On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).
The safety and efficacy of Otezla in psoriasis clinical trials was assessed in 1257 subjects in 2 multicenter, randomized, double-blind, placebo-controlled trials (Studies PSOR-1 and PSOR-2).1 In psoriatic arthritis clinical trials, the safety and efficacy of Otezla were evaluated in 1493 adult patients with active psoriatic arthritis in 3 multi-center, randomized, double-blind, placebo-controlled trials (Studies PsA-1, PsA-2, and PsA-3).1
Otezla was evaluated in a robust global clinical development program.2,3,4
ESTEEM 1 (2010) and ESTEEM 2 (2010) were two large pivotal Phase III randomized, placebo-controlled studies evaluating apremilast in patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy.2,3
LIBERATE (2012) was a global, phase 3b, placebo-controlled, double-blind, double-dummy study that evaluated use of apremilast in biologic-naïve patients with moderate to severe plaque psoriasis for up to 104 weeks.4
Otezla was evaluated in one of the largest global clinical development programs ever conducted for psoriatic arthritis.1,5
PALACE 16 (2010), PALACE 27 (2010), and PALACE 38 (2010) were three pivotal Phase III multi-center, double-blind, placebo-controlled, parallel-group studies in patients with active psoriatic arthritis, despite prior or current disease-modifying antirheumatic drug (DMARD) therapy.
ACTIVE Trial (2013) was a global phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating apremilast monotherapy in adult patients with active psoriatic arthritis who were biologic naïve for up to 104 weeks.5
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe plaque psoriasis over 52 weeks: a phase III, randomized controlled trial (ESTEEM 2). Br J Dermatol. 2015;173(6):1387-1399. 4. Reich K, Gooderham M, Green L, et al. The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 5. Nash P, Ohson K, Walsh J, et al. Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE). Ann Rheum Dis. 2018;77(5):690-698. 6. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis. 2014;73(6):1020-1026. 7. Cutolo M, Myerson GE, Fleischmann RM, et al. A phase III, randomized, controlled trial of apremilast in patients with psoriatic arthritis: results of the PALACE 2 trial. J Rheumatol. 2016;43(9):1724-1734. 8. Edwards CJ, Blanco FJ, Crowley J, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis. 2016;75(6):1065-1073.
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe 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.
Warnings and Precautions
Use in Specific Populations