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Study Design


OTEZLA has been studied in over 4000 patients with psoriasis and psoriatic arthritis worldwide1,2


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


In PALACE 1-3, 76.4% of patients were biologic-naïve. In PALACE 4, all enrolled patients were biologic-naïve, as mandated by study protocol.


In psoriatic arthritis trials, combination therapy included concomitant use of one or more of the following: methotrexate, sulfasalazine, or leflunomide, low dose oral corticosteroid and/or NSAID.

ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; NSAID, nonsteroidal anti-inflammatory drug; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; PsO, psoriasis.

StudyaTotal number of
patients (N)
DMARD combination
therapy allowedc
Clinical Trials in PsA
Palace 1504
Palace 2484
Palace 3505
Palace 4527
Clinical Trials in PsO
Esteem® 1844
Esteem 2411

PALACE Study Design1,3

Clinical development program

Clinical program3:

  • PALACE 1, 2, and 3: Multicenter, randomized, double-blind, placebo-controlled phase 3 trials of similar design
  • 1493 adult patients with active psoriatic arthritis

Study design1:

  • Randomized 1:1:1 to OTEZLA 30 mg twice daily, 20 mg twice daily, or placebo
  • Doses were titrated during the first 5 days
  • Placebo-controlled until week 24
  • Blinded OTEZLA treatment to 52 weeks, with an open-label long-term extension to 5 years

Primary endpoint3:

  • Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria3:

  • Had a documented diagnosis of psoriatic arthritis of ≥6 months’ duration
  • Had ≥3 swollen and ≥3 tender joints, despite current or prior treatment with DMARDs
  • PALACE 3: 1 qualifying psoriasis skin lesion of ≥2 cm in diameter

Selected exclusion criteria1:

  • Failed >3 agents for psoriatic arthritis (small molecules or biologics) or >1 TNF-α inhibitor
  • 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

Baseline disease characteristics and treatment history

Disease characteristics1:

  • Median duration: 5 years
  • Mean tender joint count: 21.0
  • Mean swollen joint count: 11.3

Psoriatic arthritis types3:

  • Symmetric polyarthritis: 62%
  • Asymmetric oligoarthritis: 27%
  • DIP arthritis: 6%
  • Arthritis mutilans: 3%
  • Predominant spondylitis: 2%

Treatment history1:

  • Small-molecule DMARDs only: 76%
  • Biologic DMARDs: 22%

Concomitant therapy1:

  • ≥1 DMARD: 65%
    • MTX: 55%
  • Low-dose oral corticosteroids: 14%
  • NSAIDs: 71%
  • ACR, American College of Rheumatology; DIP, distal interphalangeal joint; DMARD, disease-modifying antirheumatic drug; HIV, human immunodeficiency virus; MTX, methotrexate; NSAID, nonsteroidal anti-inflammatory drug; TB, tuberculosis; TNF, tumor necrosis factor.

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

PALACE 1, 2, and 3 were multicenter, randomized, double-blind, placebo-controlled phase 3 trials of similar design3

palace 1-3 otezla studies for otezla and psoriatic arthritis

The clinical trial program3

clinical trial details for the palace 1 2 and 3 studies

In these trials, all patients were required to have been treated with small-molecule and/or biological DMARD(s). These trials had a similar design:

Placebo-controlled phase

  • Weeks 0 to 16 (primary endpoint phase): Patients were randomized 1:1:1 to receive OTEZLA 20 mg BID, OTEZLA 30 mg BID, or placebo3
  • Weeks 16 to 24 (continuation of placebo-controlled phase): Patients whose tender joint count and swollen joint count had not improved by ≥20% were considered nonresponders and were required to be re-randomized (1:1) to apremilast 20 mg BID or 30 mg BID if they were initially randomized to placebo.3 Patients in the placebo group were re-randomized in a 1:1 blinded manner to OTEZLA 20 mg BID or OTEZLA 30 mg BID3

Active-treatment phase

  • Weeks 24 to 52: At week 24, all patients in the placebo group who did not enter the early-escape phase were re-randomized in a 1:1 blinded manner to OTEZLA 20 mg BID or OTEZLA 30 mg BID3
  • Weeks 52 to 5 years: Patients have the opportunity to participate in the open-label extension for up to 5 years total enrollment in the studies3

PALACE 4 Study Design2

otezla palace 4 clinical trial design

  • Protocol: Randomized, double-blind, placebo-controlled study evaluating OTEZLA as monotherapy*
  • Patient population: Adult patients with active PsA having no prior treatment with a conventional DMARD or biologic (DMARD- and biologic-naïve)
  • Extension phase: Prespecified 5-year open extension safety phase

Patients received OTEZLA as monotherapy but were allowed to continue on stable doses of oral corticosteroids and/or NSAIDs or narcotic analgesic.


DMARD, disease-modifying antirheumatic drugs; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy.

References: 1. Data on file, Celgene Corporation. 2. Wells AF, Edwards CJ, Kivitz AJ, et al. Apremilast Monotherapy as the First Systemic Treatment in DMARD-Naïve Patients With Psoriatic Arthritis: 3-Year Treatment Results. Presented at: the Annual European Congress of Rheumatology EULAR 2016; 8–11 June 2016; London, UK. 3. OTEZLA Summary of Product Characteristics. Celgene Europe, Ltd. Stockley Park, Uxbridge, UK.

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