Krystexxa (pegloticase) / Amgen - LARVOL DELTA

The Pattern and Severity of Gout Flares Prior to and During Pegloticase Treatment in the MIRROR and AGILE Clinical Trials (ACR Convergence 2026) - No abstract available

Clinical • Gout • Inflammatory Arthritis • Rheumatology

Real-World Use of Immunomodulation Co-therapy Among Pegloticase New Users (ACR Convergence 2026) - No abstract available

Clinical • Immunomodulating • Real-world • Real-world evidence • Immunology

Induction of Clinical Remission in Patients with Uncontrolled Gout Treated with Pegloticase and Immunomodulation: Experience in Two Community Rheumatology Practices (ACR Convergence 2026) - No abstract available

Clinical • Immunomodulating • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Retreatment with Pegloticase - A Second Chance Worth Taking (ACR Convergence 2026) - No abstract available

The Relationship in An Individual Between Urate Lowering Therapy Dose and Serum Uric Acid Before and After Pegloticase. (ACR Convergence 2026) - No abstract available

Clinical • Rheumatology

Real-World Attainment of Gout Remission Following Pegloticase Initiation in a U.S. Practice Based Rheumatology Network (ACR Convergence 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Gout • Inflammatory Arthritis • Rheumatology

Induction and Maintenance of Gout Remission During Intensive Urate-Lowering with Pegloticase: Post Hoc Analysis of a 2.5 Year Open-Label Extension Study (ACR Convergence 2026) - No abstract available

Clinical • Retrospective data • Gout • Inflammatory Arthritis • Rheumatology

ULTRA-T2D: Uric Acid Lowering Trial in Youth Onset T2D (clinicaltrials.gov) - P2 | N=11 | Completed | Sponsor: University of Colorado, Denver | Recruiting ➔ Completed

Trial completion • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Erosive gout: update on mechanisms, impact and treatment. (PubMed, Curr Opin Rheumatol) - "Erosive gout is a consequence of tophaceous gout and causes joint deformity which is difficult to reverse once established. Collectively, these findings provide a rationale for urate-lowering therapy for people with gout to prevent the consequences of tophaceous gout including joint damage."

Journal • Gout • Inflammatory Arthritis • Rheumatology • SPP1

Targeted Treatment for Hyperuricemia: The Drug Pipeline. (PubMed, Drugs Aging) - "Agents such as dotinurad have demonstrated effective urate lowering with favorable renal and hepatic safety profiles in older individuals, including patients with chronic kidney disease, suggesting potential advantages in this higher-risk population. Likewise, novel uricase-based strategies, including immune-tolerizing platforms such as nanoencapsulated sirolimus plus pegadricase (NASP), aim to overcome immunogenicity and treatment burden associated with pegloticase. Novel agents targeting the NLRP3 inflammasome and IL-1β appear to have promise for anti-inflammatory prophylaxis and flare treatment that are integral to effective ULT. Currently, with several next-generation agents in late-phase trials, efforts will be needed to enhance the generalizability of these studies to older patients with comorbidity that are common to real-world gout care."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Gout • Immunology • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology • IL1B • NLRP3

Concomitant use of canakinumab may lead to steroid-free dosing of pegloticase (EULAR 2026) - "Background Pegloticase plus methotrexate has been shown to dramatically improve response rates over pegloticase alone and reduces infusion reactions to around 4%.(1) Part of the standard protocol for pegloticase plus methotrexate is the addition of IV steroid with each dose of pegloticase ranging from 60-125 mg of Solu- Medrol with each infusion.(2) Over the course of 1 year of treatment this would amount to approximately 1400-3000mg of steroid exposure...(table 1) One patient received oral prednisone 5mg/d for renal transplant protocol...One patient stated a non-physician observed gout flare that was resolved after a single dose of colchicine and indomethacin...This new steroid free protocol shows promise of being able to dramatically reduce or eliminate steroid use during pegloticase treatment. The data strongly suggests further testing in a broader and more stringent manner is warranted."

Gout • Inflammatory Arthritis

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) - P4 | "Conclusions In this randomized, double-blind trial including co-administration with MTX, Q4W dosing of 16 mg pegloticase (56.5% response rate) did not demonstrate non-inferiority to standard Q2W dosing of 8 mg pegloticase which showed a 70.8% response rate consistent with prior trials.2 Non-inferiority was not established primarily due to higher non-response/discontinuation rates in the Q4W arm driven by the protocol SU stopping rule. Consistent with established data, this study demonstrated that every-two-week dosing of pegloticase with MTX coadministration remains the standard of care for uncontrolled gout."

