P254 Secukinumab provides rapid and sustained improvement in joint tenderness and swelling in patients with PsA: 2-year results from the Phase 3 FUTURE 5 study

Abstract Background Tender joint count (TJC) and swollen joint count (SJC) are components of composite measures used to assess treatment response, which may be impacted by confounding factors. TJC and SJC used in psoriatic arthritis (PsA), which can affect small joints of the feet, assess 78 and 76 joints. TJC and SJC are effective measures of synovitis, a key measure of disease activity. We report 16-week through 2-year effects of secukinumab upon 78 TJC and 76 SJC in PsA patients in FUTURE 5. Methods 996 patients with active PsA were randomised to subcutaneous secukinumab 300 mg with loading dose (LD), 150 mg with LD, 150 mg without LD or placebo. All patients received secukinumab or placebo at baseline, Weeks 1, 2, 3 and 4, and every 4 weeks thereafter. Placebo-treated patients were re-randomised to secukinumab 300 or 150 mg at Week 16 (non-responders) or 24 (responders). Secukinumab dose was escalated from 150 to 300 mg starting at Week 60 and maintained thereafter, if active signs of disease were observed by the physician. 78 TJC and 76 SJC were assessed at baseline, Weeks 1, 2, 3 and 4, every 4 weeks until Week 52, every 8 weeks until Week 92 and at Week 104. ACR20 response, 78 TJC and 76 SJC results are reported for the overall population over 2 years of treatment. Data are reported as observed. Results Baseline characteristics were comparable across treatment arms (Table 1). 783/996 (78.6%) patients completed 104 weeks of treatment. All secukinumab dose regimens (300 mg with LD, 150 mg with LD and 150 mg without LD) demonstrated rapid-onset ACR20 responses that were superior to placebo at Week 16 (adjusted P values: P < 0.0001 for all secukinumab regimens) and increased to 77.0%, 79.4% and 82.4% at Week 104, respectively. Adjusted 78 TJC and adjusted 76 SJC improved in all secukinumab groups vs placebo by Week 4 through Week 16 and were sustained after 2 years of treatment (Table). Numerical differences were comparable between secukinumab doses. Conclusion Secukinumab provided rapid and sustained improvements in 78 TJC and 76 SJC over 2 years of treatment in patients with active PsA. P254 Table: Selected baseline characteristics and 78/76 TJC/SJC results at Weeks 4, 16 and 104 Baseline characteristics Variable SEC 300 mg (n = 222) SEC 150 mg (n = 220) SEC 150 mgno LD (n = 222) PBO (n = 332) Mean age, years 48.9 48.4 48.8 49.0 Sex, n (%) Male 108 (48.6) 111 (50.5) 120 (54.1) 161 (48.5) Mean weight, kg 81.9 83.3 84.0 84.1 Smoking status, n (%) No 176