Amgen to Present New MOSAIC Phase 4 Data at EULAR 2023

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Amgen recently announced new research evaluating the use of apremilast (Otezla) for the treatment of psoriatic arthritis, which includes the phase 4 MOSAIC trial and an exploratory analysis of cardiometabolic risk factors that are commonly seen in patients with psoriatic disease.¹ The latest research will be presented at the 2023 European Congress of Rheumatology (EULAR) in Milan, Italy on Friday, June 2, at 12:10 p.m. CEST.

The MOSAIC phase 4 study used magnetic resonance imaging (MRI) to assess joint damage caused by psoriatic arthritis. MRIs are considered a more sensitive tool for capturing inflammation, which can begin early on and effects joints and entheses. MOSAIC evaluated apremilast’s effect on joint inflammation and structural progression of psoriatic arthritis measured by MRI.

The multicenter, single-arm, open-label study included patients with active psoriatic arthritis who were treated with apremilast for 48 weeks and had an MRI of the hand (contrast-enhanced) performed at baseline at weeks 24 and 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, which was the primary endpoint. Total inflammation score, comprised of BME, synovitis, tenosynovitis, and periarticular inflammation in fingers, as well as structural progression, were also assessed. It was noted that patients treated with apremilast had improvements in both clinical and MRI measures of inflammation up to week 48.

Some key findings include:

• Inflammation improved, reflected in the mean change from baseline in the composite inflammation score of BME, synovitis, and tenosynovitis as assessed by PsAMRIS for the full analysis set (n=98), which was -2.32 (-4.73, 0.09) at week 24 and -2.91 (-5.45, -0.37) at week 48. Significant improvements at weeks 24 and 48 in the per protocol population (n=94) were also observed
• No significant structural progression was observed with apremilast. Total damage score – a measure of disease progression – including bone erosion, showed no significant change at weeks 24 and 48
• Patients with moderate disease activity as measured by Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) experienced greater reductions in inflammation with apremilast as compared to those with high disease activity
• Common treatment-emergent adverse events were diarrhea (33.6%), nausea (12.3%), headache (10.7%), nasopharyngitis (7.4%), and dyspepsia (6.6%)

A second presentation at EULAR 2023 will review data evaluating the effects of apremilast 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 apremilast treatment was associated with improvement in cardiometabolic parameters across psoriatic disease activity groups. Key findings from these trials include:

• Mean LDL in the overall population at baseline decreased by 2.0 mg/dL on average at week 52; 52.3% of patients moved from the high LDL category (≥160 mg/dL) at baseline to borderline (>129 – <160 mg/dL) or normal (≤129 mg/dL) at week 52; and 38.3% changed from borderline high to normal LDL levels
• Mean BMI was 30.3 kg/m2 in the overall population at baseline and decreased by 0.5 kg/m2 at week 52; 9.0% of patients changed from the obese category (≥30 kg/m2) to the overweight category (25 – <30 kg/m2) and 12.3% of patients changed from the overweight category to the normal category (<25 kg/m2)
• 50.4% of patients who had prediabetes changed to normal HbA1c levels and 40.0% moved from diabetes to prediabetes at week 52

Data on the effects of apremilast on cardiometabolic parameters will be presented on Saturday, June 3, at 10:30 a.m. CEST.

Reference

1. Amgen presents new research on Otezla (apremilast) in psoriatic arthritis at EULAR 2023. Amgen. Published May 30, 2023. Accessed May 31, 2023. https://www.amgen.com/newsroom/press-releases/2023/05/amgen-presents-new-research-on-otezla-apremilast-in-psoriatic-arthritis-at-eular-2023