<h3>Five Years’ Experience with Respiratory Syncytial Virus Among Hospitalized Patients: A Retrospective Study from Jazan, Saudi Arabia</h3>

📌&nbsp;Study Design &amp; Setting:
<ul>
 <li>Retrospective observational study (2015–2020)</li>
 <li>Conducted at a tertiary hospital in Jazan, Saudi Arabia</li>
 <li>195 RSV-positive hospitalized cases analyzed</li>
</ul>
🎯&nbsp;Study Objectives:
<ul>
 <li>Understand RSV burden in hospitalized patients</li>
 <li>Identify risk factors for ICU admission</li>
 <li>Analyze seasonal trends &amp; clinical outcomes</li>
</ul>
👥&nbsp;Study Population:
<ul>
 <li>Patients with confirmed RSV infections (via rapid antigen tests)</li>
 <li>Exclusions: Other infections or repeated RSV-positive cases</li>
</ul>

Distribution of RSV cases during the studied years.

<h3>Monthly variations revealed a U-shaped pattern with most cases reported during January</h3>

Figure 2&nbsp;Number of RSV cases during the months of the studied period.

The burden of Respiratory Syncytial Virus (RSV) among infants in Saudi Arabia is significant and presents unpredictable risks that can adversely affect both healthy full-term infants and preterm infants. This observation is consistent with existing data from Europe

📊&nbsp;Total RSV Cases: 195
👶 Gestational Age Distribution:
<ul>
 <li>Full-term births: 81.54% (159 patients)</li>
 <li>Preterm births: 16.92% (33 patients)</li>
</ul>

<h3>RSV infection is one of the important causes of morbidity and intensive care admission among infants and young children in Saudi Arabia</h3>

⚠️&nbsp;ICU Admissions: 31.79% of RSV cases
🏥 Hospitalization Data:
<ul>
 <li>Oxygen Support: 40% of RSV cases required oxygen therapy</li>
 <li>Average Length of Stay: 8.1 days (ICU patients: 12.13 days)</li>
</ul>

⚠️&nbsp;Mortality Rate: 8.72%

🩺 Common Comorbidities (49.23% of cases):
<ul>
 <li>Congenital Heart Disease</li>
 <li>Bronchial Asthma</li>
 <li>Cerebral Palsy</li>
</ul>

References

RSV Burden in Jazan

RESPIRATORY-SYNCYTIAL-VIRUS

VACCINES

OTHER-RARE-DISEASE-TOPICS

RARE-DISEASE

Every Moment Matters: Navigating Diagnosis of Fabry Disease

April is Fabry Awareness Month - a time to highlight the critical role of early diagnosis in improving patient outcomes.

<h4>Efficacy and safety of belumosudil as compared with best available therapy for the treatment of chronic graft-versus-host disease in the US population Waller EK (USA)</h4>

The ROCKreal study demonstrated that BEL is an effective option for improving outcomes over BAT in patients with cGvHD, showing superior efficacy with higher ORR at 6 months and FFS at 1 year, and a favorable safety profile in real-world settings, consistent with the ROCKstar trial.
<ul>
 <li>This non-interventional study compared the efficacy and safety of BEL vs BAT for treating cGvHD in patients aged ≥12 years who had failed 2–5 prior LOTs. Data from 196 patients across 8 US sites were collected between March 1, 2015 and March 27, 2024.</li>
 <li>The ROCKreal study was designed to emulate a phase 3 RCT using causal inference methodology. Targeted maximum likelihood estimation was used to adjust for biases and correlations among multiple LOTs from the same patient.</li>
 <li>Efficacy and safety findings 
 <ul>
 <li>6-month ORR: BEL 38.7% (95% CI: 27.1–50.4) vs. BAT 26.8% (95% CI: 20.3–33.4); 44.2% improvement in ORR with BEL (p = 0.031).</li>
 <li>1-year FFS: BEL 61.2% vs. BAT 47.8%; 13.5% improvement in adjusted FFS at 1 year when treated with BEL (p = 0.032).</li>
 <li>BEL had a lower AE rate per 100 LOT-years (41.19%) vs. BAT (51.32%).</li>
 </ul></li>
</ul>

