<h3 style="text-align:center;">Efficacy and Safety of Dupilumab Versus Omalizumab in Patients<br>
 With Severe CRSwNP and Coexisting Asthma (EVEREST):<br>
 Results From a First, Prospective, Head-to-Head Phase 4 Trial</h3>
<p style="text-align:center;">De Corso E, et al. <i>EAACI</i>. 2025. Oral presentation.</p>

<figure class="table" style="width:98.81%;">
 <table class="ck-table-resized" style="background-color:#277FBB;border-style:solid;">
  <colgroup>
   <col style="width:100%;">
  </colgroup>
  <tbody>
   <tr>
    <td style="background-color:#277FBB;">
     <h3><span style="color:hsl(0,0%,100%);">Study design</span></h3></td>
   </tr>
  </tbody>
 </table>
</figure>

<figure class="table" style="width:93.46%;">
 <table class="ck-table-resized">
  <colgroup>
   <col style="width:21.59%;">
   <col style="width:78.41%;">
  </colgroup>
  <tbody>
   <tr>
    <td style="background-color:#123B55;height:20px;width:180px;">
     <h3 style="text-align:center;"><span style="color:hsl(0,0%,100%);"><strong>Safety</strong></span></h3></td>
    <td style="border-color:#123B55;">Safety profiles of <span style="color:hsl(205,69%,53%);"><strong>dupilumab</strong></span> and <span style="color:hsl(283,39%,53%);"><strong>omalizumab</strong></span> were comparable and consistent with known profiles (study-related TEAEs, 19.6% and 21.4%; serious TEAEs, 1.7% and 4.0%; discontinuations due to TEAEs, 2.8% and 1.2%, respectively; with no deaths occurring during the study).</td>
   </tr>
  </tbody>
 </table>
</figure>
<p><span class="text-small"><sup>a</sup>Patients from 17 countries in North America and Europe participated in this study. <sup>b</sup>According to the GINA 2020 guidelines. BL, baseline; EAACI, European Academy of Allergy and Clinical Immunology; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroids, LS, least-squares; LSMD, least-squares mean difference; MFNS, mometasone furoate; NP, nasal polyp; NPS, nasal polyp score; NSAID-ERD, nonsteroidal anti-inflammatory drug–exacerbated respiratory disease; q2w, every 2 weeks; q4w, every 4 weeks; R, randomization; SC, subcutaneous; SCS, systemic corticosteroids; TEAE, treatment-emergent adverse event; UPSIT, University of Pennsylvania Smell Identification Test. De Corso E, et al. <i>EAACI</i>. 2025. Oral presentation.</span></p>
<figure class="table" style="width:98.5%;">
 <table class="ck-table-resized" style="background-color:#1E618E;">
  <colgroup>
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  </colgroup>
  <tbody>
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    <td style="background-color:#1E618E;">
     <h3><span style="color:hsl(0,0%,100%);"><strong>Secondary end points</strong></span></h3></td>
   </tr>
  </tbody>
 </table>
</figure>

<figure class="table" style="width:98.29%;">
 <table class="ck-table-resized" style="background-color:#1E618E;">
  <colgroup>
   <col style="width:100%;">
  </colgroup>
  <tbody>
   <tr>
    <td style="background-color:#1E618E;">
     <h3><span style="color:hsl(0,0%,100%);"><strong>Asthma-related end points</strong></span></h3></td>
   </tr>
  </tbody>
 </table>
</figure>

<figure class="table" style="width:99.17%;">
 <table class="ck-table-resized">
  <colgroup>
   <col style="width:23.15%;">
   <col style="width:76.85%;">
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   <tr>
    <td style="background-color:#123B55;height:20px;width:180px;">
     <h3 style="text-align:center;"><span style="color:hsl(0,0%,100%);"><strong>Summary</strong></span></h3></td>
    <td style="border-color:#123B55;">In EVEREST, <span style="color:hsl(205,69%,53%);"><strong>dupilumab</strong></span> demonstrated superiority over <span style="color:hsl(283,39%,53%);"><strong>omalizumab</strong></span> for all outcomes prespecified in the testing hierarchy in patients with severe CRSwNP and coexisting asthma. Safety profiles were comparable.</td>
   </tr>
  </tbody>
 </table>
</figure>
<p><span class="text-small"><sup>a</sup>The following secondary end points were included in the multiplicity adjustment scheme and tested in the following order: Change from BL to Week 24 in (1) LoS, (2) NCS, (3) TSS. <sup>b</sup>Dupilumab vs omalizumab LSMD at Week 24. <sup>c</sup>End points not included in multiplicity adjustment hierarchy; P-values are nominal. ACQ-7, 7-item asthma control questionnaire; BD, bronchodilator; BL, baseline; EAACI, European Academy of Allergy and Clinical Immunology; FEV<sub>1</sub>, forced expiratory volume in 1 second; LoS, loss of smell; LS, least-squares; LSMD, least-squares mean difference; NCS, nasal congestion score; PNIF, peak nasal inspiratory flow; r-VAS; rhinosinusitis visual analog scale; SNOT-22, 22-item Sinonasal Outcomes Test; TSS, total symptom score. De Corso E, et al. <i>EAACI</i>. 2025. Oral presentation.</span></p>

