MRI assessment of early response to certolizumab pegol in rheumatoid arthritis: a randomised, double-blind, placebo-controlled phase IIIb study applying MRI at weeks 0, 1, 2, 4, 8 and 16
| Autor: | R. Haake, M Sejer Hansen, Henning Bliddal, Mikkel Østergaard, L. T. H. Jacobsson, B. Sundman-Engberg, C. Schaufelberger, Jwj Bijlsma, M Rell-Bakalarska, F. Staelens, A. Dudek |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Hand Joints Immunology Rheumatoid Arthritis Placebo Antibodies Monoclonal Humanized Loading dose General Biochemistry Genetics and Molecular Biology Polyethylene Glycols Anti-TNF Arthritis Rheumatoid Immunoglobulin Fab Fragments Rheumatology Double-Blind Method Synovitis Internal medicine medicine Immunology and Allergy Humans Certolizumab pegol Osteitis Inflammation business.industry Clinical and Epidemiological Research Middle Aged medicine.disease Magnetic Resonance Imaging Surgery Clinical trial Treatment Outcome Rheumatoid arthritis Certolizumab Pegol Female business Immunosuppressive Agents medicine.drug |
| Zdroj: | Annals of the Rheumatic Diseases |
| ISSN: | 1468-2060 0003-4967 |
| Popis: | ObjectivesTo identify the first time point of an MRI-verified response to certolizumab pegol (CZP) therapy in patients with rheumatoid arthritis (RA).MethodsForty-one patients with active RA despite disease-modifying antirheumatic drug therapy were randomised 2:1 to CZP (CZP loading dose 400 mg every 2 weeks at weeks 0–4; CZP 200 mg every 2 weeks at weeks 6–16) or placebo→CZP (placebo at weeks 0–2; CZP loading dose at weeks 2–6; CZP 200 mg every 2 weeks at weeks 8–16). Contrast-enhanced MRI of one hand and wrist was acquired at baseline (week 0) and weeks 1, 2, 4, 8 and 16. All six time points were read simultaneously, blinded to time, using the Outcome Measures in Rheumatology Clinical Trials RA MRI scoring system. Primary outcome was change in synovitis score in the CZP group; secondary outcomes were change in bone oedema (osteitis) and erosion scores and clinical outcome measures.ResultsForty patients were treated (27 CZP, 13 placebo→CZP), and 36 (24 CZP, 12 placebo→CZP) completed week 16. In the CZP group, there were significant reductions from baseline synovitis (Hodges–Lehmann estimate of median change, −1.5, p=0.049) and osteitis scores (−2.5, p=0.031) at week 16. Numerical, but statistically insignificant, MRI inflammation reductions were observed at weeks 1–2 in the CZP group. No significant change was seen in bone erosion score. Improvements across all clinical outcomes were seen in the CZP group.ConclusionsCZP reduced MRI synovitis and osteitis scores at week 16, despite small sample size and the technical challenge of reading six time points simultaneously. This study provides essential information on optimal MRI timing for subsequent trials.Trial registration numberClinicalTrials.gov, NCT01235598. |
| Databáze: | OpenAIRE |
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