Arcalyst (rilonacept) / Regeneron, Kiniksa, Huadong Medicine - LARVOL DELTA

Efficacy of Anti-inflammatory Therapies for Pericarditis: A Systematic Review and Network Meta-analysis (AHA 2025) - "Interestingly, there was not enough data to make a meaningful comparison between steroids and control.ConclusionIn our analysis, goflikicept, rilonacept, and anakinra were most effective at reducing recurrent pericarditis rates. Our analysis also corroborated evidence regarding the efficacy of colchicine in reducing pericarditis recurrence. For a comprehensive analysis of the benefits and harms of anti-inflammatory therapies, larger comparative studies or network meta-analyses of patient-level data are required."

Retrospective data • Review • Cardiovascular

Interleukin-1 Blockade for Rheumatic Fever Pericarditis in a Steroid-Intolerant Patient: A Case Report (AHA 2025) - "Prednisone was started instead of NSAIDs for polyarthritis due to his AKI (figure 1).Following renal recovery with supportive care, he developed pleuritic chest pain, a precordial friction rub, and a HS-troponin peak of 195 ng/L...Colchicine and high-dose aspirin were initiated, which improved his chest pain and CRP (62 mg/L)...This case highlights IL-1 inhibition as a promising therapy in rare presentations of ARF-induced pericarditis, especially when corticosteroids are not tolerated. Using anakinra as a bridge to outpatient rilonacept may offer a targeted, steroid-sparing strategy in persistent pericarditis from ARF."

Case report • Clinical • Acute Kidney Injury • Cardiovascular • CNS Disorders • Depression • Dyslipidemia • Immunology • Infectious Disease • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Psychiatry • Renal Disease • Respiratory Diseases • Rheumatology

Targeted IL-1 Inhibition in Coxsackievirus-Induced Incessant Pericarditis: An Immunotherapy Approach (AHA 2025) - "Despite urgent pericardiocentesis (550 mL) and standard anti-inflammatory therapy with NSAIDs and colchicine, she progressed to incessant pericarditis necessitating corticosteroids.Clinical Course and Timeline:Day 1: Initial presentation with tamponade physiology; Coxsackie B serology positiveDays 9–10: Escalating NSAID therapy failed to control symptomsWeek 2: Prednisone (30 mg/day) initiated with temporary symptom reliefWeek 3: Relapse during taper, resulting in rehospitalizationWeek 7: Recurrence despite slow taper to prednisone 5 mgRilonacept was initiated at week 7 due to persistent steroid dependence. This case illustrates the efficacy of IL-1–targeted therapy in a complex, steroid-dependent pericarditis case and advocates for broader clinical consideration of rilonacept in viral pericarditis. Further investigation is warranted to define optimal timing and patient selection for IL-1 blockade in this setting."

IO biomarker • Cardiovascular • Infectious Disease • Inflammation • IL1B

Real-World Experience with IL-1 Blockade in Children with Undifferentiated Systemic Autoinflammatory Diseases (uSAIDs) (ACR Convergence 2025) - "Most patients (75.8%) had trialed colchicine before starting IL-1 blockade. Treatments included Anakinra (49%), canakinumab (45.5%), or Rilonacept (5.5%)... Our study demonstrates that IL-1 blockade therapy can yield favorable outcomes in patients with uSAIDs, as reflected by improvements in flare frequency and decreased reliance on rescue medications clinically and improved inflammatory markers. These findings underscore the potential of IL-1 blockade as an effective therapeutic strategy for this challenging patient population. Nevertheless, additional research is essential to validate these results and establish standardized treatment protocols for uSAIDs."

Clinical • Real-world • Real-world evidence • Dermatology • Immunology • Inflammation • Musculoskeletal Pain • Pediatrics • Rare Diseases • Urticaria • CRP

Therapeutic Strategies in Newly Diagnosed Still's Disease: Real-Life Clinicians' Choices from the METAPHOR Project Worldwide Survey (ACR Convergence 2025) - "Difficult access to medication influenced decisions for Rilonacept (67%), Canakinumab (27%), Anakinra (17%); Tocilizumab was rarely unavailable (1.5%).In systemic-predominant SD, clinicians used NSAIDs (50%), GCs (46%), GCs pulses (42%),and Anakinra (45%) as first-line options. Second-line strategies included Tocilizumab (39%), GCs (31%), Anakinra (29%), GCs pulses (22%), and MTX (21%), while Tocilizumab (37%), JAK inhibitors (29%), and cyclosporin (24%) were the most selected options as third-line therapies... Still's disease still represents a therapeutic challenge, mainly due to its heterogeneity in clinical expression. Our data reveals significant differences in treatment approaches, driven by clinical phenotype and drug availability. Future research is essential to optimize clustering of patients to foster tailored target treatments, while ensuring equitable access to effective therapies worldwide."

