First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA SEE THE DATA
3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more
*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=58% of data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current markets.
FDA, U.S. Food and Drug Administration; PsA, psoriatic arthritis; TB, tuberculosis.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Otezla® (apremilast) FDA approval letter. March 21, 2014.
PALACE 1, PALACE 2, and PALACE 3 were 3 pivotal, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients (n=1493) with active PsA (≥3 swollen and ≥3 tender joints), despite prior or current DMARD therapy. Patients who were therapeutic failures of >3 agents for PsA (small molecules or biologics) or >1 biologic TNF blocker were excluded.1,2
PALACE 4 was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 527 DMARD-naïve adult patients with active PsA. 1,3
ACTIVE was a global, Phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating apremilast monotherapy in adult patients (n=219) with active PsA who were biologic naïve.4
DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis; TNF, tumor necrosis factor.
Contraindications
Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulationWarnings and Precautions
Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapyContraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for the full Prescribing Information.
Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for
phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 3. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 4. Nash P, Ohson K, Walsh J, et al. Ann Rheum Dis. 2018;77(5);690-698.