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Study Design

 

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

a

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

b

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.

c

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-naïveBiologic-naïvebOTEZLA
monotherapy
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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