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AB0610 Mid-term efficacy of modified-release prednisone in glucocorticoids-naive patients with rheumatoid arthritis (RA)
  1. S. Stisi1,
  2. R. De Luca Bossa2,
  3. G. Ciano3,
  4. A. Marsico4,
  5. C. Venditti1,
  6. C. Marcassa5
  1. 1Medical Sciences, Rheumatology Division, Gaetano Rummo Hospital - Benevento, Benevento
  2. 2Asl Sa1, Laurito
  3. 3Medical Sciences, Division of Internal Medicine, Ariano Irpino
  4. 4Rheumatology Unit, Taranto
  5. 5Cardiology, S. Maugeri Fnd, IRCCS, Veruno, Italy


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.

  1. Buttgereit et al. Lancet, 2008.

Disclosure of Interest None Declared

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