AB0482 A Prospective Study in Premenopausal Women with Systemic Lupus Erythematosus Supplemented with Two Different Regimens of Vitamin D: Efficacy and Safety at Twelve Months of Follow Up

Background Systemic Lupus Erythematosus (SLE) patients (pts) are at risk for low vitamin D (VitD) levels because of lack of sun exposure. The current strategies of VitD supplementation given to patients with SLEdo not seem to be sufficient not only for the prophylaxis of osteoporosis, but perhaps also to bring out the immunomodulatory effects of VitD that were highlighted by some studies in vitro. At the present time little data obtained from prospective studies are available relating to a supplementation with VitD in SLE pts. Objectives To evaluate at 6 months of follow-up (T6) the efficacy, safety and the effects on SLE disease activity of a oral Cholecalcipherolsupplementation given with 2 different regimens in a cohort of SLE pts Methods 34 premenopausal SLE female pts were enrolled: 85% Caucasian, mean age 32.5 (range 19-44) and with a mean follow-up of 8 years. A group of 17 pts(group S) were allocated to “standard” regimen of supplementation (Cholecalcipherol 25.000UI once/month). The other 17pts (group I) were given an “intensive” regimen (Cholecalcipherol 300.000UI bolus, then 50.000UI once/month). The circulating levels of 25-OH VitD were dosed with a chemiluminescence assay kindly performed by the manufacturer (DiaSorin S.p.A., Italy). Results At baseline (T0) there was no significant difference in VitD levels in the 2 groups. At T6 “group I” showed significantly higher VitD levels (median 31.1vs22.6 p=0,0012). There were no significant differences upon season of enrollment. By calculating the difference in VitD levels between T0 and T6, increased levels of vitD occurred in 3 patients in group S (17,6%) and 7 pts in I (41,1%). Eleven pts in group I (64,7%) had VitD levels >30 ng/ml at T6 while only 3 pts in group S (17,6%) reached these levels. There were no significant changes in thelevels ofserumcalcium, phosphorus and PTH between T0 and T6. In particular, at T6 there were no significant differences in PTH levels between the 2 different regimes of supplementation. The patients entering the study were in complete clinical remission (median SLEDAI: 2;median ECLAM:1) even if they displayed a serological activity characterized by anti ds-DNA antibodies (55%) and by decreased CH50, C3, C4 levels (38 %, 50%, 38%). No statistically significant variation in the titers of anti ds-DNA and in the levels of C3, C4, CH50 was observed at T6 in both groups. Conclusions Intensive supplementation with VitD has a safety profile comparable to the standard regimen and can reach levels of sufficiency in a larger number of pts. As already reported in SLE patients during clinical remission, in our experience VitD supplementation does not improve serological parameters at T6. However a longer follow-up may be needed to clarify whether the I regimen of VitD may have grater immunomodulatory effects than the S regimen. References Mora JR, et al. Nat Rev Immunol 2008;8:685-98; Cutolo M, Vitam Horm. 2011;86:327-51;C. Aranow, at al. US Interferon Signature Trial (ACR 2012, abstracts #2619, 2687) Disclosure of Interest None Declared