Clinical • Cardiovascular • Immunology • Pediatrics • Rheumatology • IL6

Kiniksa Pharmaceuticals Reports Third Quarter 2025 Financial Results and Recent Portfolio Execution (The Manila Times) - "ARCALYST net product revenue was $180.9 million for the third quarter of 2025; Since launch, more than 3,825 prescribers have written ARCALYST prescriptions for recurrent pericarditis; As of the end of the third quarter of 2025, average total duration of ARCALYST therapy in recurrent pericarditis increased to approximately 32 months, compared to approximately 27 months at the end of 2024."

Sales • Inflammation

UNMASKING LUPUS: CARDIAC TAMPONADE AS THE INITIAL PRESENTATION OF SYSTEMIC LUPUS ERYTHEMATOSUS (CHEST 2025) - "She began treatment with systemic corticosteroids and hydroxychloroquine, had her chest tube removed after two days, and was discharged with rheumatology follow-up...Emerging therapies, such as interleukin-1 inhibitors (e.g., anakinra, rilonacept), show promise for recurrent pericarditis... Cardiac tamponade is a rare, life-threatening SLE complication requiring swift recognition and management. This case emphasizes the need to consider autoimmune causes in patients with pericardial effusion, especially when clinical and serologic clues align. Early diagnosis and targeted treatment of SLE-related pericardial disease are essential to avert severe outcomes."

Cardiovascular • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CRP

Recurrent or Incident Pericarditis With Concurrent Autoimmune Disease: Stable Control With Rilonacept Interleukin-1 Pathway Inhibition (ACR Convergence 2025) - "Corticosteroids were used for RP in 12 (75%), and 13 (81%) were treated with colchicine. IL-1 pathway inhibition with rilonacept in the autoimmune RP subgroup was associated with complete abrogation of RP episodes. Further research should establish the optimum duration of treatment in the high-risk autoimmune RP cohort, evaluate the safety profile of rilonacept with concomitant DMARD therapy, and assess the efficacy of treatment in a broader spectrum of autoimmune conditions."

Cardiovascular • Immunology • Inflammatory Arthritis • Sarcoidosis • Sjogren's Syndrome

Contemporary Recurrent Pericarditis Management – Real-world Evidence of Limited Cardiac Magnetic Resonance Imaging Prior to Initiating Rilonacept (ACR Convergence 2025) - "Recurrent pericarditis is a chronic disease that requires long-term treatment, and selection of therapy is guided by multiple factors. While CMR has utility amongst expert cardiologists in diagnosis, pericardial characterization, and monitoring, it was obtained in more clinically complex RP pts; real-world data indicate that pericardial imaging with CMR prior to rilonacept initiation was performed primarily at AMCs but in less than half of AMC patients (pericardial inflammation was present in approximately half); clinical criteria informed rilonacept initiation in the remainder."

Clinical • HEOR • MRI • Real-world • Real-world evidence • Cardiovascular • Inflammation • IL1B

Increased Adoption of IL-1 Pathway Inhibition and the Steroid-sparing Paradigm Shift: Temporal Trends in Recurrent Pericarditis Treatment From the RESONANCE Patient Registry (ACR Convergence 2025) - "Prior to rilonacept availability, NSAIDs/Colchicine/Aspirin represented the highest proportion of treatment (73% of PY); steroid use was 9% of PY, IL-1 pathway inhibition (anakinra) was 13% of PY, and conventional synthetic disease modifying antirheumatic drugs (csDMARDs) were 0.46% PY (no RP-specific treatment was 5% of PY) (Fig 1). Real-world data from the RESONANCE registry reveal a temporal shift in RP management in US centers with RP-focused cardiologists, with increased proportional IL-1 pathway inhibition use since rilonacept availability in 2021. Advancing beyond 2015 guideline recommendations, IL-1 pathway inhibition is often being used as steroid-sparing treatment, i.e., after colchicine instead of chronic corticosteroids."