Clinical • Head-to-Head • P4 data • Gout • Infectious Disease • Inflammatory Arthritis • Rheumatology

Association of Gout Remission With Patient-Reported Quality of Life Outcomes After Pegloticase Treatment: MIRROR Randomized Controlled Trial (EULAR 2026) - "Methods In the MIRROR RCT, patients received pegloticase (8-mg infusion every 2 weeks) with 15 mg weekly methotrexate, or received pegloticase plus placebo (PBO), for 52 weeks. Further, those achieving remission on pegloticase have a greater magnitude of improvement in patient-perceived pain and overall health impact due to gout as well as physician-assessed severity of disease compared to pegloticase-treated patients who fail to reach remission. Although modified remission criteria were used, these findings are consistent with prior analyses of GCAN remission criteria and PROs and further validate the use of remission criteria as a treatment endpoint."

Clinical • HEOR • Gout • Inflammatory Arthritis • Rheumatology

The Impact of Elevated Serum Urate Levels and Tophi on HRQOL and Daily Functioning in Patients with Uncontrolled Gout (EULAR 2026) - "Patients included adults (≥18 years) diagnosed with UG, defined as a history of symptomatic gout (≥2 gout flares within 12 months or presence of ≥1 gout tophus, or current diagnosis of symptomatic chronic gouty arthritis) and currently taking oral urate-lowering therapy or treated with pegloticase in the past 18 months...Conclusions Despite treatment with ULTs, patients with UG continue to experience poorer HRQOL and work and activity impairment, which are further exacerbated by a history of tophi or the presence of elevated sUA levels. This underscores the need for personalized care and for urgent treatment or escalating therapy to more effectively target these unmet needs."

Clinical • Gout • Inflammatory Arthritis • Rheumatology

Baseline Predictors of Gout Remission During Intensive Urate-Lowering With Pegloticase: Post Hoc Analysis of the MIRROR Randomized Trial (EULAR 2026) - "Methods In the MIRROR RCT, patients received pegloticase (8-mg infusion every 2 weeks) with 15 mg weekly methotrexate (MTX), or received pegloticase plus placebo (PBO), for 52 weeks. Additionally, while flares and tophi burden reduced the odds of remission at 24 weeks, the effect of these variables was diminished or lost with continued treatment to 52 weeks, underscoring the benefit of a longer pegloticase course up to 52 weeks. Although a small retrospective analysis of a clinical trial, these exploratory analyses demonstrate that profound serum urate lowering may help uncontrolled gout patients with severe or longer-standing disease reach clinical remission within one year of therapy."

Clinical • Retrospective data • Chronic Kidney Disease • 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) - P4 | "Additionally, uncontrolled gout patients from the MIRROR trial had significant gout flare history in the 12 months prior to enrollment reporting 10.6 and 11.3 gout flares in the methotrexate and placebo arms respectively. Conclusions The ability of pegloticase to lower serum uric acid was observed regardless of the presence of clinically evident tophi at baseline. Gout patients without visible tophi but significant flares or chronic gouty arthritis may obtain clinically meaningful benefit from pegloticase treatment."

Clinical • Retrospective data • Gout • Inflammatory Arthritis • Rheumatology

Preinfusion Glucocorticoid Reduction and Elimination in Patients With Uncontrolled Gout on Pegloticase and Methotrexate: A Case Series. (PubMed, J Clin Rheumatol) - "This study demonstrated that preinfusion GC reduction and elimination are possible in patients with uncontrolled gout receiving pegloticase and MTX co-therapy."

Journal • Gout • Inflammatory Arthritis • Rheumatology

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

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

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

Severe Anemia and Acute Kidney Injury After Pegloticase in a Patient With Glucose-6-Phosphate Dehydrogenase Deficiency. (PubMed, Cureus) - "This case highlights the importance of recognizing delayed or atypical presentations of drug-induced hemolysis, in which traditional markers may be normal at the time of evaluation. Clinicians should maintain a high index of suspicion for hemolysis after pegloticase administration in G6PD-deficient patients and ensure appropriate screening prior to therapy."

Journal • Acute Kidney Injury • Anemia • Gout • Hematological Disorders • Inflammatory Arthritis • Metabolic Disorders • Nephrology • Renal Disease • Rheumatology • HP

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout (clinicaltrials.gov) - P4 | N=262 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Gout • Inflammatory Arthritis • Rheumatology

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

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

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