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 <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 noprednisolone 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.

Disease activity early in the course of treatment predicts response to therapy after one year in rheumatoid arthritis patients

“…We next used a categorical approach based on the notion that achieving low disease activity and remission are ultimate goals of RA therapy (34)(35)(36)(37)(38)(39)(40)(41). We therefore categorized the disease activity status of the patients at 1 year as follows: remission (SDAI Յ3.3), low disease activity (SDAI 3.3 to Յ11), moderate disease activity (SDAI Ͼ11 to Յ26), or high disease activity (SDAI Ͼ26).…”

My Treatment Approach to Rheumatoid Arthritis

“…Our approach to the use of prednisone is supported by evidence that the disease-modifying and erosion-inhibiting benefits of low-dose oral prednisone therapy (5-10 mg/d) are sustained for at least 2 years, with minimal corticosteroid-related adverse effects. 70,71 Because most of the benefit is in the first year, our recommendation is to continue prednisone at 5 mg/d for 6 months to 1 full year before gradually tapering in decrements of 1 mg every 2 to 4 weeks. It is likely that treatment using low-dose prednisone may increase the probability of a successful outcome of MTX therapy.…”

Managed Care Strategies for Improving Patient Outcomes in Rheumatoid Arthritis

“…Clinical studies have demonstrated that treatment of early RA patients with a combination of a tumor necrosis (TNF) inhibitor and methotrexate results in better clinical outcomes. 29,30 The Behandel Strategieen (BeSt) study was a single-blind clinical trial where RA patients with less than 2 years of disease duration were randomized to 1 [anti-CCP]). Physicians often use the 1987 American College of Rheumatology (ACR) Classification Criteria of RA to assist in making the diagnosis.…”