LAUSR

Background 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. Objectives Here, we report interim efficacy and safety data for both subpopulations from the ongoing trial. Methods Up to Wk48, 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 <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]<1.3 at Wk32 and <2.1 at Wk36 [or vice versa], and <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). Results Part A: Of 736 patients (Table A), 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<1.3; LOCF; Table 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. Conclusion 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. Acknowledgement We thank the patients who participated. This study was funded by UCB Pharma, medical writing by Hinal Tanna, Costello Medical, UK. Disclosure of Interests 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 & 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