Adbry (tralokinumab-ldrm) / LEO Pharma, AstraZeneca - LARVOL DELTA

Inhibition of the Interleukin Cytokines using novel Peptide Inhibitors for Allergy and Asthma Treatment (EAACI 2025) - "Inhibition of these cytokines by antibodies, including Dupilumab, Tralokinumab and Benralizumab have yeilded highly effective therapeutics for allergies and asthma, however they are limited by the inherent properties of antibody based therapeutics, notably high costs of production, invasive administration and possible immunological side effects. These peptides currently possess high concentrations for the effect, however with sequence studying and optimisation these can be greatly improved. This study proves that peptides can inhibit cytokine signalling and lays the foundation for future development of smaller, less invasive and easier to produce cytokine inhibitor therapeutics."

Allergy • Immunology • IL13 • IL4 • IL4R

TARC levels in patients with atopic dermatitis: a marker for clinical improvement following sublingual immunotherapy? (EAACI 2025) - "Background Thymus-and activation-regulated chemokine (TARC) has been identified as a biomarker for Atopic Dermatitis (AD) and has been shown to decrease after therapy with Dupilumab and Tralokinumab. Conclusion Our data confirmed that TARC levels were useful in indicating a decrease in disease activity in AD. However, we were not able to demonstrate that addition of HDM-SLIT to the therapeutic regimen in HDM allergic patients with AD would result in further decrease of TARC levels."

Clinical • IO biomarker • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Immunology

Inhibition of the Interleukin Cytokines using novel Peptide Inhibitors for Allergy and Asthma Treatment (EAACI 2025) - "Inhibition of these cytokines by antibodies, including Dupilumab, Tralokinumab and Benralizumab have yeilded highly effective therapeutics for allergies and asthma, however they are limited by the inherent properties of antibody based therapeutics, notably high costs of production, invasive administration and possible immunological side effects. These peptides currently possess high concentrations for the effect, however with sequence studying and optimisation these can be greatly improved. This study proves that peptides can inhibit cytokine signalling and lays the foundation for future development of smaller, less invasive and easier to produce cytokine inhibitor therapeutics."

Late-breaking abstract • Allergy • Immunology • IL13 • IL4 • IL4R

Letter: Effectiveness and Safety of Tralokinumab for the Elderly with Atopic Dermatitis in a Real-World Setting-IL AD. (PubMed, Dermatitis) - No abstract available

Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Real-World Effectiveness and Safety of Dupilumab, Tralokinumab, and Upadacitinib in Patients with Atopic Dermatitis: A 52-Week International, Multicenter Retrospective Cohort Study. (PubMed, Dermatol Ther (Heidelb)) - "This study provides a comprehensive real-world comparison of dupilumab, tralokinumab, and upadacitinib in AD, highlighting upadacitinib's superior effectiveness in achieving stringent treatment targets, both in the short and long term, but also a higher incidence of AEs. However, the considerable heterogeneity of the study population, an inherent limitation of real-world studies, must be acknowledged when interpreting these findings."

Journal • Real-world evidence • Retrospective data • Atopic Dermatitis • Cardiovascular • Conjunctivitis • Dermatitis • Dermatology • Hematological Disorders • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Real‑World Experience of 1 Year of Tralokinumab Treatment in Adult Patients with Atopic Dermatitis: A Single-Center Retrospective Study. (PubMed, Dermatol Ther (Heidelb)) - "This large case series provides RWE building on tralokinumab clinical trial data and highlights the potential rapid and long-term response in patients with AD irrespective of their Fitzpatrick skin type or treatment history, including patients previously treated with dupilumab."

