Krystexxa (pegloticase) / Amgen 
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 16 Diseases   4 Trials   4 Trials   584 News 


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  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Enrollment open:  ULTRA-T2D: Uric Acid Lowering Trial in Youth Onset T2D (clinicaltrials.gov) -  Mar 23, 2020   
    P2,  N=10, Recruiting, 
    Not yet recruiting --> Recruiting
  • ||||||||||  pegsiticase/SVP-rapamycin (SEL212) / Selecta, SOBI
    Enrollment closed, Trial completion date, Trial primary completion date:  A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA (clinicaltrials.gov) -  Mar 19, 2020   
    P2,  N=150, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Feb 2020 --> Aug 2020 | Trial primary completion date: Jan 2020 --> Jul 2020
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    [VIRTUAL] IMMUNOMODULATION CO-THERAPY WITH PEGLOTICASE: DATABASE TRENDS 2014-2019 (Barnes) -  Mar 4, 2020 - Abstract #EULAR2020EULAR_575;    
    We found evidence of a relatively dramatic increasing initiation of immunomodulation therapy with pegloticase beginning soon after a November 2018 presentation of a case series which demonstrated improved response rates of pegloticase when co-administered with methotrexate. These data indicate that clinicians began to more frequently employ a strategy of DMARD co-treatment with pegloticase in 2019 to improve response rates to this important gout medicine.
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    Journal:  Pegloticase-Associated Hemolysis. (Pubmed Central) -  Feb 7, 2020   
    These data indicate that clinicians began to more frequently employ a strategy of DMARD co-treatment with pegloticase in 2019 to improve response rates to this important gout medicine. No abstract available
  • ||||||||||  allopurinol / Generic mfg.
    Review, Journal:  Potential dangers of serum urate-lowering therapy. (Pubmed Central) -  Dec 29, 2019   
    On the contrary, 7 recent placebo-controlled trials of urate-lowering drugs with different mechanisms of action (uricosuric: lesinurad; xanthine oxidase inhibition: febuxostat; uricase: pegloticase) have observed higher mortality or trends to higher mortality in gout patients, with the largest decreases in serum urate...Urate accounts for most of the antioxidant capacity of plasma and strategies to increase urate are undergoing clinical trials in neurological disease. Post-hoc analysis of recent trials should explore whether the magnitude of urate lowering is associated with adverse outcomes, and safety trials are needed before guidelines recommend lowering serum urate below certain thresholds.
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Enrollment closed:  REduCing Immunogenicity to PegloticasE (RECIPE) Study (clinicaltrials.gov) -  Nov 26, 2019   
    P2,  N=35, Active, not recruiting, 
    This composite CR index can serve as an evidence-based target to inform the design and end points of future clinical trials. Recruiting --> Active, not recruiting
  • ||||||||||  Krystexxa (pegloticase) / Horizon
    Journal:  A Chromatin-Mimetic Nanomedicine for Therapeutic Tolerance Induction. (Pubmed Central) -  Oct 25, 2019   
    Moreover, we also demonstrated that prophylactic treatments with this nanomedicine could tolerize the immune system with the allergen of ovalbumin (OVA) and thus inhibit the occurrence of airway inflammation in an OVA-induced allergic asthma murine model. Collectively, our work illustrates a nature-inspired concept of immune tolerance induction and establishes a useful tool to specifically suppress unwanted immune responses for therapeutic purposes.
  • ||||||||||  Krystexxa (pegloticase) / Horizon
    PK/PD data, Preclinical, Journal:  A minimal physiologically based pharmacokinetic model that predicts anti-PEG IgG-mediated clearance of PEGylated drugs in human and mouse. (Pubmed Central) -  Oct 9, 2019   
    Our model predicts that the prolonged circulation of PEGylated drugs will be compromised only at APA concentrations greater than ~500 ng/mL, providing a quantitative explanation to why the effects of APA on PEGylated treatments appear to be limited in most patients. This mPBPK model is readily adaptable to other PEGylated drugs and particles to predict the precise levels of APA that could render them ineffective, providing a powerful tool to support the development and interpretation of preclinical and clinical studies of various PEGylated therapeutics.
  • ||||||||||  pegsiticase (SEL-037) / Selecta, Krystexxa (pegloticase) / Horizon
    Phase 2 Dose-ranging Study of SEL-212 in Symptomatic Gout Patients: Selection of Doses for Further Clinical Development (Hall B5) -  Oct 7, 2019 - Abstract #ACRARHP2019ACR_2127;    
    P2
    Based on these results, the combination of pegadricase (0.2 mg/kg) and ImmTOR (0.15 mg/kg) were selected for use in a head-to-head comparison study of SEL-212 to pegloticase, a pegylated uricase currently FDA approved for use in patients with treatment-refractory gout (NCT03905512). Cohort layout for ImmTOR dose of 0.08 mg/kg and above
  • ||||||||||  Uloric (febuxostat) / Takeda, Ipsen, Menarini, allopurinol / Generic Mfg.
