ICONIC-LEAD phase III: Continued vs withdrawn icotrokinra in plaque PsO

Results from the randomized withdrawal period (Week 24–52) of the phase III ICONIC-LEAD study (NCT06095115) assessing maintenance of response with icotrokinra in adults with moderate-to-severe plaque psoriasis (PsO) were published in the Journal of the American Academy of Dermatology by Soung et al. Patients who achieved a 75% improvement in Psoriasis Area and Severity Index (PASI75) or an Investigator’s Global Assessment (IGA) score of 0/1 at Week 24 of treatment with icotrokinra in ICONIC-LEAD were re-randomized to continue receiving icotrokinra (n = 169) or to withdraw from icotrokinra (n = 172). 

Key data: Continued icotrokinra demonstrated superior maintenance of PASI75 (89% vs 30%) and  PASI90 (84% vs 21%) responses at Week 52 vs withdrawal (multiplicity-adjusted p < 0.001). The median time-to-loss-of-response was not reached (NR) for PASI75 or PASI90 in the continued icotrokinra group vs 16.9 weeks and 10.1 weeks, respectively, in the withdrawal group (multiplicity-adjusted p < 0.001). Clear skin (PASI100 and IGA 0) was maintained in 74% of patients continuing icotrokinra vs 10% in the withdrawal group at Week 52 (nominal p < 0.001). No increase in exposure-adjusted adverse event (AE) rates were observed with continued icotrokinra through Week 52. 

Key learning: Continued icotrokinra demonstrated superior and durable maintenance of skin clearance through 52 weeks vs placebo/withdrawal in adults with moderate-to-severe plaque PsO, with a favorable safety profile, supporting its use as a long-term oral treatment option. Prolonged median time-to-loss-of-response among patients who discontinued treatment suggests a durable treatment effect that may persist beyond active icotrokinra therapy.