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  • Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial

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Clinical and epidemiological research
Extended report
Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial
  1. Vibeke Strand1,
  2. Josef S Smolen2,
  3. Ronald F van Vollenhoven3,
  4. Philip Mease4,
  5. Gerd R Burmester5,
  6. Falk Hiepe5,
  7. Dinesh Khanna6,
  8. Enkeleida Nikaï7,
  9. Geoffroy Coteur8,
  10. Michael Schiff9
  1. 1Division of Immunology/Rheumatology, Stanford University Portola Valley, California, USA
  2. 2Department of Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria
  3. 3Unit for Clinical Therapy Research, Inflammatory Diseases, Karolinska Institute, Stockholm, Sweden
  4. 4Swedish Medical Center, University of Washington, Seattle, Washington, USA
  5. 5Department of Rheumatology and Clinical Immunology, Humboldt University of Berlin, Charitié Hospital, Berlin, Germany
  6. 6Department of Medicine, Division of Rheumatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California, USA
  7. 7Business & Decision Life Sciences, Brussels, Belgium
  8. 8Global Health Outcomes & Access – Immunology, UCB Pharma SA, Brussels, Belgium
  9. 9Rheumatology Division, University of Colorado, Denver, Colorado, USA
  1. Correspondence to Vibeke Strand, Division of Immunology and Rheumatology, Stanford University, 306 Ramona Road, Portola Valley, CA 94028, USA; vstrand{at}stanford.edu

Abstract

Objective To assess the impact of certolizumab pegol (CZP) on patient-reported outcomes (PROs) in rheumatoid arthritis (RA), and to interpret these results using number needed to treat (NNT), and associations between PRO responses and longer term outcomes.

Methods A total of 619 patients with active RA were randomised to CZP 200 or 400 mg, or placebo plus methotrexate (MTX). PROs assessed included pain, patient's global assessment of disease activity (PtGA), physical function, fatigue and health-related quality of life. Treatment impact on PROs, NNT to achieve simultaneous improvements in multiple PROs and correlations between PROs were calculated. Times to onset of improvements greater than or equal to minimum clinically important differences (MCIDs) in pain as a determinant of clinical outcomes at week 24 were compared between week 6 and 12 responders, and in patients with improvements in pain ≥MCID at week 12 (week 12 responders/non-responders).

Results CZP 200 and 400 mg plus MTX were associated with rapid, clinically meaningful improvements in all PROs. The NNT for subjects to report changes ≥MCID in up to five PROs was two to three, and five for all six PROs (pain, PtGA, physical function, fatigue and short-form 36-item Physical and Mental Component Summary Scores). More patients with improvements ≥MCID in pain at week 6 than those at week 12 had lower disease activity at week 24. Week 12 pain responders had better clinical outcomes at week 24 than non-responders.

Conclusions The data demonstrate that CZP provides broad relief from the burden of RA.

Trial registration number NCT00160602.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ard.bmj.com/info/unlocked.dtl

https://doi.org/10.1136/ard.2010.143586

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    Footnotes

    • Funding The RAPID 2 study was fully funded by UCB.

    • Competing interests VS has worked as an independent biopharmaceutical consultant in clinical development and regulatory affairs since September 1991 and is currently a consultant to various sponsors including UCB, but has not and does not now hold stock in any company. JSS serves as a consultant to UCB. RFvV serves as a consultant to UCB and has received research funding from UCB. PM serves as a consultant to UCB, received research funding from UCB and has received an honorarium for speaking for UCB. GRB serves as a consultant to UCB and has received honoraria from UCB for speaking. FH has no competing interests. DK serves as a consultant to UCB. EN is a Business & Decision Life Science consultant working for UCB. GC is a full-time employee of and holds stocks in UCB. MS serves as a consultant to UCB and has received research funding from UCB.

    • Ethics approval Institutional review boards or ethics committees approved the protocol at each centre. All patients gave written consent, and the study was conducted in accordance with the Declaration of Helsinki.

    • Provenance and peer review Not commissioned; externally peer reviewed.