AD patients with stable response fare well with a monthly dose of tralokinumab

A post-hoc analysis of the ECZTRA1 and 2 trials demonstrated that a longer dosing interval of tralokinumab can be chosen without loss of efficacy in patients that fulfil the criteria of a maintained stable response. Patients who achieved clear or almost clear skin with only mild or no itch symptoms over 4 consecutive weeks did equally well with a 4-weekly compared with a 2-weekly dose interval.

The recommended initial dose of the IL-13 inhibitor tralokinumab for adult patients with moderate-to-severe atopic dermatitis (AD) is 600 mg followed by 300 mg administered every other week. It may be administered every 4 weeks, although the efficacy might be lower according to the product information. “We were therefore interested to see if we could identify potential early predictors of maintained response at week 52 with tralokinumab every 4 weeks versus every 2 weeks,” explained Prof. Stephan Weidinger (University of Kiel, Germany). The large dataset of the ECZTRA1 (NCT03131648) and ECZTRA2 (NCT03160885) was used to run a post-hoc analysis to identify predictors of maintained response, defined as patients achieving clear or almost clear skin in the Investigator´s Global Assessment (IGA 0/1).

A machine-learning algorithm identified potential predictors for a maintained response, including baseline demographic and clinical characteristics, medical/medication history, efficacy after 16 weeks or earlier, and randomised treatment. Of 115 possible predictors, the top variables to predict IGA 0/1 at week 52 were IGA 0/1 at week 16 and worst daily pruritus numerical rating scale (NRS) <3 at week 16.

For participants that fulfilled the top predictors, the 2-weekly dose still performed numerically better. A similar result was seen when the 2 variables were combined. “Since we know that AD is a fluctuating disease, we then repeated this analysis for patients that had achieved both of these criteria but over a longer period, not just week 16,” Prof. Weidinger said.

To explore the stable disease component, they looked at patients that reported IGA 0/1 and itch NRS <3 over 4 consecutive weeks (weeks 12–16). “With this more stringent criterium of early, good, and stable response, the 4-weekly dosing option performed equally well as the 2-weekly dosing option with three-quarters of patients maintaining response until week 52 without any topical corticosteroids,” Prof. Weidinger concluded. Thus, stable achievement at consecutive timepoints of IGA 0/1 and mild or no itch symptoms over 4 weeks are positive predictors of maintained long-term response with a 4-week tralokinumab dosing interval.

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   1. Weidinger S. Predictors of maintained response with tralokinumab every four weeks dosing in adults with moderate-to-severe atopic dermatitis. D3T01.2C, EADV Congress 2021, 29 Sept–2 Oct.

 

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Posted on 18 November 202118 November 2021