Adults with moderate to severe atopic dermatitis (AD) exhibit clinical improvement when treated with the anti–interleukin (IL)-13 monoclonal antibody lebrikizumab, even with single doses and twice-daily topical corticosteroid (TCS) use, according to the results of a randomized placebo-controlled double-blind study (TREBLE; ClinicalTrials.gov identifier: NCT02340234) published in the Journal of the American Academy of Dermatology.
The investigators sought to examine the efficacy and safety of lebrikizumab as add-on therapy to TCS. All patients were required to use twice-daily TCS and were randomly assigned in a 1:1:1:1 ratio to one of four treatment groups: (1) lebrikizumab 125 mg single dose (SD), (2) lebrikizumab 250 mg SD, (3) lebrikizumab 125 mg once every 4 weeks (Q4W), or (4) placebo Q4W, all for 12 weeks and after a 2-week TCS run-in period.
The 12-week treatment period was followed by an 8-week safety follow-up, during which time the patients could apply TCS on an as-needed basis. The primary end point was the percentage of patients who achieved a 50% reduction in Eczema Area and Severity Index (EASI-50) score from baseline at Week 12.
A total of 209 patients were enrolled in the study: (1) lebrikizumab 125 mg SD (n=52), (2) lebrikizumab 250 mg SD (n=53), (3) lebrikizumab 125 mg Q4W (n=51), and (4) placebo Q4W (n=53). At week 12, a significantly higher number of patients in the lebrikizumab 125 mg Q4W group achieved EASI-50 compared with patients treated with placebo (82.45% vs 62.3%, respectively; P =.026). However, no statistically significant improvements in EASI-50 scores were reported in patients in the 2 SD arms — lebrikizumab 125 mg SD and lebrikizumab 250 mg SD — compared with placebo-treated patients.
Adverse events, which were mostly mild to moderate, were similar in all groups (66.7% with lebrikizumab vs 66.0% with placebo).
The investigators concluded that although treatment with the lebrikizumab 125 mg Q4W regimen was associated with significant improvements in patients with moderate to severe AD, the twice-daily use of TCS in all treatment arms both prior to and during the study impaired their ability to fully assess the efficacy of lebrikizumab. Future studies of longer duration and in a larger population are warranted.
Simpson EL, Flohr C, Eichenfield LF, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: a randomized, placebo-controlled phase II trial (TREBLE) [published online January 15, 2018]. J Am Acad Dermatol. doi:10.1016/j.jaad.2018.01.017