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|Studya||Total number of|
|Moderate to severe psoriasis||Moderate psoriasis||Active psoriatic|
|Biologic-naïve||Prior biologic use||Systemic-naïve|
ESTEEM 1 and ESTEEM 2 were pivotal, global, multicenter, randomized, double-blind, phase 3 trials of similar design2
Patients ≥18 years of age (N = 1257) with moderate to severe plaque psoriasis were randomized to placebo (n = 419) or OTEZLA (n = 836) given orally BID. These studies had a similar design through week 32.2
ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index; UVB, ultraviolet B.
OTEZLA 30 mg (n = 83), etanercept 50 mg (n = 83), or placebo (n = 84).
Primary endpoint: Proportion of patients on OTEZLA who achieved PASI-75 at week 16 vs placebo.
Patient population also included inadequate response, intolerance, or contraindication to at least one conventional systemic agent and no prior exposure to a biologic for the treatment of psoriatic arthritis or psoriasis.
References: 1. Data on file, Celgene Corporation. 2. OTEZLA Summary of Product Characteristics. Celgene Europe, Ltd. Stockley Park, Uxbridge, UK. 3. Reich K, Gooderham M, Green L, et al. The efficacy and safety of apremilast, etancercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled study (LIBERATE). J Eur Acad Dermatol Venereol. 2016.
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