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Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial.

Publication ,  Journal Article
Keystone, EC; Combe, B; Smolen, J; Strand, V; Goel, N; van Vollenhoven, R; Mease, P; Landewé, R; Fleischmann, R; Luijtens, K; van der Heijde, D
Published in: Rheumatology (Oxford)
September 2012

OBJECTIVE: To evaluate the safety and efficacy of 2-year administration of certolizumab pegol (CZP) + MTX in patients with active RA. METHODS: Patients completing 52 weeks in the Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 1 trial (52-week completers), or withdrawing at week 16 due to lack of ACR20 response were eligible for open-label treatment (CZP 400 mg every other week + MTX). After 2 years' treatment, HAQ-Disability Index response, ACR20/50/70 responses, DAS-28 and radiographic progression were assessed in 52-week completers. ACR20/50/70 and DAS-28 were also calculated for the intent-to-treat (ITT) population. Adverse events were assessed in patients who received one or more CZP doses during the study. RESULTS: At week 100, 88.9% (n = 216) of 52-week completers who originally received CZP 200 mg + MTX and open-label treatment remained in the study. In this group, ACR20/50/70 at week 100 were 68.2, 55.2 and 35.6%, respectively. HAQ-DI and DAS-28 improvements were sustained throughout the open-label extension (mean change -0.79 and -3.5 at week 100, respectively). A total of 46.7% (n = 113) of CZP 200 mg + MTX 52-week completers achieved low disease activity by week 100. Inhibition of radiographic progression was maintained. Similar findings were observed in 52-week completers who originally received CZP 400 mg + MTX and in the ITT population. Rates of serious infection or malignancies did not increase over time and no new safety signals were observed. CONCLUSION: CZP + MTX provided sustained, 2-year inhibition of radiographic progression and sustained improvements in RA clinical signs and symptoms, with no new safety signals observed in patients who completed 2 years of treatment. TRIAL REGISTRATION: clinicaltrials.gov, http://www.clinicaltrials.gov, NCT00175877.

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Published In

Rheumatology (Oxford)

DOI

EISSN

1462-0332

Publication Date

September 2012

Volume

51

Issue

9

Start / End Page

1628 / 1638

Location

England

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Severity of Illness Index
  • Recovery of Function
  • Polyethylene Glycols
  • Middle Aged
  • Methotrexate
  • Male
  • Joints
  • Immunoglobulin Fab Fragments
 

Citation

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Keystone, E. C., Combe, B., Smolen, J., Strand, V., Goel, N., van Vollenhoven, R., … van der Heijde, D. (2012). Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford), 51(9), 1628–1638. https://doi.org/10.1093/rheumatology/kes082
Keystone, Edward C., Bernard Combe, Josef Smolen, Vibeke Strand, Niti Goel, Ronald van Vollenhoven, Philip Mease, et al. “Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial.Rheumatology (Oxford) 51, no. 9 (September 2012): 1628–38. https://doi.org/10.1093/rheumatology/kes082.
Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, et al. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep;51(9):1628–38.
Keystone, Edward C., et al. “Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial.Rheumatology (Oxford), vol. 51, no. 9, Sept. 2012, pp. 1628–38. Pubmed, doi:10.1093/rheumatology/kes082.
Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, Mease P, Landewé R, Fleischmann R, Luijtens K, van der Heijde D. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep;51(9):1628–1638.
Journal cover image

Published In

Rheumatology (Oxford)

DOI

EISSN

1462-0332

Publication Date

September 2012

Volume

51

Issue

9

Start / End Page

1628 / 1638

Location

England

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Severity of Illness Index
  • Recovery of Function
  • Polyethylene Glycols
  • Middle Aged
  • Methotrexate
  • Male
  • Joints
  • Immunoglobulin Fab Fragments