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

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

Comparisons of pericarditis patients on rilonacept with and without concomitant constrictive pericarditis: a case-control study (ESC-WCC 2025) - No abstract available

Clinical • Cardiovascular

Rilonacept as monotherapy for long-term recurrent pericarditis management: sustained disease control over three years (ESC-WCC 2025) - No abstract available

Monotherapy • Cardiovascular

Rilonacept reduces pericarditis recurrence risk: clinical outcomes from the RESONANCE patient registry (ESC-WCC 2025) - No abstract available

Clinical • Clinical data • Cardiovascular

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

Real-world data and Mendelian randomization analysis in assessing adverse reactions of rilonacept. (PubMed, Int J Clin Pharm) - "Rilonacept is effective for certain inflammatory conditions, but careful monitoring for adverse reactions, particularly involving the immune system, skin, and cardiac issues, is essential."

Journal • Real-world evidence • Cardiovascular • Dermatology • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pain • Urticaria • IL1RN

Difficult-to-treat recurrent pericarditis after SARS-CoV-2 vaccination. (PubMed, Int J Cardiol) - "Pericarditis following SARS-CoV-2 vaccination can evolve into a recurrent, difficult-to-manage inflammatory condition. Effective treatment may require IL-1 blockade to disrupt the autoinflammatory cycle. Prompt recognition and early escalation of therapy are essential to reduce morbidity and prevent complications."

Journal • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Running into trouble: exercise-exacerbated recurrent pericarditis-a case report. (PubMed, Eur Heart J Case Rep) - "Despite colchicine and NSAIDs, symptoms recurred, and MRI confirmed active pericarditis with late gadolinium enhancement of the pericardium. Given the refractory nature of his disease, biologic therapy with rilonacept was initiated. This case highlights the association between high-intensity exercise and recurrent pericarditis, underscoring the need for individualized treatment strategies, including biologics. It contributes to the understanding of refractory cases and exercise-induced inflammation."

Journal • Cardiovascular • Inflammation • Musculoskeletal Pain • Pain

Resolution of Colchicine-Resistant, Corticosteroid-Dependent Acute Idiopathic Recurrent Pericarditis With Rilonacept: A Case Report. (PubMed, Cureus) - "Eight months after the initial diagnosis, she experienced rising inflammatory markers and intermittent fevers despite treatment with ibuprofen and colchicine. Her condition progressed to corticosteroid dependence and marginal pericardial calcification, identified via an echocardiogram eight days after recurrent symptoms began. Symptom resolution and inflammation control were achieved with rilonacept, showing sustained success at a 12-month follow-up."

Journal • Cardiovascular • Diabetes • Infectious Disease • Oncology • Osteoporosis • Pain • Rheumatology

Comprehensive Clinical Analysis of Rilonacept in the Treatment of Cryopyrin-Associated Periodic Syndromes: A Systematic Review. (PubMed, J Multidiscip Healthc) - "It shows high innovativeness and acceptable suitability, with the potential for improved cost-effectiveness and accessibility. We anticipate that the effective treatment of CAPS with rilonacept will encourage further clinical and fundamental research, offering valuable insights for the treatment of other autoinflammatory diseases."

Journal • Review • Inflammation • Rare Diseases • CRP

A REVIEW OF DE NOVO INFLAMMATORY BOWEL DISEASE IN PATIENTS ON IL-1 INHIBITOR THERAPY FOR RHEUMATOLOGIC DISEASES (DDW 2025) - "Introduction : Interleukin-1 (IL-1) inhibitors, including anakinra, canakinumab, and rilonacept are increasingly utilized in the management of various rheumatologic disorders due to their ability to target proinflammatory cytokines IL-1 alpha and IL-1 beta. Clinicians should be aware of the potential complications of this class of drug. Furthermore, these reports are ripe for further study, including formal review of individual reports in an effort to seek pharmacovigilance."

