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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.
- Polymyalgia Rheumatica
- Corticosteroids
- Autoimmune Diseases
- Inflammation
- Treatment
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Footnotes
BD and FB share senior authorship.
Contributors MC, MH, BD and FB were involved in the development of study protocol. MC, BD and FB were involved in patient recruitment and data acquisition. SL was involved in data analysis. MC, MH, SL, BD and FB were involved in manuscript preparation and approved the final version of the manuscript.
Funding The investigation was supported by Mundipharma Research Limited.
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 employee of Mundipharma Research GmbH & Co. KG. SL is an employee of Mundipharma Research GmbH & Co. KG. BD received grant/research support from NAPP Pharmaceuticals, and is a consultant for Servier, Roche, Merck, GSK & Mundipharma. FB received grant/research support from Horizon Pharma, is a consultant for Mundipharma International and Horizon Pharma, and is on the speaker’s bureau for Mundipharma International and Horizon Pharma.
Ethics approval The Independent Ethics Committee of each centre reviewed and approved the protocol, and written informed consent was obtained from all patients before enrolment.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.