Quality of life among patients with moderate to severe atopic dermatitis was found to be improved with lebrikizumab treatment via improvements in the pruritus Numeric Rating Scale (NRS) score and interference of itch on sleep, according to post-hoc analysis of research presented at the 2023 Annual Meeting of the American Academy of Dermatology (AAD), held from March 17 to 21, 2023, in New Orleans, Louisiana.
Quality of life in patients with atopic dermatitis is compromised by itch and itch interference on sleep. Lebrikizumab, a monoclonal antibody that blocks the downstream effects of interleukin-13, has been evaluated for efficacy and safety in phase 3 trials as monotherapy in patients with moderate to severe atopic dermatitis. In this study, investigators sought to quantify the effect of lebrikizumab on quality of life related to its effects on itch and itch interference on sleep among this patient population.
They initiated a post hoc analysis of data from the first 16-weeks of ADvocate1 (ADv1; ClinicalTrials.gov Identifier: NCT04146363 and ADvocate2 (ADv2; ClinicalTrials.gov Identifier: NCT04178967) identically designed (52-week, randomized, double-blind, placebo-controlled), phase 3 trials to assess the efficacy and safety of lebrikizumab monotherapy in patients with moderate to severe atopic dermatitis. Both studies randomly assigned patients 2:1 to subcutaneous lebrikizumb 250 mg or placebo every 2 weeks. The validated, 11-point pruritus NRS was used to evaluate itch, the validated 30-point Dermatology Life Quality Index (DLQI) was used to evaluate quality of life, and the validated 5-point Sleep-Loss Scale was used to evaluate the interference of itch on sleep. Change from baseline in DLQI was the outcome variable in the primary mediation analysis, and change from baseline in Pruritus NRS and Sleep-Loss Scale scores were mediator variables.
Adult patients and adolescents aged from 12 years to less than 18 years were eligible for inclusion. Other inclusion criteria included weight at least 40 kg, confirmed diagnosis of moderate to severe atopic dermatitis (Eczema Area and Severity Index score ≥16, Investigator’s Global Assessment score ≥3, and ≥10% body surface involvement) for at least 1 year before screening, naïve to treatment with dupilumab and tralokinumab, and availability of DLQI score for patients at least 17 years of age.
At week 16, the investigators noted a direct effect of lebrikizumab on DLQI of 28.5% (ADv1) and 25.7% (ADv2). The indirect effect of pruritus NRS on DLQI was 34.5% (ADv1) and 35.7% (ADv2). They noted that improvements in pruritus NRS and Sleep-Loss Scale scores had an indirect effect on DLQI of 34.5% and 4.9%, respectively, in ADv1 and 35.7% and 2.1%, respectively in ADv2. Reduction in itch as measured by the pruritus NRS had an indirect effect on DLQI by mitigating sleep interference (32.1% in Adv1 and 36.5% in Adv2).
Lebrikizumab monotherapy was found to be directly associated with DLQI improvement in both studies at week 16. Improvement in Sleep-Loss Scale and pruritus NRS scores had indirect effects on improvement in DLQI. Through its effects on sleep interference, reduction in itch had an indirect effect on DLQI improvement.
Investigators concluded that their analysis “suggests that lebrikizumab is effective in improving the quality of life of patients with moderate-to-severe AD, primarily through lebrikizumab’s effect on pruritus NRS and interference of itch on sleep.”
Disclosure: This research was supported by Dermira, a wholly owned subsidiary of Eli Lilly and Company. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
- Yosipovitch G, de Bruin-Weller M, Wiseman M, et al. Lebrikizumab monotherapy improves quality of life through improvement in itch and sleep: results from 2 phase 3 trials in patients with moderate-to-severe atopic dermatitis. Poster presentation at: AAD 2023 Annual Meeting; March 17-21, 2023; New Orleans, LA. Poster 41679.
- Yosipovitch G, de Bruin-Weller M, Wiseman M, et al. Lebrikizumab monotherapy improves quality of life through improvement in itch and sleep: results from 2 phase 3 trials in patients with moderate-to-severe atopic dermatitis. Abstract presented at: AAD 2023 Annual Meeting; March 17-21, 2023; New Orleans, LA. Abstract 41679.