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2. Author Correction: Oesophageal atresia

Author

van Lennep, Marinde, Singendonk, Maartje M. J., Dall’Oglio, Luigi, Gottrand, Fréderic, Krishnan, Usha, Terheggen-Lagro, Suzanne W. J., Omari, Taher I., Benninga, Marc A., and van Wijk, Michiel P.

Published
2024
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9. Evaluation of exclusive enteral nutrition and corticosteroid induction treatment in new-onset moderate-to-severe luminal paediatric Crohn’s disease

Author

Jongsma, Maria M. E., Vuijk, Stephanie A., Cozijnsen, Martinus A., van Pieterson, Merel, Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert M., Hojsak, Iva, Kolho, Kaija-Leena, van Wijk, Michiel P., Teklenburg-Roord, Sarah T. A., de Meij, Tim G. J., Escher, Johanna C., and de Ridder, Lissy

Published
2022
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11. Diagnosis and management in Rubinstein-Taybi syndrome: first international consensus statement

Author

Lacombe, Didier, primary, Bloch-Zupan, Agnès, additional, Bredrup, Cecilie, additional, Cooper, Edward B, additional, Houge, Sofia Douzgou, additional, García-Miñaúr, Sixto, additional, Kayserili, Hülya, additional, Larizza, Lidia, additional, Lopez Gonzalez, Vanesa, additional, Menke, Leonie A, additional, Milani, Donatella, additional, Saettini, Francesco, additional, Stevens, Cathy A, additional, Tooke, Lloyd, additional, Van der Zee, Jill A, additional, Van Genderen, Maria M, additional, Van-Gils, Julien, additional, Waite, Jane, additional, Adrien, Jean-Louis, additional, Bartsch, Oliver, additional, Bitoun, Pierre, additional, Bouts, Antonia H M, additional, Cueto-González, Anna M, additional, Dominguez-Garrido, Elena, additional, Duijkers, Floor A, additional, Fergelot, Patricia, additional, Halstead, Elizabeth, additional, Huisman, Sylvia A, additional, Meossi, Camilla, additional, Mullins, Jo, additional, Nikkel, Sarah M, additional, Oliver, Chris, additional, Prada, Elisabetta, additional, Rei, Alessandra, additional, Riddle, Ilka, additional, Rodriguez-Fonseca, Cristina, additional, Rodríguez Pena, Rebecca, additional, Russell, Janet, additional, Saba, Alicia, additional, Santos-Simarro, Fernando, additional, Simpson, Brittany N, additional, Smith, David F, additional, Stevens, Markus F, additional, Szakszon, Katalin, additional, Taupiac, Emmanuelle, additional, Totaro, Nadia, additional, Valenzuena Palafoll, Irene, additional, Van Der Kaay, Daniëlle C M, additional, Van Wijk, Michiel P, additional, Vyshka, Klea, additional, Wiley, Susan, additional, and Hennekam, Raoul C, additional

Published
2024
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15. Randomised clinical trial: First-line infliximab biosimilar is cost-effective compared to conventional treatment in paediatric Crohn's disease

Author

MDL, MDL patientenzorg, Child Health, Vuijk, Stephanie A., Jongsma, Maria M.E., Hoeven, Britt M., Cozijnsen, Maarten A., van Pieterson, Merel, de Meij, Tim G.J., Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert, Hummel, Thalia, Stapelbroek, Janneke, van der Feen, Cathelijne, van Rheenen, Patrick F., van Wijk, Michiel P., Teklenburg, Sarah, Rizopoulos, Dimitris, Poley, Marten J., Escher, Johanna C., de Ridder, Lissy, MDL, MDL patientenzorg, Child Health, Vuijk, Stephanie A., Jongsma, Maria M.E., Hoeven, Britt M., Cozijnsen, Maarten A., van Pieterson, Merel, de Meij, Tim G.J., Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert, Hummel, Thalia, Stapelbroek, Janneke, van der Feen, Cathelijne, van Rheenen, Patrick F., van Wijk, Michiel P., Teklenburg, Sarah, Rizopoulos, Dimitris, Poley, Marten J., Escher, Johanna C., and de Ridder, Lissy