<h4>Clinically meaningful improvement of modified Lee symptom scale in patients treated with belumosudil for steroid-refractory chronic GvHD: Evidence from real-world outcomes Kim D (Canada)</h4>

RWE on symptom burden improvement in sR-cGvHD patients treated with BEL is limited, highlighting the need to assess PROs.
<ul>
 <li>This retrospective study evaluated treatment outcomes and mLSS in 36 patients with sR-cGvHD who received BEL under a managed access program in Canada (Mar 2023–Nov 2024). Treatment outcomes included ORR at 3/6 months, best ORR, and FFS. Clinically meaningful improvements in mLSS were assessed.</li>
 <li>Most patients were heavily pre-treated (median 5 prior lines), with severe cGvHD (69%). ORRs at 3 and 6 months were 55.0% and 69%, respectively, with a 6-month FFS of 71.9%. The mean mLSS decreased by 7.8 points within 6 months (28.7±2.4 to 20.9±4.2) after BEL treatment started and continued improving at 9 and 12 months. The most improved symptom domains were muscle/joints (54%), skin (46%), and eye/mouth (46%). No significant differences were observed between BEL/RUX and other treatments in ORR (64% vs 73%) or clinically meaningful improvements in mLSS (10.1 vs 8.6 points). Prior ECP treatment improved muscle/joint symptoms from 3 months without objective response.</li>
 <li>mLSS effectively captured early clinical improvements, supporting its role in symptom monitoring before NIH-defined objective responses.</li>
</ul>

<h4>Efficacy and safety of belumosudil for treatment of cGvHD: multicenter retrospective analysis of the French cohort of the compassionate use program Loschi M (France)</h4>

The findings of this real-world study corroborated the ROCKstar trial outcomes, even with heavily pretreated patients, and did not identify any new adverse signals.
<ul>
 <li>This study analyzed 68 patients with cGvHD across French HCT centers who received BEL under a compassionate use program between April 2022 and September 2024.</li>
 <li>Most patients (66%) received BEL 200 mg BID, with a median follow up of 46 months. First-line therapy included corticosteroids (51%) or combination with other drugs (34%), mainly CNIs/ECP. Before BEL, patients received a median of 3 LOTs (range, 2–9), with 95.5% receiving ruxolitinib at any LOT.</li>
 <li>The best ORR was 57.3% (PR, 42.6%; CR, 14.7%); ORR at 3 months was 47% (PR, 42.6%; CR, 4.4%) and at 6 months was 45.6% (PR, 35.3%; CR, 10.3%). Liver and mouth cGvHD had the highest ORRs (72.7% and 70.4%, respectively). FFS at 6 and 12 months was 89.1% and 80.4%, respectively. OS at 6, 12, and 48 months was 97.1%, 95.6%, and 90.6%, respectively.</li>
</ul>

<h4>Exploring the impact of chronic graft-versus-host disease on the health-related quality of life of patients and caregivers: a qualitative survey-based study in France Kiprijanovski D (France)</h4>

This study underscores the profound impact of cGvHD on the HrQoL of patients and caregivers, highlighting the need for improved treatments and multidisciplinary care.
<ul>
 <li>Conducted 22 interviews (17 patients, 5 caregivers) across France, focusing on experiences and needs related to cGvHD. Patients received ≥2 systemic treatments and had a cGvHD diagnosis for over 12 months.</li>
 <li>Patients and caregivers experience substantial physical, emotional, and psychological burdens, with cGvHD symptoms often perceived as a "price to pay" for surviving the original disease. Patients distinguish cGvHD symptoms from treatment side effects but experience both concurrently.</li>
 <li>Despite commendable expertise from haematologists, organ specialists often lack cGvHD knowledge, leading to ineffective treatments and strained patient-physician relationships. Patients and caregivers call for enhanced treatment efficacy and tolerability, improved physician training, psychological support, increased public awareness, and access to specialized care beyond haematology.</li>
</ul>

