Results from three studies of Natpara (rhPTH[1-84]) in chronic hypoparathyroidism presented at ENDO.- Shire.
Shire announced new data on its Natpara (rhPTH[1-84]) recombinant human parathyroid hormone in patients with chronic hypoparathyroidism, at the Endocrine Society�s 100th Annual Meeting and Exposition (ENDO), in Chicago, Illinois. In the first presentation, a total of 119 patients were included, 43 with rhPTH(1-84) treatment, selected from the ongoing open-label phase III RACE trial, and 76 historical control patients identified from the MedMining database using similar enrolment criteria to RACE, not treated with rhPTH(1-84). The historical cohort of patients not treated with rhPTH(1-84) showed a greater decline in mean eGFR compared with patients on rhPTH(1-84), after taking known confounders into account.
In a second presentation, 90 adult patients with hypoparathyroidism currently on rhPTH(1-84) and 47 adult patients with hypoparathyroidism on standard treatment completed the survey. The results indicated that patients on rhPTH(1-84) treatment experienced an average of 9.1 symptoms (range 0�34), compared with patients on standard therapy (oral calcium and/or vitamin D supplements) who experienced an average of 20.2 symptoms (range 1�39) over a recall period of up to 12 months. In addition, a numerically greater proportion of patients on standard therapy reported significant disease-associated interference with their lives (49%) and impact on work responsibilities (31%) compared with patients on rhPTH(1-84) (27% and 15%, respectively). Conclusions drawn are limited by the nature of the study design. This cross-sectional real-world non-interventional study did not control for baseline characteristic differences that could impact treatment outcomes between cohorts. The survey responses were dependent on patient recall.
Finally, RACE is an ongoing open-label study of rhPTH(1-84) for the treatment of chronic hypoparathyroidism in adults. The analysis outcomes revealed that the efficacy composite endpoint was achieved by 28 of 40 patients (70.0%) at month 60. Oral calcium and calcitriol doses were reduced by 53.4% and 75.7%, respectively, while albumin-adjusted serum calcium levels were maintained within the target range. Serum creatinine levels also remained stable at 60 months, as did eGFR. Treatment-emergent adverse events (TEAEs) were reported in 48 of 49 patients (98.0%). The most common TEAEs (more than 25% of patients) reported were hypocalcemia (36.7%), muscle spasms (32.7%), paresthesia (30.6%), sinusitis (30.6%), and nausea (30.6%). Serious TEAEs occurred in 13 patients (26.5%).
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