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The OTEZLA® international website

This site is intended for healthcare professionals outside the U.S.

STUDY DESIGNS

OTEZLA has been studied in over 4,000 patients with psoriasis and psoriatic arthritis worldwide1
 
Total number of patients (N)
Moderate to severe psoriasis
(biologic-naïve)
Moderate to severe psoriasis
Moderate psoriasis
(systemic-naïve)
Active psoriatic arthritis
STUDYa
ESTEEM 1844
ESTEEM 2411
LIBERATE250
FREEDOM254
UNVEIL221
PALACE 1-31,497
PALACE 4529
ACTIVE219

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

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

ESTEEM Study Design1-3

aDoses of apremilast were titrated during the first week of administration

bA responder was defined as a patient achieving ≥PASI-75 in both ESTEEM 1 and ESTEEM 2 at week 32.

cAt week 32, nonresponders and partial responders (ESTEEM 1) or nonresponders (ESTEEM 2) had the option of adding topical and/or UVB therapy. The decisions could be made at week 32 only but did not need to be initiated at that visit.

Protocol: Randomized, double-blind, multicenter, placebo-controlled trials evaluating the safety and efficacy of apremilast*

Patient population: Adult patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy

Extension phase: Patients entering a long-term extension phase could be treated through 5 years

*The use of low-potency topical corticosteroids on the face, axillae, and groin, coal tar shampoo and/or salicylic acid scalp preparations was permitted throughout the studies. In addition, at week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1 or a PASI-50 response in ESTEEM 2 were permitted to use topical psoriasis therapies and/or phototherapy in addition to OTEZLA 30 mg BID.

BSA ≥10%, sPGA ≥3, PASI score ≥12.

BID, twice daily; BSA, body surface area; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment; UVB, ultraviolet-B.

LIBERATE Study Design4
  • Protocol: Global, phase 3b, placebo-controlled, double-blind, multicenter 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. Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phsophodiesterase 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;73:37-49.
  3. Rich P, Gooderham M, Bachelez H, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2). JAAD. 2015;74(1):134-142.
  4. Reich K, Gooderham M, Bewley A, et al. Safety and efficacy of apremilast through 104 weeks in patients with moderate to severe psoriasis who continued on apremilast or switched from etanercept treatment: findings from the LIBERATE study. J Eur Acad Dermatol Venereol. 2018;32(3):397-402.
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