Tralokinumab effective in dermatitis treatment

Tralokinumab 300 mg showed significant improvements in pruritus and quality of life in atopic dermatitis patients in three phase 3 trials, according presentations at the American Academy of Dermatology virtual meeting.

Eric Simpson

Tralokinumab 300g (LEO Pharma), a fully human monoclonal antibody that neutralizes the IL-13 cytokine, is administered subcutaneously every 2 weeks.

The ECZTRA 1 and ECZTRA 2 trials treated patients with tralokinumab monotherapy, while ECZTRA 3 treated patients with a combination of tralokinumab and concomitant topical steroid.

In the ECZTRA 1 trial 16% of patients in the treatment arm reached the primary endpoint of an Investigator Global Assessment score of clear or almost clear skin compared to 7% of those treated with placebo. The ECZTRA 2 trial had a 22% rate of success, compared to 11% in placebo.

“This showed that blocking IL-13 cytokine was effective, statistically significant in the success endpoints for patients with moderate-to-severe atopic dermatitis,” Eric Simpson, MD, lead investigator for ECZTRA 2 and professor of dermatology at the Oregon Health & Science University, told Healio/Dermatology.

Patients who reached at least a 75% improvement in Eczema Area Severity Index totaled 25% in the ECZTRA 1 treatment arm and 33% in the ECZTRA 2 treatment arm, compared to 13% and 11% in the two trials’ respective placebo arms.

For those who responded at week 16, 51% and 59% maintained IGA of 0.1 after 52 weeks in the two trials, while 60% and 56% maintained the EASI-75 score.

In the ECZTRA 3 combination trial 39% of patients achieved IGA 0/1 at 16 weeks, while 56% achieved EASI-75.

For those who responded at week 16 90% maintained IGA 0.1 and 93% maintained EASI-75 at week 52.

“This was proof of principle that IL-13 is an extremely important cytokine in atopic dermatitis and should in the future provide us another alternative for treatment for this disease state,” Simpson said.