At 1 year, tralokinumab efficacious for atopic dermatitis treatment in adolescents
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Key takeaways:
- The phase 3 ECZTRA 6 trial evaluated tralokinumab in adolescent atopic dermatitis.
- One-third of patients reached IGA score of 0 or 1 while more than half reached EASI 75 at 52 weeks.
Tralokinumab at doses of 150 mg or 300 mg was associated with improvements over placebo in a number of efficacy outcomes at 16 weeks and 52 weeks in adolescents with moderate to severe atopic dermatitis, according to a study.
“Safe and effective long-term treatments for adolescents with moderate to severe atopic dermatitis (AD) are limited,” Amy S. Paller, MD, of the departments of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, and colleagues wrote.
In the 52-week randomized, double-blinded, placebo-controlled phase 3 ECZTRA 6 trial, Paller and colleagues assessed interleukin-13-targeted treatment with tralokinumab monotherapy in a cohort of adolescent patients aged 12 to 17 years old at 73 centers in 10 countries.
Treatment regimens included tralokinumab 150 mg, tralokinumab 300 mg or placebo assigned in a 1:1:1 ratio. Patients were treated every 2 weeks for 16 weeks. Those who failed to reach the primary endpoints of an IGA score of 0 or 1 and/or 75% or higher improvement in EASI 75 without rescue medication at week 16 were assigned maintenance treatment, while the other patients received open-label tralokinumab 300 mg every 2 weeks.
Of the 289 patients included in the final analysis, 98 received tralokinumab 150 mg, 97 received tralokinumab 300 mg and 94 received placebo. The median age of the patients was 15 years, and 51.6% of participants were boys.
At 16 weeks, 21.4% of patients in the low-dose tralokinumab group reached an IGA score of 0 or 1 without rescue medication, while 17.5% of patients in the high-dose group reached this endpoint compared with 4.3% in the placebo group (P < .001 for 150 mg; P = .002 for 300 mg).
For the EASI 75 endpoint, 28.6% of patients in the tralokinumab 150 mg group reached this outcome without rescue medication compared with 6.4% in the placebo group (P < .001). Similarly, 27.8% of patients in the tralokinumab 300 mg group reached EASI 75 (P < .001).
Overall, positive results were reported for key secondary endpoints involving Adolescent Worst Pruritus Numeric Rating Scale, SCORing AD and Children’s Dermatology Life Quality Index.
Findings from 52 weeks showed that tralokinumab efficacy persisted in more than half of patients who met the primary endpoints at week 16.
Further data from the open-label phase of the study demonstrated that 33.3% patients reached an IGA score of 0 or 1 and 57.8% of patients reached EASI 75 at 52 weeks.
The study drug was well tolerated, and rates of conjunctivitis were low at 52 weeks.
“Importantly, tralokinumab improved symptomatic and psychosocial aspects of AD in adolescents, including itch, sleep, anxiety/depression and overall quality of life, with few adverse effects and low treatment discontinuation rates,” the researchers wrote.