SAT0351 Long-Term Safety and Efficacy of Certolizumab Pegol in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis: 96-Week Outcomes of the Rapid-Axspa Trial
Authors: J. Sieper, M. Rudwaleit, D. van der Heijde, W. Maksymowych, M. Dougados, P.J. Mease, J. Braun, A. Deodhar, B. Hoepken, T. Nurminen, R. Landewé
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> Previous reports of RAPID-axSpA (NCT01087762) demonstrated efficacy and safety of certolizumab pegol (CZP) in patients (pts) with axial spondyloarthritis (axSpA) including pts with ankylosing spondylitis (AS) and pts with non-radiographic axSpA (nr-axSpA) to Week (Wk) 48.<sup>1</sup> <h3>Objectives</h3> To report the clinical efficacy and safety of CZP in axSpA from a 96-wk interim data cut of RAPID-axSpA. <h3>Methods</h3> The RAPID-axSpA trial<sup>1</sup> is double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label to Wk204. Pts fulfilled ASAS criteria and had active axSpA. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose [LD] at Wks 0, 2, 4) continued on their assigned dose in the OLE; PBO pts entering dose-blind phase were re-randomized to CZP LD followed by CZP 200mg Q2W or CZP 400mg Q4W after Wk24 or, for non-responders, after Wk16. We present efficacy data for all pts originally randomized to CZP (combined dose regimens). Outcome variables assessed included ASAS20/40 responses and ASAS PR, ASDAS, ASDAS ID, ASDAS MI, BASDAI, BASFI and BASMI-linear. Data are shown as observed case and with imputation. NRI was used for categorical measures, LOCF for continuous measures. Safety set consists of all pts treated with ≥1 dose of CZP to Wk96. <h3>Results</h3> 325 pts were randomized, of whom 218 received CZP from Wk0. Of CZP-randomized pts, 203 (93%) completed to Wk24, 191 (88%) to Wk48 and 174 (80%) to Wk96. The proportion of pts achieving ASAS20/40 and PR responses was maintained from Wk24 through to Wk96 (Figure). Improvements in all ASAS and ASDAS response measures, BASDAI, BASFI and BASMI-linear were maintained to Wk96 (Figure). Similar improvements were seen with both dosing regimens (data not shown) and in both AS and nr-axSpA pts. Rapid clinical improvements were also observed in pts originally randomized to PBO who switched to CZP at Wk 16 or 24 (data not shown). In the safety set (N=315) total exposure to CZP was 486 pt-yrs. Adverse events (AEs) occurred in 279 pts (88.6%; event rate per 100 pt-yrs=360.3) and serious AEs (SAEs) in 41 (13.0%). SAEs included 15 pts (4.8%) with serious infections, including 1 confirmed case of active tuberculosis. No deaths or malignancies were reported in the overall 96-wk period. <h3>Conclusions</h3> In RAPID-axSpA, improvements in both CZP dosing regimens observed over 24 wks in clinical efficacy and patient-reported outcomes were sustained throughout the dose-blind and open-label study periods to Wk96. Similar sustained improvements were observed in both AS and nr-axSpA subpopulations. The safety profile was in line with that previously reported from the RAPID-axSpA trial, with no new safety signals observed with increased exposure. <h3>References</h3> Landewé R. Arthritis Rheum 2013;65(10):S767 <h3>Acknowledgements</h3> The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma. <h3>Disclosure of Interest</h3> J. Sieper Consultant for: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen, Speakers bureau: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen, M. Rudwaleit Consultant for: Abbott, BMS, MSD, Pfizer, Roche, UCB Pharma, D. van der Heijde Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex, W. Maksymowych Grant/research support: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, Consultant for: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma, M. Dougados Grant/research support: UCB Pharma, Abbvie, Pfizer, Lilly, Novartis, Consultant for: UCB Pharma, Abbvie, Pfizer, Lilly, Novartis, P. Mease Grant/research support: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Vertex, Consultant for: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Vertex, Speakers bureau: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Crescendo, Genentech, Janssen, Lilly, Pfizer, UCB Pharma, J. Braun Grant/research support: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson &amp; Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson &amp; Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, A. Deodhar Grant/research support: UCB Pharma, Abbott, Amgen, Janssen, Novartis, Consultant for: UCB Pharma, Abbott, B. Hoepken Employee of: UCB Pharma, T. Nurminen Employee of: UCB Pharma, R. Landewé Grant/research support: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Consultant for: Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, Glaxo-Smith-Kline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.1636