Imaging results support long-term efficacy of certolizumab pegol for axial spondyloarthritis
medwireNews: Patients with axial spondyloarthritis (axSpA) who are treated with certolizumab pegol experience a sustained reduction in spinal inflammation, follow-up imaging results from the RAPID-axSpA trial suggest.
Previous results from this trial demonstrated that the tumor necrosis factor (TNF) inhibitor “improved the signs and symptoms of axSpA from as early as 12 weeks of treatment, which were maintained over 4 years,” write Désirée van der Heijde (Leiden University Medical Center, the Netherlands) and study co-authors.
They explain that after 24 weeks of treatment with either certolizumab pegol or placebo, all trial participants were given open-label certolizumab pegol until the 4-year follow-up.
As reported in the Annals of the Rheumatic Diseases, certolizumab-treated patients experienced a rapid reduction in magnetic resonance imaging (MRI)-quantified spinal inflammation from baseline to week 12, which was maintained until week 204. The mean Berlin scores were 7.4 points at baseline, 2.5 points at week 12, and 2.6 points at week 204 for the 92 patients with ankylosing spondylitis (AS), with corresponding scores of 4.4, 1.7, and 1.9 points for the 65 patients with non-radiographic axSpA.
And the number of patients in MRI spinal remission – defined as a Berlin score of 2 points or lower – increased from 46.4% at week 12 to 65.4% at week 204 in the AS group, and from 44.5% to 57.3% in the non-radiographic axSpA group.
Similarly, patients treated with certolizumab pegol experienced a sustained reduction in sacroiliac joint inflammation as measured by MRI, and the proportion of patients in sacroiliac joint remission was comparable at weeks 12 and 204.
Improvements in axSpA inflammation “were maintained to week 204, with similar responses observed in both [AS and non-radiographic axSpA] populations,” summarize van der Heijde and colleagues.
The team also observed low rates of radiographic progression over the course of the study; AS patients experienced a mean increase in modified Stoke Ankylosing Spondylitis Spine Scores (mSASS) from baseline to week 204 of 0.98 points, while the non-radiographic axSpA group had a mean increase of 0.06 points.
They note that AS patients experienced more progression than non-radiographic axSpA patients, and that the majority of progression occurred during the first 2 years of the study.
“This represents the longest term MRI imaging study in patients with anti-TNF-treated axSpA to date, and the only data addressing X-ray and MRI imaging of both [sacroiliac] joints and spine in AS and [non-radiographic]-axSpA subpopulations,” write the researchers.
However, they caution that the RAPID-axSpA trial findings “cannot be used in isolation to confirm an impact on disease progression” given that all patients were treated with certolizumab pegol from week 24 onwards.
And the team concludes: “In the absence of a control arm, further data are required to elucidate the natural history of AS to better understand the impact of biologic treatment on disease progression.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group