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

RILONACEPT REDUCES PERICARDITIS RECURRENCE RISK, HOSPITALIZATIONS AND ED VISITS: OUTCOMES FROM THE RESONANCE PATIENT REGISTRY (ACC 2026) - "Abstract is embargoed at this time."

Clinical • Cardiovascular

Targeting cytokine pathways: the role of biologics in autoinflammatory disorders. (PubMed, Expert Rev Clin Immunol) - "This review summarizes molecular mechanisms and therapeutic strategies, focusing on IL-1 blockade with anakinra, canakinumab, and rilonacept, as well as IL-6 and TNF inhibitors. Recognition of novel syndromes such as HA20, OTULIN deficiency, and PRAAS has expanded the therapeutic landscape. Next-generation biologics targeting multiple cytokine pathways may further personalize therapy."

Journal • Review • Amyloidosis • Genetic Disorders • Inflammation • Interferonopathies

Comment on "Risk of Pericarditis Recurrence Associated With Rilonacept and NSAID/Colchicine Therapy After Initial Pericarditis Presentation: A Retrospective Real-World Comparative Risk Analysis With TriNetX". (PubMed, Am J Ther) - No abstract available

Journal • Real-world evidence • Retrospective data • Cardiovascular

REAL-WORLD EXPERIENCE OF PERICARDITIS FLARES ON AND COMING OFF RILONACEPT IN RECURRENT PERICARDITIS PATIENTS AND PERFORMANCE OF RISK SCORES (ACC 2026) - "Abstract is embargoed at this time."

Clinical • Real-world • Real-world evidence • Cardiovascular

Idiopathic pericarditis in 2025: Advances in diagnosis and therapeutic strategies. (PubMed, Autoimmun Rev) - "Initial treatment combines non-steroidal anti-inflammatory drugs or aspirin and colchicine; in case of intolerance or resistance, second-line options include systemic corticosteroids or pharmacological blockade of IL-1...Individualized, risk-adapted management and prolonged follow-up are therefore recommended. This review summarizes contemporary data on the pathophysiology, diagnosis, management, and outcomes of idiopathic pericarditis, with a focus on autoinflammatory mechanisms and IL-1-targeted therapies."

Journal • Review • Cardiovascular • CRP

Evaluation of the Effect of IL-1 Antagonists on Pituitary Function. (PubMed, Int J Endocrinol) - "IL-1 inhibitors, such as anakinra, rilonacept, and canakinumab, have been introduced as adjunctive treatments...The control group consisted of patients receiving colchicine treatment only...However, differences were noted in FSH, total testosterone, and GH levels, with higher FSH and GH in the control group and higher testosterone in the experimental group. Although IL-1 plays a role in hormone secretion pathways, further studies are needed to better understand the effect of IL-1 antagonists on pituitary function, as no significant adrenal or pituitary insufficiencies were observed."

Journal • Endocrine Disorders • Genetic Disorders • Inflammatory Arthritis • Musculoskeletal Pain • Oncology • Pain • IGF1 • IL1B • PRL

ARCALYST (IL-1α and IL-1β cytokine trap) (The Manila Times) - "As of the end of the fourth quarter of 2025, approximately 18% of the 14,000 multiple-recurrence patients were actively on ARCALYST treatment...Kiniksa expects 2026 ARCALYST net product revenue of between $900 million and $920 million."

Commercial • Sales projection • Immunology

Disproportionality Analysis of Adverse Events Associated with IL-1 Inhibitors in the FDA Adverse Event Reporting System (FAERS). (PubMed, Pharmaceuticals (Basel)) - "Importantly, we also identified less common or previously unreported AEs, including cardiac disorders (e.g., postural orthostatic tachycardia syndrome with anakinra; pulmonary valve incompetence with rilonacept) and endocrine disorders (e.g., secondary adrenocortical insufficiency with canakinumab). Furthermore, 36.33% of cases emerged after more than 360 days of treatment with IL-1 inhibitors. This study revealed real-world safety data on IL-1 inhibitors, providing important insights to enhance the clinical use of IL-1 inhibitors and minimize potential AEs."

Adverse events • Journal • Cardiovascular • Dermatology • Endocrine Disorders • Genetic Disorders • Infectious Disease • Inflammation

Interleukin-1 Inhibitors for Management of Recurrent Pericarditis After Thoracic Organ Transplantation. (PubMed, JACC Case Rep) - "We report on rilonacept use for treatment of recurrent pericarditis in 4 patients after lung or heart transplantation, describing the clinical presentation, infectious complications, and outcomes of these cases. Our single-center experience of this highly comorbid patient population highlights the major considerations of interleukin-1 inhibitor use within these patients, particularly as related to infectious complications and immunosuppression management."

Journal • Cardiovascular • Solid Organ Transplantation • Transplantation

Pericarditis at the crossroads: Unlocking the next wave of therapies. (PubMed, Int J Cardiol Heart Vasc) - "Traditional treatments - nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and corticosteroids - have important limitations, including steroid dependence, high recurrence rates, and side effects...Key trials of IL-1 inhibitors (anakinra, rilonacept, canakinumab, goflikicept) have demonstrated dramatic reductions in recurrence rates, validating IL-1 as a therapeutic target...Overall, the therapeutic pipeline for pericarditis is robust and poised to transform management. In the coming years, integration of targeted biologics and small molecules alongside conventional anti-inflammatories may significantly improve outcomes in recurrent pericarditis, moving towards more precise and effective treatment strategies."

Journal • Review • Cardiovascular • Inflammation • NLRP3

A systems biology approach to identify key targets in KRAS/BRAF-mutated colorectal cancer. (PubMed, Discov Oncol) - "This study sheds light on the molecular mechanisms of KRAS-mutated CRC, emphasizing IL1B as a prognostic marker. Among the identified therapeutic agents, Omeprazole demonstrated the strongest interaction with AHR, suggesting a potential for repurposing in CRC treatment, while IL1B-targeting inhibitors such as Canakinumab emerged as selective candidates for modulating tumor-promoting inflammation. Novel genes such as EPSTI1, COL20A1, CDH1, and SOX9 warrant further investigation."

Journal • Colorectal Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor • BRAF • CDH1 • EGF • EPSTI1 • IL1B • KRAS • SOX9

Risk of Pericarditis Recurrence Associated With Rilonacept and NSAID/Colchicine Therapy After Initial Pericarditis Presentation: A Retrospective Real-World Comparative Risk Analysis With TriNetX. (PubMed, Am J Ther) - No abstract available

Journal • Real-world evidence • Retrospective data • Cardiovascular

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