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Biotechnology products and indications I. Proteins
Published in Ronald P. Evens, Biotechnology, 2020
Growth factor (GF) proteins number 21, as listed in Table 8.4. These proteins can be divided into two areas: blood cell GFs, also known as colony-stimulating factors (CSFs), and tissue GFs, all of which are ligands to communicate between cells and stimulate new cell outcomes and functions. The CSFs are secreted by specific cells in organs, for example, erythropoietin by the kidney, and stimulate another cell type to produce an effect; in this example, bone marrow erythroid progenitors are stimulated to accelerate their production of red blood cells and correct anemia. All these GFs are produced by rDNA technology. CSF products for leukocytes are available worldwide, that is, filgrastim, pegfilgrastim, and sargramostim in the United States, and also molgramostim, regramostim, lenograstim, and nartograstim in rest of the world. Biosimilar filgrastim products include biograstim, filgrastim-Hexal, nivestim, ratiograstim, and tevagrastim. They all stimulate white blood cell production and limit infectious complications in myeloid-suppressed cancer patients. Two epoetin molecules (epoetin alfa and epoetin beta) stimulate red blood cell production, with two U.S. products available (Epogen and Procrit), along with Eprex, NeoRecormon, Silapo and Epogin in Europe and Asia. Biosimilar products for epoetin alfa are also available, such as Retacrit. Aranesp in the United States and Nespo in Europe are the hyperglycosylated products of epoetin that have extended half-lives and require less frequent dosing. A pegylated form of epoetin alfa has been developed as well to extend the dosing interval. Becaplermin is a tissue GF for the epidermis and is used to accelerate wound healing in diabetic ulcers. The second recombinant tissue GF is palifermin, impacting keratinocytes, and is used to more rapidly resolve the mucositis in cancer patients receiving chemotherapy, radiation therapy, and bone marrow transplants. Bone growth and bone fusion are accelerated with osteogenic protein-1 and platelet derived GF-BB, both GFs. Recently, neurotrophic keratitis has become treatable with a GF, oxervate. Pegylation has been used to create new GFs with longer half-lives and extended duration of action, for example, filgrastim daily is dosed daily for 5–10 d versus peg-filgrastim (Neulasta) in a single dose. Biosimilar products have also been approved for filgratim around the world; Fulphila, Nivestym, Udencya, and Zarxio.
Time spent on erythropoietin stimulating agents administration in hemodialysis centers in Panama: a time and motion study
Published in Journal of Medical Economics, 2019
Marianne Chacón-Araya, Diego Rey-Rodríguez, Felipe Rodríguez De León, Allan Ramos-Esquivel, Tao Sunning
The mean total active HCP time was 7.81 min (95% CI = 7.65–7.97) for a single epoetin alfa administration and 5.47 min (95% CI = 5.05–5.93) for CERA administration. Estimated savings in mean total active HCP time were 2.34 min (95% CI = 1.87–2.81) (–30%) (Table 1 and Figure 1). The distribution of mean total active HCP time by task is shown in Figure 1. Preparation time for CERA was 66% lower than for epoetin alfa. Given that epoetin alfa is administered 3-times a week for patients on dialysis, 156 sessions per year are anticipated for patients receiving short-acting epoetin alfa, while 12 monthly sessions per year are anticipated for patients receiving long-acting CERA, assuming 100% adherence. Therefore, a total of 20.3 (95% CI = 19.90–20.71) h and 1.1 (95% CI = 1.01–1.19) h of HCP time would be required, respectively, to treat one patient per year with epoetin alfa and CERA. Estimated savings in active HCP time per patient per year were 19.2 (95% CI = 19.20–19.21) h (–95%) if one switches from epoetin alfa to CERA.
Investigational hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) for the treatment of anemia associated with chronic kidney disease
Published in Expert Opinion on Investigational Drugs, 2018
Lucia Del Vecchio, Francesco Locatelli
Two phase-II studies were also conducted in China [56]. In one study, 91 ND-CKD patients were randomized to either low (1.1–1.75 mg/kg) or high (1.50–2.25 mg/kg) roxadustat doses or to placebo. An Hb increase of ≥1 g/dl from baseline was obtained in 80% and 87.1% of the low- and high-dose cohorts, respectively, but in only 23.3% of the patients receiving placebo. In the dialysis study, 87 subjects were randomized to low (1.1–1.8 mg/kg), medium (1.5–2.3 mg/kg), and high (1.7–2.3 mg/kg) roxadustat doses or to continue epoetin alfa. Interestingly, at randomization, the patients were stratified according to baseline epoetin alfa doses. In the roxadustat cohorts, Hb levels were maintained in a higher percentage of patients compared to epoetin alfa (59.1%, 88.9%, and 100% in the low-, medium-, and high-dose cohorts versus 50% of the epoetin alfa-treated subjects). Similarly, to what observed in the other clinical trials, roxadustat caused a decrease in hepcidin levels, total, LDL and HDL cholesterol, and platelet count.
Roxadustat in the treatment of anaemia in chronic kidney disease
Published in Expert Opinion on Investigational Drugs, 2018
Lucia Del Vecchio, Francesco Locatelli
Recently, Chen et al. [43] reported the findings of a phase-II clinical trial, which was conducted in Chinese CKD patients. It included a double-blinded study of 91 ND-CKD patients and an open-label study of 47 HD patients. ND-CKD patients were randomized with a 2:1 ratio to either placebo or roxadustat (low and high dose regimens, 1.1–1.75 and 1.50–2.25 mg/kg, respectively). Eighty percent of the subjects in the low-dose cohort and 87.1% in the high-dose cohort had an Hb increase ≥1 g/dl from baseline versus 23.3% in the placebo arm. HD patients were randomized 3:1 either to roxadustat (sequentially to 1.1–1.8 mg/kg [low], 1.5–2.3 mg/kg [medium], and 1.7–2.3 mg/kg [high] per dose TIW on dialysis days, using weight-based dosing) or to continue epoetin alfa. Subjects were stratified by baseline epoetin alfa dose. In this cohort, the primary end point was the percentage of subjects with an Hb level maintained at no less than −0.5 g/dl below mean baseline value. A total of 59.1%, 88.9%, and 100% of subjects randomized to the low-, mid-, and high-roxadustat dose, respectively, met the primary end point as compared with only 50% of the subjects who continued on epoetin alfa. These findings may suggest that Chinese patients have similar dose requirements than Western populations.