Dupixent (dupilumab) / Sanofi, Regeneron - LARVOL DELTA

Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion) (clinicaltrials.gov) - P3 | N=365 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pediatrics • Pulmonary Disease • Respiratory Diseases

A phase 1b/2 trial of dupilumab given in conjunction with PD-1 or PD-L1 blockade and anakinra in the treatment of relapsed/refractory metastatic NSCLC (AACR 2025) - "Abstract is embargoed at this time."

Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Press Release: Sanofi: strong Q1 performance and 2025 guidance confirmed (Sanofi Press Release) - "ALTUVIIIO (hemophilia A) sales were €251 million of which 87% were in the US. Growth was driven by continued patient switches from older plasma-derived and recombinant factor medicines and to a lesser extent from non-factor treatments. Rest of World sales of €33 million benefited from the launch in Japan and sales to the collaborator in Europe....Qfitlia (hemophilia A and B) was approved in the US on March 28, 2025, with first sales recorded at the beginning of Q2 2025. Dupixent sales were €3,480 million and increased by 20.3%. Global sales were driven by increased use in all approved indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and emerging use in COPD."

Sales • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Eosinophilic Esophagitis • Hemophilia A • Hemophilia B • Prurigo Nodularis

Re-HU-TREAT: Replication of the Heads Up Atopic Dermatitis Trial With Registry Data (clinicaltrials.gov) - P=N/A | N=240 | Active, not recruiting | Sponsor: Technische Universität Dresden

Head-to-Head • New trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Dupixent: Regulatory decision in EU for chronic spontaneous urticaria in H2 2025 (Sanofi) - Q1 2025 Results: Regulatory decision in EU/China for bullous pemphigoid in 2026

China approval • EMA approval • Bullous Pemphigoid • Chronic Spontaneous Urticaria • Immunology

Dupilumab for bullous pemphigoid induced by immune checkpoint inhibitors. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Checkpoint inhibition • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology • Oncology

A phase 1b study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT06088771 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Racial and Ethnic Disparities in Biologic Prescriptions for CRSwNP in the United States (COSM 2025) - "A higher proportion of NHB patients were started on any FDA approved biologic for CRSwNP compared to NHW patients (risk difference [RD] 1.2%, p=0.0008), as well as individual biologics: omalizumab (RD 0.4%, p=0.011), dupilumab (RD 0.9%, p=0.0028), mepolizumab (RD 0.3%, p=0.0317). Retrospective analysis of claims based data for CRSwNP management found that NHB patients were more likely, and Hispanic patients were less likely, to be prescribed biologics compared to NHW patients."

Asthma • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • Urticaria

Systematic review of measured biomarker changes after biologic treatments for CRSwNP (COSM 2025) - " Of 51 included studies, breakdown by biologic was: Dupilumab- 26, Omalizumab- 8, Mepolizumab- 6, Benralizumab- 8, Resilizumab-1, and other-2. Current literature studying biologics in CRSwNP have predominantly focused on only a select few biomarkers known to be key mediators of type 2 inflammation. Systemic top 3- IgE (19), Eosinophils (37) and ECP (8). Nasal top 3- Eosinophils (10), IgE (7), ECP (7)."

Biomarker • Review • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilia • Inflammation

Patients with CRSwNP had fewer sinus procedures and less HCRU following Dupilumab initiation (COSM 2025) - "CRSwNP patients on dupilumab had fewer sinus procedures and lower HCRU following dupilumab initiation vs pre-dupilumab treatment. These findings support the effectiveness of dupilumab in treating patients with CRSwNP in real-world practice."

Clinical • Chronic Rhinosinusitis With Nasal Polyps • Otorhinolaryngology

Baseline healthcare resource utilization in patients with CRSwNP from the AROMA global registry (COSM 2025) - P | "Patients initiating dupilumab for CRSwNP have a previous history of high HCRU and loss of work productivity."

Clinical • HEOR • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Disease severity as a predictor of Dupilumab response in patients with CRSwNP (COSM 2025) - "In our cohort of 68 patients, dupilumab treatment led to significant clinical improvement. Patients with high pre-treatment NPS (?5) showed a greater degree of improvement in total SNOT score (p=0.079) and NPS at 1-year follow-up (p<0.001). Multivariate regression revealed baseline SNOT score (OR=1.57, p<0.001) and age (OR=1.37, p=0.005) significantly predicted follow-up SNOT score."

Clinical • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL4

Dupilumab for pediatric CRSwNP with immunodeficiency (COSM 2025) - "We present a case study highlighting the benefit of Dupilumab therapy for longstanding refractory CRSwNP in an immunodeficient child. Clinicians may consider dupilumab therapy for refractory pediatric rhinosinusitis, especially those who failed maximal medical management, including immune deficiency management and ESS."

Clinical • Allergic Rhinitis • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Infectious Disease • Inflammation • Nasal Polyps • Otorhinolaryngology • Pediatrics • Primary Immunodeficiency • Respiratory Diseases • Sinusitis

Bibliometric analysis on Dupilumab and chronic sinusitis with nasal olyposis (COSM 2025) - "Research regarding the use of dupilumab in the treatment of CRSwNP is rapidly evolving, highlighting the paradigm shift in treatment with the introduction of biologic therapy. This analysis showcases global interest in this topic, highlighting hallmark publications and prolific investigators, while also identifying areas for further exploration and collaboration."

Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Arthritis Related Adverse Reactions of Dupilumab in Treatment of Chronic Rhinosinusitis (COSM 2025) - "FAERS analysis showed that DAR was more common with CRSwNP treatment with 2 times higher odds of DAR compared to other treatment indications. Women and older adults were at higher risk of DAR. Otolaryngologists prescribing dupilumab for CRSwNP should be aware of the increased risk of arthritis, especially in the higher risk groups."

