Low-dose oral prednisone improves clinical and ultrasonographic remission rates in early rheumatoid arthritis. Results of a 12 month open-label randomized study.

Abstract

IntroductionIn early rheumatoid arthritis (RA), low-dose oral prednisone (PDN) co-medication yields better clinical results than monotherapy with disease-modifying anti-rheumatic drugs (DMARDs). In addition, ultrasonography (US) evaluation reveals rapid and significant effects of glucocorticosteroids on subclinical synovitis. No data currently exist that examine the clinical and US results offered by glucocorticoid co-medication over DMARD monotherapy in early RA patients.MethodsTwo hundred and twenty patients with early RA (< 1 year from clinical onset) were treated according to a low disease activity (LDA) targeted step-up protocol including methotrexate (MTX) and, in the active treatment arm, low-dose (6.25 mg/day) oral PDN over 12 months. Clinical disease activity measures were collected at baseline, 2, 4, 6, 9 and 12 months, and US examination of hands was performed at baseline, 6 and 12 months. Grey-scale and power Doppler (PD) synovitis were scored (0 to 3) for each joint. At 12 months, clinical remission according to the disease activity score among 28 joints was defined as the clinical outcome, and a total joint PD score of 0 (PD negativity) as the imaging outcome.ResultsEach group included 110 patients with comparable demographic, clinical, laboratory and US characteristics. At 12 months, the LDA rate was similar in the two groups, whilst the clinical remission rate (risk ratio = 1.61 (95% confidence interval = 1.08, 2.04)) and PD negativity rate (risk ratio = 1.31 (95% confidence interval = 1.04, 1.64)) were significantly higher in the MTX+PDN group.ConclusionIn early RA, despite a similar response rate in terms of LDA, low-dose oral PDN co-medication led to a higher proportion of clinical remission and PD negativity compared with MTX monotherapy, thus ensuring a better disease activity control.Trial registration numberCurrent Controlled Trials ISRCTN2486111

New Guidelines for the Management of Rheumatoid Arthritis (Eular, 2013): The Place of Glucocorticoids

“…[46] вошли 220 пациентов с ранним РА (длительность <1 года), кото-рые были разделены на две группы: 110 пациентов полу-чали монотерапию МТ и 110 пациентов -МТ (макси-мально 25 мг/нед) в сочетании с низкими дозами ПРЕД (12,5 мг/сут в течение 2 нед, а затем 6 мг/сут). Через 12 мес низкая активность заболевания в целом по группе имела место у 77,9% пациентов, независимо от применения ПРЕД: у 75,5% пациентов на монотерапии МТ и у 80,2% пациентов на фоне комбинированной терапии МТ и ПРЕД (p=0,44).…”

New Recommendations for the Management of Rheumatoid Arthritis (Eular, 2013): The Role of Methotrexate

“…[39] во шло 220 па ци ен тов с ран ним РА (дли тель ность <1 го да), ко то-рые бы ли раз де ле ны на две груп пы: 110 па ци ен тов по лу ча-ли мо но те ра пию МТ, еще 110 па ци ен тов -МТ (ма к си-маль но 25 мг/нед) в со че та нии с низ ки ми до за ми ПРЕД (12,5 мг/сут в те че ние 2 нед, а за тем 6 мг/сут). Че рез 12 мес 14 Н о в ы е р е к о м е н д а ц и и…”

Systematic review of 2008-2012 literature and update of recommendations for the use of methotrexate in rheumatic diseases, with a focus on rheumatoid arthritis

“…The evidence currently available, obtained from one meta-analysis and one doubleblind controlled RCT conducted on a cohort of patients with early RA, shows that, in the context of an MTX-based therapeutic strategy (titrating MTX to the maximum tolerated dose and in any case to not more than 25 mg/week until remission is achieved), the addition of a low-dose steroid improves outcomes, in terms of reduced radiographic progression and/or lower disease activity and less disability (38)(39)(40)(41)(42). The recommendation was approved by 94.4% of participants.…”