Efficacy and safety of apremilast in paediatric patients with moderate-to-severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial.

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.