An analysis of data from the phase 4 MOSAIC trail is providing clinicians with a greater understanding of the effects of apremilast in people with uncontrolled psoriatic arthritis.
An analysis of MRI data from the phase 4 MOSAIC trial is offering greater insight into the effects of apremilast on objective measures of inflammation and structural progression of psoriatic arthritis.
Results of the study, which was a single-arm, open-label trial, suggest use of apremilast was associated with improvements in both clinical indices and objective MRI indices of inflammation, including for a 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.
"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, MD, PhD, DMSc, Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases at the University of Copenhagen in Copenhagen, Denmark.
Approved by the US Food and Drug Administration in 2014 for treatment of active psoriatic arthritis, apremilast has found a home in the treatment algorithms for many patients. In the current study, investigators hoped to provide further clarity into the effects of apremilast use beyond clinical outcomes.
The primary endpoint of interest for the trial was a composite of hand bone marrow edema (BME), synovitis, and tenosynovitis in fingers 2–5, as assessed by the PsAMRIS at Week 24. Secondary outcomes of interest included total inflammation score, comprised of BME, synovitis, tenosynovitis, and periarticular inflammation in finger. Investigators pointed out structural progression was assessed by the total hand damage score, which was determined by bone erosion and bone proliferation in fingers 2–5. Per trial protocol, all MRI images were read and adjudicated by a pair of experienced readers blinded to clinical information and time of acquisition.
In total, the trial enrolled 122 patients. This cohort had a mean age of 47 years, 55% were women, and the mean duration of psoriatic arthritis was 1.9 years. Of these 122, 98 had full data from baseline and week 24. These 98 were included in the full set analysis of the primary endpoint and 94 were included in the per protocol population.
Upon analysis, results suggested the least-squares change from baseline for the composite primary endpoint was —2.32 (95% confidence interval [CI], —4.73 to 0.09) at week 24 and —2.91 (95% CI,—5.45 to —0.37) at week 48. In the per-protocol population, the least-squares mean change from baseline for the primary composite endpoint indicated a significant reduction of disease activity.
When assessing structural progression, results indicated there was no significant change from baseline to week 48. Additionally, subgroup analyses based on disease activity at baseline revealed significant improvements from baseline in inflammation among patients with moderate disease activity and no significant change from baseline in total damage. Investigators pointed out no new safety signals were observed in the trial. The most common treatment-emergent adverse events were diarrhea (33.6%), nausea (12.3%), headache (10.7%), nasopharyngitis (7.4%), and dyspepsia (6.6%).1
"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,” Østergaard added.2