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Study Design

Otezla® (apremilast) was evaluated in one of the largest global clinical development programs ever conducted in psoriatic arthritis1,2
  • PALACE Clinical Trial ProgramButton to view the study design, patient demographics, selected inclusion and exclusion criteria, and primary endpoint for the PALACE clinical trial program
  • ACTIVE Clinical Trial ProgramButton to view the study design, patient demographics, selected inclusion and exclusion criteria, and primary endpoint for the ACTIVE clinical trial

PALACE Clinical Trial Program

Program1:

  • 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 design:

  • Randomized 1:1:1 to either Otezla 30 mg twice daily, Otezla 20 mg twice daily, or placebo1
  • Doses were titrated during the first 5 days1
  • Placebo controlled to week 241
  • Blinded Otezla treatment to 52 weeks, with an open-label, long-term extension to 5 years2

Primary endpoint1:

  • Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria1:

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

Selected exclusion criteria:

  • Failed >3 agents for psoriatic arthritis (small molecules or biologics) or >1 TNF-α inhibitor1
  • Active TB or a history of incompletely treated TB; however, screening for latent TB was not required2
  • Hepatitis B or hepatitis C positive at screening2
  • History of HIV2

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; HIV, human immunodeficiency virus; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; TB, tuberculosis; TNF, tumor necrosis factor.

PALACE baseline disease characteristics and treatment history

Disease characteristics1:

  • Median duration: 5 years
  • Mean tender joint count: 23.0
  • Mean swollen joint count: 13.0

Psoriatic arthritis types1:

  • 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%) including MTX (55%)
  • Low-dose oral corticosteroids (14%)
  • NSAIDs (71%)

DIP, distal interphalangeal joint; MTX, methotrexate; NSAIDs, nonsteroidal anti-inflammatory drugs.

ACTIVE® Clinical Trial Program2,3

Program:

  • Phase IIIb multicenter, randomized, double-blind, placebo-controlled, parallel group study
  • 219 adult patients with active psoriatic arthritis

Study design:

  • Randomized 1:1 to either Otezla 30 mg twice daily, or placebo
  • Doses were titrated over the first week of treatment
  • Placebo controlled to week 24
  • At week 24, all remaining placebo patients were switched to Otezla with dose titration through week 52; open-label treatment phase up to week 104

Primary endpoint:

  • Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria:

  • Had a documented diagnosis of active psoriatic arthritis of ≥3 months’ duration
  • Had ≥3 swollen and ≥3 tender joints
  • Biologic treatment-naïve
  • May be exposed to 1 DMARD
    • Must discontinue DMARD ≥1 day prior to baseline visit
    • No requirement for DMARD washout, except for cyclosporine (4-week washout) and leflunomide (12-week washout)

Selected exclusion criteria:

  • Active TB or history of incompletely treated TB
  • Hepatitis B or C positive at screening
  • History of HIV

ACR, American College of Rheumatology; ACTIVE, Accessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients with Psoriatic Arthritis; BID, twice daily; HIV, human immunodeficiency virus; TB, tuberculosis.

Baseline disease characteristics and treatment history2,3

Disease characteristics:

  • Median duration: 1.8 years
  • Mean tender joint count: 17.8
  • Mean swollen joint count: 9.5

Treatment history:

  • Previous DMARD use: 69.4%
  • Prior MTX use: 58%

DMARD, disease-modifying antirheumatic drug; MTX, methotrexate.

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Data on file, Celgene Corporation. 3. Nash P, Ohson K, Wash J, et al. Ann Rheum Dis. doi:10.1136/annrheumdis-2017-211568.

Indications & Important Safety Information

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Reference: 1. Data on file, Celgene Corporation.
01/19 US-OTZ-19-0092