Lebrikizumab for Atopic Dermatitis Results in Long-Term Improvements Over 152 Weeks

Long-term treatment of atopic dermatitis over 152 weeks with lebrikizumab therapy results in improvements in patients’ self-reported skin symptoms, sleep disturbances, and itch, according to new findings.1

These data were the conclusion detailed in a recent study abstract titled ‘Patients with lebrikizumab reported long-term improvement of symptoms from POEM in moderate-to-severe atopic dermatitis.’ This abstract was presented at the Revolutionizing Atopic Dermatitis Conference Mid-Year Virtual Update on December 8, 2024.

The data was authored by investigators such as Peter A. Lio, MD, a clinical assistant professor of dermatology & pediatrics for Northwestern University Feinberg School of Medicine. Lebrikizumab—approved by the US Food and Drug Administration (FDA) in September 2024—was shown to be efficacious in the long-term, specifically in terms of skin symptom improvements observed in clinician assessments.2

“Here, we report the patient’s perspective of disease severity as assessed using the Patient-Oriented Eczema Measure (POEM), in patients with moderate-to-severe ADafter 152 weeks of treatment with lebrikizumab in the ADjoin study,” Lio and colleagues wrote.1

Trial Design

Data from participants included in the ADjoin study were featured in this analysis, specifically on subjects who had been given lebrikizumab therapy for up to 152 weeks. Those with responses at the 16-week mark to treatment with lebrikizumab in the earlier ADvocate 1 and 2 trials (achieving EASI-75 or IGA 0/1 with ≥ 2-point improvement and without rescue medication) were re-randomized by Lio and colleagues.

They were either placed on maintenance doses of either 250 mg on an every-4-week basis (Q4W) or every 2 weeks (Q2W). Then, the treatment was continued in ADjoin for 100 more weeks.

The investigative team highlighted POEM's value as a tool, noting that it is essential to incorporate both physician- and patient-reported outcomes within clinical research for the purposes of comprehensive understanding of the skin condition's impact and severity from the patient’s viewpoint.

The team noted that POEM provides patients the chance to record symptom frequency weekly using an electronic diary, with 7 major areas being covered: sleep disturbance, pruritus, skin bleeding, cracking, oozing, flaking, and dryness. Ratings of symptoms are based on frequency over the prior week, and POEM's scores span from 0 (“No days”) to 4 (“Every day”).

This then results in a total possible score of 0 - 28. The team noted that higher POEM scores suggest greater severity of atopic dermatitis.

Overall, their pooled analysis assessed participants' POEM responses from the 16 - 152-week marks, with subjects given lebrikizumab treatment Q4W or Q2W. The team focused on the proportion of those achieving a POEM response of 0 (no days) or 1 (1-2 days) for all of the aforementioned disease symptoms.

Notable Findings on Lebrikizumab

The investigators found that there were improvements to patient conditions noted across all individual POEM items, including sleep disturbances, pruritus, and dryness. They added that these shifts were found to have been maintained over the course of the analysis.

Subjects at the point of baseline were noted as having an average total POEM score of 20.6. Then, by the 16-week mark, it was reported by the research team that the participants' mean scores had seen improvements to 7.7 (Q4W) and then 8.5 (Q2W).

The team also highlighted reductions that were observed at the 52-week mark (7.0 and 6.5, respectively) and then at the 152-week mark (5.3 and 5.5, respectively). By the latter time point, the investigators found that majority of those assessed pointed to having minimal symptoms.

Specifically, they found that 94.5% (Q4W) and 94.0% (Q2W) noted that they had minimal sleep disturbance, 69.1% (Q4W) and 66.0% (Q2W) reported having little to no itch (0–1 days), and there were similarly high percentages for other symptoms.

Notably, the researchers found that a substantial proportion of the participants had no days of symptoms for individual items including bleeding, itch, and fluid oozing.

“In the ADjoin study, long-term treatment with lebrikizumab led to improvements in itch, sleep disturbance, and skin symptoms as reported from a patient’s perspective using POEM,” they wrote. “Most patients reported no or two or less days per week of POEM symptoms related to itch, sleep disturbance and skin dryness.”1

References

1. Lio P, Murase J, de Bruin-Weller M, et al. Patients with lebrikizumab reported long-term improvement of symptoms from POEM in moderate-to-severe atopic dermatitis. Presented as part of the 2024 Revolutionizing Atopic Dermatitis Mid-Year Virtual Update. December 8, 2024.
2. Smith T. FDA Approves Lebrikizumab Treatment of Eczema Among Patients Aged 12 and Older. HCPLive. September 13, 2024. https://www.hcplive.com/view/fda-approves-lebrikizumab-treatment-eczema-among-patients-aged-12-and-older. Date accessed: December 12, 2024.