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ACIP hints at move from three-dose to two-dose HPV vaccination schedule for youth
A work group for the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is leaning toward recommending a change from three to two doses of the human papillomavirus (HPV) vaccine in boys and girls aged 11-12 years.
Members of the ACIP Human Papillomavirus Work Group told the entire committee at ACIP’s June meeting that a review of all available data showed that, regardless of whether the HPV vaccine were bivalent, quadrivalent, or nine-valent, two doses were found to be noninferior, compared with three doses. A two-dose schedule, therefore, could possibly be recommended at the next ACIP meeting later this year.
The work group said it also could recommend that HPV vaccine–naive women up to age 26 years and HPV vaccine-naive men up to age 21 years also receive the vaccine. For persons who initiated but did not complete vaccination before age 15 years, or for persons who initiate the schedule after their 15th birthday – the same schedule as is currently recommended for 11- and 12-year-olds – a similar schedule is likely to be recommended again.
The recommendation for immunocompromised persons of any age would be to receive the three-dose schedule.
If these recommendations are put forth officially, the question of whether families also should be given a three-dose option will need to be decided, work group members said.
Although studies are ongoing to determine antibody persistence and long-term effectiveness after two doses, existing data indicate that waning antibody responses to HPV18 in persons vaccinated with three doses of quadrivalent HPV were not associated with loss of protection. This could mean that protective levels are actually lower than the minimum levels detected by assays, or that antibodies against other epitopes also are protective.
Predictive modeling showed that, if a two-dose schedule can provide more than 20 years of protection, over $118,000 per quality adjusted life year could be realized without sacrificing population health benefits.
The current CDC vaccination schedule for HPV in adolescents is for a three-dose series of the vaccine on a schedule of 0, 1-2, and 6 months. The same vaccination schedule is recommended for “catch-up” of previously unvaccinated adolescents aged 13-18 years.
On Twitter @whitneymcknight
A work group for the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is leaning toward recommending a change from three to two doses of the human papillomavirus (HPV) vaccine in boys and girls aged 11-12 years.
Members of the ACIP Human Papillomavirus Work Group told the entire committee at ACIP’s June meeting that a review of all available data showed that, regardless of whether the HPV vaccine were bivalent, quadrivalent, or nine-valent, two doses were found to be noninferior, compared with three doses. A two-dose schedule, therefore, could possibly be recommended at the next ACIP meeting later this year.
The work group said it also could recommend that HPV vaccine–naive women up to age 26 years and HPV vaccine-naive men up to age 21 years also receive the vaccine. For persons who initiated but did not complete vaccination before age 15 years, or for persons who initiate the schedule after their 15th birthday – the same schedule as is currently recommended for 11- and 12-year-olds – a similar schedule is likely to be recommended again.
The recommendation for immunocompromised persons of any age would be to receive the three-dose schedule.
If these recommendations are put forth officially, the question of whether families also should be given a three-dose option will need to be decided, work group members said.
Although studies are ongoing to determine antibody persistence and long-term effectiveness after two doses, existing data indicate that waning antibody responses to HPV18 in persons vaccinated with three doses of quadrivalent HPV were not associated with loss of protection. This could mean that protective levels are actually lower than the minimum levels detected by assays, or that antibodies against other epitopes also are protective.
Predictive modeling showed that, if a two-dose schedule can provide more than 20 years of protection, over $118,000 per quality adjusted life year could be realized without sacrificing population health benefits.
The current CDC vaccination schedule for HPV in adolescents is for a three-dose series of the vaccine on a schedule of 0, 1-2, and 6 months. The same vaccination schedule is recommended for “catch-up” of previously unvaccinated adolescents aged 13-18 years.
On Twitter @whitneymcknight
A work group for the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is leaning toward recommending a change from three to two doses of the human papillomavirus (HPV) vaccine in boys and girls aged 11-12 years.
Members of the ACIP Human Papillomavirus Work Group told the entire committee at ACIP’s June meeting that a review of all available data showed that, regardless of whether the HPV vaccine were bivalent, quadrivalent, or nine-valent, two doses were found to be noninferior, compared with three doses. A two-dose schedule, therefore, could possibly be recommended at the next ACIP meeting later this year.
