SAT0355 Observed Incidence Rates of Uveitis following Certolizumab Pegol Treatment in Patients with Axial Spondyloarthritis
Authors: M. Rudwaleit, R. Landewé, H. Marzo-Ortega, J. Sieper, D. van der Heijde, J. Rosenbaum, O. Davies, C. Stach, T. Nurminen, A. Deodhar
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> Axial spondyloarthritis (axSpA) is characterized by inflammation in the spine and sacroiliac joints, but can also manifest as inflammation at extra-spinal sites, most commonly inflammation of the uvea (uveitis).<sup>1</sup> <h3>Objectives</h3> To estimate the incidence of uveitis flares in patients (pts) with axSpA following certolizumab pegol (CZP) treatment in the RAPID-axSpA trial. <h3>Methods</h3> The RAPID-axSpA trial (NCT01087762)<sup>2</sup> was double-blind and placebo (PBO)-controlled to Week (Wk) 24 and dose-blind to Wk48. Pts fulfilled ASAS criteria and had active axSpA, including ankylosing spondylitis (AS) and non-radiographic (nr-)axSpA. Pts were randomized 1:1:1 to either CZP 200mg Q2W, 400mg Q4W (following 400mg loading dose [LD] at Wks 0, 2, 4) or PBO. PBO pts entering dose-blind phase were re-randomized to CZP LD followed by CZP 200mg Q2W or 400mg Q4W after Wk24 or, for non-responders, Wk16. Uveitis events were recorded on a specific case report form (for extra-articular manifestations) or as an adverse event (preferred term "Uveitis"). New incidences and flares were analyzed in pts with or without a history of uveitis, the former group being defined as pts with uveitis recorded on their standard medical history, ASAS classification criteria screening assessment or baseline extra-articular assessment. For Wk24 analyses, combined CZP dosing regimens were compared with PBO; and for Wk48 analyses all pts exposed to CZP were considered. Incidence rates (IR) are reported per 100 pt-yrs (PY) with censoring at the time of event. No analyses of statistical significance were carried out on these data. <h3>Results</h3> At baseline, of 218 pts randomized to CZP, 38 (17.4%) had a history of uveitis, as did 31/107 (29.0%) pts randomized to PBO. The proportion of pts with a history of uveitis was similar in the AS and nr-axSpA subpopulations (20.8% and 21.1% respectively). During the 24-wk double-blind phase, the overall IR of uveitis flares (regardless of previous history of uveitis) was lower in CZP pts (IR=2.0/100 PY) than PBO pts (IR=10.6/100 PY). There were no <i>de novo</i> cases of uveitis flares observed to Wk24; i.e. all cases were observed in pts with history of uveitis; in these pts, IR was 11.9/100 PY for CZP and 42.1/100 PY for PBO (Table A). To Wk48 in CZP-treated pts (regardless of prior history of uveitis) the overall IR of uveitis flares was 3.8/100 PY (17.8/100 PY in pts with history of uveitis and 0.5/100 PY in pts without) (Table B). The incidence of uveitis flares in CZP-treated pts (IR=3.8/100 PY) was comparable to rates observed for other anti-TNFs in AS pts including adalimumab (IR=6.9/100 PY)<sup>3</sup> and etanercept (IR=6.7/100 PY).<sup>4</sup> <h3>Conclusions</h3> The IR of uveitis flares was lower for axSpA pts treated with CZP than with PBO during the randomized controlled phase, and was comparable to the rate reported for AS pts receiving anti-TNF therapy. <h3>References</h3> Braun J. Arthritis Rheum 2005;52(8):2447-2451. Landewé R. Ann Rheum Dis 2014;73:39-47. Rudwaleit M. Ann Rheum Dis 2009;68:696-701. Sieper J. Ann Rheum Dis 2010;69:226-229. <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> M. Rudwaleit Consultant for: Abbott, BMS, MSD, Pfizer, Roche, 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, H. Marzo-Ortega Consultant for: UCB Pharma, J. Sieper Consultant for: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen, Speakers bureau: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen, 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, J. Rosenbaum Grant/research support: Avventy, Genentech, Abbvie, Eyegate, Bristol-Myers Squibb, Consultant for: Allergan, Genentech, Abbvie, UptoDate, Xoma, Santen, Sanofi, Teva, Novartis, O. Davies Shareholder of: UCB Pharma, Employee of: UCB Pharma, C. Stach Shareholder of: UCB Pharma, Employee of: UCB Pharma, T. Nurminen Employee of: UCB Pharma, A. Deodhar Grant/research support: UCB Pharma, Abbott, Amgen, Janssen, Novartis, Consultant for: UCB Pharma, Abbott <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.1806