Published
2024

16. Diagnosis and management in Rubinstein-Taybi syndrome: first international consensus statement

Author

MS Oogheelkunde, Child Health, Lacombe, Didier, Bloch-Zupan, Agnès, Bredrup, Cecilie, Cooper, Edward B., Houge, Sofia Douzgou, García-Miñaúr, Sixto, Kayserili, Hülya, Larizza, Lidia, Lopez Gonzalez, Vanesa, Menke, Leonie A., Milani, Donatella, Saettini, Francesco, Stevens, Cathy A., Tooke, Lloyd, Van Der Zee, Jill A., Van Genderen, Maria M., Van-Gils, Julien, Waite, Jane, Adrien, Jean Louis, Bartsch, Oliver, Bitoun, Pierre, Bouts, Antonia H.M., Cueto-González, Anna M., Dominguez-Garrido, Elena, Duijkers, Floor A., Fergelot, Patricia, Halstead, Elizabeth, Huisman, Sylvia A., Meossi, Camilla, Mullins, Jo, Nikkel, Sarah M., Oliver, Chris, Prada, Elisabetta, Rei, Alessandra, Riddle, Ilka, Rodriguez-Fonseca, Cristina, Rodríguez Pena, Rebecca, Russell, Janet, Saba, Alicia, Santos-Simarro, Fernando, Simpson, Brittany N., Smith, David F., Stevens, Markus F., Szakszon, Katalin, Taupiac, Emmanuelle, Totaro, Nadia, Valenzuena Palafoll, Irene, Van Der Kaay, Daniëlle C.M., Van Wijk, Michiel P., Vyshka, Klea, Wiley, Susan, Hennekam, Raoul C., MS Oogheelkunde, Child Health, Lacombe, Didier, Bloch-Zupan, Agnès, Bredrup, Cecilie, Cooper, Edward B., Houge, Sofia Douzgou, García-Miñaúr, Sixto, Kayserili, Hülya, Larizza, Lidia, Lopez Gonzalez, Vanesa, Menke, Leonie A., Milani, Donatella, Saettini, Francesco, Stevens, Cathy A., Tooke, Lloyd, Van Der Zee, Jill A., Van Genderen, Maria M., Van-Gils, Julien, Waite, Jane, Adrien, Jean Louis, Bartsch, Oliver, Bitoun, Pierre, Bouts, Antonia H.M., Cueto-González, Anna M., Dominguez-Garrido, Elena, Duijkers, Floor A., Fergelot, Patricia, Halstead, Elizabeth, Huisman, Sylvia A., Meossi, Camilla, Mullins, Jo, Nikkel, Sarah M., Oliver, Chris, Prada, Elisabetta, Rei, Alessandra, Riddle, Ilka, Rodriguez-Fonseca, Cristina, Rodríguez Pena, Rebecca, Russell, Janet, Saba, Alicia, Santos-Simarro, Fernando, Simpson, Brittany N., Smith, David F., Stevens, Markus F., Szakszon, Katalin, Taupiac, Emmanuelle, Totaro, Nadia, Valenzuena Palafoll, Irene, Van Der Kaay, Daniëlle C.M., Van Wijk, Michiel P., Vyshka, Klea, Wiley, Susan, and Hennekam, Raoul C.

