@article{10902/39103,
year = {2025},
url = {https://hdl.handle.net/10902/39103},
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.},
publisher = {Wiley},
publisher = {British Journal of Dermatology, 2025, 193(6),1120-1127},
title = {Efficacy and safety of apremilast in paediatric patients with moderate-to-severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial},
author = {Paller, Amy S. and Fiorillo, Loretta and Becker, Emily and Armesto Alonso, Susana and Kontzias, Apostolos and Oberoi, Rajneet K. and Zhang, Wendy and Amouzadeh, Hamid and Zhang, Zuoshun and Arkin, Lisa},
}