Novartis (NYSE:NVS) has announced 12-week results from its Phase IIIb ULTIMATE randomized study which showed considerable treatment response of Cosentyx® on synovitis in Psoriatic Arthritis.
Power Doppler Ultrasonography (PDUS), an advanced and sensitive imaging technique, was used to assess synovitis.
Cosentyx® shows improvement o synovitis in Psoriatic Arthritis
Dr. Maria A D’Agostino, a Rheumatology professor at the Catholic University of Rome, said that psoriatic arthritis can substantially impact patients’ joints. The joint lining inflammation, which is called synovitis if untreated, can result in devastating pain, resulting in joint damage and decreased physical function. The data is highly encouraging, indicating Cosentyx® can reduce synovitis after 12 weeks against placebo with results observed as early as the first week. D’Agostino added that the PDUS is an objective and sensitive tool for monitoring joint inflammation in PsA patients.
Using a standardized ultrasound synovitis score as the primary endpoint demonstrated objectively the benefit of Cosentyx® compared to placebo on synovitis after 12 weeks with significant improvement seen from the first week. Using Consentyx® for treatment also improved significantly the secondary endpoints compared to placebo, which included ACR20 at 68% against 34% in placebo and ACR50 at 46% against 9%, respectively. Cosentyx® safety profile was consistent with results from previous studies.
Ultrasound beneficial in PsA treatment
The company plans to disclose the full 24-week data from the ULTIMATE study at the European League Against Rheumatism (EULAR) annual meeting in 2021. Dr. Catherine Bakewell, one of the investigators of the ULTIMATE study said she is a strong believer in ultrasound’s diagnostic and treatment monitoring benefits. This is the first large randomized, placebo-controlled, double-blind clinical trial in PsA with an ultrasonographic primary endpoint, which is very exciting.
Bakewell added that using a sensitive imaging technique in assessing synovitis and enthesitis in PsA is a huge breakthrough in conceptualizing treatment goals. PDUS also offers earlier treatment response insight with patients receiving effective treatment across various heterogeneous psoriatic disease spectrum domains.