Arcalyst (rilonacept)
/ Regeneron, Kiniksa Pharmaceuticals, Huadong Medicine
- LARVOL DELTA
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March 25, 2026
Biological Therapies for Urate Lowering and Inflammation Control in Gout Management.
(PubMed, J Inflamm Res)
- "Pegloticase achieves sustained urate reduction in refractory gout. Concomitant immunomodulatory therapy using methotrexate or mycophenolate substantially improves response rates by mitigating antidrug antibody formation...Anakinra accumulated extensive off-label evidence over two decades without formal approval, while rilonacept faced regulatory rejection in 2012 despite demonstrating efficacy. Canakinumab received Food and Drug Administration (FDA) approval in August 2023 after its initial rejection in 2011, becoming the first biologic formally indicated for gout in the United States...OLT1177 has advanced through clinical development after incorporating safety lessons from the hepatotoxicity experience associated with MCC950...Remaining challenges include immunogenicity management, treatment costs that limit accessibility, and incomplete long-term safety characterization. Future progress depends on refining patient selection through predictive biomarkers and..."
Journal • Review • Chronic Kidney Disease • Gout • Immunology • Inflammation • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology • Solid Organ Transplantation • Transplantation • NLRP3
January 10, 2026
LONG-TERM IL-1 INHIBITION IN RECURRENT PERICARDITIS: A CASE FOR INDIVIDUALIZED DOSING STRATEGIES
(ACC 2026)
- "While rilonacept is FDA-approved for weekly dosing, optimal tapering strategies remain undefined, and unique considerations arise in women of childbearing age given limited pregnancy safety data. Case: A 25-year-old woman with incessant pericarditis experienced multiple relapses despite NSAIDs, steroids, and colchicine. She initially responded to anakinra but relapsed on tapering... This case highlights the need for individualized IL-1 inhibitor dosing, the limitations of serologic markers, and the value of CMR imaging in tapering decisions. Shared decision-making is critical, particularly when reproductive considerations influence management."
Clinical • Cardiovascular • Inflammation • CRP
January 10, 2026
USE OF ENDOMYOCARDIAL BIOPSY TO GUIDE MANAGEMENT OF RECURRENT MYOCARDITIS
(ACC 2026)
- "This rare case of recurrent idiopathic lymphocytic myocarditis highlights the value of tissue diagnosis and potential role of immunotherapy."
Biopsy • IO biomarker • Cardiovascular • Inflammation • Pulmonary Disease
January 10, 2026
RECURRENT "PERICARDIAL" CHEST PAIN AFTER PERICARDIECTOMY: WHEN SURGERY IS NOT THE END OF THE STORY
(ACC 2026)
- "Case: A 67-year-old female diagnosed with idiopathic pericarditis, initially treated with NSAIDs/colchicine, developed relapsing disease refractory to steroids and rilonacept, ultimately requiring radical pericardiectomy. This case illustrates the need for continued comprehensive care for patients with pericardial disease, even after pericardiectomy. Further research is needed to establish best practices for the management of patients pre and post pericardiectomy."
Surgery • Cardiovascular • Inflammation • Pain • Pulmonary Disease • Respiratory Diseases
January 10, 2026
AUTOINFLAMMATORY PERICARDITIS IN TAFAMIDIS-TREATED WILD-TYPE TRANSTHYRETIN AMYLOIDOSIS: MRI-DOCUMENTED REMISSION WITH IL-1 INHIBITION
(ACC 2026)
- "Decision-Making: Rilonacept induced rapid symptom relief, CRP normalization to <3 mg/L, and successful taper of steroids and colchicine without relapse. This case illustrates that ATTRwt-CM can be complicated by inflammatory pericarditis, identifiable by serial MRI. Phenotype-directed therapy, including IL-1 inhibition, may achieve durable remission even in advanced amyloidosis. To our knowledge, this is the first reported case of MRI-documented, IL-1-responsive pericarditis in a tafamidis-treated ATTRwt patient."
Clinical • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Inflammation
January 10, 2026
OUTCOMES ASSOCIATED WITH THE USE OF CORTICOSTEROIDS IN PATIENTS WITH RECURRENT PERICARDITIS
(ACC 2026)
- "Since rilonacept became available in April 2021, it has supplanted CS in patients failing NSAIDs/colchicine. In propensity-matched RP patients, CS-based therapy was linked to higher escalation to biologics and DMARDs, with a nonsignificant trend toward more pericardiectomies."
