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(25) SAFETY AND EFFICACY OF RECOMBINANT HUMAN PARATHYROID HORMONE 1-84 FOR THE TREATMENT OF ADULTS WITH CHRONIC HYPOPARATHYROIDISM: SIX-YEAR RESULTS OF THE RACE STUDY


Authors:

Henry Bone, MD – Director, Michigan Bone & Mineral Clinic, PC, Detroit, MI, USA

Bart L. Clarke, MD – Consultant Metabolic Bone Disease Core Group and Professor of Medicine, Mayo Clinic Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Rochester, MN, USA

On behalf of the RACE study, group – RACE Study Group, Sponsor; Shire Human Genetic Therapies, Inc., Cambridge, MA, USA

Henry Bone, MD – Director, Michigan Bone & Mineral Clinic, PC, Detroit, MI, USA

John Bilezikian, MD

Douglas Denham, DO, CPI – Medical Director, Clinical Trials of Texas, Inc., San Antonio, TX, USA

Hak-Myung Lee

Michael A. Levine

Michael Mannstadt

Munro Peacock

Jeffrey Rothman

Dolores M. Shoback

Tamara J. Vokes

Mark L. Warren

Nelson B. Watts

Abstract:

Objective :

RACE is an open-label study that assessed the long-term safety and efficacy of recombinant human parathyroid hormone 1-84 (rhPTH[1-84]) for the treatment of hypoparathyroidism in adults (ClinicalTrials.gov NCT01297309). Here, we present 6-year safety and efficacy data.

Methods :

Patients initially received 25 or 50 µg/day of rhPTH(1-84) subcutaneously, once daily, with stepwise dose adjustments of 25 µg (up or down) to 100 µg/day max. rhPTH(1-84) could be titrated and oral calcium (Ca) and calcitriol doses adjusted at any time during the study to maintain albumin-corrected serum Ca levels in the target range of 8.0–9.0 mg/dL. A composite efficacy endpoint was the proportion of patients who achieved at least a 50% reduction from baseline (BL) in oral Ca dose (or Ca ≤500 mg/day) and at least a 50% reduction from BL in calcitriol dose (or calcitriol ≤0.25 µg/day), while normalizing or maintaining albumin-corrected serum Ca compared with BL value and not exceeding the upper limit of normal for the central laboratory. Descriptive summary statistics (mean[SD]) are shown.

Results :

The study cohort consisted of 49 patients enrolled at 12 US centers (mean age, 48.1[9.78] years; 81.6% female); data from 34 patients (69.4%) who completed 72 months (M72) of rhPTH(1-84) treatment as of July 17, 2018 are presented. Oral Ca and calcitriol doses were reduced by 40.4% and 72.2% at M72, respectively, and albumin-corrected serum Ca levels were maintained within target range (BL, 8.4[0.70] mg/dL; M72, 8.4[0.68] mg/dL). At M72, 22 of 34 patients (64.7%) achieved the composite efficacy endpoint. Urinary Ca excretion declined from above-normal at BL to within normal range (BL, 356.7[200.37] mg/24 h; M72, 213.2[128.82] mg/24 h). Mean serum creatinine levels remained stable (BL, 1.0[0.21] mg/dL; M72, 0.9[0.21] mg/dL), as did estimated glomerular filtration rate (eGFR; BL, 77.7[17.67] mL/min/1.73 m2; M72, 79.4[18.39] mL/min/1.73 m2). Serum phosphorus levels declined from above-normal at BL to within normal range (BL, 4.8[0.58] mg/dL; M72, 4.0[0.62] mg/dL); calcium-phosphorus product levels also declined (BL, 42.1[6.35] mg2/dL2; M72, 33.7[5.01] mg2/dL2). Treatment-emergent adverse events and treatment-emergent serious adverse events were reported in 98.0% and 26.5% of patients, respectively; no new safety concerns were identified.

Discussion :

All key parameters declined or remained stable over time with rhPTH(1-84) treatment with no new identified safety concerns.

Conclusion :

Continuous use of rhPTH(1-84) over 6 years resulted in a favorable safety profile, was effective, and improved key measurements of mineral homeostasis, notably normalization of urinary calcium.

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