Real-world study supports tralokinumab for difficult-to-treat AD

Interim data from the real-world TRACE study confirm the benefits of the high-affinity monoclonal antibody tralokinumab for individuals with moderate-to-severe head and neck atopic dermatitis (H&N AD) after up to 9 months of treatment.

Eighty percent of the study participants had H&N AD at baseline. By month 9, only half of these patients had H&N involvement, noted Dr April Armstrong from the University of California Los Angeles in the US. This was a notable drop from the 67 percent reported at month 3.

A similar pattern was also observed at 9 months among participants who were dupilumab-naïve and dupilumab-experienced (50 percent and 57 percent, respectively). [EADV 2024, abstract 8084]

Other parameters

In patients with baseline H&N AD, only 1.4 percent had an Investigator’s Global Assessment (IGA) score of 0/1 at baseline, which corresponds to clear/almost clear skin. By month 3, a third have achieved this endpoint. This improved to 48 percent by month 6 and 57 percent by month 9.

This, in turn, was met with consistent drops in the proportions of participants with an IGA score of 4 or severe disease at baseline, dropping substantially from 38 percent to 5 percent at 3 months and 3 percent at 6 months. By month 9, this was down to 2 percent, corresponding numerically to just two patients.

For those with a baseline IGA ≥2, 46 percent achieved ≥2-point improvement at 3 months. This jumped to 59 percent at 6 months and 72 percent at 9 months.

Among patients with baseline DLQI* ≥6, the percentages of participants achieving ≥6-point reduction in DLQI at 3, 6, and 9 months were 58, 64, and 74 percent, respectively. According to Armstrong, the DLQI reductions denoted clinically meaningful improvement in quality of life (QoL).

Patient-reported eczema control also improved, as reflected by the fraction of participants with RECAP** <6 by month 9 (45 percent). “RECAP <6 identifies patients whose AD is considered completely controlled (RECAP 0–1) or mostly controlled (RECAP 2–5),” Armstrong explained.

Mean Peak Pruritus NRS*** also consistently improved across all timepoints (from 6.4 at baseline to 4.2, 3.5, and 3.3 at 3, 6, and 9 months, respectively), as did mean Sleep-NRS (from 5.2 at baseline to 2.8, 2.3, and 2.3).

Overall, response rates and improvements were consistent irrespective of treatment history, Armstrong noted.

Significant QoL burden

About three-quarters of patients with moderate-to-severe AD have H&N involvement. [J Am Acad Dermatol 2023;89:519-528] “AD with involvement of H&N, more than other body regions, is associated with social embarrassment, stigmatization, and a significant negative impact on patients’ QoL and mental health,” stressed Armstrong. “Patients can be quite dissatisfied if those areas are not treated well.”

The team thus set out to evaluate tralokinumab in this single-cohort study of tralokinumab-naïve adults with AD. At data cutoff for this interim analysis, the full analysis set comprised 824 patients at baseline, and 668, 331, and 143 patients at months 3, 6, and 9.

Of the 655 AD patients who had H&N (face, scalp, and/or neck) involvement, 154 were dupilumab-experienced, while the rest were dupilumab-naïve. Mean age was 42.1 years, 53 percent were men, and mean disease duration was 20.6 years. A third had IGA 4.

“[Taken together, the findings show that] up to 9 months of tralokinumab treatment in a real-world setting reduced H&N involvement and improved disease severity and QoL in patients with AD in the difficult-to-treat H&N area. All improvements were similar regardless of prior dupilumab use,” noted Armstrong.

In a separate news release, LEO Pharma Chief Development Officer Kreesten Meldgaard Madsen said, “We are particularly encouraged to see treatment with [tralokinumab] leading to such positive real-world outcomes in a challenging region of the body, regardless of previous biologic treatment.”