Concise report
A randomised trial of differentiated prednisolone treatment in
active rheumatoid arthritis. Clinical benefits and skeletal side
effects
Michael Hansena, Jan Pødenphantb, Adrian Florescuc d, Michael Stoltenberga b, Alice Borchb, Elga Klugere, Søren Freiesleben Sørensend, Troels Mørk Hansenb
a Department of
Rheumatology, Hvidovre Hospital, University of Copenhagen, Denmark, b Department of Rheumatology and Radiology, Herlev
Hospital, University of Copenhagen, Denmark, c Department of Internal Medicine, TTA
Rigshospitalet, National University Hospital, Denmark, d Department
of Rheumatology, Bispebjerg Hospital, University of Copenhagen, Denmark, e Gråsten Rheumatology Hospital, Denmark
Correspondence to: Dr J Pødenphant, Department of Rheumatology, Herlev Hospital.University, of Copenhagen, Herlev Ringvej, DK-2730 Herlev, Denmark.
Accepted for publication 26 July 1999
OBJECTIVES
To study
benefits and skeletal side effects of carefully monitored prednisolone
treatment in patients with active rheumatoid arthritis.
METHODSOne hundred
and two patients with active rheumatoid arthritis were randomly
allocated to treatment with disease modifying anti-inflammatory drug
(DMARD) alone or DMARD and prednisolone in a one year follow up study.
Prednisolone was given in a dose regimen adapted to the disease
activity of the individual patient. The mean dose was 6 mg and the mean
cumulated dose was 2160 mg. Patients were followed up with disease
activity parameters, radiograph of the hands (Larsen score), and bone
mineral density (BMD) of the lumbar spine, distal forearm and hand. At
one year 26 patients had withdrawn from the investigation leaving 76 patients for evaluation.
RESULTSThe results
showed that disease activity in the prednisolone treated group was
reduced within two weeks. In the DMARD alone group disease activity was
gradually reduced over months. At six months there was no difference
between the groups as evaluated by an improvement score using a number
of ACR criteria. Prednisolone in the present set up was not able to
protect significantly against radiological disease progression,
although there was a trend towards less progression in Larsen score in
the prednisolone group, a matter that was further underlined in an
intention to treat analysis. BMD data revealed a significant reduction
in spinal BMD in the prednisolone group, whereas prednisolone seemed to
have a protective effect against bone loss in the hand and distal forearm.
CONCLUSIONSThis study
does not allow any firm conclusions for or against the treatment of
rheumatoid arthritis with prednisolone. The data suggest that the
beneficial effects of prednisolone are not as clear cut in established
rheumatoid arthritis as in early disease. Furthermore the data indicate
that treatment in the chosen relatively low dose does not provide
sufficient control of disease. On the other hand the spinal bone loss
observed in the prednisolone group does invite considerations about
using higher doses.
© 1999 by Annals of the Rheumatic Diseases
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