Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)

Frank Buttgereit; Daksha Mehta; John Kirwan; Jacek Szechinski; Maarten Boers; Rieke E. Alten; Jerzy Supronik; Istvan Szombati; Ulrike Romer; Stephan Witte; Kenneth G. Saag

doi:10.1136/annrheumdis-2011-201067

Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)

Frank Buttgereit^*, Daksha Mehta, John Kirwan, Jacek Szechinski, Maarten Boers, Rieke E. Alten, Jerzy Supronik, Istvan Szombati, Ulrike Romer, Stephan Witte, Kenneth G. Saag

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

154 Citations (Scopus)

Abstract

Objective To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA).

Methods In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed.

Results MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p

Conclusion Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. ClinicalTrials.gov, number NCT00650078

Original language	English
Pages (from-to)	204-210
Number of pages	7
Journal	Annals of the Rheumatic Diseases
Volume	72
Issue number	2
DOIs	https://doi.org/10.1136/annrheumdis-2011-201067
Publication status	Published - Feb 2013

Keywords

RECOMMENDATIONS
MANAGEMENT
THERAPY
EFFICACY
GLUCOCORTICOID TREATMENT
DOUBLE-BLIND
REMISSION
AMERICAN-COLLEGE
JOINT DESTRUCTION
CIRCADIAN-RHYTHMS

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@article{2b72242e46714451a5bb22da6c156d59,

title = "Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)",

abstract = "Objective To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA).Methods In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed.Results MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, pConclusion Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. ClinicalTrials.gov, number NCT00650078",

keywords = "RECOMMENDATIONS, MANAGEMENT, THERAPY, EFFICACY, GLUCOCORTICOID TREATMENT, DOUBLE-BLIND, REMISSION, AMERICAN-COLLEGE, JOINT DESTRUCTION, CIRCADIAN-RHYTHMS",

author = "Frank Buttgereit and Daksha Mehta and John Kirwan and Jacek Szechinski and Maarten Boers and Alten, {Rieke E.} and Jerzy Supronik and Istvan Szombati and Ulrike Romer and Stephan Witte and Saag, {Kenneth G.}",

year = "2013",

month = feb,

doi = "10.1136/annrheumdis-2011-201067",

language = "English",

volume = "72",

pages = "204--210",

journal = "Annals of the Rheumatic Diseases",

issn = "1468-2060",

publisher = "BMJ Publishing Group",

number = "2",

}

TY - JOUR

T1 - Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)

AU - Buttgereit, Frank

AU - Mehta, Daksha

AU - Kirwan, John

AU - Szechinski, Jacek

AU - Boers, Maarten

AU - Alten, Rieke E.

AU - Supronik, Jerzy

AU - Szombati, Istvan

AU - Romer, Ulrike

AU - Witte, Stephan

AU - Saag, Kenneth G.

PY - 2013/2

Y1 - 2013/2

N2 - Objective To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA).Methods In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed.Results MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, pConclusion Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. ClinicalTrials.gov, number NCT00650078

AB - Objective To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA).Methods In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed.Results MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, pConclusion Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. ClinicalTrials.gov, number NCT00650078

KW - RECOMMENDATIONS

KW - MANAGEMENT

KW - THERAPY

KW - EFFICACY

KW - GLUCOCORTICOID TREATMENT

KW - DOUBLE-BLIND

KW - REMISSION

KW - AMERICAN-COLLEGE

KW - JOINT DESTRUCTION

KW - CIRCADIAN-RHYTHMS

U2 - 10.1136/annrheumdis-2011-201067

DO - 10.1136/annrheumdis-2011-201067

M3 - Article (Academic Journal)

C2 - 22562974

SN - 1468-2060

VL - 72

SP - 204

EP - 210

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

IS - 2

ER -

Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)

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