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Lebrikizumab Demonstrates Effectiveness During Induction Period of 2 Studies

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03/23/2023
pharmacytimes.com

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Eli Lilly and Company’s lebrikizumab an immunoglobulin G4 monoclonal antibody that targets interleukin (IL)-13, demonstrated effectiveness during the induction period of 2 phase 3 trials in adults and adolescents with moderate-to-serve atopic dermatitis (AD), according to the results of a study published in TheNew England Journal of Medicine.

Lebrikizumab has been used to prevent the formation of the IL-4Rα–IL-13Rα1 heterodimer receptor signaling.

Investigators conducted 2 studies that were identically designed. Both were 52-week, double-blinded, placebo-controlled phase 3 trials with a 16-week induction period.

Individuals aged 12 years and older were randomly assigned in a 2:1 ratio to received either lebrikizumab, in the 250-mg dosage, with a loading dose of 500 mg at baseline and week 2 or the placebo. The doses were administered subcutaneously every 2 weeks.

Individuals were enrolled in the first study between September 24, 2019, and February 26, 2021, and between October 29, 2019, and March 19, 2021, for the second study. In trial 1, there were 283 individuals in the treatment group and 141 in the placebo group. In trial 2, there were 281 and 146 individuals, respectively.

The primary outcome of the study was an Investigator’s Global Assessment (IGA) score of 0 or 1, which indicated clear or almost clear skin, respectively, with a reduction, which indicated improvement, of at least 2 points from baseline to week 16. The score ranged from 0 to 4, indicating disease severity.

Secondary outcomes included a 75% improvement of the Eczema Area and Severity Index score (EASI-75 response) and assessments of both itch and itch that interfered with sleep, according to investigators, who .also assessed the drug’s safety.

In the first trial (NCT04146363), the primary outcome was met in approximately 43.1% of individuals in the treatment group and just 12.7% of those in the placebo group. The EASI-75 response was approximately 58.8%and 16.2%, respectively.

In the second trial (NCT04178967), investigators found that the primary outcomes was met in 33.2% of those in the treatment group and 10.8% in the placebo group. EASI-75 response occurred in 52.1% and 18.1%, respectively.

Investigators reported that measures of itch and itch interference with sleep was improved with treatment from lebrikizumab.

However, the incidence of conjunctivitis was higher for those who received lebrikizumab compared with those who received the placebo.

The majority of adverse events (AEs) during the induction period were mild or moderate. The majority of AEs did not lead to discontinuation, according to investigators.

however 1 individual in trial 2 discontinued treatment to conjunctivitis and 1 because of keratitis.

The most common AE for both trials was conjunctivitis at 7.4% in the lebrikizumab group compared with 2.8% in the placebo group in trial 1 and at 7.5% and 2.1%, respectively, in trial 2.

Investigators plan on continuing to the maintenance period of the study as well as a long-term extension study, Adjoin (NCT04392154).

Reference

Silverberg JI, Guttman-Yassky E, Thaçi D, Irvine AD, et al. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;10.1056/NEJMoa2206714. doi:10.1056/NEJMoa2206714

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Schedule28 May 2024