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

Arthritis Rheum. 2005 Nov;52(11):3360-70. doi: 10.1002/art.21298.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorptiometry, Photon
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / pathology
  • Arthritis, Rheumatoid / 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*
  • Joints / pathology
  • Joints / physiopathology
  • Male
  • Middle Aged
  • Prednisolone / therapeutic use*
  • Remission Induction
  • Severity of Illness Index
  • Surveys and Questionnaires

Substances

  • Antirheumatic Agents
  • Glucocorticoids
  • Prednisolone