SAT0375 Certolizumab Pegol for The Treatment of Axial Spondyloarthritis: 4-Year Outcomes from The Rapid-AXSPA Trial
Authors: D. van der Heijde, M. Dougados, R. Landewé, J. Sieper, W.P. Maksymowych, M. Rudwaleit, F. van den Bosch, J. Braun, P.J. Mease, O. Davies, B. Hoepken, L. Peterson, A. Deodhar
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> The RAPID-axSpA trial (NCT01087762) investigated the efficacy and safety of certolizumab pegol (CZP) for the treatment of patients (pts) with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS; also termed radiographic-axSpA) and non-radiographic (nr)-axSpA pts. Previous reports have shown CZP to be safe and efficacious over 96 weeks (wks) of treatment.<sup>1</sup> <h3>Objectives</h3> To report 4-year efficacy and safety data from the RAPID-axSpA trial. <h3>Methods</h3> RAPID-axSpA was double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk204. Pts fulfilled ASAS criteria and had active axSpA with positive sacroiliac joint MRI and/or raised CRP (&gt;7.9mg/L). Pts originally randomized to CZP (200mg Q2W or 400mg Q4W) continued on their assigned dose in the OL period. Outcomes assessed included: ASAS responses, ASDAS, BASDAI, BASFI, BASMI-linear and enthesitis. Efficacy data are presented for pts originally randomized to CZP (combined doses) as observed case and with imputation: NRI for categorical and LOCF for continuous measures. The safety set consisted of all pts treated with ≥1 dose of CZP to Wk204. <h3>Results</h3> 325 pts were randomized, of whom 218 received CZP from Wk0. Of CZP-randomized pts, 93% completed to Wk24, 88% to Wk48 and 65% to Week 204 (AS: 67%; nr-axSpA: 63%). In the OL period, 9.2% of pts withdrew due to an adverse event (AE) and 1.4% due to lack of efficacy. The proportion of pts achieving ASAS20/40 and partial remission (PR) responses at Wk24 was maintained over 4 years (to Wk204) in pts remaining in the study (Table). Efficacy, expressed as ASDAS ID rates (LOCF: Wk24: 30.3%; Wk204: 32.1%), mean ASDAS score (baseline: 3.84; LOCF: Wk24: 2.07; Wk204: 1.98), and all other outcomes reported, was maintained to Wk204. Similar improvements were seen in AS and nr-axSpA pts (Figure/Table) and in both CZP dose regimens (data not shown). Function (BASFI) was also improved in both subpopulations, with nr-axSpA pts having a particularly low mean score by Wk204 (Table). Pts in the safety set (N=315) had a total CZP exposure of 981 patient-years (PY), with an AE rate (ER) per 100 PY of 292.9. No new safety signals were identified from Wk96 to Wk204, and no deaths were reported over 4 years. <h3>Conclusions</h3> CZP efficacy was maintained in axSpA pts over 4 years with no new safety signals. Treatment responses to CZP were similar in AS and nr-axSpA pts. <h3>References</h3> Sieper J. Arthritis Rheum 2015;67:668–77 <h3>Acknowledgement</h3> The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance. <h3>Disclosure of Interest</h3> D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma, Employee of: Director of Imaging Rheumatology bv, M. Dougados Grant/research support from: UCB Pharma, Abbvie, Pfizer, Lilly, Merck and Novartis, Consultant for: UCB Pharma, Abbvie, Pfizer, Lilly, Merck and Novartis, R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, Consultant for: Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, Glaxo-Smith-Kline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, J. Sieper Consultant for: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly and Janssen, Speakers bureau: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly and Janssen, W. Maksymowych Grant/research support from: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, Consultant for: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, M. Rudwaleit Consultant for: Abbott, BMS, Janssen, MSD, Pfizer, Roche and UCB Pharma, F. van den Bosch Consultant for: Abbvie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer, UCB Pharma, Speakers bureau: Abbvie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer, UCB Pharma, J. Braun Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson &amp; Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson &amp; Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma, P. Mease Grant/research support from: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer and UCB Pharma, O. Davies Shareholder of: UCB Pharma, Employee of: UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB Pharma