Asthma • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Dermatitis • Dermatology • Immunology • Musculoskeletal Pain • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Rheumatology • Sinusitis • ROR1

Dupilumab initiation associated with differential gene expression in CRSwNP (COSM 2025) - "Surgically recalcitrant polyp disease requiring dupilumab initiation is associated with upregulation of CLC and activation of eicosanoid pathways. Transcriptomic biomarkers may be a useful prognostic tool in the future for predicting response to treatment"

Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • LGALS1 • POSTN

Biologics and acute rhinosinusitis: A protective effect (COSM 2025) - "Objective: To assess whether biologic therapies (dupilumab, mepolizumab, and omalizumab) that are approved for chronic sinusitis with nasal polyps (CRSwNP) exhibit a protective effect on sinonasal health even in patients without CRSwNP. Dupilumab and mepolizumab appear to reduce ABRS episodes in patients without CRSwNP, suggesting a protective effect on sinonasal health. These findings highlight the potential use of biologics in managing patients with refractory recurrent acute sinusitis despite surgery. Further studies are needed to confirm these effects and to evaluate risks associated with long-term biologic use in non-CRSwNP populations."

Allergic Rhinitis • Asthma • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Rheumatic adverse events in biologics for CRS (COSM 2025) - " 21 studies met the final inclusion criteria, totalling 3,434 patients of which 2,763 (80%) received either dupilumab (n=2,257; 82%), mepolizumab (n=372; 13%), or omalizumab (n=134; 5%) for treatment of CRSwNP. Biologic therapy increases the risk of rheumatic AEs in CRSwNP patients by over two-fold. Healthcare providers should remain vigilant in monitoring rheumatic AEs and apply appropriate management strategies on a case-by-case basis."

Adverse events • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Musculoskeletal Pain • Nasal Polyps • Orthopedics • Otorhinolaryngology • Pain • Respiratory Diseases • Sinusitis

FESS versus biologic therapy for CRSwNP: A systematic review with meta-analysis (COSM 2025) - "No statistically significant between-group differences were observed in the prevalence of asthma, aspirin exacerbated respiratory disease, or prior sinus surgery. Dupilumab may be superior to FESS for long-term SNOT-22 scores, while FESS may be superior for improving endoscopy scores. Given the small number of studies included and/or heterogeneity observed, additional studies are needed before any level of certainty can be reached."

Retrospective data • Review • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

TRMs, TLS, and type 2 cytokine production in CRSwNP (COSM 2025) - "Introduction IL-4 and IL-13 are primary drivers of chronic rhinosinusitis with nasal polyps (CRSwNP) pathophysiology, as evidenced by the effectiveness of dupilumab...Conclusion This study demonstrates that TRMs are the major lymphocyte source of IL-13 in CRSwNP, as well as chronic Th2 nasal inflammation in a mouse model. Additionally, human TRMs appear to aggregate in specific tissue niches resembling TLSs, providing evidence that a special microenvironment may provide the necessary signals for their maintenance, with potential for therapeutic targeting."

Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Oncology • Otorhinolaryngology • Respiratory Diseases • Sinusitis • CD4 • CD69 • GATA3 • IL13 • IL4

Efficacy of Biologic Agents in Management of Pediatric Asthma (PAS 2025) - "Control of severe asthma has always been a challenge, and the advent of biologic therapy (omalizumab, mepolizumab, dupilumab, benralizumab, and tezepelumab) has revolutionized the treatment of this category of asthma. These factors will also be assessed for the year following initiation for evaluation of outcomes. Outcomes pre and post-biologic initiation will be compared using dependent sample t-testing, conducted with IBM SPSS."

Clinical • Asthma • Immunology • Pediatrics • Respiratory Diseases • IL4 • IL5 • TSLP

Impact Of Dupilumab on Caregiver-Reported Signs Of EOE, Using PESQ-C OVER 52 WEEKS: Results from The Phase 3 EOE Kids Study (PAS 2025) - No abstract available

P3 data • Gastroenterology

Growth Analysis in Children Aged 6 to 11 Years with Severe Atopic Dermatitis and Impact of 16 Weeks of Dupilumab Treatment on Height (PAS 2025) - P3 | "Girls aged 6−11 years (n=153) with severe AD were overrepresented below the 50th percentile in height by 4.2%; boys (n=151) by 7.6%. In contrast, children with AD were overrepresented above the 50th percentile for weight (5.6% in girls and 7.6% in boys) and BMI (17.3% in girls; 12.9% in boys). A significantly greater proportion of children below the 25th, 30th or 40th percentiles at baseline achieved a ≥5 percentile improvement in height when treated with DPL compared with PBO [ < 25th percentile: 11.9% PBO (n=42) vs 30.6% DPL (n=62), P=0.0329; < 30th percentile: 11.1% PBO (n=45) vs 31.9% DPL (n=69), P=0.0129; < 40th percentile: 15.5% PBO (n=58) vs 31.3% DPL (n=83), P=0.0467]."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Dupilumab Is Effective in Treating EoE in Patients Weighing 15 Kg and above: Results from the Phase 3 KIDS Study (PAS 2025) - No abstract available

Clinical • P3 data • Eosinophilic Esophagitis

Dupilumab Plus Medium-Dose Inhaled Corticosteroid Improves Outcomes Compared with Placebo Plus High-Dose Inhaled Corticosteroid in Pediatric Patients with Uncontrolled Asthma (PAS 2025) - No abstract available

Clinical • Asthma • Immunology • Pediatrics • Respiratory Diseases