Xolair (omalizumab) / Roche, Novartis - LARVOL DELTA

A multicentre UK snapshot audit of symptom burden in patients with indolent systemic mastocytosis utilising the ISM-SAF © (ASH 2025) - "Medications included H1 antihistamines (n=89), H2 antihistamines (n=49), proton pump inhibitors (n=22), sodium cromoglicate (n=23), montelukast (n=12), oral corticosteroid (n=1) and omalizumab (n=3). Of the 101 patients, median age at diagnosis was 46 years (range 11-76) with female predominance (62.4%). Median time to ISM diagnosis was 4.1 years (range 0.1-55.6). Median latest serum tryptase was 37.5 mcg/L (range 7.9-196; n=99) and 2 patients had levels >200 mcg/L."

Clinical • Hematological Disorders • Hematological Malignancies • Musculoskeletal Pain • Osteoporosis • Rheumatology • KIT

primary CD34+ derived mast cells provide an excellent platform to assess single agent and combination therapies for mastocytosis (ASH 2025) - "Multiple compounds targeting different receptors have been used to treat mastocytosis including Omalizumab (FcεR1A), Avapritinib (CD117), Budesonide (glucocorticoid receptor) and Salmetrol (β2 adrenergic receptors). Combinations of Avapritinib (dose response) with Omalizumb at 1 nM significantly increased the degranulation with a mean IC 50 value of 85 nM for Avapritinib. This data confirm primary MPB CD34+ cell derived mast cells provide an excellent in vitro platform with an unlimited supply of cells to assess single agent and combinations for mastocytosis and other mast cell diseases."

Combination therapy • Asthma • Cardiovascular • Dermatology • Immunology • Inflammatory Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Rosacea • CD34 • CD63 • CORT • IL6 • KIT

Biphasic effects of cyclophosphamide on l-asparaginase hypersensitivity and resistance in mice (ASH 2025) - "Additionally, we examined the effects of methotrexate (MTX) and cyclophosphamide (CY),drugs known to impair Th17 and Treg cell functions, respectively, on ASNase allergy and drug resistance. We successfully established in vivo and in vitro models for Th2-biased type I hypersensitivityto ASNase. Our findings suggest that non-anaphylactogenic neutralizing IgE antibodies, such asomalizumab, are promising candidates for treating ASNase hypersensitivity. Furthermore, CYadministration exhibited biphasic effects on ASNase allergy in sensitized mice: enhancing it at lowerdosages (150 mg/kg) by promoting Th2-biased immune responses and increasing IgE production, butattenuating it at higher dosages (300 mg/kg)."

Preclinical • Acute Lymphocytic Leukemia • Food Hypersensitivity • Hematological Malignancies • Immunology • Leukemia • IL10 • IL12A • IL4

BH09 Rapid resolution of chronic spontaneous urticaria with ritlecitinib in a patient with alopecia universalis. (PubMed, Br J Dermatol) - "Initial management included high-dose fexofenadine, famotidine, montelukast and omalizumab...Pulsed dexamethasone provided modest improvement in her urticaria symptoms but did not alter the progression of her alopecia...While JAK inhibitors are not established as a standard treatment for CSU, limited case series have documented the use of tofacitinib in refractory cases...The rapid and sustained symptom resolution observed in this patient suggests the potential of ritlecitinib as a novel therapeutic option for refractory CSU. Further investigation is warranted to evaluate its broader clinical applicability and efficacy in CSU management."

Journal • Alopecia • Asthma • Chronic Spontaneous Urticaria • Dermatology • Endocrine Disorders • Immunology • Pulmonary Disease • Respiratory Diseases • Urticaria

Late-onset inflammatory reaction with panniculitis and persistent edema following dermal fillers, successfully treated with omalizumab. (PubMed, Ital J Dermatol Venerol) - No abstract available

Journal • Aesthetic Medicine

Biological therapy in severe occupational asthma (BTS WM 2025) - "There is limited data on use of biologics in OA, with only one published study on omalizumab...Most patients were prescribed Tezepelumab (n=6) and over 60% had trialled at least 1 biologic...Over half were unemployed suggesting poor employment outcomes for severe OA. Further research to explore prevalence of OA among severe asthma and better characterise treatment responses where exposures may continue is important for this underrepresented population."

Asthma • Immunology • Respiratory Diseases

Uniform clinical benefit of biologic therapy across a regional severe asthma network (BTS WM 2025) - "Patients were prescribed: benralizumab n=442, dupilumab n=69, mepolizumab n=146, omalizumab n=51, tezepelumab n=69, not recorded n=29. Download figure Open in new tab Download powerpoint Abstract P196 Figure 1 Conclusions Following the initiation of asthma biologic therapies, acute hospital attendances, health-related quality of life and both acute and chronic corticosteroid usage improved. Whilst acknowledging both the limitations of this unblinded, non-controlled observational study but also the strengths of real-world clinical service data, the positive impact of asthma biologics on multiple patient-centred clinical endpoints is profound."

