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Abstract Number: 0665

Pegloticase Treatment for Uncontrolled Gout in Kidney Transplanted Patients: Results of an On-going Multicenter, Open-Label, Efficacy and Safety Study

Abdul Abdellatif1, Lin Zhao2, Paul M. Peloso3, Katya Cherny2, Brad Marder2, John D. Scandling4 and Kenneth Saag5, 1Kidney Hypertension Transplant Clinic Clear Lake Specialties, Webster, TX, 2Horizon Therapeutics plc, Deerfield, IL, 3Horizon Therapeutics plc, Gurnee, IL, 4Stanford Medicine, Department of Nephrology, Stanford, CA, 5University of Alabama at Birmingham, Birmingham, AL

Meeting: ACR Convergence 2021

Keywords: Biologicals, clinical trial, gout, Renal, Uric Acid, Urate

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Session Information

Date: Sunday, November 7, 2021

Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I (0660–0682)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Gout in kidney transplant (KT) recipients can be severe and particularly challenging to manage. Pegloticase (pegylated recombinant uricase) rapidly metabolizes urate and is a highly effective therapy for uncontrolled gout, but its efficacy can be limited in some pateints by the development of anti-drug antibodies. The addition of immunomodulators as co-therapy with pegloticase has been shown to improve response rates.1-2 Few cases of pegloticase use in solid organ transplant patients have been reported and the phase 3 pegloticase trials excluded organ transplant recipients.3-5 This ongoing Phase 4, open-label trial (PROTECT NCT04087720) examines the safety and efficacy of pegloticase in KT patients with uncontrolled gout.

Methods: Pegloticase treatment (8 mg IV infusion q2w for 24 wks) in KT recipients (KT >1 year ago, eGFR ≥15 mL/min/1.73m2) with uncontrolled gout (serum urate [SU] ≥7 mg/dL, urate lowering therapy contraindication/inefficacy, and either tophi, chronic gouty arthritis, or ≥2 flares in past yr). Primary endpoint is proportion of pegloticase responders during Month 6 (SU < 6 mg/dL for ≥80% of time). Other endpoints included: eGFR and health assessment questionnaire (HAQ) pain (most severe: 100) and disability (max: 3) scores.

Results: At the time of analysis, 20 patients were enrolled (mean±SD; age: 53.9±10.9 yrs, KT 14.7±6.9 yrs ago, SU: 9.4±1.5 mg/dL, gout duration: 8.4±11.6 yrs; all on stable doses of ≥2 immunosuppresive medications) and 10 completed treatment, 3 discontinuted treatment (1 withdrew consent, 2 withdrew due to COVID-19 concerns), 2 patients met SU monitoring rules (pre-dose SU >6 mg/dL at 2 consecutive visits, nonresponders) and discontinued pegloticase, 5 were ongoing treatment. All patients experienced initial substantial reductions in SU, which was sustained in the majority; 2 met monitoring rules. No notable eGFR changes were observed. In patients who completed treatment, HAQ pain and disability improved by 26.7 ± 30.3 and 0.2 ± 0.5, respectively, at Week 24 (n=10). 7 SAEs (2 cellulitis, duodenal ulcer, sepsis, a-fib, diverticulitis, and localized infection), all deemed unrelated to pegloticase, were reported in 5 patients. No anaphylaxis or infusion reaction events have occurred.

Conclusion: On-going results from the PROTECT trial demonstrate promising outcomes treating uncontrolled gout in KT recipients with pegloticase with a substantial decrease in SU levels after initiating pegloticase therapy, which is maintained for the majority of patients. Patients also demonstrate a clinically meaningful reduction in pain (HAQ pain) and disability (HAQ-DI) with a stable eGFR. This phase 4, multicenter, open-label, efficacy and safety study will reach completion in Fall 2021.

References1. Keenan RT, et al. Sem Arth Rheum. 2021, 51:347-352.
2. Botson JK, et al. J Rheum. 2020 [EPub].
3. Sundy JS, et al. JAMA. 2011, 306(7):711-20.
4. Freyne B. Trans Proc 2018, 50:4099-101.
5. Hershfield MS, et al. Arth Res Ther 2014, 16:R63.


Disclosures: A. Abdellatif, Horizon Therapeutics plc, 2, 6, Amgen, 2, 6, Janssen, 2, 6, Relypsa, 2, 6, Keyrex, 2, 6, Mallinkrodt, 2, 6, Natera, 2, 6; L. Zhao, Horizon Therapeutics plc, 3, 11; P. Peloso, Horizon Therapeutics plc, 3, 11; K. Cherny, Horizon Therapeutics plc, 3, 11; B. Marder, Horizon Therapeutics plc, 3, 11; J. Scandling, Horizon Therapeutics plc, 2; K. Saag, Arthrosi, 2, Atom Bioscience, 2, Horizon Therapeutics, 2, 5, LG Pharma, 2, Mallinkrodt, 2, SOBI, 2, 5, Takeda, 2, Shanton, 5.

To cite this abstract in AMA style:

Abdellatif A, Zhao L, Peloso P, Cherny K, Marder B, Scandling J, Saag K. Pegloticase Treatment for Uncontrolled Gout in Kidney Transplanted Patients: Results of an On-going Multicenter, Open-Label, Efficacy and Safety Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/pegloticase-treatment-for-uncontrolled-gout-in-kidney-transplanted-patients-results-of-an-on-going-multicenter-open-label-efficacy-and-safety-study/. Accessed .
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