The European Commission has authorised apremilast (Celgene’s Otezla), a first-in-class oral drug for the treatment of chronic plaque psoriasis and psoriatic arthritis in patients who have failed first-line systemic therapies, following its approval by the European Medicines Agency in November 2014. It was approved in the United States in March 2014 for the second-line treatment of plaque psoriasis.
Apremilast selectively inhibits phosphodiesterase-4, increasing intracellular levels of cyclic adenosine monophosphate (cAMP) and helping to downregulate the inflammatory response. Uniquely among treatments for psoriasis and psoriatic arthritis, Otezla is taken orally and does not require laboratory monitoring before or during treatment.
The drug is indicated for adults with moderate-to-severe chronic plaque psoriasis who have failed to respond to, who have a contraindication to, or who are intolerant of other systemic therapies. It is also indicated for use alone or in combination with disease-modifying antirheumatic drugs (DMARDs) for active psoriatic arthritis in adults who have had an inadequate response to, or who have been intolerant to, previous DMARD therapy.
The approval was based on clinical trial programmes that included some 1,250 patients with plaque psoriasis and around 1,500 patients with active psoriatic arthritis. In both diseases, apremilast showed superiority over placebo for the primary endpoints at week 16, with the clinical response being maintained to week 52.
Apremilast was well tolerated, with the most common adverse events being diarrhoea, nausea and infections of the upper respiratory tract. Adverse events were mostly mild-to-moderate and resolved without stopping treatment.
In the UK, the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium are reviewing the drug and are expected to issue guidance this year. Chris Edwards, a consultant rheumatologist from University Hospital Southampton NHS Foundation Trust, said in a Celgene company statement that apremilast was “a new, oral treatment that fills a real gap in the therapies available for patients”.