Published
2024

17. Diagnosis and management in Rubinstein-Taybi syndrome:first international consensus statement

Author

Lacombe, Didier, Bloch-Zupan, Agnès, Bredrup, Cecilie, Cooper, Edward B., Houge, Sofia Douzgou, García-Miñaúr, Sixto, Kayserili, Hülya, Larizza, Lidia, Lopez Gonzalez, Vanesa, Menke, Leonie A., Milani, Donatella, Saettini, Francesco, Stevens, Cathy A., Tooke, Lloyd, Van Der Zee, Jill A., Van Genderen, Maria M., Van-Gils, Julien, Waite, Jane, Adrien, Jean Louis, Bartsch, Oliver, Bitoun, Pierre, Bouts, Antonia H.M., Cueto-González, Anna M., Dominguez-Garrido, Elena, Duijkers, Floor A., Fergelot, Patricia, Halstead, Elizabeth, Huisman, Sylvia A., Meossi, Camilla, Mullins, Jo, Nikkel, Sarah M., Oliver, Chris, Prada, Elisabetta, Rei, Alessandra, Riddle, Ilka, Rodriguez-Fonseca, Cristina, Rodríguez Pena, Rebecca, Russell, Janet, Saba, Alicia, Santos-Simarro, Fernando, Simpson, Brittany N., Smith, David F., Stevens, Markus F., Szakszon, Katalin, Taupiac, Emmanuelle, Totaro, Nadia, Valenzuena Palafoll, Irene, Van Der Kaay, Daniëlle C.M., Van Wijk, Michiel P., Vyshka, Klea, Wiley, Susan, Hennekam, Raoul C., Lacombe, Didier, Bloch-Zupan, Agnès, Bredrup, Cecilie, Cooper, Edward B., Houge, Sofia Douzgou, García-Miñaúr, Sixto, Kayserili, Hülya, Larizza, Lidia, Lopez Gonzalez, Vanesa, Menke, Leonie A., Milani, Donatella, Saettini, Francesco, Stevens, Cathy A., Tooke, Lloyd, Van Der Zee, Jill A., Van Genderen, Maria M., Van-Gils, Julien, Waite, Jane, Adrien, Jean Louis, Bartsch, Oliver, Bitoun, Pierre, Bouts, Antonia H.M., Cueto-González, Anna M., Dominguez-Garrido, Elena, Duijkers, Floor A., Fergelot, Patricia, Halstead, Elizabeth, Huisman, Sylvia A., Meossi, Camilla, Mullins, Jo, Nikkel, Sarah M., Oliver, Chris, Prada, Elisabetta, Rei, Alessandra, Riddle, Ilka, Rodriguez-Fonseca, Cristina, Rodríguez Pena, Rebecca, Russell, Janet, Saba, Alicia, Santos-Simarro, Fernando, Simpson, Brittany N., Smith, David F., Stevens, Markus F., Szakszon, Katalin, Taupiac, Emmanuelle, Totaro, Nadia, Valenzuena Palafoll, Irene, Van Der Kaay, Daniëlle C.M., Van Wijk, Michiel P., Vyshka, Klea, Wiley, Susan, and Hennekam, Raoul C.

Abstract

Rubinstein-Taybi syndrome (RTS) is an archetypical genetic syndrome that is characterised by intellectual disability, well-defined facial features, distal limb anomalies and atypical growth, among numerous other signs and symptoms. It is caused by variants in either of two genes (CREBBP, EP300) which encode for the proteins CBP and p300, which both have a function in transcription regulation and histone acetylation. As a group of international experts and national support groups dedicated to the syndrome, we realised that marked heterogeneity currently exists in clinical and molecular diagnostic approaches and care practices in various parts of the world. Here, we outline a series of recommendations that document the consensus of a group of international experts on clinical diagnostic criteria for types of RTS (RTS1: CREBBP; RTS2: EP300), molecular investigations, long-term management of various particular physical and behavioural issues and care planning. The recommendations as presented here will need to be evaluated for improvements to allow for continued optimisation of diagnostics and care.

Published
2024

18. Navigating global collaboration:challenges faced by the international network on esophageal atresia

Author

Gottrand, Frédéric, Krishnan, Usha, Widenmann, Anke, Blom, Michaela Dellenmark, Dall’Oglio, Luigi, Wijnen, Rene, van Wijk, Michiel, Fruithof, Jo Anne, von Allmen, Daniel, Kovesi, Tom, Faure, Christophe, Gottrand, Frédéric, Krishnan, Usha, Widenmann, Anke, Blom, Michaela Dellenmark, Dall’Oglio, Luigi, Wijnen, Rene, van Wijk, Michiel, Fruithof, Jo Anne, von Allmen, Daniel, Kovesi, Tom, and Faure, Christophe

Abstract

The International Network on Esophageal Atresia (INoEA) stands as a beacon of collaboration in addressing the complexities of this congenital condition on a global scale. The eleven board members, from various countries (USA, Canada, France, Australia, Italy, Sweden, Germany, and The Netherlands) and backgrounds (pediatric gastroenterology, pediatric surgery, pediatric pulmonology, nursing, and parents) met in a face-to-face symposium in Lille in November 2023, to identify challenges and solutions for improving global collaboration of the network.