SPECIALTY-CARE

DUPIXENT

CHRONIC-RHINOSINUSITIS-WITH-NASAL-POLYPS-CRSWNP

RESPIRATORY

CRSwNP EVEREST

FABRY

RARE-DISEASE

Structured Monitoring for Early Detection of Fabry Progression

<figure class="table" style="width:91.41%;">
 <table class="ck-table-resized">
  <colgroup>
   <col style="width:100%;">
  </colgroup>
  <tbody>
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    <td style="background-color:#78C043;border-color:#117B80;border-width:3px;">
     <h3 style="text-align:center;"><span style="color:hsl(0,0%,100%);"><strong>Renal Outcomes After Switching to Agalsidase Beta</strong></span><br><span style="color:hsl(0,0%,100%);"><strong>in Fabry Disease: A Single-Center Analysis</strong></span></h3></td>
   </tr>
   <tr>
    <td style="background-color:#DAEBCC;border-color:hsl(0, 0%, 100%);border-width:3px;">
     <ul>
      <li>Renal involvement is a key feature of <strong>FD</strong>, characterized by <strong>Gb3</strong> deposition in renal cells and <strong>progressive nephropathy</strong> that can lead to kidney failure by the third to fifth decade in untreated patients with classical mutations (1).</li>
     </ul></td>
   </tr>
   <tr>
    <td style="background-color:#DAEBCC;border-color:hsl(0, 0%, 100%);border-width:3px;">
     <ul>
      <li>Specific therapies have altered <strong>FD</strong> progression where <strong>ERT</strong> remains central, with agalsidase alfa, beta, and pegunigalsidase alfa (1).</li>
     </ul></td>
   </tr>
   <tr>
    <td style="background-color:#DAEBCC;border-color:hsl(0, 0%, 100%);border-width:3px;">
     <ul>
      <li>Since recent studies highlighted a <strong>dose-dependent effect</strong> of agalsidase, showing that higher doses enhance intracellular enzymatic activity, improving <strong>Gb3</strong> clearance and slowing nephropathy progression (1).</li>
     </ul></td>
   </tr>
   <tr>
    <td style="background-color:#DAEBCC;border-color:hsl(0, 0%, 100%);border-width:3px;">
     <ul>
      <li>It has been recently suggested that a treatment for classic <strong>FD</strong> should be considered effective in preserving renal function when it maintains an <strong>eGFR decline &lt;1 mL/min/1.73 m<sup>2</sup> per year (1).</strong></li>
     </ul></td>
   </tr>
   <tr>
    <td style="background-color:#DAEBCC;border-color:hsl(0, 0%, 100%);border-width:3px;">
     <ul>
      <li>Included subjects were adult patients (≥18 years of age) with genetically determined <strong>FD,</strong> of both &nbsp;genders, with <strong>eGFR between 45 and 90 mL/min/1.73 m<sup>2</sup></strong>, switched from at least 1 year of stable &nbsp;treatment with the regular dose of agalsidase alfa or migalastat as their primary therapy, to <strong>agalsidase beta</strong> without any interval (1).</li>
     </ul></td>
   </tr>
  </tbody>
 </table>
</figure>

<figure class="table" style="width:100%;">
 <table class="ck-table-resized" style="border-color:hsl(0, 0%, 100%);border-style:solid;">
  <colgroup>
   <col style="width:100%;">
  </colgroup>
  <tbody>
   <tr>
    <td style="background-color:#78C043;border-color:#117B80;border-width:3px;">
     <h3 style="text-align:center;"><span style="color:hsl(0, 0%, 100%);"><strong>Study objective (1)</strong></span></h3></td>
   </tr>
   <tr>
    <td style="border-color:#117B80;border-width:2px;">To evaluate within-patient clinical outcomes, primarily renal outcomes, in adult patients with FD who were switched from agalsidase alfa or migalastat to agalsidase beta due to renal inefficacy of primary therapy, defined by:<br><br><strong>A linear negative eGFR slope ≥3 mL/min/1.73 m²/year in males ≥2.5 mL/min/1.73 m²/ year in females.</strong></td>
   </tr>
  </tbody>
 </table>
</figure>

