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Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX.

Publication ,  Journal Article
Choy, E; McKenna, F; Vencovsky, J; Valente, R; Goel, N; Vanlunen, B; Davies, O; Stahl, H-D; Alten, R
Published in: Rheumatology (Oxford)
July 2012

OBJECTIVE: Certolizumab pegol (CZP) is known to be effective as monotherapy at a dosage of 400  mg every 4 weeks in patients with active RA who have failed DMARDs. The aim of this study was to investigate every 4-week CZP in addition to continued MTX therapy in patients with an inadequate response to MTX alone. METHODS: Patients with active RA with inadequate response to MTX, on background MTX, were randomized to double-blind treatment with CZP 400  mg or placebo every 4 weeks for 24 weeks (NCT00544154). The primary efficacy end-point was the ACR 20% improvement criteria (ACR20) response rate at Week 24. Other end-points included ACR50 and ACR70 response rates, ACR core components, 28-joint DAS (ESR) with three variables (DAS28-3) and health-related quality-of-life outcomes in addition to safety. RESULTS: Of 247 randomized patients, 126 received CZP and 121 received placebo, in addition to MTX. ACR20 response rates were 45.9 vs 22.9%, respectively [P < 0.001 analysed by the Cochran-Mantel-Haenszel (CMH) method], with improvements being apparent from Week 1. Statistically significant improvements over placebo were seen with CZP for ACR50, ACR core components, DAS28-3 and physical functioning. Rates of treatment-related adverse events were similar between groups (25.0 vs 27.7%), and there were no deaths or serious opportunistic infections. CONCLUSION: CZP 400  mg every 4 weeks plus MTX demonstrated a favourable risk-benefit profile with rapid onset of action in RA patients with an inadequate response to an earlier MTX therapy.

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Published In

Rheumatology (Oxford)

DOI

EISSN

1462-0332

Publication Date

July 2012

Volume

51

Issue

7

Start / End Page

1226 / 1234

Location

England

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Time Factors
  • Retrospective Studies
  • Quality of Life
  • Polyethylene Glycols
  • Middle Aged
  • Methotrexate
  • Male
  • Immunologic Factors
 

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Choy, E., McKenna, F., Vencovsky, J., Valente, R., Goel, N., Vanlunen, B., … Alten, R. (2012). Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford), 51(7), 1226–1234. https://doi.org/10.1093/rheumatology/ker519
Choy, Ernest, Frank McKenna, Jiri Vencovsky, Robert Valente, Niti Goel, Brenda Vanlunen, Owen Davies, Hans-Detlev Stahl, and Rieke Alten. “Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX.Rheumatology (Oxford) 51, no. 7 (July 2012): 1226–34. https://doi.org/10.1093/rheumatology/ker519.
Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, et al. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul;51(7):1226–34.
Choy, Ernest, et al. “Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX.Rheumatology (Oxford), vol. 51, no. 7, July 2012, pp. 1226–34. Pubmed, doi:10.1093/rheumatology/ker519.
Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, Davies O, Stahl H-D, Alten R. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul;51(7):1226–1234.
Journal cover image

Published In

Rheumatology (Oxford)

DOI

EISSN

1462-0332

Publication Date

July 2012

Volume

51

Issue

7

Start / End Page

1226 / 1234

Location

England

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Time Factors
  • Retrospective Studies
  • Quality of Life
  • Polyethylene Glycols
  • Middle Aged
  • Methotrexate
  • Male
  • Immunologic Factors