The work group said it also could recommend that HPV vaccine–naive women up to age 26 years and HPV vaccine-naive men up to age 21 years also receive the vaccine. For persons who initiated but did not complete vaccination before age 15 years, or for persons who initiate the schedule after their 15th birthday – the same schedule as is currently recommended for 11- and 12-year-olds – a similar schedule is likely to be recommended again.
The recommendation for immunocompromised persons of any age would be to receive the three-dose schedule.
If these recommendations are put forth officially, the question of whether families also should be given a three-dose option will need to be decided, work group members said.
Although studies are ongoing to determine antibody persistence and long-term effectiveness after two doses, existing data indicate that waning antibody responses to HPV18 in persons vaccinated with three doses of quadrivalent HPV were not associated with loss of protection. This could mean that protective levels are actually lower than the minimum levels detected by assays, or that antibodies against other epitopes also are protective.
Predictive modeling showed that, if a two-dose schedule can provide more than 20 years of protection, over $118,000 per quality adjusted life year could be realized without sacrificing population health benefits.
The current CDC vaccination schedule for HPV in adolescents is for a three-dose series of the vaccine on a schedule of 0, 1-2, and 6 months. The same vaccination schedule is recommended for “catch-up” of previously unvaccinated adolescents aged 13-18 years.
On Twitter @whitneymcknight
FROM AN ACIP MEETING
AATS Focus on Thoracic Surgery: Current and Future Challenges
The preliminary program and registration information is now available for AATS Focus on Thoracic Surgery: Current and Future Challenges.
October 28-29, 2016
Westin Boston Waterfront Hotel, Boston, MA
Program Directors
G. Alexander Patterson
David J. Sugarbaker
Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson
Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.
More information: http://aats.org/focus/
The preliminary program and registration information is now available for AATS Focus on Thoracic Surgery: Current and Future Challenges.
October 28-29, 2016
Westin Boston Waterfront Hotel, Boston, MA
Program Directors
G. Alexander Patterson
David J. Sugarbaker
Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson
Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.
More information: http://aats.org/focus/
The preliminary program and registration information is now available for AATS Focus on Thoracic Surgery: Current and Future Challenges.
October 28-29, 2016
Westin Boston Waterfront Hotel, Boston, MA
Program Directors
G. Alexander Patterson
David J. Sugarbaker
Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson
Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.
More information: http://aats.org/focus/
AATS Focus on Thoracic Surgery: Current and Future Challenges
The preliminary program and registration information is now available for AATS Focus on Thoracic Surgery: Current and Future Challenges.
October 28-29, 2016
Westin Boston Waterfront Hotel
Boston, MA
Program Directors
G. Alexander Patterson
David J. Sugarbaker
Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson
Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.
The preliminary program and registration information is now available for AATS Focus on Thoracic Surgery: Current and Future Challenges.
October 28-29, 2016
Westin Boston Waterfront Hotel
Boston, MA
Program Directors
G. Alexander Patterson
David J. Sugarbaker
Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson
Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.
The preliminary program and registration information is now available for AATS Focus on Thoracic Surgery: Current and Future Challenges.
October 28-29, 2016
Westin Boston Waterfront Hotel
Boston, MA
Program Directors
G. Alexander Patterson
David J. Sugarbaker
Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson
Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.
Long-haul travel turbulent for many with type 1 diabetes
NEW ORLEANS – For many patients with type 1 diabetes mellitus, crossing multiple time zones by airplane upset their disease self-management. In fact, results from a new survey found that 74% reported more hyperglycemia and/or hypoglycemia while traveling overseas, and 9% avoided international travel altogether because of their disease.
“Travel has become a ubiquitous feature of modern day life. Every day around the world approximately 8 million people board an aircraft,” Benjamen E. Schoenberg said at the annual scientific sessions of the American Diabetes Association. “Based on known rates of diabetes and how often people travel, the Centers for Disease Control and Prevention and the U.S. Travel Association estimate that annually in the United States alone approximately 17 million individuals with diabetes travel for leisure, and approximately 5.6 million travel for business, and these numbers are rising by the year.”
