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Certolizumab pegol decreased spinal, sacroiliac inflammation in axial spondyloarthritis
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Patients with axial spondyloarthritis who received treatment with certolizumab pegol exhibited rapid decreases in spinal and sacroiliac-joint inflammation as observed using MRI throughout a 4-year, phase 3 study, according to findings published in the Annals of the Rheumatic Diseases.
“This is the only study of a [biologic disease-modifying anti-rheumatic drug (bDMARD)] that included patients encompassing the entire spectrum of axial spondyloarthritis (axSpA) — non-radiographic axSpA and radiographic axSpA,” Désirée van der Heijde, MD, PhD, of Leiden University Medical Center, in the Netherlands, told Healio Rheumatology. “Moreover, it is a 4-year study with extensive imaging of spine and [sacroiliac] joints by MRI and radiographs.”
To determine the outcomes in the RAPID-axSpA study of patients with ankylosing spondylitis (AS) and non-radiographic axSpA, who received treatment with certolizumab pegol, over the course of 4 years, the researchers conducted the phase-3 randomized trial at 83 centers throughout North America, Latin America and Europe. The study was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204.
The investigators classified patients who met the criteria for active axSpA, as defined by the Assessment of Spondyloarthritis International Society (ASAS), as either AS or non-radiographic axSpA. They analyzed spinal radiographs using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Further, the researchers used the Spondyloarthritis Research Consortium of Canada (SPARCC) score and Berlin spinal score for assessing sacroiliac joints.
According to the researchers, patients maintained the improvements observed from baseline to week 12 all the way to week 204. Overall, 66.7% of the patients with AS and 69.6% with non-radiographic axSpA with baseline SPARCC scores of 2 or greater achieved remission at week 204. Researchers also reported remission in 65.4% of patients with AS and 57.3% of patients with non-radiographic axSpA with a baseline Berlin score of greater than 2.
Additionally, the mean mSASSS change in AS from baseline to week 204 was 0.98 (95% CI; 0.34-1.63). From baseline to week 96 it was 0.67 (95% CI; 0.21-1.13), and from week 96 to week 204, it was 0.31 (95% CI; 0.02-0.6). Among patients with non-radiographic axSpA, the corresponding changes were 0.06 (95% CI; 0.17 to 0.28) from baseline to week 204, –0.01 (95% CI; 0.19 to 0.17) from baseline to week 96 and 0.07 (95% CI; 0.07 to 0.2) from week 96 to week 204.
“The fast reduction in MRI activity in [sacroiliac] joints and spine is sustained for 4 years,” van der Heijde said. “Progression of structural damage in the spine over the entire 4 years is very limited, and the progression in the second 2 years was less than in the first two years. As there is a relation between inflammation on MRI of the spine, and structural damage on spine radiographs, with outcomes which are important for the patients such as quality of life, it is important to reduce the inflammation on MRI and prevent structural damage progression.” – by Jason Laday
Disclosure: Van der Heijde reports receiving consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma, and is the director of Imaging Rheumatology BV.
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