Journal • Real-world evidence • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Suppression of Il5 and Il13 Gene Expression by Synthetic siRNA Molecules Reduces Nasal Hyperreactivity and Inflammation in a Murine Model of Allergic Rhinitis. (PubMed, Biochemistry (Mosc)) - "However, studies of drugs that target IL-13 alone (such as Tralokinumab and Lebrikizumab) were not successful. However, dual inactivation of IL-5 and IL-13 by siRNA does not provide any advantages over inactivating IL-13 alone in the current mouse model of AR. However, the lack of success of anti-IL-13 therapy in clinical practice indicates the promise of an approach based on the dual blocking of IL-5 and IL-13."

Journal • Preclinical • Allergic Rhinitis • Allergy • Immunology • Inflammation • IL13 • IL3 • IL4 • IL5

Real-World Clinical Experience of Tralokinumab in a Tertiary Centre: An Alternative for Patients with Conjunctivitis on Dupilumab? (PubMed, Dermatol Ther (Heidelb)) - "Our study supports using tralokinumab in atopic dermatitis with similar real-world efficacy to that shown in clinical trials. Tralokinumab offers an alternative for patients failing dupilumab because of conjunctivitis."

Journal • Real-world evidence • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • IL13

The Role of Patient-Reported Outcomes in US FDA Novel Drug Approvals and Reimbursement Decisions (2020-2024) (ISPOR 2025) - "Rinvoq (AbbVie) - PRO data showed improved quality of life in rheumatoid arthritis, contributing to $2.3 billion...Zeposia (Bristol-Myers Squibb) - PROs on fatigue reduction generated $500 million. Imcivree (Rhythm Pharmaceuticals) - PRO data supported FDA approval 2022: FDA : 37 drugs, with 30% (11 drugs) Reimbursement : 85 total approvals, with 35% (30 approvals) Adbry (LEO Pharma) - PROs on itch reduction generated $90 million . Camzyos (Bristol-Myers Squibb) - Symptom relief PROs were key 2023: FDA : 49 drugs, with 33% (16 drugs) Reimbursement 95 total approvals, with 45% (43 approvals. Leqembi (Eisai/Biogen) - FDA approval and Medicare conditional reimbursement for Alzheimer's disease leveraged PROs on cognitive function improvements, generating $200 million/ Jaypirca (Eli Lilly) - Patient-reported symptom relief supported FDA and payer decisions for mantle cell lymphoma... The inclusion of PROs in FDA novel drug approvals increased from 18% in 2020 to 40% in..."

Clinical • Patient reported outcomes • Reimbursement • US reimbursement • Alzheimer's Disease • CNS Disorders • Fatigue • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Mantle Cell Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology

Treatment-free disease control after tralokinumab in patients with moderate-to-severe atopic dermatitis (SID 2025) - P3 | "Of patients who transferred to open-label tralokinumab after experiencing a pre-determined decline from their Week 16 response (n=31), 69% regained IGA 0/1 or EASI-75 by 24 weeks of open-label treatment, with a median recapture time of 12.1 weeks. Approximately 40% of Week 16 responders maintained treatment-free disease control for six months with no rescue therapy, indicating that some patients may experience a remittive effect following specific neutralization of IL-13 with tralokinumab."

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13

STAT6 signature is not detectable in AD skin T-cells (SID 2025) - "In addition, the clinical data from IL-13 blocking antibodies lebrikizumab and tralokinumab, suggest a dominant role of IL-13 in AD. In conclusion, our analysis showed no evidence for STAT6 signaling in AD skin T-cells, implying no local stimulation by IL-4. This finding further highlights the dominant role of IL-13, and not IL-4, in AD."

Late-breaking abstract • Dermatology • Immunology • Psoriasis • IL13 • IL4 • IL4R • STAT6

Biologics for the treatment of alopecia areata: A comprehensive review of clinical trials (SID 2025) - "Studies examining Dupilumab, Secukinumab, Tralokinumab, Abatacept, Alefacept, Efalizumab, and Aldesleukin were identified. Biologics offer a favorable safety profile and hold potential as therapeutic options for AA, although response rates remain inconsistent. Further research is needed to optimize these therapies, identify more effective targets, and determine predictors of clinical response."

