Fasenra (benralizumab) / AstraZeneca, Kyowa Kirin - LARVOL DELTA

A case series on cutaneous reactions to ivig (ASH 2025) - "The rash lacked mucosal involvement and was disseminatedbeyond sun-exposed areas, first appeared two months after commencing IVIg in November 2022.Despite ongoing systemic corticosteroids and withdrawal of other, potential culprit drugs includingvoriconazole and benralizumab, the rash persisted with cyclical flares over 15 months with somecorticosteroid responsiveness...Rechallenge with IVIg (Octogam) later in 2025 resulted in rapidrecurrence of the exanthema, suggesting a likely causative role.Case 2 depicts an 88-year-old male with chronic lymphocytic leukaemia (CLL), receiving zanubrutinibsince October 2023, with significant hypogammaglobulinaemia for which he was initiated on IVIg. Afterthree uneventful infusions of IVIg (Privigen AU) in 2023, he developed a severe, desquamatingerythrodermic rash following the fourth dose...Over a year later, the patient was re-challenged with analternative IVIg product (Octagam)...Nonetheless, further research is crucial touncover..."

Clinical • Asthma • Atopic Dermatitis • Chronic Lymphocytic Leukemia • Dermatology • Dermatopathology • Hematological Malignancies • Immunology • Leukemia • Respiratory Diseases • Steven-Johnson Syndrome

Patient perspectives on the burden of hypereosinophilic syndrome: Results from the Phase 3 natron interview sub-study (ASH 2025) - P3 | "Here, we report symptoms and HRQoL impacts describedby patients in the qualitative interview sub-study of an interventional trial.Methods NATRON (NCT04191304) is a phase 3, multicenter, randomized, 24-week, double-blind (DB), placebo-controlled trial evaluating the efficacy and safety of benralizumab in patients with FIP1L1::PDGFRA-negative HES...The findings of this sub-study underscore the high burden of HES symptoms andsuggest an urgent need for timely diagnosis and targeted treatment. Additional research on patients'experiences of living with HES and with HES treatment is warranted, and further planned analyses aim toexpand on these findings."

Clinical • Interview • P3 data • Hypereosinophilic Syndrome • Immunology • Musculoskeletal Diseases • Pruritus • Rare Diseases • FIP1L1 • PDGFRA

Efficacy and safety of benralizumab in patients with hypereosinophilic syndrome: Results from the Phase 3 natron study (ASH 2025) - P3 | "After confirmation of corticosteroidresponsiveness (AEC <1x109/L after 2 days of oral corticosteroid [OCS; prednisone/prednisolone] 1mg/kg/day in addition to Background therapy), pts were randomized (1:1) to benralizumab (30 mg) orPBO every 4 weeks for 24 weeks, in addition to Background HES therapy. The addition of benralizumab to Background therapy significantly reduced the risk of flaresand of hematologic relapse, and improved fatigue compared to PBO. Benralizumab tolerability wasconsistent with its known safety profile, including in adolescents. These results demonstrate the clinicaland biological efficacy of benralizumab in pts with HES."

Clinical • P3 data • Asthma • Eosinophilia • Eosinophilic Granulomatosis With Polyangiitis • Hypereosinophilic Syndrome • Immunology • Infectious Disease • Langerhans Cell Histiocytosis • Rare Diseases • Respiratory Diseases • Septic Shock • Vasculitis • FIP1L1 • IL5 • PDGFRA

Steroid resistant, osimertinib induced hypereosinophilic syndrome (HES) treated with Benralizumab in a patient with metastatic adenocarcinoma of lung. (PubMed, Respir Med Case Rep) - No abstract available

Journal • Hypereosinophilic Syndrome • Immunology • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology

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

Competing Beyond the First Mover: How Late to Market Analogues Navigate Pricing and Access in Major Global Markets (ISPOR-EU 2025) - "HTA, pricing outcomes and payer perceptions for ten analogues (such as Alecensa, Zejula, Rozlytrek, Eylea, Fasenra) were analysed across seven global markets (US, Germany, France, Spain, UK, Brazil, Canada). Several distinct pricing strategies (discounting, parity or premium) were observed which were highly dependent on the level of clinical differentiation vs. earlier to market options. Analogue assessment considered clinical and other non clinical factors that impacted their pricing and access success or failure which can potentially be used as a guide for future portfolio development and optimisation. Demonstrating clinical differentiation vs. earlier entrants is the critical factor translating into positive HTA outcomes and securing a price premium."

Clinical • Pricing

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

Persistent airway obstruction in severe eosinophilic asthma: targeting interleukin-5 and eosinophils. (PubMed, Eur Respir Rev) - "A few studies evaluating the effectiveness of benralizumab and mepolizumab were able to identify cohorts of patients with SEA and PAO who had a significant response to these IL-5/Rα-targeted biologics. PAO in patients with SEA represents a distinct clinical entity, one which could be referred to as "persistent eosinophilic airway obstruction". Patients with persistent eosinophilic airway obstruction are likely to be responsive to targeted biologic treatment, although additional clinical studies and real-world data are needed to further assess treatment efficacy and safety in this population and provide guidance to clinical practice."

Journal • Review • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL5

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

Case Report: A potential novel treatment for drug-induced acute interstitial nephritis: Benralizumab. (PubMed, Front Immunol) - "Two weeks prior to presentation, he was prescribed etoricoxib for back pain. The administration of benralizumab-an anti-CD125 antibody-resulted in rapid and complete recovery of kidney function. This case report highlights the potential role of benralizumab in the treatment of drug-induced interstitial nephritis with eosinophiluria."

