Effects IL-13 blocker improves with longer treatment duration

Patients with atopic dermatitis (AD) who initially only showed partial response to tralokinumab showed progressive improvements when treated beyond week 16. This was the results of a pooled analysis of two phase 3 trials.

In the pivotal phase 3 ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885) trials in adults with moderate-to-severe AD, tralokinumab monotherapy provided significant and early improvements in clinically relevant endpoints. In both trials, significantly more patients receiving tralokinumab monotherapy than placebo achieved the primary endpoints of Investigator’s Global Assessment (IGA) 0/1, equivalent to clear or almost clear skin, and 75% improvement in Eczema Area and Severity Index (EASI 75). However, these are stringent endpoints; hence, achievement of mild disease severity (IGA 2) and a 50% improvement in EASI could already be considered clinically relevant for most patients. The current post-hoc analysis evaluated the treatment results of patients who did not achieve the primary endpoint at week 16 and continued to receive open-label tralokinumab plus optional topical corticosteroids (TCS) for an additional 36 weeks [1].

After 52 weeks, 20.1% of patients treated with tralokinumab plus optional TCS achieved an IGA 0/1 response, and 42.9% achieved an EASI 75 response (see Figure). More than half of the responder proportions at week 52 were achieved within 8 weeks of starting open-label treatment.

Figure: Participants achieving (A) IGA 0/1 and (B) EASI 75 at week 52 in the open-label phase [1]


Late response not due to TCS therapy

To determine whether the improved response over time was due to TCS or tralokinumab, another analysis was performed in which participants who used concomitant anti-inflammatory treatment (49.3%) were considered non-responders. In this alternative analysis, the response rates were 13.9% and 25.7% for IGA 0/1 and EASI 75, respectively, at week 52 without TCS.

The authors concluded that adult patients who did not achieve IGA 0/1 or EASI 75 at week 16 progressively improved with continued tralokinumab treatment beyond week 16. The clinical response with continued treatment beyond week 16 was mainly driven by continued tralokinumab treatment and not by the addition of optional TCS.

 

1. 
   
   1. Simpson E, et al. Tralokinumab provides progressive improvements beyond week 16 in patients with atopic dermatitis with an initial partial response. Poster P0214, EADV 2020 Virtual Congress, 29-31 Oct.

 



Posted on 17 December 202018 December 2020