Long-term tralokinumab, with or without interruption, improves atopic dermatitis severity
Click Here to Manage Email Alerts
An extension study found atopic dermatitis patients continuously treated with tralokinumab had long-term improvement in severity and those with interrupted treatment matched improvement after 12 weeks.
“The effect of being off drug for a month to several months did not lead to any adverse effects on efficacy later on,” Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center and the study’s lead investigator, told Healio. “Patients who were restarted did just as well as those who stayed continuously on treatment after being treated for 3 months.”
The ongoing phase 3, 5-year, open-label, single arm ECZTEND long-term extension trial included 345 patients (median age, 42 years [interquartile range, 30-52 years]; 58.8% men) who had previously enrolled in any of the earlier ECZTRA trials, which evaluated safety and efficacy of the investigational fully human, monoclonal antibody for 52-weeks.
Three cohorts, based on the length of time between the parent trials’ last dose and the extension trial’s first dose, were identified: continuous treatment (n = 126), defined as patients who had 5 weeks or less off treatment; interrupted treatment (n = 133), defined as those with 6 to 15 weeks off treatment; and washout (n = 86), defined as those with more than 15 weeks off treatment.
At week 56 a median improvement in Eczema Area and Severity Index from baseline was recorded in 92.7% of those in the continuous treatment group, 91.7% of those in the interrupted group and 92.7% of the washout group.
Parent trial EASI improvement was maintained for those in the continuous group, while those in the interrupted group regained parent trial levels by week 8 and those in the washout group did so by week 16.
“Normally we don’t have a lot of data like this in clinical trials because patients tend to stay on drug, but in real life and private practice we see patients all the time who, for a number of different reasons, are going on and off drug,” Blauvelt said. “The most common reason is they lose insurance and there are disruptions in treatment. The conclusion is that tralokinumab, even if patients are off of it for several months, that within 3 months of restarting they do just as well as patients who continuously stayed on drug.”
Worst weekly pruritus numeric rating scale (NRS) was 3 for all cohorts at week 56, while weekly eczema-related sleep interference NRS was 1 for the continuous and interrupted cohorts and 1.5 for the washout cohort.
“In my experience the results of this ECZTEND open label trial suggest that tralokinumab is an excellent drug for atopic dermatitis patients over time,” Blauvelt said.