A phospholipid-rich krill oil supplement marketed by Aker BioMarine as Superba Boost helped to increase the omega-3 index among patients with systemic lupus erythematosus, compared to a control group within the first month of supplementation. While no reduction in disease activity was observed among the general group of lupus patients, post-hoc sub-group analysis showed that there was a temporary reduction in disease activity in the participants categorized as having severe lupus, which was defined with a commonly-used measurement tool. These findings were published in Lupus Science & Medicine.
Systemic lupus erythematosus is a chromic, complex autoimmune disease that affects millions of people worldwide. In lupus, the immune system mistakenly recognizes the body’s own cells as foreign and prompts other immune cells to attack and potentially damage organs such as the kidneys, brain, heart, lungs, blood, skin, and joints.
The multicenter, double-blind, placebo-controlled trial was conducted among 78 adult patients with active lupus. Eligible patients were randomized to receive either four grams of krill oil or a placebo daily for the first 24 weeks, and thereafter patients could opt to enter an open-label extension with krill oil supplementation.
The primary endpoint was improvement in red blood cell Omega-3 Index from baseline to week 24. Changes in clinical features including those captured by the commonly-used SLEDAI-2K tool were also monitored.
The Omega-3 Index was consistently low in both test groups, suggesting deficiency in omega-3s among lupus patients. Omega-3 fatty acids have inflammatory-modulating properties and are associated with cardiovascular health benefits.
Treatment with krill oil significantly increased Omega-3 Index within one month, and this improvement was maintained throughout the rest of the 48-week follow-up.
This was notable, as people with lupus are at an elevated risk of cardiovascular complications, the authors noted.
The post-hoc subgroup analysis also showed that disease activity scores during the first 16 weeks of krill oil supplementation decreased among nine lupus patients with higher disease activity at baseline compared to placebo. However, the difference was no longer significant at 24 weeks, warranting further study to understand a potential benefit.
“This clinical study is hopeful for the estimated 5 million people worldwide living with lupus,” said Line Johnsen, SVP of human health ingredients R&D at Aker BioMarine. “We were pleased to work with the Lupus Research Alliance and the clinical affiliate Lupus Therapeutics to conduct the study. We were also pleased to see that in a small subset of study participants with severe lupus, phospholipid-rich krill oil temporarily lessened the severity of symptoms associated with the disease while increasing the Omega-3 Index.”
“Our mission is to improve human health, and since inception we have prioritized research & development, and intellectual property to understand the nutritional value and potential health benefits of krill oil nutrients,” said Matts Johansen, CEO, Aker BioMarine. “This new study is one of the biggest investments we have contributed to in regard to clinical trials, and we are excited to see what the future holds.”
“It’s gratifying that we were able to correct the deficiency of Omega-3 fatty acid levels in lupus patients,” commented principal investigator Jane E. Salmon, MD, director of the Lupus APS Center of Excellence and co-director of the Mary Kirkland Center for Lupus Research, at Hospital for Special Surgery in New York. “Restoring these levels has the potential to influence cardiovascular risk and there are suggestions that it improves disease activity. The clinical benefits must be demonstrated in future studies.”
The study was conducted at 20 research centers in the United States by Aker BioMarine and the Lupus Clinical Investigators Network (LuCIN) overseen by Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance (LRA). AMPEL BioSolutions, a precision medicine company specializing in autoimmune and inflammatory diseases, was instrumental in planning, executing, and reporting on this study.
“This was a team effort that documented patients with lupus were uniformly omega-3 fatty acid deficient and that supplementation with krill oil could replenish the deficiency safely,” said Peter E Lipsky, MD, CEO of AMPEL BioSolutions.
“Through this clinical study, initial data shed some light on a potential supportive option of omega-3 for people with lupus. While not statistically significant, there were preliminary signals of improved disease activity in the small subset of patients with more severe lupus. These results will need to be confirmed with further study. Individuals should not make any changes to their treatment regimen without speaking with their healthcare provider,” said Albert T. Roy, LRA president and CEO.
