Just as the American Academy of Dermatology meeting opens its doors in Denver, Celgene Corp has been boosted by a green light from US regulators for Otezla as a treatment for psoriatic arthritis.

The US Food and Drug Administration has approved Otezla (apremilast), making it the first oral treatment for adults with active PsA. The thumbs-up for the phosphodieasterase-4 (PDE-4) inhibitor is primarily based on three trials involving 1,493 patients where Otezla showed improvement in signs and symptoms of the disease, including tender and swollen joints and physical function, compared to placebo.

In granting approval, the agency stated that patients should have their weight monitored regularly by their doctor, and if unexplained or clinically significant weight loss occurs, discontinuation of treatment should be considered. Otezla was also associated with an increase in reports of depression compared to placebo and the FDA is requiring a pregnancy exposure registry as a post-marketing requirement._

Curtis Rosebraugh at the FDA’s Center for Drug Evaluation, noted that relief of pain and inflammation, plus improving physical function are important treatment goals and Otezla provides a new option for patients suffering from this disease. Treatment for PSA, which affects about 30% of the 125 million people worldwide who have psoriasis, currently involves corticosteroids, disease-modifying antirheumatic drugs (DMARDs) and injectable tumour necrosis factor (TNF) inhibitors, notably AbbVie's Humira (adalimumab) and Pfizer/Amgen's Enbrel (etanercept), as well as Johnson & Johnson's interleukin-12 and -23 inhibitor Stelara (ustekinumab).

It is clearly a competitive field but Celgene is hoping that Otezla's impressive safety profile compared with the biologics will see the drug win a considerable slice of the PsA pie. Scott Smith, the firm's head of inflammation and immunology, said it "has the potential to simplify patient management", as routine laboratory monitoring for patients is not required.   

Apremilast is also being studied for psoriasis, ankylosing spondylitis and atopic dermatitis. The FDA is expected to decide on the former indication later this year.