Noting limited existing medical literature on the topic, Mr. Schoenberg of the William Sansum Diabetes Center, Santa Barbara, Calif., and his associates set out to examine the real-life experiences of individuals with type 1 diabetes traveling long-haul by airplane – defined as crossing multiple time zones. They invited members of an online community of the T1D Exchange known as Glu to complete a 45-question online survey that collected information on respondents’ diabetes history, use of technology in self-management of their diabetes, and overall travel experiences.
Of the 503 survey respondents, 71% were female, their average age was 44 years, and 75% had type 1 diabetes for longer than 10 years. The majority of respondents (81%) reported currently having a passport, and 71% reported flying long-haul at least once in the past 5 years. Nearly three-quarters of respondents (74%) experienced increased levels of hyperglycemia and/or hypoglycemia while traveling overseas, 22% ran out of insulin at some point during a trip in the past 5 years, and 9% reported avoiding international travel altogether because of problems related to diabetes management.
Mr. Schoenberg, who is an incoming first-year medical student at Thomas Jefferson University, Philadelphia, went on to report that about one in three participants indicated that their insulin “does not work the same” in flight, compared with when they’re not flying. At the same time, 5% believe that their continuous glucose monitors are less reliable in flight, and about 10% believe that their insulin pumps are less reliable in flight.
When asked what practical difficulties they faced while traveling with type 1 diabetes, the top three responses from survey participants were airport security, taking enough supplies, and crossing time zones. “Furthermore, we found that pump users experienced more difficulty with airport security than non–pump users; 42% of pump users wore their device through body scanners, and 44% reported having at least one negative experience with airport security in the past,” he said.
When asked about their greatest fear of flying long-haul, the top four responses were more hyperglycemia and/or hypoglycemia, problems with airport security, losing supplies, and glucose variability. In addition, only about 30% of respondents reported being satisfied with currently available resources intended to help people manage their disease while traveling. “There is a call to action for providers and nonprofits to continue to develop information to better suit the needs of individuals traveling with [type 1 diabetes],” Mr. Schoenberg said. “Furthermore, 55% reported that they use the Internet as their primary source and about one in four use a smart phone regularly for their self-management.”
He concluded that long-haul air travel with type 1 diabetes “is neither straightforward nor easy. Real-life experiences suggest an unmet need for personalized information. There also may be a need to evaluate insulin and devices at altitude and across time zones. Finally, the impacts of long-haul travel become more relevant as we move toward a commercial artificial pancreas system.” The researchers reported having no financial conflicts.
NEW ORLEANS – For many patients with type 1 diabetes mellitus, crossing multiple time zones by airplane upset their disease self-management. In fact, results from a new survey found that 74% reported more hyperglycemia and/or hypoglycemia while traveling overseas, and 9% avoided international travel altogether because of their disease.
“Travel has become a ubiquitous feature of modern day life. Every day around the world approximately 8 million people board an aircraft,” Benjamen E. Schoenberg said at the annual scientific sessions of the American Diabetes Association. “Based on known rates of diabetes and how often people travel, the Centers for Disease Control and Prevention and the U.S. Travel Association estimate that annually in the United States alone approximately 17 million individuals with diabetes travel for leisure, and approximately 5.6 million travel for business, and these numbers are rising by the year.”
Noting limited existing medical literature on the topic, Mr. Schoenberg of the William Sansum Diabetes Center, Santa Barbara, Calif., and his associates set out to examine the real-life experiences of individuals with type 1 diabetes traveling long-haul by airplane – defined as crossing multiple time zones. They invited members of an online community of the T1D Exchange known as Glu to complete a 45-question online survey that collected information on respondents’ diabetes history, use of technology in self-management of their diabetes, and overall travel experiences.
Of the 503 survey respondents, 71% were female, their average age was 44 years, and 75% had type 1 diabetes for longer than 10 years. The majority of respondents (81%) reported currently having a passport, and 71% reported flying long-haul at least once in the past 5 years. Nearly three-quarters of respondents (74%) experienced increased levels of hyperglycemia and/or hypoglycemia while traveling overseas, 22% ran out of insulin at some point during a trip in the past 5 years, and 9% reported avoiding international travel altogether because of problems related to diabetes management.
