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Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.
- Source :
- Annals of the Rheumatic Diseases; Jul2020, Vol. 79 Issue 7, p920-928, 9p, 1 Diagram, 3 Charts, 2 Graphs
- Publication Year :
- 2020
-
Abstract
- <bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.<bold>Trial Registration Number: </bold>NCT02505542, ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00034967
- Volume :
- 79
- Issue :
- 7
- Database :
- Complementary Index
- Journal :
- Annals of the Rheumatic Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 144216100
- Full Text :
- https://doi.org/10.1136/annrheumdis-2019-216839