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Landewé, Robert B. M., van der Heijde, Désirée, Dougados, Maxime, Baraliakos, Xenofon, van den Bosch, Filip E., Gaffney, Karl 
ORCID: https://orcid.org/0000-0002-7863-9176, Bauer, Lars, Hoepken, Bengt, Davies, Owen R., de Peyrecave, Natasha, Thomas, Karen and Gensler, Lianne
(2020)
Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.
Annals of the Rheumatic Diseases, 79 (7).
pp. 920-928.
ISSN 0003-4967
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Abstract
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.
| Item Type: | Article |
|---|---|
| Additional Information: | © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
| Uncontrolled Keywords: | adolescent,adult,administration & dosage,administration & dosage,dose-response relationship, drug,double-blind method,female,humans,methods,methods,male,middle aged,drug therapy,treatment outcome,administration & dosage,withholding treatment,young adult |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 25 Aug 2020 00:06 |
| Last Modified: | 22 Oct 2022 06:39 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/76573 |
| DOI: | 10.1136/annrheumdis-2019-216839 |
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