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New results of the phase 3 ECZTRA 6 trial, evaluating tralokinumab for pediatric patients with eczema, found that the drug was superior to placebo in the primary and secondary endpoints.
Interleukin(IL)-13–targeted treatment of moderate-to-severe atopic dermatitis (AD) with tralokinumab is efficacious and well-tolerated in adolescents, according to new findings.1
The findings were the result of the phase 3 ECZTRA 6 trial on tralokinumab for pediatric patients with AD who were aged 12 to 17 years. The research was authored by Amy S. Paller, MD, from the Departments of Dermatology and Pediatrics at Northwestern University’s Feinberg School of Medicine in Chicago.
The skin barrier dysfunction, immune dysregulation, and microbiome dysbiosis seen in AD may be linked to IL-13, which is believed to be the primary cytokine driving the disorder’s progression.2 To address this, tralokinumab was developed as a fully human IgG4 monoclonal antibody with high IL-13 affinity.
“Herein, we report results from ECZTRA 6, a phase 3, randomized, double-blinded, placebo-controlled study that examined efficacy and safety of tralokinumab monotherapy vs placebo in adolescents with moderate to severe AD,” Paller and colleagues wrote.
The investigators conducted the phase 3 ECZTRA 6 study, which was a 2-week, randomized, double-blinded, placebo-controlled trial conducted from July of 2018 to March of 2021. The study was carried out across 72 medical centers in North America, Australia, Europe, and Asia.
The research team recruited adolescent study participants between the ages of 12 to 17 with moderate to severe AD diagnoses, as indicated by an Investigator's Global Assessment (IGA) score of ≥3 and an Eczema Area and Severity Index (EASI) score of ≥16.
The participants were randomly assigned to be given either tralokinumab (150 or 300 mg) or a placebo every 2 weeks for a total of 16 weeks. Those who showed substantial improvement in IGA score (0 or 1) and/or EASI score (75) at 16 weeks without a rescue medication were also given maintenance treatment, while others were instead switched to tralokinumab (open-label, 300 mg) every 2 weeks.
At the 16 week point, the main goals of the phase 3 trial were for the participants to report an IGA score of 0 or 1 (clear or almost clear) and/or to report an EASI 75 score. The team’s secondary objectives were to report changes in Children's Dermatology Life Quality Index from baseline to week 16, a reduction of 4 or more on the Adolescent Worst Pruritus Numeric Rating Scale, and changes in SCORing AD.
Additionally, the investigators made sure to evaluate safety endpoints, specifically the number of adverse events and serious adverse events that the participants reported.
Overall, the team’s full analysis set was made up of 289 patients with a median age of 15.0 years, and more than half of them were male.
Participants being given tralokinumab at 150 mg and 300 mg were found to have a substantial reduction in IGA scores (21.4% and 17.5% of each group, respectively) without rescue at 16 weeks versus those in the placebo arm (4.3%).
The investigators also noted that more participants given tralokinumab, 150 mg (28.6% of this group), and tralokinumab, 300 mg (27.8%), reported achieving EASI 75 without rescue at 16 weeks versus the placebo arm (6.4%).
The research team reported that tralokinumab also led to improved pruritus and Dermatology Life Quality Index scores as compared to placebo, adding that the efficacy of the drug was maintained without rescue by more than 50% of patients at 52 weeks.
Tralokinumab was found to be well-tolerated overall, with the researchers adding that the frequency of conjunctivitis did not increase through week 52. Overall, the data from the trial suggests that the drug may be an effective and safe treatment option for adolescent AD patients.
“These results are consistent with tralokinumab data reported in adults with AD,9,10 suggesting that specific targeting of IL-13 with tralokinumab is an effective and well-tolerated long-term treatment option for uncontrolled AD in adolescents,” they wrote.