Clinical • Cardiovascular
January 10, 2026
SHIFTING THE PARADIGM: IL-1 THERAPY FOR DIFFICULT-TO-TREAT RECURRENT PERICARDITIS
(ACC 2026)
- "We highlighted the evolving role of IL-1 inhibitors in refractory, inflammatory-phenotype recurrent pericarditis and underscored the utility of multimodal imaging with suspected constriction."
Cardiovascular • CNS Disorders • Depression • Inflammation • CRP
January 10, 2026
USE OF MEDICAL THERAPY AND IL-1 INHIBITION IN EFFUSIVE CONSTRICTIVE PERICARDITIS: ROLE OF EARLY INTERVENTION
(ACC 2026)
- "Case: A 59-year-old male with hypertension, obesity and metabolic syndrome presented to clinic after 2 episodes of idiopathic pericarditis over the preceding 4 months, treated incompletely with colchicine and steroids...He tolerated steroids poorly, developing weight gain and diabetes, and was started on rilonacept, allowing steroid weaning with CRP normalization... Medical therapy, including IL-1 inhibitors, can alter ECP's natural course, but early treatment is key. Prompt recognition and adequate treatment of initial pericarditis may reduce ECP risk, improve response to medical therapy, and avoid surgery."
Cardiovascular • Diabetes • Genetic Disorders • Hypertension • Inflammation • Metabolic Disorders • Obesity
January 10, 2026
RILONACEPT REDUCES PERICARDITIS RECURRENCE RISK, HOSPITALIZATIONS AND ED VISITS: OUTCOMES FROM THE RESONANCE PATIENT REGISTRY
(ACC 2026)
- "In pts failing NSAIDs/Colchicine, 2nd line rilonacept provided superior recurrence rate and disease burden reductions versus 2nd line CS, affirming the evidence-based corticosteroid-sparing paradigm shift recommended by the 2025 ACC CCG."
Clinical • Cardiovascular • Inflammation
January 10, 2026
GEOGRAPHIC DISPARITIES AND TEMPORAL TRENDS IN IL-1 INHIBITOR UTILIZATION FOR PERICARDITIS ACROSS THE UNITED STATES: INSIGHTS FROM EPIC COSMOS (2020-2025)
(ACC 2026)
- "Interleukin-1 (IL-1) inhibitors, anakinra and rilonacept, have emerged as targeted therapies, with rilonacept receiving FDA approval for recurrent pericarditis in 2021. IL-1 inhibitor prescribing for pericarditis has increased following FDA approval of rilonacept, yet overall utilization remains low and unevenly distributed across the US. Underutilization in rural regions highlights inequities in access and underscores the need for broader dissemination of guideline-directed therapy."
Cardiovascular
January 10, 2026
EFFICACY OF COLCHICINE MONOTHERAPY COMPARED TO COMBINATION THERAPY WITH COLCHICINE ADDED AS ADJUNCTIVE THERAPY IN ACUTE PERICARDITIS
(ACC 2026)
- "Background: Dual anti-inflammatory therapy with a nonsteroidal anti-inflammatory drug (NSAID)/aspirin and colchicine is recommended as first line therapy for the treatment of acute pericarditis, but many patients have contraindications to NSAID use due to concomitant disease states or medical therapies...Key secondary outcomes included time to first recurrent episode within 12 months, number of recurrent episodes within 12 months, prescription of additional medications for pericarditis after discharge (i.e. addition of corticosteroids, rilonacept, or anakinra), and hospitalization or medical contact for pericarditis within 12 months... Conclusion pending full data analysis."
Clinical • Combination therapy • Monotherapy • Cardiovascular • Infectious Disease • Respiratory Diseases • Tuberculosis
January 10, 2026
REAL-WORLD EXPERIENCE OF PERICARDITIS FLARES ON AND COMING OFF RILONACEPT IN RECURRENT PERICARDITIS PATIENTS AND PERFORMANCE OF RISK SCORES
(ACC 2026)
- "This large real-world RP cohort treated with rilonacept had infrequent RP flares on rilonacept, and almost half experiencing flares after coming off rilonacept, with only the Klein score useful prognostically in the latter setting."
