Efficacy and safety of apremilast in paediatric patients with moderate-to-severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial
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Identificadores
URI: https://hdl.handle.net/10902/39103DOI: 10.1093/bjd/ljaf305.
ISSN: 0007-0963
ISSN: 1365-2133
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Paller, Amy S.; Fiorillo, Loretta; Becker, Emily; Armesto Alonso, Susana
; Kontzias, Apostolos; Oberoi, Rajneet K.; Zhang, Wendy; Amouzadeh, Hamid; Zhang, Zuoshun; Arkin, Lisa
Fecha
2025Derechos
Attribution 4.0 International © The Author(s) 2025. Published by Oxford University Press on behalf of British Association of Dermatologists
Publicado en
British Journal of Dermatology, 2025, 193(6),1120-1127
Editorial
Wiley
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Resumen/Abstract
Background Oral treatment options for paediatric patients with moderate-to-severe plaque psoriasis are limited. In the 16-week double-blind
placebo-controlled phase of the SPROUT trial, apremilast demonstrated efficacy vs. placebo in paediatric patients with psoriasis.
Objectives To evaluate the 52-week efficacy and safety of apremilast in SPROUT.
Methods SPROUT was a phase III multicentre randomized double-blind placebo-controlled parallel-group study (NCT03701763). Patients
were randomized 2 : 1 to receive apremilast 20 or 30 mg (for patients weighing 20 to<50 kg or≥50 kg at baseline, respectively) twice daily or
placebo for 16 weeks, after which all patients received apremilast through week 52 (apremilast/apremilast or placebo/apremilast, respectively). Patients were aged 6–17 years and had moderate-to-severe psoriasis that was inadequately controlled by or intolerant to topical therapy.
Results Of 245 patients randomized, 221 (apremilast/apremilast, n=149; placebo/apremilast, n=72) entered the apremilast extension phase
and 186 (apremilast/apremilast, n=125; placebo/apremilast, n=61) completed 52 weeks. With continued apremilast treatment, rates of static
Physician Global Assessment (sPGA) response (score of 0 or 1 with≥2-point reduction from baseline) further improved from week 16 (30.1%)
to week 52 (47.7%). In the placebo/apremilast group, sPGA response rates increased from 9.8% at week 16 to 44.4% at week 52. The proportions of patients with≥75% reduction from baseline in Psoriasis Area and Severity Index increased from 42.3% at week 16 to 60.4% at
week 52 in the apremilast/apremilast group and from 13.4% to 63.9% in the placebo/apremilast group. No new safety signals were observed.
Conclusions Improvements in clinical outcomes were sustained through 52 weeks with apremilast treatment in paediatric patients with
moderate-to-severe psoriasis. Safety findings were consistent with the known safety profile.
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