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This activity is provided by an independent medical education grant from Chiesi, USA Inc.
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    Faculty & Disclosures
    Dr Barbara K Burton

    Feinberg School of Medicine, Chicago, IL, USA

    Dr Barbara K Burton is a professor of paediatrics at the Northwestern University Feinberg School of Medicine, and an attending physician in the Division of Genetics, Birth Defects and Metabolism at the Ann & Robert H. Lurie Children’s Hospital of Chicago, IL, USA. She is board certified in paediatrics, clinical genetics and clinical biochemical genetics. read more

    Dr Burton’s clinical and research interests are focused on inborn errors of metabolism and newborn screening. She is an investigator in numerous natural history studies and clinical trials of new therapies for a wide range of metabolic disorders, including many lysosomal disorders. She has published over 300 peer-reviewed articles and 50 chapters in books, and is an editor of two textbooks.

    Dr Burton is active in professional organizations and is a past president of the Society for Inherited Metabolic Disorders and the Chicago Pediatric Society. She served for 4 years as a member of the Secretary’s Advisory Committee on Heritable Disorders in Infants and Children, the federal advisory committee that makes recommendations regarding newborn screening in the US, and served for many years as chair of the Newborn Screening Advisory Committee of the Illinois Department of Public Health.

    She is an emeritus member of the board of directors of the Greater Chicago Area March of Dimes and received a Lifetime Achievement Award from the March of Dimes in 2017. She received the PKU Hero Award from the National PKU Alliance in 2018 and the Legacy Award for Clinical Practice from the National MPS Society in 2024. She is a member of the scientific advisory board of the National MPS Society and serves on the medical advisory board of a number of other patient advocacy organizations.

    Dr Barbara K Burton discloses: Advisory board/panel fees from Amgen, JCR Pharma, Moderna and Orchard. Consultancy fees from Alltrna, Chiesi, Passage Bio, Takeda and Ultragenyx. Speaker’s bureau fees from Amgen, Biomarin and Takeda.
    Dr Can (John) Ficicioglu

    Children’s Hospital of Philadelphia, Philadelphia, PA, USA

    Dr Can (John) Ficicioglu is professor of paediatrics at the Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. He is director of the Biochemical Genetics section of the Newborn Metabolic Screening Program and Lysosomal Storage Disease Center at The Children’s Hospital of Philadelphia, USA. read more

    Dr Ficicioglu received his MD and PhD from the University of Istanbul Medical School. He completed his residency at Montefiore Children’s Hospital and Genetics fellowship at Children’s Hospital Boston, Harvard Medical School. Dr Ficicioglu’s expertise encompasses newborn metabolic screening and lysosomal storage disorders. He is involved in clinical trials of new drugs to treat inborn errors of metabolism, such as lysosomal storage disorders and phenylketonuria, for which he has received several grants to support his clinical research.

    Dr Ficicioglu has received multiple grants from the Pennsylvania and New Jersey states’ newborn screening programmes and from the National Institutes of Health (NIH), and funding from the pharmaceutical sector for registries and clinical trials (including gene therapies). His research has resulted in over 100 peer-reviewed journal articles, as well as significant contributions to scientific committees, with an emphasis on newborn screening and inborn errors of metabolism.

    Dr Can (John) Ficicioglu discloses: Advisory board/panel fees from Chiesi (relationship terminated). Grant/research support fees from Denali Therapeutics, JCR Pharmaceuticals, Moderna, Passage Bio, Regenexbio and Trevena.
    Dr Christina Lampe

    University of Giessen, Giessen, Germany

    Dr Christina Lampe is director of the Centre for Rare Diseases within the Department of Pediatric Neurology, Muscular Diseases, and Social Pediatrics at the University of Giessen, Germany. read more

    After studying medicine at the Humboldt University of Berlin (Charité), she completed her internship in the Surgical Department of the same university. In 2007, Dr Lampe transitioned to the metabolic field and began working at Villa Metabolica in the Department of Pediatric and Adolescent Medicine at Johannes Gutenberg University of Mainz, Germany.

    In January 2014, together with Prof. Maurizio Scarpa, Dr Lampe established a Centre for Rare Diseases at the Dr. Horst Schmidt Kliniken in Wiesbaden, Germany, primarily focused on lysosomal diseases and related disorders. In October 2018, she established the Center for Rare Diseases at the University Hospital in Giessen (ZSEGI), where she continues to care for a large number of paediatric and adult patients with lysosomal diseases and related conditions. Dr Lampe serves as both an investigator and co-investigator in several clinical trials concerning lysosomal diseases.

    Dr Christina Lampe discloses: Advisory board/panel and consultancy fees from Alexion, Amicus, BioMarin, Chiesi, Sanofi and Takeda.
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    touchENDOCRINOLOGY touchENDOCRINOLOGY
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    How often do you use a care coordinator for patients with complex needs?

    Submit your answer to see the results

    Always
       
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    In your opinion, what is the most important unmet need in the treatment of AM?

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    Potential for corrective gene therapies
       
    Expanded ERT options to better tailor treatment
       
    More effective therapies that reduce the burden of hospital-based management
       
    Improved efficacy at targeting non-CNS manifestations
       

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    Which do you consider most important to support treatment needs along the lifespan?