Published
2024

19. Diagnosis and management in Rubinstein-Taybi syndrome: first international consensus statement

Author

Lacombe, Didier, Bloch-Zupan, Agnès, Bredrup, Cecilie, Cooper, Edward B., Houge, Sofia Douzgou, García-Miñaúr, Sixto, Kayserili, Hülya, Larizza, Lidia, Lopez Gonzalez, Vanesa, Menke, Leonie A., Milani, Donatella, Saettini, Francesco, Stevens, Cathy A., Tooke, Lloyd, Van der Zee, Jill A., Van Genderen, Maria M., Van-Gils, Julien, Waite, Jane, Adrien, Jean-Louis, Bartsch, Oliver, Bitoun, Pierre, Bouts, Antonia H. M., Cueto-González, Anna M., Dominguez-Garrido, Elena, Duijkers, Floor A., Fergelot, Patricia, Halstead, Elisabeth, Huisman, Sylvia A., Meossi, Camilla, Mullins, Jo, Nikkel, Sarah M., Oliver, Chris, Prada, Elisabetta, Rei, Alessandra, Riddle, Ilka, Rodriguez-Fonseca, Cristina, Rodríguez Pena, Rebecca, Russell, Janet, Saba, Alicia, Santos-Simarro, Fernando, Simpson, Brittany N., Smith, David F., Stevens, Markus F., Szakszon, Katalin, Taupiac, Emmanuelle, Totaro, Nadia, Valenzuena Palafoll, Irene, Van Der Kaay, Daniëlle C. M., Van Wijk, Michiel P., Vyshka, Klea, Wiley, Susan, Hennekam, Raoul C., Lacombe, Didier, Bloch-Zupan, Agnès, Bredrup, Cecilie, Cooper, Edward B., Houge, Sofia Douzgou, García-Miñaúr, Sixto, Kayserili, Hülya, Larizza, Lidia, Lopez Gonzalez, Vanesa, Menke, Leonie A., Milani, Donatella, Saettini, Francesco, Stevens, Cathy A., Tooke, Lloyd, Van der Zee, Jill A., Van Genderen, Maria M., Van-Gils, Julien, Waite, Jane, Adrien, Jean-Louis, Bartsch, Oliver, Bitoun, Pierre, Bouts, Antonia H. M., Cueto-González, Anna M., Dominguez-Garrido, Elena, Duijkers, Floor A., Fergelot, Patricia, Halstead, Elisabeth, Huisman, Sylvia A., Meossi, Camilla, Mullins, Jo, Nikkel, Sarah M., Oliver, Chris, Prada, Elisabetta, Rei, Alessandra, Riddle, Ilka, Rodriguez-Fonseca, Cristina, Rodríguez Pena, Rebecca, Russell, Janet, Saba, Alicia, Santos-Simarro, Fernando, Simpson, Brittany N., Smith, David F., Stevens, Markus F., Szakszon, Katalin, Taupiac, Emmanuelle, Totaro, Nadia, Valenzuena Palafoll, Irene, Van Der Kaay, Daniëlle C. M., Van Wijk, Michiel P., Vyshka, Klea, Wiley, Susan, and Hennekam, Raoul C.

Abstract

Rubinstein-Taybi syndrome (RTS) is an archetypical genetic syndrome that is characterised by intellectual disability, well-defined facial features, distal limb anomalies and atypical growth, among numerous other signs and symptoms. It is caused by variants in either of two genes (CREBBP, EP300) which encode for the proteins CBP and p300, which both have a function in transcription regulation and histone acetylation. As a group of international experts and national support groups dedicated to the syndrome, we realised that marked heterogeneity currently exists in clinical and molecular diagnostic approaches and care practices in various parts of the world. Here, we outline a series of recommendations that document the consensus of a group of international experts on clinical diagnostic criteria for types of RTS (RTS1: CREBBP; RTS2: EP300), molecular investigations, long-term management of various particular physical and behavioural issues and care planning. The recommendations as presented here will need to be evaluated for improvements to allow for continued optimisation of diagnostics and care.

