MUCOPOLYSACCHARIDOSIS-MPS

RARE-DISEASE

MPSI – Endocrinology Case Study

<p>By simulating a real-life Scenario this case study developed to increase the awareness of MPS I, by highlighting familiar symptoms that suggest the possibility of an unfamiliar underlying metabolic disease for Endocrinologist specialty.</p>

<h2>Are you interested in knowing more about this topic?</h2>

PRURIGO-NODULARIS

DERMATOLOGY

Mechanism of Prurigo Nodularis Disease

<p>In this comprehensive exploration, we delve into the intricate pathophysiology of Prurigo Nodularis (PN), highlighting the pivotal roles of neuronal sensitization, inflammation, and pruritus. This challenging dermatological condition is characterized by dermatological condition histopathologic alterations, including enhanced hypervascularization, epidermal hyperkeratosis, and dermal fibrosis. Explore the connection between PN and the proinflammatory Th2 cytokine IL-13, shedding light on its binding to IL-4R across various skin components.</p>

<h2>Consensus based on literature supporting clinical presentation and recommendations</h2>
<p style="text-align: center;">Literature Analysis on LOPD Symptoms (Pulmonology): Hierarchy of Evidence</p>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td>
    <ul>
     <li>Systemic review and meta-analysis</li>
     <li>Randomized controlled trials</li>
     <li>Observational studies (cohort studies/screening studies)</li>
     <li>Case series studies</li>
     <li>Case series, case reports</li>
     <li>Expert Opinion</li>
    </ul></td>
  </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td>
    <ul>
     <li>4 studies for adult<sup>#</sup>&nbsp;LOPD</li>
     <li>7 studies for pediatric* LOPD and 11 studies for adult<sup>#</sup>&nbsp;LOPD</li>
    </ul></td>
  </tr>
 </tbody>
</table>

<h3 style="text-align: center;">Pulmonology-Specific</h3>
<p style="text-align: center;">Clinical Presentation for Pediatric/Juvenile* and Adult# LOPD Proposed During the First Meeting</p>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td>
    <ul>
     <li>&nbsp;Respiratory failure/insufficiency</li>
     <li>&nbsp;Diaphragm weakness</li>
     <li>&nbsp;Dyspnea</li>
     <li>&nbsp;Orthopnea</li>
     <li>&nbsp;Sleep-disordered breathing</li>
    </ul></td>
  </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="text-align: center;">High CK/elevated<br>
     LDH, ALT, and AST</td>
  </tr>
 </tbody>
</table>

<h3 style="text-align: center;">Pulmonology-Specific</h3>
<p style="text-align: center;">Diagnostic Algorithm Proposed During the Second Meeting</p>

<h3>Conclusion</h3>
<p>A consensus-based diagnostic algorithm simplifies LOPD diagnosis across specialties</p>
<ul>
 <li>Guides clinicians in the differential diagnosis of LOPD</li>
 <li>&nbsp;Facilitates direct referral for early and accurate diagnosis of LOPD</li>
</ul>

<p><strong>Recommendation</strong><br>
  Testing for Pompe disease must be done if any one specialty-specific symptom plus elevated CK/LDH/ALT/AST or a family history of unexplained muscle weakness are present.</p>

<h2>Conclusion</h2>
<p>*The age of patients with pediatric/juvenile LOPD ranges from 1 to 17 years; #The age of patients with adult LOPD is usually 18 years and above.</p>

Abbreviations

Reference

Expert Group Consensus From the Arabian Peninsula On the Diagnosis of Lopd

POMPE

ACID-SPHINGOMYLENASE-DEFICIENCY-NIEMANN-PICK

How do you know if you or a loved one has ASMD?

<p>This video explains the diagnosis process and its potential delay due to overlap with other conditions.</p>

<h2>Were You Expecting Leukaemia?</h2>
<h3>Think Gaucher Disease</h3>
<h3>A Diagnostic Algorithm for Adults<sup>1</sup></h3>

<h2>Understanding Gaucher Disease Type <sup>1</sup></h2>

<p>GD is the most common LSD caused by a deficiency in glucocerebrosidase enzyme. GD patients may experience 10 years of diagnostic delay.</p>
<p><strong>Test for diagnosis</strong></p>
<ul>
 <li>Enzyme activity test on DBS</li>
 <li>Whole blood sample analysis to confirm diagnosis</li>
</ul>

