FRI0408 EARLIER TREATMENT OF NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WITH CERTOLIZUMAB PEGOL RESULTS IN IMPROVED CLINICAL OUTCOMES. (June 2019)

• Record Type: Journal Article
• Authors: Rudwaleit, Martin; Gensler, Lianne S.; Deodhar, Atul; Kay, Jonathan; Maksymowych, Walter P.; Haroon, Nigil; Landewé, Robert B.M.; Auteri, Simone; Peyrecave, Natasha de; Kumke, Thomas; Heijde, Désirée van der
• Is Part Of: Annals of the rheumatic diseases. Volume 78(2019)Supplement 2
• Page Start: 891
• Page End: 891
• Publication Date: 2019-06
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2019-eular.790
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Patients (pts) with axial spondyloarthritis (axSpA) often experience delayed diagnosis, which leads to treatment delay. 1 Whilst certolizumab pegol (CZP) has been shown to improve the signs and symptoms of non-radiographic (nr)-axSpA, 2 whether earlier CZP treatment is beneficial in these pts is unclear. Objectives: To report clinical outcomes in pts with nr–axSpA treated with CZP or placebo (PBO) over 52 weeks (wks) by their symptom duration. Methods: Post-hoc analyses of disease outcomes in pts stratified by symptom duration (<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. 2 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<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. Results: 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 <5 yrs. At Wks 12 and 52, ASDAS-MI, ASAS40 and ASAS-PR responder rates, the proportions of pts reaching ASDAS-ID and ASDAS<2.1, and mean CFB in BASDAI, were substantially better among CZP-treated pts with shorter symptom duration (<5 yrs at BL) vs longer symptom duration (Table ). Amongst PBO pts, responses were low and there was no consistent trend in outcomes by symptom duration (Table ). Conclusion: In this post-hoc analysis, CZP-treated nr-axSpA pts with shorter symptom duration (<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. References: [1] Rudwaleit M. Arthritis Rheum 2009;60:717–27; 2. Deodhar A. Arthritis Rheumatol 2018;70(S9):2073–4. Acknowledgement: We thank the patients who participated. This study was funded by UCB Pharma, medical writing by Jessica Patel, Costello Medical, UK.sts: Disclosure of Intere: 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 & 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