Otezla reduces PsA inflammation in MRI outcomes, improves cardiometabolic health
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Key takeaways:
- According to the psoriatic arthritis MRI score, Otezla decreased inflammation 2.32 points from baseline.
- Otezla showed improvement in cardiometabolic parameters across psoriatic disease activity groups.
At the 2023 European Congress of Rheumatology, Amgen presented study results evaluating the use of Otezla for the treatment of psoriatic arthritis, according to a company press release.
Presented data on Otezla (apremilast), an oral small molecule that inhibits phosphodiesterase 4 first FDA-approved to treat psoriatic arthritis (PsA) in 2024, were from the phase 4 study MOSAIC and an exploratory analysis.
MOSAIC study
“The main objective of the phase 4 MOSAIC study was to evaluate the efficacy of [Otezla] on inflammation, as measured by dedicated MRI of the hand and whole-body MRI,” Mikkel Østergaard, MD, PhD, DMSc, professor of clinical medicine at the University of Copenhagen, told Healio. “MOSAIC is the first global study to evaluate the effects of [Otezla] on MRI outcomes of inflammation in PsA.”
In this multicenter, single-arm, open-label study, 98 Otezla-treated patients with PsA received an MRI of the hand at baseline, week 24 and week 48 to evaluate the change in hand bone marrow edema (BMD), synovitis and tenosynovitis. This was measured by the psoriatic arthritis MRI score (PsAMRIS) with the primary endpoint being an improvement by week 24.
Results showed that inflammation significantly improved in Otezla-treated patients. The mean change from baseline of inflammation as assessed by PsAMRIS was –2.32 (95% CI, –4.73 to 0.09) at week 24 and –2.91 (95% CI, –5.45 to –0.37) at week 48.
Results also showed that disease progression, including bone erosion, did not change from baseline to weeks 24 and 48.
“Since many psoriasis patients develop psoriatic arthritis, the MOSAIC study results, taken together with previous clinical findings, should provide confidence to dermatologists that [Otezla] is reducing objective measures of joint inflammation in psoriatic arthritis,” Østergaard said.
Exploratory analysis
Amgen’s second presentation showed data from an exploratory analysis that evaluated the effects of Otezla on cardiometabolic parameters including low- and high-density lipoprotein (LDL, HDL), BMI and HbA1c levels.
A total of 781 patients with PsA from five pooled phase 3 trials were included in the study. Data was taken after 52 weeks of Otezla treatment.
Results showed Otezla was associated with improvement in cardiometabolic parameters across psoriatic disease activity groups.
Mean LDL decreased by 2 mg/dL at week 52 in the overall population. More specifically, 52.3% of patients transitioned from high LDL at baseline to borderline or normal LDL at week 52 and 38.3% achieved normal LDL levels.
Mean BMI decreased by 0.5 kg/m² at week 52, with 9% of patients changing from the obese category to the overweight category and 12.3% changing from the overweight category to the normal category, according to the press release.
Further, by week 52, 50.4% of patients with prediabetes transitioned to normal HbA1c levels and 40% of patients at diabetic levels transitioned to prediabetic levels.