APREMILAST demonstrated sustained efficacy and a consistent safety profile over 52 weeks in paediatric patients with moderate to severe plaque psoriasis.
Oral treatment options for children and adolescents with moderate to severe plaque psoriasis remain limited, with many patients relying on topical therapies that may not adequately control symptoms. The SPROUT trial aimed to address this gap by evaluating the long-term efficacy and safety of apremilast, a PDE4 inhibitor, in a paediatric population aged 6–17 years with inadequately controlled or intolerant plaque psoriasis.
The SPROUT study was a Phase III, multicentre, double-blind, placebo-controlled trial. Patients (n=245) were randomised in a 2:1 ratio to receive either apremilast (20 mg or 30 mg, based on body weight) or placebo twice daily for 16 weeks, after which all patients received apremilast through to Week 52. Of the original cohort, 221 patients entered the extension phase (149 continued apremilast; 72 switched from placebo to apremilast), and 186 completed 52 weeks. Efficacy continued to improve over time. The proportion of patients achieving static Physician Global Assessment (sPGA) response increased from 30.1% at Week 16 to 47.7% at Week 52 in the apremilast/apremilast group, and from 9.8% to 44.4% in the placebo/apremilast group. Similarly, Psoriasis Area and Severity Index 75 (PASI-75) responses rose from 42.3% to 60.4% and from 13.4% to 63.9%, respectively. Importantly, no new safety concerns were identified throughout the extended treatment period.
These findings suggest that apremilast is a safe and effective long-term oral treatment option for children and adolescents with moderate to severe plaque psoriasis. For clinicians, this offers a promising alternative for patients who have limited options beyond topical agents. Continued improvement beyond the initial 16 weeks highlights the importance of maintaining treatment for sustained benefit. As safety remained consistent with the known profile of apremilast, its use in clinical practice could potentially fill a crucial gap in paediatric dermatology. Future studies could further explore long-term quality-of-life outcomes and comparative effectiveness with other systemic therapies in this age group.
Reference
Paller AS et al. Efficacy and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial. Br J Dermatol. 2025; DOI: 10.1093/bjd/ljaf305. [Epub ahead of print]