Clinical • Real-world • Real-world evidence • Cardiovascular
January 10, 2026
INTERLEUKIN-1 BLOCKERS IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: INDIRECT COMPARISON OF ANAKINRA AND GOFLIKICEPT
(ACC 2026)
- "We present an indirect comparison between two IL-1 blockers tested in phase II trials: anakinra, an IL-1 receptor antagonist, and goflikicept, a recombinant IL-1 trap. In STEMI, anakinra and goflikicept achieve a similar reduction in systemic inflammation and HF-related events, supporting IL-1 blockade as a class effect and promising strategy to improve outcomes."
Cardiovascular • Congestive Heart Failure • Heart Failure • Inflammation • Myocardial Infarction • CRP
March 16, 2026
Mechanistic Insights and Emerging Therapeutic Strategies in Recurrent Pericarditis.
(PubMed, Methodist Debakey Cardiovasc J)
- "Traditional management with nonsteroidal anti-inflammatory drugs, colchicine, and corticosteroids has historically provided symptomatic relief but is limited by high recurrence rates, steroid dependence, and substantial morbidity. The introduction of IL-1 inhibitors, including anakinra and rilonacept, has reshaped contemporary practice by reducing recurrence rates, minimizing corticosteroid dependence, and establishing a precision-based approach to disease activity-guided therapy. The purpose of this review is to synthesize contemporary evidence surrounding the pathophysiology and evolving treatment paradigms for recurrent pericarditis, with a focus on novel targeted therapies."
Journal • Review • Cardiovascular • Immunology • Infectious Disease • Inflammation • NLRP3
March 06, 2026
Demyelination Reported with Biologic Therapies for Rheumatologic and Inflammatory Bowel Diseases: Insights from FAERS
(AAN 2026)
- "Mechanistic classes included: anti–tumor necrosis factor (TNF)-α agents, anti-integrin antibodies (excluding natalizumab), anti-interleukin agents (including IL-12/23, IL-23, IL-17, IL-6, and IL-1 inhibitors), B-cell targeted therapies (excluding rituximab), and T-cell co-stimulation modulators... Safety signals for demyelination were identified with TNF-α inhibitors (infliximab, adalimumab, certolizumab pegol, golimumab, and etanercept) with a PRR of 7.34 (95% CI: 6.75–7.98), and abatacept, a selective T-cell co-stimulation modulator (PRR: 2.12; 95% CI: 1.41–3.20). No safety signals were observed for IL-12/23 inhibitors (ustekinumab), IL-17 inhibitors (secukinumab, ixekizumab, bimekizumab), IL-23 inhibitors (mirikizumab, guselkumab, tildrakizumab, risankizumab), and anti-α4β7 integrin (vedolizumab). Reporting counts were insufficient for IL-6 inhibitors (tocilizumab and sarilumab), IL-1 inhibitors (anakinra, canakinumab, and rilonacept), and B-lymphocyte stimulator..."
Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • IL12A • IL17A • IL23A
March 10, 2026
Interleukin-1 receptor type 1 in pancreatic cancer progression and metastasis: a review.
(PubMed, Int J Clin Oncol)
- "Therapeutic blockade of the IL-1 pathway with agents, such as anakinra, canakinumab, or rilonacept, reduces tumor growth, metastasis, and immune suppression in preclinical PDAC models. Summarily, IL-1R1 is a central driver of PDAC aggressiveness and a therapeutic target. Targeting this pathway may enable biomarker-guided strategies to improve outcomes in this disease."
IO biomarker • Journal • Review • Infectious Disease • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CTCs • IL1B • IL1R1 • MYD88 • STAT3
February 26, 2026
French protocol for the diagnosis and management of recurrent pericarditis.
(PubMed, Rev Med Interne)
- "During acute flares, NSAIDs or aspirin are recommended in combination with colchicine...In severe or refractory forms, early use of interleukin-1 inhibitors-particularly anakinra or rilonacept-should be considered...Coordinated follow-up within structured care networks is essential to ensure optimal access to treatment and advanced therapies. This French Protocol for Diagnosis and Management aims to provide clinicians with clear, harmonised, and up-to-date guidance to improve the diagnosis, treatment, and long-term care of patients with recurrent pericarditis."
Journal • Review • Cardiovascular • Immunology • Inflammation • Pain • CRP
February 01, 2026
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
January 29, 2026
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
February 01, 2026
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
January 14, 2026
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
January 12, 2026
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
December 31, 2025
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
December 04, 2025
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
November 24, 2025
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
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