TY - JOUR T1 - Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 920 LP - 928 DO - 10.1136/annrheumdis-2019-216839 VL - 79 IS - 7 AU - Robert BM Landewé AU - Désirée van der Heijde AU - Maxime Dougados AU - Xenofon Baraliakos AU - Filip E Van den Bosch AU - Karl Gaffney AU - Lars Bauer AU - Bengt Hoepken AU - Owen R Davies AU - Natasha de Peyrecave AU - Karen Thomas AU - Lianne Gensler Y1 - 2020/07/01 UR - http://ard.bmj.com/content/79/7/920.abstract N2 - Background The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor certolizumab pegol (CZP) following achievement of sustained remission in patients with early axSpA.Methods C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at Weeks 32/36 and 48) were randomised to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg every 4 weeks (Q4W; reduced maintenance dose) or placebo (withdrawal) for a further 48 weeks. The primary endpoint was remaining flare-free (flare: ASDAS ≥2.1 at two consecutive visits or ASDAS >3.5 at any time point) during the double-blind period.Results At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p<0.001 vs placebo in both CZP groups). Responses in radiographic and non-radiographic axSpA patients were comparable.Conclusions Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal.Trial registration number NCT02505542, ClinicalTrials.gov. ER -