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Abstract Number: 1814

Pegloticase for Uncontrolled Gout in Patients with History of Kidney Transplant: Pharmacokinetics and Immunogenicity in the PROTECT Clinical Trial

Abdul Abdellatif1, Yan Xin2, Jason Chamberlain3, Lin Zhao2, Katya Cherny3, Brad Marder4, John D Scandling5 and kenneth saag6, 1Kidney Hypertension Transplant Clinic Clear Lake Specialties, Webster, TX, 2Horizon Therapeutics, Deerfield, IL, 3Horizon Therapeutics plc, Deerfield, IL, 4Horizon Therapeutics, Denver, CO, 5Stanford University School of Medicine, Division of Nephrology, Palo Alto, CA, 6University of Alabama at Birmingham, Birmingham, AL

Meeting: ACR Convergence 2022

Keywords: gout, Renal, Uric Acid, Urate

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Session Information

Date: Monday, November 14, 2022

Title: Metabolic and Crystal Arthropathies – Basic and Clinical Science Poster

Session Type: Poster Session D

Session Time: 1:00PM-3:00PM

Background/Purpose: Immunomodulator co-therapy with pegloticase has been shown to reduce immunogenicity (anti-drug antibody [ADA] development), which markedly improves response rates with pegloticase while reducing risk for infusion reactions.1-3 PROTECT (NCT04087720), an open-label, single-arm study in uncontrolled gout patients (pts) with functioning kidney transplant (KT) on stable immunosuppressants demonstrated that pegloticase was effective in reducing serum urate (SU) levels with a high (88.9% [95%CI: 65.3, 98.6]) responder rate while preserving key graft function indicators.4 The objective of this analysis was to evaluate the pharmacokinetics (PK) and immunogenicity of pegloticase in uncontrolled gout pts with a history of KT on immunosuppression.

Methods: Pegloticase (8 mg infusion [IV]) was administered every two weeks for 24 weeks. PK evaluation of pegloticase concentrations and immunogenicity of anti-monomethoxy-poly [ethylene glycol] (PEG) and anti-uricase IgG antibodies analysis was performed on serum samples. Responders were defined as pts achieving and maintaining a SU of < 6 mg/dL for at least 80% of time during Month 6. Two pts who withdrew consent due to coronavirus disease 2019 (COVID-19) concerns prior to Month 6 were not included in the responder analysis, per the statistical analysis plan.

Results: Twenty pts received at least 1 dose of pegloticase and were included in the analysis. The mean (SD) age was 53.9 (10.9) with the majority (90.0%) 40 to 81 years of age. Most were male (85.0%), 45.0% white, and 35.0% black or African American. Median baseline estimated glomerular filtration rate (eGFR) and baseline Urine Albumin-Creatinine Ratio (UACR) were 41.70 mL/min/1.73m2 and 312.00 mg/g, respectively. Following treatment initiation, the median (min, max) pre-dose pegloticase concentration ranged from 0.97 (0.8, 1.9) µg/mL (at Week 2; n=20) to 1.59 (0.8, 4.1) µg/mL (at Week 14; n=15) and the median (min, max) post-dose pegloticase concentration ranged from 1.57 (1.0, 2.6) µg/mL (at Week 1; n=18) to 3.60 (2.0, 5.9) µg/mL (at Week 14; n=16) across visits. Measurable pegloticase concentrations were maintained in SU responders through Month 6. In contrast, the 2 non-responders both had pre-dose pegloticase concentrations below the limit of quantification (BLQ), and one had a BLQ value post-pegloticase infusion, which was consistent with the immunogenicity (ADA) results. No infusion reactions or anaphylaxis occurred during the trial.

Conclusion: Pegloticase exposures in kidney transplant patients on stable immunosuppression were higher than those previously observed on pegloticase monotherapy1-3, which corresponded to the high clinical response rate previously reported for this kidney transplant patient cohort.4

References:
1. Keenan RT, et al. Seminars in Arthritis and Rheumatism 2021; 51:347-352
2. Botson J, et al. J Rheumatol 2021;48:767-74
3. Xin Y, et al. EULAR 2022; POS1163
4. Abdellatif A, et al. Amer Soc Neph; 2021, Abstract PO1127


Disclosures: A. Abdellatif, Amgen, Aurinia, Bayer, Horizon Therapeutics, Janssen, Keryx, Mallinckrodt, Merck, Natera, Opko, Rockwell, Vifor Pharma, Pharmacosmos; Y. Xin, Horizon Therapeutics; J. Chamberlain, Horizon Therapeutics; L. Zhao, Horizon Therapeutics; K. Cherny, Horizon Therapeutics; B. Marder, Horizon Therapeutics; J. Scandling, Horizon Therapeutics; k. saag, Horizon Therapeutics, SOBI, Shanton, AbbVie/Abbott.

To cite this abstract in AMA style:

Abdellatif A, Xin Y, Chamberlain J, Zhao L, Cherny K, Marder B, Scandling J, saag k. Pegloticase for Uncontrolled Gout in Patients with History of Kidney Transplant: Pharmacokinetics and Immunogenicity in the PROTECT Clinical Trial [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/pegloticase-for-uncontrolled-gout-in-patients-with-history-of-kidney-transplant-pharmacokinetics-and-immunogenicity-in-the-protect-clinical-trial/. Accessed .
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