<h4>Impact of belumosudil treatment in advanced chronic graft-versus-host disease (cGvHD): insights into response-based T- and B-cell subpopulation dynamics Ponce D (USA)</h4>

BEL treatment in advanced cGvHD shows promising immune modulation, with distinct shifts in T- and B-cell subpopulations among responders.
<ul>
 <li>This study evaluated 35 patients with steroid-refractory cGvHD treated with BEL from August 2021 to December 2022. Blood samples were collected at baseline, 6, and 12 months. Treatment response was defined as responders or nonresponders at 6 months.</li>
 <li>Immune Dynamics: Responders (n=20) exhibited higher baseline levels of activated T and B cells, including CD8+CTLA4+, CD8+HLA-DR+, CD19+CD27low, and CD19+CD24highCD38high. During therapy, both cohorts showed dynamic immune changes, with increases in CD4+TEM and CD8+TIM3+ cells. Responders demonstrated more favorable shifts, including a decrease in CD4+ naïve T cells and recent thymic emigrants, and a significant increase in B cells at 6 and 12 months (p = 0.026 and 0.018, respectively).</li>
 <li>BEL preserves immune function and induces beneficial immune changes in responders. Baseline immune profiles may help predict treatment response, warranting further studies with larger cohorts.</li>
</ul>

<h4>Description of patients and management of cGvHD in France based on natural language processing (NLP) from medical documents available in hospital electronic medical files Kiprijanovski D (France)</h4>

In Europe, there is no standard therapeutic strategy for cGvHD in patients post allo-HSCT who fail second systemic LOT. This innovative approach uses AI-NLP to provide an insight into realworld cGvHD management in France.
<ul>
 <li>A cohort of allo-HSCT patients, with cGVHD and at least 12 months of follow-up was identified based on ADS using AINLP to structure data. The NLP derived data accuracy and completeness were validated through a three-step quality check: clinical research associate review, comparison with the European Bone Marrow Transplant registry, and expert validation.</li>
 <li>Out of 306 patients, 20 met the eligibility criteria, 60% of whom were males. Common reasons for allo-HSCT included acute myeloid leukemia (50.0%), and non-Hodgkin's lymphoma (27.8%). Median time to cGvHD was 128 days. Seven patients received at least 3 LOTs at the time of analysis.</li>
 <li>This novel AI-NLP approach efficiently identified and structured cGvHD patient data from medical records providing an insight into real-world cGvHD management in France. Eight hospitals and 220 patients are participating in this project, with ongoing analyses to validate the AI-NLP tool and describe treatments.</li>
</ul>

<h4>Living with GvHD - impact and experience Barata A (USA)</h4>

Living with aGvHD and cGvHD significantly impacts patients' QoL, both physically and psychologically, necessitating comprehensive supportive care and interventions.
<ul>
 <li>Patients with aGvHD experience worsening symptoms such as insomnia (36%), nausea (21%), bowel trouble (32%), and pain (23%), within the first 2 weeks of hospitalization. These symptoms lead to psychological distress, including anxiety and depression, and increase the risk of PTSD, resulting in decreased QoL.1</li>
 <li>cGvHD results in substantial impairments in physical functioning, social roles, and mental health, comparable to those seen in autoimmune diseases. Severity of cGvHD correlates with greater QoL impairments. Patients with severe cGvHD reported the lowest scores in all domains examined, including PCS and MCS of the SF-36 survey. cGvHD survivors face ongoing challenges, including late effects such as cognitive impairments, increased risk of recurrence and new cancers, and chronic conditions.2,3</li>
 <li>Effective management of aGvHD and cGvHD includes routine screening for psychological distress, integrating PROs, maximizing care for the treatment of organ-specific aGvHD, optimizing nutrition, physical therapy and rehabilitation, access to psycho-oncology and mental health clinicians, and involvement of palliative care to address complex symptoms and improve overall well-being.4,5</li>
</ul>

<h4>Incidence of graft versus host disease according to prophylaxis strategy in matched related and unrelated donor allogeneic hematopoietic stem cell transplantation: realworld experience of GETH-TC Bento L (Spain)</h4>

