Background: New erythropoiesis-stimulating agents (ESAs) with a longer half-life have been developed for the treatment of anemia as a complication of patients with end-stage renal disease. Objectives: The objective of...Background: New erythropoiesis-stimulating agents (ESAs) with a longer half-life have been developed for the treatment of anemia as a complication of patients with end-stage renal disease. Objectives: The objective of the present study was to assess the hemoglobin (Hb) stability of a Japanese cohort of hemodialysis (HD) patients who were simultaneously switched from darbepoetin alfa (DA) to epoetin beta pegol (CERA). Methods: This was an observational, prospective study of HD patients 20 years of age or more who were switched from intravenous (IV) DA to IV CERA and continued on HD for at least 3 months. The dose was adjusted to maintain the Hb level to within 1.0 g/dl of the baseline value. Results: A total of 68 HD patients (75.0% male, median age 63.0 years) were enrolled. The patients’ mean Hb levels were 10.8 ± (0.6) g/dl at Month 0, 10.9 ± 0.7 at Month 1, 10.8 ± 0.7 at Month 2, and 10.9 ± 0.8 at Month 3, and the differences from the level at Month 0 were not significant. After the switch, the ESA dose decreased significantly (P P < 0.0001). Conclusion: Switching from DA to CERA was associated with approximate 89% reduction of the required dose in Japanese HD patients being treated with an ESA and showed a favorable impact on the treatment of renal anemia, including the need for less frequent injections and a reduction of the ESA dose.展开更多
目的挖掘培塞利珠单抗相关药品不良反应(adverse drug reaction,ADR)风险信号,为其临床安全应用提供参考。方法采用报告比值比(reporting odds ratio,ROR)法对美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)2008年4月1日至2023年9...目的挖掘培塞利珠单抗相关药品不良反应(adverse drug reaction,ADR)风险信号,为其临床安全应用提供参考。方法采用报告比值比(reporting odds ratio,ROR)法对美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)2008年4月1日至2023年9月30日收到的培塞利珠单抗为首要怀疑药物的ADR进行挖掘。检测阈值为报告数大于10,ROR≥3,且95%置信区间(CI)下限大于1的ADR。结果设定时段内FAERS共收到以培塞利珠单抗为首要怀疑药物的ADR报告54927例,风险信号5197个,涉及27个系统-器官分类(SOC),其中“全身性疾病及给药部位反应”最为常见,妊娠、产褥期和围生期使用培塞利珠单抗的女性存在与孕妇及胎儿相关的潜在风险(ROR>3),呼吁临床予以关注。结论本研究通过真实世界数据补充了说明书未充分明确的ADR(如妊娠相关风险),提示需持续完善药品警戒措施,未来结合实验室检查数据进一步验证信号与因果关联。展开更多
The use of anti-tumor necrosis factor-α therapy for inflammatory bowel disease represents the most important advance in the care of these patients since the publication of the National Co-operative Crohn＇s disease s...The use of anti-tumor necrosis factor-α therapy for inflammatory bowel disease represents the most important advance in the care of these patients since the publication of the National Co-operative Crohn＇s disease study thirty years ago. The recommendations of numerous consensus groups worldwide are now supported by a wealth of clinical trials and several meta-analyses. In general, it is suggested that tumor necrosis factor-c~ blockers （TNFBs） are indicated （1） for persons with moderately-severe Crohn＇s disease or ulcerative colitis （UC） who have failed two or more causes of glucocorticosteroids and an acceptably long cause （8 wk to 12 wk） of an immune modulator such as azathioprine or methotrexate; （2） non-responsive perianal disease; and （3） severe UC not responding to a 3-d to 5-d course of steroids. Once TNFBs have been introduced and the patient is responsive, therapy given by the IV and SC rate must be continued. It remains open to definitive evidence if concomitant immune modulators are required with TNFB maintenance ther- apy, and when or if TNFB may be weaned and discon- tinued. The supportive evidence from a single study on the role of early versus later introduction of TNFB in the course of a patient＇s illness needs to be confirmed. The risk/benefit profile of TNFB appears to be accept- able as long as the patient is immunized and tested for tuberculosis and viral hepatitis before the initiation of TNFB, and as long as the long-term adverse effects on the development of lymphoma and other tumors do not prone to be problematic. Because the rates of ben- efits to TNFB are modest from a population perspec- tive and the cost of therapy is very high, the ultimate application of use of TNFBs will likely be established by cost/benefit studies.展开更多
In developed countries,age-related macular degeneration(AMD)is the main cause of visual impairment in the elderly.Though the etiology of AMD is still unclear,it has been well understood that vascular endothelial growt...In developed countries,age-related macular degeneration(AMD)is the main cause of visual impairment in the elderly.Though the etiology of AMD is still unclear,it has been well understood that vascular endothelial growth factor(VEGF)is involved in the development of aberrant vasculature that represents the neovascular AMD(nAMD).Hence,VEGF inhibition is a more effective way to control nAMD.Pegaptanib,ranibizumab,and aflibercept are three drugs approved by the US Food and Drug Administration(FDA)to treat nAMD.Bevacizumab(an anti-VEGF medication comparable to ranibizumab)is already widely used off label.Existing anti-VEGF medicines are made up of antibodies or pieces of antibodies.Synthetic designed ankyrin repeat proteins(DARPins)imitate antibodies introduced recently by evolutions in bioengineering technology.These agents are designed to have high specificity and affinity to a specific target,smaller molecular size,and better tissue penetration,making them more stable and longer-acting at less concentration.Abicipar pegol(Allergan,Dublin,Ireland)is a DARPin that interlocks all VEGF-A isoforms.It has a greater affinity for VEGF and a longer intraocular half-life than ranibizumab,making it a feasible anti-VEGF agent.This review describes the properties and efficacy of abicipar,the new anti-VEGF agent,in clinical practice,which aims to improve outcomes,safety,and treatment burden of nAMD.展开更多
