Patient selection considerations for AADC deficiency gene therapy

Abstract Background Aromatic ʟ‐amino acid decarboxylase (AADC) deficiency is a rare, severe neurological disorder caused by pathogenic variants in the dopa decarboxylase (DDC) gene, resulting in a combined deficiency of monoamine neurotransmitters. Clinically, patients present with a range of dysfun...

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Main Authors: Agathe Roubertie, Irina Anselm, Bruria Ben‐Zeev, Wuh‐Liang Hwu, Ashutosh Kumar, Berrin Monteleone, Shin‐ichi Muramatsu, Vincenzo Leuzzi, Salvador Ibáñez, Scellig Stone, Phillip L. Pearl
Format: Article
Language:English
Published: Wiley 2024-03-01
Series:Annals of the Child Neurology Society
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Online Access:https://doi.org/10.1002/cns3.20052
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author Agathe Roubertie
Irina Anselm
Bruria Ben‐Zeev
Wuh‐Liang Hwu
Ashutosh Kumar
Berrin Monteleone
Shin‐ichi Muramatsu
Vincenzo Leuzzi
Salvador Ibáñez
Scellig Stone
Phillip L. Pearl
author_facet Agathe Roubertie
Irina Anselm
Bruria Ben‐Zeev
Wuh‐Liang Hwu
Ashutosh Kumar
Berrin Monteleone
Shin‐ichi Muramatsu
Vincenzo Leuzzi
Salvador Ibáñez
Scellig Stone
Phillip L. Pearl
author_sort Agathe Roubertie
collection DOAJ
description Abstract Background Aromatic ʟ‐amino acid decarboxylase (AADC) deficiency is a rare, severe neurological disorder caused by pathogenic variants in the dopa decarboxylase (DDC) gene, resulting in a combined deficiency of monoamine neurotransmitters. Clinically, patients present with a range of dysfunctions that impact motor, autonomic, and cognitive development. The constellation of symptoms of AADC deficiency varies among patients, and clinical presentation falls across a wide spectrum. However, most patients with AADC deficiency experience significant impairments when compared with children with normal development, irrespective of genotype, phenotype, or disease severity. Further, AADC deficiency is associated with increased mortality. Methods In response to the recent approval of a disease‐modifying gene therapy for AADC deficiency, this review presents considerations for the selection of patients for treatment. Conclusion Suggested clinical criteria to determine whether a patient is a candidate for gene therapy are: (1) genetically and biochemically confirmed AADC deficiency; (2) lack of achievement of gross motor milestones and/or persistence of clinically significant movement disorders; (3) persistent neurocognitive or systemic symptoms secondary to AADC deficiency despite standard medical therapy; and (4) informed parental/guardian decision and consent to treatment.
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spelling doaj-art-deca6b443a2e40fb99fb7e172d08a5852025-08-20T02:16:56ZengWileyAnnals of the Child Neurology Society2831-32672024-03-0121535910.1002/cns3.20052Patient selection considerations for AADC deficiency gene therapyAgathe Roubertie0Irina Anselm1Bruria Ben‐Zeev2Wuh‐Liang Hwu3Ashutosh Kumar4Berrin Monteleone5Shin‐ichi Muramatsu6Vincenzo Leuzzi7Salvador Ibáñez8Scellig Stone9Phillip L. Pearl10Départment de Neuropédiatrie Centre Hospitalier Universitaire de Montpellier Montpellier FranceDepartment of Neurology, Boston Children's Hospital Harvard Medical School Boston Massachusetts USASackler Faculty of Medicine Tel Aviv University Tel Aviv IsraelDepartment of Medical Genetics National Taiwan University Hospital Taipei City TaiwanDepartment of Pediatrics and Neurology Penn State Health Hershey Pennsylvania USADepartment of Clinical Genetics NYU Long Island School of Medicine New York New York USADivision of Neurological Gene Therapy, Center for Innovation Jichi Medical University Tochigi JapanDepartment of Human Neuroscience Sapienza University of Rome Rome ItalyDepartment of Pediatric Neurology Arrixaca University Hospital Murcia SpainDepartment of Neurosurgery, Boston Children's Hospital Harvard Medical School Boston Massachusetts USADepartment of Neurology, Boston Children's Hospital Harvard Medical School Boston Massachusetts USAAbstract Background Aromatic ʟ‐amino acid decarboxylase (AADC) deficiency is a rare, severe neurological disorder caused by pathogenic variants in the dopa decarboxylase (DDC) gene, resulting in a combined deficiency of monoamine neurotransmitters. Clinically, patients present with a range of dysfunctions that impact motor, autonomic, and cognitive development. The constellation of symptoms of AADC deficiency varies among patients, and clinical presentation falls across a wide spectrum. However, most patients with AADC deficiency experience significant impairments when compared with children with normal development, irrespective of genotype, phenotype, or disease severity. Further, AADC deficiency is associated with increased mortality. Methods In response to the recent approval of a disease‐modifying gene therapy for AADC deficiency, this review presents considerations for the selection of patients for treatment. Conclusion Suggested clinical criteria to determine whether a patient is a candidate for gene therapy are: (1) genetically and biochemically confirmed AADC deficiency; (2) lack of achievement of gross motor milestones and/or persistence of clinically significant movement disorders; (3) persistent neurocognitive or systemic symptoms secondary to AADC deficiency despite standard medical therapy; and (4) informed parental/guardian decision and consent to treatment.https://doi.org/10.1002/cns3.20052AADC deficiencygene therapyrare disease
spellingShingle Agathe Roubertie
Irina Anselm
Bruria Ben‐Zeev
Wuh‐Liang Hwu
Ashutosh Kumar
Berrin Monteleone
Shin‐ichi Muramatsu
Vincenzo Leuzzi
Salvador Ibáñez
Scellig Stone
Phillip L. Pearl
Patient selection considerations for AADC deficiency gene therapy
Annals of the Child Neurology Society
AADC deficiency
gene therapy
rare disease
title Patient selection considerations for AADC deficiency gene therapy
title_full Patient selection considerations for AADC deficiency gene therapy
title_fullStr Patient selection considerations for AADC deficiency gene therapy
title_full_unstemmed Patient selection considerations for AADC deficiency gene therapy
title_short Patient selection considerations for AADC deficiency gene therapy
title_sort patient selection considerations for aadc deficiency gene therapy
topic AADC deficiency
gene therapy
rare disease
url https://doi.org/10.1002/cns3.20052
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