Apremilast efficacious in pediatric psoriasis

Key takeaways:

• PASI and static Physician Global Assessment scores significantly improved in pediatric patients with psoriasis treated with apremilast vs. placebo.
• The best results were seen in patients aged 6 to 11 years.

Pediatric patients with psoriasis experienced significant improvement with oral apremilast treatment, according to phase 3 trial results.

“There isn’t any oral option for treatment of psoriasis in children that has been studied specifically in children,” Loretta Fiorillo, MD, director of pediatric dermatology at the University of Alberta and one of the study authors, told Healio. “There is a need for proper studies in children and the need for other medications for children. While the biologics have been good and are definitely the drug of choice for adults, when it comes to children, many refuse to have needles.”

The multicenter, randomized, double-blind, placebo-controlled, phase 3 SPROUT study included 245 patients aged 6 to 17 years with moderate to severe plaque psoriasis.

Loretta Fiorillo

Patients were randomly assigned to receive twice-daily apremilast (n = 163; mean age, 12.3 years) — 20 mg or 30 mg based on body weight — or placebo (n = 82; mean age, 12.2 years) for 16 weeks. An extension period continued through week 52 with all patients receiving apremilast.

At week 16, the primary endpoint of a static Physician Global Assessment response, defined as a score of 0 or 1 with at least a 2-point reduction from baseline, was achieved by 33.1% of the patients in the apremilast group compared with 11.5% of the placebo group (P

Secondary endpoints included a PASI 75 response in 45.4% of patients taking apremilast vs. 25.2% of those taking placebo, as well as a PASI 90 response in 25.2% of the trial group vs. 4.9% of the placebo group (P .0001 for both).

The percentage decrease in PASI score was 65.3% in the apremilast group and 38.3% in the placebo group, which the authors called a significant difference (P

In addition to these main endpoints, scalp and genital psoriasis were improved in the apremilast group compared with the placebo group.

The apremilast group also showed consistent improvement in all age ranges and weight groups; however, younger patients aged 6 to 11 years had a greater response.

“We had very favorable results with improvement of PASI score, improvement of the itch, improvement of scalp psoriasis. ... All the parameters we looked at were improved by apremilast,” Fiorillo said.

Adverse events occurred in 65% of the treatment group and 41.3% of the placebo group, with gastrointestinal issues being the most common in the apremilast group.

“[Apremilast] is a very easy option for children. It is a medication where they have to take a pill twice a day, but it does not require routing bloodwork,” Fiorillo said. “It seems to work particularly well for the younger age group ... and also seems to work better in children who are of normal body mass or lean.”