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Clinical Question:
Do Prednisolone plus DMARD decreased disease progression in patient with
Rheumatoid Arthritis?
Bottom Line:
The very low daily dose of 5 mg prednisolone given over 2 years in
combination with background DMARD therapy substantially decreased
radiographic progression in early RA at low risk.
Reference:
Very low-dose prednisolone in early rheumatoid arthritis retards
radiographic progression over two years: A multicenter, double-blind,placebo-controlled
trial. Wassenberg S, Rau R, Steinfeld P, Zeidler H.Arthritis Rheum. 2005 Oct
27;52(11):3371-3380
Study Design:
A multicenter, double-blind, placebo-controlled trial
Synopsis:
To assess the effect of 5 mg/day prednisolone on disease progression in
patients with early rheumatoid arthritis (RA) receiving standardized
disease-modifying antirheumatic drug (DMARD) therapy.Patients with active RA
of <2 years' duration were randomly assigned in a double-blinded manner to
receive prednisolone or placebo while starting concomitant DMARD therapy
(gold sodium thiomalate or methotrexate). Hand and foot radiographs were
taken at baseline and at 6, 12, and 24 months and were evaluated according
to the Ratingen score and the total modified Sharp/van der Heijde score (SHS).
Of 192 included patients, 166 were available for the intent-to-treat
analysis (ITT). Seventy-six patients completed the study per protocol (PP).
Radiographic progression (increase in the Ratingen score) was significantly
less with prednisolone than with placebo. The difference in the progression
rate between the groups was greatest in the first 6 months. At 24 months in
the ITT population, the least squares (LS) mean difference was 3.14 (95%
confidence interval [95% CI] 0.94, 5.34), P = 0.006. The results were
confirmed by the total SHS in the ITT population (LS mean difference 7.20
[95% CI 0.93, 13.47], P = 0.022) and with the PP population. Clinical and
functional outcomes tended to be better and the rate of remissions was
higher in the prednisolone group. Side effects were observed more frequently
in the prednisolone group than in the control group: weight gain (4 versus 0
patients), hypertension (6 versus 2 patients), glaucoma (3 versus 0
patients), Cushing's syndrome (5 versus 0 patients), gastric distress (9
versus 4 patients), and gastric ulcers (only with concomitant nonsteroidal
antiinflammatory drug therapy; 3 versus 0 patients). No new lumbar fractures
were found in either group. |