PATIENTS REPORT IMPROVED QUALITY OF LIFE1
Sustained improvement in physical function up to 4 years1,a
aPALACE 1 study. 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 = 168; placebo, n = 168. 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
- Patients taking OTEZLA 30 mg BID achieved significant improvement in quality of life, as measured by reduction in HAQ-DI (disability) score, vs placebo at week 166*
OTEZLA relieved fatigue and reduced pain
- Patients taking OTEZLA 30 mg BID achieved significant improvements in baseline FACIT-F fatigue scores vs placebo at week 16, with an overall improvement of 5.7 points at 4 years1†
- Patients taking OTEZLA 30 mg BID achieved significantly greater reductions in baseline pain VAS score vs placebo at week 16‡,with an overall reduction of -17.4 at 1 year5§
*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; minimum clinically important difference; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; VAS, visual analogue scale.
- Kavanaugh A, Chen P, Fang L, et al. Durability of apremilast response in patients with psoriatic arthritis: long-term (208-week) results from the PALACE 1 trial. Ann Rheum Dis. 2017;76 (suppl 2): Abstract SAT0436.
- Mease PJ, Wollenhaupt J, Hall S, et al. Assessment of Disability Levels in a Cohort of 1,489 Patients With Active Psoriatic Arthritis, and the Effect of Apremilast Treatment: Pooled Data From Three Phase III, Randomized, Controlled Trials. Presented at: the 2015 ACR/ARHP Annual Meeting; November 7-11, 2015; San Francisco, CA.
- Kavanaugh A, Gladman DD, Edwards CJ, et al. Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term (104-Week) Improvement in Fatigue in Patients With Psoriatic Arthritis: Pooled Results From 3 Phase 3, Randomized, Controlled Trials. Presented at: the 2015 ACR/ARHP Annual Meeting; November 7-11, 2015; San Francisco, CA.
- Kavanaugh A, Gladman DD, Gomez-Reino JJ, et al. Long-term (156-Week) Efficacy and Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Psoriatic Arthritis: Results From a Phase III, Randomized, Controlled Trial and Open-Label Extension (PALACE 1). Presented at: the Annual European Congress of Rheumatology EULAR 2016; 8-11 June 2016; London, UK.
- Gladman D, Strand V, Kavanaugh A, et al. Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Improvement of Pain, Fatigue, and Disability for Up to 52 Weeks in Patients With Psoriatic Arthritis: Results From 3 Phase 3, Randomized, Controlled Trials. Presented at: the 2014 ACR/ARHP Annual Meeting; November 15-19, 2014; Boston, MA.
- Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis. 2014;73(6):1020-1026.