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

Abstract

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