Shire Announces Important Progress in the Treatment of Chronic Hyperparathyroidism with rhPTH(1-84)
March 22, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];British drug manufacturer Shire is a global leader in the field of rare diseases. Recently, the company announced its recombinant human parathyroid hormone product Natpara (rhPTH[1-84]) for chronic hypoparathyroidism at the 100th Annual Meeting of the American Endocrinology Society (ENDO 2018) in Chicago, USA. Hypoparathyroidism, abbreviated hypoPT, referred to as "parathyroid reduction" new data.
Parathyroidism is a rare endocrine disorder caused by insufficient parathyroid hormone (PTH) levels secreted by the parathyroid glands, resulting in imbalance of mineral balance in the body, manifested as hypocalcemia and hyperphosphatemia. The disease can have a significant impact on the lives and work of patients. Patients diagnosed with chronic hypoparathyroidism have low calcium levels in their blood and low levels of PTH. Postoperative chronic hypoparathyroidism is characterized by a parathyroid reduction after surgery for at least 6 months.
It is worth mentioning that hyperparathyroidism is one of the few hormone-deficient endocrine diseases that are not treated with hormone replacement therapy. So far, the clinical management of the disease mainly through oral calcium and vitamin D supplements to maintain blood calcium levels, but still a considerable number of patients receiving this standard therapy can not fully control the disease, and its serum calcium levels are still fluctuating.
Natpara is a recombinant form of human endogenous PTH with a total length of 84 amino acids. PTH releases calcium into the bloodstream and causes elevated blood calcium. In clinical studies, Natpara supplemented with calcium and vitamin D, can effectively maintain blood calcium levels, and can reduce the supplemental dose of oral calcium and active vitamin D. In the United States, Natpara was approved for listing in January 2015; in the European Union, the drug was approved in May 2017 under the brand name Natpara. This medicine is intended as an adjunct to the increase in serum calcium levels in adult patients who cannot adequately control their condition with standard therapy (calcium + vitamin D).
Shire Senior Vice President and Chief Medical Officer Dr. Howard Mayer said that the new data released at the meeting made us take another step in understanding chronic hypothyroidism, while at the same time in terms of the burden of disease and how it affects the lives of such rare diseases. Provides new insights.
Dr. Dolores M. Shoback, head of the RACE study, said that parathyroidism is a rare mineral imbalance caused by PTH deficiency. rhPTH (1-84) is a relatively new treatment in the clinical management of this disease, so it is very important to further improve our understanding of the safety and efficacy of the drug, especially the long-term management of the disease.
The focus of the report was on renal function studies in patients with chronic hypoparathyroidism, their impact on quality of life, and long-term safety and efficacy analysis of rhPTH (1-84):
(1) MON-453: rhPTH (1-84) treatment group has improved renal function compared with historical control group
Parathyroidism is associated with an increased incidence of renal complications, including kidney stones, renal calcinosis, and renal insufficiency. This analysis compared estimated glomerular filtration rate (eGFR) between patients receiving rhPTH (1-84) and those receiving no rhPTH (1-84) treatment over a 3-year period of treatment. eGFR is a key indicator of renal function and its lowering indicates lower renal function.
A total of 119 patients were included in the analysis, including 43 patients who received rhPTH (1-84) therapy from an ongoing open-label phase III RACE study, and were screened from the MedMining database using the same inclusion criteria as RACE. 76 historical control patients who did not receive rhPTH (1-84) treatment.
Analysis showed that the mean eGFR of the historical control group showed a greater reduction compared to the rhPTH (1-84) treated patients, taking into account known confounding factors.
(2) MON-452: rhPTH (1-84) can reduce the patient's symptom burden and improve quality of life compared with standard therapy
Chronic hypoparathyroidism is associated with multiple symptoms and a reduction in health-related quality of life (HRQoL). This web-based patient survey provides further insight into the serious impact of chronic hyperparathyroidism on the quality of life of patients, including the impact on work responsibilities and physical and psychological impact.
A total of 90 adult patients currently receiving rhPTH (1-84) and 47 patients receiving standard therapy completed the survey.
The results of the survey showed that patients treated with rhPTH (1-84) experienced an average of 9.1 symptoms (range: 0-34) during the 12-month recall period and received standard treatment (oral calcium and/or vitamin D supplements). The patient experienced an average of 20.2 symptoms. In addition, a higher proportion of patients receiving standard therapy reported a significant disease-related impact on life (49%) and work (31%), and 27% of patients treated with rhPTH (1-84), respectively. And 15%.
(3) OR20-3: RACE study 5-year data provides the efficacy and safety of rhPTH (1-84) long-term treatment
Analysis showed that in the 60th month, 28 of the 40 patients achieved a composite end point (70.0%). Oral calcium and calcitriol doses were reduced by 53.4% ​​and 75.7%, respectively, while albumin-corrected serum calcium levels remained within the target range. At the 60th month, serum creatinine levels and eGFR also remained stable.
In terms of safety, 48 of the 49 patients reported adverse events (TEAEs), the most common (25% of patients) were hypocalcemia (36.7%) and muscle spasm (32.7%). , abnormal feeling (30.6%), sinusitis (30.6%), nausea (30.6%). Severe TEAEs (26.5%) occurred in 13 patients. (Sina Pharmaceutical Compilation/newborn)
Article Reference Source: New Data Presented at the Endocrine Society's 2018 Annual Meeting Advances Understanding of the Rare Disease Chronic Hypoparathyroidism
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