Background Exogenous glucocorticoids (GC) added to DMARDs are effective in the treatment of RA. Timing of GC administration can improve the treatment; in particular, modified -release prednisone (MR-P, given at bedtime and released 4 h after ingestion) has been shown to improve RA management, reducing morning stiffness (MS) and interleukin-6 levels when compared to conventional, immediate-release prednisone; the improvement has been preliminary shown sustained for at least 12 months.
Objectives We investigated the mid-term efficacy of MR-P chronotherapy for up to 4 months in unselected outpatients with active RA and inadequate response to DMARDs.
Methods 70 consecutive patients with documented RA (average duration 109 months) and on active treatment with DMARDs and/or biologic agents referring from February 1st to April 30th 2011 at physicians discretion started low-dose P-MR and were followed bimonthly for 16 weeks. Clinical markers considered at first (T1) and T2-T3 follow-up visits included morning stiffness (min), patient- and physician global assessment (GA, 0–10 scale) and DAS 28 score. Temporal differences were analysed by variance analysis for repeated measures (ANOVA).
Results Mean patients’ age was 55±15 (females 79%); 67.8% of patients were assuming methotrexate, 16.9%, leflunomide, 30.5% were assuming other DMARDs also in combination, and 32.2% were on biologics. During the follow-up, MR-P was well tolerated, only 1 patient dropped out prematurely switching to another GC; 3 (6.3%) other patients started ex-novo biologics. Among the 69 patients (98.4%) who completed the 4-month survey on MR-P, morning stiffness decreased from 65±43 min at the first visit (T1) to 30±24 min at the final T3 visit (p<0.0001); patient- and physician- global assessment improved from 6.4±2.2 to 4.1±2.1 and from 5.9±2.3 to 3.8±2.1, respectively (both p<0.001). DAS28 score decreased from 4.62±1.1 at T1 to 3.6±1.0 at T3 (p<0.001). Daily MR-P starting dosage was 7.5±4.8 mg and decreased to 6.7±3.9 at T3 visit (p<0.001). Daily assumption of analgesics and/or NSAIDs decreased from 35.3% to 5.1% (p 0.001).
Conclusions In unselected RA patients on active antirheumatic treatment, modified-release prednisone (given at bedtime) induced a substantial benefit over a medium-term observation and was well tolerated.
Buttgereit et al. Lancet, 2008.
Disclosure of Interest None Declared