    Comparative Risk of Cardiovascular Events in US Veterans with Gout Treated with Febuxostat versus Allopurinol (Hall B5) -  Oct 7, 2019 - Abstract #ACRARHP2019ACR_1231;    
    Exclusion criteria included patients with end stage renal disease or on dialysis; use of pegloticase or rasburicase in the 365 days before the index date. By using marginal structural model to reduce bias caused by non-random censoring and treatment assignment, we found no differences in the risk of MACE events between febuxostat and allopurinol users in a large cohort of veterans with gout.
  • ||||||||||  allopurinol / Generic Mfg.
    Patterns of Newer Gout Medication Use in a U.S. Electronic Health Record-Based Registry (Hall B5) -  Oct 7, 2019 - Abstract #ACRARHP2019ACR_1224;    
    Febuxostat users had a higher prevalence of cardiovascular-related comorbidities compared to allopurinol users, inviting caution in the selection of patients to receive this therapy given recent FDA warnings. Disclaimer: This data was supported by the ACR’s RISE Registry.
  • ||||||||||  Krystexxa (pegloticase) / Horizon
    Development of a Multivariable Improvement Measure for Gout (Hall B5) -  Oct 7, 2019 - Abstract #ACRARHP2019ACR_1217;    
    GMIM20,50,70 may serve as an evidence-based tool for assessment of the quality of response to therapies in subjects with gout in medical practice or in clinical trials. Figure 1.
  • ||||||||||  allopurinol / Generic Mfg.
    3S040 MTP: 010 - Crystal: Gout Diagnosis & Management (A401) -  Sep 3, 2019 - Abstract #ACRARHP2019ACR_194;    
    Faculty will also review several representative abstracts on the treatment of gout presented at the 2019 ACR/ ARP Annual Meeting. Learning Objectives:Discuss xanthine oxidase inhibitors and cardiovascular eventsReview treatment options beyond allopurinol and febuxostat for the treatment of chronic goutDiscuss various ways to use pegloticase to reduce adverse events and increase efficacyDiscuss challenges related to medication adherence
  • ||||||||||  Krystexxa (pegloticase) / Horizon
    Journal:  The Needle or Knife: Pegloticase for Refractory Crippling Gout in a Nonagenarian. (Pubmed Central) -  Aug 21, 2019   
    Learning Objectives:Discuss xanthine oxidase inhibitors and cardiovascular eventsReview treatment options beyond allopurinol and febuxostat for the treatment of chronic goutDiscuss various ways to use pegloticase to reduce adverse events and increase efficacyDiscuss challenges related to medication adherence No abstract available
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Trial initiation date:  ULTRA-T2D: Uric Acid Lowering Trial in Youth Onset T2D (clinicaltrials.gov) -  Aug 1, 2019   
    P2,  N=10, Not yet recruiting, 
    No abstract available Initiation date: Jun 2019 --> Sep 2019
  • ||||||||||  Krystexxa (pegloticase) / Horizon
    Pegloticase in Gout Management (B304-B305) -  Jul 17, 2019 - Abstract #ACRARHP2019ACR_218;    
    Initiation date: Jun 2019 --> Sep 2019 Learning Objectives:Discuss urate-lowering therapeutic strategies in goutDiscuss the rationale for using pegloticase in gout Assess the results of the pegloticase clinical trial
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    New P4 trial:  MIRROR RCT: Study of KRYSTEXXA (clinicaltrials.gov) -  Jun 20, 2019   
    P4,  N=135, Recruiting, 
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Enrollment closed, Phase classification, Enrollment change, Trial completion date:  Study of Pegloticase (KRYSTEXXA (clinicaltrials.gov) -  Jun 4, 2019   
    P4,  N=17, Active, not recruiting, 
    Learning Objectives:Discuss urate-lowering therapeutic strategies in goutDiscuss the rationale for using pegloticase in gout Assess the results of the pegloticase clinical trial Recruiting --> Active, not recruiting | Phase classification: P2 --> P4 | N=30 --> 17 | Trial completion date: Dec 2019 --> Dec 2020
  • ||||||||||  allopurinol / generics
    Clinical, Journal:  Safety and tolerability of available urate-lowering drugs: a critical review. (Pubmed Central) -  May 17, 2019   
    Rasburicase and pegloticase are usually well tolerated with some specific exceptions. Before prescribing UL drugs, physicians should take into account their safety profile tailoring the treatment on the patient characteristics.
  • ||||||||||  Krystexxa (pegloticase) / Horizon
    KRYSTEXXA (Twitter) -  Apr 15, 2019   
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    New P2 trial:  ULTRA-T2D: Uric Acid Lowering Trial in Youth Onset T2D (clinicaltrials.gov) -  Apr 2, 2019   
    P2,  N=10, Not yet recruiting, 
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Enrollment open:  Study of Pegloticase (KRYSTEXXA (clinicaltrials.gov) -  Sep 24, 2018   
    P2,  N=30, Recruiting, 
    Before prescribing UL drugs, physicians should take into account their safety profile tailoring the treatment on the patient characteristics. Not yet recruiting --> Recruiting
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    New P2 trial:  Study of Pegloticase (KRYSTEXXA (clinicaltrials.gov) -  Aug 17, 2018   
    P2,  N=30, Not yet recruiting, 
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Enrollment open:  REduCing Immunogenicity to PegloticasE (RECIPE) Study (clinicaltrials.gov) -  Jun 2, 2018   
    P2,  N=32, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting