Lebrikizumab plus topical steroids safe, effective in atopic dermatitis treatment
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Combination lebrikizumab and topical corticosteroids outperformed topical corticosteroids alone in the treatment of atopic dermatitis in adolescents and adults, according to a phase 3 study.
“Currently, emollients and topical corticosteroids (TCS) are mainstay treatments for mild AD. In moderate to severe AD, the addition of systemic therapy and/or phototherapy is recommended,” Eric L. Simpson, MD, MCR, Frances J. Storrs Medical Dermatology Professor at Oregon Health and Science University and principal investigator of the ADhere trial, and colleagues wrote. “Due to the heterogeneity of AD, there remains a need to provide additional therapeutic options for long-term management.”
The 16-week, double-blind, placebo-controlled, multicenter, phase 3 ADhere trial analyzed the efficacy and safety of lebrikizumab, a novel monoclonal antibody that targets and neutralizes interleukin-13 signaling, in combination with low- to mid-potency TCS for the treatment of AD in adolescents and adults. These results, published in JAMA Dermatology, follow an Eli Lilly press release from April 2022.
In the study, a total of 211 patients (median age, 37.2 years; 48.8% female) were randomly assigned to receive 500 mg of subcutaneous lebrikizumab at baseline and week 2 followed by 250 mg every 2 weeks plus TCS or placebo plus TCS for 16 weeks.
By week 16, results showed 41.2% of lebrikizumab plus TCS-treated patients achieved the primary endpoint of a 0 or 1 IGA score compared with 22.1% of the placebo group (P = .01). Additionally, 69.5% of patients treated with lebrikizumab plus TCS achieved the key secondary endpoint of EASI 75 compared with 42.2% of the placebo group (P < .001).
Safety data demonstrated findings consistent with previously reported AD trials. Most treatment-related adverse events were not considered serious and were mild or moderate in severity, according to the study, and included conjunctivitis, headache, hypertension, injection site reactions and herpes infection. Serious adverse events were reported by two patients in the lebrikizumab plus TCS group and one patient in the placebo group.
“Treatment with [lebrikizumab plus TCS vs. placebo plus TCS] achieved statistically significant improvements in the signs and symptoms of moderate to severe AD in adolescents and adults,” Simpson and colleagues wrote. “The [lebrikizumab plus TCS] group had a benefit to risk profile consistent with prior lebrikizumab AD studies. Taken together, the efficacy and safety data reported herein suggest that [lebrikizumab plus TCS] may be an effective treatment option for adult and adolescent patients with moderate to severe AD.”