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
| Autor: | J. Braun, A. Deodhar, Joachim Sieper, Bengt Hoepken, Walter P. Maksymowych, John D. Reveille, C. Stach, Philip J. Mease, M. de Longueville, M. Rudwaleit, Robert Landewé, D. van der Heijde, Andreas Fichtner, Maxime Dougados, G. Coteur |
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| Přispěvatelé: | AII - Amsterdam institute for Infection and Immunity, Clinical Immunology and Rheumatology |
| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Immunology Antibodies Monoclonal Humanized Placebo General Biochemistry Genetics and Molecular Biology Polyethylene Glycols law.invention Placebos Immunoglobulin Fab Fragments Double-Blind Method Rheumatology Randomized controlled trial law Internal medicine Spondylarthritis Clinical endpoint Humans Immunology and Allergy Medicine Spondylitis Ankylosing Certolizumab pegol BASDAI Spondylitis Ankylosing spondylitis business.industry Middle Aged Clinical and Epidemiological Research medicine.disease Treatment Outcome Certolizumab Pegol Physical therapy Female business BASFI Immunosuppressive Agents medicine.drug |
| Zdroj: | Annals of the Rheumatic Diseases, 73(1), 39-47 Annals of the rheumatic diseases, 73(1), 39-47. BMJ Publishing Group Annals of the Rheumatic Diseases |
| ISSN: | 1468-2060 0003-4967 0108-7762 |
| DOI: | 10.1136/annrheumdis-2013-204231 |
| Popis: | Objectives To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-axSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and non-radiographic 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 |
| Databáze: | OpenAIRE |
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