Objectives To report 4-year imaging outcomes in the RAPID-axSpA (NCT01087762) study of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), treated with certolizumab pegol (CZP).
Methods This phase III, randomised trial was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204. Patients fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria with active disease were stratified (AS/nr-axSpA) according to the modified New York (mNY) criteria at randomisation. Spinal radiographs were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). 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).
Results MRI improvements from baseline (BL) to week 12 were maintained to week 204 (SPARCC BL: AS=8.5, nr-axSpA=7.5; SPARCC week 204: AS=1.3, nr-axSpA=2.4; Berlin BL: AS=7.4, nr-axSpA=4.4; Berlin week 204: AS=2.6, nr-axSpA=1.9). 66.7% of patients with AS and 69.6% of patients with nr-axSpA with BL SPARCC scores ≥2, and 65.4% of patients with AS and 57.3% of patients with nr-axSpA with BL Berlin score >2, achieved remission at week 204. Mean mSASSS change in AS from BL to week 204 was 0.98 (95% CI 0.34, 1.63); 0.67 (95% CI 0.21,1.13) from BL to week 96; and 0.31 (95% CI 0.02,0.60) from week 96 to week 204. Corresponding nr-axSpA changes were 0.06 (95% CI −0.17,0.28), –0.01 (95% CI −0.19,0.17) and 0.07 (95% CI −0.07,0.20). 4.5% of patients with nr-axSpA fulfilled the mNY criteria at week 204, while 4.3% of patients with AS no longer did so.
Conclusions In patients with CZP-treated axSpA, rapid decreases in spinal and SIJ MRI inflammation were maintained to week 204. Overall, 4-year spinal progression was low, with less progression during years 2–4 than 0–2. Radiographic SIJ grading changes demonstrated limited progression.
Trial registration number NCT01087762; Post-results.
- ankylosing spondylitis
- magnetic resonance imaging
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Data from this study have previously been presented at the ACR/ARHP Annual Meeting 2016 and the European League Against Rheumatism Annual Meeting 2017.
Handling editor Josef S Smolen
Contributors Substantial contributions to study conception/design, or acquisition/analysis/interpretation of data: DvdH, XB, K-GAH, RBML, PMM, WPM, ORD, NdP, BH, LB, TN and JB. Drafting of the publication or revising it critically for important intellectual content: DvdH, XB, K-GAH, RBML, PMM, WPM, ORD, NdP, BH, LB, TN and JB. Final approval of the publication: DvdH, XB, K-GAH, RBML, PMM, WPM, ORD, NdP, BH, LB, TN and JB.
Funding UCB Pharma sponsored the study and the development of this manuscript, and reviewed the text to ensure that from UCB perspective, the data presented in the publication are scientifically, technically and medically supportable, that they do not contain any information that has the potential to damage the intellectual property of UCB, and that the publication complies with applicable laws, regulations, guidelines and good industry practice. The authors approved the final version to be published after critically revising the manuscript for important intellectual content.
Competing interests DvdH has received 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. XB has received consulting and/or speaker’s fees and/or research grants from AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma. K-GAH has received speaker’s fees for AbbVie, MSD, Pfizer and UCB Pharma. RBML has received consulting fees and/or research grants and/or speaker’s bureau from Abbott, Ablynx, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. PMM has received consulting/speaker’s fees from AbbVie, Centocor, Janssen, MSD, Novartis, Pfizer and UCB Pharma. WPM has received consulting and/or speaker’s fees and/or grants from AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi and UCB Pharma, and is the Chief Medical Officer of Canadian Research Education (CaRE) Arthritis. ORD, NdP, BH, LB and TN are employees of UCB Pharma. JB has received consulting fees/research grants from Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma.
Patient consent Obtained.
Ethics approval The study protocol, amendments and subject informed consent were reviewed by a national, regional or independent ethics committee (IEC) or institutional review board (IRB).
Provenance and peer review Not commissioned; externally peer reviewed.
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