Lebrikizumab + topical corticosteroid therapy can be considered a viable treatment option for patients with moderate-to-severe atopic dermatitis.
Atopic dermatitis (AD), also known as eczema, is a chronic and relapsing inflammatory skin disease affecting millions worldwide. AD is characterized by intense itching, skin dryness, redness, and the formation of scaly patches, which can lead to a reduced quality of life, social isolation, and psychological distress. AD treatments include topical and systemic corticosteroids, topical calcineurin inhibitors, and systemic immunomodulators. Lebrikizumab (LEB) is a high-affinity monoclonal antibody that targets interleukin (IL)-13, a cytokine that plays a key role in AD pathogenesis. By blocking IL-13, LEB can reduce inflammation and itching, improving AD symptoms. A study published in JAMA Dermatology assessed the effectiveness and safety of using LEB with topical corticosteroids (TCS) of low-to-moderate potency in patients with moderate-to-severe AD.
The Study Parameters
The ADhere trial was a multicenter phase 3 clinical trial that lasted for 16 weeks and was randomized, double-blinded,and placebo-controlled. It involved 211 participants from the US, Canada, Poland, and Germany, with a treatment allocation ratio of 2:1 for LEB and placebo (PBO).
LEB with TCS Significantly Improves the IGA Score
A significantly greater proportion of patients receiving LEB+TCS (41.2%) achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 with 2 or more points improvement from baseline compared to patients receiving PBO+TCS (22.1%) (P = 0.01).
Outcomes of the Combination Therapy With LEB and TCS
The proportion of patients achieving Eczema Area and Severity Index (EASI)-75 responses at week 16 was significantly greater in the LEB+TCS group (69.5%) compared to the PBO+TCS group (42.2%) (P < 0.001). LEB+TCS also showed statistically significant improvements in all key secondary endpoints, including itch, sleep interference, and quality of life.
Safety Profile of LEB+TCS
LEB+TCS had a similar and low frequency (less than 2%) of serious adverse events compared to PBO+TCS. The most common treatment-emergent adverse events in the LEB+TCS group were non-serious and mild or moderate in severity, including conjunctivitis, headache, hypertension, injection site reactions, and herpes infection.
The ADhere trial demonstrated that LEB+TCS is an effective and safe treatment option for patients with moderate-to-severe AD. The study’s results show that LEB+TCS can significantly improve AD symptoms and quality of life in patients while having a similar and low frequency of serious adverse events compared to the placebo.
Simpson, E. L., Gooderham, M., Wollenberg, A., Weidinger, S., Armstrong, A., Soung, J., Ferrucci, S., Lima, R. G., Witte, M. M., Xu, W., ElMaraghy, H., Natalie, C. R., Pierce, E., & Blauvelt, A. (2023). Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). JAMA Dermatol, 159(2), 182-191. https://doi.org/10.1001/jamadermatol.2022.5534