Cleveland Clinic led trial shows drug effective in 96% of patients with recurrent pericarditis

November 16, 2020

EMBARGOED UNTIL 8:34 P.M. ET, Monday, November 16, 2020, Cleveland: Cleveland Clinic researchers leading a global clinical trial have found that rilonacept, an FDA approved drug for other inflammatory diseases, resolved acute pericarditis episodes and reduced risk of pericarditis recurrence. The study was published today in the New England Journal of Medicine and presented at the American Heart Association's Scientific Sessions.

Pericarditis is an inflammation of the pericardium, which is two thin layers of tissue that surround the heart and help it function. A common symptom is severe sharp chest pain, which is caused by the inflamed layers rubbing against the heart. Pericarditis can be acute, recurrent or chronic, and often occurs after a viral infection or cardiac surgery. Recurrent pericarditis usually occurs 4-6 weeks after the first episode of acute pericarditis and often causes debilitating chest pain, physical limitations, hospitalizations and decreased quality of life.

Currently, there are no FDA approved therapies for pericarditis. Anti-inflammatories and steroids- often with harsh side effects- are used to treat the condition. The Rhapsody global Phase 3 clinical trial studied 61 patients with recurrent pericarditis, who were randomized to rilonacept or placebo. After 16 weeks of treatment, 81% of patients on once-weekly rilonacept, reported no or minimal pericarditis symptoms versus 25% on the placebo. The drug not only resolved active episodes after the first dose, but it also decreased recurrences by 96%.

All patients involved who had been taking corticosteroids tapered and successfully transitioned to rilonacept.

"Recurring pericarditis is painful and can be debilitating to those who suffer from it," said Allan Klein M.D., director of the Center for the Diagnosis and Treatment of Pericardial Diseases at Cleveland Clinic, co-principal investigator of the study, and a paid member of Kiniksa Pharmaceuticals' scientific advisory board. "The Rhapsody trial was highly successful, essentially stopping this disease, and provides a new hope for these patients."

Of the 25 safety events in the study, 23 occurred in the placebo group, while only two occurred in the rilonacept group.
-end-
The study was sponsored by Kiniksa Pharmaceuticals, Ltd., the maker of Rilonacept, however all analyses were independently confirmed by the Cleveland Clinic Center for Clinical Research.

About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Among Cleveland Clinic's 67,554 employees worldwide are more than 4,520 salaried physicians and researchers, and 17,000 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,026-bed health system that includes a 165-acre main campus near downtown Cleveland, 18 hospitals, more than 220 outpatient facilities, and locations in southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2019, there were 9.8 million total outpatient visits, 309,000 hospital admissions and observations, and 255,000 surgical cases throughout Cleveland Clinic's health system. Patients came for treatment from every state and 185 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.

Editor's Note: Cleveland Clinic News Service is available to provide broadcast-quality interviews and B-roll upon request.

Cleveland Clinic

Related Placebo Articles from Brightsurf:

Effect of fluvoxamine vs placebo on clinical deterioration in outpatients with symptomatic COVID-19
This randomized trial compares the effects of fluvoxamine, a selective serotonin reuptake inhibitor with immunomodulatory effects, versus placebo on a composite of dyspnea or pneumonia and oxygen desaturation among adult outpatients with polymerase chain reaction-confirmed mild COVID-19 illness.

Hydroxychloroquine no more effective than placebo in preventing COVID-19
Clinical trial with COVID-19 testing of participants shows health care workers in contact with coronavirus patients who took hydroxychloroquine each day did not reduce their rate of infection.

Compared to placebo, vitamin D has no benefit for severe asthma attacks
Contrary to earlier observational results, vitamin D supplements do not prevent severe asthma attacks in at-risk children, according to the first placebo-controlled clinical trial to test this relationship.

UMN trial shows hydroxychloroquine has no benefit over placebo in preventing COVID-19
Today, University of Minnesota Medical School researchers published the results from the first randomized clinical trial testing hydroxychloroquine for the post-exposure prevention of COVID-19.

The placebo effect and psychedelic drugs: tripping on nothing?
A new study from McGill suggests that, in the right context, some people may experience psychedelic-like effects from placebos alone.

Methotrexate reduces joint damage progression over placebo in erosive hand OA
According to new research findings presented at the 2019 ACR/ARP Annual Meeting, methotrexate did not demonstrate superior efficacy over placebo for pain relief and function evolution at three and 12 months in patients with erosive hand osteoarthritis, but did significantly reduce the progression of joint damage over placebo and seems to facilitate bone remodeling in these patients.

Botulinum toxin reduces chronic migraine attacks, compared to placebo
A growing body of evidence supports the effectiveness of botulinum toxin injections in reducing the frequency of chronic migraine headaches, concludes an updated review and analysis in the January issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

Opioids vs. placebo, nonopioid alternatives for chronic noncancer pain
An estimated 50 million adults in the United States were living with chronic noncancer pain in 2016 and many of them were prescribed opioid medications, even though a clinical benefit is uncertain.

Probiotic no better than placebo for acute gastroenteritis in children
While probiotics are often used to treat acute gastroenteritis (also known as infectious diarrhea) in children, the latest evidence shows no significant differences in outcomes, compared to a placebo.

Most common shoulder operation is no more beneficial than placebo surgery
In a landmark study published this week in the BMJ, Finnish researchers show that one of the most common surgical procedures in the Western world is probably unnecessary.

Read More: Placebo News and Placebo Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.