Low-dose prednisolone in addition to the initial disease-modifying antirheumatic drug in patients with early active rheumatoid arthritis reduces joint destruction and increases the remission rate: a two-year randomized trial.

Abstract

OBJECTIVE:

To assess the efficacy of low-dose prednisolone on joint damage and disease activity in patients with early rheumatoid arthritis (RA).

METHODS:

At the start of their initial treatment with a disease-modifying antirheumatic drug (DMARD), patients with early (duration < or =1 year) active RA were randomly assigned to receive either 7.5 mg/day prednisolone or no prednisolone for 2 years. Radiographs of the hands and feet were obtained at baseline and after 1 and 2 years and scored according to the Sharp score as modified by van der Heijde. Remission was defined as a Disease Activity Score in 28 joints of <2.6. Bone mineral density was measured by dual x-ray absorptiometry at baseline and after 2 years.

RESULTS:

Of the 250 patients included, 242 completed the study and 225 had radiographs available both at baseline and at 2 years. At 2 years, the median and interquartile range (IQR) change in total Sharp score was lower in the prednisolone group than in the no-prednisolone group (1.8 [IQR 0.5-6.0] versus 3.5 [IQR 0.5-10]; P = 0.019). In the prednisolone group, there were fewer newly eroded joints per patient after 2 years (median 0.5 [IQR 0-2] versus 1.25 [IQR 0-3.25]; P = 0.007). In the prednisolone group, 25.9% of patients had radiographic progression beyond the smallest detectable difference compared with 39.3% of patients in the no-prednisolone group (P = 0.033). At 2 years, 55.5% of patients in the prednisolone group had achieved disease remission, compared with 32.8% of patients in the no-prednisolone group (P = 0.0005). There were few adverse events that led to withdrawal. Bone loss during the 2-year study was similar in the 2 treatment groups.

CONCLUSION:

Prednisolone at 7.5 mg/day added to the initial DMARD retarded the progression of radiographic damage after 2 years in patients with early RA, provided a high remission rate, and was well tolerated. Therefore, the data support the use of low-dose prednisolone as an adjunct to DMARDs in early active RA.

• Authors: Björn Svensson, Annelies Boonen, Kristina Albertsson, Désirée van der Heijde, Catharina Keller, Ingiäld Hafström
• Journal: Arthritis and rheumatism (Arthritis Rheum) Vol. 52 Issue 11 Pg. 3360-70 (Nov 2005) ISSN: 0004-3591 [Print] United States
• PMID: 16255010 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Glucocorticoids
• Prednisolone

Topics

• Absorptiometry, Photon
• Antirheumatic Agents (therapeutic use)
• Arthritis, Rheumatoid (drug therapy, pathology, physiopathology)
• Arthrography
• Bone Density
• Disease Progression
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Early Diagnosis
• Female
• Glucocorticoids (therapeutic use)
• Health Status
• Humans
• Joints (drug effects, pathology, physiopathology)
• Male
• Middle Aged
• Prednisolone (therapeutic use)
• Remission Induction
• Severity of Illness Index
• Surveys and Questionnaires