The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial

Background The phase 3 FUTURE 5 trial (NCT02404350) showed the clinical and radiographical efficacy of secukinumab in patients with psoriatic arthritis. This analysis aimed to assess effect on patient-reported outcomes (PROs). Methods was a 3, multicentre, parallel-group randomised which who were 18 years old or older, met classification criteria for arthritis at screening, had symptoms moderate-to-severe least 6 months randomly assigned receive 300 mg, 150 mg no loading dose (NL), placebo weekly from baseline week 4 every weeks thereafter. prespecified PROs assessed first overall population. We report mean changes proportion reporting improvements equal more than minimum clinically important differences (MCIDs) scores normative values patient global assessments (PtGA) disease activity; psoriasis visual analogue scale (VAS) scores; pain VAS; Health Assessment Questionnaire Disability Index (HAQ-DI); 36-item Short Form Survey (SF-36); Functional Chronic Illness Therapy Fatigue (FACIT-F); quality life questionnaires. Patients then stratified according their tumour necrosis factor (TNF) inhibitor status (TNF-naive TNF-inadequate responder [TNF-IR] populations) as post-hoc analysis. Findings all groups reported significant least-squares 16 except SF-36 mental component summary (MCS), irrespective TNF use. These included PtGA (300 difference vs −12·2 [95% CI −16·3 −8·1], −8·22 [−12·4 −4·1], NL −8·3 [−12·5 −4·2]; p<0·0001), VAS −14·3 [−18·3 −10·2], −11·5 [−15·6 −7·5], −11·3 [−15·3 −7·2]; HAQ-DI −0·33 [−0·42 −0·24], −0·23 [−0·32 −0·14], −0·24 [−0·33 −0·15]; FACIT-F 4·8 [3·2 6·4], 4·2 [2·6 5·8], 3·5 [1·9 5·1]; p<0·0001). Similarly, better MCID higher group compared most regardless Interpretation Secukinumab resulted early, statistically significant, meaningful, sustained across doses active seen previous use, results indicate that provides comprehensive improvement arthritis, therapy. Funding Novartis.