Characterization of the phenotypic diversity in DupEx2 Duchenne Muscular Dystrophy and identification of predictive/prognostic markers
- 2.9 Years 2022/2025
- 193.600€ Total Award
Duchenne muscular dystrophy (DMD) is an X-linked recessive disorder characterized by progressive weakening of skeletal muscles leading to loss of ambulation between 10-14 years. DMD is caused by mutations in the dystrophin gene and in 11% of these are duplications. The most promising therapeutic approaches include mutation-specific therapies. Notably, there is increasing evidence that specific groups of mutations may underlie different disease trajectories compared to the “average” DMD population. It is therefore mandatory to obtain more information about genotype-phenotype correlations and patterns of progression related to different genotypes.
Duplication of exon 2 (Dup2) is the most common DMD duplication and the only one for which a Phase I/IIa study on AAV-delivered, snRNA-mediated exon skipping is currently ongoing. Dup2 is expected to induce a severe DMD phenotype, consistent with most case series and large databases available to date. However, Dup2 has been occasionally reported with milder phenotype. We have identified all the viable Dup2 DMD patients in Italy: 26 subjects from 13 centers. Preliminary findings suggest that these patients have collectively a milder progression of the disease when compared to the classical DMD phenotype. More interestingly, about 30% of Dup2 patients have a significantly very milder phenotype, some of them still ambulatory at age of 20 years. Preliminary attempts to reveal mechanism involved in attenuating the phenotype seem to confute the hypothesis of alternative spicing transcripts as previously described for DMD patients harbouring deletion of exon 2. With the present application we propose to clinically characterize the Italian Dup2 population, including motor deterioration, respiratory and cardiac function, to perform whole genome sequencing to characterize DNA breakpoints to correlate with the phenotype and to collect available muscle biopsy samples and uro-stem cells/PBMC for future proteomic studies.
Scientific Publications
- 2014 JOURNAL OF EXPERIMENTAL MEDICINE
Jab1 regulates Schwann cell proliferation and axonal sorting through p27
- 2020 NEUROLOGY
Pregnancy in Charcot-Marie-Tooth disease: Data from the Italian CMT national registry.
- 2021 JOURNAL OF NEUROLOGY
A 5-year clinical follow-up study from the Italian National Registry for FSHD.
- 2020 FRONTIERS IN MOLECULAR NEUROSCIENCE
LAMA2 Neuropathies: Human Findings and Pathomechanisms From Mouse Models.
- 2020 FRONTIERS IN GENETICS
The Genetic Landscape of Dystrophin Mutations in Italy: A Nationwide Study.
- 2016
- 2016 AMERICAN JOURNAL OF HUMAN GENETICS
Association Study of Exon Variants in the NF-?B and TGFß Pathways Identifies CD40 as a Modifier of Duchenne Muscular Dystrophy.
- 2017 NATURE COMMUNICATIONS
Evidence for ACTN3 as a genetic modifier of Duchenne muscular dystrophy.
- 2020
- 2019
- 2014
- 2012
- 2020
- 2020
- 2021
- 2020
- 2020 Journal of clinical medicine
Duchenne Dilated Cardiomyopathy: Cardiac Management from Prevention to Advanced Cardiovascular Therapies.
- 2018 PLOS ONE
Implicit learning deficit in children with Duchenne muscular dystrophy: Evidence for a cerebellar cognitive impairment?
- 2019 Neuromuscular disorders : NMD
Longitudinal natural history in young boys with Duchenne muscular dystrophy.
- 2018 NEUROLOGY
The relationship between deficit in digit span and genotype in nonsense mutation Duchenne muscular dystrophy.
- 2019
- 2019 Neuromuscular disorders : NMD
Evaluation of gait in Duchenne Muscular Dystrophy: Relation of 3D gait analysis to clinical assessment.
- 2018 PLOS ONE
Upper limb function in Duchenne muscular dystrophy: 24 month longitudinal data.
- 2016 Neuromuscular disorders : NMD
Histological effects of givinostat in boys with Duchenne muscular dystrophy.
- 2014 PLOS ONE
6 Minute walk test in Duchenne MD patients with different mutations: 12 month changes.
- 2012 Molecular therapy : the journal of the American Society of Gene Therapy
Exon 45 skipping through U1-snRNA antisense molecules recovers the Dys-nNOS pathway and muscle differentiation in human DMD myoblasts.
- 2016 NEUROMUSCULAR DISORDERS
Health-related quality of life and functional changes in DMD: A 12-month longitudinal cohort study
- 2012 BMC MEDICAL GENETICS
Genetic characterization in symptomatic female DMD carriers: lack of relationship between X-inactivation, transcriptional DMD allele balancing and phenotype.
