ULTIMATE trial: Secukinumab reduces synovitis in patients with PsA
medwireNews: Phase 3 trial results suggest that secukinumab treatment reduces synovitis among biologic-naïve patients with psoriatic arthritis (PsA) and an inadequate response to conventional DMARDs.
The ULTIMATE study was “the first large, placebo-controlled phase 3 ultrasound study to assess synovitis response in PsA patients treated with secukinumab,” said lead author Maria D’Agostino (Université de Versailles-Saint Quentin en Yvelines, France) in a poster presentation at the ACR Convergence 2020 virtual meeting.
D’Agostino reported that the least-squares mean (LSM) decrease in global EULAR-OMERACT synovitis score (GLOESS) – an ultrasonography composite scoring system – from baseline to week 12 was 9 points for the 83 participants who were randomly assigned to receive secukinumab 150 mg or 300 mg/week.
This was significantly greater than the LSM decrease of 6 points for the 83 participants who were instead given placebo, with a significant between-group difference seen as early as week 1. Average baseline GLOESS scores were 24 and 27 points in the secukinumab and placebo arms, respectively.
These findings demonstrated an “objectively significant benefit” of treatment with the interleukin (IL)-17A inhibitor versus placebo on synovitis, said D’Agostino.
In accordance with previous results from the FUTURE and EXCEED studies, participants treated with secukinumab achieved significantly higher ACR20 (68 vs 34%) and ACR50 (46 vs 9%) response rates from baseline to week 12 relative to those in the placebo arm. Patients in the secukinumab group also experienced significantly greater LSM improvements in Spondyloarthritis Research Consortium of Canada enthesitis index scores, at a decrease of 2.4 versus 1.7 points from average baseline scores of 4.0 points in both groups.
D’Agostino said that “no new or unexpected adverse events were reported up to week 12” in the ULTIMATE trial, and the safety profile of the IL-17A inhibitor was consistent with previous reports. There were no serious adverse events in the secukinumab group, and two in the placebo arm.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2020 Springer Healthcare Ltd, part of the Springer Nature Group