Brand Name: Otezla
Generic Name: apremilast
Medication Class: phosphodiesterase 4 enzyme inhibitor
Similar Drugs: Daliresp (roflumilast)
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?
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.
Next: Side Effects, Dosage, Drug Interactions, Facts