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%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%).

CONCLUSION:

Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.

• Authors: Frank Buttgereit, Daksha Mehta, John Kirwan, Jacek Szechinski, Maarten Boers, Rieke E Alten, Jerzy Supronik, Istvan Szombati, Ulrike Romer, Stephan Witte, Kenneth G Saag
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 72 Issue 2 Pg. 204-10 (Feb 2013) ISSN: 1468-2060 [Electronic] England
• PMID: 22562974 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Antirheumatic Agents
• Prednisone

Topics

• Adult
• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents (administration & dosage, adverse effects)
• Antirheumatic Agents (administration & dosage)
• Arthritis, Rheumatoid (drug therapy)
• Double-Blind Method
• Drug Chronotherapy
• Female
• Humans
• Male
• Middle Aged
• Pain (etiology)
• Prednisone (administration & dosage, adverse effects)
• Quality of Life