Background Axial spondyloarthritis (axSpA) includes both ankylosing spondylitis (AS) and axSpA with no definitive sacroiliitis on X-ray (non-radiographic axSpA, nr-axSpA).¹ One of the features of axSpA is bone marrow edema of sacroiliac joints (SIJ) and spine. RAPID-axSpA (NCT01087762) investigated certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, efficacy and safety in patients (pts) with axSpA, including AS and nr-axSpA.

Objectives To report the impact of CZP on inflammation of spine and SIJ in axSpA pts using MRI.

Methods The ongoing 158-week (wk) Phase 3 RAPID-axSpA trial was double-blind and placebo controlled to Wk24. Recruited pts had adult-onset active axSpA according to the ASAS criteria,¹ and included AS pts also meeting the modified New York criteria and nr-axSpA pts.² Pts must have failed ≥1 NSAID. Pts were randomized 1:1:1 to placebo (PBO) every 2 weeks (Q2W), or 400mg CZP at Wk0, 2 and 4 (loading dose) followed by either 200mg CZP Q2W or 400mg CZP every 4 weeks (Q4W). MRI scans of the SIJ and spine,³ using short-tau-inversion recovery sequences, were evaluated using an analysis of covariance model. MRI endpoints were least square difference to PBO in change from baseline (BL) in the Spondyloathritis Research Consortium of Canada (SPARCC) SIJ score for inflammation and Berlin modification of AS spine MRI score for disease activity in the spine (ASspiMRI-a). Data are reported for all pts included in imaging sub-study (the MRI set).

Results 325 pts were randomized, of which 153 were included in the MRI set. BL characteristics were similar between treatment arms in the MRI set. The MRI set was representative of overall RAPID-axSpA pt population. BL SPARCC MRI SIJ scores were comparable between AS and nr-axSpA populations, while Berlin ASspiMRI-a scores were higher in AS pts. Improvements in SPARCC MRI SIJ scores and ASspiMRI-a Berlin modification were observed in both CZP dose arms compared to PBO in the overall, and both AS and nr-axSpA, populations (Figure). Greater reductions in SIJ inflammation were observed for pt subgroups with <5 year symptom duration, age <45 years and in males.

Conclusions CZP reduced inflammation in the SIJ and spine, as assessed by MRI in pts with axSpA, and in both AS and nr-axSpA populations.

References

1. Rudwaleit M. Ann Rheum Dis 2009;68(6):770-776,

2. Landewé R. Arthritis Rheum 2012;64(10):336-337,

3. Lambert RGW. Arthritis Rheum 2007;56(12):4005-4040

Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.

Disclosure of Interest D. van der Heijde Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex, Employee of: Imaging Rheumatology bv, W. Maksymowych Grant/research support from: bbott, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, Consultant for: bbott, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, Speakers bureau: bbott, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Consultant for: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Speakers bureau: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, C. Stach Shareholder of: UCB Pharma, Employee of: UCB Pharma, B. Hoepken Shareholder of: UCB Pharma, Employee of: UCB Pharma, A. Fichtner Employee of: UCB Pharma, D. Kielar Shareholder of: UCB Pharma, Employee of: UCB Pharma, J. Braun Grant/research support from: Abbott, BMS, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, Consultant for: Abbott, BMS, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma