First-oral therapy approved for adults with active psoriatic arthritis

March 27, 2014

FDA has approved apremilast (Otezla, Celgene), an oral, selective inhibitor of phosphodiesterase 4 (PDE4) to treat adults with active psoriatic arthritis (PsA).

FDA has approved apremilast (Otezla, Celgene), an oral, selective inhibitor of phosphodiesterase 4 (PDE4) to treat adults with active psoriatic arthritis (PsA).

"Prior to prescribing, it is important for prescribing providers to assess patients' capacity to afford this new treatment option for PsA because it may not be affordable for all," said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala. "But alternatively it may prove to be an effective treatment for those whose disease has failed other treatments."  

PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness, and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

Otezla joins (tofacitinib (Xeljanz) as an orally administered agent for the treatment of forms of arthritis (psoriatic for Otezla and rheumatoid for Xeljanz) previously dominated by injectable-only formulations, according to Robert Taketomo, PharmD, MBA, president and CEO of Ventegra, Glendale, Calif.

"The significance of a drug dosage form comes into play when benefit design is considered. Injectable drugs may be covered under a medical benefit while almost all oral agents are covered under the pharmacy benefit," Dr Taketomo said. "Thus, different copayments, access-formulary-benefit coverage rules and other utilization management processes may apply depending upon how the payor is categorizing a given drug by formulation. One issue that could mitigate the extensive use of Otezla is its adverse drug reaction profile-reflected in its propensity to cause weight loss through its effects on the GI tract.”

 

The approval was based on safety and effectiveness results from 3 multicenter, randomized, double-blind, placebo-controlled trials - PALACE 1,2, and 3 - involving 1,493 patients with active PsA. More than 75% of patients had been treated previously with disease-modifying anti-rheumatic drugs (DMARDS) only; 22% had been treated previously with biologics. Patients treated with Otezla showed improvement in the signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.

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.

As a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure, FDA is requiring a pregnancy exposure registry.
 
In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.