The safety profile for lebrikizumab for treatment of moderate-to-severe atopic dermatitis consists of nonserious, mild/moderate adverse events that do not lead to treatment discontinuation, according to authors of a study published in the American Journal of Dermatology.
Researchers conducted an integrated analysis of 8 phase 2 and phase 3 clinical trials to evaluate the safety of the interleukin-13 blocker lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis. Data from the 8 trials were summarized in 2 datasets. The first dataset compared the safety of placebo vs lebrikizumab at a dosage of 250 mg every 2 weeks (LEBQ2W) during a 16-week, placebo-controlled period for patients in 1 phase 2b and 3 phase 3 double-blind studies (All-PC Week 0-16). The second dataset evaluated the long-term safety of lebrikizumab for all patients who received at least 1 dose of the drug during any of the 8 atopic dermatitis clinical trials (All LEB); it included 4 additional studies, some of which were open label. Dosages evaluated included 250 mg every 2 weeks, 125 mg or 250 mg every 4 weeks, and single doses of 125-mg or 250-mg. The placebo-controlled dataset for this analysis included both monotherapy and combination studies with administration of topical corticosteroids.
In the All-PC Week 0-16 dataset, the placebo and LEBQ2W groups had a similar frequency of patients experiencing at least 1 treatment-emergent adverse event (TEAE): 53.1% and 49.2%, respectively. Most TEAEs were mild/moderate, with 91.6% in the placebo group and 95.3% in the LEBQ2W group. The most commonly reported events were conjunctivitis (with a frequency of 2.5% in the placebo group and 8.5% in the LEBQ2W group) and atopic dermatitis. Atopic dermatitis was reported more frequently in the placebo group (18.4% vs 6.0% in the LEBQ2W group), while conjunctivitis was reported more frequently in the LEBQ2W group (6.5% vs 1.8% in the placebo group). Apart from conjunctivitis, among patients in the LEBQ2W group there were more reports of nasopharyngitis, headache, allergic conjunctivitis, dry eye, and allergic rhinitis compared with patients in the placebo group.
In the All-LEB dataset, the most common TEAEs (reported with a single preferred term at a rate greater than 5%) were nasopharyngitis (9.1%), COVID-19 (7.7%), atopic dermatitis (7.4%), and conjunctivitis (6.5%).
Injection site reactions were more frequent among patients who received lebrikizumab (2.6% in the LEBQ2W group compared with 1.5% in the placebo group). TEAEs that led to treatment discontinuation were rare, with only 2.3% of participants in the LEBQ2W group experiencing this compared with 1.4% in the placebo group. Overall, the frequency of TEAEs in the LEBQ2W group was 4.2%, compared with a 3.1% frequency in the placebo group.
The researchers noted several limitations of this study, including its short placebo-controlled period, and the fact that the open-label and long-term safety studies included in the integrated analysis lacked a control arm and had few patient-years.
The researchers concluded, “This integrated safety analysis in adolescent and adult patients with moderate-to-severe [atopic dermatitis] is consistent with the previously published safety profile of lebrikizumab. The incidence of most TEAEs did not increase with longer duration of exposure.”
Disclosure: This research was supported by Dermira, Inc, a wholly owned subsidiary of Eli Lilly and Company. Please see the original reference for a full list of disclosures.
This article originally appeared on Dermatology Advisor
Stein Gold L, Thaçi D, Thyssen JP, et al. Safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis: an integrated analysis of eight clinical trials. Am J Clin Dermatol. Published online May 17, 2023. doi:10.1007/s40257-023-00792-6