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Study Design

 

OTEZLA has been studied in over 4000 patients with psoriasis and psoriatic arthritis worldwide1

a

This table does not include the full list of clinical trials in which OTEZLA has been evaluated.

ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; LIBERATE, Evaluation from a Placebo-Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; PsO, psoriasis; UNVEIL, Evaluating Apremilast in a Phase 4 Trial of Efficacy and Safety in Patients with Moderate Plaque Psoriasis.

StudyaTotal number of
patients (N)
Moderate to severe psoriasisModerate psoriasisActive psoriatic
arthritis
Biologic-naïvePrior biologic useSystemic-naïve
Esteem® 1844
Esteem 2411
Liberate®250
Freedom254
Unveil221
Palace 1-31497
Palace 4529
 

ESTEEM Study Design

Psoriasis clinical development program

Clinical program2:

  • 2 large, global, multicenter, randomized, double-blind, phase 3 trials of similar design
  • 1257 adult patients with moderate to severe plaque psoriasis

Selected inclusion criteria2:

  • BSA involvement of ≥10%
  • sPGA ≥3 (moderate or severe disease)
  • PASI score ≥12
  • Candidates for phototherapy or systemic therapy

Selected exclusion criteria1:

  • Active TB, history of incompletely treated TB, or significant infection within 4 weeks of screening
  • No purified protein derivative or QuantiFERON® screening for latent TB was required
  • Hepatitis B or hepatitis C positive at screening
  • History of HIV

Trial duration2:

  • Placebo-controlled to week 16
  • Maintenance and randomized withdrawal phase through 52 weeks with long-term extension to 5 years

Primary endpoint2:

  • Proportion of patients who achieved PASI-75 at week 16

Selected secondary and exploratory endpoints1:

  • Percent change from baseline in NAPSI score at week 16 for patients with baseline nail psoriasis
  • Proportion of patients with ScPGA scores of 0 (clear) or 1 (minimal) at week 16 in patients with scalp psoriasis at baseline
  • Change from baseline in pruritus VAS at week 16

Baseline disease characteristics and treatment history

Demographics and disease characteristics:

  • Median age: 46 years (18 to 83 years)1
  • Median duration of psoriasis: 19 years1
  • Mean baseline BSA involvement: 25%2
  • Mean baseline PASI score: 192
  • Proportion of patients with baseline sPGA score 3 (moderate): 70%2
  • Proportion of patients with baseline sPGA score 4 (severe): 30%2
  • History of psoriatic arthritis: 18%2

Treatment and disease history:

  • Prior psoriasis therapy2:
    • Phototherapy: 30%
    • Conventional systemic therapy: 37%
    • Biologic therapy: 30%
    • No prior phototherapy, conventional systemic therapy, or biologics: approximately one-third
  • Disease history1:
    • Scalp psoriasis: 95%
    • Nail psoriasis: 68%
    • Palmoplantar psoriasis: 28%
  • BSA, body surface area; HIV, human immunodeficiency virus; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; sPGA, Static Physician Global Assessment; ScPGA, Scalp Psoriasis Physician Global Assessment; TB, tuberculosis; VAS, Visual Analog Scale.

The efficacy and safety of OTEZLA were evaluated in global, multicenter clinical trials

ESTEEM 1 and ESTEEM 2 were pivotal, global, multicenter, randomized, double-blind, phase 3 trials of similar design2

esteem 1 and
esteem 2 were pivotal, global, multicenter, randomized, double-blind, phase 3 trials of similar design

The clinical trial program1,2

the otezla clinical trial design

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

  • Weeks 0 to 16 (placebo-controlled phase): Patients were randomized 2:1 to OTEZLA BID or placebo BID2
  • Weeks 16 to 32 (maintenance phase): All patients received OTEZLA2
  • Weeks 32 to 52 (randomized withdrawal phase)1
    • Patients originally randomized to OTEZLA who achieved at least a 75% reduction in PASI score (PASI-75) in ESTEEM 1, or at least a 50% reduction in PASI score (PASI-50) in ESTEEM 2 at week 32, were re-randomized to either placebo or OTEZLA. Patients who were re-randomized to placebo and who lost their PASI-75 response (ESTEEM 1), or 50% of the improvement that they achieved at week 32 compared to baseline (ESTEEM 2), were re-treated with OTEZLA. Patients who did not achieve the designated PASI response by week 32 had the option of adding topical and/or UVB therapy
    • Patients originally randomized to placebo and transitioned to OTEZLA, who then achieved at least PASI-75 in ESTEEM 1, or at least PASI-50 in ESTEEM 2, at week 32, were allowed to continue on OTEZLA. Patients who did not achieve the designated PASI response by week 32 had the option of adding topical and/or UVB therapy

ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index; UVB, ultraviolet B.

 

LIBERATE Study Design3

  • Protocol: Global, phase 3b, placebo-controlled, double-blind, multi-center study of the safety and efficacy of OTEZLA up to 104 weeks. Patients were randomized 1:1:1 to either OTEZLA twice daily, etanercept once weekly, or placebo through week 16. At week 16, all patients crossed over to the OTEZLA arm*
  • Patient population: Adult patients with chronic plaque psoriasis, for ≥12 months prior to screening, who are naïve to biologic therapy and were candidates for phototherapy and/or systemic therapy
*

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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