The development and publication of this content was fully funded by LEO Pharma A/S and is for healthcare professionals (HCPs) from UK and other countries. This material is not intended for healthcare professionals in Ireland. For HCPs outside of the UK, please consult your local Summary of Product Characteristics before prescribing.
Adtralza®▼ (tralokinumab) is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.1,2 Prescribing information can be found here. Adverse Event reporting information can be found at the bottom of this page.
Pivotal Trials (ECZTRA 1, 2, 3)
The efficacy and safety of tralokinumab, as monotherapy and with concomitant topical corticosteroids (TCS), were evaluated in three randomised, double-blind, placebo-controlled trials: ECZTRA 1 (n=802), ECZTRA 2 (n=794) and ECZTRA 3 (n=380) in adults (≥18 years) with moderate-to-severe atopic dermatitis (IGA 3–4), baseline EASI ≥16 and ≥10% BSA involvement.1,2
All three trials met their primary endpoints: IGA 0–1 (“clear” or “almost clear”) and ≥75% reduction in EASI (EASI-75) from baseline to Week 16.1,2
Open-label Extension Study (ECZTEND)
ECZTEND was an open-label, single-arm, multicentre, long-term extension study. As observed data from a subgroup of patients (n=523) continually treated with tralokinumab monotherapy for 52 weeks in ECZTRA 1 and 2, followed by 152 weeks of treatment in ECZTEND (data cut-off: 30 April 2022).1 Patients received a 600 mg loading dose of tralokinumab when entering ECZTEND.1,2
The primary endpoint was the number of adverse events from baseline through to the last treatment visit (up to Week 268). No additional safety signals were detected.1,2
According to the primary trials and the summary of product characteristics, the most common adverse reactions are upper respiratory tract infections (23.4%; mainly reported as common cold), injection site reactions (7.2%), conjunctivitis (5.4%) conjunctivitis allergic (2.0%) and eosinophilia (01.3%).1 In summary the overall safety profile was consistent in ECZTEND.1,2
References:
- Electronic Medicines Compendium (eMC). Adtralza 150mg – Summary of Product Characteristics. 2025. Available at: https://www.medicines.org.uk/emc/product/12725/smpc/print. Last accessed: 1 December 2025.
- Electronic Medicines Compendium (eMC). Adtralza 300mg – Summary of Product Characteristics. 2025. Available at: https://www.medicines.org.uk/emc/product/15142/smpc/print. Last accessed: 1 December 2025.
Speakers:
Melinda Gooderham1-3
April Armstrong4
1. SkiN Centre for Dermatology, Peterborough, Canada
2. Probity Medical Research, Peterborough, Canada
3. Queen’s University, Peterborough, Canada
4. Division of Dermatology, University of California, Los Angeles, USA
MAT-77698 December 2025
| Adverse events should be reported
For the United Kingdom, reporting forms and information can be found at: yellowcard.mhra.gov.uk. Adverse events should also be reported to Drug Safety at LEO Pharma by calling +44 (0)1844 347333 or e-mail [email protected] or search for MHRA Yellow Card in the Google Play or Apple App Store. |
