In giving a nod to Celgene's Otezla (apremilast), the U.S. Food and Drug Administration (FDA) is offering active psoriatic arthritis (PsA) patients a new treatment option that is taken orally, in pill form. Injected corticosteroids, tumor necrosis factor (TNF) blockers, and interleukin-12/interleukin-23 inhibitors are among the treatments currently available for PsA.
PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. The main symptoms of PsA are joint pain, stiffness, and swelling.
Otezla is approved as a twice-daily 30-milligram treatment for adults with active PsA. The dosage will gradually increase over the first five days until the patient reaches the recommended dose of 30 milligrams.
How Does Otezla Work?
Otezla inhibits an enzyme called phosphodiesterase 4, or PDE4, to regulate inflammation in people with PsA and help control symptoms of the disease.
In clinical trials, the most common side effects were diarrhea, nausea, and headache, which occurred in the first two weeks and tended to lessen with continued treatment.
In trials, patients treated with Otezla showed improvement in the signs and symptoms of PsA, including tender and swollen joints and impaired physical function.
Commenting on the approval of the new medication, Randy Beranek, president and CEO of the National Psoriasis Foundation, told Healthline that his organization is pleased that there is another treatment option available for people with PsA.
“We welcome the full range of treatments that will improve patients' lives and disease outcomes. There are a number of treatments currently available for psoriatic arthritis, ranging from over-the-counter nonsteroidal anti-inflammatories to DMARDS [disease-modifying antirheumatic drugs] and biologic drugs. Otezla is different from these other treatments in its mechanism of action and its delivery as an oral drug," said Beranek.
Dr. Indy Chabra, a dermatologist at Midlands Clinic in South Dakota who also offers teledermatology at Skin MD Now, told Healthline, “For psoriasis patients, our treatment currently fits into four categories: topical meds, oral medications, biologics, and phototherapy. This new drug may prove to be an important addition to treating psoriasis in patients who prefer oral therapy."
Scalp, Hands, Feet, and Nails
Otezla also shows promise for treating psoriasis. Late last year, Celgene filed for FDA approval of Otezla as a psoriasis treatment. Approval is still pending; a ruling is expected in fall of 2014.
At the 72nd Annual Meeting of the American Academy of Dermatology (AAD), held in late March in Denver, Colo., Celgene released new research findings on Otezla from two phase III studies in patients with moderate to severe plaque psoriasis.
According to the company, Otezla offered sustained improvements for adult patients with moderate to severe plaque psoriasis.
Commenting from the AAD meeting, Chabra told Healthline, “The data from the [Celegene] study shows improvement in nails, scalp, hands, and feet, which have been relatively difficult areas to treat.”
According to the National Psoriasis Foundation, an estimated 7.5 million Americans suffer from psoriasis. As many as 30 percent of these patients also have PsA, with pain and swelling in their joints.
Emphasizing that the two key side effects of Otezla in the studies were weight loss in 5 percent of people and depression in 1 percent, Chabra said, “That’s something that we will be monitoring and looking at.”
Finally, Chabra said, “Otezla is targeted therapy and it’s oral, and that is the big advantage. It’s not an injection or an infusion. Otezla will help patients, especially those who either can’t afford biologics or they don’t want injections.”
Otezla tablets are slated to become available starting April 2 at specialty and mail-order pharmacies.