05.28.2015

by Diana Swift
Contributing Writer

Cholecalciferol supplementation reduces disease activity and improves fatigue in patients with juvenile-onset systemic lupus erythematosus (JoSLE), a Brazilian study reports online May 18 in Arthritis Care and Research.

In the first study to test supplementation in this population, rheumatologists from the medical faculty at the University of Sao Paulo randomized 45 female JoSLE patients (mean age about 19) to receive oral cholecalciferol 50,000 IU/week (JoSLE-VitD) or placebo (JoSLE-PL). All were being treated during 2012-2013 in the juvenile outpatient clinic of the university hospital and had SLE onset before age 16. Of these 40 were evaluable.

Vitamin D modulates immune cells, and a deficiency of this vitamin has been associated with autoimmune diseases from diabetes and multiple sclerosis to rheumatoid arthritis and SLE. “Moreover, vitamin D deficient SLE patients have higher levels of antids [anti-double strand] DNA antibodies and higher disease activity scores, involving particularly renal and hematological manifestations,” wrote investigators led by Glauce L. Lima, MD.

Medications remained stable throughout the study. Serum levels of 25OHD were measured using radioimmunoassay. Disease activity was assessed using the SLE Disease Activity Index (SLEDAI) and the European Consensus Lupus Activity Measurement(ECLAM). Fatigue was assessed using the Kids Fatigue Severity Scale (K-FSS).

At baseline, groups were similar in age, body mass index, organ involvement, glucocorticoid dose, and use of immunosuppressive drugs, as well as SLEDAI, ECLAM, K-FSS and levels of 25OHD. Compliance was similar in both arms (85% versus 75% (P= .69). After 24 weeks, the mean level of 25OHD was higher in the supplemented arm than in the placebo arm (P<0.001), altering from 19.1 ng/mL and 19.6 ng/mL, respectively, to 31.3 ng/mL and 16.5 ng/mL, respectively. Supplementation produced adequate levels of >30 ng/mL in 70% of treatment patients, while 0% of placebo patients achieved this.

Compliance in the JoSLE-VitD group was similar in patients with normal levels of 25OHD and those with insufficient levels after 24 weeks: 86% versus 83% (P=1.0). Furthermore, at 6 months, proteinuria levels were comparable between patients with 25OHD levels >30 ng/mL and ≤30 ng/mL: 165 (50-1,104) mg/24h versus 325 (40-3,740) mg/24h (P=0.328).

At the end of the intervention, there was a significant improvement in SLEDAI scores over baseline: 6M – Baseline: 0 (-4 to 5) versus 1 (-12 to 6), P=0.011.

There was also a tendency toward improved ECLAM: 0 (-2 to 1) versus 0 (-6 to 3),P=0.006) in JoSLE-VitD patients versus JoSLE-PL patients.

As for domains associated with SLEDAI improvement, in the JoSLE-VitD group, anti-dsDNA became negative in 15% versus in none of the placebo group (P=0.03), with no significant differences for other domains. The apparent reduction of cutaneous involvement in the treatment (5% versus 0%), and the improvement in articular manifestations (5%) versus worsening (10%) in the placebo group did not reach statistical significance.

A reduction in the fatigue related to social life score was found in the intervention group. Treatment patients had a better global fatigue score than the placebo group: 3.15 (1.44) versus 4.30 (1.33), P=0.012. The K-FSS revealed a significant improvement for social life in the JoSLE-VitD group compared with the JoSLE-PL group: -0.95 (1.95) versus 0.60 (1.53),P=0.008]. Moreover, after 24 weeks fatigue scores — including becoming fatigued easily, fatigue during exercise, fatigue due to medium efforts, and fatigue considered a problem — were significantly better in the JoSLE-VitD group than in the JoSLE-PL group (P<0.05)

The authors said cholecalciferol was well tolerated with no serious adverse events in the treatment arm.

Noting that vitamin D supplementation may improve immune modulation in JoSLE, the authors concluded that “a therapeutic intervention may decrease disease activity scores and fatigue” and called for large confirmatory trials.

• Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College and Dorothy Caputo, MA, BSN, RN, Nurse Planner

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