What to Know About Otezla (Apremilast)

Oral Treatment for Psoriatic Arthritis and Psoriasis

Otezla pill bottle

On March 21, 2014, the FDA announced the approval of Otezla (apremilast) for the treatment of active psoriatic arthritis in adults. Otezla is a selective inhibitor of phosphodiesterase-4 (PDE4). Otezla is the only FDA-approved oral treatment specifically for psoriatic arthritis. On September 23, 2014, the FDA approved Otezla for an additional indication, the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

Prior to the approval of Otezla, psoriatic arthritis was typically treated with corticosteroids, TNF blockers, or Stelara (ustekinumab), an interleukin-12/interleukin-23 inhibitor approved in September 2013.

How Is Otezla Administered?

Otezla comes as diamond-shaped, film-coated tablets in three strengths: 10 mg., 20 mg., and 30 mg. The initial recommended dosage of Otezla involves a titration from day 1 to day 5 to get to the recommended maintenance dose of 30 mg. twice daily starting on day 6. The usual titration schedule is:

Day 1: 10 mg. in the morning

Day 2: 10 mg. in the morning and 10 mg. in the evening

Day 3: 10 mg. in the morning and 20 mg. in the evening

Day 4: 20 mg. in the morning and 20 mg. in the evening

Day 5: 20 mg. in the morning and 30 mg. in the evening

Day 6 and beyond: 30 mg. in the morning and 30 mg. in the evening

(Note: Patients with severe renal impairment will need adjustments to the dosage schedule).

What Common Side Effects Have Been Associated With Otezla?

In clinical trials, diarrhea, headache, and nausea were the most commonly reported side effects associated with Otezla. Most of the adverse events occurred within the first two weeks of treatment and resolved over time with continued use of Otezla.

Are There Any Contraindications or Warnings and Precautions Associated With Otezla?

Otezla is contraindicated in patients with a known hypersensitivity to apremilast. With regard to warnings and precautions, Otezla is associated with an increased risk of depression. Weight decrease was also noted during clinical trials as a possible adverse event. Patients should watch for unexplained and clinically significant weight loss.

Also, there can be a possible drug interaction between Otezla and cytochrome P450 enzyme inducers, such as rifampin, phenobarbital, carbamazepine, and phenytoin which would lower the effectiveness of Otezla. The combination is not recommended.

Well-controlled studies with Otezla have not been conducted in pregnant women. Otezla should be used during pregnancy only when the potential benefit outweighs the potential risk to the fetus. It is also not known if Otezla or metabolites of Otezla are present in human milk, therefore nursing woman must be cautious. As part of the FDA approval, there will be a registry for women who are pregnant and being treated with Otezla.

How Did Otezla Perform in Clinical Trials?

The safety and effectiveness of Otezla were evaluated in three clinical trials involving 1,493 patients with active psoriatic arthritis. In the trials, named PALACE-1, PALACE-2, and PALACE-3, study participants were randomly assigned placebo, Otezla 20 mg. or 30 mg. twice daily. Patients were allowed to continue with DMARDs, low dose corticosteroids, or NSAIDs during the trial. The primary endpoint was ACR20 by week 16. Otezla plus DMARDs compared to placebo plus DMARDs was associated with greater improvement in signs and symptoms of psoriatic arthritis. There was also evidence of greater improvement in physical function with Otezla (30 mg. twice daily) than placebo.

What Is the Cost of Otezla?

The drugmaker, Celgene, has set a wholesale price of $22,500 per year for Otezla.

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