A randomised trial of differentiated prednisolone treatment in active rheumatoid arthritis. Clinical benefits and skeletal side effects

Objectives-To study benefits and skeletal side effects of carefully monitor ed prednisolone treatment in patients with active rheumatoid arthritis. Methods-One hundred and two patients with active rheumatoid arthritis were randomly allocated to treatment with disease modifying anti-inflammatory dr ug (DMARD) alone or DMARD and prednisolone in a one year follow up study. P rednisolone 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, ra diograph of the hands (Larsen score), and bone mineral density (BMD) of the lumbar spine, distal forearm and hand. At one year 26 patients had withdra wn from the investigation leaving 76 patients for evaluation. Results-The results showed that disease activity in the prednisolone treate d group was reduced within two weeks. In the DMARD alone group disease acti vity was gradually reduced over months. At six months there was no differen ce between the groups as evaluated by an improvement score using a number o f 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. BM D data revealed a significant reduction in spinal BMD in the prednisolone g roup, whereas prednisolone seemed to have a protective effect against bone loss in the hand and distal forearm. Conclusions-This study does not allow any firm conclusions for or against t he treatment of rheumatoid arthritis with prednisolone. The data suggest th at the beneficial effects of prednisolone are not as clear cut in establish ed rheumatoid arthritis as in early disease. Furthermore the data indicate that treatment in the chosen relatively low dose does not provide sufficien t control of disease. On the other hand the spinal bone loss observed in th e prednisolone group does invite considerations about using higher doses.