RT Journal Article
SR Electronic
T1 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
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 1156
OP 1163
DO 10.1136/annrheumdis-2014-206359
VO 74
IS 6
A1 M Østergaard
A1 L T H Jacobsson
A1 C Schaufelberger
A1 M Sejer Hansen
A1 J W J Bijlsma
A1 A Dudek
A1 M Rell-Bakalarska
A1 F Staelens
A1 R Haake
A1 B Sundman-Engberg
A1 H Bliddal
YR 2015
UL http://ard.bmj.com/content/74/6/1156.abstract
AB Objectives To identify the first time point of an MRI-verified response to certolizumab pegol (CZP) therapy in patients with rheumatoid arthritis (RA).Methods Forty-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.Results Forty 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.Conclusions CZP 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 number ClinicalTrials.gov, NCT01235598.