FDA approves oral drug for psoriatic arthritis
Summit, New Jersey, March 25, 2014
Celgene Corporation said the US Food and Drug Administration (FDA) 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 characterised by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning.
Dr Alvin Wells, director of Rheumatology and Immunotherapy Center, Franklin, said: “The approval of oral Otezla is significant for patients living with psoriatic arthritis, which is a debilitating, painful disease that has a significant effect on a patient’s day-to-day activities.”
“Otezla offers physicians and patients a meaningful new treatment option, with the potential to benefit psoriatic arthritis patients irrespective of prior treatment.”
The approval was based on safety and efficacy results from three multi-centre, randomised, double-blind, placebo-controlled trials – Palace 1, 2 and 3 – conducted in adult patients with active psoriatic arthritis who were inadequately controlled by disease-modifying anti-rheumatic drugs (Dmards) and/or biologics. More than 75 per cent of patients were previously treated with Dmards only and 22 per cent of patients were previously treated with biologics.
Otezla treatment with or without concomitant Dmards, compared with placebo with or without concomitant Dmards, resulted in greater improvement in the signs and symptoms of psoriatic arthritis, as demonstrated by the proportion of patients with an ACR 20 response at week 16.
In Palace-1, 38 per cent of patients treated with Otezla 30 mg twice daily achieved an ACR 20 response at week 16 versus 19 per cent of patients on placebo.
Consistent results were observed in Palace-2 and Palace-3. Improvement in ACR 50 and ACR 70 responses were observed at week 16 across the three studies.
At week 16, patients treated with Otezla achieved a reduction in tender and swollen joint counts compared with placebo. It resulted in improvement for each of the seven ACR components measured, compared with placebo, at week 16. Improvements were also seen in disease-related physical functioning.
The treatment also 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.
During the 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. It included 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 per cent for patients taking Otezla 30 mg twice daily and 1.2 per cent for patients taking placebo.
Otezla is contraindicated for use in patients with a known severe allergic reaction to it or other components in it.
Across the three Palace studies, one per cent of patients treated with Otezla reported depression or depressed mood compared with 0.8 per cent treated with placebo; 0.3 per cent of patients treated with Otezla discontinued treatment due to depression or depressed mood compared with none among placebo-treated patients.
About 10 per cent of patients taking the drug, compared with 3.3 per cent of patients taking placebo, reported weight loss of five to ten per cent.
Scott Smith, global head, Inflammation and Immunology, Celegene, 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.”
Otezla (apremilast) is expected to be available in the US in March and will be dispensed through a comprehensive network of specialty pharmacies. - TradeArabia News Service