Otezla (apremilast)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved March 2014

Specific Treatments:

psoriatic arthritis

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General Information

Otezla (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP).

Otezla is specifically indicated for adults with active psoriatic arthritis.

Otezla is supplied as a tablet for oral administration. Otezla should be titrated from Day 1 to Day 5. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.

Clinical Results

FDA Approval
The FDA approval of Otezla was based on three multi-center, randomized, double-blind, placebo-controlled trials (Studies PsA-1, PsA-2, and PsA-3) of similar design. A total of 1,493 adult patients with active PsA (= 3 swollen joints and = 3 tender joints) despite prior or current treatment with disease-modifying antirheumatic drug (DMARD) therapy were randomized. Patients enrolled in these studies had a diagnosis of PsA for at least 6 months. Across the three studies, patients were randomly assigned to placebo , Otezla 20 mg or 30 mg, given orally twice daily. Titration was used over the first 5 days. Patients were allowed to receive stable doses of concomitant medication. The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at Week 16. Otezla (30 mg twice daily) ± DMARDs, compared with placebo ± DMARDs resulted in a greater improvement in signs and symptoms of psoriatic arthritis as demonstrated by the proportion of patients with an ACR 20 response at Week 16. PsA-1: placebo group = 19% versus Otezla = 38%; PsA-2: placebo group = 19% versus Otezla = 32%; PsA-3: placebo group = 18% versus Otezla = 41%; (p<0.05 for all three trials).

Side Effects

Adverse events associated with the use of Otezla may include, but are not limited to, the following:

  • diarrhea
  • nausea
  • headache

Mechanism of Action

Otezla (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action in psoriatic arthritis patients is not well defined.

Additional Information

For additional information regarding Otezla or active psoriatic arthritis, please visit the Otezla web page.