The federal Food and Drug Administration has given its nod to Otezla (apremilast) for the treatment of adults with active psoriatic arthritis (PsA).
Manufactured for Celgene Corporation, the new agent works by blocking Phosphodiesterase 4 (PDE4) within the cell. PDE4 inhibition allows for higher levels of cyclic Adenosine monophosphate (AMP) within the cell.
Put another way: “PDE4 breaks down, cyclic AMP goes up, and inflammation goes down,” explains George Martin, MD, a dermatologist in Kihei, Hawaii. “We raise the cyclic AMP to turn off inflammation within the cell.”
The new agent may hold important advantages over existing therapies. Taken by mouth twice daily, Otezla will not require the same monitoring as many of the existing systemic PsA treatments.
“You always want to screen before starting a new systemic therapy, but the nice thing about this agent is that we don’t have to monitor with lab testing as is the case with methotrexate and the biologics,” he says.
The approval is based on the drug’s performance in three clinical trials involving 1,493 patients with active PsA. Patients treated with Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.
So far, there have been no infection or cancer risks seen with the new drug, Martin says. In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.
Patients treated with Otezla should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered.
Treatment with Otezla was also associated with an increase in reports of depression compared to placebo.
The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.