- 2007 FASEB journal : official publication of the Federation of American Societies for Experimental Biology
Gene expression profiling in the early phases of DMD: a constant molecular signature characterizes DMD muscle from early postnatal life throughout disease progression.
- 2015 Neuromuscular disorders : NMD
Benefits of glucocorticoids in non-ambulant boys/men with Duchenne muscular dystrophy: A multicentric longitudinal study using the Performance of Upper Limb test.
- 2014 Neuromuscular disorders : NMD
Reliability of the Performance of Upper Limb assessment in Duchenne muscular dystrophy.
- 2017 HUMAN MOLECULAR GENETICS
Oxidative stress in Duchenne muscular dystrophy: focus on the NRF2 redox pathway.
- 2010 Neuromuscular disorders : NMD
North Star Ambulatory Assessment, 6-minute walk test and timed items in ambulant boys with Duchenne muscular dystrophy.
- 2009 Neuromuscular disorders : NMD
Reliability of the North Star Ambulatory Assessment in a multicentric setting.
- 2020
- 2020 ORPHANET JOURNAL OF RARE DISEASES
Global epidemiology of Duchenne muscular dystrophy: an updated systematic review and meta-analysis.
- 2019 MUSCLE & NERVE
Expanding the central nervous system disease spectrum associated with FLNC mutation.
- 2020 PHARMACOLOGICAL RESEARCH
Rimeporide as a first- in-class NHE-1 inhibitor: Results of a phase Ib trial in young patients with Duchenne Muscular Dystrophy.
- 2017
- 2020
- 2020 ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY
Genetic modifiers of respiratory function in Duchenne muscular dystrophy.
- 2019 Journal of neurology, neurosurgery, and psychiatry
Expanding the spectrum of genes responsible for hereditary motor neuropathies.
- 2019 ANNALS OF NEUROLOGY
A multicenter retrospective study of charcot-marie-tooth disease type 4B (CMT4B) associated with mutations in myotubularin-related proteins (MTMRs).
- 2017 Neuromuscular disorders : NMD
Diagnosis of Duchenne Muscular Dystrophy in Italy in the last decade: Critical issues and areas for improvements.
- 2020
- 2012 DEVELOPMENT
Vimentin regulates peripheral nerve myelination
- 2020 Journal of neurology, neurosurgery, and psychiatry
Nusinersen safety and effects on motor function in adult spinal muscular atrophy type 2 and 3.
- 2020 HUMAN MOLECULAR GENETICS
Impaired turnover of hyperfused mitochondria in severe axonal neuropathy due to a novel DRP1 mutation.
- 2019 PLOS ONE
Correction: Long-term natural history data in Duchenne muscular dystrophy ambulant patients with mutations amenable to skip exons 44, 45, 51 and 53.
- 2019 PLOS ONE
Long-term natural history data in Duchenne muscular dystrophy ambulant patients with mutations amenable to skip exons 44, 45, 51 and 53.
- 2012
- 2016
- 2012
- 2007
- 2020 NEUROLOGY
Suitability of external controls for drug evaluation in Duchenne muscular dystrophy.
- 2014
- 2017
- 2010
- 2021
- 2019
- 2017
- 2021 Neuromuscular disorders : NMD
The nonsense mutation stop+4 model correlates with motor changes in Duchenne muscular dystrophy.
- 2021
- 2016
- 2020
- 2020
- 2019
- 2019
- 2016
- 2019
- 2021
- 2012
- 2020
- 2021
- 2014
- 2010
- 2020
- 2012
- 2021
- 2020
- 2017
- 2017
- 2021
- 2020
- 2020
- 2021
- 2021 HUMAN MUTATION
A single NGS-based assay covering the entire genomic sequence of the DMD gene facilitates diagnostic and newborn screening confirmatory testing.
- 2020 Journal of neuromuscular diseases
Clinical Phenotypes of DMD Exon 51 Skip Equivalent Deletions: A Systematic Review.
- 2021 Brain Sciences
A Phase 1/2 Study of Flavocoxid, an Oral NF-?B Inhibitor, in Duchenne Muscular Dystrophy.
- 2021 Science (New York, N.Y.)
RNA-targeted drugs for neuromuscular diseases.
- 2021 Neurology. Genetics
Ethnicity-related DMD Genotype Landscapes in European and Non-European Countries.
- 2020 European journal of human genetics : EJHG
EMQN best practice guidelines for genetic testing in dystrophinopathies.
- 2010
- 2020 PLOS ONE
Genetic testing offer for inherited neuromuscular diseases within the EURO-NMD reference network: A European survey study.
- 2015
- 2016
- 2020
- 2018
- 2014
- 2018
- 2018
- 2021
- 2020
- 2019 Annals of internal medicine
Cardiac and Neuromuscular Features of Patients With LMNA-Related Cardiomyopathy.