Mr. Schoenberg, who is an incoming first-year medical student at Thomas Jefferson University, Philadelphia, went on to report that about one in three participants indicated that their insulin “does not work the same” in flight, compared with when they’re not flying. At the same time, 5% believe that their continuous glucose monitors are less reliable in flight, and about 10% believe that their insulin pumps are less reliable in flight.
When asked what practical difficulties they faced while traveling with type 1 diabetes, the top three responses from survey participants were airport security, taking enough supplies, and crossing time zones. “Furthermore, we found that pump users experienced more difficulty with airport security than non–pump users; 42% of pump users wore their device through body scanners, and 44% reported having at least one negative experience with airport security in the past,” he said.
When asked about their greatest fear of flying long-haul, the top four responses were more hyperglycemia and/or hypoglycemia, problems with airport security, losing supplies, and glucose variability. In addition, only about 30% of respondents reported being satisfied with currently available resources intended to help people manage their disease while traveling. “There is a call to action for providers and nonprofits to continue to develop information to better suit the needs of individuals traveling with [type 1 diabetes],” Mr. Schoenberg said. “Furthermore, 55% reported that they use the Internet as their primary source and about one in four use a smart phone regularly for their self-management.”
He concluded that long-haul air travel with type 1 diabetes “is neither straightforward nor easy. Real-life experiences suggest an unmet need for personalized information. There also may be a need to evaluate insulin and devices at altitude and across time zones. Finally, the impacts of long-haul travel become more relevant as we move toward a commercial artificial pancreas system.” The researchers reported having no financial conflicts.
NEW ORLEANS – For many patients with type 1 diabetes mellitus, crossing multiple time zones by airplane upset their disease self-management. In fact, results from a new survey found that 74% reported more hyperglycemia and/or hypoglycemia while traveling overseas, and 9% avoided international travel altogether because of their disease.
“Travel has become a ubiquitous feature of modern day life. Every day around the world approximately 8 million people board an aircraft,” Benjamen E. Schoenberg said at the annual scientific sessions of the American Diabetes Association. “Based on known rates of diabetes and how often people travel, the Centers for Disease Control and Prevention and the U.S. Travel Association estimate that annually in the United States alone approximately 17 million individuals with diabetes travel for leisure, and approximately 5.6 million travel for business, and these numbers are rising by the year.”
Noting limited existing medical literature on the topic, Mr. Schoenberg of the William Sansum Diabetes Center, Santa Barbara, Calif., and his associates set out to examine the real-life experiences of individuals with type 1 diabetes traveling long-haul by airplane – defined as crossing multiple time zones. They invited members of an online community of the T1D Exchange known as Glu to complete a 45-question online survey that collected information on respondents’ diabetes history, use of technology in self-management of their diabetes, and overall travel experiences.
Of the 503 survey respondents, 71% were female, their average age was 44 years, and 75% had type 1 diabetes for longer than 10 years. The majority of respondents (81%) reported currently having a passport, and 71% reported flying long-haul at least once in the past 5 years. Nearly three-quarters of respondents (74%) experienced increased levels of hyperglycemia and/or hypoglycemia while traveling overseas, 22% ran out of insulin at some point during a trip in the past 5 years, and 9% reported avoiding international travel altogether because of problems related to diabetes management.
Mr. Schoenberg, who is an incoming first-year medical student at Thomas Jefferson University, Philadelphia, went on to report that about one in three participants indicated that their insulin “does not work the same” in flight, compared with when they’re not flying. At the same time, 5% believe that their continuous glucose monitors are less reliable in flight, and about 10% believe that their insulin pumps are less reliable in flight.
When asked what practical difficulties they faced while traveling with type 1 diabetes, the top three responses from survey participants were airport security, taking enough supplies, and crossing time zones. “Furthermore, we found that pump users experienced more difficulty with airport security than non–pump users; 42% of pump users wore their device through body scanners, and 44% reported having at least one negative experience with airport security in the past,” he said.