Clinical • Review • Alopecia • Immunology • CTLA4 • IL12A • IL13 • IL2 • IL23A

Number Needed to Treat and Associated Costs Per Additional Responder of Biologic Therapies in Adult Patients With Moderate To Severe Atopic Dermatitis (ISPOR 2025) - "Dupilumab demonstrated a lower NNT and approximately 1.5- and 2-times lower CPR/year, compared to tralokinumab and lebrikizumab, respectively. Dupilumab appears to have considerable economic benefits in the management of AD over other biologics."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Deciding which patients with atopic dermatitis to prioritize for biologics and Janus kinase inhibitors. (PubMed, J Allergy Clin Immunol Pract) - "Dupilumab, tralokinumab, lebrikizumab, and nemolizumab are injectable biologics that offer durable control by targeting the underlying skewing to type 2 inflammation...In contrast, JAK inhibitors-upadacitinib, abrocitinib, and baricitinib-are oral therapies, offering rapid relief of inflammation and pruritus by inhibiting the JAK-STAT (signal transducer and activator of transcription) pathway, which is downstream of type 2 immune receptors...This review highlights key considerations for selecting among these advanced therapies, including age, comorbidities, efficacy, and safety profiles. By integrating the latest evidence, this article provides a practical guide for clinicians to tailor treatment approaches and improve outcomes for individuals with AD."

Journal • Asthma • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Pruritus • Pulmonary Disease • Respiratory Diseases • Sleep Disorder

European Guideline (EuroGuiDerm) on atopic eczema: Living update. (PubMed, J Eur Acad Dermatol Venereol) - "The systemic treatment options discussed in the guideline comprise conventional immunosuppressive drugs (azathioprine, ciclosporin, glucocorticosteroids, methotrexate and mycophenolate mofetil), biologics (dupilumab, lebrikizumab, nemolizumab and tralokinumab) and Janus kinase (JAK) inhibitors (abrocitinib, baricitinib and upadacitinib). Additionally, the updated guidelines address considerations for paediatric, adolescent, pregnant and breastfeeding patients. For all other aspects, please refer to the 2022 version."

Journal • Atopic Dermatitis • Dermatology • Immunology • Pediatrics

“Update of sections 4.8 and 5.1 of the SmPC in order to update clinical efficacy and safety information based on the final clinical trial report of the open-label extension PASS study LP0162-1337 (ECZTEND)… . In addition, the MAH took the opportunity to update the PI according to the updated EU Excipient guideline…to update the list of local representatives in the Package Leaflet” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 5 - 8 May 2025: “For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP”

PRAC • Atopic Dermatitis • Immunology

Editor's Highlights-June 2025. (PubMed, Int J Dermatol) - "Also featured here is new real-world evidence supporting dupilumab efficacy following tralokinumab failure. Finally, data on bimekizumab's safety and effectiveness in patients with chronic kidney disease address a critical clinical gap. These contributions highlight a shift toward precision medicine, integrating immunologic insight with patient age, comorbidity profiles, and therapeutic sequencing to inform truly individualized care."

Journal • Atopic Dermatitis • Chronic Kidney Disease • Dermatitis • Dermatology • Immunology • Inflammation • Nephrology • Prurigo Nodularis • Psoriasis • Renal Disease • Urticaria

A Case of Cutaneous Fungal Infection Following the Administration of Dupilumab. (PubMed, Cureus) - "IL-13 plays critical roles in fungal colony formation, and tralokinumab, an IL-13 inhibitor, has shown potential efficacy in treating this head and neck dermatitis. While the relationship between microbiome changes and biologics like lebrikizumab and nemolizumab remains unexplored, investigating the differential effects of these therapies on the cutaneous microbiome could provide deeper insights into not only the unique characteristics of each biologic agent but also the roles of Th2 cytokines such as IL-4, IL-13, and IL-31 in the pathophysiology of AD. The present case underscores the importance of the comprehensive therapeutic approach for AD that accounts for microbiome dynamics and adapts to evolving skin changes throughout the course of treatment."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • IL13 • IL4

