MADRID — Individuals with psoriatic arthritis who have inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and who have axial manifestations could experience improvements with secukinumab, according to research presented at the 2019 European League Against Rheumatism (EULAR) Congress, held June 12-15, in Madrid, Spain.
This phase 3b, double-blind, placebo-controlled study (MAXIMISE; ClinicalTrials.gov identifier: NCT02721966) included 498 participants with psoriatic arthritis, all of whom were diagnosed with axial involvements and who had spinal pain (visual analog scale score of at least 40/100) and Bath Ankylosing Spondylitis Disease Activity Index score of at least 4. All participants had responded inadequately to at least 2 NSAIDs.
Participants were randomly assigned to either placebo or subcutaneous secukinumab 300 or 150 mg every week for a month, then once per 4 weeks afterward. At week 12, those treated with placebo were randomly assigned to secukinumab 300 or 150 mg.
The proportion of participants on secukinumab 300 mg with a satisfactory week 12 ASAS20 response constituted the primary end point, with the secondary end point being adequate week 12 ASAS20 response on secukinumab 150 mg following establishment of superiority in the 300 mg dose. Multiple imputation was used in analysis.
At week 12, ASAS20 response rates were 63.1% among those given secukinumab 300 mg (P <.0001), 66.3% among those given 150 mg (P <.0001), and 31.3% among those given placebo.
Among those taking concomitant methotrexate, ASAS20 responses were 65.1% for 300 mg, 67.3% for 150 mg, and 33.9% for placebo. Among those not taking methotrexate, ASAS20 responses were 60.5% for 300 mg, 64.4% for 150 mg, and 27.1% for placebo. Through week 12, all groups showed a similar safety profile.
The study researchers concluded that “MAXIMISE is the first randomised controlled trial evaluating the efficacy of a biologic in the management of the axial manifestations of [psoriatic arthritis]. [Secukinumab] 300 [mg] and 150 mg provided rapid and significant improvement in ASAS20 responses through [week] 12 in [psoriatic arthritis patients] with axial manifestations and inadequate responses to NSAIDs.”
Disclosure: This study was sponsored by Novartis Pharmaceuticals. Several authors are employees of Novartis. See the reference for complete disclosure information.
Baraliakos X, Coates LC, Gossec L, et al. Secukinumab improves axial manifestations in patients with psoriatic arthritis and inadequate response to NSAIDS: primary analysis of the MAXIMISE trial. Presented at: European League Against Rheumatism (EULAR) Congress 2019; June 12-15, 2019; Madrid, Spain. Abstract OP0235.