Published
2024

20. Randomised clinical trial:First-line infliximab biosimilar is cost-effective compared to conventional treatment in paediatric Crohn's disease

Author

Vuijk, Stephanie A., Jongsma, Maria M.E., Hoeven, Britt M., Cozijnsen, Maarten A., van Pieterson, Merel, de Meij, Tim G.J., Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert, Hummel, Thalia, Stapelbroek, Janneke, van der Feen, Cathelijne, van Rheenen, Patrick F., van Wijk, Michiel P., Teklenburg, Sarah, Rizopoulos, Dimitris, Poley, Marten J., Escher, Johanna C., de Ridder, Lissy, Vuijk, Stephanie A., Jongsma, Maria M.E., Hoeven, Britt M., Cozijnsen, Maarten A., van Pieterson, Merel, de Meij, Tim G.J., Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert, Hummel, Thalia, Stapelbroek, Janneke, van der Feen, Cathelijne, van Rheenen, Patrick F., van Wijk, Michiel P., Teklenburg, Sarah, Rizopoulos, Dimitris, Poley, Marten J., Escher, Johanna C., and de Ridder, Lissy

Abstract

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.

Published
2024

21. Randomised clinical trial: First‐line infliximab biosimilar is cost‐effective compared to conventional treatment in paediatric Crohn's disease.

Author

Vuijk, Stephanie A., Jongsma, Maria M. E., Hoeven, Britt M., Cozijnsen, Maarten A., van Pieterson, Merel, de Meij, Tim G. J., Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert, Hummel, Thalia, Stapelbroek, Janneke, van der Feen, Cathelijne, van Rheenen, Patrick F., van Wijk, Michiel P., Teklenburg, Sarah, Rizopoulos, Dimitris, Poley, Marten J., Escher, Johanna C., and de Ridder, Lissy

Subjects
CROHN'S disease, INFLIXIMAB, CHILD patients, DISEASE remission, CLINICAL trials, PEDIATRICS
Abstract

Summary: 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. [ABSTRACT FROM AUTHOR]

Published
2024
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23. A riddle wrapped in an enigma: acute kidney injury in a girl with Crohn's disease: Answers

Author

Regev, Lilach C., Bouts, Antonia H.M., Groothoff, Jaap W., van Wijk, Joanna A.E., van Wijk, Michiel, van der Valk, Paul, and Bökenkamp, Arend

Subjects
Acute renal failure -- Diagnosis -- Risk factors -- Demographic aspects, Crohn's disease -- Complications and side effects -- Demographic aspects, Health
Abstract

Author(s): Lilach C. Regev [sup.1] , Antonia H.M. Bouts [sup.2] , Jaap W. Groothoff [sup.2] , Joanna A.E. van Wijk [sup.2] , Michiel van Wijk [sup.3] , Paul van der [...]

Published
2020
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27. Protocol for an international multicenter randomized controlled trial assessing treatment success and safety of peroral endoscopic myotomy vs endoscopic balloon dilation for the treatment of achalasia in children

Author

Mussies, Carlijn, primary, van Lennep, Marinde, additional, van der Lee, Johanna H., additional, Singendonk, Maartje J., additional, Benninga, Marc. A., additional, Bastiaansen, Barbara A., additional, Fockens, Paul, additional, Bredenoord, Albert J., additional, and van Wijk, Michiel P., additional

Published
2023
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31. Oesophageal atresia

Author

van Lennep, Marinde, Singendonk, Maartje M. J., Dall’Oglio, Luigi, Gottrand, Fréderic, Krishnan, Usha, Terheggen-Lagro, Suzanne W. J., Omari, Taher I., Benninga, Marc A., and van Wijk, Michiel P.

Published
2019
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41. Development and validation of a condition-specific quality of life instrument for adults with esophageal atresia: the SQEA questionnaire

Author

ten Kate, Chantal A, primary, Teunissen, Nadine M, additional, van Rosmalen, Joost, additional, Kamphuis, Lieke S, additional, van Wijk, Michiel P, additional, Joosten, Maja, additional, van Tuyll van Serooskerken, E Sofie, additional, Wijnen, René, additional, IJsselstijn, Hanneke, additional, Rietman, André B, additional, and Spaander, Manon C W, additional

Published
2022
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46. Evaluation of exclusive enteral nutrition and corticosteroid induction treatment in new-onset moderate-to-severe luminal paediatric Crohn's disease

