The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
moderate to severe plaque psoriasis
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
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.
placebo: 15 (5.3%) and Otezla: 186 (33.1%)
placebo 11 (3.9%) and Otezla 122 (21.7%)
placebo: 8 (5.8%) and Otezla 79 (28.8%)
placebo 6 (4.4%) and Otezla 56 (20.4%)
Adverse effects associated with the use of Otezla may include, but are not limited to, the following:
- 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.
For additional information regarding Otezla or moderate to severe plaque psoriasis, please visit www.otezla.com