Lebrikizumab plus topical corticosteroids improves outcomes in moderate-to-severe AD

Treatment with lebrikizumab in combination with topical corticosteroids (TCS), compared with TCS alone, results in early and sustained improvements in patient-reported outcomes (PROs) among individuals with moderate-to-severe atopic dermatitis (AD), as shown in a Japan study.

Lebrikizumab is a novel, high-affinity monoclonal antibody that “selectively targets [the] interleukin-13 with a slow dissociation rate and high potency.” [Dermatol Ther (Heidelb) 2023;13:1535-1547]

Furthermore, lebrikizumab has demonstrated its efficacy in several monotherapy and TCS-combination phase III trials, including ADvocate1, ADvocate2, and ADhere. [N Engl J Med 2023;388:1080-1091; Br J Dermatol 2023;188:740-748; JAMA 2023;159:182-191]

In the present study, a team of investigators headed by Akio Tanaka from the Graduate School of Biomedical and Health Sciences, Hiroshima University in Hiroshima, Japan, evaluated lebrikizumab 250 mg every 2 weeks (Q2W, 500-mg loading dose at baseline and week 2), lebrikizumab 250 mg every 4 weeks (Q4W, 500-mg LD at baseline), or placebo with TCS on PROs during the induction period.

A total of 286 patients, including 18 adolescent participants, were randomly assigned to receive either lebrikizumab Q2W (n=123), lebrikizumab Q4W (n=81), or placebo (n=82).

Improved outcomes

More patients on lebrikizumab achieved ≥4-point improvement in Skin Pain Numeric Rating Scale from baseline compared with those on placebo (lebrikizumab Q2W: 48.4 percent; lebrikizumab Q4W: 35.0 percent; placebo: 4.7 percent; p<0.001). [AAD 2024, poster 48964]

Additionally, 68.8 percent of patients on lebrikizumab Q2W, 53.3 percent of those on lebrikizumab Q4W, and 20.6 percent of those on placebo achieved ≥4-point improvement from baseline on the Dermatology Life Quality Index (DLQI; p<0.001).

From baseline, the least squares mean (LSM) changes in Patient Oriented Eczema Measure (POEM) were as follows: ‒7.9 in the lebrikizumab Q2W arm, ‒6.8 in the lebrikizumab Q4W arm, and ‒0.3 in the placebo arm (p<0.001).

For the Work Productivity and Impairment-AD (WPAI-AD) scales, the respective LSM changes in the lebrikizumab Q2W, Q4W, and placebo groups were ‒0.6, ‒0.9, and ‒0.6 for absenteeism (p>0.05); ‒21.5, ‒16.2, and ‒21 for presenteeism (p<0.001); ‒21.7, ‒16.5, and ‒2.2 for work impairment (p<0.001); and ‒24.1, ‒17.5, and ‒2.3 for daily activity impairment.

“Lebrikizumab combined with TCS, compared with TCS alone, improved PROs in Japanese patients with moderate-to-severe AD,” Tanaka said. “Both lebrikizumab Q2W and Q4W treatment showed improvements in Skin Pain, DLQI, POEM, and most WPAI-AD scores.”

The current study was limited by the cross-cultural validity of instruments and the small number of adolescent patients in the analysis population, according to Tanaka and colleagues.

A chronic skin disease, AD is associated with serious burden and may affect sleep, daily activities, and social relationships. [Dermatitis 2019;30:247-254]

In a recent study, AD was also found to increase the likelihood of learning and memory difficulties in children. However, this finding was limited to those with a diagnosis of attention deficit/hyperactivity disorder or learning disabilities. [AAD 2024, poster 48657]