BACKGROUND: The phase 3 FUTURE 5 trial (NCT02404350) demonstrated the clinical and radiographic efficacy of secukinumab in patients with psoriatic arthritis (PsA). This analysis evaluated its impact on patient-reported outcomes (PROs).
METHODS: Patients received secukinumab 300 mg, 150 mg, 150 mg no loading dose (NL), or placebo weekly from baseline to week 4 and every 4 weeks thereafter. Mean changes from baseline and proportions of patients reporting improvements ≥ minimum clinically important differences (MCIDs) and scores ≥ normative values were determined for patient global assessments (PtGA) of disease activity, psoriasis and arthritis visual analog scale (VAS) scores, pain VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), and quality of life questionnaires. Patients were stratified by prior tumor necrosis factor inhibitor (TNFi) use.
FINDINGS: Patients in all secukinumab groups reported significantly greater improvements vs placebo in all PROs except SF-36 mental component summary (MCS), irrespective of TNFi use. Treatment responses were generally higher with secukinumab 300 mg vs 150 mg and 150 mg NL at week 16. By week 16, the proportion of overall, TNF naive, and TNF–inadequate responder patients reporting improvements ≥ MCID in PtGA (18%, 13%, 30%), pain VAS (16%, 16%, 16%), HAQ-DI (26%, 24%, 32%), and FACIT-F (20%, 15%, 31%), respectively, significantly increased, (p<0·0005) relative to baseline. Patients receiving secukinumab 300 mg reported significantly shorter (p<0·0005) median days to response in PtGA (9·0), pain (9·0), HAQ-DI (22·0), and FACIT-F (34·5) vs placebo. More secukinumab-treated patients reported scores ≥ normative values in PROs at week 16 vs placebo, and these improvements continued through week 104.
INTERPRETATION: Secukinumab resulted in early, statistically significant, clinically meaningful, sustained improvements in PROs across all doses compared with placebo in patients with active PsA, irrespective of prior TNFi use. These results demonstrate secukinumab as a treatment to provide comprehensive improvement for patients with PsA, regardless of line of therapy.
