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

• Published in: Rheumatology (Oxford, England) Vol. 46; no. 6; pp. 994 - 998
• Main Authors: Saviola, G., Abdi. Ali, L., Shams. Eddin, S., Coppini, A., Cavalieri, F., Campostrini, L., Sacco, S., Bucci, M., Cirino, G., Rossini, M.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.06.2007; Oxford Publishing Limited (England)
• Subjects: Adult; Aged; Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents - therapeutic use; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Psoriatic - drug therapy; Arthritis, Rheumatoid - drug therapy; Biological and medical sciences; Cross-Over Studies; Diseases of the osteoarticular system; Drug Administration Schedule; Drug Therapy, Combination; Glucocorticoids - adverse effects; Glucocorticoids - therapeutic use; Humans; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; Inflammatory joint diseases; Male; Medical sciences; Methylprednisolone - adverse effects; Methylprednisolone - therapeutic use; Middle Aged; Miscellaneous. Osteoarticular involvement in other diseases; Osteoporosis - chemically induced; Osteoporosis. Osteomalacia. Paget disease; Pilot Projects; Pregnenediones - adverse effects; Pregnenediones - therapeutic use; Severity of Illness Index; Treatment Outcome; Alps; Europe; Glucocorticoid-induced osteoporosis; Deflazacort; Methylprednisolone; Rheumatoid arthritis; Psoriatic arthritis; Osteoprotegerin; Antineoplastic agent; Skin disease; Calcium; Estrogen; Diseases of the osteoarticular system; Vitamin; Autoimmune disease; Male; Inflammatory joint disease; Inorganic element; Estradiol; Glucocorticoid; Spondylarthropathy; Osteoporosis; Prednisolone; Colecalciferol; Corticosteroid; Immunopathology; Psoriasis; Steroid hormone; Low dose; Antiinflammatory agent; Chronic; Treatment; Adrenal hormone; Arthropathy; Immunosuppressive agent; Bone
• ISSN: 1462-0324; 1462-0332
• DOI: 10.1093/rheumatology/kem030

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.