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Cutolo M, Hopp M, Liebscher S, et al. Modified-release prednisone for polymyalgia rheumatica: a multicentre, randomised, active-controlled, double-blind, parallel-group study. RMD Open. 2017;3(1):e000426doi: 10.1136/rmdopen-2016-000426.
Cutolo, M., Hopp, M., Liebscher, S., Dasgupta, B., & Buttgereit, F. (2017). Modified-release prednisone for polymyalgia rheumatica: a multicentre, randomised, active-controlled, double-blind, parallel-group study. RMD open, 3(1), e000426. https://doi.org/10.1136/rmdopen-2016-000426
Cutolo, Maurizio, et al. "Modified-release prednisone for polymyalgia rheumatica: a multicentre, randomised, active-controlled, double-blind, parallel-group study." RMD open vol. 3,1 (2017): e000426. doi: https://doi.org/10.1136/rmdopen-2016-000426
Cutolo M, Hopp M, Liebscher S, Dasgupta B, Buttgereit F. Modified-release prednisone for polymyalgia rheumatica: a multicentre, randomised, active-controlled, double-blind, parallel-group study. RMD Open. 2017 Mar 17;3(1):e000426. doi: 10.1136/rmdopen-2016-000426. eCollection 2017. PMID: 28405475; PMCID: PMC5372105.
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RMD Open. 2017 Mar 17;3(1):e000426. doi: 10.1136/rmdopen-2016-000426. eCollection 2017.

Modified-release prednisone for polymyalgia rheumatica: a multicentre, randomised, active-controlled, double-blind, parallel-group study.

RMD open

Maurizio Cutolo, Michael Hopp, Stefan Liebscher, Bhaskar Dasgupta, Frank Buttgereit

Affiliations

  1. Research Laboratories and Academic Division of Clinical Rheumatology , University of Genova , Genova , Italy.
  2. Mundipharma Research GmbH & Co. KG , Limburg, Hessen , Germany.
  3. Department of Rheumatology , Southend University Hospital , Westcliff-on-Sea , UK.
  4. Department of Rheumatology and Clinical Immunology , Charité University Medicine , Berlin , Germany.

PMID: 28405475 PMCID: PMC5372105 DOI: 10.1136/rmdopen-2016-000426

Abstract

OBJECTIVE: To assess the efficacy and safety of modified-release (MR) versus immediate-release (IR) prednisone in newly diagnosed glucocorticoid (GC)-naïve patients with polymyalgia rheumatica (PMR).

METHODS: Patients were randomised to double-blind MR prednisone (taken at approximately 22:00) or IR prednisone (taken in the morning), 15 mg/day for 4 weeks. The primary end point was complete response rate (≥70% reduction in PMR visual analogue scale, duration of morning stiffness and C reactive protein (CRP) (or CRP <2× upper limit of normal (ULN))) at week 4. Non-inferiority was decided if the lower 95% confidence limit (MR vs IR prednisone) was above -15%. 400 patients were planned but only 62 were enrolled due to difficulties in recruiting GC-naïve patients with PMR with CRP ≥2×ULN.

RESULTS: The percentage of complete responders at week 4 was numerically greater for MR prednisone (53.8%) than for IR prednisone (40.9%). Non-inferiority of MR versus IR prednisone was not proven in the primary analysis on the per protocol population (N=48; treatment difference: 12.22%; 95% CI -15.82% to 40.25%). However, sensitivity analysis on the full analysis population showed an evident trend favouring MR prednisone (N=62; treatment difference: 15.56%; 95% CI -9.16% to 40.28%). Adverse events were generally mild and transient with no unexpected safety observations.

CONCLUSIONS: The study showed a clear trend for favourable short-term efficacy of MR prednisone versus IR prednisone in early treatment of PMR. Further studies are warranted.

TRIAL REGISTRATION NUMBER: EudraCT number 2011-002353-57; Results.

Keywords: Autoimmune Diseases; Corticosteroids; Inflammation; Polymyalgia Rheumatica; Treatment

Conflict of interest statement

Competing interests: MC received grant/research support from Horizon Pharma, is a consultant for Mundipharma International and is on the speaker’s bureau for Mundipharma International. MH is an employ

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