ECZTEND: Tralokinumab Use Leads to Stable Long-Term Effects in Atopic Dermatitis

Individuals with moderate-to-severe atopic dermatitis who attain treatment goals after 16 weeks of tralokinumab are likely to maintain stable clinical benefit for up to 3 years of continued use, according to new data, even if individual response patterns fluctuate.¹

These new late-breaking findings on tralokinumab were announced by LEO Pharma and presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. They were presented at EADV by investigator Andrew Blauvelt, MD, MBA, the president of the Oregon Medical Research Center,

Atopic dermatitis flare-ups are a hallmark of the condition, and durable disease control is viewed as a treatment priority among both patients and clinicians. Tralokinumab was designed as a high-affinity monoclonal antibody that can selectively inhibit interleukin (IL)-13, a central mediator of atopic dermatitis inflammation. In this analysis, Blauvelt and colleagues assessed the durability of response with long-term tralokinumab use, given with optional topical corticosteroids (TCS), and identified sustained benefit predictors.

In this post-hoc study, investigators evaluated patients included in the phase 3 ECZTRA 3 trial (NCT03363854) who were shown to have responded at the 16-week mark to tralokinumab 300 mg every 2 weeks (Q2W) with optional TCS. These subjects subsequently carried on with their treatment in the open-label extension ECZTEND (NCT03587805). At 16 weeks, responders were defined as those who attained at least a single one of the following: a Dermatology Life Quality Index score of 0 or 1 (DLQI 0/1), ≥75% or 90% reduction from baseline in their Eczema Area and Severity Index (EASI-75 or EASI-90) scores, or a combined EASI-90 plus DLQI 0/1 response.

Blauvelt et al described those who reached EASI-90 as “super responders.” They evaluated patients’ outcomes through Week 120 of the ECZTEND study, representing up to 3 years of treatment with the drug. Absolute EASI scores were assessed at the 16-week mark as predictors of long-term outcomes among EASI-75 and EASI-90 responder subgroups.

By the 16-week mark in ECZTRA 3, Blauvelt and coauthors found that response rates among subjects were as follows: 56% attained EASI-75, 33% attained EASI-90, 25% attained DLQI 0/1, and 15% attained both EASI-90 and DLQI 0/1. Among these individuals, 86%, 92%, 81%, and 90%, respectively, entered the ECZTEND study. At least 60% of subjects in each category of response, by the 120-week mark, remained on the medication.

The investigative team noted that discontinuations due to lack of efficacy or adverse events did not go over 13%. Among both the EASI-75 responders and those labeled as super responders, a stable trajectory of ≥90% improvement in mean EASI scores from baseline throughout ECZTEND was observed.

Among these participants, the team concluded that lower absolute EASI values at the 16-week mark were strongly predictive of long-term improvement (P < .0001). Among individuals who attained scores of EASI-90 with DLQI 0/1 at 16 weeks, Blauvelt and colleagues concluded that more than 48% were able to sustain this composite response at each of the subsequent assessments up to the 120-week mark.

For any additional information on late-breaking data presented at EADV, view the latest coverage of the conference.

References

1. Blauvelt A, Ardern-Jones M, Guttman-Yassky E, et al. 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. September 19, 2025. Accessed September 20, 2025. Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.