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Rheumatology Advance Access originally published online on March 23, 2007
Rheumatology 2007 46(6):994-998; doi:10.1093/rheumatology/kem030
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© The Author 2007. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Compared clinical efficacy and bone metabolic effects of low-dose deflazacort and methyl prednisolone in male inflammatory arthropathies: a 12-month open randomized pilot study

G. Saviola, L. Abdi. Ali, S. Shams. Eddin, A. Coppini1, F. Cavalieri2, L. Campostrini3, S. Sacco3, M. Bucci4, G. Cirino4 and M. Rossini5

Salvatore Maugeri Foundation IRCCS, Rheumatology and Rehabilitation Unit, 1Medical Advisor, Florence and 2C. Poma Hospital, Rehabilitation Centre of Bozzolo, Mantua3Laboratory of Clinical Biochemistry, Castel Goffredo, Mantua4Department of Experimental Pharmacology, Federico II University, Naples5Rheumatology Unit, University of Verona. Italy

Correspondence to: G. Saviola, Rheumatology and Rehabilitation Unit, Salvatore Maugeri Foundation IRCCS, 46042 Castel Goffredo, Mantua, Italy. E-mail: gsaviola{at}fsm.it


   Abstract

Objective. To evaluate: (i) a correct equivalence ratio of clinical efficacy between low-dose deflazacort (DFZ) and methyl prednisolone (MP); and (ii) bone metabolic effects of low-dose DFZ and MP in the treatment of male RA and PsA.

Methods. A total of 21 male patients with active RA or PsA, naive to steroid treatment were chosen for the study. Group I: 10 patients treated for 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD. Group II: 11 patients treated for 6 months with MP 4 mg, calcium, cholecalciferol and a DMARD; for the following 6 months with DFZ 7.5 mg, calcium, cholecalciferol and a DMARD. At day 0, 90, 180, 240 and 360 evaluation of ACR improvement criteria; a blood sample for total and bone-specific ALP, calcium, phosphorus, PTH, SHBG, estradiol, ACTH, osteocalcin, LH, OPG; a sample of urine for calcium, phosphorus, creatinine and DPD.

Results. 13/21 patients (6/10 Group I; 7/11 Group II) reached ACR 20 at 6 months; 14/21 (7/10 Group I, 7/10 Group II) at 12 months. Only at the third month we observed in Group II vs Group I a reduction of OPG (24% vs 6%, P = n.s.); ALP (P < 0.001) and osteocalcin (P = 0.006) decreased in both groups from the third month; DPD decreased in both groups only from the sixth month (P = 0.002).

Conclusions. The correct equivalence ratio of DFZ to MP is 1.875:1, and of DFZ to prednisolone 1.5:1. We found a relative prevalence of bone resorption compared to bone formation in the first 6 months of treatment. The trend of OPG requires further investigation.

KEY WORDS: Deflazacort, Methylprednisolone, Rheumatoid arthritis, Psoriatic arthritis, Glucocorticoid-induced osteoporosis, Osteoprotegerin

Submitted 4 August 2006; revised version accepted 16 January 2007.
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