Otezla, an oral therapy for treatment of active psoriatic arthritis, has been approved by the FDA.
Oral treatment Otezla (apremilast) has been approved by the US Food and Drug Administration (FDA) to treat psoriatic arthritis.
The oral treatment was approved after 3 clinical trials involving 1,493 patients with active psoriatic arthritis. Before the study, more than 75% of participants were treated with disease-modifying anti-rheumatic drugs (DMARDs) and 22% were treated with biologics.
By week 16 in all 3 phases, the researchers observed improved American College of Rheumatology (ACR) 50 and ACR 70 responses. Specifically, patients treated with Otezla saw reduction in tender and swollen joints, improvement in dactylitis (inflammation of fingers and toes) and enthesitis (inflammation where tendons and ligaments meet bone).
“Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management,” Scott Smith, Global Head of Inflammation and Immunology at Celgene Corporation, said in a statement. “Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis. The FDA approval of Otezla is good news for patients and healthcare professionals who are looking for a different way to manage this disease.”
The most common side effects noted were diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis, upper abdominal pain, and increased depression. The FDA warned that patients taking Otezla should monitor their weight with their healthcare professional. If unexplained or clinically significant weight loss occurs, patients should talk to their doctor about discontinuing treatment and starting a weight loss plan.