Apremilast provides skin clearance in paediatric psoriasis

Treatment with apremilast showed clear or almost clear skin in paediatric patients with moderate-to-severe plaque psoriasis, according to the SPROUT study presented at AAD 2023.

This phase III, multicentre, double-blind, placebo-controlled, parallel-group study involved 245 patients (mean age 12.2 years, 47.8 percent male) with moderate-to-severe plaque psoriasis (PASI* score ≥12, BSA** ≥10 percent, sPGA*** score ≥3) who were intolerant to topical therapy. Participants were randomized to receive either apremilast 20 or 30 mg twice daily (n=163) or placebo (n=82) for 16 weeks. At baseline, patients weighing ≥20 to <50 kg received apremilast 20 mg and those weighing ≥50 kg received apremilast 30 mg. All patients were stratified according to age group: 6–11 years (n=101) and 12–17 years (n=144). [AAD 2023, abstract 42163]

At week 16, patients treated with apremilast achieved a significantly higher rate of sPGA response, defined as an sPGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline, compared with placebo (33.1 percent vs 11.5 percent; p<0.0001).

Significantly more patients on apremilast also achieved a PASI-75, defined as ≥75-percent reduction from baseline in PASI score, than those on placebo (45.4 percent and 16.1 percent; p<0.0001).

Response rates for PASI-50 and PASI-90 were also significantly higher in the apremilast group than those in the placebo group (70.5 percent vs 32.1 percent; p<0.0001 and 25.2 percent vs 4.9 percent; p_nominal=0.0001, respectively).

In both weight subgroups, sPGA response rates were higher in the apremilast group than the placebo group among patients who weighed ≥20 to <50 kg (47.4 percent vs 21.8 percent) and ≥50 kg (19.2 percent vs 1.6 percent), as were the PASI-75 response rates (52.4 percent vs 21.4 percent [≥20 to <50 kg] and 38.7 percent vs 11.0 percent [≥50 kg]).

Moreover, apremilast-treated patients achieved significant improvements in total PASI score (least squares [LS] mean change from baseline, -65.3 percent vs -38.3 percent; p<0.0001) and affected BSA (LS mean change from baseline, -56.6 percent vs -21.8 percent; p<0.0001) than the placebo-treated patients.

In terms of safety, treatment-emergent adverse event (TEAE) rate was higher in the apremilast group than the placebo group (65.0 percent vs 41.3 percent). The most common TEAE was diarrhoea, which was resolved within 3 days.

“No new safety signals were identified, and AEs were consistent with the known safety profile of apremilast,” the researchers noted.

“Overall, apremilast significantly reduced psoriasis severity in paediatric patients with moderate-to-severe plaque psoriasis who were inadequately controlled or intolerant to topical therapy compared with placebo,” they concluded

*PASI: Psoriasis Area and Severity Index

**BSA: Body surface area

*** sPGA: static Physician Global Assessment