Long-term CZP treatment for axSpA yields sustained cuts in inflammation, limits progression
In patients with axial spondyloarthritis (axSpA), early improvements in inflammation achieved with certolizumab pegol (CZP) may be maintained for up to 204 weeks, with a decreased rate of spinal progression between years 2 and 4, according to a study.
A total of 325 patients were randomized to receive either placebo (n=107) or CZP (200 mg Q2W: n=111; 400 mg Q4W: n=107). The study was placebo-controlled and double-blind until week 24, dose-blind to week 48 and open-label to week 204.
There were 315 patients (174 had ankylosing spondylitis [AS] and 141 had nonradiographic [nr]-axSpA) who received ≥1 dose CZP at any point in the trial, with 199 completing the study to week 204 and 158 having valid magnetic resonance imaging (MRI) assessments at baseline.
MRI improvements in inflammation from baseline to week 12 were sustained to week 204. The Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac (SI) joints decreased from 8.5 to 1.3 in the AS subgroup and from 7.5 to 2.4 in the nr-axSpA subgroup. The Berlin spinal score also dropped from 7.4 to 2.6 in the AS subgroup and from 4.4 to 1.9 in the nr-axSpA subgroup.
Remission was achieved at week 204 in 66.7 percent of patients with AS and 69.6 percent of those with nr-axSpA having SPARCC scores ≥2 at baseline, and in 65.4 percent of patients with AS and 57.3 percent of those with nr-axSpA having Berlin scores >2 at baseline.
Mean modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) changes in the AS subgroup were 0.98 from baseline to week 204, 0.67 from baseline to week 96, and 0.31 from week 96 to week 204. Corresponding mSASSS changes in the nr-axSpA subgroup were 0.06, –0.01 and 0.07.
At week 204, 4.5 percent of patients with nr-axSpA subgroup fulfilled the modified New York criteria, while 4.3 percent of patients with AS no longer did so.
The present data demonstrate the long-term efficacy of CZP in the treatment of axSpA, with a rapid reduction in inflammation, sustained rates of remission in both SI joint and spinal examinations, reduced rate of spinal progression, and limited SI joint progression during the 4 years of study, researchers said.