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A new oral therapy for psoriasis and its relatedjoint condition, psoriatic arthritis, has been granted marketing authorisationfrom the European Commission.
The European Commission has licensed apremilast (Otezla®), a oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:
- 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.
Helen McAteer, Chief Executive of the Psoriasis Association commented: “People with moderate-severe psoriasis and/or psoriatic arthritis report that the conditions can often have a negative impact on their physical, mental and social lives. We also know, from our members, that they find current treatment options unappealing owing to both experienced and potential side effects, or the way in which the treatment is administered. A new, convenient treatment has long been sought.”
In clinical studies, apremilast demonstrated significant improvements in psoriatic skin plaques (PASI 75) at week 16 versus placebo. One third of patients in the apremilast treated group achieved this primary endpoint. In addition, apremilast demonstrated a treatment benefit across multiple manifestations of psoriasis, including itch, nail and scalp involvement, and quality of life measures. In patients with psoriatic arthritis, Apremilast demonstrated significant improvement in ACR 20 at week 16, with twice as many patients treated with apremilast achieving this primary endpoint versus placebo (37% versus 19%). In addition, improvements in number of swollen joints, number of painful/tender joints, dactylitis, enthesitis and physical function were seen in the apremilast-treated patients.
“This decision marks an advance in the management of psoriasis and psoriatic arthritis. Apremilast is a new, oral treatment that fills a real gap in the therapies available for patients. An effective medication that doesn’t require regular monitoring will be welcomed by both patients and physicians,” stated Dr Chris Edwards, Consultant Rheumatologist, University Hospital Southampton NHS Foundation Trust.
Apremilast has a novel mechanism of action in psoriasis and psoriatic arthritis, offering a second line treatment option that does not require tuberculosis pre-screening or regular laboratory monitoring. It works by specifically targeting PDE4, which in turn elevates intracellular cAMP levels and helps to regulate the uncontrolled immune responses that cause the symptoms associated with psoriasis and psoriatic arthritis.
Psoriasis can occur on any area of the body, including the scalp and under the nails. It affects approximately 1.3-2.6% of people in the UK. Up to 30% of people with psoriasis may develop psoriatic arthritis,which involves inflammation, pain and swelling in joints, and may lead to significant disability.
Apremilast has been submitted for review by both the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) whose decisions are expected later this year.
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