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


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  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    Pharmacokinetics of Pegloticase and Methotrexate Polyglutamate(s) in Patients with Uncontrolled Gout Receiving Pegloticase and Co-treatment with Methotrexate (Poster View 8) -  May 6, 2022 - Abstract #EULAR2022EULAR_2560;    
    The combination of immunomodulation with pegloticase should be considered in routine clinical practice to improve durability of response, efficacy, and safety among patients with uncontrolled gout who otherwise have limited therapeutic options. Pegloticase 8 mg IV every 2 weeks with MTX co-treatment (oral 15 mg weekly) reduced anti-PEG Ab incidence and resulted in higher pegloticase exposures compared to pegloticase administered with PBO, consistent with the increased clinical efficacy observed with pegloticase + MTX co-administration.
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Enrollment open:  A Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia (clinicaltrials.gov) -  Apr 8, 2022   
    P1,  N=45, Recruiting, 
    These results transcend uricase and can be applied to other PEGylated therapeutics and the broader class of biologics with suboptimal PK. Not yet recruiting --> Recruiting
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    907 Gout: Exploring a Chronic Systemic Disease of the Kidney () -  Mar 19, 2022 - Abstract #NKFSCM2022NKF_SCM_843;    
    Session Description Describe the increasing burden of gout and review the efficacy and safety of KRYSTEXXA (pegloticase) for the management of uncontrolled gout. Supported by Horizon Therapeutics
  • ||||||||||  Journal:  What's new on the front-line of gout pharmacotherapy? (Pubmed Central) -  Feb 26, 2022   
    Novel uricosurics are a class for continued drug development; verinurad and arhalofenate are agents with future promise...Its immunogenicity significantly threatens the achievement of sustained urate lowering responses. Abrogating pegloticase's immunogenicity with immunomodulatory co-therapy may lend to sustained efficacy.
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Trial completion date:  ULTRA-T2D: Uric Acid Lowering Trial in Youth Onset T2D (clinicaltrials.gov) -  Feb 16, 2022   
    P2,  N=10, Recruiting, 
    Abrogating pegloticase's immunogenicity with immunomodulatory co-therapy may lend to sustained efficacy. Trial completion date: Dec 2023 --> May 2023
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    Engineering Graft-to Polynorbornene Based Uricase Conjugates with low immunogenicity (Marriott Grand Ballroom: Section 2 (Marriott Marquis San Diego Marina)) -  Jan 28, 2022 - Abstract #ACSSp2022ACS_Sp_10933;    
    Pegloticase (PEG-uricase) used for the treatment of gout was met with 38% patients eliciting anti-PEG antibodies in Phase I and 89% patients in the Phase III trials leading to a loss of treatment response, increased drug clearance and risk of infusion reactions and adverse events in at least 90% of the patients...We expect that our PNB-uricase conjugates will have a reduced antibody recognition compared to the unmodified uricase enzyme. Additionally, it eliminates the chances of polymer specific anti-PEG antibody binding.Fig 1: Synthesis scheme of graft-to Uricase-conjugates
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    Review, Journal:  The Management of Gout in Renal Disease. (Pubmed Central) -  Dec 16, 2021   
    We review the available data linking CKD, gout, and hyperuricemia, providing practice guidelines on managing gout in CKD patients and kidney transplant recipients. We advocate for much greater involvement of nephrologists in the management of gout in renal patients.
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Trial completion date, Trial initiation date, Trial primary completion date:  Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome (clinicaltrials.gov) -  Nov 26, 2021   
    P4,  N=10, Not yet recruiting, 
    Active, not recruiting --> Completed Trial completion date: Sep 2021 --> Sep 2022 | Initiation date: Mar 2021 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Sep 2022
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    Preclinical, Journal:  High MW polyethylene glycol prolongs circulation of pegloticase in mice with anti-PEG antibodies. (Pubmed Central) -  Nov 24, 2021   
    In contrast, pre-infusion of free PEG into PEG-sensitized mice restored the AUC of pegloticase to ~80% of that seen in naïve mice, resulting in a similar biodistribution to pegloticase in naïve mice over time. These results suggest that pre-infusion of free PEG may be a promising strategy to enable the safe and efficacious use of pegloticase and other PEGylated drugs in patients that have previously failed therapy due to induced APA.
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Trial completion:  REduCing Immunogenicity to PegloticasE (RECIPE) Study (clinicaltrials.gov) -  Nov 10, 2021   
    P2,  N=35, Completed, 
    These results suggest that pre-infusion of free PEG may be a promising strategy to enable the safe and efficacious use of pegloticase and other PEGylated drugs in patients that have previously failed therapy due to induced APA. Active, not recruiting --> Completed
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    [VIRTUAL] Safety of Pegloticase with Immunomodulation Co-Therapy: Literature Review () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_3910;    
    Due to the frequency of CKD in gout patients, other IMM agents were frequently used, including mycophenolate mofetil, leflunomide, azathioprine, and cyclosporine...Semin Arthritis Rheum. 2021 Apr;51(2):347-352.
