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OP0206 Efficacy of modified-release prednisone in patients with rheumatoid arthritis (RA) chronically treated with standard glucocorticoids: An italian multicenter survey
  1. L. Iaccarino1,
  2. I. Farina2,
  3. A. Sulli3,
  4. A. Bortoluzzi2,
  5. C. Marcassa4,
  6. A. Doria1,
  7. M. Govoni2,
  8. M. Cutolo3
  1. 1Division of Rheumatology, University of Padova, Padova
  2. 2Rheumatology Unit, University of Ferrara, Ferrara
  3. 3Research Laboratory and Academic Rheumatology, University of Genova, Genova
  4. 4Fondazione Maugeri IRCCS, Veruno (NO), Italy

Abstract

Background Recent studies documented the additional disease-modifying potential of low-dose glucocorticoids (GC) when added to DMARDs in the treatment of RA. Modified-release prednisone (P-MR, taken at bedtime and released 4 h after ingestion) was recently found superior to standard immediate-release GC in reducing morning stiffness and IL-6 plasma levels in a 12-week randomised double-blind trial.

Objectives We assessed the efficacy of P-MR under real-life conditions in a large cohort of RA outpatients already on active treatment with GC.

Methods 1928 consecutive outpatients with documented RA (average duration 76.7 months) treated with oral standard prednisone (SP) or methyl-prednisolone (MP) and referring to 100 rheumatologists from February 1st to April 30th 2011 were considered. Of them, 950 subjects (513 on SP, average dose 9.4±5.4 mg; 437 on MP, average dose 6.7±3.7 mg) were switched at physicians discretion to low-dose P-MR at corresponding dosage and followed bimonthly for 16 weeks. Clinical markers considered at first (T1) and T2-T3 follow-up visits included morning stiffness (min), pain severity (NRS, 0-10 scale), patient- and physician global assessment (GA, 0–10 scale) and DAS 28 score. Differences between/within groups were analysed by variance analysis for repeated measures (ANOVA).

Results Mean patients’ age was 57±13 (females 75%, bone erosions present in 55%); 83.7% were assuming methotrexate, 10.5%, leflunomide, 12.2% other DMARDs, and 15.8% were on biologics. During the follow-up, MR-P was well tolerated, 6 pts (0.6%) stopped itand 24 others downgraded to their previous GC. Among the 920 patients (96.8%) who completed the 4-month survey on MR-P, morning stiffness decreased from 58±37 min at the first visit (T1) to 32±24 min at the final T3 visit (p<0.001); pain intensity was reduced from 5.4±1.8 to 3.5±1.4 (p<0.001), patient- and physician- global assessment improved from 5.4±1.7 to 3.5±1.4 and from 5.1±1.7 to 3.3±1.4, respectively (p<0.001). DAS28 score decreased from 4.2±1.4 to 3.3±1.2 (p<0.001). Mean MR-P daily dosage was 8.2 mg at T1 and 6.7 at T3 visit. During follow-up, 33/800 (4.1%) biologics-naïve patients started them. Differences between patients who switched from MP or SP were:

Conclusions In unselected RA patients chronically treated with standard GC, modified-release prednisone (given at bedtime) induced a significant improvement over a medium-term observation, particularly in those patients who switched from methyl-prednisolone.

  1. Buttgereit F et al, Lancet 2008;371: 205–214.

Disclosure of Interest None Declared

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