Intensive Ergocalciferol Supplementation May Be Indicated for Patients With RA

Alice Goodman

June 22, 2010

June 22, 2010 (Rome, Italy) — Vitamin D deficiency is common in rheumatoid (RA) and other forms of arthritis, and the recommended daily dose of vitamin D did not normalize levels in patients with RA who had deficient levels of vitamin D, according to one study presented here at the European League Against Rheumatism (EULAR) Congress 2010.

Another study presented here found that intensive vitamin D therapy with ergocalciferol (Deltalin, Eli Lilly) could normalize vitamin D levels in most patients with RA, but levels fell below normal in a substantial percentage of patients after resumption of standard maintenance therapy with lower doses.

In the first study, a retrospective review conducted in Italy, 100 patients — 43 with inflammatory autoimmune disease (RA, spondyloarthritis, and connective tissue disease) and 57 with nonautoimmune inflammatory disease (osteoarthritis and osteoporosis) — received daily supplementation with cholecalciferol 800 to 1000 IU for 6 months.

After treatment, only 29% of patients had levels of vitamin D considered to be "normal" in healthy subjects, reported lead investigator Pier Paolo Sainaghi, MD, from the Immuno-Rheumatology Clinic at A. Avogadro University of Eastern Piedmont in Novara, Italy. No significant difference in levels was seen between patients with inflammatory and those with noninflammatory autoimmune disease.

"Vitamin D deficiency is often seen in patients with inflammatory autoimmune diseases, but the effects of supplementation have not been fully studied," said Dr. Sainaghi. "Our study showed that daily standard supplementation is not sufficient to normalize vitamin D levels in patients with rheumatologic or bone conditions. It seems that we need a higher dose to correct this deficiency."

Preliminary results of a placebo-controlled randomized study presented here suggest that Dr. Sainaghi and colleagues are correct. This study focused on the effect of intensive vitamin D therapy with ergocalciferol in RA patients with deficient levels of vitamin D.

"About 60% of RA patients in our clinic are vitamin D–deficient, and this has been replicated by others," said Uzma Jalal Haque, MD, from Johns Hopkins University in Baltimore, Maryland, who is lead author of the second study.

Dr. Haque presented a preliminary analysis of 89 RA patients seen at the Johns Hopkins clinic from January to November 2009. The cutoff level used for vitamin D deficiency was a 25-hydroxy vitamin D (25[OH]D) level below 30 ng/mL, which is standard in the United States, she said.

Patients with deficient levels of vitamin D were randomized to receive ergocalciferol 50,000 IU per week or placebo for 8 weeks. All patients — those in the ergocalciferol group and those in the placebo group — were then put on maintenance therapy with ergocalciferol 50 IU per month for 16 weeks.

After 8 weeks of active intensive vitamin D therapy, Dr. Haque reported that 25(OH)D levels doubled, from a mean of 22.9 ng/mL at baseline to a mean of 41.7 ng/mL. No change was seen in the placebo group.

After 16 weeks of maintenance therapy, vitamin D levels declined to a mean of 26 ng/mL in patients who had been in the ergocalciferol group and did not normalize in those who had been in the placebo group, suggesting that higher doses are needed continuously to maintain sufficient vitamin D levels in RA patients.

"Our preliminary results suggest that standard maintenance therapy for vitamin D deficiency may not be adequate in patients with RA," Dr. Haque observed.

Commenting on vitamin D deficiency in patients with arthritis, Silvano Adami, MD, from the University of Verona in Italy, said that vitamin D deficiency is quite common in arthritis patients, even those on vitamin D supplementation.

"We need to study higher levels of vitamin D supplementation. But we still don't know whether arthritic disease leads to vitamin D deficiency, or [whether it is] the other way around. That is the main question we need to answer," Dr. Adami told meeting attendees.

Dr. Haque, Dr. Sainaghi, and Dr. Adami have disclosed no relevant financial relationships.

European League Against Rheumatism (EULAR) Congress 2010. Abstracts SAT0506 and OP0011. Presented June 19, 2010.


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