دورية أكاديمية
أعرض في EDS

First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn's disease: an open-label multicentre randomised controlled trial.

التفاصيل البيبلوغرافية
العنوان: First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn's disease: an open-label multicentre randomised controlled trial.
المؤلفون: Jongsma MME; Paediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands., Aardoom MA; Paediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands., Cozijnsen MA; Paediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands., van Pieterson M; Paediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands., de Meij T; Paediatric Gastroenterology, University Medical Center Amsterdam-Location VUmc, Amsterdam, The Netherlands., Groeneweg M; Paediatrics, Maasstad Hospital, Rotterdam, The Netherlands., Norbruis OF; Paediatrics, Isala Hospital, Zwolle, The Netherlands., Wolters VM; Paediatric Gastroenterology, Utrecht Medical Center/Wilhelmina Children's Hospital, Utrecht, The The Netherlands., van Wering HM; Paediatrics, Amphia Hospital, Breda, The Netherlands., Hojsak I; Referral centre for Paediatric Gastroenterology and Nutrition, Children's Hospital Zagreb, Zagreb, Croatia.; University JJ Strossmayer, School of Medicine Osijek, Osijek, Croatia., Kolho KL; Paediatric Gastroenterology, Children's Hospital, University of Tampere, Helsinki, Finland.; Tampere University, Tampere, Finland., Hummel T; Paediatrics, Medical Spectrum Twente, Enschede, The Netherlands., Stapelbroek J; Paediatrics, Catharina Hospital, Eindhoven, The Netherlands., van der Feen C; Paediatrics, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands., van Rheenen PF; Paediatric Gastroenterology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands., van Wijk MP; Paediatric Gastroenterology, University Medical Center Amsterdam-Location VUmc, Amsterdam, The Netherlands., Teklenburg-Roord STA; Paediatrics, Isala Hospital, Zwolle, The Netherlands., Schreurs MWJ; Immunology, Erasmus MC, Rotterdam, The Netherlands., Rizopoulos D; Biostatistics, Erasmus MC, Rotterdam, The Netherlands., Doukas M; Pathology, Erasmus MC, Rotterdam, The Netherlands., Escher JC; Paediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands., Samsom JN; Laboratory of Pediatrics, Division of Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands., de Ridder L; Paediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands l.deridder@erasmusmc.nl.
المصدر: Gut [Gut] 2022 Jan; Vol. 71 (1), pp. 34-42. Date of Electronic Publication: 2020 Dec 31.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: British Medical Assn Country of Publication: England NLM ID: 2985108R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1468-3288 (Electronic) Linking ISSN: 00175749 NLM ISO Abbreviation: Gut Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London, British Medical Assn.
مواضيع طبية MeSH: Crohn Disease/*drug therapy , Gastrointestinal Agents/*therapeutic use , Infliximab/*therapeutic use, Adolescent ; Anti-Inflammatory Agents/therapeutic use ; Azathioprine/therapeutic use ; Child ; Child, Preschool ; Female ; Humans ; Immunosuppressive Agents/therapeutic use ; Male ; Prednisolone/therapeutic use ; Remission Induction ; Severity of Illness Index
مستخلص: Objective: In newly diagnosed paediatric patients with moderate-to-severe Crohn's disease (CD), infliximab (IFX) is initiated once exclusive enteral nutrition (EEN), corticosteroid and immunomodulator therapies have failed. We aimed to investigate whether starting first-line IFX (FL-IFX) is more effective to achieve and maintain remission than conventional treatment.
Design: In this multicentre open-label randomised controlled trial, untreated patients with a new diagnosis of CD (3-17 years old, weighted Paediatric CD Activity Index score (wPCDAI) >40) were assigned to groups that received five infusions of 5 mg/kg IFX at weeks 0, 2, 6, 14 and 22 (FL-IFX), or EEN or oral prednisolone (1 mg/kg, maximum 40 mg) (conventional). The primary outcome was clinical remission on azathioprine, defined as a wPCDAI <12.5 at week 52, without need for treatment escalation, using intention-to-treat analysis.
Results: 100 patients were included, 50 in the FL-IFX group and 50 in the conventional group. Four patients did not receive treatment as per protocol. At week 10, a higher proportion of patients in the FL-IFX group than in the conventional group achieved clinical (59% vs 34%, respectively, p=0.021) and endoscopic remission (59% vs 17%, respectively, p=0.001). At week 52, the proportion of patients in clinical remission was not significantly different (p=0.421). However, 19/46 (41%) patients in the FL-IFX group were in clinical remission on azathioprine monotherapy without need for treatment escalation vs 7/48 (15%) in the conventional group (p=0.004).
Conclusions: FL-IFX was superior to conventional treatment in achieving short-term clinical and endoscopic remission, and had greater likelihood of maintaining clinical remission at week 52 on azathioprine monotherapy.
Trial Registration Number: ClinicalTrials.gov Registry (NCT02517684).
Competing Interests: Competing interests: LdR reports grants from ZonMW, ECCO, Crocokids and Pfizer and consultancy fees from Abbvie, during the conduct of the study. MAA received a consultant fee from Abbvie, outside the submitted work. MAC reports grants from ZonMw and Crocokids, and grants and non-financial support from Pfizer during the conduct of the study. IH received a payment/honorarium for lectures from BioGaia, Nutricia, Oktal pharma, Nestle, Biocodex and AbelaPharm. K-LK received consultant fees from Abbvie, Biocodex, Ferring, MSD and Tillotts Pharma, and research grants from the Pediatric Research Foundation (Finland) and the Helsinki University Research Fund, outside the submitted work. TH received a consultant fee from Pfizer, outside the submitted work. JS reports personal fees from Nutricia, outside the submitted work. MPvW reports personal fees from Danone and Laborie, outside the submitted work. STAT-R received a consultant fee from Pfizer, outside the submitted work. JCE received consultant fees from Abbvie and Janssen, as well as research support from MSD and Nutricia.
(© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)
التعليقات: Comment in: Gut. 2022 Jan;71(1):2-3. (PMID: 33722861)
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فهرسة مساهمة: Keywords: IBD clinical; inflammatory bowel disease; infliximab; paediatric gastroenterology
سلسلة جزيئية: ClinicalTrials.gov NCT02517684
المشرفين على المادة: 0 (Anti-Inflammatory Agents)
0 (Gastrointestinal Agents)
0 (Immunosuppressive Agents)
9PHQ9Y1OLM (Prednisolone)
B72HH48FLU (Infliximab)
MRK240IY2L (Azathioprine)
تواريخ الأحداث: Date Created: 20210101 Date Completed: 20220110 Latest Revision: 20220110
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC8666701
DOI: 10.1136/gutjnl-2020-322339
PMID: 33384335
قاعدة البيانات: MEDLINE
الوصف
تدمد:1468-3288
DOI:10.1136/gutjnl-2020-322339