Clinical • Review • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Rheumatology • IL1A • IL1B

A Case of Recurrent Hemophagocytic Lymphohistiocytosis-like Episodes in a Patient with XIAP Deficiency (CIS 2025) - "Concerned he may have developed antibodies to canakinumab, he was trialed on anakinra, which resolved his fever and symptoms. He was discharged on rilonacept and has remained fever- and symptom-free since. Discussions regarding HSCT remain ongoing. This case highlights the importance of targeted pharmaceutical therapies, such as anti-IL-1, in managing complex inflammatory conditions like XLP2."

Clinical • Anemia • Bone Marrow Transplantation • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Pain • Primary Immunodeficiency • Rare Diseases • CD163 • CD4 • CD8 • CXCL9 • IL18 • IL1B • LAMP1 • XIAP

Kiniksa Pharmaceuticals Reports First Quarter 2025 Financial Results and Recent Portfolio Execution (GlobeNewswire) - "ARCALYST (rilonacept) Q1 2025 net product revenue of $137.8 million, representing 75% year-over-year growth; ARCALYST 2025 expected net product revenue increased to $590 - $605 million."

Sales • Cardiovascular • Immunology • Inflammation

Tumor Necrosis Factor Receptor-Associated Periodic Syndrome: Genetics, Autoinflammation, and Recurrent Pericarditis. (PubMed, JACC Case Rep) - "RP is often labeled idiopathic, but autoinflammatory diseases such as TRAPS should be considered in such cases on the basis of the clinical presentation. Interleukin-1 inhibitors have emerged as promising treatments for RP, with radical pericardiectomy being considered as a last resort."

Journal • Cardiovascular • Immunology • Oncology • Pain • TNFA

Rilonacept Use in Recurrent Pericarditis After Combined Heart-Liver Transplantation (ISHLT 2025) - "We describe the use of rilonacept in a heart-liver transplant recipient with recurrent pericarditis despite prednisone and colchicine.Case Report A 22 year-old male with hypoplastic left heart syndrome post-Fontan surgery and Fontan-associated liver disease underwent heart-liver transplantation with pulmonary artery reconstruction...His immunosuppression regimen at the time included tacrolimus with trough of 10-12 ng/mL, mycophenolate mofetil 1000 mg twice daily and prednisone 7.5 mg daily...Summary Rilonacept is an option for recurrent pericarditis in heart transplant patients who do not respond to more conventional therapies. Further data are needed regarding the management of immunosuppression and risk of infection during rilonacept therapy."

Cardiovascular • Gastrointestinal Disorder • Hepatology • Infectious Disease • Pain • Pulmonary Embolism • Respiratory Diseases • Solid Organ Transplantation • Transplantation • CRP

TO FIND THE EXIT AT A DIFFICULT CROSSROADS: MANAGEMENT OF INFECTIVE ENDOCARDITIS (IE) REQUIRING REDO STERNOTOMY, IN A PATIENT ON RILONACEPT THERAPY FOR RECURRENT POST-PERICARDIOTOMY PERICARDITIS - Bianca Honnekeri (ACC 2025) - "Planning redo sternotomy in patients with IE with demonstrated response to rilonacept for previous post-pericardiotomy syndrome involves complex planning due to lack of high quality data on optimal postoperative rilonacept therapy resumption strategies, balanced against the risk of postoperative pericarditis flare. In the absence of evidence-based guidelines, management should be individualized based on shared, multidisciplinary decision-making."

Clinical • Cardiovascular • Heart Failure • Infectious Disease • Inflammation • Pain

INTRACTABLE PERICARDITIS ASSOCIATED WITH FIBROSING MEDIASTINITIS DESPITE BIOLOGICS AND RADICAL PERICARDIECTOMY - Sakthi Surya Prakash (ACC 2025) - "Initial treatment involved triple therapy (colchicine, prednisone, ibuprofen). However, attempts to taper steroids led to recurrences, and quadruple therapy with azathioprine, anakinra, and rilonacept was tried sequentially... Chronic recurrent pericarditis could be a rare complication of FM. Even after radical pericardiectomy, CMR guided therapy with rilonacept may be necessary to maintain steroid free remission."