Journal • Acute Kidney Injury • Back Pain • Cardiovascular • Hypertension • Musculoskeletal Pain • Nephrology • Pain • Renal Disease

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

Adjunctive dual biologic therapy for persistent nasal symptoms in eosinophilic granulomatosis with polyangiitis (EGPA). (PubMed, Am J Otolaryngol) - "Although anti-IL-5/IL-5R biologics such as mepolizumab and benralizumab are established therapies for maintaining systemic remission, a subset of patients continues to experience refractory sinonasal symptoms. We report two EGPA cases with well-controlled systemic disease under anti-IL-5/IL-5R therapy but persistent uncontrolled CRSwNP, who were treated with add-on dupilumab...Careful patient selection and close multidisciplinary monitoring are essential to ensure safety and optimize efficacy. Further studies are warranted to confirm long-term effectiveness and safety profiles."

Journal • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Sinusitis • Vasculitis • IL5

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

NLRP3 inflammasome expression in pediatric asthma: sputum-based insights, inflammatory mechanisms, and targeted therapeutic strategies. (PubMed, Allergy Asthma Clin Immunol) - "Biologics such as mepolizumab, benralizumab, and dupilumab are well known for their corticosteroid-sparing effects especially in cases of severe eosinophilic asthma. Although promising data, application of this data in clinical practice is still challenging due to many causes, including diagnostic challenges, ethical considerations in trials involving children, and the lack of approved NLRP3 inhibitors for use in children. More research is required and essential to confirm that NLRP3 could be used as a biomarker or therapeutic target in pediatric asthma."

Journal • Review • Asthma • Immunology • Inflammation • Pediatrics • Pulmonary Disease • Respiratory Diseases • NLRP3

Eczema following IL-5 inhibitors for the treatment of severe asthma with improvement after switching to an IL-4Ra mAb. (PubMed, J Allergy Clin Immunol Pract) - No abstract available

Journal • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pulmonary Disease • Respiratory Diseases • IL4R • IL5

The effectiveness of benralizumab in the management of chronic eosinophilic pneumonia (BTS WM 2025) - "Though there was a statistically significant fall in ACQ with treatment in patients started on biologics, this did not meet the ACQ MCID, and the ACQ of 2.3 was also above the ACQ cut-off for good control of 0.75. These data support the Lind Alliance Breathlessness consensus that interventions to address non-T2 high breathlessness in severe asthma clinics is a research priority."

Asthma • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

Improvements in FEV1 and St George's respiratory questionnaire (SGRQ) at 4 and 16 weeks on benralizumab are strongly associated with clinical remission at 1 year (BTS WM 2025) - "FEV 1 and SGRQ improvement are strongly associated with subsequent remission. Download figure Open in new tab Download powerpoint Abstract S133 Figure 1 Early change predictors of clinical remission on benralizumab Conclusion An improvement in FEV 1 of ≥100 ml and SGRQ change of double the MCID at 4 and 16 weeks on benralizumab are strongly associated with clinical remission at one year."

Clinical • Asthma • Immunology • Respiratory Diseases

Shifting COPD and asthma care left: analysis of the 'one stop' community diagnostic clinic in the West of Ireland (BTS WM 2025) - "We describe our experience of prescribing benralizumab alongside non-SA MAbs at a tertiary centre...One patient reported persistent flu-type symptoms, which is a documented adalimumab-related AE, and resolved on cessation of adalimumab. Eight patients retained good asthma control whilst receiving dual Mab therapy, with one patient stopping mepolizumab at 12 months due to poor asthma response...Dual biologic prescribing, furthermore, did not appear to affect asthma control. Further real-world data are required, and use of national registry data could be used to generate more robust safety data."

Ankylosing Spondylitis • Asthma • Chronic Obstructive Pulmonary Disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Osteoporosis • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Stringent American (ATS/ACAAI/AAAAI) endorsed 6-component definition of asthma remission is not achievable in a real-world benralizumab cohort (BTS WM 2025) - "These preliminary findings will help anticipate and address potential acceptability barriers, supporting the progression to a future clinical trial to evaluate TLUS in patients with suspected ILO. Ethical approval is in place for this study"

Clinical • Real-world • Real-world evidence • Asthma • Immunology • Respiratory Diseases

Tracking eosinophils following prednisolone or benralizumab at the time of an exacerbation in the ABRA trial (BTS WM 2025) - "Reference Moran AM, Ramakrishnan S, Borg CA, Connolly CM, Couillard S, Mwasuku CM, Pavord ID, Hinks TSC, Lehtimäki L. Blood eosinophil depletion with mepolizumab, benralizumab, and prednisolone in eosinophilic asthma. doi: 10.1164/rccm.202003–0729LE. PMID: 32584603; PMCID: PMC7605198"

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Effect of benralizumab on airway function measured by impulse oscillometry during eosinophilic exacerbations: results from the ABRA study (BTS WM 2025) - "Benralizumab alone or in combination was associated with consistent improvements in reactance parameters, reinforcing previously observed findings, 1 while oral prednisolone alone appeared less effective in restoring peripheral airway function. Benralizumab: from the basic mechanism of action to the potential use in the biological therapy of severe eosinophilic asthma. BioMed Research International 2018(1):4839230."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases

Treatment failures during an eosinophilic exacerbation following treatment with benralizumab or prednisolone: data from ABRA (BTS WM 2025) - "Other variables, including age, smoking status and eosinophil count and FeNO at time of exacerbation, were not significantly associated with treatment outcome. View this table: View inline View popup Abstract M16 Table 1 Patient characteristics for those patients who had treatment failure vs those who did not in the ABRA trial Conclusion Reduced baseline lung function and monotherapy with prednisolone were key predictors of treatment failure in the ABRA study."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases