FRI0408 EARLIER TREATMENT OF NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WITH CERTOLIZUMAB PEGOL RESULTS IN IMPROVED CLINICAL OUTCOMES
Authors: Martin Rudwaleit, Lianne S. Gensler, Atul Deodhar, Jonathan Kay, Walter P. Maksymowych, Nigil Haroon, Robert B.M. Landewé, Simone Auteri, Natasha de Peyrecave, Thomas Kumke, Désirée van der Heijde
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Patients (pts) with axial spondyloarthritis (axSpA) often experience delayed diagnosis, which leads to treatment delay.<sup>1</sup>Whilst certolizumab pegol (CZP) has been shown to improve the signs and symptoms of non-radiographic (nr)-axSpA,<sup>2</sup> whether earlier CZP treatment is beneficial in these pts is unclear. <h3>Objectives</h3> To report clinical outcomes in pts with nr–axSpA treated with CZP or placebo (PBO) over 52 weeks (wks) by their symptom duration. <h3>Methods</h3> Post-hoc analyses of disease outcomes in pts stratified by symptom duration (&lt;5 vs ≥5 yrs at baseline [BL]) from C-axSpAnd (NCT02552212) were performed. In this 52–week, phase 3, multicentre, double-blind, PBO-controlled study, pts were randomised 1:1 to PBO or CZP (400mg at Wks 0/2/4, then 200mg every 2 wks), and could adjust non-biologic background medication or switch to open-label biologics at any point.<sup>2</sup> Outcomes reported: responder rates for Ankylosing Spondylitis Disease Activity Score – major improvement (ASDAS-MI), ASAS 40% improvement (ASAS40) and ASAS partial remission (ASAS-PR); the proportion of pts who reached ASDAS-inactive/low disease (ASDAS-ID/LD) or ASDAS&lt;2.1; and change from BL (CFB) in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Missing values or values observed after discontinuing double-blind study treatment were considered to be non-response for categorical measures or, for quantitative measures, imputed by carrying forward the last observation from double–blind treatment. <h3>Results</h3> Of 317 recruited pts, 159 were randomised to CZP, and 158 to PBO. The mean (standard deviation [SD]) BL symptom duration was 7.8 (7.7) yrs for CZP-treated pts and 8.0 (7.5) yrs for PBO pts. 50.3% (80/159) CZP pts and 48.7% (77/158) PBO pts had a symptom duration &lt;5 yrs. At Wks 12 and 52, ASDAS-MI, ASAS40 and ASAS-PR responder rates, the proportions of pts reaching ASDAS-ID and ASDAS&lt;2.1, and mean CFB in BASDAI, were substantially better among CZP-treated pts with shorter symptom duration (&lt;5 yrs at BL) vs longer symptom duration (<b>Table</b>). Amongst PBO pts, responses were low and there was no consistent trend in outcomes by symptom duration (<b>Table</b>). <h3>Conclusion</h3> In this post-hoc analysis, CZP-treated nr-axSpA pts with shorter symptom duration (&lt;5 vs ≥5 yrs) showed greater improvements across multiple signs and symptoms of disease. These results indicate that early CZP treatment for nr-axSpA may be beneficial to pts. <h3>References</h3> [1] Rudwaleit M. Arthritis Rheum 2009;60:717–27; 2. Deodhar A. Arthritis Rheumatol 2018;70(S9):2073–4. <h3>Acknowledgement</h3> We thank the patients who participated. This study was funded by UCB Pharma, medical writing by Jessica Patel, Costello Medical, UK.<b>sts:</b> <h3>Disclosure of Intere:</h3> Martin Rudwaleit Consultant for: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Consultant for: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Lianne S. Gensler Grant/research support from: Abbvie, Amgen, UCB Pharma, Consultant for: Novartis, Lilly, Janssen, Atul Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, BMS, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Jonathan Kay Grant/research support from: Gilead Sciences, Pfizer, UCB Pharma, Consultant for: AbbVie, Boehringer Ingelheim GmbH, Celltrion Healthcare, Merck Sharp &amp; Dohme Corp., Novartis Pharmaceuticals, Pfizer, Samsung Bioepis, Sandoz, UCB Pharma, Walter P Maksymowych Grant/research support from: AbbVie, Pfizer, Janssen, Novartis, Consultant for: AbbVie, Eli Lilly, Boehringer, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma; Chief Medical Officer for Canadian Research and Education Arthritis, Nigil Haroon Consultant for: AbbVie, Amgen, Janssen, Merck, Novartis, UCB Pharma, Robert B.M. Landewé: None declared, Simone Auteri Employee of: Employee of UCB Pharma, Natasha de Peyrecave Employee of: Employee of UCB Pharma, Thomas Kumke Employee of: UCB Pharma, Désirée van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, Union Chimique Belge