Background/Purpose
Polymyalgia rheumatica (PMR) is a chronic inflammatory disorder of the elderly, characterised by morning stiffness, pain and aching in the hip and shoulder girdles and acute phase reactants increase. The response to low-dose prednisone (Pd) is marked and fast on both Patient Reported Outcomes (PROs) and acute phase reactants, but most patients require a treatment course of 1–3 years. A new modified-release delivery system Prednisone adapts the release of the administered glucocorticoid to the circadian rhythms and proved to be useful for morning stiffness, fatigue and disease activity control in Rheumatoid Arthritis. We compared Prednisone (Pd) to modified release Prednisone (MR-Pd) on PROs and acute phase reactants in Polymyalgia Rheumatica.
Methods
We studied 15 patients (5 men, mean age 70 years, SD 8.25) with newly diagnosed PMR and previously untreated. They received the same tapering dose of prednisone starting from 15 mg: 8 patients received a MR-Pd tablet, and 7 a Pd tablet. We observed no drop-outs but only ten patients have completed the 16-week assessment period by now (3 men, mean age 72 years, SD 5.48). CRP/ESR, VAS for stiffness duration/intensity and fatigue and HAQ-DI (PROs) were obtained at baseline and at week 4 and 16. We used Standardized Response Means (SRM), a measure of responsiveness, to evaluate acute phase response and clinical parameters improvement at week 4 and 16.
Results
The mean relative changes of the CRP/ESR and PROs from baseline to 4th and 16th week were not statistically different between Pd and MR-Pd (p > 0.05), confirming their same efficacy at the same dosage. We noticed that after 4 weeks CRP, fatigue, stiffness duration and HAQ assessment showed a better response in the group treated with modified release CS (CRP SRM 1.03-0.71, fatigue SRM 1.25-0.80; stiffness duration 1.40–0.40, HAQ SRM 1.74-1.10 for modified and immediate release Prednisone respectively). However at week 16 there were no significantly differences between CRP and HAQ (SRM 0.56 – 0.67 and 1.83 – 1.82 respectively), whereas fatigue and stiffness duration improved in patients treated with Pd (SRM 1.12- 7.03 and 0.72 – 1.01). Otherwise impact on stiffness intensity was constantly better in patients treated with Pd (after 4 and 16 weeks respectively: SRM 1.70-1.15 and 4.19-1.16).
Conclusion
Modified-Release Prednisone and Prednisone showed the same overall efficacy on Patient Reported Outcomes and acute phase reactants in patients with PMR, but with different timings and impacts on various disease aspects.
Disclosure:
M. Betelli,
None;
G. Erba,
None;
M. Ricci,
None;
C. Valena,
None;
E. Allevi,
None;
M. Riva,
None;
G. Grosso,
None;
S. Barbarossa,
None;
F. Bonomi,
None;
M. R. Pozzi,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patient-reported-outcomes-and-acute-phase-reactants-in-polymyalgia-rheumatica-in-patients-treated-with-prednisone-versus-modified-release-prednisone/