Can a patient with a history of recurrent pericarditis and alcohol use be treated with Arcalyst (rilonacept)?

Arcalyst (Rilonacept) for Recurrent Pericarditis in Patients with Alcohol Use

Yes, a patient with recurrent pericarditis and alcohol use can be treated with Arcalyst (rilonacept), as there are no specific contraindications related to alcohol consumption in the FDA labeling or clinical guidelines. 1

FDA-Approved Indication

Arcalyst is FDA-approved for the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older. 1 This represents a major therapeutic advance for patients who have failed conventional therapy with NSAIDs, colchicine, and corticosteroids. 1

Dosing for Recurrent Pericarditis

For adults with recurrent pericarditis:

• Loading dose: 320 mg delivered as two 2-mL subcutaneous injections of 160 mg each, administered on the same day at two different injection sites 1
• Maintenance: 160 mg once weekly as a single 2-mL subcutaneous injection 1

Alcohol-Specific Considerations

The FDA prescribing information for Arcalyst does not list alcohol use as a contraindication or require dose adjustment. 1 However, several clinical considerations are important:

Infection Risk Assessment

• Arcalyst lowers immune system function and increases infection risk, including serious and life-threatening infections 1
• Chronic alcohol use can impair immune function, potentially compounding this risk 1
• Before starting Arcalyst, ensure the patient does not have active infection, chronic recurring infections, or signs of infection (fever, cough, flu-like symptoms) 1

When to Avoid Arcalyst

Do not initiate Arcalyst if the patient has: 1

• Active infection or signs of infection
• History of chronic recurring infections
• Untreated tuberculosis or close TB contact
• HIV, hepatitis B, or hepatitis C (requires careful assessment)

Monitoring Requirements

• Stop Arcalyst immediately if serious infection develops during treatment 1
• Monitor for infection signs at each visit, particularly in patients with alcohol use who may have compromised immunity 1
• Ensure vaccination status is current before starting therapy, including pneumococcal and influenza vaccines 1

Clinical Efficacy Evidence

Rilonacept demonstrated rapid and sustained efficacy in recurrent pericarditis trials: 2

• Pain scores (NRS) decreased from 4.5 at baseline to 0.7 by end of treatment period 2
• CRP decreased from 4.62 mg/dL to 0.38 mg/dL 2
• Median time to CRP normalization: 9 days 2
• 84.6% of patients on corticosteroids at baseline successfully discontinued steroids without recurrence 2

The RHAPSODY trial confirmed these findings with significant improvements in quality of life, sleep, and symptom severity while on rilonacept treatment. 3

Treatment Algorithm for Recurrent Pericarditis

First-line therapy remains aspirin/NSAIDs plus colchicine for at least 6 months: 4

• Aspirin 500-1000 mg every 6-8 hours OR ibuprofen 600 mg every 8 hours 4
• Colchicine 0.5 mg twice daily (≥70 kg) or 0.5 mg once daily (<70 kg) 4

Second-line: Low-dose corticosteroids (prednisone 0.2-0.5 mg/kg/day) if NSAIDs/colchicine fail or are contraindicated 4

Third-line: Rilonacept is indicated for patients who: 1, 5

• Remain refractory to colchicine
• Become corticosteroid-dependent
• Cannot tolerate conventional therapy
• Have had at least 3 pericarditis episodes 6

Critical Safety Warnings

Contraindicated concomitant medications: 1

• Do not use with TNF blockers (etanercept, adalimumab, infliximab) 1
• Do not use with other IL-1 blockers (anakinra) 1
• These combinations significantly increase serious infection risk 1

Additional monitoring: 1

• Blood cholesterol and triglyceride levels (Arcalyst can alter lipid profiles) 1
• Cancer surveillance (immune-modulating drugs may increase cancer risk) 1
• Allergic reaction monitoring (rash, swollen face, trouble breathing) 1

Practical Considerations with Alcohol Use

While alcohol itself is not a contraindication, consider:

• Alcohol-related liver disease may affect drug metabolism and increase infection susceptibility (general medical knowledge)
• Alcohol use disorder may impact medication adherence for weekly injections (general medical knowledge)
• Ensure hepatitis B and C screening is completed before initiating therapy if alcohol use history suggests risk 1

The decision to use Arcalyst should prioritize the severe morbidity associated with recurrent pericarditis—which significantly impairs quality of life—balanced against the manageable infection risk with appropriate monitoring. 5, 3