<figure class="table" style="width:100%;">
 <table class="ck-table-resized">
  <colgroup>
   <col style="width:100%;">
  </colgroup>
  <tbody>
   <tr>
    <td style="background-color:#78C043;border-color:#117B80;border-width:3px;">
     <h3 style="text-align:center;"><span style="color:hsl(0, 0%, 100%);"><strong>Study design and population (1)</strong></span></h3></td>
   </tr>
   <tr>
    <td style="background-color:#EEF5DF;border-color:#117B80;border-width:2px;">
     <ul>
      <li>This <strong>single-centre</strong> observational study enrolled 11 adult patients (≥18 years) with genetically confirmed <strong>FD</strong> and baseline eGFR 45–90 mL/min/1.73 m².</li>
     </ul></td>
   </tr>
   <tr>
    <td style="background-color:#D0E6BD;border-color:#117B80;border-width:2px;">
     <ul>
      <li>Patients meeting the inclusion criteria were adults of both genders who had received stable primary therapy for ≥1 year with <strong>agalsidase alfa</strong> or <strong>migalastat.</strong></li>
     </ul></td>
   </tr>
   <tr>
    <td style="background-color:#EEF5DF;border-color:#117B80;border-width:2px;">
     <ul>
      <li>The cohort was predominantly male (82%), with a mean age of 48.1 ± 11.0 years, and had received primary therapy for a mean duration of 55.3 ± 31.2 months; classical GLA variants were present in 82% and late-onset variants in 18%.</li>
     </ul></td>
   </tr>
   <tr>
    <td style="background-color:#D0E6BD;border-color:#117B80;border-width:2px;">
     <ul>
      <li>Patients meeting inclusion criteria were followed for <strong>24 months after the switch.</strong></li>
     </ul></td>
   </tr>
  </tbody>
 </table>
</figure>

<figure class="table" style="width:89.35%;">
 <table class="ck-table-resized">
  <colgroup>
   <col style="width:100%;">
  </colgroup>
  <tbody>
   <tr>
    <td style="background-color:#78C043;border-color:#117B80;border-width:3px;text-align:center;">
     <h3 style="text-align:center;"><span style="color:hsl(0, 0%, 100%);"><strong>Study endpoints (1)</strong></span></h3></td>
   </tr>
  </tbody>
 </table>
</figure>

