Document Detail


Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study.
MedLine Citation:
PMID:  23348607     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The purpose of this 24-month phase III study was to examine structural preservation with tofacitinib in patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX). Data from a planned 12-month interim analysis are reported.
METHODS: In this double-blind, parallel-group, placebo-controlled study, patients receiving background MTX were randomized 4:4:1:1 to tofacitinib at 5 mg twice daily, tofacitinib at 10 mg twice daily, placebo to tofacitinib at 5 mg twice daily, and placebo to tofacitinib at 10 mg twice daily. At month 3, nonresponder placebo-treated patients were advanced in a blinded manner to receive tofacitinib as indicated above; remaining placebo-treated patients were advanced at 6 months. Four primary efficacy end points were all analyzed in a step-down procedure.
RESULTS: At month 6, response rates according to the American College of Rheumatology 20% improvement criteria for tofacitinib at 5 mg and 10 mg twice daily were higher than those for placebo (51.5% and 61.8%, respectively, versus 25.3%; both P < 0.0001). At month 6, least squares mean (LSM) changes in total modified Sharp/van der Heijde score for tofacitinib at 5 mg and 10 mg twice daily were 0.12 and 0.06, respectively, versus 0.47 for placebo (P = 0.0792 and P ≤ 0.05, respectively). At month 3, LSM changes in the Health Assessment Questionnaire disability index score for tofacitinib at 5 mg and 10 mg twice daily were -0.40 (significance not declared due to step-down procedure) and -0.54 (P < 0.0001), respectively, versus -0.15 for placebo. At month 6, rates of remission (defined as a value <2.6 for the 4-variable Disease Activity Score in 28 joints using the erythrocyte sedimentation rate) for tofacitinib at 5 mg and 10 mg twice daily were 7.2% (significance not declared due to step-down procedure) and 16.0% (P < 0.0001), respectively, versus 1.6% for placebo. The safety profile was consistent with findings in previous studies.
CONCLUSION: Data from this 12-month interim analysis demonstrate that tofacitinib inhibits progression of structural damage and improves disease activity in patients with RA who are receiving MTX.
Authors:
Désirée van der Heijde; Yoshiya Tanaka; Roy Fleischmann; Edward Keystone; Joel Kremer; Cristiano Zerbini; Mario H Cardiel; Stanley Cohen; Peter Nash; Yeong-Wook Song; Dana Tegzová; Bradley T Wyman; David Gruben; Birgitta Benda; Gene Wallenstein; Sriram Krishnaswami; Samuel H Zwillich; John D Bradley; Carol A Connell;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Arthritis and rheumatism     Volume:  65     ISSN:  1529-0131     ISO Abbreviation:  Arthritis Rheum.     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-26     Completed Date:  2013-04-24     Revised Date:  2013-06-05    
Medline Journal Info:
Nlm Unique ID:  0370605     Medline TA:  Arthritis Rheum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  559-70     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013 by the American College of Rheumatology.
