MOSAIC Study is First to use MRI to Assess Inflammation in Peripheral Joints and Entheses in Psoriatic Arthritis Patients
Exploratory Analysis Examines Effects of Otezla on Cardiometabolic Parameters
THOUSAND OAKS, Calif., May 30, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new research examining the use of Otezla® (apremilast) in psoriatic arthritis, including the Phase 4 MOSAIC study and an exploratory analysis of cardiometabolic risk factors, which are commonly elevated in patients with psoriatic disease. The findings will be presented at the 2023 European Congress of Rheumatology (EULAR), taking place May 31-June 3 in Milan, Italy.
"Research presented at EULAR sheds new light on psoriatic arthritis and the role of our oral medication Otezla," said Ponda Motsepe-Ditshego, vice president, Global Medical at Amgen. "Using MRI, the MOSAIC study visually captured an improvement in inflammation and no significant change in structural progression, with the effects being greater in patients with moderate as opposed to high disease activity."
MOSAIC Phase 4 Study
Unlike X-ray imaging – commonly used to assess joint damage caused by psoriatic arthritis – MOSAIC used magnetic resonance imaging (MRI), a more sensitive tool for imaging inflammation, which begins early and continues throughout the disease course in joints and entheses (sites where tendons or ligaments attach to bones). MOSAIC evaluated Otezla's effect on joint inflammation and structural progression of psoriatic arthritis measured by MRI.
"MOSAIC is the first study to use MRI to assess inflammation in peripheral joints and entheses in a clinical trial, and shows MRI offers a promising way to measure inflammatory disease activity in patients with this condition," said Professor Mikkel Østergaard, M.D., Ph.D., DMSc, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, University of Copenhagen in Copenhagen, Denmark. "The results of this study are encouraging, as they provide important insights about Otezla treatment and its efficacy on both clinical and inflammatory manifestations of psoriatic arthritis."
In MOSAIC, a multicenter, single-arm, open-label study, patients with active psoriatic arthritis who were treated with Otezla for 48 weeks had MRI of the hand (contrast-enhanced) performed at baseline, week 24 and week 48. The study evaluated change from baseline in the composite score of hand bone marrow edema (BME), synovitis and tenosynovitis in fingers 2-5, assessed by the psoriatic arthritis MRI score (PsAMRIS) at week 24 (the primary endpoint). Total inflammation score, comprised of BME, synovitis, tenosynovitis and periarticular inflammation in fingers, as well as structural progression, were also assessed.
Patients treated with Otezla had improvements in both clinical and MRI measures of inflammation up to week 48. Detailed findings include:
Findings will be presented Friday, June 2 at 12:10 p.m. CEST: POS0226, Poster Tour Session: Apremilast Reduces Inflammation as Measured by MRI of the Hand in Patients with Psoriatic Arthritis: Primary Results from the Phase 4 MOSAIC Study.
Otezla's Effect on Cardiometabolic Parameters in Psoriatic Arthritis
A second EULAR presentation includes data evaluating the effects of Otezla on cardiometabolic parameters (low- and high-density lipoprotein [LDL, HDL], body mass index [BMI] and HbA1c levels) in 781 patients with psoriatic arthritis at 52 weeks. The post-hoc exploratory analysis of data from five pooled Phase 3 trials (PALACE 1-4, ACTIVE) showed Otezla treatment was associated with improvement in cardiometabolic parameters across psoriatic disease activity groups. Among the findings reported:
Findings will be presented Saturday, June 3 at 10:30 a.m. CEST: POS1527, Poster Session: Effects of Apremilast on Changes in Cardiometabolic Parameters by Diabetes and Obesity Status in Patients with Psoriatic Arthritis.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic, inflammatory form of arthritis, which can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. It is estimated that nearly 38 million people worldwide have psoriatic arthritis.1 Around a third of people living with psoriasis may go on to develop psoriatic arthritis.1 If left untreated, psoriatic arthritis can cause disability.
About Otezla® (apremilast)
Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Since its initial FDA approval in 2014, Otezla has been prescribed to more than 840,000 patients worldwide.2
Otezla® (apremilast) U.S. INDICATIONS
Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
Otezla® (apremilast) U.S. IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Use in Specific Populations
Please click here for Otezla® Full Prescribing Information.
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1 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/psoriasis-statistics/. Accessed May 18, 2023.
2 Amgen Data on File. March 2023.