In this real-world setting, PTCy, the most frequently used prophylaxis regimen, demonstrated superior effectiveness in reducing aGvHD and cGvHD incidence compared to traditional strategies in HLA-matched donor allo-HSCT, and should be recommended for GvHD prophylaxis, though further prospective studies are warranted.
<ul>
 <li>This retrospective study analyzed 859 allo-HSCT procedures (MSD, 447; MUD, 412) across 13 Spanish centers (2018–2020), assessing the incidence and severity of aGvHD and cGvHD using different prophylaxis strategies: PTCy, CNI + MTX, sirolimus, and ATG.</li>
 <li>The 3-year OS and PFS were 66% (95% CI 63–69) and 57% (95% CI 54–60), respectively, with a 1-year NRM of 14% (95% CI 12–16).</li>
 <li>The 6-month cumulative incidence of grade 2-4 aGvHD was 19% (95% CI 15.3–22.2) and grade 3-4 aGvHD was 6% (95% CI 3.7–7.8), with lower incidence of grade 2-4 aGvHD observed with PTCy compared to CNI + MTX and sirolimus-based prophylaxis. The 2-year cumulative incidence of moderate-severe cGvHD was 25% (95% CI 20.7–28.7), with lower incidence in PTCy compared to CNI + MTX in MUD transplants.</li>
</ul>

<h4>Challenges and opportunities of biomarkers in GvHD Greinix HT (Austria)</h4>

While many promising biomarkers have been identified and validated, challenges remain in standardization, comparative study designs, and translation into routine clinical practice. Future focus lies in multi-center validation, early detection, risk-adapted therapy, and combining biomarkers with clinical scoring to improve patient outcomes in GvHD.
<ul>
 <li>The NIH consensus group definitions for biomarkers for either cGvHD or aGvHD is as follows: diagnostic, predictive, response and prognostic categorised as cellular, mediator, antibody types.6</li>
 <li>aGvHD: REG3α and ST2 indicate GI tissue damage. Both the biomarkers identified patients with a significant 6- month NRM of 28% in the high-risk group and 7% in the low-risk group. GvHD related mortality was also significant with the risk-score: 18% vs. 4%, p &lt; 0.001, and is GI GvHD related: 17% vs. 8%, p &lt; 0.001.7 Urinary proteomic profile aGvHD_MS17 is also available.8</li>
 <li>cGvHD: CXCL10, BAFF, IL-15, CD163, DKK3, ST2+CXCL9+MMP3+OPN (as a panel) are few promising biomarkers but yet to be confirmed in studies with test and verification cohorts.</li>
</ul>

<h4>Grade your GvHD yourself - development of an app to document chronic graft-versus-host disease by patients and caregivers Denk A (Germany)</h4>

The development of the cGvHD app enables continuous and remote documentation of cGVHD symptoms by patients and caregivers, improving early detection and management.
<ul>
 <li>An app was developed to incorporate existing PROMs (LSS, NIH cGvHD self-assessment, and toxicity-related PROMs) for tracking cGvHD symptoms and toxicity over time. It enabled 24/7 symptom documentation, requiring at least weekly entries with bi-weekly reminders for 2 years.</li>
 <li>This adaptive design preselected questions based on previous responses. Data were automatically transferred to the German- Austrian-Swiss GvHD registry, allowing comparison of patientreported symptoms with physician assessments and paperbased PROMs from outpatient visits.</li>
 <li>Pilot testing of the cGvHD app was completed with 10 patients during routine follow-up after allo-HSCT, confirming feasibility with only 1 minor adjustment needed. The app demonstrated sufficient content validity, with no relevant symptoms missed compared to paper-based PROMs. Patients emphasized the need for weekly reminders and access to app results during clinic visits for symptom discussions. A shortcut function to report no symptoms was requested. Symptom severity was categorized into four grades across seven domains. The app aligned with paperbased PROMs in 67% of assessments (28/42), with only one severity-grade difference in the remaining cases.</li>
</ul>