<p>AEs considered were IARs, dyspnoea, hypertension, gastrointestinal symptoms, rigors, temperature change sensation, fever, headache, rhinitis, flushing, and pruritus.<br>
  &nbsp;</p>
<figure class="table" style="width:100%;">
 <table class="ck-table-resized">
  <colgroup>
   <col style="width:100%;">
  </colgroup>
  <tbody>
   <tr>
    <td style="background-color:#78C043;border-color:#117B80;border-width:3px;">
     <h3 style="text-align:center;"><span style="color:hsl(0,0%,100%);"><strong>Study result (1)</strong></span></h3></td>
   </tr>
  </tbody>
 </table>
</figure>
<figure class="table" style="width:100%;">
 <table class="ck-table-resized" style="border-color:hsl(0, 0%, 100%);border-style:solid;">
  <colgroup>
   <col style="width:34.55%;">
   <col style="width:24.04%;">
   <col style="width:20.1%;">
   <col style="width:21.31%;">
  </colgroup>
  <tbody>
   <tr>
    <td style="background-color:#EAF2D2;" colspan="4"><strong>Parameter comparison across therapy initiation, pre-switch, post-switch visits</strong><br>
      The results compare parameters assessed at primary FD therapy initiation (T0), last pre-switch (T1), and last post-switch visit (T2). No deaths occurred, and no renal, cardiac,or cerebrovascular events were reported during either the pre-switch or post switch periods.</td>
   </tr>
   <tr>
    <td style="background-color:#78C043;"><span style="color:hsl(0, 0%, 100%);">Parameter</span></td>
    <td style="background-color:#78C043;"><span style="color:hsl(0, 0%, 100%);">Start of primary</span><br><span style="color:hsl(0, 0%, 100%);">Fabry therapy (T0)</span></td>
    <td style="background-color:#78C043;"><span style="color:hsl(0, 0%, 100%);">Last pre-switch</span><br><span style="color:hsl(0, 0%, 100%);">visit (T1)</span></td>
    <td style="background-color:#78C043;"><span style="color:hsl(0, 0%, 100%);">Last post-switch</span><br><span style="color:hsl(0, 0%, 100%);">visit (T2)</span></td>
   </tr>
   <tr>
    <td style="background-color:#EAF2D2;">eGFR (mL/min/1.73 m²)</td>
    <td style="background-color:#EAF2D2;">95.5 ± 16.4</td>
    <td style="background-color:#EAF2D2;">67.9 ± 20.0*</td>
    <td style="background-color:#EAF2D2;">67.0 ± 23.6*</td>
   </tr>
   <tr>
    <td style="background-color:#D0E6BD;">Clinical events, n (%)</td>
    <td style="background-color:#D0E6BD;">0 (0)</td>
    <td style="background-color:#D0E6BD;">0 (0)</td>
    <td style="background-color:#D0E6BD;">0 (0)</td>
   </tr>
   <tr>
    <td style="background-color:#EAF2D2;">Proteinuria (mg/day)</td>
    <td style="background-color:#EAF2D2;">559.1 ± 479.1</td>
    <td style="background-color:#EAF2D2;">645.0 ± 1064.4</td>
    <td style="background-color:#EAF2D2;">513.6 ± 846.6</td>
   </tr>
   <tr>
    <td style="background-color:#D0E6BD;">LVMI (g/m²)</td>
    <td style="background-color:#D0E6BD;">44.3 ± 12.2</td>
    <td style="background-color:#D0E6BD;">42.5 ± 12.2</td>
    <td style="background-color:#D0E6BD;">513.6 ± 846.6</td>
   </tr>
   <tr>
    <td style="background-color:#EAF2D2;">Neurologic changes, n (%)</td>
    <td style="background-color:#EAF2D2;">0 (0)</td>
    <td style="background-color:#EAF2D2;">1 (9)</td>
    <td style="background-color:#EAF2D2;">0 (0)</td>
   </tr>
   <tr>
    <td style="background-color:#D0E6BD;">FD-related symptoms, n (%)</td>
    <td style="background-color:#D0E6BD;">10 (91)</td>
    <td style="background-color:#D0E6BD;">4 (36)*</td>
    <td style="background-color:#D0E6BD;">2 (18)*</td>
   </tr>
   <tr>
    <td style="background-color:#EAF2D2;">Adverse events, n (%)</td>
    <td style="background-color:#EAF2D2;">Not applicable</td>
    <td style="background-color:#EAF2D2;">2 (18)</td>
    <td style="background-color:#EAF2D2;">2 (18)</td>
   </tr>
   <tr>
    <td style="background-color:#D0E6BD;">Lyso-Gb3 (ng/mL)</td>
    <td style="background-color:#D0E6BD;">20.5 ± 17.9</td>
    <td style="background-color:#D0E6BD;">8.7 ± 8.1</td>
    <td style="background-color:#D0E6BD;">6.9 ± 5.3*</td>
   </tr>
  </tbody>
 </table>
</figure>
<p>*Significantly different vs T0 (p&lt;0.05).</p>

<p><strong>Pre and post-switch outcome trajectories</strong><br>
  Switching to <strong>agalsidase beta</strong> stabilized renal function after prior decline, maintained improvements in FD-related symptoms, sustained reductions in <strong>lyso-Gb3,</strong> and showed comparable safety, with no increase in adverse events <strong>post-switch</strong> (1).&nbsp;</p>

<p>*Significantly different vs T0 (p&lt;0.05).<br><br><strong>Fabry-related symptoms and biomarkers:</strong><br>
  Most <strong>FD</strong>-related symptoms improved with primary therapy and <strong>remained stable</strong> after switching. Plasma <strong>lyso-Gb3</strong> levels showed progressive reduction, reaching statistical significance at 24 months versus baseline <strong>(p&lt;0.05),</strong> although slope differences between treatment periods were not significant (1).</p>

<p>Consistent with these findings, <strong>switching to agalsidase beta</strong> in patients with progressive renal decline under agalsidase alfa or migalastat resulted in <strong>stabilization of eGFR slope, </strong>reinforcing the role of dose optimization in ERT to attenuate FD progression and improve renal outcomes (1).<br>
  &nbsp;</p>
<p><strong>Abbreviation</strong><br>
  FD – Fabry disease; Gb3 – Globotriaosylceramide; ERT – Enzyme replacement therapy; eGFR – Estimated glomerular filtration rate; CKD-EPI – Chronic Kidney Disease Epidemiology Collaboration; LVMI – Left ventricular mass index; Lyso-Gb3 –&nbsp; Globotriaosylsphingosine; GLA – α-Galactosidase A; T0 – Start of primary Fabry therapy; T1 – Last pre-switch visit; T2 – Last post-switch&nbsp; visit; AE – Adverse event; IARs – Infusion-related reactions; MI – Myocardial infarction<br>
  &nbsp;</p>

<p><strong>Reference</strong></p>

FABRAZYME

Renal Outcomes After Switching to Agalsidase Beta: A Single-Center Analysis

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