083 Prolonged Q16W treatment interval of guselkumab is non-inferior to Q8W dosing for maintaining disease control in super responders: primary results from GUIDE at Week 68 in patients with psoriasis

The Phase IIIb, double-blind GUIDE study evaluates the impact of early intervention and prolonged treatment intervals with guselkumab (GUS) on disease course in super responder (SRe) patients (pts) moderate–severe psoriasis (PSO). SRes (PASI=0 at Weeks [W] 20+28 GUS 100 mg Q8W [every 8W] treatment) were randomized to continue or extend Q16W, stratified by duration (short [SDD], ≤2 years [y]; long [LDD], >2 y). primary endpoint was proportion achieving PASI <3 W68. A non-inferiority margin 10% allowed for comparing Q16W vs Q8W. Of 880 pts enrolled, 297 (33.8%) W28. Baseline demographic data (median values) Q8W/Q16W groups balanced: BMI 26.7/26.2 kg/m2, age 36.5/37.0 y, 2.1/2.0 16.7/16.7, prior biologic therapy 4.7/9.4% pts. In intent-to-treat (ITT) population, W68 achieved 137/148 (92.6%) 137/149 (91.9%) pts, respectively, meeting (P=0.001) Subgroup analyses SDD also showed (nominal P=0.005) achievement (90.7% Q8W, 93.4% pts). Corresponding rates LDD 94.5% 90.4%, respectively; not met P=0.104). ITT set, PASI=0 rate significantly different P=0.016) (120/148 [81.1%]) (103/149 [69.1%]) is non-inferior PASI<3 W68, indicating potential dose-interval flexibility maintenance PSO control pt-tailored therapeutic strategies SRes.