aPALACE 1-3 pooled analysis. Data as observed; includes all patients who received OTEZLA 30 mg BID, regardless of whether they were initially randomized to OTEZLA or were placebo patients re-randomized to OTEZLA at week 16 or week 24. Randomized patients who received ≥1 dose of study medication: OTEZLA 30 mg BID, n = 497; placebo, n = 498. The n at each time point represents the number of patients with available data at the time point.
OTEZLA improves physical function, relieves pain, and reduces fatigue2-5
*PALACE 1 study. OTEZLA 30 mg BID vs placebo: -0.24 vs -0.09 (ITT, P = 0.0017).
†Pooled analysis of PALACE 1-3. Week 16 improvement in FACIT-F score, OTEZLA 30 mg BID vs placebo: 3.45 (n = 473) vs 1.14 (n = 475); P < 0.001.
‡Pooled analysis of PALACE 1-3. Week 16 improvement in pain VAS score, OTEZLA 30 mg BID vs placebo: -12.7 (n = 472) vs -5.8 (n = 480), P < 0.0001.
§Patients randomized to OTEZLA 30 mg BID at baseline who remained on treatment for 52 weeks.
BID, twice daily; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue; HAQ-DI, Health Assessment Questionnaire–Disability Index; ITT, intent to treat; MCID; minimal clinically important difference; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; VAS, visual analog scale.
On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).