Trial reportArthritis research & therapy2013
Tophus burden reduction with pegloticase: results from phase 3 randomized trials and open-label extension in patients with chronic gout refractory to conventional therapy.
Trial report in Arthritis research & therapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout
Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
Who cites it
38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.
- 2020 American College of Rheumatology Guideline for the Management of Gout.Arthritis care & research · 2020Guideline
- Uric acid lowering therapies for preventing or delaying the progression of chronic kidney disease.The Cochrane database of systematic reviews · 2017Pooled it
- Serum uric acid and its metabolism-a vital factor in the inflammatory transformation of cancer.Journal of advanced research · 2026Review
- Review
- From soluble uric acid to sodium urate crystal: immune metabolic inflammation driven by uric acid morphological transformation and mechanism-oriented therapy.Frontiers in immunology · 2026Review
- Nanotechnology Approaches for Mitigating Biologic Immunogenicity: A Literature Review.Pharmaceutics · 2025Review
- Case Report: Sliding gouty tophi: a case of dynamic ultrasound diagnosis of carpal tunnel syndrome.Frontiers in surgery · 2025Article
- Refractory Gout and Metabolic Syndrome in a Chinese Cohort: A Propensity Score Matching and Nonlinear Relationship Analysis.Journal of inflammation research · 2025Article
- Arthroscopic surgery for ankle gouty arthritis: a retrospective analysis of clinical outcomes at six month follow-up based on a novel classification system.International orthopaedics · 2024Article
- Mechanisms and rationale for uricase use in patients with gout.Nature reviews. Rheumatology · 2023Review
- The Hong Kong Society of Rheumatology consensus recommendations for the management of gout.Clinical rheumatology · 2023Review
- Generation of Photopolymerized Microparticles Based on PEGDA Hydrogel Using T-Junction Microfluidic Devices: Effect of the Flow Rates.Micromachines · 2023Article
- The Singapore Experience With Uncontrolled Gout: Unmet Needs in the Management of Patients.Cureus · 2023Review
- Article
- Critical appraisal of serum urate targets in the management of gout.Nature reviews. Rheumatology · 2022Review
- Clinical features of gout in adult patients with type Ia glycogen storage disease: a single-centre retrospective study and a review of literature.Arthritis research & therapy · 2022Review
- Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia.Nature communications · 2022Article
- Expert Opinion on Pegloticase with Concomitant Immunomodulatory Therapy in the Treatment of Uncontrolled Gout to Improve Efficacy, Safety, and Durability of Response.Current rheumatology reports · 2022Review
- Immunogenicity of biologic agents in rheumatology.Nature reviews. Rheumatology · 2021Review
- Therapeutic Strategies for the Treatment of Chronic Hyperuricemia: An Evidence-Based Update.Medicina (Kaunas, Lithuania) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTwo replicate randomized, placebo-controlled six-month trials (RCTs) and an open-label treatment extension (OLE) comprised the pegloticase development program in patients with gout refractory to conventional therapy. In the RCTs, approximately 40% of patients treated with the approved dose saw complete response (CR) of at least one tophus. Here we describe the temporal course of tophus resolution, total tophus burden in patients with multiple tophi, tophus size at baseline, and the relationship between tophus response and urate-lowering efficacy.
methodsBaseline subcutaneous tophi were analyzed quantitatively using computer-assisted digital images in patients receiving pegloticase (8 mg biweekly or monthly) or placebo in the RCTs, and pegloticase in the OLE. Tophus response, a secondary endpoint in the trials, was evaluated two ways. Overall tophus CR was the proportion of patients achieving a best response of CR (without any new/enlarging tophi) and target tophus complete response (TT-CR) was the proportion of all tophi with CR.
resultsAmong 212 patients randomized in the RCTs, 155 (73%) had ≥ 1 tophus and 547 visible tophi were recorded at baseline. Overall tophus CR was recorded in 45% of patients in the biweekly group (P = 0.002 versus placebo), 26% in the monthly group, and 8% in the placebo group after six months of RCT therapy. TT-CR rates at six months were 28%, 19%, and 2% of tophi, respectively. Patients meeting the primary endpoint of sustained urate-lowering response to therapy (responders) were more likely than nonresponders to have an overall tophus CR at six months (54% vs 20%, respectively and 8% with placebo).
conclusionsPegloticase reduced tophus burden in patients with refractory tophaceous gout, especially those achieving sustained urate-lowering. Complete resolution of tophi occurred in some patients by 13 weeks and in others with longer-term therapy. TRIAL REGISTRATIONS: NCT00325195, NCT01356498.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.