Abbreviations: 
 ADS, automated data structuration; AE, adverse event; aGvHD, acute graft-versus-host disease; AI-NLP, artificial intelligence natural language processing; allo-HSCT, allogenic hematopoietic stem-cell transplantation; ATG, ati-thymocyte globulin; BAFF, Bcell activating factor; BAT, best available therapy; BID, twice daily; BEL, belumosudil; CD, cluster of differentiation; cGvHD, chronic graft-versus-host disease; CI, confidence interval; CNI, calcineurin inhibitor; CR, complete response; CTLA4; cytotoxic Tlymphocyte associated protein 4; CXCL10, C-X-C motif chemokine ligand 10; DKK3, dickkopf WNT signaling pathway inhibitor 3; ECP, extracorporeal photopheresis; FFS, failure-free survival; GETH-TC, Spanish Group of Hematopoietic Stem Cell Transplantation and Cell Therapy; GI, gastrointestinal; GvHD, graft-versus-host disease; HCT, hematopoietic cell transplantation; HLA, human leukocyte antigen; HrQoL, helath realted quality of life; IL-15, interleukin-15; LOT, lines of therapy; LSS, Lee Symptom Scale; MCS, mental component score; mLSS, modified Lee symptom scale; MMP3, matrix metalloproteinase 3; MS17, mass spectrometry 17; MSD, matched sibling donor; MTX, methotrexate; MUD, matched unrelated donor; NIH, National Institutes of Health; NRM, non-relapse mortality; OPN, osteopontin; ORR, overall response rate; OS, overall survival; PCS, physical component score; PFS, progression-free survival; PR, partial response; PRO, patient-reported outcomes; PTCy, post-transplant cyclophosphamide; PTSD, post-truamatic stress disorder; QOL, quality of life; RCT, randomized controlled trial; REG3α, regenerating islet-derived 3-alpha; RUX, ruxolitinib; RWE, Real-world evidence; sR-cGvHD, steroid-refractory chronic graftversus- host disease; ST2, suppression of tumorigenicity 2; TEM, effector memory T cells; TIM 3, immunoglobulin and mucin domain 3.
 
 &nbsp;

References:

The Congress Connection: cGvHD and Transplant Key Takeaways in 2025

CHRONIC-GRAFT-VERSUS-HOST-DISEASE-CGVHD

TRANSPLANT

<h3 style="text-align:center;">Chronic rhinosinusitis with nasal polyps (CRSwNP):</h3>

<h3 style="text-align:center;">A chronic type 2 inflammatory disease of the nasal/paranasal sinuses of the upper airway characterized by rhinosinusitis and bilateral nasal polyps1,2</h3>

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 <h3 style="text-align:center;">&nbsp; Type 2 inflammation drives disease pathology in up to 87% of patients with CRSwNP4</h3></td>
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</figure>

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 <h3 style="text-align:center;">Loss of smell may be used as a diagnostic symptom and may predict CRSwNP patients with poor long-term outcomes requiring approaches beyond the standard of care</h3></td>
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 <h3 style="text-align:center;">Loss of Smell: A Diagnostic Symptom</h3></td>
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</figure>

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 <h3 style="text-align:center;">Steroid and Surgical Effects on Loss of Smell</h3></td>
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</figure>

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 <h3 style="text-align:center;">&nbsp;&nbsp;&nbsp; Type 2 inflammation in CRSwNP is associated with loss of smell</h3></td>
 </tr>
 </tbody>
 </table>
</figure>