Drug survival of dupilumab, tralokinumab and upadacitinib in patients with atopic dermatitis. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

LEO Pharma marks 1 year of Adtralza in Korea with long-term data showing gains in hard-to-treat atopic dermatitis (Korea Biomedical Review) - P3 | N=1,672 | ECZTEND (NCT03587805) | Sponsor: LEO Pharma | "By week 248 in the ECZTEND trial, 93 percent of patients reached EASI-75, a benchmark for clinical response, while 67 percent achieved 'clear' or 'almost clear' skin on the Investigator’s Global Assessment (IGA) scale, Lee said. He added that more than 70 percent maintained low disease activity (EASI ≤7) for over 80 percent of the treatment period, and fewer than 1 percent experienced paradoxical facial erythema -- an inflammatory flare-up in the face that runs counter to the drug’s anti-inflammatory purpose....In TRACE, 67 percent of patients had head and neck involvement at baseline, falling to 52 percent by month nine. Over the same period, the share of patients reporting improved quality of life rose from 58 percent to 74 percent."

P3 data • Atopic Dermatitis

Real-World pharmacovigilance analysis of drug-related conjunctivitis using the FDA adverse event reporting system database. (PubMed, Sci Rep) - "Among 38 drugs most frequently reported for conjunctivitis, two ophthalmic agents-brimonidine (ROR = 23.04) and latanoprost (ROR = 10.55)-and eight non-ophthalmic drugs, including tralokinumab (ROR = 83.3), dupilumab (ROR = 18.92), and allopurinol (ROR = 5.04), were associated with positive signals. Notably, ophthalmic agents had a significantly shorter induction period than non-ophthalmic drugs (mean 125.9 vs. 298.4 days). These findings underscore the need for vigilant pharmacovigilance and further investigation into the etiology and prevention of drug-related conjunctivitis."

Adverse events • Journal • Real-world evidence • Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Incidence of upper respiratory tract infections with biological therapies in moderate to severe atopic dermatitis: a systematic review and meta-analysis. (PubMed, Front Med (Lausanne)) - "Treatment for moderate-to-severe AD includes biologics like dupilumab, tralokinumab, lebrikizumab, and JAK inhibitors (abrocitinib, upadacitinib). Prospero registration code: [392093]. PROSPERO, Centre for Reviews and Dissemination: CRD42023392093."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Respiratory Diseases

Long-Term Efficacy and Potential Predictors of Tralokinumab Dose Optimization in Elderly Patients: A Multicentre Study. (PubMed, Dermatol Ther (Heidelb)) - "Tralokinumab demonstrated sustained efficacy and safety in elderly patients with moderate-to-severe AD, even with multiple comorbidities. Dose optimization to Q4 W was feasible in a subset of patients. Early systemic treatment initiation was linked to better outcomes, emphasizing the need for proactive disease management."

Clinical • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Oncology • Pruritus

Chronic Pruritus: A Review of Its Pathophysiology and Current Treatments (PubMed, Rev Med Chil) - "A stepped pharmacological approach, tailored to the individual symptomatology of each patient, facilitates the treatment of chronic pruritus. Although progress has been made in understanding the pathophysiology and pharmacology associated with pruritus management, this symptom still requires further national epidemiological studies to determine its prevalence and to objectively assess its impact on the quality of life of affected individuals."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • TSLP

Effectiveness of Switching From Upadacitinib to Tralokinumab in Patients With Moderate-to-Severe Atopic Dermatitis: A Real-World Clinical Practice. (PubMed, Ann Dermatol) - "Transitioning to tralokinumab substantially alleviated rash in patients with AD who experienced suboptimal responses or AEs to 15 mg of upadacitinib."

Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13