Apremilast approved in Europe for psoriasis
The new treatment can also be used for psoriatic arthritis patients
New treatment apremilast (Otezla) has been approved by the European Commission for the treatment of patients with psoriasis and psoriatic arthritis.
The drug, a selective PDE4 inhibitor, is the first oral treatment in 20 years to receive approval for patients with psoriasis and in the last 15 years to receive approval for psoriatic arthritis.
The licences are:
- For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
- Alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
The marketing authorisation is based on efficacy and safety data from two Phase III programmes, ESTEEM AND PALACE, which demonstrate a maintained clinical response among patients with psoriasis (ESTEEM) and psoriatic arthritis (PALACE) treated with the drug through 52 weeks, across multiple endpoints.
In the ESTEEM studies, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 scores at week 16, the primary endpoint.
Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch.
In the PALACE programme, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20 per cent improvement in the American College of Rheumatology disease activity criteria) response at week 16, the primary endpoint.
Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, dactylitis, enthesitis and overall physical function and quality of life.
Consistently, across these Phase III clinical studies, the most commonly reported adverse reactions were diarrhoea, nausea, upper respiratory tract infection, tension headache and headache.
Gastrointestinal adverse reactions were mostly mild to moderate in severity, with 0.3 per cent of diarrhoea and 0.3 per cent of nausea reported as being severe.