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    Earlier accurate diagnosis
       
    Coordinated MDT monitoring and follow-up
       
    Earlier access to approved therapies
       
    Comprehensive treatment guidelines
       
     
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    Rare Disease Day, Cardiovascular Risk, General Endocrinology CE/CME accredited

    touchPANEL DISCUSSION
    A visually engaging discussion designed to emulate a ‘live’ panel experience and provide clinicians with practical expert insights to address their clinical challenges. Useful tips below will show how to navigate the activity. Close

    Integrating treatment advances for alpha-mannosidosis into effective MDT care

    Faculty Podcast Featured
    Useful tips
    • A practice aid is available for this activity in the Toolkit
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    Learning Objectives

    After watching this activity, participants should be better able to:

    • Identify unmet needs along the alpha-mannosidosis treatment journey, including implications for milestone attainment
    • Appraise the latest clinical evidence and potential role for replacement and corrective therapies in the treatment of alpha-mannosidosis
    • Formulate strategies to integrate the latest treatment advances into individualized MDT management plans in alpha-mannosidosis
    Overview

    World experts come together to discuss how to optimize the multidisciplinary management of alpha-mannosidosis along the disease continuum. read more

    Target Audience

    Paediatricians, neurologists, geneticists and neurology nurse specialists involved in the management of AM.

    USF Accreditation

    Disclosures

    USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

    Faculty

    Dr Barbara K Burton discloses: Advisory board/panel fees from Amgen, JCR Pharma, Moderna and Orchard. Consultancy fees from Alltrna, Chiesi, Passage Bio, Takeda and Ultragenyx. Speaker’s bureau fees from Amgen, Biomarin and Takeda.

    Dr Can (John) Ficicioglu discloses: Advisory board/panel fees from Chiesi (relationship terminated). Grant/research support fees from Denali Therapeutics, JCR Pharmaceuticals, Moderna, Passage Bio, Regenexbio and Trevena.

    Dr Christina Lampe discloses: Advisory board/panel and consultancy fees from Alexion, Amicus, BioMarin, Chiesi, Sanofi and Takeda.

    Content reviewer

    Danielle Walker, DNP, APRN, AGNP-C, nurse reviewer and planner, has no financial interests/relationships or affiliations in relation to this activity.

    touchIME Medical Contributors

    Judah Issa has no financial interests/relationships or affiliations in relation to this activity.

    USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

    Requirements for Successful Completion

    In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

    If you have questions regarding credit please contact cpdsupport@usf.edu 

    Accreditations

    Physicians

    This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

    USF Health designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditsTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Advanced Practice Providers

    Physician Assistants may claim a maximum of 0.75 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

    The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

    Nurses

    USF Health is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

    A maximum of 0.75 contact hour may be earned by learners who successfully complete this  continuing professional development activity. USF Health, the accredited provider, acknowledges touchIME as the joint provider in the planning and execution of this CNE activity.

    Date of original release: 17 April 2025. Date credits expire: 17 April 2026.

    If you have any questions regarding credit, please contact cpdsupport@usf.edu

    This activity is CE/CME accredited

    To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

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    Topics covered in this activity

    Rare Disease Day / Cardiovascular Risk / General Endocrinology
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    This activity is funded by:

    An independent medical education grant from Chiesi, USA Inc.
    The activity is jointly provided by USF Health and touchIME.

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgement of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals outside of the UK only.

    Date of original release: 17 April 2025.

    Date credits expire: 17 April 2026.

    Claim Credit
    touchPANEL DISCUSSION
    Integrating treatment advances for alpha-mannosidosis into effective MDT care
    0.75 CE/CME credit
    Question 1/6
    Which of the following signs and symptoms of alpha-mannosidosis is considered a dominant symptom in younger patients and has an important impact on quality of life?

    As outlined by Guffon et al, the three most dominant symptoms in patients ≤10 years of age are speech delay, hearing loss and developmental delay.

    Reference
    Guffon N, et al. Mol Genet Metab. 2019;126:470–4.

    Question 2/6
    You are developing a treatment plan for your 23-year-old patient with alpha-mannosidosis. Based on identified needs along the patient’s journey with the disease, which of the following treatment goals should you prioritize to optimize this patient's outcomes?

    In alpha-mannosidosis, motor function is often impaired due to abnormal balance, hypotonia, ataxia and pain.1 Pain is a prominent component of living with alpha-mannosidosis; however, given the multisystem spectrum of manifestations, it can be challenging to identify the source of pain.1 Therefore, it is recommended that surveillance of patients with alpha-mannosidosis includes assessment for muscle pain, joint aches and bone pain.2

    References

    1. Borgwadt L et, al. J Inborn Errors Metab Screen. 2018;6:1–12.
    2. Ficicioglu C, Stepien KM. In: Adam MP, Feldman J, et al, editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993–2025.
    Question 3/6
    Which of the following statements best reflects findings from long-term data on ERT with velmanase alfa in patients with alpha-mannosidosis treated in the rhLAMAN-07/-09 trials, with up to 12 years’ follow-up?

