Study Design

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 endpoint:

• Percentage of patients achieving ACR20 response at week 16¹

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
• Study 3: 1 qualifying psoriasis 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

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%)