Celgene has received approval from the US Food and Drug Administration (FDA) for its oral, selective inhibitor of phosphodiesterase 4 (PDE4) ‘OTEZLA (apremilast)’ as a treatment for adult patients with active psoriatic arthritis.
Psoriatic arthritis is a chronic disorder and is characterised by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning.
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According to the company, OTEZLA is the only FDA-approved oral treatment for psoriatic arthritis.
Rheumatology and Immunotherapy Center director Alvin Wells said the approval of oral OTEZLA is significant for patients living with psoriatic arthritis.
"OTEZLA offers physicians and patients a meaningful new treatment option, with the potential to benefit psoriatic arthritis patients irrespective of prior treatment," Wells said.
FDA approval of OTEZLA was based on safety and efficacy results from three multi-centre, randomised, double-blind, placebo-controlled trials, PALACE 1, 2 and 3, carried out in adult patients with active psoriatic arthritis who were inadequately controlled by disease-modifying anti-rheumatic drugs (DMARDs)and biologics.
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By GlobalDataMore than 75% of patients were previously treated with DMARDs only and 22% of patients received with biologics.
Swedish Medical Center rheumatology clinical research division director Philip Mease said OTEZLA works differently from other therapies approved for psoriatic arthritis through the intracellular inhibition of PDE4.
"The approval of an oral therapy with a novel mechanism of action for patients with psoriatic arthritis offers a different approach to patient care," Mease said.
The company said that OTEZLA treatment with or without (±) concomitant DMARDs, compared with placebo ± concomitant DMARDs, resulted in greater improvement in the signs and symptoms of psoriatic arthritis, as showed by the proportion of patients with an ACR 20 response at week 16.
In PALACE-1, 38% of patients treated with OTEZLA 30mg twice daily achieved an ACR 20 response at week 16 versus 19% of patients on placebo and consistent results were observed in PALACE-2 and PALACE-3.
Improvement in ACR 50 and ACR 70 responses were seen at week 16 across the three studies, the company said.
At week 16, patients treated with the drug achieved a reduction in tender and swollen joint counts compared with placebo.
Treatment with OTEZLA resulted in improvement for each of the seven ACR components measured, compared with placebo, at week 16.
Celgene global head of Inflammation and Immunology Scott Smith said 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," Smith said.
"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 will be available in the US in March 2014 and will be dispensed through a comprehensive network of specialty pharmacies.
Image: Magnetic resonance images of the fingers in psoriatic arthritis. Photo: courtesy of Stevenfruitsmaak.
