Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial.

Background: Approved systemic treatment options are limited for pediatric patients with moderate to severe plaque psoriasis.

Objective: To assess the efficacy and safety of apremilast over 16 weeks in pediatric patients with plaque psoriasis.

Methods: SPROUT (NCT03701763) was a phase 3, multicenter, randomized, double-blind, placebo-controlled study of apremilast in patients aged 6-17 years with moderate-to-severe psoriasis (Psoriasis Area and Severity Index [PASI] ≥12, body surface area ≥10%, static Physician Global Assessment [sPGA] ≥3) inadequately controlled by/inappropriate for topical therapy.

Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study.

Background: Many patients with psoriasis are bothered by symptoms in highly visible, pruritic areas, such as the scalp.

Objective: To evaluate the efficacy and safety of apremilast for moderate to severe scalp psoriasis.

Methods: This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to at least 1 topical scalp psoriasis therapy (NCT03123471).

Pharmacokinetics and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: Results from a phase 2 open-label study.

Background: No oral systemic treatments are approved for pediatric patients with psoriasis.

Objective: To evaluate the pharmacokinetics and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in pediatric patients with psoriasis.

Methods: This phase 2, multicenter, open-label study enrolled pediatric patients with moderate to severe plaque psoriasis.

Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp.

Pruritus is a prevalent and bothersome symptom of scalp psoriasis. Validated scales assessing scalp itch are needed to evaluate treatment efficacy. To evaluate comprehensibility and reproducibility of the Scalp Itch Numeric Rating Scale (NRS), a novel scale being used in a phase 3 study of apremilast.