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Abstract
Background and aims Deflazacort (DFZ), oxazoline prednisolone (PDN) derivative, has dose equivalence of 1.2:1 (mg) to PDN. No study has compared adverse effects and efficacy of high doses of DFZ and PDN, in SLE.
Aims-To compare adverse effects of high dose DFZ and PDN in SLE patients concerning cushingoid features and body weight changes, 3 and 6 months after initiation.
Methods (Figure 1)
Showing the study design.
Outcome parameters for a)Cushingoid features assessed using Cushing’s Severity Index (CSI) b) Hirsuitism with Ferriman Gallaway score c) Weight gain assessed by difference (Δ) of weight (kilograms) during 3 visits. Significant adverse event (SAE) was defined as a)10% increment in weight b)20% increase in scores for hirsuitism and cushing’s indices
Results Number of SAEs (mean±SD) in DFZ group were 5.9±6 and 4.8±3.7 as compared to 14.1±7.7 and 9.4±5.5 events in PDN group (p<0.001) at 3 and 6 months respectively. By multiple regression analysis, adjusting for dose and duration of prior steroid intake, PDN group had 6.7 more SAEs (95% CI: 2.5–10.9) at 3 months and 4.2 more events (95% CI: 1.3–7.2) at 6 months, compared to DFZ group (p-0.01,0.03). There was no significant difference by generalised estimation equation between the groups w.r.t changes in SLEDAI, Renal SLEDAI, Anti dsDNA and C3/C4 levels. There were 2 serious infections (needing hospitalisation/IV antibiotics) in PDN group while none in DFZ group (Tables 1 and 2).
Showing comparison of baseline parameters in both treatment groups.
Showing Δ Changes for Outcome parameters concerning Primary Objectives (in terms absolute and percentege change) from baseline to the follow up visits.
Conclusions DFZ and PDN used in comparable manner in SLE had similar efficacy with significantly lesser weight gain, lesser cushingoid features ( including lesser glycaemic elevation) seen in DFZ group.