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-Aug 2022; US=approximately 60% 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.
ADVANCE was a multicenter, randomized,
placebo-controlled, double-blind study. Biologic-naïve adults with mild to moderate plaque psoriasis (N=595) were randomized 1:1 to receive Otezla or placebo for a 16-week phase, followed by a 16-week extension phase and a 4-week post-treatment observation phase. 1,3
ESTEEM consists of 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients aged ≥18 years with moderate to severe plaque psoriasis (N=1257) were randomized 2:1 to Otezla 30 mg BID (n=836) or placebo (n=419) for 16 weeks after a week-long titration. 1,4,5
STYLE was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 303 adult patients with moderate to severe plaque psoriasis and moderate to severe scalp psoriasis. 1
DISCREET was a PHASE 3, multicenter, randomized, placebo-controlled, double-blind study of 289 adult patients with moderate to severe plaque psoriasis and moderate to severe genital psoriasis. 6
LIBERATE was a global, randomized, Phase 3b, placebo-controlled, double-blind, double-dummy study that evaluated the use of apremilast in biologic-naïve patients with moderate to severe plaque psoriasis for up to 104 weeks. 2
BID, twice daily.
Contraindications
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. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 3. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 4. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 5. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 6. Merola F, Parish L, Guenther L, et al. Abstract presented at: the 31st Annual Meeting of the European Academy of Dermatology and Venereology (EADV); September 7-10, 2022.