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    [VIRTUAL] Claims-Based Evaluation of Pegloticase Use in Gout Patients with a History of Kidney Transplant () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_3909;    
    A main consideration with pegloticase efficacy is potential development of anti-drug antibodies (ADAs). Given that solid-organ transplant patients are on IMS medications to preserve their grafted organ, this likely contributed to prevention of ADAs indicated by the longer average duration of therapy compared to other real-world pegloticase datasets.
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    [VIRTUAL] Improving the Management of Gout in Patients with CKD or Kidney Transplant: Effect of Online Education () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_2193;    
    Specific areas of improvement include: Treat-to-target strategy with a target of serum UA level < 6 mg/dL in patients taking urate lowering therapy (20% relative improvement, P<.05) Starting low-dose allopurinol in a patient previously diagnosed with gout and stage 3 CKD, presenting with painful subcutaneous tophi (25% relative improvement, P<.01) Recommending pegloticase without dose adjustment for the management of refractory gout in patients with stage 4 or 5 CKD (222% relative improvement, P<.001) Post-education, 48% of nephrologists had a measurable increase in confidence in their ability to manage patients with CKD who may develop gout. Conclusion This study demonstrated the success of online, segmented, mini-lectures on improving the evidence-based knowledge, competence, and confidence of nephrologists in appropriately managing gout in patients with CKD or kidney transplant.
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    [VIRTUAL] 8M701: KRYSTEXXA: The First and Only Biologic for Uncontrolled Gout (Room 1) -  Oct 13, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_3104;    
    we believe that the results of this study allow us to recommend ULT with topiroxostat or febuxostat for patients with CKD. Developed and offered by Horizon Therapeutics
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    Clinical, Journal, Combination therapy:  Pegloticase in combination with methotrexate in patients with uncontrolled gout: A multicenter, open-label study (MIRROR). (Pubmed Central) -  Sep 29, 2021   
    P4
    In this study, an increased proportion of patients maintained therapeutic response at 6 months when treated concomitantly with methotrexate and pegloticase when compared to the previously reported 42% using pegloticase alone. These results support the need for a randomized study of methotrexate or placebo with pegloticase to validate these open label findings.
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    Clinical, Review, Journal:  The effect of immunomodulators on the efficacy and tolerability of pegloticase: a systematic review. (Pubmed Central) -  Sep 24, 2021   
    These results support the need for a randomized study of methotrexate or placebo with pegloticase to validate these open label findings. Published reports suggest that immunomodulation co-therapy has the potential to markedly improve pegloticase responder rates in patients with uncontrolled gout.
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    [VIRTUAL] Gout Stigma: Investigating the Existence of Gout Stigma and Its Impact on Patient Perceptions and Treatment Decisions () -  Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_936;    
    Despite advanced training and high knowledge of gout, rheumatologists’ causal beliefs and illness perceptions for patients with gout/UG compared to RA reflect negative gout related stereotypes, with implications for treatment recommendations. Patients with gout/UG vs. RA were perceived as more responsible for their own condition and less likely to adhere to or benefit from biological pharmacological treatment.
  • ||||||||||  Krystexxa (pegloticase) / Horizon Therapeutics
    [VIRTUAL] Concomitant Immunomodulation and Pegloticase Therapy: Experiences with a Variety of Immunomodulatory Agents in Two Community Rheumatology Practices () -  Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_926;    
    All patients received pre-infusion prophylaxis (125 mg IV methylprednisolone or 100 mg hydrocortisone, 180 mg oral fexofenadine or 25 mg IVP diphenhydramine)...Immunomodulator co-therapy was initiated prior to (5.3±3.0 weeks, n=32) or at (n=2) first pegloticase infusion and included subcutaneous (subQ) methotrexate (MTX; 15.4±4.9mg/week [range: 10-25 mg/week], n=20), oral MTX (15.3±3.6 mg/week [range: 7.5-20 mg/week], n=9), oral mycophenolate mofetil (MMF; all 1000 mg/day, n=3), and oral azathioprine (AZA; all 100 mg/day, n=2)... These data provide further support for concomitant immunomodulator/pegloticase therapy, showing similar efficacy rates to both an open-label trial with oral MTX (79%) 4 and a systematic literature review of all immunomodulators (83%).
  • ||||||||||  Zurampic (lesinurad) / AstraZeneca, Krystexxa (pegloticase) / Horizon Therapeutics
    Clinical, Review, Journal:  Interventions for tophi in gout. (Pubmed Central) -  Sep 19, 2021   
    Lesinurad (400 mg or 200 mg) plus allopurinol is probably not beneficial for tophi resolution, and there was no difference in adverse events between these groups. RCTs on interventions for managing tophi in gout are needed, and the lack of trial data is surprising given that allopurinol is a well-established treatment for gout.