Head to head comparison of adverse effects and efficacy between high dose deflazacort and high dose prednisolone in systemic lupus erythematosus: a prospective cohort study.

Abstract

Deflazacort (DFZ), an oxazoline derivative of prednisolone (PDN), has a dose equivalence of 1.2:1 (mg) to PDN. No study to date has compared adverse effects and efficacy of high doses of DFZ as against high-dose PDN in systemic lupus erythematosus (SLE). To compare adverse effects of high dose DFZ and PDN in SLE patients, especially in terms of cushingoid features and gain in body weight, 3 and 6 months after initiation of these agents. In both the steroid arms, the following outcome parameters were assessed at 3 and 6 months: (a) cushingoid features by Cushing's Severity Index (CSI) (b) hirsutism by modified Ferriman Gallwey score (c) weight gain by difference (Δ, delta) of weight (in kilograms). Patients on PDN had 1.6 kg (3.2%) and 2 kg (5.1%) higher median weight gain as compared to those on DFZ at 3 and 6 months respectively ( p = 0.012 and 0.001). PDN caused 10% and 22.2% higher increment in median hirsutism scores as compared to DFZ at 3 months and 6 months follow-up, respectively ( p = 0.004 and 0.002). PDN caused 100% higher increase in median CSI scores than DFZ at 6 months ( p = 0.03). There was no significant difference by generalized estimation equation between the groups with respect to changes in SLEDAI, renal SLEDAI, anti-dsDNA titres and C3/C4 levels. There were two serious infections (requiring hospitalization/intravenous antibiotics) in the PDN group, while none in the DFZ group. Comparable intake and tapering of high dose DFZ and PDN in active SLE revealed 2-fold less weight gain, 2.5-fold less hirsutism and 1.5-fold lower cushingoid severity index as well as lower glycaemic elevation in the DFZ group as compared to PDN group. Both had similar efficacy.