The following article is a part of conference coverage from the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, being held in Atlanta, Georgia. The team at Rheumatology Advisor will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the 2019 ACR/ARP Annual Meeting.
ATLANTA — Secukinumab 300 mg and 150 mg can provide significant improvement in axial manifestations of psoriatic arthritis (PsA), despite the use of at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs), according to research results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia.
Study investigators evaluated the week 12 results of the phase 3b, double-blind, placebo-controlled, multicenter, 52-week MAXIMISE trial (Study of the Efficacy and Safety of Secukinumab in Participants with Active Psoriatic Arthritis With Axial Skeleton Involvement; ClinicalTrials.gov Identifier: NCT02721966).
A total of 498 patients with PsA aged ≥18 years who met the Classification Criteria for Psoriatic Arthritis, had clinician-diagnosed axial involvement, spinal pain >40/100 on the Visual Analog Scale, and Bath Ankylosing Spondylitis Disease Activity Index >4 despite at least 2 NSAIDs were randomly assigned to receive either subcutaneous secukinumab 300 mg, 150 mg, or placebo weekly for 4 weeks and every 4 weeks thereafter. At 12 weeks, patients in the placebo group were rerandomized to receive subcutaneous secukinumab 300 mg or 150 mg.
The primary end point for the study was Assessment of SpondyloArthritis international Society (ASAS) 20 response with secukinumab 300 mg at week 12. The key secondary end point was ASAS20 with secukinumab 150 mg at week 12, after superiority of secukinumab 300 mg had been established.
Baseline demographic and disease characteristics were comparable across all 3 groups (77%, 81%, and 88% men; ages, 46.2±12.3 years, 46.9±11.5 years, and 46.6±11.5 years, respectively). Study results indicated that both primary and key secondary end points were met: ASAS20 response rates at 12 weeks were 63.1% and 66.3% in the secukinumab 300 mg and 150 mg groups, respectively (P<.0001), compared with 31.3% in the placebo group. ASAS20 responses in patients receiving concomitant methotrexate were 65.1% and 67.3% in the 300 mg and 150 mg groups, respectively, compared with 33.9% in the placebo group. Among patients who were not receiving concomitant methotrexate, the corresponding values were 60.5%, 64.4%, and 27.1%, respectively.
The safety profile was similar across all groups through 12 weeks.
“MAXIMISE is the first randomized controlled trial evaluating the efficacy of a biologic in the management of the axial manifestations of [PsA],” the researchers concluded. “Secukinumab 300 mg and 150 mg provided rapid and significant improvement in ASAS20 responses in patients with…inadequate responses to NSAIDs.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Barallakos X, Coates L, Gossec L, et al. Secukinumab improves axial manifestations in patients with psoriatic arthritis and inadequate response to NSAIDs: primary analysis of phase 3 trial. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 2880.