EBGLYSS (Eli Lilly, NYSE:LLY) met its primary and secondary endpoints in the Phase 3b ADtouch study, with 53% of adults and adolescents treated for hand-and-foot atopic dermatitis achieving clear or almost clear hands and feet at Week 16. The placebo comparator reached 27%.

The trial enrolled 221 participants who received EBGLYSS monotherapy every two weeks or placebo over 16 weeks. Hand-and-foot disease carries particular weight in atopic dermatitis care because palmar and plantar involvement drives functional impairment, itch and pain that generalised severity scores can understate.

The secondary endpoints tracked symptom burden in patients with baseline symptom scores of at least four. Here, 57% of EBGLYSS patients reported a four-point improvement in itch versus 19% on placebo. Pain improvement followed the same pattern: 59% versus 19%. Adverse events occurred in 41.8% of the EBGLYSS arm and 39.6% of the placebo arm, a 2.2-percentage-point difference that signals a tolerability profile comparable to what earlier EBGLYSS trials reported.

Patient-reported satisfaction data reinforce the clinical endpoints. Among participants initially dissatisfied with the clearance of their hands, 77% of EBGLYSS-treated patients reported being satisfied or very satisfied at Week 16. In the placebo group, that figure was 40%.

Lilly has submitted the ADtouch data to the U.S. Food and Drug Administration. The company stated it plans additional submissions to select global regulators in support of a potential EBGLYSS label update, a step that would give prescribers an explicitly studied indication for hand-and-foot disease rather than off-label use extrapolated from generalised atopic dermatitis trials.

For clinicians, the ADtouch results arrive as biologics and systemic agents compete for a place in a treatment paradigm long dominated by topical corticosteroids and off-label systemic therapy for palmoplantar disease. A labelled option with monotherapy efficacy data, itch and pain endpoints, and a placebo-controlled safety comparison in this specific anatomic subset would simplify shared decision-making for one of the most functionally disabling presentations of atopic dermatitis.

The FDA review of the ADtouch submission, and the pace of Lilly's filings with other regulators, will determine how quickly the hand-and-foot data translate into prescribing information.