The primary endpoint of the study was the safety of the medication at two weeks and pharmacokinetics of the drug, which were calculated using validated liquid chromatography tandem mass spectrometry. The secondary endpoint was the taste of the medication, which was measured using a faces Likert scale.
A total of 42 patients participated in the study, but 31 patients (74%) concluded the 52 week study. Of the 11 patients (26%) who withrew from the study, only 2 patients (5%) did so due to adverse events. Researchers found that apremilast reached its maximal serum levels two to three hours after ingestion. Most patients didn’t dislike the taste of the medication with only five participants reporting negatively on the faces Likert scale.
The safety of apremilast has been extensively reported in adults with psoriasis, but studies have been lacking in children. This open label phase 2 trial suggests that the safety observed in adults may be reproducible in children. The authors emphasize that finding safe systemic options for pediatric patients is vital as this patient population’s treatment course can last for many years, compounding risk of adverse events.
For now, most systemic therapies, including methotrexate, acitretin, TNF inhibitors and other biologics, are used off-label; however, many of these treatments have serious side effects that limit their use. The importance of finding durable, safe treatment options for children with psoriasis is paramount. This study is encouraging as its findings suggest that apremilast has the same safety in children that it has in adults.
Paller, Amy S., et al. "Pharmacokinetics and Safety of Apremilast in Pediatric Patients With Moderate to Severe Plaque Psoriasis: Results From a Phase 2 Open-Label Study." Journal of the American Academy of Dermatology. 2019.