SAT0382 Palace 4, A Phase 3, Randomized, Controlled TRIAL of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Treatment of Psoriatic Arthritis: Long-Term (52-WEEK) Improvements in Physical Function

Abstract

disease in patients with psoriatic arthritis (PsA). Objectives: To compare the presence of CV risk factors and disease in patients with PsA and the normal population. Further to estimate the 10-year risk of a fatal CV event by using the Systematic Coronary Evaluation (SCORE) algorithm. 1 Methods: Patients and control subjects were recruited from the Nord-Trøndelag Health Study (HUNT) 3, and the diagnoses of PsA (n=338) were verified according to the Classification of Psoriatic Arthritis (CASPAR) criteria. 2 The control group (n=50468) consisted of other individuals enrolled in the HUNT 3 study. Age and sex adjusted prevalence rates of CV risk factors and co morbidity were calculated. Results: Mean (SD) age was 54.3±11.9 years and 53.9±16.1 years in PsA and controls, respectively (p=0.58) and the gender ratio was nearly equally distributed in both groups (p=0.31). Patients with PsA were more often smokers compared to controls (p=0.02). The other traditional CV risk factors included in the SCORE CV risk algorithm (age, gender, systolic blood pressure and total cholesterol/HDL) were comparable between PsA patients and controls. Of untraditional CV risk factors; CRP, body mass index (BMI) and triglycerides were elevated in PsA patients compared to controls, (p<0.001, p<0.001 and p=0.01, respectively). The mean calculated CV risk (SD) in PsA patients was low (1.45±1.79) and comparable to controls (1.59±1.95) (p=0.63). The distribution across CV risk classes (low, moderate and high + very high) was comparable amongst PsA patients and controls (figure 1). There was no difference in the prevalence of established CV disease in the PsA cohort and the control group (p=0.2). Conclusions:The low CV risk in patients with PsA was related to low levels of traditional risk factors. Although, PsA patients had elevated levels of untraditional CV risk factors such as CRP, BMI and triglycerides, which are not included in the SCORE risk algorithm. Whether these factors will affect long term CV outcome is not known.Background: Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. PALACE 4 compared APR efficacy/safety with placebo (PBO) in patients (pts) with active PsA who were DMARD-naïve. Objectives: Evaluate the impact of APR over 52 wks on physical function among PALACE 4 pts. Methods: Pts were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Pts with <20% reduction from BL in SJC or TJC at Wk 16 were required to be re-randomized to APR20 or APR30 if initially randomized to PBO, or continued on the initial APR dose. At Wk 24, all remaining PBO pts were re-randomized to APR20 or APR30. This analysis reports data for Wks 0-52.

A criterion-based approach to systematic and transparent comparative effectiveness: a case study in psoriatic arthritis

“…Applying the inclusion and exclusion criteria and designating placebo as the comparator for a potential NMA, we were able to link 18 unique RCTs (Table 1) [15,16,[31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] for apremilast and seven active comparators (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab). Of note, two studies of MTX monotherapy were excluded because they lacked the required clinical response variables [47,48], and one apremilast abstract from 2014 (PALACE 4) was excluded for a similar lack of needed extraction variables [49]. During analysis, additional results from McInnes et al for secukinumab and two follow-up studies for apremilast [15,16,31] were discovered and added.…”