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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

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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.

Source:

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