Improvement in Patients with PsA at Week 16 in FUTURE Trialsa | |||||
Select PsA Core Domains | Measures and Improvement Definitions | Secukinumab 300 mg, n = 461 | Secukinumab 150 mg, n = 572 | Secukinumab 150 mg No Load, n = 335 | Placebo, n = 681 |
Pain | PsA pain, mean change from BL (SE)b,c | −19.75 (1.11), n = 440 | −15.94 (0.98), n = 545 | −15.44 (1.32), n = 320 | −4.46 (0.93), n = 616 |
PtGA | Patient global assessment, mean change from BL (SE)b,c | −20.04 (1.11), n = 440 | −15.92 (0.98), n = 545 | −14.60 (1.33), n = 320 | −5.31 (0.93), n = 616 |
Physical function | HAQ-DI, mean change from BL (SE)b | −0.48 (0.02), n = 438 | −0.36 (0.02), n = 544 | −0.40 (0.03), n = 320 | −0.16 (0.02), n = 615 |
HRQOL | PsAQOL, mean change from BLb | −3.65, n = 443 | −3.26, n = 548 | −3.16, n = 319 | −1.20, n = 622 |
DLQI, mean change from BLb,c | −7.11, n = 273 | −6.57, n = 166 | −6.29, n = 339 | −2.14, n = 356 | |
Fatigue | FACIT-Fatigue, mean change from BLb,c | 6.21, n = 442 | 5.26, n = 546 | 5.42, n = 319 | 1.79, n = 621 |
Improvement in Patients with Ankylosing Spondylitis at Week 16 in MEASURE 2a,d | |||||
Secukinumab 150 mg, n = 72 | Placebo, n = 74 | ||||
Spine symptoms | BASDAI, mean change from BL (SD) | −2.19 (0.25) | −0.85 (0.25) |
↵a All p values vs placebo were p < 0.05. All p values were for hypothesis generation. No adjustment was made for multiple comparisons.
↵b Least squares mean change from BL; n is the number of patients with measures at both BL and Week 16 visit.
↵c No MCID has been defined in PsA.
↵d Baeten D, et al. N Engl J Med 2015;373:2534-48. BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BL: baseline; DLQI: Dermatology Life Quality Index; FACIT-Fatigue: Functional Assessment of Chronic Illness Therapy–Fatigue scale; GRAPPA: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis; HAQ-DI: Health Assessment Questionnaire–Disability Index; HRQOL: health-related quality of life; OMERACT: Outcome Measures in Rheumatology; PsA: psoriatic arthritis; PsAQOL: PsA-specific quality of life; PtGA: patient’s global assessment; SE: standard error; MCID: minimal clinically important difference.