Lebrikizumab Maintains Efficacy With Reduced Dosing Interval

Long-term data from a 32-week extension of the ADjoin trial suggest that lebrikizumab, an IL-13 inhibitor approved for once-monthly dosing, may maintain clinical efficacy in patients with moderate-to-severe atopic dermatitis (AD) even when administered once every 8 weeks.

The extension study enrolled 103 patients who had completed 100 weeks of continuous lebrikizumab in parent studies (ADvocate1, ADvocate2, ADore, and ADopt-VA). Participants were re-randomized to receive either 250 mg lebrikizumab every 4 weeks (LEBQ4W, n=52) or every 8 weeks (LEBQ8W, n=51). Importantly, the re-randomization followed a mean 60-day off-treatment interval, enabling evaluation of durability of disease control.

At Week 32 of the extension, 62.0% of patients on LEBQ8W achieved IGA 0/1 (clear or almost clear skin), compared to 73.0% in the LEBQ4W arm. EASI 75 was achieved by 79.1% of the LEBQ8W group and 86.2% of the LEBQ4W group. EASI 90 was attained by 68.7% and 78.2%, respectively. Mean POEM scores—a patient-reported measure of symptom impact—remained low in both groups (9.2 in LEBQ8W vs. 5.4 in LEBQ4W), supporting sustained quality-of-life benefits.

“What’s exciting is that this shows one-quarter of the original dosing schedule may still be effective for some patients,” said Peter Lio, MD, a study investigator. “For patients used to dosing every 2 weeks, moving to once every 8 weeks is a game-changer in terms of freedom, cost, and simplicity.”

Beyond convenience, the reduced frequency could represent a clinical differentiator in a crowded AD treatment landscape.

“If approved, this could be a powerful way to show that there’s a real difference,” Dr. Lio said. “It helps future-proof the therapy, especially with less frequent biologics on the horizon.”

Safety findings were reassuring, with all reported adverse events classified as mild or moderate. There were no serious adverse events, no discontinuations due to treatment-emergent events, and no increases in anti-drug antibodies during the extension phase.

"It's always interesting to see how far we can go," Dr. Lio said.