Otezla® is the commercial brand name of Apremilast Tablets, an orally active phosphodiesterase 4 (PDE4) inhibitor developed by Amgen. It inhibits PDE4 to modulate intracellular cyclic adenosine monophosphate levels, regulates the balance of pro-inflammatory and anti-inflammatory mediators, and alleviates inflammatory responses.
Main Indications
Treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
Treatment of adult patients with active psoriatic arthritis;
Treatment of adult patients with recurrent oral ulcers associated with Behçet’s disease.
Clinical Research
Global multicenter phase III ESTEEM pivotal trials confirmed significant improvement of skin lesions for moderate-to-severe plaque psoriasis patients receiving apremilast monotherapy;
Global phase III PALACE trials demonstrated sustained improvement in joint symptoms and physical function for patients with active psoriatic arthritis;
Phase III RELIEF registration trial validated effective relief of recurrent oral ulcers in adult patients with Behçet’s disease;
Dose-finding research verified balanced anti-inflammatory efficacy and gastrointestinal tolerability of the 30 mg twice-daily maintenance regimen;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for domestic inflammatory disease populations.
Common Side Effects
Common mild adverse reactions: Diarrhea, nausea, vomiting, headache, fatigue and upper abdominal pain;
Laboratory abnormalities: Transient mild weight loss;
Severe but uncommon risks: Severe gastrointestinal adverse events, depression and suicidal ideation.
Approval Status in China
Original drug Otezla® (Apremilast Tablets) was officially approved for marketing in China in 2019, with the specification including 10mg, 20mg and 30mg tablets, 27 tablets per box. It is currently a prescription anti-inflammatory drug included in China’s Category B medical insurance catalogue.
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