    ERT, enzyme replacement therapy.

    Pooled data from two multicentre, open-label phase IIIb extension trials, rhLAMAN-07 (N=13; NCT01908712) and rhLAMAN-09 (N=8; NCT01908725), evaluated the long-term effects of velmanase alfa. Sixteen patients who had previously completed phase I–III rhLAMAN-02/-03/-04/-05/-08 trials and five ERT-naïve patients were included and divided by age at treatment baseline into paediatric (n=14) and adult (n=7) subgroups.

    Distance walked according to 6MWT increased or stabilized in paediatric patients, while in adults, either stabilization or slight decline was observed. Similarly, paediatric patients performed better in the 3MSCT. Changes in FVC, % predicted, were comparable in both subgroups with up to 6 years’ of observation, diverging thereafter. Overall, descriptive statistical analyses showed sustained sOLIGO clearance (reduction in sOLIGO levels) and increase in serum IgG levels from treatment initiation until last common observation. Hearing ability (according to bone as well as air conduction) remained mostly stable but with variable degrees of fluctuation among patients.

    Abbreviations

    3MSCT, 3-minute stair climb test; 6MWT, 6-minute walk test; ERT, enzyme replacement therapy; FVC, forced vital capacity; Ig, immunoglobulin; sOLIGO, serum oligosaccharides.

    Reference
    Guffon N, et al. J Inherit Metab Dis. 2025;48:e12799.

    Question 4/6
    Your patient is a 19-year-old with alpha-mannosidosis currently receiving treatment with an approved ERT. At their last infusion, they experienced an infusion-related reaction requiring symptomatic treatment. You note that the patient is now becoming anxious when they are due for the next infusion. What would you consider to support the patient with their treatment experience?

    ERT, enzyme replacement therapy; HSCT, haematopoietic stem cell transplant; Ig, immunoglobulin

    Infusion-related reactions have been reported on administration of approved ERT (velmanase alfa) in patients with alpha-mannosidosis. Pretreatment (prior to ERT administration) with antihistamines, antipyretics and/or corticosteroids may be considered in order to reduce risk of infusion-related reactions.1,2

    Abbreviations
    ERT, enzyme replacement therapy.

    References

    1. FDA. Velmanase alfa PI. Available at: https://rb.gy/tznrwf (accessed 11 March 2025).
    2. EMA. Velmanase alfa SmPC. Available at: https://rb.gy/2bs8jd (accessed 11 March 2025).
    Question 5/6
    When considering treatment options for alpha-mannosidosis, how do HSCT and ERT differ in their therapeutic effects?

    CNS, central nervous system; ERT, enzyme replacement therapy; HSCT, haematopoietic stem cell transplant.

    HSCT has been explored as a potential therapeutic option for alpha-mannosidosis; however, data are limited and there have been no head-to-head comparisons with ERT. Available data show HSCT can attenuate CNS disease, suggesting that healthy donor cells are playing a role in alleviating neuropathology.1 Approved ERT (velmanase alfa) is indicated for the treatment of non-CNS/2non-neurological3 manifestations, leaving HSCT as the only modality with potential neurocognition preservation.1

    Abbreviations
    CNS, central nervous system; ERT, enzyme replacement therapy; HSCT, haematopoietic stem cell transplant.

    References

    1. Naumchik BM, et al. Cells. 2020;9:1411.
    2. FDA. Velmanase alfa PI. Available at: https://rb.gy/tznrwf (accessed 26 March 2025).
    3. EMA. Velmanase alfa SmPC. Available at: https://rb.gy/2bs8jd (accessed 26 March 2025).
    Question 6/6
    Your patient is a 36-year-old man who lives in a rural location, far from the specialist centre. He is currently receiving his ERT infusions at a local clinic, but has to travel for his physiotherapy appointments, his psychiatric care, and his regular assessments. During his latest appointment, his caregiver expresses frustration at having to travel long distances to different hospitals in order to complete all of the required assessments and treatments. What might you consider next in the management of this patient?

    ERT, enzyme replacement therapy.

    A recent Delphi consensus document highlighted the importance of coordinated care and an MDT approach to treatment to improve patient-centred care in alpha-mannosidosis. The Delphi panellists recognized existing barriers to such approaches (e.g. financial burden and healthcare resource utilization costs associated with use of a designated ‘case worker’, alongside region- or practice-specific limitations), but nonetheless reached high agreement (90%) on the use of a designated case worker to support care navigation when access to a coordinated MDT clinic is not available.1 This need was echoed in a recent real-world patient–physician panel conducted in Italy, exploring unmet needs in lysosomal storage disorders.2

    Abbreviation
    MDT, multidisciplinary team.

    References

    1. Guffon N, et al. Mol Genet Med. 2024;142:108519.
    2. Castaman G, et al. Clin Med. 2024;13:6981.
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    This activity is funded by:

    An independent medical education grant from Chiesi, USA Inc.
    The activity is jointly provided by USF Health and touchIME.

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgement of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals outside of the UK only.

    Date of original release: 17 April 2025.

    Date credits expire: 17 April 2026.

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