Amgen has announced the approval of a new oral treatment option for children and adolescents with moderate to severe plaque psoriasis. This marks the first time that young patients and their caregivers have an oral option to address the uncomfortable and visible symptoms of this chronic disease. The efficacy and safety of the treatment, Otezla, were demonstrated in a Phase 3 study called SPROUT, which included pediatric patients aged 6 to 17 years.
According to Murdo Gordon, the Executive Vice President of Global Commercial Operations at Amgen, Otezla has been prescribed to over one million adults worldwide in the past decade. The approval of Otezla for pediatric patients represents a significant advancement in providing relief to a younger population.
Leah M. Howard, JD, the President and CEO of the National Psoriasis Foundation, highlighted the limited treatment options available for children with moderate to severe plaque psoriasis. The addition of an oral treatment option like Otezla, with a well-established safety profile, is welcome news for children and their families, especially since previous FDA-approved systemic treatments for youth have been limited to injections or infusions.
The most common side effects of Otezla include diarrhea, nausea, upper respiratory tract infections, tension headache, and headache. The maintenance dosage of Otezla for pediatric patients will vary based on weight, with doses of 20 or 30 mg administered twice daily after the initial titration period.
Amgen is dedicated to ensuring that plaque psoriasis patients have affordable access to Otezla. Psoriasis is a chronic disease characterized by the rapid buildup of skin cells, resulting in red, scaly, and itchy patches. Approximately 125 million people worldwide, including 14 million in Europe and over 8 million in the United States, are affected by psoriasis. About 80% of psoriasis patients have plaque psoriasis, and one in five pediatric patients with plaque psoriasis have moderate to severe disease.
Otezla, an oral small-molecule inhibitor, has shown positive results in treating plaque psoriasis in both adult and pediatric patients. The safety profile of Otezla in pediatric patients aligns with its established safety record in adults. Otezla is indicated for the treatment of plaque psoriasis in adult and pediatric patients, psoriatic arthritis, and oral ulcers associated with Behçet’s Disease.
It is important to note that Otezla is contraindicated in patients with a known hypersensitivity to apremilast or any excipients in the formulation. Patients should be monitored for side effects such as diarrhea, nausea, vomiting, and depression, especially in those with a history of mental health conditions. Weight changes and potential drug interactions should also be closely monitored.
For more information about Otezla and psoriasis, individuals can visit the Amgen website.
