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The RAPID-axSpA study of ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) patients showed that certolizumab pegol (CZP) treatment yielded rapid clinical improvement with limited radiographic progression and MRI inflammation at the sacroiliiac (SI) joint over 4 years.
Investigators randomized 325 patients to receive either double-blind placebo or CZP -controlled for 24 weeks and were dose-blinded from week 24 to 48. Thereafter they received open-label to week 204.
Patients were assessed clinically using the ASAS axSpA criteria. Spinal X-rays were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) and MRI inflammation used the Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac joints (SIJ) and the Berlin spinal score (remission defined as SPARCC <2 and Berlin ≤2, respectively).
Clinical results (previously reported) showed higher 12 week ASAS20 response rates for CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). Week 24 results also favored CZP over PBO for BASFI, BASDAI and BASMI.
The current report analyzed the imaging results over a 4 year period. Significant improvement in MRI SI joint scores (Berlin and SPARCC) observed between baseline and week 12 were maintained out to week 204
Mean changes in Xrays (mSASSS scores) showed limited progression in SI joint grading out to week 204: 2/44 (4.5%) patients with nr-axSpA fulfilled the mNY criteria, while 4/93 (4.3%) patients with AS no longer did so at week 204.
AS and axSpA patients treated with CZP were found to have less SI jont MRI inflammation and limited radiographic changes out to week 204.
In this study 81% of patients with AS did not progress (<2 mSASSS change) after 4 years. These findings are consistent with recent reports from the MEASURE 1 (secukinumab) trial, in which 79% of patients with AS treated with secukinumab did not progress (<2 mSASSS points change from baseline) over 4 years.