Author

Jongsma, Maria ME, Vuijk, Stephanie A, Cozijnsen, Martinus A, van Pieterson, Merel, Norbruis, Obbe F, Groeneweg, Michael, Wolters, Victorien M, van Wering, Herbert M, Hojsak, Iva, Kolho, Kaija-Leena, van Wijk, Michiel P, Teklenburg-Roord, Sarah TA, de Meij, Tim GJ, Escher, Johanna C, de Ridder, Lissy, Children's Hospital, HUS Children and Adolescents, Clinicum, University of Helsinki, Pediatrics, Erasmus MC other, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam Reproduction & Development (AR&D), Tampere University, Clinical Medicine, and Department of Paediatrics

Subjects
POLYMERIC DIET, Adolescent, CHILDREN, Pediatrics, THERAPY, Inflammatory bowel disease, VALIDATION, Enteral Nutrition, Crohn Disease, Adrenal Cortex Hormones, 3123 Gynaecology and paediatrics, Azathioprine, SCORE, Humans, Child, METAANALYSIS, OUTCOMES, Science & Technology, Crohn’s disease, Endoscopic remission, Mucosal healing, Remission Induction, REMISSION, Crohn's disease, Treatment Outcome, MUCOSAL, 3121 General medicine, internal medicine and other clinical medicine, Pediatrics, Perinatology and Child Health, Life Sciences & Biomedicine, INFLAMMATORY-BOWEL-DISEASE
Abstract

To induce remission in luminal paediatric Crohn’s disease (CD), the ESPGHAN/ECCO guideline recommends treatment with exclusive enteral nutrition (EEN) or oral corticosteroids. In newly diagnosed moderate-to-severe paediatric CD patients, we determined the proportion of patients in which EEN or corticosteroids induced remission and maintained remission on azathioprine monotherapy. We included patients from the “TISKids” study assigned to the conventional treatment arm. Patients were aged 3–17 years and had new-onset, untreated luminal CD with weighted paediatric CD activity index (wPCDAI) > 40. Induction treatment consisted of EEN or oral corticosteroids; all received azathioprine maintenance treatment from start of treatment. The primary outcome of this study was endoscopic remission defined as a SES-CD score p = 0.661). Twenty-nine of 47 consented to endoscopy at 10 weeks, showing endoscopic remission rates without treatment escalation in 2/16 (13%) of EEN-treated patients and in 1/13 (8%) of corticosteroid-treated patients (p = 1.00). At week 52, 23/27 (85%) EEN-treated patients received treatment escalation (median 14 weeks) and 13/20 (65%) corticosteroid-treated patients (median 27 weeks), p = 0.070.Conclusion: In children with moderate-to-severe newly diagnosed CD, induction treatment with EEN or CS regularly is insufficient to achieve endoscopic remission without treatment escalation at week 10. Trial registration number: NCT02517684 What is Known:• Endoscopic remission is associated with a low risk of disease progression.• FL-IFX was superior to conventional treatment in achieving and maintaining remission in paediatric patients with moderate-to-severe CD the first year from diagnosis. What is New:• In children with newly diagnosed moderate-to-severe CD, clinical remission rates and endoscopic remission rates without treatment escalation at week 10 were 30% and 13% after EEN and 37% and 8% after corticosteroid induction treatment.• The current treatment target was often not achieved by either EEN or corticosteroid induction treatment after bridging to azathioprine.

Published
2022

47. Evaluation of exclusive enteral nutrition and corticosteroid induction treatment in new-onset moderate-to-severe luminal paediatric Crohn’s disease

Author

Jongsma, Maria M.E., Vuijk, Stephanie A., Cozijnsen, Martinus A., van Pieterson, Merel, Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert M., Hojsak, Iva, Kolho, Kaija Leena, van Wijk, Michiel P., Teklenburg-Roord, Sarah T.A., de Meij, Tim G.J., Escher, Johanna C., de Ridder, Lissy, Jongsma, Maria M.E., Vuijk, Stephanie A., Cozijnsen, Martinus A., van Pieterson, Merel, Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert M., Hojsak, Iva, Kolho, Kaija Leena, van Wijk, Michiel P., Teklenburg-Roord, Sarah T.A., de Meij, Tim G.J., Escher, Johanna C., and de Ridder, Lissy

