Rilonacept improves outcomes in recurrent pericarditis
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PHILADELPHIA — Rilonacept in patients with recurrent pericarditis led to improvements in clinical and patient-reported measures as soon as after the first injection, according to data presented at the American Heart Association Scientific Sessions.
“Recurrent pericarditis is not well known how to treat and is often mistreated or maltreated,” Allan Klein, MD, past president of the American Society of Echocardiography, director of cardiovascular imaging research, director of the Center for the Diagnosis and Treatment of Pericardial Diseases and a staff cardiologist in the section of cardiovascular imaging at the Sydell and Arnold Miller Family Heart and Vascular Institute at Cleveland Clinic, told Healio. “Patients are in the prime of their life ... but they are very disabled. Now you have some hope for these patients.”
Researchers analyzed data from 25 patients (mean age, 43 years) with recurrent pericarditis who were treated with rilonacept (Arcalyst, Regeneron).
“Rilonacept is a new medicine, it’s a weekly, subcutaneously-injected biologic drug that blocks inflammatory cytokines interleukin-1alpha and interleukin-1beta signaling,” Klein said in an interview. “It’s precision medicine against a disease — recurrent pericarditis — that’s being inadequately treated currently.”
The drug was first administered as a loading dose of 320 mg subcutaneously, then 160 mg subcutaneously once per week for a 6-week treatment period. There was also an 18-week extension period. Drugs taken at baseline, particularly colchicine, NSAIDs and/or corticosteroids, were continued during the treatment period and were optionally weaned off during the extension period.
Efficacy endpoints included disease activity after corticosteroid tapering and change in C-reactive protein and pericardial pain.
Of the patients enrolled in the study, 23 completed rilonacept treatment for 6 months. Patients with symptomatic recurrent pericarditis who had a CRP level greater than 1 mg/dL had lower CRP levels and pain after the first injection, which was preserved until the end of the study.
“The mean time to drop [CRP levels] was 9 days,” Klein said in an interview.
There were also improvements in quality-of-life scales of mental health and physical health scores, in addition to either an improvement or resolution of other pericarditis manifestations including ECG changes, pericardial effusion and pericardial rub.
No episodes of recurrent pericarditis were seen during the extension period. Twelve patients on corticosteroids at baseline completed the extension period, of which 10 patients stopped taking it during this time and one patient reduced their dose of corticosteroid.
“It’s very dramatic that all the endpoints that were looked at in this pilot [study] were very successful,” Klein told Healio.
There were two serious adverse events including atypical chest pain and skin abscess, which resulted in the discontinuation of rilonacept. Both events were resolved. Although the most common adverse events were injection site reactions, none required drug discontinuation and all were mild.
“Down the road, if this is successful, we’re doing a phase 3 study now,” Klein said in an interview. “If that is successful and the FDA approves it, patients will go on NSAIDs and colchicine first and instead of going on steroids or even doing surgery, they’ll go on the biologic rilonacept. We’re in the era of precision medicine, and now you have a precision drug, which was repurposed for recurrent pericarditis.” – by Darlene Dobkowski
Reference:
Klein A, et al. Experimental and Therapeutic Approaches for Cardiovascular Disease. Presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2019; Philadelphia.
Disclosures: Klein reports he received honoraria from Elsevier, Pfizer, Sobi and Wolters Kluwer and a research grant from Kiniksa. Please see the abstract for all other authors’ relevant financial disclosures.