文摘Background: New erythropoiesis-stimulating agents (ESAs) with a longer half-life have been developed for the treatment of anemia as a complication of patients with end-stage renal disease. Objectives: The objective of the present study was to assess the hemoglobin (Hb) stability of a Japanese cohort of hemodialysis (HD) patients who were simultaneously switched from darbepoetin alfa (DA) to epoetin beta pegol (CERA). Methods: This was an observational, prospective study of HD patients 20 years of age or more who were switched from intravenous (IV) DA to IV CERA and continued on HD for at least 3 months. The dose was adjusted to maintain the Hb level to within 1.0 g/dl of the baseline value. Results: A total of 68 HD patients (75.0% male, median age 63.0 years) were enrolled. The patients’ mean Hb levels were 10.8 ± (0.6) g/dl at Month 0, 10.9 ± 0.7 at Month 1, 10.8 ± 0.7 at Month 2, and 10.9 ± 0.8 at Month 3, and the differences from the level at Month 0 were not significant. After the switch, the ESA dose decreased significantly (P P < 0.0001). Conclusion: Switching from DA to CERA was associated with approximate 89% reduction of the required dose in Japanese HD patients being treated with an ESA and showed a favorable impact on the treatment of renal anemia, including the need for less frequent injections and a reduction of the ESA dose.
文摘目的挖掘培塞利珠单抗相关药品不良反应(adverse drug reaction,ADR)风险信号,为其临床安全应用提供参考。方法采用报告比值比(reporting odds ratio,ROR)法对美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)2008年4月1日至2023年9月30日收到的培塞利珠单抗为首要怀疑药物的ADR进行挖掘。检测阈值为报告数大于10,ROR≥3,且95%置信区间(CI)下限大于1的ADR。结果设定时段内FAERS共收到以培塞利珠单抗为首要怀疑药物的ADR报告54927例,风险信号5197个,涉及27个系统-器官分类(SOC),其中“全身性疾病及给药部位反应”最为常见,妊娠、产褥期和围生期使用培塞利珠单抗的女性存在与孕妇及胎儿相关的潜在风险(ROR>3),呼吁临床予以关注。结论本研究通过真实世界数据补充了说明书未充分明确的ADR(如妊娠相关风险),提示需持续完善药品警戒措施,未来结合实验室检查数据进一步验证信号与因果关联。
文摘The use of anti-tumor necrosis factor-α therapy for inflammatory bowel disease represents the most important advance in the care of these patients since the publication of the National Co-operative Crohn＇s disease study thirty years ago. The recommendations of numerous consensus groups worldwide are now supported by a wealth of clinical trials and several meta-analyses. In general, it is suggested that tumor necrosis factor-c~ blockers （TNFBs） are indicated （1） for persons with moderately-severe Crohn＇s disease or ulcerative colitis （UC） who have failed two or more causes of glucocorticosteroids and an acceptably long cause （8 wk to 12 wk） of an immune modulator such as azathioprine or methotrexate; （2） non-responsive perianal disease; and （3） severe UC not responding to a 3-d to 5-d course of steroids. Once TNFBs have been introduced and the patient is responsive, therapy given by the IV and SC rate must be continued. It remains open to definitive evidence if concomitant immune modulators are required with TNFB maintenance ther- apy, and when or if TNFB may be weaned and discon- tinued. The supportive evidence from a single study on the role of early versus later introduction of TNFB in the course of a patient＇s illness needs to be confirmed. The risk/benefit profile of TNFB appears to be accept- able as long as the patient is immunized and tested for tuberculosis and viral hepatitis before the initiation of TNFB, and as long as the long-term adverse effects on the development of lymphoma and other tumors do not prone to be problematic. Because the rates of ben- efits to TNFB are modest from a population perspec- tive and the cost of therapy is very high, the ultimate application of use of TNFBs will likely be established by cost/benefit studies.
文摘In developed countries,age-related macular degeneration(AMD)is the main cause of visual impairment in the elderly.Though the etiology of AMD is still unclear,it has been well understood that vascular endothelial growth factor(VEGF)is involved in the development of aberrant vasculature that represents the neovascular AMD(nAMD).Hence,VEGF inhibition is a more effective way to control nAMD.Pegaptanib,ranibizumab,and aflibercept are three drugs approved by the US Food and Drug Administration(FDA)to treat nAMD.Bevacizumab(an anti-VEGF medication comparable to ranibizumab)is already widely used off label.Existing anti-VEGF medicines are made up of antibodies or pieces of antibodies.Synthetic designed ankyrin repeat proteins(DARPins)imitate antibodies introduced recently by evolutions in bioengineering technology.These agents are designed to have high specificity and affinity to a specific target,smaller molecular size,and better tissue penetration,making them more stable and longer-acting at less concentration.Abicipar pegol(Allergan,Dublin,Ireland)is a DARPin that interlocks all VEGF-A isoforms.It has a greater affinity for VEGF and a longer intraocular half-life than ranibizumab,making it a feasible anti-VEGF agent.This review describes the properties and efficacy of abicipar,the new anti-VEGF agent,in clinical practice,which aims to improve outcomes,safety,and treatment burden of nAMD.
