Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis

24-week results of a double-blind randomised placebo-controlled Phase 3 study

R. Landewé, J. Braun, Atulya (Atul) Deodhar, M. Dougados, W. P. Maksymowych, P. J. Mease, J. D. Reveille, M. Rudwaleit, D. Van Der Heijde, C. Stach, B. Hoepken, A. Fichtner, G. Coteur, M. De Longueville, J. Sieper

Research output: Contribution to journalArticle

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Abstract

Objectives To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPIDaxSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA). Methods Patients with active axSpA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). In total 325 patients were randomised. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society 20) response at week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear. Results Baseline disease activity was similar between AS and nr-axSpA. At week 12, ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). At week 24, combined CZP arms showed significant (p

Original languageEnglish (US)
Pages (from-to)39-47
Number of pages9
JournalAnnals of the Rheumatic Diseases
Volume73
Issue number1
DOIs
StatePublished - Jan 2014

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Ankylosing Spondylitis
Signs and Symptoms
Placebos
Baths
Certolizumab Pegol
Safety

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

Cite this

Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis : 24-week results of a double-blind randomised placebo-controlled Phase 3 study. / Landewé, R.; Braun, J.; Deodhar, Atulya (Atul); Dougados, M.; Maksymowych, W. P.; Mease, P. J.; Reveille, J. D.; Rudwaleit, M.; Van Der Heijde, D.; Stach, C.; Hoepken, B.; Fichtner, A.; Coteur, G.; De Longueville, M.; Sieper, J.

In: Annals of the Rheumatic Diseases, Vol. 73, No. 1, 01.2014, p. 39-47.

Research output: Contribution to journalArticle

Landewé, R, Braun, J, Deodhar, AA, Dougados, M, Maksymowych, WP, Mease, PJ, Reveille, JD, Rudwaleit, M, Van Der Heijde, D, Stach, C, Hoepken, B, Fichtner, A, Coteur, G, De Longueville, M & Sieper, J 2014, 'Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study', Annals of the Rheumatic Diseases, vol. 73, no. 1, pp. 39-47. https://doi.org/10.1136/annrheumdis-2013-204231
Landewé, R. ; Braun, J. ; Deodhar, Atulya (Atul) ; Dougados, M. ; Maksymowych, W. P. ; Mease, P. J. ; Reveille, J. D. ; Rudwaleit, M. ; Van Der Heijde, D. ; Stach, C. ; Hoepken, B. ; Fichtner, A. ; Coteur, G. ; De Longueville, M. ; Sieper, J. / Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis : 24-week results of a double-blind randomised placebo-controlled Phase 3 study. In: Annals of the Rheumatic Diseases. 2014 ; Vol. 73, No. 1. pp. 39-47.
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