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

PRAC reviewed the final results of the ECZTEND phase 3 extension study of tralokinumab in moderate-to-severe atopic dermatitis, leading to updated efficacy and safety information in the SmPC. RMP v2.1 was submitted, and the PI was updated with a polysorbate warning, excipient guideline alignment, editorial changes, and revised local representative details. [AI-generated summary] (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 1 - 4 Sep 2025

PRAC • Atopic Dermatitis • Immunology

Development of a questionnaire for the detection of flares in atopic dermatitis treated with biologics and small molecules: a pilot study. (PubMed, Ital J Dermatol Venerol) - "The pilot and observational nature does not allow validation of the questionnaire-used, which therefore needs wider integration in clinical use and studies confirming its usefulness. Implementing a questionnaire such as ours that evaluates flares in clinical practice could optimize the therapeutic management of the atopic patient being treated with systemic medication whether biologic or small molecules."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics. (PubMed, Curr Issues Mol Biol) - "Although biologic agents such as dupilumab, tralokinumab, and lebrikizumab have revolutionized AD management, their high costs, injectable administration, and limited global accessibility highlight the need for alternative options...This review provides a comprehensive analysis of key agents including Janus kinase (JAK) inhibitors (upadacitinib, abrocitinib, baricitinib, ruxolitinib, delgocitinib), phosphodiesterase 4 (PDE4) inhibitors (crisaborole, difamilast, roflumilast, apremilast), as well as STAT6 degraders (KT621, NX3911), aryl hydrocarbon receptor modulators, histamine H4 receptor antagonists (adriforant, izuforant), and sphingosine-1-phosphate receptor modulators (etrasimod, BMS-986166). We summarize their mechanisms of action, pharmacological profiles, and pivotal clinical trial data, emphasizing their potential to address unmet therapeutic needs. Finally, we discuss safety concerns, long-term tolerability, and future directions for integrating small molecule..."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • STAT6

Rapid response and sustained remission of Hailey-Hailey disease under IL-13 inhibition with tralokinumab (EADV 2025) - No abstract available

Clinical • Genetic Disorders • IL13

Effect of tralokinumab on QoL in atopic patients with head and neck involvement (EADV 2025) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

Effectiveness of 12-months tralokinumab treatment in 654 adults with atopic dermatitis with head & neck area involvement: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study (EADV 2025) - No abstract available

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

Patient-reported outcomes evaluations of 12-months tralokinumab treatment in 824 adults with atopic dermatitis: Real-world data from the prospective, non-interventional, international, single-cohort TRACE study (EADV 2025) - No abstract available

Clinical • Patient reported outcomes • Real-world • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Effectiveness of tralokinumab and lebrikizumab in Japanese atopic dermatitis patients with persistent head and neck dermatitis after long-term treatment with dupilumab: A single-centerretrospective study (EADV 2025) - No abstract available

Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Tralokinumab therapy in head and neck atopic dermatitis: a case series of 18 patients (EADV 2025) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Real-world use of tralokinumab: monotherapy versus overlapping treatment with conventional immunosuppressants in atopic dermatitis (EADV 2025) - No abstract available

Clinical • Monotherapy • Real-world • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Multicenter Study of 209 Patients with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab in a Real-World Practice. Efficacy and Safety Data at 52 Weeks (EADV 2025) - No abstract available

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

Incidence, Risk Factors, and Management of Conjunctivitis in Atopic Dermatitis Patients Treated with Dupilumab or Tralokinumab: Results from a Multicentre, Observational, Retrospective Study (EADV 2025) - No abstract available

Retrospective data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Recalcitrant Atopic Dermatitis: Switch from Tralokinumab to Lebrikizumab (EADV 2025) - No abstract available

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Drug Survival of Tralokinumab in Severe Atopic Dermatitis: A Two-Year Multicenter Study (EADV 2025) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-term efficacy with tralokinumab in patients with moderate-to-severe atopic dermatitis: final results from the 5-year ECZTEND study (EADV 2025) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Tralokinumab for Cronic Hand Eczema: 52-week experience and flexible dosing outcomes (EADV 2025) - No abstract available

Atopic Dermatitis • Contact Dermatitis • Dermatology • Immunology

Effectiveness of Tralokinumab Across Atopic Dermatitis Phenotypes (EADV 2025) - No abstract available

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Effectiveness and safety of 12-months tralokinumab treatment in 824 adults with atopic dermatitis: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study (EADV 2025) - No abstract available

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

Rosacea-like folliculitis associated with tralokinumab therapy: a diagnostic challenge (EADV 2025) - No abstract available

Dermatology • Rosacea

Effectiveness and safety of dupilumab versus tralokinumab in atopic dermatitis: A propensity score– matched analysis from the BioDay registry (EADV 2025) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Initial "Super Response" to Tralokinumab Leads to Stable Long-term Response in Patients with Moderate-to-Severe Atopic Dermatitis: Responder and Predictor Analysis from the ECZTRA 3 & ECZTEND Trials (EADV 2025) - No abstract available

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

Drug Survival and Predictors of Systemic Treatment Outcome in Atopic Dermatitis: Data From a Nationwide Swedish Cohort. (PubMed, Acta Derm Venereol) - "This study aimed to describe the drug survival, with associated predictors, of treatment with abrocitinib, baricitinib, cyclosporine, dupilumab, methotrexate, tralokinumab, and upadacitinib among patients with atopic dermatitis in Sweden who were recruited into the multicentre prospective SwedAD cohort between January 2017 and April 2024. In conclusion, dupilumab therapy demonstrated longer drug survival than methotrexate in atopic dermatitis. The impact of national treatment guidelines and time since drug approval should be considered when interpreting the results."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Molecular Signatures in Inflammatory Skin Disease (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Prof. Dr. Stephan Weidinger | Trial completion date: Dec 2028 ➔ Dec 2029 | Trial primary completion date: Dec 2027 ➔ Dec 2028

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Oncology • Psoriasis

Conjunctivitis secondary to novel systemic dermatologic agents: a growing concern. (PubMed, Curr Opin Ophthalmol) - "With the expanding use of novel systemic dermatologic therapies, ocular surface complications have become an important concern. Multidisciplinary collaboration and increased awareness are vital to prevent vision-threatening outcomes. Ongoing research is needed to elucidate pathophysiology and optimize therapeutic approaches that balance effective skin disease control with ocular health."

Journal • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Psoriasis

Incidence, Risk Factors, and Management of Conjunctivitis in Atopic Dermatitis Patients Treated With Dupilumab or Tralokinumab: Results From a Multicenter, Observational, Retrospective Study. (PubMed, Int J Dermatol) - "Conjunctivitis represents a relatively frequent AE in patients with AD receiving dupilumab or tralokinumab. However, earlier onset of conjunctivitis with tralokinumab and higher discontinuation rates with dupilumab suggest differing tolerability profiles. Early recognition of ocular symptoms is essential, and dermatologists should promptly initiate supportive eye care and refer to ophthalmologists when appropriate to avoid unnecessary treatment interruptions."

Journal • Retrospective data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology