Tralokinumab a promising treatment option in young people with moderate-to-severe AD

Targeting interleukin (IL)-13 with tralokinumab monotherapy helps reduce disease activity in adolescents with moderate-to-severe atopic dermatitis (AD) with a low frequency of conjunctivitis throughout the treatment period, according to data from the phase III ECZTRA 6 trial.

ECZTRA 6 included 301 adolescents with moderate-to-severe AD (Investigator’s Global Assessment [IGA] score ≥3; Eczema Area and Severity Index [EASI] ≥16). They were randomly assigned to receive treatment with tralokinumab (150 or 300 mg) or placebo every 2 weeks for 16 weeks. Those who achieved an IGA score of 0 (clear) or 1 (almost clear) and/or at least 75-percent improvement in EASI (EASI 75) at week 16 without rescue medication received maintenance treatment through week 52, whereas the other participants were switched to open-label tralokinumab 300 mg, administered every 2 weeks.

The primary endpoints were an IGA score of 0 or 1 and/or achievement of EASI 75 at week 16. Key secondary endpoints included a reduction in Adolescent Worst Pruritus Numeric Rating Scale of ≥4, change in SCORing AD, and change in Children’s Dermatology Life Quality Index from baseline to week 16. Safety was also assessed through the number of adverse events and serious adverse events.

Of the participants, 289 were included in the full analysis set (median age 15.0 years, 51.6 percent male). At week 16, more participants who received tralokinumab 150 or 300 mg vs placebo achieved an IGA score of 0 or 1 without rescue medication (21.4 percent and 17.5 percent, respectively, vs 4.3 percent; adjusted difference, 17.5 percent and 13.8 percent; p<0.001 and p=0.002, respectively).

Likewise, EASI 75 without rescue at week 16 occurred more frequently in the tralokinumab group than in the placebo group (28.6 percent with 150 mg and 27.8 percent with 300 mg vs 6.4 percent; adjusted difference, 22.5 percent and 22.0 percent; p<0.001 and p<0.001, respectively).

The number of patients with Adolescent Worst Pruritus Numeric Rating Scale reduction of ≥4 was higher with tralokinumab 150 and 300 mg than with placebo (23.2 percent and 25.0 percent vs 3.3 percent). Compared with placebo, tralokinumab 150 and 300 mg led to greater adjusted mean changes in SCORing AD (–27.5 percent and –29.1 percent vs –9.5 percent) and in Children’s Dermatology Life Quality Index (–6.1 percent and –6.7 percent vs –4.1 percent) at week 16.

At week 52, tralokinumab efficacy was maintained without rescue in more than 50 percent of the participants who met the primary endpoint(s) at week 16. In the open-label phase, IGA score of 0 or 1 and EASI 75 were documented in in 33.3 percent and 57.8 percent, respectively.

Treatment was well tolerated, without increased frequency of conjunctivitis through week 52.