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Oral administration of GLPG0259, an inhibitor of MAPKAPK5, a new target for the treatment of rheumatoid arthritis: a phase II, randomised, double-blind, placebo-controlled, multicentre trial

René Westhovens, Filip De Keyser UGent, Dmytro Rekalov, Evgeny L Nasonov, Johan Beetens, Annegret Van der Aa, Piet Wigerinck, Florence Namour, Frédéric Vanhoutte and Patrick Durez (2013) ANNALS OF THE RHEUMATIC DISEASES. 72(5). p.741-744
abstract
Background: Mitogen-activated protein (MAP) kinases are key regulators of cytokine production, and are therefore potential targets for treatment of rheumatoid arthritis (RA). Objective: This two-part phase II study investigated the efficacy and safety of a once-daily 50 mg GLPG0259 (an inhibitor of MAP kinase-activated protein kinase 5) dose vs placebo (part A). An interim analysis after part A would determine whether the dose-finding part (part B) would be performed. Methods: In part A, eligible methotrexate (MTX)-refractory patients with RA were randomised to receive either a once-daily 50 mg dose of GLPG0259 or placebo, in addition to a stable dose of MTX, for 12 weeks. The primary efficacy end point was the percentage of patients achieving an American College of Rheumatology 20% improvement (ACR20) response after 12 weeks. Results: The interim analysis showed no difference between the percentage of subjects achieving the primary efficacy variable of ACR20 or the secondary efficacy variables (ACR50, ACR70 and Disease Activity Score 28) at week 12 in the GLPG0259-treated (n=19) and placebo-treated (n=11) groups. Owing to lack of efficacy, the study was terminated, and part B was not initiated. Conclusions: This innovative study design quickly provided conclusive results on the lack of efficacy of GLPG0259 in patients with RA.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
journal title
ANNALS OF THE RHEUMATIC DISEASES
Ann. Rheum. Dis.
volume
72
issue
5
pages
741 - 744
Web of Science type
Article
Web of Science id
000317050400027
JCR category
RHEUMATOLOGY
JCR impact factor
9.27 (2013)
JCR rank
2/30 (2013)
JCR quartile
1 (2013)
ISSN
0003-4967
DOI
10.1136/annrheumdis-2012-202221
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
4207257
handle
http://hdl.handle.net/1854/LU-4207257
date created
2013-12-12 10:01:16
date last changed
2016-12-19 15:45:11
@article{4207257,
  abstract     = {Background: Mitogen-activated protein (MAP) kinases are key regulators of cytokine production, and are therefore potential targets for treatment of rheumatoid arthritis (RA).
Objective: This two-part phase II study investigated the efficacy and safety of a once-daily 50 mg GLPG0259 (an inhibitor of MAP kinase-activated protein kinase 5) dose vs placebo (part A). An interim analysis after part A would determine whether the dose-finding part (part B) would be performed.
Methods: In part A, eligible methotrexate (MTX)-refractory patients with RA were randomised to receive either a once-daily 50 mg dose of GLPG0259 or placebo, in addition to a stable dose of MTX, for 12 weeks. The primary efficacy end point was the percentage of patients achieving an American College of Rheumatology 20\% improvement (ACR20) response after 12 weeks.
Results: The interim analysis showed no difference between the percentage of subjects achieving the primary efficacy variable of ACR20 or the secondary efficacy variables (ACR50, ACR70 and Disease Activity Score 28) at week 12 in the GLPG0259-treated (n=19) and placebo-treated (n=11) groups. Owing to lack of efficacy, the study was terminated, and part B was not initiated.
Conclusions: This innovative study design quickly provided conclusive results on the lack of efficacy of GLPG0259 in patients with RA.},
  author       = {Westhovens, Ren{\'e} and De Keyser, Filip and Rekalov, Dmytro and Nasonov, Evgeny L and Beetens, Johan and Van der Aa, Annegret and Wigerinck, Piet and Namour, Florence and Vanhoutte, Fr{\'e}d{\'e}ric and Durez, Patrick},
  issn         = {0003-4967},
  journal      = {ANNALS OF THE RHEUMATIC DISEASES},
  language     = {eng},
  number       = {5},
  pages        = {741--744},
  title        = {Oral administration of GLPG0259, an inhibitor of MAPKAPK5, a new target for the treatment of rheumatoid arthritis: a phase II, randomised, double-blind, placebo-controlled, multicentre trial},
  url          = {http://dx.doi.org/10.1136/annrheumdis-2012-202221},
  volume       = {72},
  year         = {2013},
}

Chicago
Westhovens, René, Filip De Keyser, Dmytro Rekalov, Evgeny L Nasonov, Johan Beetens, Annegret Van der Aa, Piet Wigerinck, Florence Namour, Frédéric Vanhoutte, and Patrick Durez. 2013. “Oral Administration of GLPG0259, an Inhibitor of MAPKAPK5, a New Target for the Treatment of Rheumatoid Arthritis: a Phase II, Randomised, Double-blind, Placebo-controlled, Multicentre Trial.” Annals of the Rheumatic Diseases 72 (5): 741–744.
APA
Westhovens, René, De Keyser, F., Rekalov, D., Nasonov, E. L., Beetens, J., Van der Aa, A., Wigerinck, P., et al. (2013). Oral administration of GLPG0259, an inhibitor of MAPKAPK5, a new target for the treatment of rheumatoid arthritis: a phase II, randomised, double-blind, placebo-controlled, multicentre trial. ANNALS OF THE RHEUMATIC DISEASES, 72(5), 741–744.
Vancouver
1.
Westhovens R, De Keyser F, Rekalov D, Nasonov EL, Beetens J, Van der Aa A, et al. Oral administration of GLPG0259, an inhibitor of MAPKAPK5, a new target for the treatment of rheumatoid arthritis: a phase II, randomised, double-blind, placebo-controlled, multicentre trial. ANNALS OF THE RHEUMATIC DISEASES. 2013;72(5):741–4.
MLA
Westhovens, René, Filip De Keyser, Dmytro Rekalov, et al. “Oral Administration of GLPG0259, an Inhibitor of MAPKAPK5, a New Target for the Treatment of Rheumatoid Arthritis: a Phase II, Randomised, Double-blind, Placebo-controlled, Multicentre Trial.” ANNALS OF THE RHEUMATIC DISEASES 72.5 (2013): 741–744. Print.