References

<p>One JLT Building, Level 3, Jumeirah Lake Towers, PO Box 53899, Dubai, UAE For further medical information, please contact: For UAE 800 MEDICAL Toll Free Number. For all Gulf countries +971 565776791 or email:&nbsp;<a href="mailto:medical-information.gulf@sanofi.com."><u>medical-information.gulf@sanofi.com.</u></a></p>
<p>Full prescribing information is available upon request.<br>
  To Report adverse events please call: +971 561747001 or email&nbsp;<a href="mailto:Gulf.Pharmacovigilance@sanofi.com"><u>Gulf.Pharmacovigilance@sanofi.com</u></a><br><a href="http://www.sanofi.com"><u>www.sanofi.com</u></a><br>
  To report any side effect(s): Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC): SFDA call center: 19999 • E-mail:&nbsp;<a href="mailto:npc.drug@sfda.gov.sa"><u>npc.drug@sfda.gov.sa</u></a>&nbsp;• Website:&nbsp;<a href="mailto:https://ade.sfda.gov.sa/"><u>https://ade.sfda.gov.sa/</u></a></p>
<p>Full Prescribing Information is available upon request:<br>
  SANOFI, Kingdom of Saudi Arabia, P.O. Box 9874, Jeddah 21423, K.S.A. Tel: +966-12-669-3318, Fax: +966-12-663-6191<br>
  For Medical Information, Please contact: +966-12-669-3318,&nbsp;<a href="mailto:ksa.medicalinformation@sanofi.com"><u>ksa.medicalinformation@sanofi.com</u></a><br>
  For Pharmacovigilance, Please contact: +966-54-428-4797,&nbsp;<a href="mailto:ksa_pharmacovigilance@sanofi.com"><u>ksa_pharmacovigilance@sanofi.com</u></a></p>
<p>To report any Product Technical Complaint, please contact SANOFI Quality Department:<br>
  Email:&nbsp;<a href="mailto:quality.greatergulf@Sanofi.com"><u>quality.greatergulf@Sanofi.com</u></a><br><a href="mailto:www.sanofi.com.sa"><u>www.sanofi.com.sa</u></a></p>
<p>MAT-BH-2300002-V2 Mar-25</p>

<h2>Were You Expecting Leukaemia?</h2>
<h3>Think Gaucher Disease</h3>
<h3>A Diagnostic Algorithm for Paediatric Patients<sup>1</sup></h3>

<p>Image adapted from Di Rocco M, et al. Pediatric Blood Cancer 2014. 61(11):1905–1909.</p>

<p>One JLT Building, Level 3, Jumeirah Lake Towers, PO Box 53899, Dubai, UAE For further medical information, please contact: For UAE 800 MEDICAL Toll Free Number. For all Gulf countries +971 565776791 or email:&nbsp;<a href="mailto:medical-information.gulf@sanofi.com."><u>medical-information.gulf@sanofi.com.</u></a></p>
<p>Full prescribing information is available upon request.<br>
  To Report adverse events please call: +971 561747001 or email&nbsp;<a href="mailto:Gulf.Pharmacovigilance@sanofi.com"><u>Gulf.Pharmacovigilance@sanofi.com</u></a><br><a href="http://www.sanofi.com"><u>www.sanofi.com</u></a><br>
  To report any side effect(s): Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC): SFDA call center: 19999 • E-mail:&nbsp;<a href="mailto:npc.drug@sfda.gov.sa"><u>npc.drug@sfda.gov.sa</u></a>&nbsp;• Website:&nbsp;<a href="https://ade.sfda.gov.sa/"><u>https://ade.sfda.gov.sa/</u></a></p>
<p>Full Prescribing Information is available upon request:<br>
  SANOFI, Kingdom of Saudi Arabia, P.O. Box 9874, Jeddah 21423, K.S.A. Tel: +966-12-669-3318, Fax: +966-12-663-6191<br>
  For Medical Information, Please contact: +966-12-669-3318,&nbsp;<a href="mailto:ksa.medicalinformation@sanofi.com"><u>ksa.medicalinformation@sanofi.com</u></a><br>
  For Pharmacovigilance, Please contact: +966-54-428-4797,&nbsp;<a href="mailto:ksa_pharmacovigilance@sanofi.com"><u>ksa_pharmacovigilance@sanofi.com</u></a></p>
<p>To report any Product Technical Complaint, please contact SANOFI Quality Department:<br>
  Email:&nbsp;<a href="mailto:quality.greatergulf@Sanofi.com"><u>quality.greatergulf@Sanofi.com</u></a><br><a href="http://www.sanofi.com.sa"><u>www.sanofi.com.sa</u></a></p>

