Tralokinumab Benefits Adolescent Eczema Patient-Reported Outcomes at 16 Weeks

Weily Soong, MD

Tralokinumab provides both symptom and psychosocial benefit for adolescent patients with moderate to severe atopic dermatitis over 16 weeks, according to new findings.

In new data derived from the phase 3 ECZTRA clinical trial program for the interleukin 13 (IL-13) inhibitor agent, a team or US investigators reported improved sleep, anxiety and depression, and quality of life associated with the disease among treated adolescents.

The findings further support use of the LEO Pharma drug—recently approved by the US Food and Drug Administration (FDA) for adults with atopic dermatitis—as a comprehensive benefit for adolescents whose psychosocial factors may be heightened due to the chronic skin disease.

Led by Weily Soong, MD, a physician at the AllerVie Health - Alabama Allergy & Asthma Center, investigators evaluated the effect of tralokinumab on patient-reported outcomes in the ECZTRA 6 trial through 16 weeks. Previously, the phase 3 study showed tralokinumab provided “substantial efficacy” and good tolerability in adolescent patients.

Their patient population included 301 adolescents aged 12-17 years old randomized to receive either subcutaneous tralokinumab 150 mg (n = 100), 300 mg (n = 101), or placebo (n = 100) once every 2 weeks. Key patient-reported outcomes included:

• Itch per worst pruritus Numeric Rating Scale (NRS)
• Sleep interference per eczema-related sleep NRS
• Children’s Dermatology Life Quality Index (CDLQI)
• Patient Oriented Eczema Measure (POEM)
• Hospital Anxiety and Depression Scale (HADS)

Trial participants who received rescue therapy or had missing data were defined as non-responders.

Investigators observed significantly greater proportions of patients receiving either dose of tralokinumab achieving a ≥4 point improvement in adolescent worst pruritus NRS:

• 150 mg tralokinumab, 23.2% (P <.001)
• 300 mg tralokinumab, 25.0% (P <.001)
• Placebo, 3.3%

Investigators additionally observed ≥6 point improvements in CDLQI in 31.0% (P = .029) and 39.5% (P <.001) of the tralokinumab arm, respectively, versus 15.9% of the placebo arm. Another 38.7% (P <.001) and 46.8% (P <.001) of the tralokinumab treatment arms reported ≥6 point improvement in poem versus 10.5% of the placebo arm.

Similarly to the other outcomes, tralokinumab was associated significant improvements in eczema-related sleep NRS and mean change in HADS versus placebo.

“Tralokinumab significantly improved symptomatic and psychosocial impacts of moderate to severe atopic dermatitis in adolescents using clinically relevant patient-reported outcomes at week 16, including itch, sleep interference, anxiety/depression, and overall quality of life,” they concluded.

The study, “Tralokinumab Treatment Substantially Improves Patient-Reported Outcomes in Adolescents with Moderate-to-Severe Atopic Dermatitis at 16 Weeks,” was published online in JDPA.