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16-week vs 8-week guselkumab maintenance treatment in patients with plaque psoriasis: Results from the phase III GUIDE trial
| The ongoing phase IIIb GUIDE trial (NCT03818035) is assessing the safety and efficacy of guselkumab, a fully human monoclonal antibody that targets the p19 subunit of interleukin (IL)-23, in patients with moderate-to-severe plaque psoriasis.1 Results from Part 1 of this trial were reported previously by the PsOPsA Hub. In Part 2 (Week 28–68), patients from Part 1 who achieved a Psoriasis Area and Severity Index (PASI) score of 0 at both Week 20 and Week 28, or super responders (SRes), were randomized to continue guselkumab 100 mg every 8 weeks (Group 2A; n = 148) or every 16 weeks (Group 2B; n = 149).1 Non-SRes continued guselkumab every 8 weeks (Group 2C; n = 525).1 Results from Part 2 of this trial were published in JAMA Dermatology by Eyerich, et al.1 |
| Key learnings: |
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The primary endpoint of noninferiority of guselkumab was met; extending guselkumab dosing intervals to 16 weeks was found to be noninferior to the standard 8-week regimen for maintaining disease control in SRes, with 92.6% and 91.9% of patients in Groups 2A and 2B, respectively, achieving a PASI score of <3 at Week 68 (p = 0.001). |
| The study found that both dosing schedules resulted in similar immunologic responses, including sustained reductions in skin CD8-positive tissue-resident memory T cells and serum levels of inflammatory cytokines such as IL-17A, IL-17F, and IL-22, which are crucial in psoriasis pathogenesis. |
| Guselkumab was well tolerated across both dosing regimens, with no new safety concerns identified, supporting its potential for de-escalation strategies in clinical practice. |
| These findings suggest that extending guselkumab dosing intervals could reduce treatment burden while maintaining effective long-term disease control, offering a valuable option for personalized psoriasis management. |
- Eyerich K, Asadullah K, Pinter A, 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. Online ahead of print. DOI: 10.1001/jamadermatol.2024.2463
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