Study Design

Otezla^® (apremilast) was evaluated in one of the largest global clinical development programs ever conducted in psoriatic arthritis^1,2

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PALACE 1-3 Clinical Trial Program
PALACE 4 Clinical Trial Program
ACTIVE Clinical Trial Program

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 study^2,3
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 1-3^2-6

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

Program^2,7:

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

Study design^2,7:

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 endpoint^2,7:

Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria^2,7:

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 TB^2,7
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: 17.8^2,7
Mean swollen joint count: 9.5^2,7

Treatment history^2,7:

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

MTX, methotrexate.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 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.

Study Design

PALACE 1-3 clinical trial program

Program¹:

Study design:

Primary endpoint¹:

Selected inclusion criteria¹:

Selected exclusion criteria:

Baseline disease characteristics and treatment history

Disease characteristics¹:

Psoriatic arthritis types¹:

Treatment history¹:

Concomitant therapy¹:

PALACE 4 clinical trial program

Program:

Study design:

Primary endpoint³:

Selected inclusion criteria³:

Selected exclusion criteria:

Baseline disease characteristics and concomitant therapy

Disease characteristics:

Concomitant therapy³*:

ACTIVE^® clinical trial program

Program^2,7:

Study design^2,7:

Primary endpoint^2,7:

Selected inclusion criteria^2,7:

Selected exclusion criteria:

Baseline disease characteristics and treatment history

Disease characteristics:

Treatment history^2,7:

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Study Design

PALACE 1-3 clinical trial program

Program1:

Study design:

Primary endpoint1:

Selected inclusion criteria1:

Selected exclusion criteria:

Baseline disease characteristics and treatment history

Disease characteristics1:

Psoriatic arthritis types1:

Treatment history1:

Concomitant therapy1:

PALACE 4 clinical trial program

Program:

Study design:

Primary endpoint3:

Selected inclusion criteria3:

Selected exclusion criteria:

Baseline disease characteristics and concomitant therapy

Disease characteristics:

Concomitant therapy3*:

ACTIVE® clinical trial program

Program2,7:

Study design2,7:

Primary endpoint2,7:

Selected inclusion criteria2,7:

Selected exclusion criteria:

Baseline disease characteristics and treatment history

Disease characteristics:

Treatment history2,7:

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Program¹:

Primary endpoint¹:

Selected inclusion criteria¹:

Disease characteristics¹:

Psoriatic arthritis types¹:

Treatment history¹:

Concomitant therapy¹:

Primary endpoint³:

Selected inclusion criteria³:

Concomitant therapy³*:

ACTIVE^® clinical trial program

Program^2,7:

Study design^2,7:

Primary endpoint^2,7:

Selected inclusion criteria^2,7:

Treatment history^2,7: