Krystexxa (pegloticase) / Amgen - LARVOL DELTA

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

A Phase 4, randomized, double-blind, multicenter non-inferiority trial evaluating the efficacy and safety of intravenous pegloticase administered every 4 weeks vs every 2 weeks with weekly methotrexate (EULAR 2026) - No abstract available

Clinical • Head-to-Head • P4 data • Gout • Rheumatology

Association of Gout Remission With Patient-Reported Quality of Life Outcomes After Pegloticase Treatment: MIRROR Randomized Controlled Trial (EULAR 2026) - No abstract available

Clinical • HEOR • Gout • Inflammatory Arthritis • Rheumatology

Concomitant use of canakinumab may lead to steroid-free dosing of pegloticase (EULAR 2026) - No abstract available

Baseline Predictors of Gout Remission During Intensive Urate-Lowering With Pegloticase: Post Hoc Analysis of the MIRROR Randomized Trial (EULAR 2026) - No abstract available

Clinical • Retrospective data • Gout • Inflammatory Arthritis • Rheumatology

Reduction of Gout Flares With Pegloticase in Patients With or Without Tophi at Baseline: a Post Hoc Analysis of the MIRROR Trial (EULAR 2026) - No abstract available

Clinical • Retrospective data • Gout • Inflammatory Arthritis • Rheumatology

Plain language summary: gout remission with pegloticase. (PubMed, Ther Adv Musculoskelet Dis) - "Patients take pegloticase with a medicine called methotrexate, which prevents their immune systems from making pegloticase ineffective. These analyses showed that lowering serum urate levels with pegloticase for 12 months put gout into remission in a large proportion of these patients with hard-to-treat disease. Importantly, these findings indicate that the simplified criteria adapted from the G-CAN definition were practical to use in routine clinical care and could be used to see how well treatment is working in patients with uncontrolled gout."

Journal • Review • Gout • Immunology • Inflammatory Arthritis • Pain • Rheumatology

Treatment Patterns and Clinical Outcomes in Patients with both Uncontrolled Gout and Chronic Kidney Disease (NKF-SCM 2026) - "At current ULT initiation, patients had a mean sUA of 10.1 mg/dl and 3.7 tophi.The most prescribed ULTs were allopurinol (62%), febuxostat (31%), and pegloticase (13%). CONCLUSION Patients with UG and CKD experienced high disease burden at diagnosis, prolonged periods of time with poor symptom control and elevated sUA levels despite treatment with ULT for over a year. This indicates suboptimal treatment response and a need for more efficacious and population specific treatment option."

Clinical • Clinical data • Chronic Kidney Disease • Gout • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology

A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout (clinicaltrials.gov) - P3 | N=270 | Recruiting | Sponsor: Amgen

New P3 trial • Gout • Inflammatory Arthritis • Rheumatology

Nanoencapsulated Sirolimus Plus Pegadricase (NASP) in Uncontrolled Gout: Current Status and Future Directions. (PubMed, Drugs) - "The Food and Drug Administration recently approved the co-administration of methotrexate with pegloticase to inhibit ADA formation and enhance the efficacy and tolerability of pegloticase. Video abstract available online. Video Abstract."

Journal • Allergy • Gout • Inflammatory Arthritis • Rheumatology

Research progress on multidimensional intervention strategies for hyperuricemia: Western medicine, Traditional Chinese Medicine, and emerging therapies. (PubMed, Front Endocrinol (Lausanne)) - "This article systematically reviews the current various intervention methods and research status for the treatment of hyperuricemia: In the field of Western medicine, it deeply analyzes the efficacy, mechanism of action, and clinical limitations of drugs that promote uric acid excretion (such as benzbromarone and dotinurad), drugs that inhibit uric acid synthesis (such as allopurinol, febuxostat, and topiroxostat), and drugs that promote uric acid hydrolysis (such as pegloticase and rasburicase). It focuses on elaborating the research breakthroughs of URAT1 inhibitor derivatives and the new drug SHR4640...At the same time, it details the action pathways and clinical evidence of emerging therapies such as SGLT2 inhibitors, the GLP-1/GCG dual-receptor agonist Mazdutide, probiotics, and washed microbiota transplantation (WMT). By summarizing mechanistic insights, clinical progress, and translational prospects, this review aims to inform the development of individualized and..."

Journal • Review • Cardiovascular • Gout • Inflammatory Arthritis • Metabolic Disorders • Rheumatology • Transplantation • GCG

Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome (clinicaltrials.gov) - P4 | N=10 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2025 ➔ Jul 2026 | Trial primary completion date: Dec 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology • Solid Tumor

Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout (clinicaltrials.gov) - P1 | N=2 | Completed | Sponsor: University of California, Los Angeles | Enrolling by invitation ➔ Completed | Trial completion date: Feb 2027 ➔ Nov 2024 | Trial primary completion date: Feb 2026 ➔ Nov 2024

Trial completion • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Pegloticase for Tumor Lysis Syndrome (KIDNEY WEEK 2025) - "In our analysis of 398 cases of TLS at UTMD Anderson Cancer Center in 2018, we found that almost 60% (240 cases) needed repeated doses of rasburicase, often up to 3 doses several days apart to bring the serum uric acid down to 6.0 and help with recovery of acute kidney injury (AKI). Conclusion Pegloticase is extremely effective and safe in cancer patients with severe tumor lysis syndrome. Uric acid levels were less than 1 for 14 days after a single dose and stayed below 3.5 for 30 days."

Acute Kidney Injury • Nephrology • Oncology • Renal Disease

Meaningful Clinical Improvement in Serum Uric Acid (sUA) Levels with Concomitant Use of Low-Dosage Mycophenolate Mofetil (MMF) and Pegloticase in Patients with CKD and Uncontrolled Gout (KIDNEY WEEK 2025) - P2 | "Conclusion This small, retrospective study evaluating a lower daily dose of MMF ≤500mg BID concomitantly with pegloticase led to rapid sUA reduction, clinical improvement in gout symptoms, with both low AEs and discontinuation rate. Kidney function showed stability in most patients with both less severe and more severe stages of CKD."

Clinical • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Diabetes • Diabetic Nephropathy • Gout • Hypertension • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Nephrology • Peripheral Arterial Disease • Renal Disease • Rheumatology

Kidney Safety Findings in Patients with Uncontrolled Gout Treated with Pegloticase with and Without Methotrexate (KIDNEY WEEK 2025) - "Mild hematological AEs (Grade 1 leukopenia and Grade 2 anemia) occurred in 1 pt in the MTX group (none in PBO group). Conclusion MTX safety data from MIRROR RCT indicate that low-dose MTX was generally well tolerated among uncontrolled gout pts with no observed adverse impact on renal function."

Clinical • Anemia • Chronic Kidney Disease • Dermatology • Gastrointestinal Disorder • Gout • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Leukopenia • Renal Disease • Rheumatology

Management of Uncontrolled Gout Among Nephrology Professionals: Findings from a Medical Chart Audit (KIDNEY WEEK 2025) - "ULTs most recently administered were allopurinol (60%), febuxostat (35%), colchicine (18%) and pegloticase (7%). Conclusion Despite available ULTs, patients with UG and CKD still have high sUA levels and experience gout-related symptoms which negatively impact their quality of life. These findings highlight the existing burden in patients with UG and CKD as well as a need for treatment optimization and new therapies."

Cardiovascular • Chronic Kidney Disease • Diabetes • Genetic Disorders • Gout • Hypertension • Inflammatory Arthritis • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Obesity • Orthopedics • Renal Disease • Rheumatology

Patient and Caregiver Perspectives on the Burden of Disease in Uncontrolled Gout: A Cross-Sectional Survey Study (ACR Convergence 2025) - "Patients were currently using the following ULT treatments: allopurinol (49%), pegloticase (26%), febuxostat (20%), and probenecid (4%). This is the first study to present data on caregiver burden associated with UG, highlighting significant challenges and reduced HRQOL for caregivers and patients with UG. Both reported HRQOL below the general US population with the largest impact in physical health-related domains, likely due to clinical manifestations of UG for patients, and for caregivers, the physical demands of caring for a patient. Employed individuals also experienced notable work impairment demonstrating the multifaceted impacts of UG."

Clinical • HEOR • Gout • Inflammatory Arthritis • Rheumatology

Management of Uncontrolled Gout Among Rheumatologists: Findings from a Medical Chart Audit (ACR Convergence 2025) - "Other patients most recently received febuxostat (24%), colchicine (18%) and pegloticase (4%). This study highlights the challenges rheumatologists face in managing UG and unmet needs in gout treatments as evidenced by high sUA levels, frequent flares and tophi presence and low adherence rates to current ULTs."

Cardiovascular • Genetic Disorders • Gout • Hypertension • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Obesity • Orthopedics • Renal Disease • Rheumatology

Racial Differences in Real-World Use of Urate-Lowering and Adjunctive Therapies for Gout: A 10-Year Propensity-Matched Cohort Study (ACR Convergence 2025) - "Outcomes captured 1–10 y post-index were initiation of allopurinol, febuxostat, pegloticase, colchicine, oral corticosteroids, NSAIDs, IL-1 inhibitors, arthrocentesis, most-recent SU, and composite MACE (myocardial infarction, heart failure, stroke). Despite similar comorbidity profiles, minority adults with gout were less likely to initiate guideline-preferred allopurinol yet more likely to receive febuxostat and multiple acute agents, had higher residual SU, and experienced greater cardiovascular morbidity than non-Hispanic-White adults. These findings highlight treatment and outcome inequities and call for targeted dose-titration protocols, SU monitoring, and cardiovascular-risk mitigation strategies to improve gout care in underserved populations."

