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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 1-3 Clinical Trial ProgramButton to view the study design, patient demographics, selected inclusion and exclusion criteria, and primary endpoint for the PALACE clinical trial program
  • PALACE 4 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 1-3 clinical trial program

Program1:

  • 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.

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 joint 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.

PALACE 4 clinical trial program

Program:

  • Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel group study2,3
  • 527 DMARD-naïve adult patients with active psoriatic arthritis3

Study design:

  • Randomized 1:1:1 to either Otezla 30 mg twice daily, Otezla 20 mg twice daily, or placebo3
  • Doses were titrated during the first week of treatment3
  • Placebo controlled to week 243
    • Patients on placebo whose swollen and tender joint scores had not improved by ≥20% at week 16 were re-randomized 1:1 to the Otezla arms. At week 24, all remaining placebo patients were also re-randomized to the Otezla arms3
  • Open-label long-term extension phase continued up to 5 years3
  • The study design of PALACE 4 was consistent with PALACE 1-32-6

Primary endpoint3:

  • Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria3:

  • Had a documented diagnosis of psoriatic arthritis of ≥3 months’ duration
  • Had ≥3 swollen and ≥3 tender joints

Selected exclusion criteria:

  • Previous treatment with csDMARDs or biologics3
  • Active TB or a history of incompletely treated TB; however, screening for latent TB was not required3
  • Hepatitis B or hepatitis C positive at screening2
  • History of HIV2

ACR, American College of Rheumatology; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; DMARD, disease-modifying antirheumatic drug; HIV, human immunodeficiency virus; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; TB, tuberculosis.

Baseline disease characteristics and concomitant therapy

Disease characteristics:

  • Median duration: 1.1 years2
  • Mean tender joint count: 20.13
  • Mean swollen joint count: 11.23

Concomitant therapy3*:

  • Stable dose oral corticosteroids (7.2%)
  • Stable dose of NSAIDs (73%)
*

Stable doses of oral corticosteroids (prednisone ≤10 mg/day or equivalent for ≥1 month) and NSAIDs (≥2 weeks) before study entry.

NSAIDs, nonsteroidal anti-inflammatory drugs.

ACTIVE® clinical trial program

Program2,7:

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

Study design2,7:

  • 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 endpoint2,7:

  • Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria2,7:

  • 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 TB2,7
  • Hepatitis B or C positive at screening2
  • History of HIV2

ACR, American College of Rheumatology; ACTIVE, Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients With Psoriatic Arthritis; DMARD, disease-modifying antirheumatic drug; HIV, human immunodeficiency virus; TB, tuberculosis.

Baseline disease characteristics and treatment history

Disease characteristics:

  • Median duration: 1.8 years2
  • Mean tender joint count: 17.82,7
  • Mean swollen joint count: 9.52,7

Treatment history2,7:

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

MTX, methotrexate.

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Data on file, Celgene Corporation. 3. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 4. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. J Rheumatol. 2015;42(3):479-488. 5. Cutolo M, Myerson GE, Fleischmann RM, et al. J Rheumatol. 2016;43(9):1724-1734. 6. Edwards CJ, Blanco JC, Crowley J, et al. Ann Rheum Dis. 2016;75(6):1065-1073. 7. Nash P, Ohson K, Walsh J, et al. Ann Rheum Dis. 2018;77(5):690-698.

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