When asked about their greatest fear of flying long-haul, the top four responses were more hyperglycemia and/or hypoglycemia, problems with airport security, losing supplies, and glucose variability. In addition, only about 30% of respondents reported being satisfied with currently available resources intended to help people manage their disease while traveling. “There is a call to action for providers and nonprofits to continue to develop information to better suit the needs of individuals traveling with [type 1 diabetes],” Mr. Schoenberg said. “Furthermore, 55% reported that they use the Internet as their primary source and about one in four use a smart phone regularly for their self-management.”
He concluded that long-haul air travel with type 1 diabetes “is neither straightforward nor easy. Real-life experiences suggest an unmet need for personalized information. There also may be a need to evaluate insulin and devices at altitude and across time zones. Finally, the impacts of long-haul travel become more relevant as we move toward a commercial artificial pancreas system.” The researchers reported having no financial conflicts.
AT THE ADA SCIENTIFIC SESSIONS
Key clinical point: Long-haul air travel poses certain challenges for patients with type 1 diabetes.
Major finding: Nearly three-quarters of respondents (74%) experienced increased levels of hyperglycemia and/or hypoglycemia while traveling overseas, and 22% ran out of insulin at some point during a trip in the past 5 years.
Data source: A online survey of 503 individuals with type 1 diabetes who were asked about their real-life experiences while traveling across multiple time zones.
Disclosures: The researchers reported having no financial disclosures.
Interhospital Transfer Handoff Practice Variance at U.S. Tertiary Care Centers
Clinical question: How do interhospital handoff practices differ among U.S. tertiary care centers, and what challenges and innovations have providers encountered?
Background: Little has been studied regarding interhospital transfers. Many centers differ in the processes they follow, and well-delineated national guidelines are lacking. Adverse events occur in up to 30% of transfers. Standardization of these handoffs has been shown to reduce preventable errors and near misses.
Study design: Survey of convenience sample of institutions.
Setting: Transfer center directors from 32 tertiary care centers in the U.S.
Synopsis: The authors surveyed directors of 32 transfer centers between 2013 and 2015. Hospitals were selected from a nationally ranked list as well as those comparable to the authors’ own institutions. The median number of patients transferred per month was 700.
Only 23% of hospitals surveyed identified significant EHR interoperability. Almost all required three-way recorded discussion between transfer center staff and referring and accepting physicians. Only 29% had available objective clinical information to share. Only 23% recorded a three-way nursing handoff, and only 32% used their EHR to document the transfer process and share clinical information among providers.
Innovations included electronic transfer notes, a standardized system of feedback to referring hospitals, automatic internal review for adverse events and delayed transfers, and use of a scorecard with key measures shared with stakeholders.
Barriers noted included complexity, acuity, and lack of continuity. Increased use of EHRs, checklists, and common processes were identified as best practices.
Limitations of the study included reliance on verbal qualitative data, a single investigator doing most of the discussions, and possible sampling bias.
Bottom line: Interhospital transfer practices at academic tertiary care centers vary widely, and optimizing and aligning practices between sending and receiving hospitals may improve efficiency and patient outcomes.
References: Herrigel DJ, Carroll M, Fanning C, Steinberg MB, Parikh A, Usher M. Interhospital transfer handoff practices among US tertiary care centers: a descriptive survey. J Hosp Med. 2016;11(6):413-417.
Clinical question: How do interhospital handoff practices differ among U.S. tertiary care centers, and what challenges and innovations have providers encountered?
Background: Little has been studied regarding interhospital transfers. Many centers differ in the processes they follow, and well-delineated national guidelines are lacking. Adverse events occur in up to 30% of transfers. Standardization of these handoffs has been shown to reduce preventable errors and near misses.
Study design: Survey of convenience sample of institutions.
Setting: Transfer center directors from 32 tertiary care centers in the U.S.
Synopsis: The authors surveyed directors of 32 transfer centers between 2013 and 2015. Hospitals were selected from a nationally ranked list as well as those comparable to the authors’ own institutions. The median number of patients transferred per month was 700.
Only 23% of hospitals surveyed identified significant EHR interoperability. Almost all required three-way recorded discussion between transfer center staff and referring and accepting physicians. Only 29% had available objective clinical information to share. Only 23% recorded a three-way nursing handoff, and only 32% used their EHR to document the transfer process and share clinical information among providers.
