OBJECTIVE: To evaluate apremilast treatment in patients with active psoriatic 
arthritis, including current skin involvement, despite prior therapy with 
conventional disease-modifying antirheumatic drugs and/or biologic agents.
METHODS: Patients (N=505) were randomised (1:1:1) to placebo, apremilast 20 mg 
twice daily, or apremilast 30 mg twice daily. Rescue therapy with apremilast was 
designated at week 16 for placebo patients not achieving 20% improvement in 
swollen and tender joint counts. At week 24, the remaining placebo patients were 
then randomised to apremilast 20 mg twice daily or 30 mg twice daily. The 
efficacy and safety of apremilast were assessed over 52 weeks.
RESULTS: At week 16, significantly more patients receiving apremilast 20 mg 
twice daily (28%) and 30 mg twice daily (41%) achieved 20% improvement in 
American College of Rheumatology response criteria versus placebo (18%; p=0.0295 
and p<0.0001, respectively), and mean decrease in the Health Assessment 
Questionnaire-Disability Index score was significantly greater with apremilast 
30 mg twice daily (-0.20) versus placebo (-0.07; p=0.0073). In patients with 
baseline psoriasis body surface area involvement ≥3%, significantly more 
apremilast 30 mg twice daily patients achieved 50% reduction from baseline 
Psoriasis Area and Severity Index score (41%) versus placebo (24%; p=0.0098) at 
week 16. At week 52, observed improvements in these measures demonstrated 
sustained response with continued apremilast treatment. Most adverse events were 
mild to moderate in severity; the most common were diarrhoea, nausea, headache 
and upper respiratory tract infection.
CONCLUSIONS: Apremilast demonstrated clinically meaningful improvements in 
psoriatic arthritis and psoriasis at week 16; sustained improvements were seen 
with continued treatment through 52 weeks. Apremilast was generally well 
tolerated and demonstrated an acceptable safety profile.
TRIAL REGISTRATION NUMBER: NCT01212770.