Ab1118 effect of apremilast on psoriatic disease domains stratified by extent of skin involvement in patients with psoriatic arthritis

Background It has been suggested that greater skin involvement in patients with psoriatic arthritis (PsA) may be associated with greater joint disease activity. Objectives To assess the impact of APR on PsA disease domains in patients with BSA <3% vs BSA ≥3% at 52 weeks using pooled data from 2 phase 3 trials. Methods PALACE 1 & 2 were randomized, placebo (PBO)-controlled, phase 3 studies in patients with active PsA. Eligible patients had ≥3 swollen and ≥3 tender joints despite prior treatment with a conventional systemic Disease Modifying Antirheumatic Drug (csDMARD) and/or biologic DMARD (bDMARD) or concurrent treatment with csDMARD. Patients were randomized to receive APR or PBO for up to 24 weeks, after which all patients received APR until Week 52. This ad-hoc analysis includes pooled data from patients randomized to APR 30 mg BID at Week 0 in these studies. Assessments included change from baseline at Week 52 in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), swollen joint count (SJC), tender joint count (TJC), patient assessment of pain visual analog scale (VAS), and Patient Global Assessment of Disease Activity (PtGA) VAS stratified by baseline psoriasis body surface area (BSA) involvement (<3% vs ≥3%). Results Of 330 patients randomized to APR 30 mg BID at Week 0, 171 had BSA <3% and 159 had BSA ≥3%. Of those with available data, 98.2% of patients with BSA <3% and 100% of patients with BSA ≥3% had a history of psoriasis; mean BSA at baseline was 1.2 in the <3% group and 14.3 in the ≥3% group. More patients with BSA ≥3% at baseline were men with higher rates of nail and SJC involvement, and slightly higher rates of oligoarthritis and TJC ( Table 1 ). At Week 52, both subgroups showed mean decreases (improvement) from baseline in clinical parameters with APR treatment, including cDAPSA (BSA <3%: -18.0, BSA ≥3%: -23.3), SJC (BSA <3%: -6.1, BSA ≥3%: -8.7), TJC (BSA <3%: -10.1, BSA ≥3%: -13.0), Patient Assessment of Pain (BSA <3%: -15.5, BSA ≥3%: -18.0), and PtGA (BSA <3%: -11.8, BSA ≥3%: -16.8) ( Table 1 ). There were numerically greater decreases in these parameters among patients with baseline BSA ≥3% than those with BSA <3%. Improvements in enthesitis and dactylitis were also observed in both subgroups. Conclusion Patients with PsA in PALACE 1 & 2 with higher BSA had higher disease activity in some disease domains at baseline. Both BSA subgroups showed improvement with APR at Week 52 regardless of disease severity, although numerically greater improvements were seen in patients with BSA ≥3%. To our knowledge, this is a novel analysis assessing treatment efficacy in patients with PsA by level of skin involvement. Acknowledgements This study was sponsored by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Rebecca Lane, PhD of Peloton Advantage, LLC, an OPEN Health company, and Dawn Nicewarner, PhD, employee of and stockholder in Amgen Inc. Disclosure of Interests Alvin F. Wells Speakers bureau: AbbVie, Alexion, Amgen Inc., BMS, Celgene, Horizon, Lilly, Novartis, and UCB – consultant and speakers bureau, Consultant of: AbbVie, Alexion, Amgen Inc., BMS, Celgene, Horizon, Lilly, Novartis, and UCB – consultant and speakers bureau, Grant/research support from: AbbVie, Celgene, and Lilly – grant/research support, Lichen Teng Shareholder of: Amgen Inc. – employees and stockholders, Employee of: Amgen Inc. – employees and stockholders, Stephen Colgan Shareholder of: Amgen Inc. – employees and stockholders, Employee of: Amgen Inc. – employees and stockholders, Cynthia Deignan Shareholder of: Amgen Inc. – employees and stockholders, Employee of: Amgen Inc. – employees and stockholders, Shauna Jardon Shareholder of: Amgen Inc. – employees and stockholders, Employee of: Amgen Inc. – employees and stockholders, Yuri Klyachkin Shareholder of: Amgen Inc. – employees and stockholders, Employee of: Amgen Inc. – employees and stockholders, Amar Majjhoo Speakers bureau: AbbVie, Amgen Inc., Eli Lilly, and Jansen – consultant, speaker, Consultant of: AbbVie, Amgen Inc., Eli Lilly, and Jansen – consultant, speaker, Arthur Kavanaugh Consultant of: AbbVie, Amgen Inc., BMS, Eli Lilly, Janssen, Novartis, Pfizer, and UCB – consultant.