‘Clinically meaningful’ results seen with tralokinumab
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For some atopic dermatitis patients treated with tralokinumab who do not reach clear or almost clear skin, clinically meaningful results can still occur.
“The FDA approves drugs in atopic dermatitis based solely on the proportion of patients or percentage of patients who get clear or almost clear after 16 weeks of treatment,” Eric Simpson, MD, director of the clinical studies unit at Oregon Health and Science University, told Healio. “But for patients with very severe atopic dermatitis, if that’s the only metric that you use, you miss a lot of patients who might be doing well on a medication but not getting clear skin.”
This post hoc analysis of data from the ECZTRA 1 and ECZTRA 2 multinational, double-blind, randomized, placebo controlled, 52-week phase 3 trials, which was presented at the Society for Investigative Dermatology 2022 Annual Meeting, examined patients treated with tralokinumab (Adbry, Leo Pharma) monotherapy who did not achieve IGA 0/1 but did achieve other clinically meaningful endpoints.
Two groups were identified for this trial. The nonresponder imputation (NRI) group included those who had utilized rescue medication or had missing data and the as observed (AO) group included those with missing data that was ignored.
Of these patients, EASI50 was achieved in 33% of the NRI group and 54.5% of the AO group, compared with 13.1% and 31.2% of the two respective placebo groups.
An improvement of at least three grades on the worst daily pruritus Numeric Rating Scale (NRS) occurred in 22.7% and 39.9%, compared with 9.6% and 29% of those in the two respective placebo groups.
DLQI improvements of at least 4 points occurred in 41.3% and 71.1% of the treatment groups and 24.8% and 58.8% of the placebo groups, respectively.
At least one of these outcomes was experienced by 48.8% of patients, with 82.2% experiencing at least one in the AO analysis.
The NRI analysis found 28.8% to have clinically meaningful change in at least one of these three treatment outcomes.
“There’s still a substantial percentage of patients getting clinically relevant responses, even if they don’t meet the FDA definition of success,” Simpson said. “Most of these type 2 blockers are going to provide a spectrum of improvement for the majority of patients. A smaller percentage might get really high response, but clinically relevant responses occur in the majority of patients.”