Novartis’ Cosentyx Demonstrates Early Reduction in Synovitis in Psoriatic Arthritis Patients in First-Ever Imaging-Based Phase IIIb Trial

Nov. 06, 2020 /BioonBIOON/ --NovartisNovartis recently announced the 12-week results from the randomized, controlled Phase IIIb ULTIMATE trial evaluating Cosentyx (Chinese brand name: Keshanting; generic name: secukinumab; commonly known as “Su Jin Dan Kang”) for the treatment of psoriatic arthritis (PsA). The data demonstrated that, compared with placebo, Cosentyx produced significant therapeutic effects on PsA synovitis (inflammation of the synovial membrane), with improvements observed as early as Week 1. In this study, synovitis was assessed using an advanced and sensitive imaging technique known as power Doppler ultrasound (PDUS).

It is worth noting that ULTIMATE is the first phase IIIb imaging study ever conducted, using power Doppler ultrasound (PDUS) to primarily assess the time course of response to Cosentyx in patients with psoriatic arthritis (PsA) who were previously naive to biologic therapy. PDUS is a sensitive technique capable of detecting and monitoring early changes in synovitis and enthesitis, thereby providing early insights into treatment efficacy.

Cosentyx is the only biologic agent effective across all key manifestations of PsA.Dr. Maria A. D’Agostino, Professor of Rheumatology at the Catholic University of Rome, stated, “Psoriatic arthritis has a significant impact on patients’ joints. Synovitis, also known as inflammation of the synovial membrane, if left untreated, can lead to worsening pain, joint damage, and potentially reduced physical function. These data are highly encouraging, demonstrating that Cosentyx significantly reduces synovitis compared with placebo at Week 12, with efficacy evident as early as Week 1. Furthermore, ultrasound is a sensitive and objective tool for monitoring joint inflammation in patients with psoriatic arthritis (PsA).”

Psoriatic Arthritis (Image source: onhealth.com)

Using the standardized ultrasound synovitis score (GLOESS) as the primary endpoint, Cosentyx demonstrated a significant advantage over placebo in reducing synovitis at Week 12, with early improvements observed as early as Week 1. Compared with placebo, Cosentyx treatment also significantly improved key secondary endpoints, including ACR20 (68% vs. 34%), ACR50 (46% vs. 9%), and enthesitis (mean change from baseline in the Spondyloarthritis Research Consortium of Canada Enthesitis Index [SPARCC] score: -2.4 vs. -1.7). The safety profile of Cosentyx over 12 weeks was consistent with previous studies.

NovartisThe complete 24-week data from the ongoing ULTIMATE trial are expected to be presented at the 2021 European Alliance of Associations for Rheumatology (EULAR) annual congress, as well as at ACR 2021.Conference. Publish the final analysis results on the above.

“An investigator in the ULTIMATE study, Dr. Catherine Bakewell of Intermountain Healthcare, stated: ‘As ultrasoundDiagnosisA staunch believer in the benefits of treatment monitoring, this is the first large-scale randomized, double-blind, placebo-controlled trial in psoriatic arthritis (PsA) with ultrasound as the primary endpoint.Clinical TrialThis is very exciting. The ability to use sensitive imaging techniques to assess synovitis and enthesitis in psoriatic arthritis (PsA) represents a breakthrough in how we conceptualize treatment targets. Among other benefits, power Doppler ultrasound (PDUS) facilitates early assessment of treatment response, enabling more effective management of patients across multiple domains of this heterogeneous psoriatic spectrum.”

Psoriatic arthritis (PsA) is a complex disease with diverse manifestations driving patient symptoms. It is estimated that PsA affects up to 50 million people worldwide. This condition belongs to a category of chronic inflammatory diseases known as spondyloarthritides, which primarily target the joints. PsA is closely associated with psoriasis, with up to 40% of psoriasis patients developing PsA. In PsA, synovitis can lead to joint damage, which may become irreversible if left untreated. In addition to reducing synovitis, Cosentyx has been demonstrated to inhibit radiographic progression in PsA over the long term, limit joint damage, and help improve outcomes for patients suffering from this debilitating condition.

Cosentyx is the first fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A). It selectively blocks the activity of circulating IL-17A, reduces immune system activity, and improves disease symptoms. Studies have revealed that IL-17A drives the body’s response in variousAutoimmunityplays an important role in the immune response of inflammatory diseases, including psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx was approved for market launch in January 2015 and has currently received approval for four indications (PsO, PsA, AS, and nr-axSpA). Cosentyx is supported by robust clinical evidence, including five-year data for the top three indications (PsO, PsA, AS) as well as real-world evidence. These data reinforce the unique position of Cosentyx as a rapid, durable, and comprehensive treatment option across axSpA, PsA, and psoriasis. Since its launch, more than 400,000 patients worldwide have been treated with Cosentyx.NovartisPlan to expand the therapeutic indications for Cosentyx to 10 within the next 10 years.

In China, Cosentyx® (Cosentyx) received approval from the National Medical Products Administration (NMPA) in late April this year for adult patients with ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. This marks the second indication approved for Cosentyx® in China, following its initial approval in March 2019 for the treatment of moderate-to-severe plaque psoriasis (PsO). It is currently the first and only interleukin inhibitor approved in China for the treatment of ankylosing spondylitis (AS).

In mid-June, Cosentyx® (Secukinumab) Sensoready® Pen was approved in China. As an upgraded version of the Cosentyx® pre-filled syringe, the Cosentyx® Sensoready® Pen comprehensively optimizes the original administration method. Its “one-touch” operation reduces injection difficulty, enhances patient treatment experience, and effectively prevents medication waste caused by operational errors, thereby providing a more convenient, safe, and efficient new treatment experience for the vast majority of Chinese patients with moderate-to-severe plaque psoriasis and ankylosing spondylitis. (Bioon.com)

Original Source: Novartis Cosentyx® shows early synovitis reduction in patients with psoriatic arthritis in first-of-its-kind study