*Clinical consequences are listed in descending order based on patient questionnaire: “Please mark the most important items affecting your health.” †Loss of smell is included in CRSwNP diagnostic criteria in the following international guideline publications: EPOS 2020, ICAR:RS 2021, EUFOREA 2021, and EAACI 2021. CRSwNP, chronic rhinosinusitis with nasal polyps; EAACI, European Academy of Allergy and Clinical Immunology; EPOS, European Position Paper on Rhinosinusitis and Nasal Polyps; EUFOREA, European Forum for Research and Education in Allergy and Airway Diseases; ICAR:RS, International Consensus Statement on Allergy and Rhinology: Rhinosinusitis; IL, interleukin; SCS, systemic corticosteroids; SOC, standard of care. 1. Fokkens WJ, et al. Rhinology. 2020;58(suppl S29):1-464. 2. Schleimer RP. Annu Rev Pathol. 2017;12:331-357. 3. Mullol J, et al. J Allergy Clin Immunol Pract. 2022;10(4):1086-1095.e5. 4. Stevens WW, et al. J Allergy Clin Immunol Pract. 2019;7(8):2812-2820. 5. Kato A. Allergol Int. 2015;64(2):121-130. 6. Gandhi NA, et al. Nat Rev Drug Discov. 2016;15(1):35-50. 7. Wise SK, et al. Int Forum Allergy Rhinol. 2014;4(5):361-370. 8. Takabayashi T, et al. J Allergy Clin Immunol. 2013;132(3):584-592.e4. 9. Chalermwatanachai T, et al. Sci Rep. 2018;8(1):7926. 10. Bachert C, et al. J Allergy Clin Immunol. 2021;147(1):29- 36. 11. Orlandi RR, et al. Int Forum Allergy Rhinol. 2021;11(3):213-739. 12. Agache I, et al. Allergy. 2021;76(1):14-44. 13. Rimmer J, et al. Cochrane Database Syst Rev. 2014;(12):CD006991. 14. Bakhshaee M, et al. Iran J Otorhinolaryngol. 2016;28(85):125-134. 15. Van Zele T, et al. J Allergy Clin Immunol. 2010;125:1069-1076.e4. 16. Seys SF, et al. Allergy. 2020;75(11):2867-2878.

CHRONIC-RHINOSINUSITIS-WITH-NASAL-POLYPS-CRSWNP

RHINOLOGY

Loss of Smell Is a Key Symptom in CRSwNP

<h3 style="text-align:center;">Mucus Overproduction and Decreased Mucociliary Clearance Can Lead to Mucus Plugs1</h3>

<h3 style="text-align:center;">Mucus Plugs Can Be Identified and Quantified Using CT Imaging of the Lungs2</h3>

<h4 style="text-align:center;">Segments of each lobe are examined for mucus plugs and given a score of 1 (present) or 0 (absent). Segment scores of each lobe are summed to generate a total mucus score ranging from 0-20.</h4>

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 <h4 style="text-align:center;">High mucus scores (≥4 bronchial subsegments with 1 or more airways completely occluded with mucus) were associated with low FEV1 and air trapping in patients with chronic, severe asthma2</h4></td>
 </tr>
 </tbody>
 </table>
</figure>

Republished with permission of American Society for Clinical Investigation, from Journal of Clinical Investigation, Dunican EM, Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction, Vol 128/No. 3, Copyright 2018; permission conveyed through Copyright Clearance Center, Inc. CT, computed tomography; FEV1, forced expiratory volume in 1 second; IL, interleukin. 1. Jesenak M, et al. Respir Med. 2023;218:107372. 2. Dunican EM, et al. J Clin Invest. 2018;128(3):997-1009. 3. Tang M, et al. Am J Respir Crit Care Med. 2022;205(9):1036-1045. 4. Chan R, et al. J Allergy Clin Immunol Pract. 2023;11(1):195-199.e2.

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 </tr>
 </tbody>
 </table>
</figure>

<h3 style="text-align:center;">The SARP-3 Study Showed Persistence of Mucus Plugs in Asthma Patients Over 3 Years3</h3>

<figure class="table" style="width:100%;">
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 <td style="background-color:#1c8ea1;">Low Global Mucus Score: 0.5-3.5</td>
 <td style="background-color:#E94C1F;">
 High Global Mucus Score: 4-202</td>
 </tr>
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</figure>

<h3 style="text-align:center;">Persistent mucus plugs are associated with chronic OCS use and a greater symptom burden, measured by ACT33</h3>

<h2 style="text-align:center;">Presence of Mucus Plugs Is Associated With Worsening Clinical Asthma Outcomes</h2>

