Data Show Continuous Response to LEO's Tralokinumab in Adults with AD

After two years of continuous treatment with tralokinumab, adult patients with moderate-to-severe atopic dermatitis maintained improvements in signs and symptoms, itch severity, and sleep interference, according to interim findings from the Phase 3 ECZTEND trial presented as an oral presentation during the European Academy of Dermatology and Venereology (EADV) Congress 2021.

The interim analysis in the ECZTEND trial (NCT03587805) investigated continued treatment with tralokinumab 300 mg every other week plus optional topical corticosteroids (TCS) as well as the ability to regain response after pausing and reinitiating tralokinumab. Tralokinumab, which is in development in the US by LEO Pharma and not FDA approved, is a high-affinity, human monoclonal antibody that specifically binds to and inhibits IL-13

Long-term efficacy outcomes were assessed in patients (n=345) who had received two years of treatment with tralokinumab, including the full 52-weeks in the pivotal Phase 3 parent trials (ECZTRA 1 and 2) and 56 weeks in the ECZTEND trial. Patients were split into three cohorts based on the length of time between their last dose of tralokinumab in the parent trial and their first dose in ECZTEND. Continuous treatment was defined as ≤5 weeks between the last dose in the parent trial and the first dose in ECZTEND (n=126), interrupted treatment was defined as 6-15 weeks (n=133), and >15 weeks (n=86) was considered a washout of treatment.

Patients who received continuous treatment with tralokinumab over two years experienced long-term control in atopic dermatitis signs and symptoms, as demonstrated by a median Eczema Area and Severity Index score (EASI) improvement from parent trial baseline of 92.7%.

Maintenance of improvements in patient-reported outcomes, including pruritus (itch) severity and sleep interference, were demonstrated at two years as well. Itch severity and sleep interference were reported using a Numeric Rating Scale (NRS) of 0-10. Patients who received continuous treatment reported improvements in itch severity, with worst weekly NRS shifting from 8.1 (severe) at parent trial baseline to 3.0 (mild) following two years of treatment. Improvements in median NRS score for sleep interference were also reported after two years of treatment, from 7.3 (severe sleep interference) at parent trial baseline to 1.0 (mild sleep interference) in ECZTEND. During the parent trials, patients recorded their daily itch and sleep interference, and weekly averages of scores were used.5 During ECZTEND, worst itch severity and sleep interference of the previous week were reported.

A decline in median improvement in EASI was observed in the washout cohort within the period without treatment. After one year of treatment in the parent trial, results showed a median EASI percent improvement of 86.9% compared to baseline. Following the washout of treatment (>15 weeks), median EASI percent improvement (vs. parent trial baseline) declined to 68.6%. Within 12 weeks from treatment re-initiation with tralokinumab in ECZTEND, patients regained a median EASI percent improvement equivalent to response at one year in the parent trials.1

The adverse event profile of tralokinumab in this interim analysis was consistent with the parent trials.