Innovations included electronic transfer notes, a standardized system of feedback to referring hospitals, automatic internal review for adverse events and delayed transfers, and use of a scorecard with key measures shared with stakeholders.
Barriers noted included complexity, acuity, and lack of continuity. Increased use of EHRs, checklists, and common processes were identified as best practices.
Limitations of the study included reliance on verbal qualitative data, a single investigator doing most of the discussions, and possible sampling bias.
Bottom line: Interhospital transfer practices at academic tertiary care centers vary widely, and optimizing and aligning practices between sending and receiving hospitals may improve efficiency and patient outcomes.
References: Herrigel DJ, Carroll M, Fanning C, Steinberg MB, Parikh A, Usher M. Interhospital transfer handoff practices among US tertiary care centers: a descriptive survey. J Hosp Med. 2016;11(6):413-417.
Clinical question: How do interhospital handoff practices differ among U.S. tertiary care centers, and what challenges and innovations have providers encountered?
Background: Little has been studied regarding interhospital transfers. Many centers differ in the processes they follow, and well-delineated national guidelines are lacking. Adverse events occur in up to 30% of transfers. Standardization of these handoffs has been shown to reduce preventable errors and near misses.
Study design: Survey of convenience sample of institutions.
Setting: Transfer center directors from 32 tertiary care centers in the U.S.
Synopsis: The authors surveyed directors of 32 transfer centers between 2013 and 2015. Hospitals were selected from a nationally ranked list as well as those comparable to the authors’ own institutions. The median number of patients transferred per month was 700.
Only 23% of hospitals surveyed identified significant EHR interoperability. Almost all required three-way recorded discussion between transfer center staff and referring and accepting physicians. Only 29% had available objective clinical information to share. Only 23% recorded a three-way nursing handoff, and only 32% used their EHR to document the transfer process and share clinical information among providers.
Innovations included electronic transfer notes, a standardized system of feedback to referring hospitals, automatic internal review for adverse events and delayed transfers, and use of a scorecard with key measures shared with stakeholders.
Barriers noted included complexity, acuity, and lack of continuity. Increased use of EHRs, checklists, and common processes were identified as best practices.
Limitations of the study included reliance on verbal qualitative data, a single investigator doing most of the discussions, and possible sampling bias.
Bottom line: Interhospital transfer practices at academic tertiary care centers vary widely, and optimizing and aligning practices between sending and receiving hospitals may improve efficiency and patient outcomes.
References: Herrigel DJ, Carroll M, Fanning C, Steinberg MB, Parikh A, Usher M. Interhospital transfer handoff practices among US tertiary care centers: a descriptive survey. J Hosp Med. 2016;11(6):413-417.
Oral Steroids as Good as NSAIDs for Acute Gout
Clinical question: Are oral steroids as effective as NSAIDs in treating acute gout?
Background: Two small trials have suggested that oral steroids are as effective as NSAIDs in treating acute gout. Wider acceptance of steroids as first-line agents for acute gout may require more robust evidence supporting their safety and efficacy.
Study design: Multicenter, double-blind, randomized equivalence trial.
Setting: Four EDs in Hong Kong.
Synopsis: The study included 416 patients presenting to the ED with clinically suspected acute gout who were randomized to treatment with either oral indomethacin or oral prednisolone for five days. A research investigator assessed response to therapy in the ED at 30, 60, 90, and 120 minutes after administration of the initial dose of medication. Patients then kept pain-assessment diaries for 14 days after discharge from the ED.
Pain scores were assessed using a visual analog scale of 0 mm (no pain) to 100 mm (worst pain the patient had experienced). Clinically significant changes in pain scores were defined as decreases of >13 mm on the visual analog scale.
The number of patients with clinically significant decreases in pain scores did not differ statistically between groups. Both groups had similar reductions in mean pain scores over the course of the study. Patients in the indomethacin group had a statistically significant increase in minor adverse events. No patients in either group had major adverse events.
Bottom line: Oral prednisolone appears to be a safe and effective first-line agent for the treatment of acute gout.
Citation: Rainer TH, Chen CH, Janssens HJEM, et al. Oral prednisolone in the treatment of acute gout. Ann Intern Med. 2016;164(7):464-471.
