Article Text

Download PDFPDF

Extended report
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
  1. M Østergaard1,
  2. L T H Jacobsson2,
  3. C Schaufelberger2,,
  4. M Sejer Hansen3,
  5. J W J Bijlsma4,
  6. A Dudek5,
  7. M Rell-Bakalarska6,
  8. F Staelens7,
  9. R Haake8,
  10. B Sundman-Engberg9,
  11. H Bliddal10
  1. 1Copenhagen Center for Arthritis Research, Copenhagen University Hospital at Glostrup, Glostrup, Denmark
  2. 2Department of Rheumatology & Inflammation Research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
  3. 3Department of Rheumatology, Gentofte Hospital, Gentofte, Denmark
  4. 4University Medical Center Utrecht, Utrecht, The Netherlands
  5. 5Medica Pro Familia, Warsaw, Poland
  6. 6Rheuma Medicus, Warsaw, Poland
  7. 7UCB Pharma, Brussels, Belgium
  8. 8UCB Pharma, Raleigh, North Carolina, USA
  9. 9UCB Pharma, Stockholm, Sweden
  10. 10Department of Rheumatology, The Parker Institute, Frederiksberg, Denmark
  1. Correspondence to Professor Mikkel Østergaard, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup Hospital, Nordre Ringvej 57, Glostrup DK-2600, Denmark; mo{at}dadlnet.dk

Abstract

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.

  • Rheumatoid Arthritis
  • Magnetic Resonance Imaging
  • Anti-TNF
  • Inflammation
  • Synovitis

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

View Full Text

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.