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Related Experiment Videos

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

Maurizio Cutolo1, Michael Hopp2, Stefan Liebscher2

  • 1Research Laboratories and Academic Division of Clinical Rheumatology , University of Genova , Genova , Italy.

RMD Open
|April 14, 2017
PubMed
Summary

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This summary is machine-generated.

Modified-release prednisone showed a favorable trend for treating polymyalgia rheumatica (PMR) compared to immediate-release prednisone. Further research is needed to confirm the efficacy of modified-release prednisone for early PMR treatment.

Area of Science:

  • Rheumatology
  • Pharmacology
  • Clinical Trial Research

Background:

  • Polymyalgia rheumatica (PMR) is an inflammatory condition affecting older adults.
  • Glucocorticoids (GCs) are the standard treatment for PMR.
  • Optimizing GC delivery for improved efficacy and safety is an ongoing area of research.

Purpose of the Study:

  • To compare the efficacy and safety of modified-release (MR) prednisone versus immediate-release (IR) prednisone in newly diagnosed, glucocorticoid (GC)-naïve patients with polymyalgia rheumatica (PMR).
  • To evaluate if MR prednisone offers a therapeutic advantage over IR prednisone in the initial management of PMR.

Main Methods:

  • A double-blind, randomized trial involving 62 GC-naïve PMR patients.
  • Patients received either MR prednisone (taken at 22:00) or IR prednisone (taken in the morning) at 15 mg/day for 4 weeks.
Keywords:
Autoimmune DiseasesCorticosteroidsInflammationPolymyalgia RheumaticaTreatment

Related Experiment Videos

  • The primary endpoint was the complete response rate at week 4, defined by reductions in PMR visual analogue scale, morning stiffness, and C-reactive protein (CRP).

    • Main Results:

    • The complete response rate at week 4 was numerically higher for MR prednisone (53.8%) than for IR prednisone (40.9%).
    • Non-inferiority of MR versus IR prednisone was not statistically proven in the primary analysis.
    • Sensitivity analysis indicated a trend favoring MR prednisone, with generally mild and transient adverse events.

    Conclusions:

    • The study suggests a trend towards favorable short-term efficacy of MR prednisone compared to IR prednisone in the early treatment of PMR.
    • Further clinical studies are warranted to confirm these findings and explore the role of MR prednisone in PMR management.