Patients with psoriatic arthritis (PsA) treated with secukinumab saw a sustained improvement in axial and nail manifestations for 52 weeks while enrolled in the MAXIMISE trial, the first randomized controlled trial evaluating a biologic agent for treatment of axial PsA.
MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab) (ClinicalTrials.gov Identifier NCT02721966), a Phase 3b double blind, placebo-controlled, 52-week trial included 498 adult patients with PsA and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or higher, a spinal pain Visual Analog Scale (VAS) score of 40/100, and an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs).
Investigators randomly assigned patients 1:1:1 to subcutaneous secukinumab 300 mg, 150 mg or placebo weekly for 4 weeks, and then every 4 weeks thereafter. At week 12, investigators randomly assigned placebo patients 1:1 to subcutaneous secukinumab 300 mg or 150 mg. The primary and secondary endpoints were a change in the Assessment of SpondyloArthritis international Society (ASAS20) criteria for patients taking secukinumab 300 and 150 mg, respectively, by week 12. An ASAS20 response was defined as an improvement of 20% or greater and 1 or more units in 3 of the 4 ASAS20 domains. Investigators also recorded the modified nail psoriasis severity index (mNAPSI) score at weeks 12 and 52 as an exploratory endpoint.
Of the 425 patients who completed the study through week 52, an ASAS20 response was seen in 62.9% of patients taking 300 mg (P <.0001) and 66.3% of patients taking 150 mg (P <.0001) compared with 31.2% in patients receiving placebo. Improvements were sustained through week 52, with an ASAS20 response seen in 81.3% of patients taking 300 mg and 80.1% of patients taking 150 mg of secukinumab. mNAPSI scores improved in patients taking secukinumab 300 mg (-4.8) and 150 mg (-3.5) compared with placebo (-1.4) at week 12. By week 52, 84% of patients on 300 mg and 81% of patients on 150 mg of secukinumab had full clearance of nail symptoms, with a mNAPSI score of 2 or less.
“[The] safety profile of secukinumab was favorable and consistent with previous reports,” the study authors noted.
Disclosure: This investigation was sponsored by Novartis Pharma AG, Basel, Switzerland.
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Baraliakos X, Coates LC, Pournara E, et al. Efficacy of secukinumab in managing axial manifestations and nail psoriasis in patients with psoriatic arthritis: Results from the MAXIMISE trial. Presented at: AAD VMX 2021; April 23-25, 2021. Abstract/Poster 25851.