- 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.
The IL-13 inhibitor tralokinumab was recently approved in the European Union for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients that are candidates for systemic therapy. The recommended initial dose 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).
The researchers first used a machine-learning algorithm to identify predictors for maintained response at week 52. Potential predictors included baseline demographic and clinical characteristics, medical/medication history, efficacy after 16 weeks or earlier, and randomised treatment. “In a second step, we looked at how well the top-ranked variables alone or in combination were able to predict maintenance of response,” Prof. Weidinger explained.
Of 115 possible predictors that were identified 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. They first looked at participants that fulfilled the top variable, but the 2-weekly dose in this group 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 of time, 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 performs 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 IGA0/1 and mild or no itch symptoms over 4 weeks is a positive predictor of maintained long-term response with a 4-week tralokinumab dosing interval.