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3/24/2014

Oral Therapy Approved to Treat Active Psoriatic Arthritis

Cheryl A. Thompson

FDA and Celgene Corporation on March 21 announced the approval of apremilast, or Otezla, for the treatment of adults with active psoriatic arthritis.

The selective phosphodiesterase-4 inhibitor, Celgene said, is the only FDA-approved oral therapy that treats psoriatic arthritis.

According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, psoriatic arthritis produces both the skin lesions common in psoriasis and the joint inflammation common in arthritis, though not necessarily at the same time.

Apremilast's FDA-approved labeling (PDF)External Link recommends a maintenance dosage of 30 mg twice daily for patients without severe renal impairment and 30 mg once daily for patients with a creatinine clearance less than 30 mL/min. To reduce their risk for gastrointestinal symptoms, all patients should start apremilast therapy at a dosage of 10 mg in the morning and increase over the next five days to the maintenance dosage. The labeling describes "initial dosage titration" schedules for both types of patients.

FDA said patients with active psoriatic arthritis who received apremilast during the drug's three major clinical studies showed improvement in the signs and symptoms of their disease. These patients, according to the drug's labeling, had at least three swollen joints and at least three tender joints despite treatment with a disease-modifying antirheumatic drug.

The most common adverse reactions to apremilast 30 mg twice daily during the three major studies were diarrhea, nausea, and headache, the labeling states.

Otezla will be available as 10-, 20-, and 30-mg tablets that must be stored at less than 30 °C. Only the 30-mg tablets will be available in a standalone form: 30-count bottles of loose tablets and 28-count cartons with two 14-day blister cards. The 10- and 20-mg tablets are part of the two-week starter pack that includes the initial dosage titration. None of the tablets, the labeling states, should be crushed, split, or chewed.

Celgene said it expected for Otezla to be available this month through a network of specialty pharmacies.

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