Results from a phase 3, randomized, placebo-controlled trial supported the safe use of tralokinumab for the treatment of moderate-to-severe atopic dermatitis (AD) among adolescents, according to study findings published in JAMA Dermatology.
Researchers conducted the phase 3, randomized, placebo-controlled ECZTRA 6 (ClinicalTrials.gov Identifier: NCT03526861) trial to evaluate the safety, tolerability, and efficacy of tralokinumab among adolescents aged 12 to 17 years. Patients (N=289) with moderate-to-severe AD were recruited at 72 centers in 10 countries and randomly assigned in a 1:1:1 ratio to receive tralokinumab 150 mg (n=98), tralokinumab 300 mg (n=97), or placebo (n=94) every 2 weeks for 16 weeks. All participants received a loading dose that was double the allocated intervention dosage.
The subset of participants who responded to treatment at week 16 and did not require rescue medication after week 2 (n=50) were randomly assigned again in a 1:1 ratio to receive maintenance therapy with their original treatment and dosage every 2 or 4 weeks until week 52. All nonresponders or those who lost response received open-label tralokinumab 300 mg every 2 weeks. The primary outcome was treatment response, which was defined as a 75% or greater improvement in Eczema Area and Severity Index (EASI) score and/or achieving an Investigator’s Global Assessment (IGA) score of 0 or 1.
The study population comprised adolescents with a median age of 15.0 (IQR, 13.0-16.0) years, and 51.6% were boys. They had an AD duration of 13.0 (IQR, 11.0-15.0) years, 44.6% had 3 comorbid atopic diseases, they had a median EASI score of 28.0 (IQR, 21.1-38.1) points, and 46.7% had an IGA score of 4.
More participants who achieved an IGA score of 0 or 1 at week 16 without rescue received tralokinumab 150 mg (21.4%; P <.001) or tralokinumab 300 mg (17.5%; P =.002) compared with placebo (4.3%). Similarly, more tralokinumab 150 mg (adjusted difference, 22.5%; P <.001) and tralokinumab 300 mg (adjusted difference, 22.0%; P <.001) tralokinumab recipients achieved a 75% improvement in EASI scores compared with placebo.
After the maintenance period at week 52, 62.9% and 53.2% of tralokinumab recipients maintained their IGA response and EASI response without rescue, respectively.
A total of 214 participants were transferred to open-label high-dose tralokinumab. At week 52, 35.4% of those who switched from tralokinumab 150 mg, 31.4% who were switched from tralokinumab 300 mg, and 27.8% who were switched from placebo achieved IGA response and 63.1%, 52.9%, and 65.8% achieved EASI response, respectively.
The tralokinumab intervention was also associated with significant improvements to itch, sleep, anxiety, depression, and quality of life outcomes.
Adverse events were reported by 67.3% to 64.9% of tralokinumab recipients compared with 61.7% of placebo recipients. Most events were of mild or moderate severity. One patient withdrew from the 150 mg tralokinumab group due to an adverse event.
This study may have been limited by not including a placebo group during the maintenance phase.
The study authors conclude, “[T]ralokinumab monotherapy was effective and had a favorable benefit-to-risk profile in adolescents with moderate to severe AD over 52 weeks.”
Disclosures: This research was supported by LEO Pharma. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
This article originally appeared on Dermatology Advisor
Paller AS, Flohr C, Cork M, et al. Efficacy and safety of tralokinumab in adolescents with moderate to severe atopic dermatitis the phase 3 ECZTRA 6 randomized clinical trial. JAMA Dermatol. 2023;e230627. doi:10.1001/jamadermatol.2023.0627