Lebrikizumab Demonstrates Efficacy, Safety in Patients With Skin of Color With AD

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RAD 2025. Lebrikizumab improved skin clearance, itch, and pigmentation in patients with skin of color and atopic dermatitis, with strong safety data through 24 weeks, according to late-breaking data.

Final results from the phase 3b ADmirable trial presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference show that lebrikizumab provided substantial improvements in skin clearance, itch reduction, and quality of life in patients with moderate-to-severe atopic dermatitis (AD) and skin of color, with a favorable safety profile through 24 weeks.

At week 24, 78% of patients achieved EASI 75 (≥75% improvement from baseline), 47% achieved EASI 90, and 54% reached IGA 0/1 with ≥2-point improvement. Clinically meaningful itch reduction (≥4-point improvement on the pruritus numeric rating scale [NRS]) was reported by 60% of participants. Improvements in Dermatology Life Quality Index (DLQI) scores were also seen in 73% of participants.

The open-label, single-arm study (NCT05372419) enrolled 90 biologic-naïve patients aged ≥12 years with Fitzpatrick skin types IV–VI and chronic, moderate-to-severe AD not adequately controlled by topical therapies. Participants received lebrikizumab 250 mg subcutaneously every 2 weeks following a 500 mg loading dose at baseline and week 2. Responders at week 16 transitioned to once-monthly dosing through week 24.

At baseline, the mean EASI score was 26.4 (SD 12.2), BSA involvement was 37.8% (SD 20.5), and pruritus NRS was 7.0 (SD 2.2). Most patients had IGA scores of 3 (69%) or 4 (30%).

In addition to improvements in disease severity and symptoms, lebrikizumab also reduced pigmentary sequelae, a common concern in patients with skin of color. Among patients with baseline hyperpigmentation (n = 52), 64% showed improvement by week 24. Of those with baseline hypopigmentation (n = 16), 25% improved. Few patients transitioned from one pigmentary change to another.

Only 1.1% of patients required rescue therapy. Use of concomitant low- or moderate-potency topical corticosteroids was reported in 34.4% of participants. No high-potency corticosteroids, topical JAK inhibitors, or systemic immunosuppressants were used.

The safety profile of lebrikizumab remained consistent with previous trials. Through 24 weeks, 32.2% of patients experienced treatment-emergent adverse events (TEAEs), most of which were mild (18.9%) or moderate (11.1%). No serious adverse events or deaths occurred. TEAEs related to the study drug occurred in 7.8%. Incidences of conjunctivitis and injection site reactions were low (1.1% each).

The ADmirable trial is the first prospective study of a biologic in a cohort composed exclusively of patients with skin of color and moderate-to-severe AD. These results support lebrikizumab as an effective and well-tolerated first-line biologic option following topical therapy, offering once-monthly maintenance dosing after the initial 4-month induction phase.

Source: Alexis A, Moiin A, Waibel J, et al. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: final 24-wWeek results from the phase 3b, open-label ADmirable study. Presented at: 2025 Revolutionizing Atopic Dermatitis (RAD) Conference; June 6-7, 2025; Nashville, TN.

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