Patients with Atopic Dermatitis See Treatment-Free Disease Control with Tralokinumab Use

Approximately 40% of those with moderate-to-severe atopic dermatitis who respond to tralokinumab therapy may maintain their disease control for up to 6 months following cessation, recent findings suggest, indicating a potential remittive effect of interleukin (IL)-13 inhibition.1

These data were authored by such investigators as Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center. Blauvelt and colleagues’ findings were presented in a poster at the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference in Las Vegas, Nevada.

Blauvelt and coauthors highlighted the long-lasting nature of atopic dermatitis, an inflammatory skin condition marked by immune dysregulation. The disease is driven by interleukin-13 (IL-13), often necessitating ongoing medication. Tralokinumab, a high-affinity monoclonal antibody designed to target and neutralize IL-13. The drug was approved therapy for individuals aged 12 years and older with moderate-to-severe atopic dermatitis.

In clinical settings, patients implementing the medication may discontinue the drug temporarily for different reasons, and this prompts the need for clinicians to understand the potential outcomes resulting from such interruptions. To address these questions, Blauvelt et al carried out a post hoc analysis via pooled data from the phase 3 ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885) trials.

In this analysis, they focused on trial subjects who responded to tralokinumab at the 16-week mark. Response was defined by attainment of an Investigator’s Global Assessment (IGA) score of 0 or 1 and/or a 75% improvement in subjects' Eczema Area and Severity Index scores (EASI-75). These responders were re-randomized by the investigators to continue tralokinumab every 2 weeks (Q2W), escalate to once-weekly dosing (QW), or shift to the placebo arm for a 36-week maintenance phase.

Among the key outcome assessed, the investigative team looked at treatment-free disease control, which they defined as no utilization of rescue medications such as topical corticosteroids. It was also defined as a lack of transition to the open-label arm and a lack of permanent cessation due to lack of efficacy.

Individuals in the study who lost their initial response were changed to an open-label regimen (tralokinumab Q2W with optional TCS). A Kaplan-Meier analysis was implemented by Blauvelt et al to evaluate both the duration of treatment-free control and the time required to regain response to therapy after restarting the medication.

The investigators sought to evaluate the length of time long disease control could be maintained without active treatment in tralokinumab responders who were shifted to the placebo arm. Among those randomized to placebo (n = 73), Blauvelt and colleagues concluded that the median time of sustained treatment-free disease control was 22.3 weeks. For further assessment, a 26-week timepoint (Week 42 from baseline) was utilized as a standardized marker of 6-month control.

Overall, Blauvelt et al found that 40% of those evaluated maintained disease control for 6 months without requiring rescue therapy. Such participants tended to have milder disease at the point of baseline—indicated by lower EASI scores, lower IgE levels, smaller body surface area (BSA) involvement. They were also less likely to have comorbid asthma. These individuals additionally demonstrated a stronger 16-week treatment response compared to subjects who did not maintain control.

Among those who reported a relapse during the treatment interruption, the majority were able to re-establish disease control within 3 months of resuming the use of tralokinumab. These data provide clinical insights into the potential for a remittive effect following IL-13 inhibition via treatment with tralokinumab.

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References

1. Blauvelt A, Bhutani T, Chovatiya R, et al. Treatment-Free Disease Control After Tralokinumab in Patients with Moderate-to-Severe Atopic Dermatitis. Poster presented at the DERM 2025 NP/PA CME Conference; July 23 - 26, 2025; Las Vegas, Nevada.