A phase 2b clinical trial showed lebrikizumab, an IL-13 monoclonal antibody, was safe and effective for patients with moderate to severe atopic dermatitis (AD). The study results were published in JAMA Dermatology.
The double-blind, placebo-controlled, randomized clinical trial included 280 participants with moderate to severe AD. Participants were randomized 2:3:3:3 to placebo every 2 weeks (n=52), subcutaneous lebrikizumab 125 mg every 4 weeks (n=73), 250 mg every 4 weeks (n=80), or 250 mg every 2 weeks (n=75).
The primary end point included the percentage change in Eczema Area and Severity Index (EASI) from baseline to week 16. Secondary end points included the proportion of participants who achieved an Investigator’s Global Assessment score of 0 or 1; EASI improvement of at least 50%, 75%, or 90% from baseline; percentage change in pruritus numeric rating scale (NRS) score; and pruritus NRS score improvement of at least 4 points. In addition, the researchers recorded treatment-emergent adverse events.
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Compared with placebo, participants treated with lebrikizumab showed dose-dependent, statistically significant improvements in EASI scores at week 16. The researchers also observed differences in pruritus NRS improvement of at least 4 points or more between lebrikizumab and placebo groups, which was seen as early as day 2 among those in the high dose lebrikizumab group.
Treatment-emergent adverse events were mainly mild to moderate and did not lead to discontinuation. These were reported in:
- 24 of 52 participants (46.2%) in the placebo group
- 42 of 73 participants (57.5%) in the lebrikizumab 125 mg every 4 weeks group
- 39 of 80 participants (48.8%) in the lebrikizumab 250 mg every 4 weeks group
- 46 of 75 participants (61.3%) in the lebrikizumab 250 mg every 2 weeks group
In addition, the researchers observed low rates of injection-site reactions, herpes virus infections, and conjunctivitis.
“These data support the central role of IL-13 in AD pathophysiology. If these findings replicate in phase 3 studies, lebrikizumab may meaningfully advance the standard of care for moderate to severe AD,” the researchers concluded.
Guttman-Yassky E, Blauvelt A, Eichenfield LF, et al. Efficacy and safety of lebrikizumab, a high-affinity interleukin 13 inhibitor, in adults with moderate to severe atopic dermatitis: A phase 2b randomized clinical trial [published online February 26, 2020]. JAMA Dermatol. doi:10.1001/jamadermatol.2020.0079