Secukinumab provides sustained improvements in the signs and symptoms of active psoriatic arthritis: 4-year results from the Phase 3 FUTURE 2 study

Abstract

Background: Secukinumab (SEC), a fully human monoclonal antibody that selectively neutralises interleukin-17A, provided significant and sustained improvement in the signs and symptoms of active psoriatic arthritis (PsA) over 2 years in the FUTURE 2 study (NCT01752634). Objectives: To report 4-year efficacy and safety results from the FUTURE 2 study. 3-year data is presented here, with 4-year data to follow.

Methods: Overall, 397 patients with active PsA were randomised to receive subcutaneous SEC (300, 150 or 75 mg) or placebo (PBO) at baseline (BL), Weeks 1, 2, 3 and 4, and every 4 weeks thereafter. Assessments at week 156 are from patients originally randomised to SEC and included ACR20/50, PASI 75, HAQ-DI, and resolution of dactylitis and enthesitis. Analyses by prior anti-tumour necrosis factor (TNF) use (naive/inadequate response [IR]) and with/without concomitant methotrexate (MTX) were assessed. Data are reported as observed for SEC 300 and 150 mg (approved doses). Safety analyses included all patients who received ≥1 dose of SEC.

Results: In total, 73/100 (73.0%) and 72/100 (72.0%) patients in the SEC 300 and 150 mg groups, respectively, completed 156 weeks of treatment. Sustained clinical improvements were observed in those continuing with SEC across all endpoints through week 156 (Table 1). ACR20 response rates at week 156 in anti-TNF-naive patients were 85.2% and 76.5% with SEC 300 and 150 mg respectively; corresponding rates in anti-TNF-IR patients were 55.6% and 54.5%, respectively. ACR20 response rates in patients receiving concomitant MTX were 73.0% and 77.1% with SEC 300 and 150 mg, respectively; rates in patients without concomitant MTX use were 77.3% and 63.2%, respectively. Over the study (mean SEC exposure of 991.3 days) the type, incidence and severity of adverse events (AEs) were consistent with that reported previously. Exposure adjusted incidence rates with SEC for selected AEs of interest were: serious infections (1.8), Candida infections (1.8), inflammatory bowel disease (0.1), major adverse cardiovascular event (0.2) and malignant/unspecified tumours (1.2).

Conclusion: SEC 300 and 150 mg provided sustained improvements in the signs and symptoms of active PsA through 3 years. Secukinumab was well tolerated, with a safety profile consistent with that reported previously.