Short Take
Rate Control as Effective as Rhythm Control in Postoperative Atrial Fibrillation
This study randomized patients with postoperative atrial fibrillation to rhythm control (using amiodarone and/or direct current cardioversion) or rate control and found neither treatment strategy has a clinical benefit over the other.
Citation: Gillinov AM, Bagiella E, Moskowitz AJ, et al. Rate control versus rhythm control for atrial fibrillation after cardiac surgery. N Engl J Med. 2016;374(20):1911-1921.
Clinical question: Are oral steroids as effective as NSAIDs in treating acute gout?
Background: Two small trials have suggested that oral steroids are as effective as NSAIDs in treating acute gout. Wider acceptance of steroids as first-line agents for acute gout may require more robust evidence supporting their safety and efficacy.
Study design: Multicenter, double-blind, randomized equivalence trial.
Setting: Four EDs in Hong Kong.
Synopsis: The study included 416 patients presenting to the ED with clinically suspected acute gout who were randomized to treatment with either oral indomethacin or oral prednisolone for five days. A research investigator assessed response to therapy in the ED at 30, 60, 90, and 120 minutes after administration of the initial dose of medication. Patients then kept pain-assessment diaries for 14 days after discharge from the ED.
Pain scores were assessed using a visual analog scale of 0 mm (no pain) to 100 mm (worst pain the patient had experienced). Clinically significant changes in pain scores were defined as decreases of >13 mm on the visual analog scale.
The number of patients with clinically significant decreases in pain scores did not differ statistically between groups. Both groups had similar reductions in mean pain scores over the course of the study. Patients in the indomethacin group had a statistically significant increase in minor adverse events. No patients in either group had major adverse events.
Bottom line: Oral prednisolone appears to be a safe and effective first-line agent for the treatment of acute gout.
Citation: Rainer TH, Chen CH, Janssens HJEM, et al. Oral prednisolone in the treatment of acute gout. Ann Intern Med. 2016;164(7):464-471.
Short Take
Rate Control as Effective as Rhythm Control in Postoperative Atrial Fibrillation
This study randomized patients with postoperative atrial fibrillation to rhythm control (using amiodarone and/or direct current cardioversion) or rate control and found neither treatment strategy has a clinical benefit over the other.
Citation: Gillinov AM, Bagiella E, Moskowitz AJ, et al. Rate control versus rhythm control for atrial fibrillation after cardiac surgery. N Engl J Med. 2016;374(20):1911-1921.
Clinical question: Are oral steroids as effective as NSAIDs in treating acute gout?
Background: Two small trials have suggested that oral steroids are as effective as NSAIDs in treating acute gout. Wider acceptance of steroids as first-line agents for acute gout may require more robust evidence supporting their safety and efficacy.
Study design: Multicenter, double-blind, randomized equivalence trial.
Setting: Four EDs in Hong Kong.
Synopsis: The study included 416 patients presenting to the ED with clinically suspected acute gout who were randomized to treatment with either oral indomethacin or oral prednisolone for five days. A research investigator assessed response to therapy in the ED at 30, 60, 90, and 120 minutes after administration of the initial dose of medication. Patients then kept pain-assessment diaries for 14 days after discharge from the ED.
Pain scores were assessed using a visual analog scale of 0 mm (no pain) to 100 mm (worst pain the patient had experienced). Clinically significant changes in pain scores were defined as decreases of >13 mm on the visual analog scale.
The number of patients with clinically significant decreases in pain scores did not differ statistically between groups. Both groups had similar reductions in mean pain scores over the course of the study. Patients in the indomethacin group had a statistically significant increase in minor adverse events. No patients in either group had major adverse events.
Bottom line: Oral prednisolone appears to be a safe and effective first-line agent for the treatment of acute gout.
Citation: Rainer TH, Chen CH, Janssens HJEM, et al. Oral prednisolone in the treatment of acute gout. Ann Intern Med. 2016;164(7):464-471.
Short Take
Rate Control as Effective as Rhythm Control in Postoperative Atrial Fibrillation
This study randomized patients with postoperative atrial fibrillation to rhythm control (using amiodarone and/or direct current cardioversion) or rate control and found neither treatment strategy has a clinical benefit over the other.