Clinical • Cardiovascular • Inflammation • IL1A • IL1B

Comparative analysis of recurrence rates following various cessation strategies for rilonacept in recurrent pericarditis. (PubMed, Heart) - "Long-term Rl therapy beyond 18-24 months leads to sustained disease remission in RP, and therapy withdrawal is associated with a recurrence in two-thirds of patients. A strategy that involves a gradual taper of RI therapy appears to be associated with a relatively lower risk of disease recurrence compared with discontinuation without tapering. Larger-scale, multicentre studies with extended follow-up periods are warranted to elucidate optimal treatment durations and to establish standardised cessation protocols."

Journal • Cardiovascular

Rilonacept for Recurrent Postcardiac Injury Syndrome Pericarditis in a Young Hockey Player: When to Return to Exercise. (PubMed, JACC Case Rep) - "Gradual reintroduction of exercise based on clinical stability and inflammatory markers is key in managing recurrent pericarditis due to PCIS after coronary artery bypass grafting."

Journal • Cardiovascular • Coronary Artery Disease • Immunology • Myocardial Infarction • Ventricular Tachycardia

A Phase 2 Study Of Rilonacept In Patients With Cardiac Sarcoidosis: Study Design (HFSA 2025) - P2 | "Patients will be randomized 1:1 to receive either rilonacept (320 mg SC [loading dose] on day 1 followed by 160 mg SC weekly [maintenance dose]) added to standard therapy or non-biologic standard therapy (corticosteroids and steroid-sparing agents [e.g., azathioprine, methotrexate, mycophenolate, or leflunomide]) alone. REPAIR-CS will measure the efficacy of rilonacept added to standard therapy vs. non-biologic standard therapy alone in patients with CS, given the efficacy of rilonacept in certain diseases in which the IL-1 pathway is implicated."

Clinical • P2 data • Cardiovascular • Congestive Heart Failure • Heart Failure • Immunology • Infectious Disease • Sarcoidosis • CRP • IL1B

Use of an IL-1 Inhibitor for Refractory Steroid-Dependent Lupus Pericarditis With Constrictive Physiology. (PubMed, JACC Case Rep) - "Lupus pericarditis can be steroid dependent and refractory to standard SLE immunosuppression, including B cell-directed biologics. Interleukin-1 inhibition offers a potential therapeutic strategy for breaking the autoinflammatory cycle that can sustain recurrent pericarditis."

Journal • Cardiovascular • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Phase 2 Study of Rilonacept in Patients with Cardiac Sarcoidosis: Study Design (WASOG-AASOG 2025) - P2 | "Patients will be randomized 1:1 to receive either rilonacept (320 mg SC [loading dose] on day 1 followed by 160 mg SC weekly [maintenance dose]) added to standard therapy or non-biologic standard therapy (corticosteroids and steroid-sparing agents [e.g., azathioprine, methotrexate, mycophenolate, or leflunomide]) alone. REPAIR-CS will measure the efficacy of rilonacept added to standard therapy vs. non-biologic standard therapy alone in patients with CS, given the efficacy of rilonacept in certain diseases in which the IL-1 pathway is implicated."

Clinical • P2 data • Cardiovascular • Congestive Heart Failure • Heart Failure • Immunology • Infectious Disease • Sarcoidosis • CRP • IL1B

Comparisons of pericarditis patients on rilonacept with and without concomitant constrictive pericarditis: a case-control study (ESC-WCC 2025) - "Management of CP+ patients continues to be challenging, when rilonacept can be trialed to limit pericarditis flares, however pericardiectomy remains warranted in the majority. Further research is necessary to determine the optimal treatment strategy for CP+ pericarditis patients."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure

Rilonacept as monotherapy for long-term recurrent pericarditis management: sustained disease control over three years (ESC-WCC 2025) - "Rilonacept as monotherapy provided recurrence-free persistence over the three-year trial duration when used continuously without interruption; pericarditis recurrences occurred only after interruptions. These findings support evidence-based use of rilonacept as monotherapy, minimizing the need for adjunctive treatments and reducing polypharmacy in long-term RP management. Further investigations are warranted to address how to assess pts as candidates for long-term treatment with rilonacept and when to cease rilonacept treatment."