- 2014
- 2017 Contemporary clinical trials
Developing standardized corticosteroid treatment for Duchenne muscular dystrophy.
- 2011 BMC MEDICAL GENETICS
Clinical and molecular characterization of a cohort of patients with novel nucleotide alterations of the Dystrophin gene detected by direct sequencing.
- 2015
- 2020
- 2016 EMBO MOLECULAR MEDICINE
Niacin-mediated Tace activation ameliorates CMT neuropathies with focal hypermyelination
- 2014 JAMA NEUROLOGY
Biochemical characterization of patients with in-frame or out-of-frame DMD deletions pertinent to exon 44 or 45 skipping.
- 2018
- 2014
- 2018 PLOS ONE
A multicenter comparison of quantification methods for antisense oligonucleotide-induced DMD exon 51 skipping in Duchenne muscular dystrophy cell cultures.
- 2018
- 2012
- 2014
- 2020
- 2014 PLOS ONE
6 Minute Walk Test in Duchenne MD Patients with Different Mutations: 12 Month Changes
- 2018 Neuromuscular disorders : NMD
226th ENMC International Workshop:: Towards validated and qualified biomarkers for therapy development for Duchenne muscular dystrophy 20-22 January 2017, Heemskerk, The Netherlands.
- 2011 BMC MEDICAL GENETICS
Clinical and molecular characterization of a cohort of patients with novel nucleotide alterations of the Dystrophin gene detected by direct sequencing
- 2017 Neuromuscular disorders : NMD
Diagnosis of Duchenne muscular dystrophy in Italy in the last decade: Critical issues and areas for improvements.
- 2020 Acta myologica : myopathies and cardiomyopathies : official journal of the Mediterranean Society of Myology
Impaired myocardial strain in early stage of Duchenne muscular dystrophy: its relation with age and motor performance.
- 2019 JCI insight
A recurrent COL6A1 pseudoexon insertion causes muscular dystrophy and is effectively targeted by splice-correction therapies.
- 2006
- 2015 NEUROMUSCULAR DISORDERS
Benefits of glucocorticoids in non-ambulant boys/men with Duchenne muscular dystrophy: A multicentric longitudinal study using the Performance of Upper Limb test
- 2019
- 2014 PLOS ONE
Long term natural history data in ambulant boys with duchenne muscular dystrophy: 36-month changes
- 2012 NEUROLOGY
Importance of SPP1 genotype as a covariate in clinical trials in Duchenne muscular dystrophy
- 1994 Neuromuscular disorders : NMD
Mutation of dystrophin gene and cardiomyopathy.
- 2000 NEUROLOGY
Loss of Dp140 dystrophin isoform and intellectual impairment in Duchenne dystrophy.
- 2003 HUMAN GENETICS
Relevance of sequence and structure elements for deletion events in the dystrophin gene major hot-spot.
- 2002 FEBS LETTERS
The dystrophin gene is alternatively spliced throughout its coding sequence.
- 2000
- 2001 JOURNAL OF THE NEUROLOGICAL SCIENCES
Transcriptional activation of the non-muscle, full-length dystrophin isoforms in Duchenne muscular dystrophy skeletal muscle.
- 1999 Lancet (London, England)
Absence of brain Dp140 isoform and cognitive impairment in Becker muscular dystrophy.
- 2020 ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY
Genetic modifiers of respiratory function in Duchenne muscular dystrophy
- 2003 Neuromuscular disorders : NMD
Two dystrophin proteins and transcripts in a mild dystrophinopathic patient.
- 2011 JOURNAL OF NEUROLOGY
Genotype and phenotype characterization in a large dystrophinopathic cohort with extended follow-up
- 2006 FASEB journal : official publication of the Federation of American Societies for Experimental Biology
A region in the dystrophin gene major hot spot harbors a cluster of deletion breakpoints and generates double-strand breaks in yeast.
- 2001 HUMAN MUTATION
A novel splice site mutation (3157+1G>T) in the dystrophin gene causing total exon skipping and DMD phenotype.
- 2001 HUMAN GENETICS
Analysis of splicing parameters in the dystrophin gene: relevance for physiological and pathogenetic splicing mechanisms.
- 1995 HUMAN MOLECULAR GENETICS
A G+1-->A transversion at the 5' splice site of intron 69 of the dystrophin gene causing the absence of peripheral nerve Dp116 and severe clinical involvement in a DMD patient.
- 2002 Genetics
Comparative analysis of the human dystrophin and utrophin gene structures.
- 1995 Neuromuscular disorders : NMD
Duplication of dystrophin gene and dissimilar clinical phenotype in the same family.