Otezla (apremilast)

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

Company:

Approval Status:

Approved September 2014

Specific Treatments:

moderate to severe plaque psoriasis

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General Information

Otezla (apremilast) is an inhibitor of phosphodiesterase 4 (PDE4), a proinflammatory mediator.

Otezla is specifically indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is supplied as as tablet for oral administration. The recommended initial dosage titration of Otezla from Day 1 to Day 5 is shown below. 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. Otezla can be administered without regard to meals. Do not crush, split, or chew the tablets. 

Day 1: AM: 10mg

Day 2: AM: 10mg and PM: 10mg

Day 3: AM: 10mg and PM: 20mg

Day 4: AM; 20mg and PM: 20mg

Day 5: AM; 20mg and PM: 30mg

Day 6 and thereafter: AM; 30mg and PM: 30mg

Clinical Results

FDA Approval

The FDA approval of Otezla for psoriasis was based on two multicenter, randomized, double-blind, placebo-controlled trials (Studies PSOR-1 and PSOR-2) which enrolled a total of 1,257 subjects 18 years of age and older with moderate to severe plaque psoriasis. Study PSOR-1 enrolled 844 subjects and Study PSOR-2 enrolled 413 subjects. In both studies, subjects were randomized 2:1 to Otezla 30 mg BID or placebo for 16 weeks. Both studies assessed the proportion of subjects who achieved PASI-75 at Week 16 and the proportion of subjects who achieved a sPGA score of clear (0) or almost clear (1) at Week 16. 

PSOR-1: 

PASI-75

placebo: 15 (5.3%) and Otezla: 186 (33.1%)    

sPGA score

placebo 11 (3.9%) and Otezla 122 (21.7%)

PSOR-2: 

PASI-75

placebo: 8 (5.8%) and Otezla 79 (28.8%) 

sPGA score

placebo 6 (4.4%) and Otezla 56 (20.4%)

Side Effects

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

  • diarrhea
  • nausea
  • upper respiratory tract infection
  • headache, including tension 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 and psoriasis patients is not well defined.

Additional Information

For additional information regarding Otezla or moderate to severe plaque psoriasis, please visit www.otezla.com