GUIDE
Trial question
Is 16-week guselkumab noninferior to 8-week guselkumab for maintenance therapy in patients with moderate-to-severe psoriasis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 297
297 patients (95 female, 202 male).
Inclusion criteria: adult patients with moderate-to-severe psoriasis.
Key exclusion criteria: previous receipt of therapeutic agent directly targeting IL-23; receipt of systemic immunosuppressant or anakinra within 4 weeks of the first administration of study drug; positive test for HBV infection.
Interventions
N=149 guselkumab every 16 weeks (at a dose of 100 mg at weeks 0, 4, 12, and 20, followed by 100 mg every 16 weeks between weeks 28-68).
N=148 guselkumab every 8 weeks (at a dose of 100 mg at weeks 0, 4, 12, and 20, followed by 100 mg every 8 weeks between weeks 28-68).
Primary outcome
Psoriasis Area and Severity Index < 3 at week 68
91.9%
92.6%
92.6 %
69.4 %
46.3 %
23.1 %
0.0 %
Guselkumab every 16
weeks
Guselkumab every 8
weeks
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in Psoriasis Area and Severity Index < 3 at week 68 (91.9% vs. 92.6%; OR 0.92, 90% CI 0.45 to 1.87).
Secondary outcomes
Significant decrease in Psoriasis Area and Severity Index ≤ 1 at week 68 (79.2% vs. 89.9%; ARD -10.7, 90% CI -17.5 to -3.8).
Significant decrease in Psoriasis Area and Severity Index of 0 in at week 68 (69.1% vs. 81.1%; ARD -12, 90% CI -20.1 to -3.8).
No significant difference in Dermatology Life Quality Index 0/1 in at week 68 (77.9% vs. 83.1%; ARD -5.2, 95% CI -12.8 to 2.3).
Safety outcomes
No significant difference in treatment-emergent serious adverse events and drug-related treatment-emergent adverse events.
Conclusion
In adult patients with moderate-to-severe psoriasis, guselkumab every 16 weeks were noninferior to guselkumab every 8 weeks with respect to Psoriasis Area and Severity Index < 3 at week 68.
Reference
Kilian Eyerich, Khusru Asadullah, Andreas Pinter et al. Noninferiority of 16-Week vs 8-Week Guselkumab Dosing in Super Responders for Maintaining Control of Psoriasis: The GUIDE Randomized Clinical Trial. JAMA Dermatol. 2024 Jul 31:e242463.
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