Efficacious 2-year AD control with IL-13 inhibitor tralokinumab

Tralokinumab resulted in Eczema Area and Severity Index (EASI) improvements greater than 90% over 2 years of treatment in patients with moderate-to-severe atopic dermatitis (AD) in the open-label ECZTEND trial. It also led to a substantial amelioration of itch and sleep impairment.

The open-label extension ECZTEND trial (NCT03587805) investigated the 2-year efficacy and safety of the anti-IL-13 antibody tralokinumab. Prof. Andrew Blauvelt (Oregon Medical Research Center, OR, USA) presented an interim analysis that included all 345 participants with moderate-to-severe AD who completed 52 weeks on the parent tralokinumab monotherapy trials ECZTRA 1 and 2 (NCT03131648 and NCT03160885) and ≥60 weeks in ECZTEND until the end of April 2020 [1].

The 3 different cohorts in the study consisted of (1) those on continuous treatment who were off tralokinumab for ≤5 weeks between the parent trials (continuous), (2) those with a 6–15 weeks pause of tralokinumab (intermittent), and (3) those with >15 weeks off the drug (washout). The baseline characteristics included a median age of 42 years and 51.2% of women. As the participants had previously been on treatment in ECZTRA 1 and 2, the median baseline EASI scores were relatively low with 2.8 (continuous), 5.8 (intermittent), and 7.6 (washout).

Over 2 years of therapy with tralokinumab, most study participants achieved median EASI improvements in over 90%: 92.7% in the continuous group, 91.7% in the intermittent group, and 92.7% in the washout group(see Figure). Regarding worst weekly pruritus on a numeric rating scale (NRS), continuous treatment led to a median score around 3 (i.e. mild) at the study end. Likewise, median worst eczema-related sleep disturbance was also reduced to a mild degree.

Figure: Median EASI with tralokinumab in parent trials and ECZTEND over 2 years of tralokinumab treatment [1]

In the 2-year overall cohort, serious adverse events occurred in 4.9% of the participants, with 2% discontinuing due to adverse events. Viral upper respiratory tract infections were most common.

“Over 2 years, tralokinumab provided long-term control of the extent and severity of AD as well as improved itch and reduced sleep interference,” concluded Prof. Blauvelt.

1. 
   
   1. Blauvelt A. Two-year maintenance of response with tralokinumab in moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. FC01.04, EADV Congress 2021, 29 Sept–2 Oct.

 

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Posted on 18 November, 202118 November, 2021