- |||||||||| Revolixys (anivamersen/pegnivacogin) / AbbVie, Omontys (peginesatide) / Affymax, Krystexxa (pegloticase) / Horizon Therapeutics
ROS-scavenging (Regency Ballroom C (Hyatt Regency Indianapolis)) - Feb 14, 2023 - Abstract #ACSSp2023ACS_SP_12755; B. Unlike with PEG, no anti-polymer antibodies were formed in PTGG/OVA treated mice.
- |||||||||| Krystexxa (pegloticase) / Amgen
Trial completion date, Trial primary completion date: Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome (clinicaltrials.gov) - Dec 8, 2022 P4, N=10, Recruiting, Pegloticase + methotrexate co-therapy resulted in sustained SU-lowering with meaningful improvements in clinical measures, urate burden, and patient-reported outcomes. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Krystexxa (pegloticase) / Horizon Therapeutics
eGFR Changes in Uncontrolled Gout Patients Undergoing Pegloticase Plus Methotrexate Co-Therapy (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_3294; Conclusion These limited data show similar pegloticase+MTX urate-lowering efficacy in CKD and non-CKD pts. Most CKD pts had renal stability/improvement during therapy, but further study is needed.
- |||||||||| Krystexxa (pegloticase) / Amgen
Enrollment open: Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome (clinicaltrials.gov) - Sep 30, 2022 P4, N=10, Recruiting, Conclusion Pegloticase 8 mg IV q2w with standard of care immunosuppressants in transplant patients resulted in a high SU responder rate and improved pegloticase exposure. Active, not recruiting --> Recruiting
- |||||||||| Krystexxa (pegloticase) / Horizon Therapeutics
eGFR Changes in Uncontrolled Gout Patients Undergoing Pegloticase + Methotrexate Co-therapy (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2991; These limited data show similar pegloticase+MTX urate-lowering efficacy in CKD and non-CKD patients. Additionally, no new safety signals were identified with the majority of CKD patients showing eGFR stability or improvement during therapy.
- |||||||||| Krystexxa (pegloticase) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date: Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome (clinicaltrials.gov) - Sep 7, 2022 P4, N=10, Active, not recruiting, These findings verify higher treatment response rate, lower IR incidence, and lower immunogenicity when pegloticase is co-administered with MTX. Recruiting --> Active, not recruiting | Trial completion date: Sep 2022 --> Dec 2022 | Trial primary completion date: Sep 2022 --> Dec 2022
- |||||||||| Krystexxa (pegloticase) / Horizon Therapeutics
PK/PD data, Journal: A multicentre, efficacy and safety study of methotrexate to increase response rates in patients with uncontrolled gout receiving pegloticase (MIRROR): 12-month efficacy, safety, immunogenicity, and pharmacokinetic findings during long-term extension of an open-label study. (Pubmed Central) - Sep 3, 2022 P4 Pegloticase + methotrexate co-therapy was well-tolerated over 12 months, with sustained SU lowering, progressive gout flare reduction, and no new safety concerns. Antibody/PK findings suggest methotrexate attenuates ADA formation, coincident with higher treatment response rates.
- |||||||||| Krystexxa (pegloticase) / Horizon Therapeutics
Review, Journal: A glance into the future of gout. (Pubmed Central) - Aug 6, 2022 Overall, the single change that will most impact gout management is greater uptake of international rheumatology society recommendations. Innovative strategies, such as nurse-led interventions based on these recommendations have recently demonstrated treatment success for people with gout.
- |||||||||| Krystexxa (pegloticase) / Horizon Therapeutics
PEGLOTICASE USE IN RENAL TRANSPLANT RECIPIENTS WITH GOUT: AN INSURANCE CLAIMS STUDY () - May 24, 2022 - Abstract #EULAR2022EULAR_3976; 7 Real world data from KT patients support the hypothesis that transplant immunosuppression may allow more patients to receive a longer course of pegloticase therapy, presumably via anti-drug antibody attenuation. This is of particular importance for this vulnerable patient group that is at a high risk for developing uncontrolled gout.
- |||||||||| Krystexxa (pegloticase) / Horizon Therapeutics
REAL-WORLD REPORTING OF GOUT FLARES IN UNCONTROLLED GOUT PATIENTS CO-TREATED WITH PEGLOTICASE AND METHOTREXATE () - May 24, 2022 - Abstract #EULAR2022EULAR_3975; Consistent with clinical trials, 2,3 flare rate was highest during the first 4 weeks of pegloticase treatment, progressively decreasing over time. Interestingly, these data suggest that patients who experience gout flares on pegloticase may have more obesity and a higher comorbidity burden than those who do not experience flares.
- |||||||||| Krystexxa (pegloticase) / Horizon Therapeutics
Pegloticase Use in Renal Transplant Recipients with Gout: Findings from an Insurance Claims Database Study (Hynes Halls C & D: Board No. A160) - May 20, 2022 - Abstract #ATC2022ATC_3228; These findings are consistent with other reports of immunomodulation with pegloticase. This study showed a higher median number of pegloticase infusions than reported in prior claims-based studies of non-KT patients.7 Real world data from KT patients support the hypothesis that transplant immunosuppression can prevent the development of anti-drug antibodies to improve the rate of complete response to pegloticase in this vulnerable patient group that has a high risk for uncontrolled gout.
- |||||||||| Krystexxa (pegloticase) / Amgen
Trial completion: MIRROR RCT: Study of KRYSTEXXA (clinicaltrials.gov) - May 16, 2022 P4, N=152, Completed, This study showed a higher median number of pegloticase infusions than reported in prior claims-based studies of non-KT patients.7 Real world data from KT patients support the hypothesis that transplant immunosuppression can prevent the development of anti-drug antibodies to improve the rate of complete response to pegloticase in this vulnerable patient group that has a high risk for uncontrolled gout. Active, not recruiting --> Completed
- |||||||||| Krystexxa (pegloticase) / Amgen
Enrollment change, Trial completion date, Trial primary completion date: A Phase 4, Open-label Study of KRYSTEXXA (clinicaltrials.gov) - May 16, 2022 P4, N=40, Recruiting, Active, not recruiting --> Completed N=30 --> 40 | Trial completion date: Jan 2023 --> Oct 2023 | Trial primary completion date: Oct 2022 --> Aug 2023
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