Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
Long-term safety and efficacy of secukinumab in paediatric severe plaque psoriasis: 236-week, Phase 3 trial results.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Kaszuba Andrzej, Papanastasiou Philemon, Krasowska Dorota, De Lucas Laguna Raul, Ziv Michael, Ravichandran Shoba, Bansal Amita, Dahale Swapnil S, Martin Ruvie, Paguet Bertrand, Magnolo Nina, Kingo Kulli
Аннотация
BACKGROUND: Plaque psoriasis, a chronic inflammatory disease, affects up to 2.1% of the global paediatric population. In a Phase 3 study (NCT02471144), secukinumab treatment for up to 104 weeks demonstrated good tolerability and efficacy in paediatric patients with severe chronic plaque psoriasis.
OBJECTIVES: Final long-term safety and efficacy results of secukinumab through 236 weeks of treatment in paediatric patients with severe chronic plaque psoriasis.
METHODS: During the extension period (Weeks 52-236), paediatric patients aged 6 to <18 years with severe chronic plaque psoriasis received either 'Any secukinumab' low dose (LD; patients receiving secukinumab LD up to Week 52; patients on placebo who transitioned to secukinumab LD) or 'Any secukinumab' high dose (HD; patients receiving secukinumab HD up to Week 52 and patients on placebo who transitioned to secukinumab HD). Assessments included Psoriasis Area and Severity Index (PASI) 75/90/100 responses, Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response, relapse, rebound, Children's Dermatology Life Quality Index (CDLQI) score, CDLQI 0/1 response and long-term safety up to Week 236.
RESULTS: Secukinumab maintained efficacy through 236 weeks of treatment, with consistent responses observed in most assessments across both dose groups. At Week 236, the responder rate for IGA mod 2011 0/1 was 69.4% ('Any secukinumab' LD) and 79.5% ('Any secukinumab' HD); the PASI 75/90/100 responses were 97.2%/77.8%/50.0% ('Any secukinumab' LD) and 97.4%/84.6%/69.2% ('Any secukinumab' HD). CDLQI 0/1 responses remained consistent in both dose groups and were maintained up to Week 236 ('Any secukinumab' LD: 64.3%; 'Any secukinumab' HD: 67.7%). The most common adverse events were nasopharyngitis (EAIR/100 PYs [95% CI]:13.9 [10.0, 18.7]), headache (5.8 [3.7, 8.8]) and tonsillitis (4.7 [2.8, 7.4]). Candida infections were reported in 3 patients.
CONCLUSIONS: These findings support the sustained efficacy and favourable safety profile of secukinumab in paediatric patients with severe plaque psoriasis over a 236-week treatment period.
OBJECTIVES: Final long-term safety and efficacy results of secukinumab through 236 weeks of treatment in paediatric patients with severe chronic plaque psoriasis.
METHODS: During the extension period (Weeks 52-236), paediatric patients aged 6 to <18 years with severe chronic plaque psoriasis received either 'Any secukinumab' low dose (LD; patients receiving secukinumab LD up to Week 52; patients on placebo who transitioned to secukinumab LD) or 'Any secukinumab' high dose (HD; patients receiving secukinumab HD up to Week 52 and patients on placebo who transitioned to secukinumab HD). Assessments included Psoriasis Area and Severity Index (PASI) 75/90/100 responses, Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response, relapse, rebound, Children's Dermatology Life Quality Index (CDLQI) score, CDLQI 0/1 response and long-term safety up to Week 236.
RESULTS: Secukinumab maintained efficacy through 236 weeks of treatment, with consistent responses observed in most assessments across both dose groups. At Week 236, the responder rate for IGA mod 2011 0/1 was 69.4% ('Any secukinumab' LD) and 79.5% ('Any secukinumab' HD); the PASI 75/90/100 responses were 97.2%/77.8%/50.0% ('Any secukinumab' LD) and 97.4%/84.6%/69.2% ('Any secukinumab' HD). CDLQI 0/1 responses remained consistent in both dose groups and were maintained up to Week 236 ('Any secukinumab' LD: 64.3%; 'Any secukinumab' HD: 67.7%). The most common adverse events were nasopharyngitis (EAIR/100 PYs [95% CI]:13.9 [10.0, 18.7]), headache (5.8 [3.7, 8.8]) and tonsillitis (4.7 [2.8, 7.4]). Candida infections were reported in 3 patients.
CONCLUSIONS: These findings support the sustained efficacy and favourable safety profile of secukinumab in paediatric patients with severe plaque psoriasis over a 236-week treatment period.