Republished with permission of American Society for Clinical Investigation, from Journal of Clinical Investigation, Dunican EM, Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction, Vol 128/No. 3, Copyright 2018; permission conveyed through Copyright Clearance Center, Inc. Reprinted from the American Journal of Respiratory and Critical Care Medicine, Tang M, et al, Mucus Plugs Persist in Asthma, and Changes in Mucus Plugs Associate with Changes in Airflow over Time, Vol 205/Issue 9, Copyright 2022, with permission from the American Thoracic Society. *Data from 146 of the 658 adult patients with asthma enrolled in SARP. Of those included in SARP (n=658), 66% of patients met American Thoracic Society/European Respiratory Society criteria for severe asthma. Patients were non-smokers and were required to have evidence of bronchial hyperresponsiveness or reversible airflow obstruction. ACT, Asthma Control Test; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; OCS, oral corticosteroid; SARP, Severe Asthma Research Program. 1. Jesenak M, et al. Respir Med. 2023;218:107372. 2. Dunican EM, et al. J Clin Invest. 2018;128(3):997-1009. 3. Tang M, et al. Am J Respir Crit Care Med. 2022;205(9):1036-1045. 4. Chan R, et al. J Allergy Clin Immunol Pract. 2023;11(1):195-199.e2.

ASTHMA

RESPIRATORY

Mucus Plugging Is a Key Component of Remodeling
in Asthma, Leading to Fixed Airway Obstruction

<h3 style="text-align:center;">Effect of Dupilumab on Exhaled Nitric Oxide, Mucus Plugs, and Functional Respiratory Imaging in Patients With Type 2 Asthma (VESTIGE): A Randomised, Double-blind, Placebo-controlled, Phase 4 Trial</h3>
<h4 style="text-align:center;">Castro M, et al. Lancet Respir Med.2025 Online first</h4>

*All characteristics are mean unless otherwise noted. bAs the primary imaging endpoint did not reach statistical significance (P&gt;0.05), all subsequent endpoints were reported using nominal p-values. cThe statistical significance represents the correlations between 2 parameters. ACQ, asthma control questionnaire; BD, bronchodilator; CT, computed tomography; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; FOT, forced oscillation technique FRI, functional residual imaging; ICS, inhaled corticosteroids; ITT, intention-to-treat; iV/Q, image-based ventilation-perfusion ratio; LS, least squares; ppFEV1, percent predicted forced expiratory volume in 1 second; q2w, every 2 weeks.

<h3>Disclaimer: This study is not added yet in to the local label in Kingdom of Saudi Arabia.</h3>

VESTIGE study

Beyond High-Risk: Expanding RSV Protection for Newborns and Infants

RSV is a leading cause of severe respiratory infections in infants, often resulting in hospitalization and complications such as bronchiolitis and pneumonia. While high-risk infants have traditionally been prioritized for preventive measures, the burden of RSV extends to all newborns, necessitating broader protection strategies.
Welcome to an insightful discussion with Dr. Ali AlMudeer, Lead of the Neonatal ICU at the Ministry of Health, Kingdom of Saudi Arabia. In this exclusive interview, Dr. AlMudeer, Lead of the Neonatal ICU at the Ministry of Health, Kingdom of Saudi Arabia. In this exclusive interview, Dr. AlMudeer explores the urgent need for universal protection against RSV, highlighting advancements in prevention beyond high-risk groups to safeguard all newborns and infants.

OTHER-VACCINES-TOPICS

Infectious Disease During Mass Gathering

With the easing of COVID-19 travel restrictions globally, increasing numbers of people travelled for the 2023 Hajj, during which Saudi Arabia hosted 1.85 million pilgrims including 1.66 million international pilgrims.1
A further substantial increase in these numbers many of whom will be older people with comobidities, is anticipated for the fortcoming Hajj pilgrimage in June, 2025.1

Reference:

<h2>Loss of Smell Improvement in Patients With CRSwNP: Results From SINUS-24 and SINUS-52a</h2>