Clinical • Real-world • Real-world evidence • Cardiovascular • Congestive Heart Failure • Gout • Heart Failure • Inflammatory Arthritis • Myocardial Infarction • Rheumatology

Tolerance of Methotrexate Coadministered with Pegloticase in Patients with Uncontrolled Gout: Findings from MIRROR RCT (ACR Convergence 2025) - "MTX safety data from MIRROR RCT demonstrates that MTX in uncontrolled gout pts does not lead to an increased number/frequency of TEAEs vs PBO, including no increase in durable liver function changes and no increase in infections. These findings further underscore the safety of MTX coadministration with pegloticase during the 12 month MIRROR RCT."

Clinical • Anemia • Cardiovascular • Dental Disorders • Dermatology • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Gout • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Inflammatory Arthritis • Leukopenia • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Rheumatology • Stomatitis

Pharmacokinetics of Ready-to-Use Pegloticase Formulation Compared to Standard Pegloticase Dosing: Data from the AGILE Study (ACR Convergence 2025) - "Background/Purpose: Pegloticase is approved for uncontrolled gout as 8-mg infusions admixed in 250 cc of normal saline over 120 minutes or more administered every 2 wks with methotrexate (MTX) coadministration. Pegloticase given in RTU form of premixed 50 cc with 8 mg of pegloticase coadministered with MTX over 60 minutes showed comparable safety, efficacy, and PK results to standard pegloticase. Among a small number of patients that switched from standard pegloticase to RTU formulation, no change in PK was seen."

PK/PD data • Gout • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Rheumatology

Evaluating Patient Outcomes Pre and Post Pegloticase Initiation among Uncontrolled Gout Patients: Findings from MORE2 Registry and Medicare Fee-For-Service Claims Data (ACR Convergence 2025) - "However, real-world data on its effectiveness, particularly with methotrexate co-treatment, remains limited...The primary outcome, gout flare, was identified as follows: 1) having an inpatient visit with a primary diagnosis of gout or 2) having an outpatient or emergency department claim with a diagnosis of gout accompanied by treatment or follow-up visit within a 7-day period, or 3) an outpatient or ED claim with a diagnosis for unspecified joint pain accompanied by a claim for oral/injectable colchicine within 7 days... Pts with CRG, treated with pegloticase in the MORE2 and Medicare FFS, showed a substantial reduction in the rate of gout flares during the follow-up periods. These data further support the use of pegloticase, as a uric acid debulker, for CRG management, thus decreasing the risk of flareup."

Clinical • Medicare • Reimbursement • US reimbursement • Cardiovascular • Chronic Kidney Disease • Diabetes • Gout • Hypertension • Immunology • Inflammatory Arthritis • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Orthopedics • Osteoarthritis • Renal Disease • Rheumatology • Type 2 Diabetes Mellitus

Co-Use of Mycophenolate Mofetil with Pegloticase Yielded Similar Clinical Outcomes as the Co-Use of Methotrexate (ACR Convergence 2025) - "49% of pegloticase patients were treated with immunomodulating co-therapy, among which MMF was 33% of IMM use, with most patients going on MMF having advanced CKD. Pegloticase duration, effectiveness in terms of sUA reduction and eGFR stability in the MMF group were similar to the MTX group. The co-therapy of MMF and pegloticase may be an option for patients with pre-existing renal impairment."

Clinical • Clinical data • Chronic Kidney Disease • Gout • Immunology • Inflammatory Arthritis • Renal Disease • Rheumatology

Efficacy of Pozdeutinurad (AR882) in Treatment Naïve and Suboptimally Treated Gouty Arthritis with Tophi (ACR Convergence 2025) - "To date, only intravenous (IV) therapies such as pegloticase is indicated in urate-lowering (ULT) refractory patients and has demonstrated tophi dissolution by caliper measurement and Dual Energy Computer Tomography (DECT). Pozdeutinurad 75 mg monotherapy or in combination with allopurinol in tophaceous patients refractory and naïve to ULT were effective in sUA lowering, demonstrating high rates of complete resolution of target tophus and reduction in urate crystal burden. Pozdeutinurad alone or combination may provide an effective treatment option for patients with chronic tophi and inadequate response to their current treatment regimens."

Clinical • Gout • Immunology • Inflammatory Arthritis • Rheumatology