Less frequent lebrikizumab dosing yields similar efficacy in atopic dermatitis
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MILAN — Maintenance dosing of lebrikizumab every 4 weeks showed similar efficacy as dosing every 2 weeks in patients with atopic dermatitis, according to a presentation at the European Academy of Dermatology and Venereology Congress.
Andrew Blauvelt, MD, president of Oregon Medical Research Center and one of the study investigators, presented the new, detailed results from the ADvocate 1 and ADvocate 2 phase 3 clinical trials that evaluated lebrikizumab, a monoclonal antibody that binds to interleukin-13 protein.
Maintenance dosing of lebrikizumab every 4 weeks showed similar efficacy as dosing every 2 weeks in patients with atopic dermatitis.
“We mostly found the 4-week dosing did just as well as every 2 weeks, and even patients who were put onto placebo had a prolonged response with about half of them still doing well at 1 year,” Blauvelt told Healio.
Patients who responded initially to lebrikizumab 250 mg (Almirall, Eli Lilly and Company) every 2 weeks during a 16-week induction period — defined by a 75% reduction in EASI score or an IGA of 0 or 1 with at least a 2-point improvement — were then randomly assigned 2:2:1 to continue every 2-week dosing, switch to every 4-week dosing or switch to placebo.
Of those in the 2-week dosing groups, 75.8% in ADvocate 1 and 64.6% in ADvocate 2 maintained clear or almost clear skin at week 52. In the 4-week dosing groups, 74.2% in ADvocate 1 and 80.6% in ADvocate 2 achieved the same.
EASI 75 was maintained by 79.2% of both groups in ADvocate 1 at week 52, whereas 77.4% of the 2-week dosing group and 84.7% of the 4-week dosing group maintained EASI 75 in ADvocate 2.
In the placebo groups, 46.5% in ADvocate 1 and 49.8% in ADvocate 2 maintained IGA 0 or 1 through 52 weeks, and EASI 75 was maintained by 61.3% and 72%, respectively.
“The main competitors for lebrikizumab would be tralokinumab and dupilumab, and they both have maintenance dosing of every 2 weeks, so showing the patients doing very well with every 4-week maintenance dosing potentially leads to more convenient, long-term dosing than the other drugs in this class,” Blauvelt said.
The safety profile of the drug showed most treatment-emergent adverse events to be mild or moderate, with conjunctivitis (8.3% and 8.1%), atopic dermatitis (7.8% and 10.1%) and nasopharyngitis (6.8% and 9.6%) being the most common adverse events in the two studies.
At week 52, 58.1% and 67.8% of patients in the two trials reported an adverse event, which led to 2.3% and 3.9% of patients discontinuing the trials.