New York, NY—January 15, 2019
Can krill oil improve the quality of life of people living with systemic lupus erythematous? A clinical trial, involving 20 centers in the United States, is currently enrolling patients to answer this question. Hospital for Special Surgery (HSS), in New York City, is aiming to enroll four patients with active disease into the trial, which has a target accrual of 76 people diagnosed with lupus. Krill, small crustaceans found in the world’s oceans, are rich in omega-3-phospholipids and also contain naturally occurring nutrients choline and astaxanthin. Krill oil is a safe supplement.
"Omega-3 fatty acids in krill oil inhibit a number of aspects of inflammation, and krill oil supplementation has been proposed as an over-the-counter supplement for many different indications, including cardiovascular disease. In this trial, we are formally testing its potential to lessen the severity of symptoms associated with lupus," said Jane Salmon, MD, coordinating investigator of the multicenter trial and Director of the Lupus APS Center of Excellence and Co-Director of the Mary Kirkland Center for Lupus Research, both at HSS. "This multicenter clinical trial reflects our responsiveness to the wishes of our patients, a safe option that has the potential to attenuate lupus disease activity and the cardiovascular complications associated with it."
Kyriakos Kirou, MD, rheumatologist at HSS and site coordinator for the trial, said that if the trial is positive, he foresees using krill oil in people with active and inactive lupus. "This supplement is predicted to help the lipids in the bodies of patients with lupus," said Dr. Kirou. "People with lupus may develop premature cardiovascular disease because of dyslipidemia, problems with levels of lipids. When people affected by lupus are in their 40s, they are more at risk for developing heart attacks or strokes than others without the disease. Even people whose lupus has become quiet may develop atherosclerosis and heart disease."
Lupus, most often diagnosed between the ages of 15 and 45, is an acute and a chronic autoimmune, multisystem illness in which the body attacks its healthy tissues, resulting in redness or swelling, pain, and organ damage. It affects each person differently and can be very mild or severe. A panoply of symptoms, such as facial rash, painful or swollen joints, and inflammation of organs may come and go without warning.
Researchers are launching the new trial, in part, because there is evidence that polyunsaturated fatty acids (PUFA) such as omega-3s inhibit inflammation, that people diagnosed with lupus are deficient in omega-3 PUFA, and that krill oil decreases disease activity in patients with rheumatoid arthritis. "Polyunsaturated fatty acids in animal models of lupus and lupus nephritis have shown improvement in survival, kidney disease, and levels of autoantibodies," said Dr. Kirou. "Omega-3s are the backbone for the synthesis of Specialized Pro-Resolving Molecules (SPM), anti-inflammatory mediators." In particular, krill oil contains omega-3 fatty acids that are bound to phospholipids, which significantly helps your body’s cells absorb the omega-3s better.
Patients in the double-blind trial will be randomized to receive either a soft gel formulation of krill oil (Aker BioMarine [AKBM]-3031, Omega-3 Phospholipids from krill) or placebo for 6 months and then all patients will receive the active supplement for another six months. "It is a safe supplement. There is strong rationale that it will effectively decrease inflammation in lupus," said Dr. Kirou.
Matts Johansen, CEO at Aker BioMarine said, "Lupus is a frustrating, chronic disease with no known cure which affects millions of people all over the world. We are so excited that molecules from krill can potentially reduce the symptoms associated with lupus."
The trial’s primary objective is to assess the ability of the supplements to replenish the omega-3 dietary deficiency in people with lupus, by measuring the omega-3 index and red blood cells in patients. Secondary objectives include assessing safety and quality of life, whether the correction of the omega-3 deficiency may reduce disease activity in patients with lupus, and whether it has a steroid-sparing effect.
HSS began enrolling patients on January 11. While in the clinical trial, patients will be maintained on stable doses of other medications, except for glucocorticoids; decreases in doses of glucocorticoids will be encouraged during the first 20-weeks of both the randomized and open-label extension portions of the trial. The trial will exclude patients on anticoagulants and those with shellfish allergies.
FDA-approved treatments for lupus are very limited, with only one new drug approved in that last 60 years. Researchers don’t expect krill oil to reverse very serious, life-threatening organ damage, but think it could be used an adjuvant and that it could attenuate disease by increasing the production of specializing pro-resolving molecules, thus decreasing the symptoms of lupus.
"Krill oil may help the natural mechanisms of healing," said Dr. Salmon. "Steroids and immunosuppressive drugs have a range of side effects that people with lupus find hard to tolerate. If we can give them alternative therapies that allow them to take lower doses of their traditional drugs, it would make a very big difference to their quality of life. I don’t expect krill oil to be as potent as the immunosuppressive therapies we administer, but if it is even modestly effective, we may be able to maintain low disease activity with less medication."