Gaucher

GAUCHER

<h3>Fabry Disease Can Result in Substantial Heart Damage<sup>1</sup></h3>
<p>Fabry disease is a rare, progressive, and potentially life-threatening disorder that starts in early childhood and affects men and women.<sup>1-3</sup><br>
  As an X-linked lysosomal storage disorder that is multisystemic, Fabry disease is caused by complete or partial deficiency of the lysosomal enzyme α-GAL A, leading to GL-3 and lyso-GL-3 accumulation that can result in damage to the heart, kidneys, and cerebrovascular system.<sup>2,3</sup></p>

<h3>Early Diagnosis and Management Are Critical as Fabry Disease Can Decrease Life Expectancy Due to Heart and Organ Damage<sup>2,4-6</sup></h3>

<p>Worldwide Incidence<sup>7</sup></p>
<p><strong>1 in 40,000</strong></p>
<p>FD is an X-linked disease caused due to deficiency of α-galactosidase A. An average diagnostic delay of 15–18 years is seen in FD.</p>
<p><strong>Test for diagnosis</strong></p>
<ul>
 <li>Enzyme assays to detect α-Gal activity</li>
 <li>Genetic testing to confirm diagnosis</li>
</ul>

<h2>Cardiac Disease is the Leading cause of Death in Patients with Fabry Disease<sup>1</sup></h2>
<h3><strong>Consider Fabry Disease in your Differential Diagnosis when</strong><sup>10</sup>:</h3>
<p><strong>Presentation:</strong>&nbsp;Unexplained HCM and/or LVH, fibrosis in the lateral wall of the left ventricle, low native T1 values, elevated hs-troponin in the absence of acute event<sup>9,11</sup></p>
<p><strong>Family history:</strong>&nbsp;Cardiomyopathy, premature stroke, sudden cardiac death, and renal failure<sup>10,12</sup></p>
<p><strong>ECG:</strong>&nbsp;Bradycardia, short PR interval (young age), AV block (cardiac clinical manifestations in the 3rd decade of life onward), voltage criteria for LVH, ST segment changes, T-wave inversion<sup>8,10</sup></p>

<h3>If you see Unexplained Cardiomyopathy, Consider Fabry Disease.<sup>13</sup></h3>
<p><strong>Cardiologists have the tools to screen for, diagnose, and manage Fabry disease.</strong></p>

<div>
 <table border="1" cellpadding="10" cellspacing="1">
  <tbody>
   <tr>
    <td colspan="2" rowspan="1"><strong>Testing is Straightforward</strong><sup>8,14,15</sup></td>
    <td rowspan="3"><strong>In patients with unexplained HCM, conduct genetic testing that includes the&nbsp;GLA&nbsp;gene.</strong></td>
    <td colspan="1" rowspan="2">Treatment is Available for your Patients with Fabry Disease</td>
   </tr>
   <tr>
    <td><strong>Males</strong></td>
    <td><strong>α-GAL A enzyme assay</strong><br>
      and/or<br><strong>GLA&nbsp;gene sequencing</strong></td>
   </tr>
   <tr>
    <td><strong>Females</strong></td>
    <td>
     <p><strong>GLA&nbsp;gene sequencing</strong></p>
     <p>Affected females may have normal to low enzyme<br>
       activity in plasma or leukocytes; therefore,&nbsp;GLA&nbsp;gene<br>
       sequencing is required to confirm diagnosis in females.</p></td>
    <td><strong>Stabilizing disease progression is an<br>
       important goal.</strong><sup>8</sup></td>
   </tr>
  </tbody>
 </table>
</div>
<p>Damage to cardiac, renal, and cerebrovascular systems can have life-threatening impact. Monitor patients in accordance with published management guidelines and clinicians’ medical expertise.<sup>8</sup></p>