Clinical • Asthma • Immunology • Respiratory Diseases

Clinical outcomes after switching from omalizumab to anti-IL-5/IL-5R biologics in severe asthma: a retrospective cohort study. (PubMed, BMC Pulm Med) - "In severe asthma patients who do not achieve adequate control with omalizumab, switching to interleukin-5 (IL-5) targeted biological therapies may provide clinically significant improvements. Baseline clinical parameters can serve as useful predictors for the need to change biological treatment."

Clinical data • Journal • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

Modifying the course of asthma: mechanisms and strategies for clinical remission. (PubMed, Curr Opin Allergy Clin Immunol) - "Clinical remission in asthma is now a feasible target. Achieving this goal requires a multidimensional approach that integrates biologics, early treatment, comorbidity management, and lifestyle interventions. Standardized definitions and biomarkers are essential to guide therapeutic decisions and predict long-term outcomes."

IO biomarker • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

The frequency and predictability of switching biologic agents in severe asthma: A real-world perspective. (PubMed, Asia Pac Allergy) - "In the first-line treatment, 111 patients (68%) were started on omalizumab, 43 patients (26%) on mepolizumab, and 11 patients (6%) on benralizumab. Patients with higher annual attacks at baseline and lower responsiveness at the first postbiologic efficacy assessment can be useful in predicting switching status. However, further well-designed studies involving a larger number of patients and conducted over a longer term are needed to identify additional factors that could assist in selecting the most appropriate biologic."

Journal • Real-world evidence • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

How to choose a biologic agent considering comorbidities of bronchial asthma. (PubMed, Respir Investig) - "Herein, we summarize recent evidence on the prevalence of comorbidities associated with type 2 inflammation, including chronic spontaneous urticaria, atopic dermatitis, prurigo nodularis, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, eosinophilic otitis media, aspirin-exacerbated respiratory disease, allergic rhinitis, allergic bronchopulmonary mycosis, obesity, and chronic obstructive pulmonary disease, and review the efficacy of five major biologics (omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab) in these settings. In conclusion, the assessment of comorbidities in addition to biomarkers is essential for tailoring biologic therapies for severe asthma. Integrating comorbidity profiles into treatment strategies allows for a more precise and effective use of biologics, ultimately improving outcomes in complicated asthma cases."

Journal • Review • Allergic Rhinitis • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Eosinophilic Granulomatosis With Polyangiitis • Genetic Disorders • Immunology • Inflammation • Langerhans Cell Histiocytosis • Nasal Polyps • Obesity • Otorhinolaryngology • Prurigo Nodularis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Sinusitis • Urticaria • Vasculitis • IL5 • TSLP

Impact of type 2-targeted therapies on respiratory infection risk. (PubMed, Curr Opin Allergy Clin Immunol) - "T2-modulating biologics not only control allergic inflammation but also restore epithelial and immune homeostasis, contributing to maintained or reduced respiratory infection risk. These therapies represent a dual benefit of barrier repair and immune rebalancing. Further studies are warranted to evaluate long-term infection outcomes in high-risk populations."

Journal • Allergy • Infectious Disease • Inflammation • Respiratory Diseases • IL13 • IL4 • IL5

Emerging IgE and non-IgE targeted therapies for chronic urticaria. (PubMed, Ann Allergy Asthma Immunol) - "Dupilumab received FDA approval for antihistamine refractory chronic spontaneous urticaria (CSU) supporting the targeting of type-2 cytokines, IL-4 and IL-13, in this disease. Bruton's tyrosine kinase (BTK) inhibitors show promise, with remibrutinib receiving FDA approval and demonstrating significant reductions in UAS7 in Phase 3 trials. c-Kit (c-Kit or KIT) inhibition with barzolvolimab shows robust efficacy with sustained effects post-treatment...Although some programs have been discontinued due to safety concerns or lack of efficacy such as fenebrutinib (BTK inhibitor), THB001 (c-Kit inhibitor), EP262 (MRGPRX2 antagonist), tezepelumab (anti- TSLP), as well as lirentelimab and AK006 (Siglec-targeting agents), these studies have informed many of the other positive studies. In summary, over the last year, we have seen the CU pipeline mature with multiple Phase 3 programs and new approvals representing diverse mechanisms of action. Nevertheless, significant..."

Journal • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL13 • IL4 • TSLP

Dominant clinical improvements and durability of biologic response in severe asthma (BTS WM 2025) - "Quadruple-domain response (ACQ+OCS+FEV 1 +admission reduction) increased from 18.0% to 38.7% for benralizumab, 27.3% to 36.4% for dupilumab, 24.2% to 40.9% for mepolizumab, and 11.1% to 33.3% for omalizumab from Year 1 to Year 3. Quadruple-domain response was observed irrespective of biomarker profile but was less frequent among those on maintenance steroids at baseline. Tracking cumulative, multidomain outcomes is essential for optimal biologic selection and asthma management."

Clinical • Asthma • Immunology • Respiratory Diseases

Distinct Effects of Biological Treatments on Eosinophils and Neutrophils in Chronic Rhinosinusitis With Nasal Polyp Patients. (PubMed, Clin Transl Allergy) - "Biological treatments effectively reduced eosinophilic inflammation in nasal polyps. However, most biologics could induce an eosinophil-to-neutrophil shift, indicating that solely targeting eosinophils may be insufficient as a treatment approach. Understanding these secondary effects on local immune pathways is critical for optimizing CRSwNP treatment strategies."

