184 Secukinumab provides sustained remission and low disease activity related to disease activity index for psoriatic arthritis: two year results from the FUTURE 2 study

Abstract

Background: Disease Activity Index for Psoriatic Arthritis (DAPSA) is a validated tool to measure disease activity states, focusing on peripheral joint involvement in psoriatic arthritis (PsA), and can be used to assess targets such as remission or low‐disease activity (LDA). This post‐hoc exploratory analysis assessed DAPSA states through to week 104 in FUTURE 2. Methods: In total, 397 active PsA patients were randomised to subcutaneous (s.c.) secukinumab or placebo at baseline and weeks 1, 2, 3 and 4, and every 4 weeks (q4w) thereafter. Placebo patients were re‐randomised to secukinumab 300 or 150mg s.c. q4w from Week 16 or 24, depending on week 16 clinical response. DAPSA was derived as the sum of five variables: tender joint and swollen joint counts (TJC68 and SJC66); patient global assessment and pain assessed on a 10‐cm visual analogue scale; and C‐reactive protein levels (mg/dL) with validated cut‐offs to indicate remission (≤4), LDA (>4 and ≤14), moderate‐disease activity (MDA; >14 and ≤28) and high‐disease activity (HDA; >28). DAPSA was assessed in the overall population and in patients stratified by prior tumour necrosis factor inhibitor (TNFi) use (TNFi‐naive vs. inadequate response/intolerance to these agents [TNFi‐IR]) and time since first PsA diagnosis (≤2 vs. >2 years) using observed data. Only data for secukinumab 300 and 150mg (approved doses) are reported. Results: Baseline demographics and clinical characteristics were similar across treatment groups and have been previously reported. DAPSA score at baseline (mean [SD]) was 42.0 (17.4), 46.8 (24.3) and 44.9 (25.3) in the secukinumab 300 mg, 150 mg, and placebo groups, respectively. In the overall population, at Week 16, remission was achieved in 14/97 (14.4%) with secukinumab 300mg and 10/100 (10%) with secukinumab 150mg vs. placebo 4/87 (4.6%); LDA in 27/ 97 (27.8%) and 34/100 (34%) vs. 12/87 (13.8%), respectively. Remission or LDA were sustained through Week 104 with secukinumab 300 and 150mg (55/84 [65.5%; remission+LDA] and 41/77 [53.2%; remission+LDA], respectively). At Week 16, a higher proportion of TNFi‐naive patients treated with secukinumab achieved and sustained DAPSA remission than TNFi‐IR patients and a higher proportion of patients with early diagnosis (≤2 years) achieved DAPSA remission vs. patients diagnosed later (>2 years). Conclusion: In the overall population, a higher proportion of patients treated with secukinumab at week 16 achieved DAPSA remission than those treated with placebo, with remission and LDA being sustained through to Week 104. The proportion of patients treated with secukinumab achieving remission was greater in TNFi‐naive and in early PsA patients (time since diagnosis ≤2 years) vs. TNFi‐IR patients and patients with established PsA (>2 years).