074. LONG-TERM (UP TO 156 WEEKS) SAFETY PROFILE OF ORAL APREMILAST IN PATIENTS WITH PSORIATIC ARTHRITIS: POOLED ANALYSIS OF PALACE 1–3

Abstract

Background: The PALACE 1 (NCT01172938), 2 (NCT01212757), and 3 (NCT01212770) studies compared the efficacy and safety of apremilast (APR) with placebo in patients with active psoriatic arthritis despite prior conventional disease-modifying anti-rheumatic drugs and/or biologics. We assessed long-term APR safety for up to 3 years. Method(s): Patients were randomized (1:1:1) to receive placebo, APR 30mg BID (APR30), or APR 20mg BID (APR20). Placebo patients were re-randomized to APR30 or APR20 at Week 16 (early escape) or Week 24. Double-blind APR treatment continued to Week 52; patients could continue APR during an open-label treatment phase. Result(s): 1,493 patients were randomized; 1,441 patients had 0 to-52 weeks of APR exposure, 1,028 had >52 to-104 weeks of APR exposure, and 865 had >104 to-156 weeks of APR exposure at the 3-year data cut. During Weeks 0 to-52, adverse events (AEs) occurring in>=5% of APR-exposed patients were diarrhoea, nausea, headache, upper respiratory tract infection and nasopharyngitis (Table 1). Diarrhoea and nausea usually occurred and resolved without intervention early in treatment (-2 weeks and -4 weeks, respectively). During Weeks >52 to-104 and >104 to-156, the frequency of gastrointestinal AEs decreased; other common AEs occurring in>=5% of APR-exposed patients decreased in frequency or remained stable (Table 1). Most AEs were mild to moderate in severity. The rate of serious AEs remained consistent across all 3 APR-exposure periods (Table 1). Discontinuation rates decreased every year, reaching 1.6% during Weeks >104 to-156 (Table 1). Major cardiac events, malignant neoplasms, opportunistic infections, and marked laboratory abnormalities remained infrequent throughout treatment. Conclusion(s): APR treatment demonstrated a favorable safety profile up to 156 weeks, marked by stable or decreasing AE incidence and lack of immunosuppression accumulation or need for laboratory monitoring. (Table Presented).