Abstract

To induce remission in luminal paediatric Crohn’s disease (CD), the ESPGHAN/ECCO guideline recommends treatment with exclusive enteral nutrition (EEN) or oral corticosteroids. In newly diagnosed moderate-to-severe paediatric CD patients, we determined the proportion of patients in which EEN or corticosteroids induced remission and maintained remission on azathioprine monotherapy. We included patients from the “TISKids” study assigned to the conventional treatment arm. Patients were aged 3–17 years and had new-onset, untreated luminal CD with weighted paediatric CD activity index (wPCDAI) > 40. Induction treatment consisted of EEN or oral corticosteroids; all received azathioprine maintenance treatment from start of treatment. The primary outcome of this study was endoscopic remission defined as a SES-CD score < 3 without treatment escalation at week 10. Secondary outcomes included proportion of patients without treatment escalation at week 52. In total, 27/47 patients received EEN and 20/47 corticosteroids. At baseline, patient demographics and several inflammation parameters were similar between the two treatment groups. At 10 weeks, clinical remission rates were 7/23 (30%) for EEN and 7/19 (37%) for corticosteroids (p = 0.661). Twenty-nine of 47 consented to endoscopy at 10 weeks, showing endoscopic remission rates without treatment escalation in 2/16 (13%) of EEN-treated patients and in 1/13 (8%) of corticosteroid-treated patients (p = 1.00). At week 52, 23/27 (85%) EEN-treated patients received treatment escalation (median 14 weeks) and 13/20 (65%) corticosteroid-treated patients (median 27 weeks), p = 0.070. Conclusion: In children with moderate-to-severe newly diagnosed CD, induction treatment with EEN or CS regularly is insufficient to achieve endoscopic remission without treatment escalation at week 10. Trial registration number: NCT02517684 What is Known:• Endoscopic remission is associated with a low risk of disease progression.• FL-IFX was superi

Published
2022

49. 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

Author

Jongsma, Maria M.E., Aardoom, Martine A., Cozijnsen, Martinus A., Van Pieterson, Merel, De Meij, Tim, Groeneweg, Michael, Norbruis, Obbe F., Wolters, Victorien M., Van Wering, Herbert M., Hojsak, Iva, Kolho, Kaija Leena, Hummel, Thalia, Stapelbroek, Janneke, Van Der Feen, Cathelijne, Van Rheenen, Patrick F., Van Wijk, Michiel P., Teklenburg-Roord, Sarah T.A., Schreurs, Marco W.J., Rizopoulos, Dimitris, Doukas, Michail, Escher, Johanna C., Samsom, Janneke N., De Ridder, Lissy, Jongsma, Maria M.E., Aardoom, Martine A., Cozijnsen, Martinus A., Van Pieterson, Merel, De Meij, Tim, Groeneweg, Michael, Norbruis, Obbe F., Wolters, Victorien M., Van Wering, Herbert M., Hojsak, Iva, Kolho, Kaija Leena, Hummel, Thalia, Stapelbroek, Janneke, Van Der Feen, Cathelijne, Van Rheenen, Patrick F., Van Wijk, Michiel P., Teklenburg-Roord, Sarah T.A., Schreurs, Marco W.J., Rizopoulos, Dimitris, Doukas, Michail, Escher, Johanna C., Samsom, Janneke N., and De Ridder, Lissy

Abstract

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).

Published
2022

50. Evaluation of exclusive enteral nutrition and corticosteroid induction treatment in new-onset moderate-to-severe luminal paediatric Crohn’s disease

Author

MDL onderzoek 1, MDL patientenzorg, MDL, Child Health, Jongsma, Maria M.E., Vuijk, Stephanie A., Cozijnsen, Martinus A., van Pieterson, Merel, Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert M., Hojsak, Iva, Kolho, Kaija Leena, van Wijk, Michiel P., Teklenburg-Roord, Sarah T.A., de Meij, Tim G.J., Escher, Johanna C., de Ridder, Lissy, MDL onderzoek 1, MDL patientenzorg, MDL, Child Health, Jongsma, Maria M.E., Vuijk, Stephanie A., Cozijnsen, Martinus A., van Pieterson, Merel, Norbruis, Obbe F., Groeneweg, Michael, Wolters, Victorien M., van Wering, Herbert M., Hojsak, Iva, Kolho, Kaija Leena, van Wijk, Michiel P., Teklenburg-Roord, Sarah T.A., de Meij, Tim G.J., Escher, Johanna C., and de Ridder, Lissy

Published
2022

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