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Potential New Treatment for Pericarditis Identified

Anikinra may offer hope for rheumatology patients with the heart condition

SAN FRANCISCO —A new study, presented this week at the American College of Rheumatology Annual Meeting in San Francisco, shows anakinra (Kineret®) to be a safe and effective treatment for pericarditis – the swelling and irritation of the thin membrane that surrounds the heart, which can be found in 30 percent of people with rheumatic diseases.

Pericarditis can be very disabling, causing pain in the chest and accumulation of fluid in the pericardium. This condition can eventually lead to, severe chest pain, coughing, difficulty breathing, and life-threatening pressure on the heart (called cardiac tamponade).

People with recurring pericarditis often don’t respond – or are intolerant — to Nonsteroidal anti-inflammatory drugs (called NSAIDS), corticosteroids and colchicine, or must be treated chronically with high dosages of corticosteroids. Additionally, the use of corticosteroids can cause a difficult-to-break cycle where the person does well while taking them, but has a flare as soon as they try to stop. Because of these challenges, and because recurring pericarditis shares many clinical features with rheumatic diseases, these patients are often seen by rheumatologists.

Researchers from Italy recently showed that low dose of corticosteroids or colchicine halved the recurrences of pericarditis in several well-conducted trials. The same researchers recently tested the safety and effectiveness of anakinra as an alternative treatment option for people with recurrent pericarditis.

“We first used anakinra in pediatric patients who were very ill with high fever, strikingly elevated c-reactive protein, large pericardial effusions, several recurrences,” recalls lead investigator in the study, Antonio Brucato, MD; chief, Internal Medicine; Ospeadale Papa Giovanni XXIII; Bergamo, Italy.“In this study, we observed spectacular results, so we asked ourselves whether patients of any age, with a severe disease and a long-lasting necessity of steroids, might benefit from this therapy.”

Dr. Brucato’s team recruited 21 patients (20 adults and one child) who were taking steroids and colchicine to treat ongoing idiopathic recurring pericarditis and followed them between June 2014 and June 2015. The adult patients were predominately women with an average age of just over 45 years. To be included in the study, these patients had a history of recurring pericarditis with at least two recurrences with an elevation of c-reactive protein, which was considered a sign of more acute inflammation that may respond better to anakinra.  

The adult participants were given 100 mg of anakinra via subcutaneous injection each day for two months, and the child participant was given 2mg/kg each day for the same time period. Dosages of NSAIDs and colchicine were tapered over period of two weeks, and corticosteroids over maximum six weeks. All patients completed the first two months of the study and responded well with their c-reactive protein levels returning to normal within one week and disappearance of pain and of pericardial effusion.

After two months the group was divided and 11 participants were randomly assigned to continue their treatment while the other 10 participants received placebo for six additional months. Neither the patients nor the researchers knew who was assigned to each group. During this part of the study, the researchers documented the recurrence rates and how long it took each patient to experience a pericarditis flare (called “time to flare”).

They noted flares occurred in 90 percent of the patients in the placebo group (with the median time to flare of 12 days) and in only in 18 percent of the patients who were taking anakinra. Because there were so few flares in the anakinra group, the researchers couldn’t assess a median time to flare.

In addition to being effective, anakinra was shown to be acceptably safe. “The most common side effect of the treatment was a skin reaction at the site of the injection. While this occurred in 95 percent of the participants, it disappeared after one month, and no patient discontinued the study due to this side effect,” explains Dr. Brucato who goes on to note, “Two serious side effects occurred in patients who continued taking anakinra. One patient developed shingles, and the other developed an ischemic optic neuropathy in one eye side effects which cannot absolutely be attributed to anakinra.”

Overall, this study in a small series of patients shows that anakinra is very effective and safe for treatment of steroid dependent and colchicine resistant severe recurring pericarditis.  While this study is hopeful, Dr. Brucato believes more studies are needed, saying, “Anakinra is quite effective, and generally well tolerated, particularly if compared to chronic therapy with corticosteroids at medium dosages, but recurrences may occur after its discontinuation. We need more studies to define a better way to taper anakinra, and to test it in combination with other effective therapies, such as colchicine.”

Editor’s note:  When revisiting the data for the final analysis, the cardiologic center in Turin formally changed some data as compared to the original abstract. This was because two patients had minor symptoms that, at the end, satisfied the pre-specified criteria for a recurrence; so the final data are marginally different from that given in the abstract.

Jocelyn Givens
During Annual Meeting: Newsroom – 415-978-3605 or 415-978-3604
Office – 404-633-3777, ext. 810
jgivens@rheumatology.org

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