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Study Design

Otezla® (apremilast) was evaluated in a robust global clinical development program for plaque psoriasis that enrolled over 1,200 patients1,2
  • ESTEEM 1 & ESTEEM 2
    Details
  • Clinical Trial Program
  • Patient
    Demographics

ESTEEM® 1 and ESTEEM 21,2

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In ESTEEM 1, patients were switched to Otezla if they lost their PASI-75, but no later than at week 52. In ESTEEM 2, patients were switched to Otezla if they lost 50% of the PASI improvement obtained at week 32 compared to baseline, but no later than at week 52.

a

Doses of Otezla were titrated during the first week of administration.

b

A responder was defined as a patient achieving ≥ PASI-75; a partial responder was defined as a patient achieving PASI-50 to PASI-74; a nonresponder was defined as a patient achieving < PASI-50 in both ESTEEM 1 and ESTEEM 2 at week 32.

c

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

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

  • Weeks 0 to 16 (placebo-controlled phase): Patients were randomized 2:1 to Otezla twice daily or placebo twice daily2,3
  • Weeks 16 to 32 (maintenance phase): All patients received Otezla1,2
  • Weeks 32 to 52 (withdrawal phase)1,2
      • 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, but no later than week 52. 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
  • Weeks 52 to 260 (long-term extension phase)1,2
      • Patients entering a long-term extension phase could be treated through 5 years
Otezla was evaluated in 2 multicenter, randomized, double-blind, placebo-controlled trials of similar 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 twice daily. These studies had a similar design through week 32.1-3

ESTEEM® 1 and ESTEEM 2 criteria and endpoints

Selected inclusion criteria2,3:

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

Selected exclusion criteria:

  • Active TB or incompletely treated TB; however, there was no requirement for latent TB screening1,2
  • Hepatitis B or hepatitis C positive at screening1
  • History of HIV1

Primary endpoint1,2:

  • The proportion of patients who achieved PASI-75 at week 16

Selected secondary endpoints1,2:

  • Proportion of patients who achieved sPGA score of clear (0) or almost clear (1) at week 16
  • Change from baseline in pruritus VAS at week 16

Selected exploratory endpoints1,2:

  • Percent change from baseline in NAPSI score at week 16 for patients with baseline nail psoriasis
  • Proportion of patients with scalp psoriasis with improvement of ScPGA scores to 0 (clear) and 1 (minimal) at week 16

BSA, body surface area; HIV, human immunodeficiency virus; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment; TB, tuberculosis; VAS, visual analog scale.

Patient demographics

Median age3:

  • 46 years (18 to 83 years)

Mean baseline BSA involvement3:

  • 25%

Mean baseline PASI score2,3:

  • 19

Proportion of patients with baseline sPGA score 3 (moderate)3:

  • 70%

Proportion of patients with baseline sPGA score 4 (severe)3:

  • 30%

Prior psoriasis therapy:

  • Phototherapy - 30%3
  • Conventional systemic therapy - 37%3
  • Biologic therapy - 30%3
  • No prior phototherapy, conventional systemic therapy, or biologics - 35%1

History of psoriatic arthritis3:

  • 18%

Concomitant psoriasis medications allowed2,3:

  • Low-potency topical corticosteroids on the face, axillae, and groin
  • Coal tar shampoo and/or salicylic acid preparations for scalp lesions

BSA, body surface area; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment.

References: 1. Data on file, Celgene Corporation. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Otezla [package insert]. Summit, NJ: Celgene Corporation.

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