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Ann Rheum Dis 2009;68:797-804 doi:10.1136/ard.2008.101659
  • Clinical and epidemiological research

Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial

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  1. J Smolen1,
  2. R B Landewé2,
  3. P Mease3,
  4. J Brzezicki4,
  5. D Mason5,
  6. K Luijtens6,
  7. R F van Vollenhoven7,
  8. A Kavanaugh8,
  9. M Schiff9,
  10. G R Burmester10,
  11. V Strand11,
  12. J Vencovský12,
  13. D van der Heijde13
  1. 1
    Division of Rheumatology, Department of Internal Medicine III, Medical University of Vienna and 2nd Department of Medicine, Hietzing Hospital, Vienna, Austria
  2. 2
    Department of Internal Medicine/Division of Rheumatology and Caphri Research Institute, University Hospital of Maastricht, Maastricht, The Netherlands
  3. 3
    Seattle Rheumatology Associates, Swedish Medical Center, Seattle, Washington, USA
  4. 4
    Oddzial Reumatologii ul, Wojewodzki Szpital Zespolony, Elblag, Poland
  5. 5
    Research and Development, UCB Inc, Atlanta, Georgia, USA
  6. 6
    UCB Inc, Brussels, Belgium
  7. 7
    Rheumatology Unit, Karolinska Institute, Stockholm, Sweden
  8. 8
    Division of Rheumatology, University of California, San Diego, California, USA
  9. 9
    University of Colorado, Denver, Colorado, USA
  10. 10
    Department of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin, Germany
  11. 11
    Division of Immunology/Rheumatology, Stanford University, Portola Valley, California, USA
  12. 12
    Institute of Rheumatology, Prague, Czech Republic
  13. 13
    Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands
  1. Professor J Smolen, Division of Rheumatology, Medical University of Vienna, Vienna A-1090, Austria; josef.smolen{at}meduniwien.ac.at
  • Accepted 28 October 2008
  • Published Online First 17 November 2008

Abstract

Background: Certolizumab pegol is a PEGylated tumour necrosis factor inhibitor.

Objective: To evaluate the efficacy and safety of certolizumab pegol versus placebo, plus methotrexate (MTX), in patients with active rheumatoid arthritis (RA).

Methods: An international, multicentre, phase 3, randomised, double-blind, placebo-controlled study in active adult-onset RA. Patients (n = 619) were randomised 2:2:1 to subcutaneous certolizumab pegol (liquid formulation) 400 mg at weeks 0, 2 and 4 followed by 200 mg or 400 mg plus MTX, or placebo plus MTX, every 2 weeks for 24 weeks. The primary end point was ACR20 response at week 24. Secondary end points included ACR50 and ACR70 responses, change from baseline in modified Total Sharp Score, ACR core set variables and physical function.

Results: Significantly more patients in the certolizumab pegol 200 mg and 400 mg groups achieved an ACR20 response versus placebo (p≤0.001); rates were 57.3%, 57.6% and 8.7%, respectively. Certolizumab pegol 200 and 400 mg also significantly inhibited radiographic progression; mean changes from baseline in mTSS at week 24 were 0.2 and −0.4, respectively, versus 1.2 for placebo (rank analysis p≤0.01). Certolizumab pegol-treated patients reported rapid and significant improvements in physical function versus placebo; mean changes from baseline in HAQ-DI at week 24 were −0.50 and −0.50, respectively, versus −0.14 for placebo (p≤0.001). Most adverse events were mild or moderate, with low incidence of withdrawals due to adverse events. Five patients developed tuberculosis.

Conclusion: Certolizumab pegol plus MTX was more efficacious than placebo plus MTX, rapidly and significantly improving signs and symptoms of RA and physical function and inhibiting radiographic progression.

Trial registration number: NCT00175877

Footnotes

  • Competing interests: Declared. JS, RBL, PM, RFvV, AK, MS, GRB, VS and DvdH serve as consultants to UCB, Inc. RBL, AK, MS and DvdH receive research funding from UCB, Inc and GRB and JV have received honorarium from UCB, Inc for speaking. DM and KL are employees of UCB, Inc. JB has nothing to disclose.

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

  • JS had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

  • ‣ Additional data are published online only at http://ard.bmj.com/content/vol68/issue6

  • Ethics approval: Ethics committee approval obtained.

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