<h2>Discover Fabry Disease:</h2>
<h2>The Role of the Nephrologist</h2>

<h3>Renal Manifestations of Fabry Disease are common and can be Life Threatening.<sup>1,2</sup></h3>
<p>Fabry disease is a rare, progressive, and potentially life-threatening disorder that starts in early childhood and affects men and women.<sup>2-4</sup><br>
  As an X-linked lysosomal storage disorder that is multisystemic, Fabry disease is caused by complete or partial deficiency of the lysosomal enzyme α-GAL A, leading to GL-3<sup>*</sup>&nbsp;and lyso-GL-3 accumulation that can result in damage to the kidneys, heart, and cerebrovascular system.<sup>4</sup></p>

<h3>Early Diagnosis and Management are Critical as Fabry Disease can Decrease Life Expectancy due to Organ Damage.<sup>4-7</sup></h3>

<h2>Understanding Fabry Disease</h2>
<p><strong>Worldwide Incidence<sup>7</sup></strong></p>
<p><strong>1 in 40,000</strong></p>
<p>FD is an X-linked disease caused due to deficiency of α-galactosidase A. An average diagnostic delay of 15–18 years is seen in FD.</p>
<p><strong>Test for diagnosis</strong></p>
<ul>
 <li>Enzyme assays to detect α-Gal activity</li>
 <li>Genetic testing to confirm diagnosis</li>
</ul>

<h2>Renal Manifestations are a Prominent Indication of Fabry Disease and can be Life Threatening<sup>10</sup></h2>
<p><strong>Presentation:</strong>&nbsp;Microalbuminuria, proteinuria, reduced GFR, hematuria (rare), renal cysts (mainly parapelvic), and (in early disease) reduced systemic BP and glomerular hyperfiltration<sup>11</sup></p>
<p><strong>Family history:</strong>&nbsp;Cardiomyopathy, premature stroke, sudden cardiac death, and renal failure<sup>12,13</sup></p>
<p><strong>Laboratory and Biopsy Findings</strong><br><strong>Urinalysis:</strong>&nbsp;“Maltese cross,” “urinary mulberry cells,” biomarkers GL3<sup>*</sup>&nbsp;and lyso-GL3<sup>11</sup><br><strong>Biopsy:</strong>&nbsp;Glomerulosclerosis, vascular lesions, vacuolation, and lysosomal GL3 deposits<sup>11</sup></p>
<p><strong>Rule out Fabry disease in your patients with unexplained CKD.</strong></p>

<div>
 <table border="1" cellpadding="10" cellspacing="1">
  <tbody>
   <tr>
    <td colspan="2" rowspan="1"><strong>Renal Best Practice Screening Recommendations</strong><sup>14</sup></td>
    <td colspan="1"><strong>Testing is Straightforward</strong><sup>9,15</sup></td>
   </tr>
   <tr>
    <td><strong>Males</strong></td>
    <td><strong>Screening&nbsp;MALES&nbsp;&lt;50 years of age with unexplained CKD</strong></td>
    <td colspan="1"><strong>α-GAL A enzyme assay</strong><br>
      and/or<br><strong>GLA&nbsp;gene sequencing</strong></td>
   </tr>
   <tr>
    <td><strong>Females</strong></td>
    <td><strong>Screening&nbsp;FEMALES&nbsp;at any age with unexplained CKD and other symptoms associated with Fabry disease</strong></td>
    <td>
     <p><strong>GLA&nbsp;gene sequencing</strong><br>
       Affected females may have normal-to-low enzyme activity in plasma or leukocytes; therefore, GLA gene sequencing is required to confirm diagnosis in females.</p></td>
   </tr>
  </tbody>
 </table>
</div>
<p>Damage to renal, cardiac, and cerebrovascular systems can have a life-threatening impact. Monitor patients in accordance with published management guidelines and clinicians’ medical expertise.<sup>9</sup></p>
<p><sup>*</sup>GL-3 and Gb3 are interchangeable terms for globotriaosylceramide.</p>

Fabry

FABRY

<h2>Consensus based on literature supporting clinical presentation and recommendations</h2>
<h3>Literature Analysis on LOPD Symptoms (Neurology): Hierarchy of Evidence</h3>

<div>
 <table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
  <tbody>
   <tr>
    <td style="text-align: center;"><strong>Neurology-Specific Clinical Presentation for Pediatric/Juvenile*and Adult# LOPD Proposed During the First Meeting</strong></td>
   </tr>
  </tbody>
 </table>
 <p>&nbsp;</p>
</div>

