Lebrikizumab effective in moderate to severe atopic dermatitis through 52 weeks
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Key takeaways:
- Percentages of patients with at least one atopic comorbidity ranged from 69.9% to 75.4%.
- Percentages of patients who maintained IGA scores of 0 or 1 ranged from 68% to 80% with treatment.
BOSTON — Patients with moderate to severe atopic dermatitis experienced relief with lebrikizumab for 52 weeks, according to an abstract presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
Outcomes improved regardless of whether these patients had atopic comorbidities as well, Ellen R. Sher, MD, a physician with Allergy Partners of New Jersey, said during her presentation.
“ADvocate1 and ADvocate2 were the original studies of lebrikizumab treatment,” Sher said. “They were 16-week trials that showed clinically meaningful improvements in skin, itch, sleep and quality of life.”
During the ADvocate1 and ADvocate2 maintenance period, treatment with lebrikizumab (Ebglyss, Eli Lilly and Company) every 2 or 4 weeks continued for up to 52 weeks, and skin and itch improvement continued.
“The objective of this abstract is to evaluate the efficacy of lebrikizumab during the maintenance period — so between week 16 and week 52 — looking specifically at the patient with moderate to severe atopic dermatitis, both with and without atopic comorbidities,” Sher said.
The researchers used the American Academy of Dermatology Consensus Criteria to diagnose atopic dermatitis among the patients in the study, who were aged 12 years and older.
Specifically, the researchers defined moderate to severe atopic dermatitis as an Eczema Area and Severity Index (EASI) score of 16 or higher, an Investigator Global Assessment (IGA) score of 3 or higher, and body surface area involvement of 10% or more.
The patients had been diagnosed with atopic dermatitis at least a year before screening. Also, they were considered candidates for systemic therapy after inadequate response to topical medications.
The researchers defined response to lebrikizumab as achieving both an EASI 75 score, indicating a 75% improvement from baseline, an IGA score of 0 or 1, and an improvement of 4 points or more in Pruritus Numeric Rating Scale (NRS) assessments.
Patients who had responded to lebrikizumab during the 16-week induction period were again randomly assigned to receive 250 mg of lebrikizumab every 2 or every 4 weeks or a placebo every 2 weeks for the next 36 weeks.
“So, some of those patients were actually taken off drugs for that main 9 months,” Sher said.
Those who had not responded to lebrikizumab during the induction period began receiving 250 mg of lebrikizumab every 2 weeks.
During the maintenance period, the placebo group included 45 patients with and 15 without atopic comorbidities. The group receiving lebrikizumab once every 4 weeks had 89 patients with and 29 without atopic comorbidities. Those receiving lebrikizumab once every 2 weeks had 79 patients with and 34 without atopic comorbidities.
These comorbidities included any allergy, allergic rhinitis or hay fever, food allergy, asthma, history of asthma, allergic conjunctivitis and eosinophilic esophagitis.
The most common comorbidity was any allergy, including 68.3% of the placebo group, 70.3% of the monthly treatment group and 67.3% of the biweekly treatment group.
Sher additionally said the demographics in each group were “very well matched.”
“There were no significant differences there between age, region [or] sex,” she said. “The only thing that stands out a little bit is that the patients that were in the nonatopic group were a little bit more severe and had a later onset disease.”
Among patients with one or more atopic comorbidities, 83% of the monthly treatment group, 79% of the biweekly treatment group and 64% of the placebo group still had EASI 75 status at week 52.
Similarly, among patients who did not have any atopic comorbidities, 79% of the monthly treatment group, 78% of the biweekly treatment group and 75% of the placebo group still had EASI 75 status at week 52.
“About 80% maintained their EASI 75 scores during that 9 months, and there was not a significant difference between the patients that had atopic comorbidities and those who did not,” Sher said. “It’s interesting to note that even in the lebrikizumab withdrawal group, they maintained pretty good efficacy, even without taking it anymore.”
Also at week 52, 80% of the monthly treatment group, 68% of the biweekly treatment group and 38% of the placebo group maintained their IGA 0 or 1 scores, among the patients with one or more atopic comorbidities.
There was “a little bit more falloff in the patients that were not taking lebrikizumab,” Sher said. “That’s understandable.”
The patients who did not have any comorbidities and maintained their IGA 0 or 1 scores included 78% in the weekly treatment group, 76% in the placebo group and 70% in the monthly treatment group.
Percentages of patients among those with one or more atopic comorbidities who maintained a Pruritus NRS improvement of 4 points or more included 84% of the weekly treatment group, 81% of the monthly treatment group and 69% of the placebo group.
In the group of patients who did not have any atopic comorbidities, 94% of those on monthly treatment, 87% of those on biweekly treatment and 58% of the placebo group maintained their Pruritus NRS improvement of 4 points or more.
“Again, good efficacy maintained,” Sher said.
Sher noted that some of the subgroups had small sample sizes, particularly in some of the subgroups of patients who did not have any atopic comorbidities. Yet she and her colleagues concluded that efficacy was maintained for 52 weeks among patients with moderate to severe atopic dermatitis whether or not they had any atopic comorbidities.
“And the efficacy results for both skin and itch were similar, regardless of atopic comorbidity status,” Sher said.