Cimzia Prevented Disease Progression, Inflammation in Axial SpA, Phase 3 Trial Shows
Treatment with Cimzia (certolizumab pegol) decreased long-term inflammation and disease progression in patients with axial spondyloarthritis (axSpA), an analysis of Phase 3 trial data shows.
The results appeared in the study, “Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial,” published in the Annals of the Rheumatic Disease.
The RAPID-axSpA study (NCT01087762) was the first large scale trial to include both patients with non-radiographic axSpA and radiographic axSpA — evidence of structural damage to the sacroiliac joints detectable using X-ray imaging — providing a broad overview of the disease.
The trial was conducted at 83 centers in Europe, North America, and Latin America, and enrolled 325 patients.
Study participants, who were followed for four years, were randomized to receive either placebo or Cimzia, a biologic medication made of an antibody fragment specific to the inflammatory molecule TNF-a.
An evaluation of active inflammation and disease progression was done by magnetic resonance imaging (MRI) and spinal radiographs.
A previous analysis of the trial data had shown that patients treated with Cimzia had reduced symptoms of axSpA observed as early as 12 weeks from the start of treatment. This beneficial effect was found to be sustained over four years of follow-up.
In this post-hoc analysis, researchers focused on the study’s imaging outcomes and evaluated imaging data collected from 92 patients with radiographic axSpA, and 66 with non-radiographic axSpA who were treated with Cimzia and completed the 204 weeks of the trial.
MRI results revealed that joint and spinal inflammation were significantly reduced after 12 weeks of treatment with Cimzia compared to baseline (start of study) levels in both groups of patients.
This positive effect was sustained for more than 24 weeks and until the study was completed.
Collectively, the MRI data showed that 66.7% of radiographic axSpA patients and 69.6% of those with non-radiographic axSpA had achieved joint remission, and 65.4% and 57.3%, respectively, achieved spinal remission by week 204.
“MRI assessments demonstrated a rapid reduction of inflammation and sustained rates of remission in both [sacroiliac] joint and spinal examinations,” the researchers wrote.
Cimzia was also found to have a positive long-term effect preventing disease progression, as demonstrated by spinal radiographs. Only two patients with non-radiographic axSpA showed signs of disease progression.
In the radiographic axSpA group, 80.6% of patients had not progressed by week 204. In the cases that progressed, the majority occurred during the first two years of treatment rather than in the last two years.
Supported by these findings and previously reported results, researchers believe that long-term Cimzia “could have the potential to inhibit structural progression by suppressing disease activity.”
Limitations of this analysis include a lack of a comparative control to fully appreciate the long-term benefits of Cimzia in axSpA progression.
