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

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

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

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

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

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

Infection risk in atopic dermatitis patients treated with biologics and JAK inhibitors: BioDay results. (PubMed, J Eur Acad Dermatol Venereol) - "This cohort study demonstrated an increased risk of infection during JAKi treatment compared to dupilumab for moderate-to-severe AD. These findings enhance understanding of the differential infection risk with targeted therapies in AD, aiding tailored treatment choices that consider patient-specific risks such as prior skin infections."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease

A Case of Unexpected Successful Treatment of Alopecia Areata With Tralokinumab in a Patient With Atopic Dermatitis. (PubMed, Int J Dermatol) - No abstract available

Journal • Allergic Rhinitis • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Effectiveness of Tralokinumab Across Atopic Dermatitis Phenotypes. (PubMed, J Clin Med) - "The classical and generalized lichenoid were the fastest phenotypes to improve. However, given the uneven distribution of phenotypes and the gradual reduction in patient numbers over time, larger prospective studies are essential to confirm the observed trends."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13

Investigating Efficacy of Atopic Dermatitis Systemic Therapeutics After Discontinuation Part I: Biologics. (PubMed, J Clin Aesthet Dermatol) - "Five clinical trial programs met our inclusion criteria, each investigating a different biologic: dupilumab, tralokinumab, lebrikizumab, amlitelimab, and rocatinlimab. The variability in eligibility criteria, treatment durations, and withdrawal periods across trials presents a major challenge in assessing biologics for AD, complicating the comparison of their sustained responses in the absence of head-to-head studies. This heterogeneity, combined with factors such as disease duration and prior use of systemic medications before trial enrollment, hampers the identification of key pathways in AD pathogenesis and impedes efforts to better understand and characterize the disease."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Real-world experience of switching from tralokinumab to lebrikizumab in atopic dermatitis. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

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

Long-Term Disease Control and Minimal Disease Activity of Head and Neck Atopic Dermatitis in Patients Treated with Tralokinumab up to 4 Years. (PubMed, Am J Clin Dermatol) - P3 | "Tralokinumab provided progressive and sustained improvements in H&N AD, with H&N EASI 0/1 observed in nearly 90% of patients treated up to 4 years. Improvements in H&N EASI were similar to improvements observed for other body regions and were associated with improvements in patient quality of life, particularly for skin discomfort and self-consciousness/embarrassment due to skin."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13

Effectiveness and Safety of Tralokinumab in Atopic Dermatitis: 1-year Results From a Real-world Multicentre Study. (PubMed, Acta Derm Venereol) - "Tralokinumab can be an effective and safe treatment for patients with moderate-to-severe AD. Involvement of certain body areas, such as hands and feet, might positively predict a clinical response to tralokinumab."

Journal • Observational data • Real-world evidence • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Dry Eye Disease • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • IL13

Long-term Outcomes of New Systemic Agents in Atopic Dermatitis: Drug Survival Analyses and Treatment Patterns in Daily Practice. (PubMed, Acta Derm Venereol) - "Data from a prospective observational single-centre registry were collected from 549 adult AD patients (759 treatment courses) receiving biologics (dupilumab, tralokinumab) or JAKi (abrocitinib, baricitinib, upadacitinib) and analysed using Kaplan-Meier survival curves. In conclusion, dupilumab showed superior survival rates while baricitinib had the lowest survival rate. Frequent switching highlights the need for biomarkers that predict response to advanced systemic treatments to improve attrition rates."

Journal • Observational data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Biologic and small molecule therapy switch in atopic dermatitis patients with dupilumab-associated ocular surface disease: a systematic review (AAD 2025) - "CR of DAOSD was reported in 51.4% (n=55) of cases following treatment with tralokinumab (n=10), abrocitinib (n=3), baricitinib (n=15) and upadacitinib (n=25). This review describes DAOSD incidence and its resolution after AD treatment switch."

Clinical • Review • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Dry Eye Disease • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Real-world experience of tralokinumab for atopic dermatitis in adults and adolescents: A 16-week multicenter retrospective study (AAD 2025) - "Our real-world results for tralokinumab are comparable to clinical trials and confirm its utility for AD. Study limitations include its retrospective nature and short follow-up."

Real-world • Real-world evidence • Retrospective data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pain • Urticaria • IL13

Increased risk of herpes infections in patients with atopic dermatitis who started a JAK-inhibitor vs. Th2 cytokine-inhibitor: a propensity-score matched claims data study (AAD 2025) - "New users of upadacitinib or abrocitinib (JAK-inhibitors) constituted the exposure group. Initiators of dupilumab or tralokinumab (Th2 cytokine-inhibitors) were the comparator group...Patients treated with Th2 cytokine-inhibitors had an 80% increased risk of conjunctivitis (1.81; 1.31-2.56). Conclusion Patients with AD who started treatment with a JAK-inhibitor had a 2.7-fold increase in the 6-month risk of zoster and a 1.8-fold increase for herpes simplex infections compared to patients treated with Th2 cytokine-inhibitors."

Clinical • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Herpes Simplex • Herpes Zoster • Immunology • Infectious Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Varicella Zoster

Rural-urban disparities in the use of targeted and non-targeted systemic medications for inflammatory dermatologic conditions: A DataDerm study (AAD 2025) - " Urban patients were more likely to receive any targeted systemic therapy (OR: 1.44, p0.05). Prescribing patterns of targeted and non-targeted systemic therapies for chronic inflammatory skin diseases highlight disparities between rural and urban communities, particularly among FDA-approved biologics and JAK inhibitors. Whether such disparities are due to barriers in accessing dermatologic care or other factors warrants further research (4)."

Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Psoriasis

Serious infections in patients with atopic dermatitis who started a JAK-inhibitor vs. cytokine-inhibitor: a nationwide propensity-score matched cohort study (AAD 2025) - "The exposure group was new users of a JAK-inhibitor (upadacitinib or abrocitinib); the comparator group was new users of a Th2 cytokine-inhibitor (dupilumab or tralokinumab). Patients treated with Th2 cytokine-inhibitors had a 40% increased risk of conjunctivitis (1.42; 1.02-1.96). Conclusion Patients who started treatment with a JAK inhibitor to treat AD had a 2.4-fold increase in the 6-month risk of serious infection compared to patients who started Th2 cytokine inhibitors."

Clinical • Atopic Dermatitis • Candidiasis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Ocular Infections • Ocular Inflammation • Ophthalmology