pediatrics 2018;141:e20170900.
Constant BD, de Zoeten EF, Stahl MG, et al. Delays related to prior authorization in inflammatory bowel disease. Pediatrics 2022;149:e2021052501.
Kahn SA, Bousvaros A. Denials, dilly-dallying, and despair: navigating the insurance labyrinth to obtain medically necessary medications for pediatric inflammatory bowel disease patients. J Pediatr Gastroenterol Nutr 2022;75:418–22.