Amgen 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.
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.
