FRI0397 EFFICACY AND SAFETY OUTCOMES IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS TREATED WITH CERTOLIZUMAB PEGOL: RESULTS FROM THE 48-WEEK RUN-IN PART OF C-OPTIMISE
Authors: Robert B.M. Landewé, Désirée van der Heijde, Maxime Dougados, Xenofon Baraliakos, Filip van den Bosch, Karl Gaffney, Natasha de Peyrecave, Lars Bauer, Bengt Hoepken, Karen Thomas, Lianne S. Gensler
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> C-OPTIMISE is the first trial to evaluate whether certolizumab pegol (CZP) can be reduced/discontinued in patients with radiographic(r)-axSpA/ankylosing spondylitis (AS) and non-radiographic(nr)-axSpA achieving sustained remission after 48 weeks' (wks') treatment. <h3>Objectives</h3> Here, we report interim efficacy and safety data for both subpopulations from the ongoing trial. <h3>Methods</h3> Up to Wk48<b>,</b> C-OPTIMISE (NCT02505542) was open-label (Part A), followed by 48-wk parallel-group, double-blind, placebo-controlled treatment (full dose and half dose) to Wk96 (Part B). Patients with adult-onset axSpA of &lt;5 years' duration, fulfilling Assessment of SpondyloArthritis international Society (ASAS) classification criteria, were recruited. Part A: patients received CZP 400mg at Wks0/2/4, then 200mg every 2 weeks [Q2W]); patients achieving sustained remission (Ankylosing Spondylitis Disease Activity Score [ASDAS]&lt;1.3 at Wk32 and &lt;2.1 at Wk36 [or vice versa], and &lt;1.3 at Wk48) were eligible for Part B (secondary outcome). Primary outcome (not reported): percentage of patients in Part B not experiencing a flare. Missing values were imputed using non-responder imputation (NRI) and last observation carried forward (LOCF). <h3>Results</h3> Part A: Of 736 patients (<b>Table A</b>), 43.9% achieved sustained remission (r-axSpA/AS: 42.8%; nr-axSpA: 45.3%; NRI). At baseline, 98.5% patients had high/very high disease activity (ASDAS≥2.1); at Wk48, 52.7% (r-axSpA/AS: 52.6%; nr-axSpA: 52.9%) had inactive disease (ASDAS&lt;1.3; LOCF; <b>Table B</b>). The treatment-emergent adverse event (TEAE) rate/100 patient-years' exposure was 224.2; 3.9% patients discontinued CZP due to TEAEs. No new safety signal was identified. <h3>Conclusion</h3> The run-in phase of C-OPTIMISE shows that similar and substantial proportions of patients with r–axSpA/AS and nr-axSpA achieved sustained remission during 48 wks' CZP treatment. No new safety signal was identified. <h3>Acknowledgement</h3> We thank the patients who participated. This study was funded by UCB Pharma, medical writing by Hinal Tanna, Costello Medical, UK. <h3>Disclosure of Interests</h3> Robert B.M. Landewé: None declared, 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, maxime dougados Grant/research support from: Eli Lilly and Company, Pfizer, AbbVie, and UCB Pharma, Consultant for: Eli Lilly and Company, Pfizer, AbbVie, and UCB Pharma, Xenofon Baraliakos Grant/research support from: AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Chugai, Janssen, MSD, Novartis, Pfizer Inc, Roche and UCB, Grant/research support from: AbbVie, Pfizer, Merck Sharp &amp; Dohme, UCB Pharma, Novartis, Consultant for: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen Biologics, Novartis, Pfizer, UCB Pharma, Galapagos, Speakers bureau: AbbVie, Chugai, Janssen, Novartis, Pfizer, UCB Pharma, Filip van den Bosch Consultant for: AbbVie, BMS, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, BMS, Janssen, Lilly, Merck, Novartis, Pfizer and UCB., Karl Gaffney Grant/research support from: Abbvie, Pfizer, Consultant for: Abbvie, Lilly, Novartis, UCB, Speakers bureau: Abbvie, Biogen, Gilead, Lilly, Novartis, UCB, Natasha de Peyrecave Employee of: Employee of UCB Pharma, Lars Bauer Employee of: Employee of UCB Pharma, Bengt Hoepken Employee of: Employee of UCB Pharma, Karen Thomas Employee of: Contracted Statistician of UCB Pharma., Lianne S. Gensler Grant/research support from: Abbvie, Amgen, UCB Pharma, Consultant for: Novartis, Lilly, Janssen