The greatest improvements in quality of life measures were seen in the 300 mg tralokinumab group.
Results from the phase 3 ECZTRA 6 trial (NCT03526861) demonstrated that monotherapy with tralokinumab (Adbry; LEO Pharma) outperformed placebo in efficacy among adolescent patients aged 12 to 17 years with moderate to severe atopic dermatitis (AD).
Now, in a poster1 presented at the Society of Dermatology Physician Assistants (SDPA) 20th Annual Fall Dermatology Conference, investigators report on quality of life (QoL) and school life outcomes for the human monoclonal antibody that specifically binds to and inhibits IL-13.
AD can carry a significant psychosocial burden for adolescents, which can bleed into school life and affect behaviors such as task completion, connectedness, and impulsivity. Investigators sought to study the effect of tralokinumab on AD-related QoL during weeks 0-16 of the ECZTRA 6 trial, using the Children’s Dermatology Life Quality Index (CDLQI).
In ECZTRA 6, 289 adolescents with mild to severe AD aged 12 to 17 years received either 150 or 300 mg of tralokinumab or placebo every 2 weeks during the initial phase of the study, which was 0-16 weeks. The research team assessed participants’ QoL using CDLQI, a 10-item questionnaire that analyzed either caregiver or self-reported AD impact.
Questionnaire topics included how embarrassed or self-conscious patients felt; how AD affected their friendships; how AD influenced what they wore; how it affected going out, playing, or hobbies; whether AD caused them to avoid swimming or other sports; AD’s impact on problems at school; how it contributed to problems with other people; and how much of a problem treatment was.
Overall, at week 16, the adjusted mean change in CDLQI from baseline was significantly greater for patients receiving tralokinumab 150 mg (–6.1) or 300 mg (–6.7) versus placebo (–4.1) (difference –2.0 [P = .04] and –2.6 [P = .007] respectively).
With the study drug, more patients experienced > 6-point reduction: 31% of the 150 mg group, and 39.5% of the 300 mg group versus 15.9% of the placebo group (difference 14.1% [P = .029] and 23.9% [P < .001], respectively).
The largest improvements in QoL were seen in the 300 mg tralokinumab group. At week 16, 49% of the 150 mg group and 47.9% of the 300 mg group reported that AD had “not at all” affected how embarrassed or self-conscious the patient felt, versus 37% of the placebo group.
Similarly, the treatment group outperformed the placebo group in measurements of whether AD had affected friendships, clothing decisions, play, hobbies, or going out. Treated patients also avoided activities like swimming less than those in the placebo arm.
“Tralokinumab improved several patient-reported outcomes that encompass psychosocial effects of AD in this vulnerable pediatric age group, as measured by the CDLQI,” investigators concluded. “Tralokinumab had a substantial benefit on the impact of AD on subdomains in the CDLQI related to school/holiday at week 16. There was a trend towards treatment benefit with tralokinumab vs placebo across multiple other psychosocial domains.”
Last month, the European Commission extended the marketing authorization for tralokinumab to include adolescents aged 12 to 17 with moderate to severe AD, with US agencies mulling a similar move to broaden the indication.
Paller A, Silverberg J B, Hong H, et al. The impact of tralokinumab on quality of life and school in patients aged 12–17 with atopic dermatitis: results from the phase 3 ECZTRA 6 trial. Poster presented at: SDPA 20th Annual Fall Dermatology Conference; November 17-20, 2022; Miami, FL. Accessed November 16, 2022. https://www.sdpaconferences.org/hub/events/08d628c0-db6c-4633-8960-74ba986b221a/exhibitors