Nektar Rezpegaldesleukin Maintains 71% Monthly, 83% Quarterly EASI-75 Responses
In the REZOLVE-AD trial, 24 µg/kg monthly and quarterly rezpegaldesleukin dosing maintained EASI-75 in 71% and 83% of patients and vIGA-AD 0/1 in 85% and 63% at week 52. Maintenance dosing produced a 2–5× increase in EASI-100 rates, paving way for Phase 3.
1. Trial Design
The REZOLVE-AD Phase 2b study enrolled 393 moderate-to-severe atopic dermatitis patients who underwent a 16-week induction period with rezpegaldesleukin. Responders achieving ≥50% EASI reduction were re-randomized to 24 µg/kg monthly (Q4W) or quarterly (Q12W) dosing for a 36-week blinded maintenance phase through week 52.
2. Efficacy Results
At week 52, 71% of Q4W and 83% of Q12W patients maintained EASI-75, while 85% and 63% maintained vIGA-AD 0/1 responses. New and deepened responses included up to a 5-fold increase in EASI-100 rates, rising from 4% to 22% with Q4W and from 9% to 18% with Q12W maintenance.
3. Safety and Advancement
Rezpegaldesleukin showed a favorable safety profile with no new adverse signals in conjunctivitis, herpes or malignancies. Durability of responses under both dosing regimens validates the regulatory T-cell mechanism and supports initiation of a pivotal Phase 3 maintenance program.