Affiliation:
Leiden University Medical Center, Leiden, The Netherlands. mail@dvanderheijde.nl
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00847613
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MeSH Terms
Descriptor/Qualifier:
Adult
Antirheumatic Agents / administration & dosage*
Arthritis, Rheumatoid / drug therapy*,  radiography*
Disease Progression
Drug Resistance
Female
Humans
Janus Kinase 3 / antagonists & inhibitors*
Male
Methotrexate / administration & dosage*
Middle Aged
Motor Activity / drug effects
Pyrimidines / administration & dosage*,  adverse effects
Pyrroles / administration & dosage*,  adverse effects
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antirheumatic Agents; 0/Pyrimidines; 0/Pyrroles; 59-05-2/Methotrexate; 87LA6FU830/tofacitinib; EC 2.7.10.2/Janus Kinase 3
Investigator
Investigator/Affiliation:
Prabha Adhikari / ; Kouichi Amano / ; Sang-Cheol Bae / ; Srikantiah Chandrashekara / ; Arvind K Chopra / ; Ping-Ning Hsu / ; Mitsuhiro Iwahashi / ; Jugal Kishore Kadel / ; Yojiro Kawabe / ; Eun-Mi Koh / ; Joung-liang Lan / ; Soo-Kon Lee / ; Hsiao-Yi Lin / ; Lieh-bang Liou / ; Ming-Fei Liu / ; Kiyoshi Migita / ; Toshiaki Miyamoto / ; Nobuyuki Miyasaka / ; Shunsuke Mori / ; Yasuhiko Munakata / ; Shuji Ohta / ; Sung-Hwan Park / ; Won Park / ; Uppuluri Ramakrishna Rao / ; Seung Cheol Shim / ; Vineeta Shobha / ; Yeong-Wook Song / ; Yoshinari Takasaki / ; Tsutomu Takeuchi / ; Yoshiya Tanaka / ; Shigeto Tohma / ; Wen-Chan Tsai / ; Yukitaka Ueki / ; Sarath Chandra Mouli Veeravalli / ; Shrikant Wagh / ; Hisashi Yamanaka / ; Bin Yoo / ; Stephen Hall / ; David Nicholls / ; Maureen Rischmueller / ; Milton F Baker / ; Louis Bessette / ; Alfred A Cividin / ; Boulos Haraoui / ; Henry Niall Jones / ; Edward C Keystone / ; Majed Khraishi / ; J Thorne / ; Anastas Batalov / ; Daniela Bichovska / ; Zdenek Dvorak / ; Ivan Goranov / ; Halyna M Hrytsenko / ; Jana Kopackova / ; Zdenka Mosterova / ; Boycho Oparanov / ; Andriy Petrov / ; Ines Pokrzywnicka-Gajek / ; Vladyslav V Povoroznyuk / ; Jan Rosa / ; Zofia Ruzga / ; Loukas Settas / ; Mykola A Stanislavchuk / ; Dana Tegzova / ; Vira Iosypivna Tseluyko / ; Petr Vitek / ; Joao Carlos Tavares Brenol / ; Mario H Cardiel-Rios / ; William Jose Otero Escalante / ; Javier Dario Marquez Hernandez / ; Edwin Antonio Jauregui / ; Mauro W Keiserman / ; Ana Claudia Cauceglia Melazzi / ; Virginia Pascual- Ramos / ; Luciana Teixeira Pinto / ; Juan Jose Jaller Raad / ; Sebastiao C Radominski / ; Antonio Carlos Ximenes / ; Cristiano Augusto de Freitas Zerbini / ; Herbert Stuart Block Baraf / ; Joan Marie Bathon / ; Charles Allen Birbara / ; Alan Lawrence Brodsky / ; John Joseph Cush / ; Ara Hagop Dikranian / ; Erdal Diri / ; Paul Andrew Dura / ; Roy Mitchell Fleischmann / ; Robert Michael Griffin / ; Dale George Halter / ; Jody Kay Hargrove / ; Geneva Louise Hill / ; Raymond Edward Jackson / ; Shelly Pearl Kafka / ; Jeffrey Louis Kaine / ; Paul L Katzenstein / ; Kevin James Kempf / ; Karen Sue Kolba / ; Joel Marc Kremer / ; Selden Longley / ; Steven D Mathews / ; Ami Charise Milton / ; Richard James Misischia / ; Haydon Anthony Moorman / ; Larry W Moreland / ; Mark William Niemer / ; William Rodney Palmer / ; Michael Eugene Sayers / ; Patrick Thomas Schuette / ; Talha Shamim / ; William Julius Shergy / ; David Hilton Sikes / ; Joel Charles Silverfield / ; Chokkalingam Siva / ; James D Taborn / ; Bridget Tyrell Walsh / ; Alvin Francis Wells / ; Sanford Mayer Wolfe /

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