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

Efficacy of omalizumab in the treatment of STAT3 loss-of-function mutations associated with autosomal dominant hyperimmunoglobulin E syndrome-a case report. (PubMed, Transl Pediatr) - "The administration of omalizumab in combination with conventional therapy resulted in varying degrees of clinical improvement. The combination of omalizumab with conventional therapy may contribute to improved pulmonary and dermatological symptoms in patients with AD-HIES resulting from STAT3 LOF mutations."

Journal • Asthma • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatology • Immunology • Infectious Disease • Primary Immunodeficiency • Pulmonary Disease • Respiratory Diseases • Urticaria • STAT3

Co-existence of chronic spontaneous urticaria with atopic dermatitis: clinical and immunological perspectives. (PubMed, Front Allergy) - "A substantial subset of co-morbid cases required biologic treatments with Dupilumab, offering benefit in AD-dominant cases unresponsive to Omalizumab. High total IgE and asthma comorbidity may indicate an underlying AD component in CSU patients. Recognition of this overlap is essential for appropriate therapeutic decision-making, including potential escalation to biologic agents targeting T-cell cytokine pathways."

Journal • Allergic Rhinitis • Asthma • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • Urticaria

Acquired Hemophilia A Following Omalizumab Treatment in a Patient With Chronic Spontaneous Urticaria. (PubMed, J Investig Allergol Clin Immunol) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Hematological Disorders • Hemophilia • Hemophilia A • Immunology • Rare Diseases • Urticaria

Predictors of response to omalizumab for chronic spontaneous urticaria: a retrospective audit on a rural and regional patient cohort in Darwin, Australia. (PubMed, Intern Med J) - "Median CSU duration was 36 months prior to omalizumab. There is insufficient evidence to recommend routine IgE testing to predict omalizumab response as it is unlikely to change management."

Journal • Retrospective data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Predicting the Dynamic Viscosity of High-Concentration Antibody Solutions with a Chemically Specific Coarse-Grained Model. (PubMed, J Phys Chem Lett) - "We show that a refined Martini 3 force field, with optimized protein-protein interactions, can predict the elevated viscosities observed in concentrated solutions of F(ab')2 fragments of the therapeutic monoclonal antibody (mAb) omalizumab. Furthermore, we show that our previously developed Martini 3-exc model for arginine excipients successfully captures the trend of lowering viscosity, as observed in our rheology experiments. These findings open the way to physics-based computational prediction of the properties of dense biopharmaceutical solutions via large-scale MD simulations."

Journal

Assessing the Impact of GLP-1R Agonists in Post-sinus Surgery Management. (PubMed, Otolaryngol Head Neck Surg) - "Our results indicate that GLP-1RAs are associated with reduced postoperative revision FESS at up to a 5-year follow-up in CRSwNP patients. Future mechanistic and prospective studies are needed to confirm the association between GLP-1R agonists and improved post-sinus surgery outcomes identified in this study."

Journal • Chronic Rhinosinusitis With Nasal Polyps • Genetic Disorders • Immunology • Nasal Polyps • Obesity • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A vaccine targeting human IgE induces long-term protection against anaphylaxis in humanized mice. (PubMed, Sci Transl Med) - "Anti-IgE antibodies were detected in the sera of IgE-K-immunized mice for up to 12 months postvaccination with a similar avidity as the approved anti-IgE mAb omalizumab...Our results demonstrate that long-term reduction in IgE activity can be achieved through vaccination with human kinoids and can protect against anaphylaxis in humanized mice. This may represent a cost-effective, long-term therapeutic strategy for the treatment of IgE-mediated diseases."

Journal • Preclinical • Allergy • Dermatology • Food Hypersensitivity • Immunology

Allergic bronchopulmonary aspergillosis in patients with chronic obstructive pulmonary disease: a case series and literature review. (PubMed, BMC Pulm Med) - "ABPA should be considered in COPD patients with persistent or recurrent respiratory symptoms, higher blood eosinophils, particularly those with bronchiectasis on chest CT. ABPA represents a treatable trait in COPD patients. While corticosteroids remain the first-line therapy, treatment-resistant cases may benefit from biologic agents."

Journal • Review • Allergic Bronchopulmonary Aspergillosis • Asthma • Bronchiectasis • Chronic Cough • Chronic Obstructive Pulmonary Disease • Cough • Immunology • Pulmonary Disease • Respiratory Diseases

Benefits of CMAB007 in Chinese Patients Having Inadequately Controlled Moderate/Severe Asthma With Increased Total IgE: A Randomized Phase 3 Trial. (PubMed, Allergy Asthma Immunol Res) - P3 | "CMAB007 reduces AE and improves asthma control, lung function and quality of life without additional safety concern in Chinese patients having moderate to severe asthma with increased total IgE level."

Journal • P3 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Response to comments on "Effectiveness of transitioning from omalizumab to dupilumab in chronic spontaneous urticaria patients with inadequate response to omalizumab". (PubMed, World Allergy Organ J) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria