SUMMIT, N.J. — Celgene on Friday announced that the Food and Drug Administration has approved Otezla (apremilast), the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning. Otezla is the only FDA-approved oral treatment for psoriatic arthritis.
Otezla is expected to be available in the United States in March 2014 and will be dispensed through a comprehensive network of specialty pharmacies.
"Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management. 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," stated Scott Smith, global head, Inflammation and Immunology, Celgene Corporation. "The FDA approval of Otezla is good news for patients and healthcare professionals who are looking for a different way to manage this disease."
"Otezla works differently from other therapies approved for psoriatic arthritis through the intracellular inhibition of PDE4," stated Philip Mease, director of the Rheumatology Clinical Research Division of Swedish Medical Center and Clinical Professor, University of Washington. "The approval of an oral therapy with a novel mechanism of action for patients with psoriatic arthritis offers a different approach to patient care."
A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints. At week 16, patients treated with Otezla achieved a reduction in tender and swollen joint counts compared with placebo. Otezla treatment resulted in improvement for each of the seven American College of Rheumatology components measured, compared with placebo, at week 16. Improvements were also seen in disease-related physical functioning.
Treatment with Otezla resulted in improvement in dactylitis (inflammation of fingers and toes) and enthesitis (inflammation at sites where tendons or ligaments insert into bone) in patients with these pre-existing symptoms. Enthesitis and dactylitis are specific disease manifestations related to psoriatic arthritis.
In Otezla clinical trials, the majority of the most common adverse reactions occurred within the first two weeks of treatment and tended to resolve over time with continued dosing. Adverse reactions reported in at least 2% of patients on Otezla 30 mg twice daily and at least 1% greater than that observed in patients on placebo for up to 16 weeks were diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis and upper abdominal pain. The proportion of patients who discontinued treatment due to any adverse reaction was 4.6% for patients taking Otezla 30 mg twice daily and 1.2% for patients taking placebo. The most common adverse reactions leading to discontinuation among patients treated up to 16 weeks with OTEZLA 30 mg twice daily were nausea (1.8%), diarrhea (1.8%) and headache (1.2%).