November 5, 2020:Novartis, a leader in rheumatology and immuno-dermatology, today announced 12-week results from the first-of-its-kind Phase IIIb ULTIMATE randomized controlled trial, which demonstrated the significant treatment response of Cosentyx® (secukinumab) on synovitis (joint lining inflammation) in psoriatic arthritis (PsA) versus placebo.
Synovitis was assessed using an advanced and sensitive imaging technique called Power Doppler ultrasonography (PDUS).
These data are being presented at the American College of Rheumatology (ACR) All-Virtual Annual Meeting, November 5-9, 2020.
“Psoriatic arthritis can have a significant impact on a patient’s joints. Joint lining inflammation, also known as synovitis, if left untreated, can cause pain to worsen, joint damage and may decrease physical function,” said Dr. Maria A. D’Agostino, Professor of Rheumatology at the Catholic University of Rome.
“These data are highly encouraging, showing Cosentyx can significantly reduce synovitis at Week 12 versus placebo with results seen as early as Week 1, and that ultrasound is a sensitive and objective tool to monitor joint inflammation in PsA patients.”
The use of a standardized ultrasound synovitis score (GLOESS) as the primary endpoint showed objectively the significant benefit of Cosentyx versus placebo on synovitis at Week 12 with an early improvement observed from Week one.
Treatment with Cosentyx also significantly improved key secondary endpoints versus placebo, including ACR20 (68% vs 34%, respectively), ACR50 (46% vs 9%, respectively) and enthesitis (mean change from baseline in Spondyloarthritis Research Consortium of Canada enthesitis index score [SPARCC] of -2.4 vs -1.7 respectively).
The safety profile of Cosentyx through 12 weeks was consistent with previous studies.
Novartis anticipates disclosing full 24-week data from the ongoing ULTIMATE trial at the European League Against Rheumatism (EULAR) annual meeting in 2021 and final analysis at ACR 2021.
“As a strong believer in the diagnostic and treatment monitoring benefits of ultrasound, this first large randomized double-blind placebo-controlled clinical trial in PsA with an ultrasonographic primary endpoint is incredibly exciting.
The ability to use a sensitive imaging technique to assess synovitis and enthesitis in PsA represents a breakthrough in how we conceptualize treatment goals,” said Dr. Catherine Bakewell of Intermountain Medical Group in Salt Lake City, UT and an investigator in the ULTIMATE study.
“In addition to other measures, PDUS helps to provide earlier insight into treatment response, and that patients are more effectively treated across multiple domains of this heterogeneous psoriatic disease spectrum.”
PsA is a complex disease with multiple manifestations driving patient symptoms.
In PsA, synovitis may lead to joint damage and if left untreated, the joint damage can be irreversible5,6. In addition to reducing synovitis, Cosentyx has been proven to provide long-lasting inhibition of radiographic progression in PsA, limiting joint damage and helping to improve outcomes for patients with this debilitating condition.
https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-early-synovitis-reduction-patients-psoriatic-arthritis-first-its-kind-study
