American College of Rheumatology Annual Meeting

American College of Rheumatology Annual Meeting

Source:

Costenbader K. Abstract 0957. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).

Disclosures: Costenbader reports research collaborations with the American College of Rheumatology, Amgen, Astra Zeneca, Eli Lilly & Co., Exagen Diagnostics, Merck, Gilead Sciences, GlaxoSmithKline and the Lupus Foundation of America; consulting fees from Neutrolis; research support from the NIH; and trial donation from Pharmavite, Pronova BioPharma/BASF and Quest Diagnostics.
November 08, 2021
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Vitamin D, omega-3 supplements reduced risk for incident autoimmune disease

Source:

Costenbader K. Abstract 0957. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).

Disclosures: Costenbader reports research collaborations with the American College of Rheumatology, Amgen, Astra Zeneca, Eli Lilly & Co., Exagen Diagnostics, Merck, Gilead Sciences, GlaxoSmithKline and the Lupus Foundation of America; consulting fees from Neutrolis; research support from the NIH; and trial donation from Pharmavite, Pronova BioPharma/BASF and Quest Diagnostics.
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Karen Costenbader

The use of vitamin D3 or omega-3 fatty acid supplements over a 5-year period may reduce the incidence of autoimmune disease in older adults by 25% to 30%, according to data presented at ACR Convergence 2021.

“In past ecologic observations, inflammatory bowel disease, multiple sclerosis and type 2 diabetes have been shown to be more prevalent at northern latitudes, where circulating vitamin D levels are lower,” Karen Costenbader, MD, MPH, director of the Lupus Program at Brigham and Women's Hospital, told attendees at the virtual meeting. “Both high plasma 25-OH vitamin D and high residential UV exposure were associated with a decreased risk for rheumatoid arthritis among women in the Nurses’ Health Study in our past work.”

Vitamin D Pills
“The clinical importance of these results is very high given that these are well-tolerated, non-toxic supplements, that there are no other known effective therapies to reduce incidence for autoimmune diseases,” Karen Costenbader, MD, MPH, told attendees. Source: Adobe Stock

“In past observational studies, lower RA risk has been observed in those with increased fatty fish intake,” she added. “In another study, higher [omega-3 (n-3)] fatty acid-to-total lipid proportion in [red blood cell] membranes was associated with a lower prevalence anti-CCP and rheumatoid factor antibodies, and lower progression to inflammatory arthritis among healthy volunteers.”

However, to date, no prospective randomized trials have tested the effects of vitamin D or omega-3 fatty acid supplementation on the incidence of autoimmune diseases over time, Costenbader noted. To examine both for the prevention of autoimmune disease, she and colleagues conducted VITAL, a large, nationwide, randomized, double-blind, placebo-controlled trial. The researchers enrolled a total of 25,871 adults aged 50 years or older, for men, and 55 years or older, for women.

These participants were first randomized 1:1 to receive either 2,000 UI per day of vitamin D3 or placebo, and then, in a two-by-two factorial design, again randomized 1:1 to either 1 mg per day of n-3 fatty acids or placebo. Randomization occurred from November 2011 to March 2014, with treatment continuing through December 2017. Physician-diagnosed autoimmune diseases were reported by participants each year and confirmed via medical records.

The primary endpoint was total incident autoimmune disease, including RA, polymyalgia rheumatica, autoimmune thyroid disease, psoriasis and others. Secondary endpoints included individual most common autoimmune diseases and probable autoimmune disease, defined as evidence of autoimmune disease that nonetheless lacks sufficient medical record data to confirm. The researchers used Cox regression models to calculate hazard ratios of incident autoimmune diseases.

According to the researchers, during a median follow-up of 5.3 years, 117 participants from the vitamin D group were confirmed to have developed an autoimmune disease, compared with 150 in the placebo group (HR = 0.78; 95% CI, 0.61-1). Excluding the first 2 years in pre-specified analyses of the primary endpoint, the hazard ratio for vitamin D3 was 0.61 (95% CI, 0.43-0.86).

Meanwhile, 123 participants in the omega-3 fatty acids group had confirmed autoimmune disease, compared with 144 in the placebo group (HR = 0.85; 95% CI, 0.67-1.09). Excluding the first 2 years, the hazard ratio for the primary endpoint was 0.9 (95% CI, 0.64-1.26).

When analyzed based on factorial design subgroups, hazard ratios for all three active arms compared with placebo/placebo were reduced by 25% to 30%, according to the researchers. In addition, number needed to treat with both supplements for 5 years to prevent one autoimmune disease was 167 (95% CI, 94-769).

“The reduced incidence of RA and polymyalgia rheumatica are very important for rheumatology,” Costenbader said. “The more pronounced effect after 2 to 3 years of use with vitamin D makes sense biologically and supports long-term use. There is an ongoing extension study confirming incident cases in further follow-up. The clinical importance of these results is very high given that these are well-tolerated, non-toxic supplements, that there are no other known effective therapies to reduce incidence for autoimmune diseases.”