Madrid, Spain—In patients with axial spondyloarthritis (axSpA), reductions in inflammation of the spine and sacroiliac joints were maintained with continuous certolizumab pegol treatment over 4 years, according to the first report of long-term imaging results for antitumor necrosis factor therapy. The treated population included patients with ankylosing spondylitis (AS) and nonradiographic (nr)-axSpA, stated lead investigator Désirée van der Heijde, MD, PhD, Professor, Rheumatology, Leiden University Medical Center, The Netherlands, at the 2017 European League Against Rheumatism annual meeting.
The imaging analysis was subsequent to earlier presentation of data from RAPID-axSpA, a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial of certolizumab pegol in patients with axSpA, AS, and nr-axSpA (Landewé R, et al. Ann Rheum Dis. 2014;73:39-47). The study had shown rapid clinical improvements after 12 weeks of treatment that were then sustained through 4 years of therapy in patients with AS and nr-axSpA. Magnetic resonance imaging (MRI) and spinal x-rays at 96 weeks had shown evidence of reduced inflammation and limited progression, respectively.
“Objective information from imaging is important because, especially in axial spondyloarthritis, many of the outcome measures are purely patient reported, and few abnormalities can be found by physical investigation. The imaging data completes the clinical data, which by themselves do not give a full picture,” Dr van der Heijde said in an interview with Value-Based Care in Rheumatology. She also stated that MRIs reveal objective signs of inflammation and radiographs show structural damage.
The current study objective was to report x-ray and MRI assessments over 4 years of certolizumab pegol treatment in 315 patients with axSpA (mean age, 39.7 years). MRI assessments were available for 158 patients, and 198 had ≥1 Modified Stoke AS Spinal Score (mSASSS) assessments. In addition, 273 patients had sacroiliac joint x-rays at baseline. Mean age in the AS group (n = 174) was 41.5 years and in the nr-axSpA cohort (n = 141) it was 37.5 years.
Dr van der Heijde reported that spinal progression over 4 years during treatment with certolizumab pegol was limited in patients with AS (n = 113) and nr-axSpA (n = 83). From baseline to 96 weeks, mSASSS scores increased in patients with AS by 0.67 (13.17 to 13.84), and at week 204, had increased by only 0.31 to 14.15 (increase of 0.98 weeks 0 to 204). mSASSS scores in patients with nr-axSpA decreased by 0.01 from 4.42 to 4.41 at week 96, and increased by 0.07 to 4.48 at week 204 (increase of 0.05 weeks 0 to 204).
Although 4.5% of patients (n = 42) progressed from nr-axSpA to AS over the 4 years, 4.3% (n = 89) improved from AS to nr-axSpA.
The number of patients with AS in spinal remission (ie, a Berlin score ≤2) increased from 42.4% at baseline to 67.2%, 67.6%, and 76.0% at weeks 12, 96, and 204, respectively. The number of patients with nr-axSpA in spinal remission increased from 62.3% at baseline to 76.2%, 69.6%, and 84.4% at weeks 12, 96, and 204, respectively. The number of patients with AS in sacroiliac joint remission (ie, a Spondyloarthritis Research Consortium of Canada score <2) increased from 52.7% at baseline to 85.7%, 83.6%, and 75.6% at weeks 12, 96, and 204, respectively, and the number of patients with nr-axSpA in sacroiliac joint remission increased from 43.3% at baseline to 69.8%, 72.3%, and 80.6% at weeks 12, 96, and 204, respectively.
Dr van der Heijde observed that MRI improvements in Berlin Spine Scores were sustained in patients with AS and patients with nr-axSpA. The mean baseline score of 7.4 in patients with AS decreased to 2.7, 2.7, and 2.6 at weeks 12, 96, and 204, respectively. In patients with nr-axSpA, the Berlin Spine Score decreased from 4.2 to 1.4, 1.6, and 1.4 at weeks 12, 96, and 204, respectively. Similarly, MRI assessments of Spondyloarthritis Research Consortium of Canada sacroiliac joint scores revealed sustained improvements; in patients with AS, a baseline of 8.5 decreased to 2.0, 1.3, and 1.8 at weeks 12, 96, and 204, respectively, and, in patients with nr-axSpA, a baseline of 7.7 decreased to 2.3, 2.5, and 2.0 at weeks 12, 96, and 204, respectively.
“These imaging data confirm the good clinical outcome over 4 years during treatment with certolizumab pegol,” Dr van der Heijde concluded.