Cardiovascular • Fibrosis • Inflammation

TURNING THE TIDE ON REFRACTORY PERICARDITIS WITH IL-1 INHIBITORS - Jean Michel Saad (ACC 2025) - "Despite trials of colchicine, celecoxib, ibuprofen and steroids, he remained with recurrent symptoms. Post-ablation pericarditis poses significant management challenges, with traditional treatments sometimes inadequate for refractory cases. Integrating IL-1 inhibitors into treatment strategies could enhance outcomes for these patients, highlighting the need for continued exploration and adoption of these advanced therapies."

Cardiomyopathy • Cardiovascular • Inflammation • Pain

A CASE OF RECURRENT PERICARDITIS AFTER INCOMPLETE PARTIAL PERICARDIECTOMY - RILONACEPT OR REDO- PERICARDIECTOMY? - Sakthi Surya Prakash (ACC 2025) - "It was treated with drainage, partial pericardiectomy and colchicine, which was switched to prednisone due to diarrhea. Recurrent pericarditis can occur with partial pericardiectomy. In such cases, CMR can be used to initiate biologic therapy and monitor progress, reserving redo-pericardiectomy for refractory cases."

Clinical • Cardiovascular • Inflammation • Pain

EFFUSIVE-CONSTRICTIVE PERICARDITIS: WHEN TO WAIT AND WHEN TO OPERATE? - Ushasi Saraswati (ACC 2025) - "Cardiac MRI showed severe pericardial inflammation.Decision-making: After multidisciplinary discussions, urgent pericardiectomy was deferred due to active inflammation, and the patient started on anakinra, later switched to rilonacept (aimed to manage inflammation), with outpatient monitoring. This case highlights the complexities of managing effusive-constrictive pericarditis with active inflammation. A comprehensive approach involving regular follow-ups and multidisciplinary collaboration is essential for effective management."

Cardiovascular • Congestive Heart Failure • Heart Failure • Inflammation • Respiratory Diseases • Ventricular Tachycardia

RECURRENT PERICARDITIS: WHEN IS IT TOO LATE TO OPERATE? - Ushasi Saraswati (ACC 2025) - "Initial treatment with ibuprofen led to recurrent chest pain and a large pericardial effusion requiring pericardiocentesis. She was started on prednisone (60 mg daily) and colchicine (0.6 mg twice daily) after pain recurrence during prednisone tapering. Cardiac MRI revealed severe pericardial late gadolinium enhancement (LGE).Decision-making: Azathioprine was initiated but later switched to anakinra due to persistent symptoms. Tapering anakinra led to recurrence, prompting rilonacept... Early intervention with biologic therapy is beneficial, but uncertainties about long-term risks underscore the need for evaluating pericardiectomy in patients with severe LGE. Further research is needed to identify which patients may benefit most from surgical intervention versus continued medical management."

Cardiovascular • Infectious Disease • Oncology • Pain

RELAPSE AFTER RELAPSE: A SIX-YEAR JOURNEY OF RECURRENT PERICARDITIS MANAGED WITH RILONACEPT, TREATED WITH IMAGE-GUIDED THERAPY - Tess Calcagno (ACC 2025) - "A tailored approach, including imaging and gradual tapering, is crucial in managing recurrent pericarditis."

Cardiovascular

CONTEMPORARY RECURRENT PERICARDITIS MANAGEMENT- REAL-WORLD EVIDENCE OF LIMITED CARDIAC MAGNETIC RESONANCE IMAGING PRIOR TO INITIATING RILONACEPT - Brittany Weber (ACC 2025) - "While CMR has utility amongst expert cardiologists in diagnosis, pericardial characterization, and monitoring, it was obtained in more clinically complex RP pts; rilonacept initiation was informed mostly by clinical criteria."

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