Secukinumab provides sustained pasdas related low disease activity in psoriatic arthritis: Two year results from the future 2 study

Background: Psoriatic Arthritis Disease Activity Score (PASDAS) assesses multiple facets of psoriatic arthritis (PsA) and has been demonstrated to distinguish treatment effect, perform better in statistical terms than traditional joint-only indices and can be used as a treatment target in clinical trials in PsA. Secukinumab provided sustained improvement in the signs and symptoms of PsA over 104 weeks in the FUTURE 2 study. Here, we report the ability of secukinumab to reach and sustain PASDAS-based low-disease activity (LDA) up to 104 weeks in the FUTURE 2 study using a posthoc exploratory analysis. Methods: 397 patients with active PsA were randomised to subcutaneous (s.c.) secukinumab (300, 150, or 75 mg) or placebo at baseline, weeks 1, 2, 3, and 4 and then every four weeks (q4w). Placebo non-responder and responder patients were re-randomised to secukinumab 300 or 150mg s.c. q4w from week 16 and 24, respectively. PASDAS is derived from patient and physician global visual analogue scale (VAS) scores, Short Form-36 Physical Component Summary (SF-36 PCS) score, tender and swollen joint counts (TJC68 and SJC66), Leeds Enthesitis Index score, dactylitis count and C-reactive protein (CRP) level and has cut-off points for high-disease activity (HDA; ≥5.4), low-disease activity (LDA; <3.2) and remission (-1.9). PASDAS was assessed in the overall population and in patients stratified by prior tumour necrosis factor inhibitor (TNFi) use (naive vs. inadequate responder/intolerant [IR]) and disease duration (-2 years vs. >2 years since diagnosis) and reported using nonmutually exclusive categories at group level and as observed analysis. Only data for approved doses of secukinumab (300/150mg are shown). Results: PASDAS score (mean [SD]) at baseline was 5.9 (0.9), 6.0 (1.0), and 5.8 (1.0) in the secukinumab 300 mg, 150 mg, and placebo groups, respectively. In the overall population at week 16, PASDAS LDA was achieved in 37/96 (38.5%) and 34/99 (34.3%) of patients treated with secukinumab 300mg and 150 mg, respectively; vs. 14/87 (16.1%) with placebo. A high proportion of patients treated with secukinumab 300 and 150mg achieved LDA (49/83 [59.0%] and 38/77 [49.4%], respectively) at week 104. A higher proportion of TNFi-naive patients treated with secukinumab achieved and sustained PASDAS LDA than TNFi-IR patients, whereas similar proportion of patients treated with secukinumab achieved PASDAS LDA irrespective of time since diagnosis (-2 years vs. >2 years). Conclusion: A higher proportion of secukinumab-treated patients achieved PASDAS LDA than placebo at week 16, with LDA sustained at group level at week 104. The discriminatory effect of PASDAS was consistent with that previously reported in the GRACE project.