P45 GUIDE trial results after withdrawal in Part 3: long-term remission in patients with psoriasis treated with guselkumab within 15 months from onset of symptoms
Аннотация:Abstract GUIDE is an ongoing Phase 3b, randomized, double-blind trial examining early intervention with guselkumab in moderate-to-severe psoriasis. Super-responder [psoriasis area and severity index (PASI) = 0 at Weeks 20 and 28] patients with PASI < 3 at Week 68 were withdrawn from treatment in Part 3 of GUIDE (Weeks 68–220). Super-responder with short disease duration (SDD, guselkumab initiated ≤2 years from symptom onset) remained treatment-free longer than super-responders with long disease duration (LDD, >2 years; median 378 vs. 259 days). Here, we further investigate the impact of psoriasis disease duration on the median treatment-free period and long-term remission following guselkumab withdrawal in Part 3 of the GUIDE trial. Of 880 patients enrolled, 303 (34.4%) were super-responders; 273 were withdrawn from guselkumab at Week 68 [135 (49.5%) LDD; 138 (50.5%) SDD, thereof 71 (26.0%) had intermediate-SDD (ISDD; 15–24 months disease duration); and 67 (24.5%) had ultra-SDD (USDD, <15 months disease duration) patients]. Following guselkumab withdrawal, 35.5% of SDD and 18.5% of LDD patients remained treatment-free through Week 116 (PASI ≤5 at all visits). Among SDD patients, 43.3% of USDD vs. 28.2% of ISDD patients remained treatment-free through Week 116. Median treatment-free time was 449 days for USDD vs. 291 days for ISDD patients (hazard ratio: 0.39; 95% confidence interval: 0.24–0.62; nominal-P < 0.001). Among patients with clear skin (PASI = 0) at Week 116/Week 128/Week 140, 60.9%/76.5%/76.9% had USDD, 21.7%/17.6%/15.4% had ISDD, and 17.4%/5.9%/7.7% had LDD. After treatment withdrawal, super-responders treated with guselkumab within <15 months from symptom onset had a longer treatment-free time and were more likely to have clear skin than super-responders treated within 15–24 months. Findings suggest that very early intervention with guselkumab may modify disease mechanisms and counter disease progression.
Год издания:2024
Издательство:Oxford University Press
Источник:British Journal of Dermatology
Ключевые слова:Psoriasis: Treatment and Pathogenesis, Dermatology and Skin Diseases, Cholinesterase and Neurodegenerative Diseases