Monotherapy • Cardiovascular • CRP • IL1B

Rilonacept reduces pericarditis recurrence risk: clinical outcomes from the RESONANCE patient registry (ESC-WCC 2025) - "This first report of real-world outcomes from RESONANCE shows that rilonacept-containing regimens for RP as 1st, 2nd, or 3rd line therapy reduced recurrence risk over long- term (>2 year) treatment, supporting prolonged management during RP natural history."

Clinical • Clinical data • Cardiovascular • IL1B

IL-1 Pathway Inhibition in Recurrent Pericarditis Management: Real-World Adoption of Corticosteroid Sparing in RESONANCE. (PubMed, JACC Adv) - P | "In RESONANCE, IL-1 pathway inhibition increasingly replaced corticosteroids as second-line therapy. Most patients starting corticosteroids transitioned to IL-1 pathway inhibition; few transitioned from second-line IL-1 pathway inhibition to long-term corticosteroids. These findings may inform treatment algorithms and patient-provider decision-making."

Journal • Real-world evidence • Cardiovascular • Inflammation • Pediatrics

A Comprehensive Clinical Evaluation of Rilonacept in the Treatment of Recurrent Pericarditis: A Systematic Review. (PubMed, J Inflamm Res) - "Rilonacept is effective, tolerable, innovative, and suitable in the treatment of RP, while also showing promise in improving its cost-effectiveness and accessibility. Further comparative and cost-effectiveness studies are needed to fully define the therapeutic role of rilonacept in the RP treatment paradigm."

Journal • Review • Cardiovascular • Inflammation • Pain • Rare Diseases • CRP

Desmoplakin Cardiomyopathy Presenting With Recurrent Myopericarditis Responsive to Interleukin-1 Blockade. (PubMed, JACC Case Rep) - "Nine months after initiating rilonacept, the patient remained asymptomatic, had been off prednisone for 8 months, and demonstrated improved exercise tolerance and normalized troponin I levels. This case highlights the potential benefit of interleukin-1 blockade in managing DSP-related recurrent myopericarditis."

Journal • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Crohn's disease • Gastroenterology • Gene Therapies • Genetic Disorders • Heart Failure • Immunology • Inflammatory Bowel Disease • Pain • KCNQ1OT1

Kiniksa Pharmaceuticals Reports Second Quarter 2025 Financial Results… (GlobeNewswire) - "ARCALYST net product revenue was $156.8 million for the second quarter of 2025; Since launch, more than 3,475 prescribers have written ARCALYST prescriptions for recurrent pericarditis; As of the end of the second quarter of 2025, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 30 months....Kiniksa expects 2025 ARCALYST net product revenue of between $625 million and $640 million, compared to prior guidance of between $590 million and $605 million; Kiniksa expects its current operating plan to remain cash flow positive on an annual basis."

Sales • Sales projection • Immunology • Inflammation • Rare Diseases

Schnitzler syndrome - a rare cause of chronic urticaria. Case report. (PubMed, Oxf Med Case Reports) - "Treatment options include highly effective interleukin-1 blockade therapies such as anakinra, canakinumab, and rilonacept. This case emphasizes the importance of a thorough differential diagnosis of chronic urticaria and encourages clinicians to participate in the SchS database for improved recognition and management."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Monoclonal Gammopathy • Urticaria • Vasculitis • CRP

Systematic Review of Adverse Events of IL-1 and IL-6 Inhibitor Use in Pediatrics. (PubMed, J Pediatr Pharmacol Ther) - "Risks of biological use should be considered alongside the immunosuppressive benefits when prescribing IL-1 and IL-6 inhibitors in the pediatric population. Few data were available on long-term follow-up of these patients."

Adverse events • Journal • Infectious Disease • Musculoskeletal Pain • Pain • Pediatrics

Expanding the Patient Pool for Rilonacept. (PubMed, JACC Case Rep) - "The RHAPSODY trial (Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis) showed rilonacept, an interleukin-1 cytokine trap, to be an effective therapeutic option for patients with pericarditis recurrence. This case series demonstrates the utility and challenges of rilonacept use in the types of patients excluded from RHAPSODY."

Journal • Cardiovascular