دورية أكاديمية
Randomised clinical trial: First-line infliximab biosimilar is cost-effective compared to conventional treatment in paediatric Crohn's disease.
| العنوان: | Randomised clinical trial: First-line infliximab biosimilar is cost-effective compared to conventional treatment in paediatric Crohn's disease. |
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| المؤلفون: | Vuijk SA; Department of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands., Jongsma MME; Department of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands., Hoeven BM; Department of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands., Cozijnsen MA; Department of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands., van Pieterson M; Department of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands., de Meij TGJ; Department of Paediatric Gastroenterology, Emma Children's Hospital, Amsterdam UMC, VU University, Amsterdam, The Netherlands., Norbruis OF; Department of Paediatric Gastroenterology, Isala Hospital, Zwolle, The Netherlands., Groeneweg M; Department of Paediatric Gastroenterology, Maasstad Hospital, Rotterdam, The Netherlands., Wolters VM; Department of Paediatric Gastroenterology, UMC Utrecht/Wilhelmina Children's Hospital, Utrecht, The Netherlands., van Wering H; Department of Paediatric Gastroenterology, Amphia Hospital, Breda, The Netherlands., Hummel T; Department of Paediatric Gastroenterology, Medical Spectrum Twente, Enschede, The Netherlands., Stapelbroek J; Department of Paediatric Gastroenterology, Catharina Hospital, Eindhoven, The Netherlands., van der Feen C; Department of Paediatric Gastroenterology, Jeroen Bosch Hospital, 's Hertogenbosch, The Netherlands., van Rheenen PF; Department of Paediatric Gastroenterology, University Medical Center, University of Groningen, Groningen, The Netherlands., van Wijk MP; Department of Paediatric Gastroenterology, Emma Children's Hospital, Amsterdam UMC, VU University, Amsterdam, The Netherlands., Teklenburg S; Department of Paediatric Gastroenterology, Isala Hospital, Zwolle, The Netherlands., Rizopoulos D; Department of Biostatistics, Erasmus MC, Rotterdam, The Netherlands.; Department of Epidemiology, Erasmus MC, Rotterdam, The Netherlands., Poley MJ; Institute for Medical Technology Assessment and Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands.; Department of Pediatric Surgery and Intensive Care, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands., Escher JC; Department of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands., de Ridder L; Department of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands. |
| المصدر: | Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2024 Jun; Vol. 59 (12), pp. 1510-1520. Date of Electronic Publication: 2024 Apr 21. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Comparative Study; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 8707234 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2036 (Electronic) Linking ISSN: 02692813 NLM ISO Abbreviation: Aliment Pharmacol Ther Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Oxford : Wiley-Blackwell Original Publication: [Oxford, OX] : Blackwell Scientific Publications, [c1987- |
| مواضيع طبية MeSH: | Crohn Disease*/drug therapy , Crohn Disease*/economics , Infliximab*/economics , Infliximab*/therapeutic use , Cost-Benefit Analysis* , Gastrointestinal Agents*/economics , Gastrointestinal Agents*/therapeutic use , Biosimilar Pharmaceuticals*/economics , Biosimilar Pharmaceuticals*/therapeutic use, Humans ; Male ; Female ; Child ; Adolescent ; Treatment Outcome ; Azathioprine/therapeutic use ; Azathioprine/economics ; Immunosuppressive Agents/economics ; Immunosuppressive Agents/therapeutic use ; Adrenal Cortex Hormones/therapeutic use ; Adrenal Cortex Hormones/economics ; Adrenal Cortex Hormones/administration & dosage ; Health Care Costs/statistics & numerical data |
| مستخلص: | Background: Data on cost-effectiveness of first-line infliximab in paediatric patients with Crohn's disease are limited. Since biologics are increasingly prescribed and accompanied by high costs, this knowledge gap needs to be addressed. Aim: To investigate the cost-effectiveness of first-line infliximab compared to conventional treatment in children with moderate-to-severe Crohn's disease. Methods: We included patients from the Top-down Infliximab Study in Kids with Crohn's disease randomised controlled trial. Children with newly diagnosed moderate-to-severe Crohn's disease were treated with azathioprine maintenance and either five induction infliximab (biosimilar) infusions or conventional induction treatment (exclusive enteral nutrition or corticosteroids). Direct healthcare consumption and costs were obtained per patient until week 104. This included data on outpatient hospital visits, hospital admissions, drug costs, endoscopies and surgeries. The primary health outcome was the odds ratio of being in clinical remission (weighted paediatric Crohn's disease activity index<12.5) during 104 weeks. Results: We included 89 patients (44 in the first-line infliximab group and 45 in the conventional treatment group). Mean direct healthcare costs per patient were €36,784 for first-line infliximab treatment and €36,874 for conventional treatment over 2 years (p = 0.981). The odds ratio of first-line infliximab versus conventional treatment to be in clinical remission over 104 weeks was 1.56 (95%CI 1.03-2.35, p = 0.036). Conclusions: First-line infliximab treatment resulted in higher odds of being in clinical remission without being more expensive, making it the dominant strategy over conventional treatment in the first 2 years after diagnosis in children with moderate-to-severe Crohn's disease. Trial Registration Number: NCT02517684. (© 2024 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.) |
| التعليقات: | Comment in: Aliment Pharmacol Ther. 2024 Jul;60(1):93-94. doi: 10.1111/apt.18033. (PMID: 38773786) |
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| معلومات مُعتمدة: | WI213008 Pfizer; 113202001 Netherlands ZONMW_ ZonMw; Erasmus MC Sophia Foundation (Crocokids project) |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02517684 |
| SCR Disease Name: | Pediatric Crohn's disease |
| تواريخ الأحداث: | Date Created: 20240422 Date Completed: 20240521 Latest Revision: 20240710 |
| رمز التحديث: | 20240711 |
| DOI: | 10.1111/apt.18000 |
| PMID: | 38644588 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1365-2036 |
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| DOI: | 10.1111/apt.18000 |