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Pediatric/Juvenile* LOPD</strong></td>
  </tr>
 </tbody>
</table>

<ul>
 <li>Delayed motor milestones</li>
 <li>Low/absent reflexes</li>
 <li>Mild facial muscle weakness</li>
 <li>HyperCKemia/paucisymptomatic</li>
 <li>Negative SMA/DMD</li>
 <li>Shortness of breath at rest or on effort</li>
 <li>Muscle pain and elevated ALT/AST</li>
 <li>Gait abnormalities</li>
 <li>Scoliosis/scapular winging</li>
 <li>Disproportional weakness of the neck flexors and difficulty in raising the head</li>
</ul>

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Adult# LOPD</strong></td>
  </tr>
 </tbody>
</table>

<ul>
 <li>LGMW</li>
 <li>Swallowing difficulties</li>
 <li>Frequent falls</li>
 <li>Difficulty chewing/jaw muscle fatigue</li>
 <li>Difficulty in walking and climbing stairs</li>
 <li>Double-seronegative MG</li>
 <li>Muscle pain and elevated ALT/AST</li>
 <li>Gait abnormalities</li>
 <li>HyperCKemia/paucisymptomatic</li>
 <li>Unexplained myopathy</li>
 <li>Scoliosis/scapular winging</li>
</ul>

<p>High CK/elevated LDH,<br>
  ALT,and AST</p>

<p style="text-align: center;">Family history of unexplained<br>
  muscle weakness or respiratory<br>
  failure</p>

<h2>Proposed Diagnostic Algorithm for Neurologists During the Second Meeting</h2>
<h3>Conclusion</h3>

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
  <tr>
   <td style="text-align: center;">
    <p><b>Recommendation</b></p>
    <p>Testing for Pompe disease must be done if any one specialty-specific symptom plus elevated CK/LDH/ALT/AST or a family history of unexplained muscle weakness is present.</p></td>
  </tr>
 </tbody>
</table>

<p data-font="legal"><sup>*</sup>The age of patients with pediatric/juvenile LOPD ranges from 1 to 17 years;&nbsp;<sup>#</sup>The age of patients with adult LOPD is usually 18 years and above.</p>

Expert group consensus from the Arabian Peninsula on the diagnosis of Late Onset Pompe Disease (LOPD)

<h2>Consensus based on literature supporting clinical presentation and recommendations</h2>
<h3>Literature Analysis on LOPD Symptoms (Orthopedics): Hierarchy of Evidence</h3>

<p><strong>Orthopedics-Specific</strong><br><b>Clinical Presentation for Pediatric/Juvenile* LOPD Proposed During the First Meeting</b></p>

<h3>Rheumatology-Specific</h3>
<p><b>Recommendation</b></p>
<p>Testing for Pompe disease must be done if any one specialty-specific symptom plus elevated CK/LDH/ALT/AST or a family history of unexplained muscle weakness is present.</p>

<p data-font="legal">*The age of patients with pediatric/juvenile LOPD ranges from 1 to 17 years.</p>

Expert Group Consensus From The Arabian Peninsula On The Diagnosis Of Late Onset Pompe Disease for orthopedists

<h2>GPs/Peds/IM-Specific</h2>
<p>Clinical Presentation for Pediatric/Juvenile<sup>*</sup>&nbsp;and Adult<sup>#</sup>&nbsp;LOPD Proposed During the First Meeting</p>

<p>► Difficulty in standing up from a chair</p>

<p>► Difficulty in washing the hair</p>

<p>► Difficulty in placing an object at a level over the head</p>

<p>► Muscle cramps and exercise intolerance</p>

<p>► Difficulty in breathing at rest or on effort</p>

<p>► Feeding/swallowing difficulties and jaw muscle fatigue</p>

<p>Family history of unexplained muscle weakness or respiratory failure</p>

<h2>GPs/Peds/IM-Specific Diagnostic Algorithm Proposed During the Second Meeting</h2>

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
  <tr>
   <td>
    <p style="text-align: justify;"><b>Recommendation</b></p>
    <p style="text-align: justify;">Testing for Pompe disease must be done if any one specialty-specific symptom plus elevated CK/LDH/ALT/AST or a family history of unexplained muscle weakness is present.</p></td>
  </tr>
 </tbody>
</table>

Experts recommendations on Late Onset Pompe Disease (LOPD) differential diagnosis from GCC

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