Otezla, Apremilast, Cost, Prescribing Information for Psoriasis, Dosage, and Side Effects | Steven Ma, PharmD | RxEconsult
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Otezla (apremilast) Cost, Prescribing Information for Psoriasis, Dosage, Side Effects Category: Dermatology by - June 25, 2014 | Views: 38606 | Likes: 1 | Comment: 0  

Otezla, apremilast

Brand Name: Otezla 
Generic Name: apremilast

Medication Class: phosphodiesterase 4 enzyme inhibitor    
Similar Drugs: Daliresp (roflumilast)
Manufacturer: Celgene
Approval date: March 21, 2014

What is Otezla?

Otezla is used for the treatment of psoriatic arthritis. Psoriasis is a skin condition where scaly red and white patches develop on the skin. People with psoriasis can develop psoriatic arthritis which also includes inflammation of the joint. Otezla is a phosphodiesterase 4 (PDE4) inhibitor. Phosphodiesterase 4 is an enzyme that is a part of the inflammation pathway. By inhibiting this enzyme, Otezla is able to regulate inflammation in patients with psoriatic arthritis and help control symptoms.

What is Otezla approved for?

  • Otezla is indicated for the treatment of adults with active psoriatic arthritis.
  • Patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 

How effective is Otezla?

The efficacy of Otezla was determined in three randomized, double-blind, placebo-controlled trials. Patients were given either a placebo, Otezla 20 mg twice daily, or Otezla 30 mg twice daily. Patients were also allowed to be on stable doses of methotrexate, sulfasalazine, leflunomide, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone a day), or nonsteroidal anti-inflammatory drugs during the trial. Efficacy of Otezla was measured by using ACR 20 response, which means that a patient's tender and swollen joint count improved by at least 20%. In the first clinical trial, 19% of patients achieved ACR 20 in the placebo group and 38% of patients achieved ACR 20 in the Otezla 30 mg group. In the second clinical trial, 19% of patients achieved ACR 20 in the placebo group and 32% of patients achieved ACR 20 in the Otezla 30 mg group. In the third clinical trial, 18% of patients who received placebo achieved ACR 20  and 41% of patients achieved ACR 20 in the Otezla 30 mg group.

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