SECUKINUMAB improves axial manifestations in patients with psoriatic arthritis and inadequate response to NSAIDS: primary analysis of the maximise trial

Abstract

Background Secukinumab (SEC) has provided significant and sustained improvement in the signs and symptoms of active psoriatic arthritis (PsA) and ankylosing spondylitis 1. Evidence on the efficacy of biologics in the treatment of PsA patients (pts) with axial manifestations affecting 30–70% of PsA pts is limited2, particularly as validated classification criteria for this subtype of PsA are not yet available; an effort to develop criteria is being undertaken by ASAS/GRAPPA. MAXIMISE is an ongoing study evaluating the efficacy and safety of secukinumab 300 or 150mg in managing axial manifestations in PsA pts

Objectives To report the primary analysis results at Week (Wk) 12 from MAXIMISE (NCT02721966) trial

Methods This phase 3b, double blind, placebo (PBO)-controlled, multicentre 52-wk trial included 498 pts (aged ≥18 years) with PsA (CASPAR criteria), clinician-diagnosed axial involvements, spinal pain VAS >40/100 and BASDAI >4 despite trial of at least two NSAIDs. Pts were randomised to subcutaneous (SC) SEC (300/150 mg) or PBO weekly for 4 wks and every 4 wks thereafter. At Wk 12, PBO pts were re-randomised to SC SEC 300/150 mg. The primary endpoint was proportion of pts achieving ASAS20 response with SEC 300 mg at Wk 12. The key secondary endpoint was ASAS20 response with SEC 150 mg at Wk 12 after superiority of 300 mg was established. Analyses used multiple imputation

Results Demographic and baseline (BL) disease characteristics were comparable across groups (Table). Primary and key secondary endpoints were met; ASAS20 response rates at Wk 12 were 63.1% (SEC 300 mg; P<0.0001) and 66.3% (150 mg; P<0.0001) vs 31.3% (PBO; Figure). ASAS20 responses in pts using concomitant MTX were 65.1% [300 mg], 67.3% [150 mg] vs 33.9% [PBO] and corresponding values in No MTX group were 60.5%, 64.4% vs 27.1%. The safety profile was similar across groups through Wk 12

Conclusion MAXIMISE is the first randomised controlled trial evaluating the efficacy of a biologic in the management of the axial manifestations of PsA. SEC 300 and 150 mg provided rapid and significant improvement in ASAS20 responses through Wk 12 in PsA pts with axial manifestations and inadequate responses to NSAIDs