The results of a randomized controlled trial presented today at the Annual European Congress of Rheumatology (EULAR 2019) demonstrate high levels of treatment success in approximately two thirds of patients despite tapered glucocorticoid (GC) discontinuation, while a small loss of disease control was observed at the total study population level.
On the basis of our results, we believe that all patients achieving low disease activity or remission with tocilizumab should be offered glucocorticoid tapering,"
Professor Gerd R. Burmester, Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Germany
Results demonstrate, after 24 weeks, a small but significant difference in disease activity following GC tapering with a between arm difference of 0.6 DAS28-ESR units (95% confidence interval (CI):0.3-0.9; p<0.001). However, most patients in both arms achieved treatment success at the end of the study (77% of continued GC and 65% of GC taper, p=0.021). Flares were experienced in 26% of GC taper patients and 11% of those on continued GC, although only one patient in the study (continued GC group) discontinued blinded treatment due to insufficient flare control. Serious adverse events (no deaths) were reported for 5% of the continued GC group and 3% of the GC taper group. No patients had symptomatic adrenal insufficiency.
"The risk to benefit profile of glucocorticoid therapy in rheumatoid arthritis is very controversial," said Professor John D. Isaacs, Chairperson of the Abstract Selection Committee, EULAR. "We welcome these data to inform our understanding in this area and ultimately the better management of patients suffering with this disease."
Rheumatoid arthritis is a chronic inflammatory disease that affects the joints, causing pain and disability. It can also affect internal organs. The efficacy of GC therapy in these patients is well established. However, it is recommended that it should be gradually reduced and ultimately stopped, ideally within three to six months. This is due to many potential risks including osteoporosis, infections, diabetes, and cardiovascular disease.
The study included 259 patients with rheumatoid arthritis taking GC therapy (prednisone 5mg/day) as well tocilizumab with or without a conventional synthetic disease modifying anti-rheumatic drug (csDMARD) for 24 weeks or more. At randomization, they had to be in remission or have low disease activity (DAS28-ESR<3.2) for at least four weeks. They were randomized to continue the prednisone 5mg/day or undergo blinded tapering (from 4mg/day with a 1mg reduction every 4 weeks to 0mg/day at weeks 16-24) whilst receiving stable tocilizumab and csDMARD doses. Patients who had a flare were given open-label rescue prednisone at 5mg for two weeks and continued blinded treatment.
European League Against Rheumatism