These materials are presented by Sanofi and Regeneron Medical for scientific exchange purposes only. Please refer to the product label for full prescribing information. Figures were reproduced with permission from the publisher. *P&lt;0.05/**P&lt;0.01/***P&lt;0.001 /****Nominal P&lt;0.0001 vs placebo. aPlease see manuscripts for full details.1–3 bEligible patients were aged ≥18 years with bilateral nasal polyps and symptoms of CRS despite INCS therapy before randomization and had received SCS in the preceding 2 years (or had a medical contraindication or intolerance to SCS) or previous sinonasal surgery. In SINUS-24, patients were randomly assigned (1:1) to dupilumab 300 mg SC q2w or to matching placebo. In SINUS-52, patients were randomly assigned (1:1:1) to dupilumab 300 mg SC q2w for 52 weeks, the same schedule for the first 24 weeks followed by dupilumab 300 mg SC q4w, or placebo. cScale 0–3: Higher scores indicate greater disease severity. dPooled data from SINUS-24 and SINUS-52. e(n=724). fOnly the 710 patients who completed an UPSIT assessment at BL were included in this analysis. gNominal.hTwo deaths occurred during the study period that were deemed unrelated to the study drug; 1 patient given placebo in SINUS-24 had suspected myocardial infarction occurring after the period of TEAEs, and 1 treated with dupilumab in SINUS-52 had intracranial hemorrhage after a fall, occurring within the period of TEAEs. These patients were not included in the safety population. iInjection site reactions cluster included injection site reaction, pain, bruising and swelling. jConjunctivitis cluster included conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation. BL, baseline; CRS, chronic rhinosinusitis; INCS, intranasal corticosteroids; LoS, loss of smell; LS, least-squares; LSMD, least-squares mean difference; q2w, every 2 weeks; q4w, every 4 weeks; SC, subcutaneously; SCS, systemic corticosteroids; SOC, standard of care; TEAE, treatment-emergent adverse event; UPSIT, University of Pennsylvania Smell Identification Test. 1. Bachert C, et al. Lancet. 2019;394:1638–1650. 2. Mullol J, et al. J Allergy Clin Immunol Pract. 2022;10:1086-1095.e5. 3. Hopkins C, et al. Int Forum Allergy Rhinol. 2021;11:1087–1101. 4. Dupixent (dupilumab) Prescribing Information. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; Tarrytown, NY: Regeneron Pharmaceuticals, Inc. 2024

<h2>Loss of Smell Improvement in Patients With CRSwNP: Real-World Dataa</h2>

These materials are presented by Sanofi and Regeneron Medical for scientific exchange purposes only. Please refer to the product label for full prescribing information.&nbsp; *P&lt;0.001/ **P&lt;0.0001. aPlease see manuscripts for full details.1–3 Note that real-world data are collected from diverse sources outside the controlled environment of a clinical trial. As such, the reliability of real-world data can be hindered by data quality issues, confounding variables, and limitations in establishing causality.4 bA phase 4 real-life, observational, retrospective, multicenter study that assessed the effectiveness and safety of dupilumab 300 mg SC q2w in patients with severe uncontrolled CRSwNP over the first year of treatment. Patients enrolled were treated between November 2020 and March 2022. cA real-world prospective observational study that included patients with CRswNP who underwent treatment with dupilumab. Patients were treated with dupilumab 300 mg SC q2w as an add-on therapy to INCS. The treatment period for this study wasnot specified in the manuscript. dAn observational, retrospective multicenter study. Patients were treated with dupilumab 300 mg SC q2w as an add-on therapy to INCS for ≥1 year and followed between February 2020 and November 2022. eData from different studies are not meant to be directly compared. Data reported are not comprehensive. fThe manuscript does not provide data on the statistical significance of the change from baseline to the specified timepoint. BL, baseline; INCS, intranasal corticosteroids; LoS, loss of smell; q2w, every 2 weeks; SC, subcutaneously; VAS, Visual Analogue Scale. 1. De Corso E, et al. Allergy. 2023;78:2669–2683. 2. Albrecht T, et al. World Allergy Organ J. 2023;16:100780. 3. Ottaviano G, et al. J Pers Med. 2023;13:234. 4. Kim HS, Kim JH. J Korean Med Sci. 2019;34(4):e28. 
 &nbsp;

Loss of Smell Improvement in Patients With CRSwNP

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