| Adolescents with moderate or severe forms of atopic dermatitis (AD) have limited treatment options. It is intended to
determine whether TRALOKINIUMAB monotherapy can reduce AD symptoms in adolescents with interleukin-13-
responsive AD and is safe, along with its efficacy. The investigator's global assessment was completed by 24 to 34 patients
with severe and moderate AD (IGA score 3; EASI 16). Randomization was made between patients (1:1:1) and tralokinumab
(75 or 150 mg). Without maintenance treatment after week 16 without rescue medication, those with 0 or 1 IGA score and/or
EASI 75 score improved 75% to 100%; others A 2-week cycle of 150 mg of tralokinumab was switched to open-label
tralokinumab. Obtaining either an IGA score of 0 or 1 or an EASI score of 75 was the primary endpoint at week 16 The
median age of the 144 patients randomized was 14 with 74 males. The proportion of patients who achieved an IGA score of
1 or 0 without rescue medication at week 16 following 75 mg tralokinumab (n = 47; 2) and 150 mg tralokinumab (n = 49)
was higher than that of placebo (n = 48). The adjusted difference was 16.4% (95% CI, 8.4%-24.6%); P <0.002, and the
difference was 12.7% (95 % CI, 5.3%-22.3%); P <0.002). There was no difference between treated patients and placebo at
week 16 (adjusted difference, 21.4% [95% CI, 11.3%-31.5%]; P<0.001) due to tralokinumab 75mg and 150 mg without
rescue. Compared to placebo, tralokinumab 75 mg or 150 mg improved four or more points on the Adolescent Worst
Pruritus Numeric Rating Scale. There was a decrease of 27.5% in Scoring AD (and a decrease of 28% in Scoring AD) with
tralokinumab, 75 mg, and 150 mg when compared to placebo (-4.1%). There was a decrease in Children's Dermatology Life
Quality Index by 9.5% and a decrease in Scoring AD by 5% when compared to placebo. In every case where the primary end
point was met at week 16, no tralokinumab was required for rescue. 32.2 percent of participants achieved an IGA score of 0
or 1, whereas 56.7% achieved an EASI score of 75. Week 52 did not see a conjunctivitis outbreak. Talokinumab side effects
were mildddd |
