FDA Approves Otezla® for Pediatric Psoriatic Arthritis in Patients 6 Years and Older

The FDA has granted approval for Otezla® (apremilast) to treat active psoriatic arthritis in pediatric patients aged 6 years and older who weigh at least 20 kg. This landmark approval is backed by robust evidence from controlled clinical trials, including the PALACE Phase 3 studies in adults and the SPROUT Phase 3 study involving 245 pediatric patients.

For appropriate candidates, the recommended dosage regimen is weight-based: pediatric patients weighing 50 kg or more should receive 30 mg twice daily. In comparison, those weighing between 20 kg and 50 kg should take 20 mg twice daily. An initial titration schedule is advised to mitigate gastrointestinal side effects. It is important to note that the safety and efficacy of Otezla have not been established in patients younger than 6 years or those weighing less than 20 kg. For comprehensive prescribing information, please refer to the official documentation.

Please click here for the full prescribing information.

Elevate-Derm Alliance Editorial Committee