Citation: Gillinov AM, Bagiella E, Moskowitz AJ, et al. Rate control versus rhythm control for atrial fibrillation after cardiac surgery. N Engl J Med. 2016;374(20):1911-1921.
Drug enables transfusion independence in lower-risk MDS
COPENHAGEN—Results from a pair of phase 2 trials suggest luspatercept can produce erythroid responses and enable transfusion independence in patients with lower-risk myelodysplastic syndromes (MDS).
In a 3-month base study, 51% of patients treated with luspatercept had an erythroid response, and 35% achieved transfusion independence.
In an ongoing extension study, 81% of luspatercept-treated patients have had an erythroid response, and 50% have achieved transfusion independence.
The majority of adverse events in both trials were grade 1 and 2.
Uwe Platzbecker, MD, of the University Hospital in Dresden, Germany, presented these results at the 21st Congress of the European Hematology Association (abstract S131*). The studies were sponsored by Acceleron Pharma, Inc.
Luspatercept (formerly ACE-536) is a modified activin receptor type IIB fusion protein that increases red blood cell (RBC) levels by targeting molecules in the TGF-β superfamily. Acceleron and Celgene are developing luspatercept to treat anemia in patients with rare blood disorders.
The phase 2 base study was a dose-escalation trial in which MDS patients received luspatercept for 3 months. In the ongoing extension study, patients from the base study are receiving luspatercept for an additional 24 months.
In both studies, patients with high transfusion burden (≥4 RBC units/8 weeks) and those with low transfusion burden (<4 RBC units/8 weeks) received luspatercept once every 3 weeks.
Base study
This study included 58 patients with a median age of 71.5 (range, 27-90). Their median time since diagnosis was 2.4 years (range, 0-14). Seventeen percent of patients had prior lenalidomide treatment, and 66% had previously received erythropoiesis-stimulating agents (ESAs).
In patients with low transfusion burden (n=19), the median hemoglobin at baseline was 8.7 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=39), the median number of RBC units transfused per 8 weeks was 6 (range, 4-18).
Patients received luspatercept subcutaneously every 3 weeks for up to 5 doses. The study included 7 dose-escalation cohorts (n=27, 0.125 to 1.75 mg/kg) and an expansion cohort (n=31, 1.0 to 1.75 mg/kg).
The primary outcome measure was the proportion of patients who had an erythroid response. In non-transfusion-dependent patients, an erythroid response was defined as a hemoglobin increase of at least 1.5 g/dL from baseline for at least 14 days.
In transfusion-dependent patients, an erythroid response was defined as a reduction of at least 4 RBC units transfused or a reduction of at least 50% of RBC units transfused compared to pretreatment.
Fifty-one percent (25/49) of patients treated at the higher dose levels had an erythroid response. And 35% (14/40) of transfused patients treated at the higher dose levels were transfusion independent for at least 8 weeks.
Extension study
This study includes 32 patients with a median age of 71.5 (range, 29-90). Their median time since diagnosis was 2.9 years (range, 0-14). Nineteen percent of patients had prior lenalidomide treatment, and 59% had previously received ESAs.
In patients with low transfusion burden (n=13), the median hemoglobin at baseline was 8.5 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=19), the median number of RBC units transfused per 8 weeks was 6 (range, 4-14).
In this ongoing study, patients are receiving luspatercept (1.0 to 1.75 mg/kg) subcutaneously every 3 weeks for an additional 24 months.
At last follow-up (March 4, 2016), 81% (26/32) of patients had an erythroid response. And 50% (11/22) of patients who were transfused prior to study initiation achieved transfusion independence for at least 8 weeks (range, 9-80+ weeks).
Dr Platzbecker noted that, in both studies, erythroid responses were observed whether or not patients previously received ESAs and regardless of patients’ baseline erythropoietin levels.
Safety
There were three grade 3 adverse events that were possibly or probably related to luspatercept—an increase in blast cell count, myalgia, and worsening of general condition.
Adverse events that were possibly or probably related to luspatercept and occurred in at least 2 patients were fatigue (7%, n=4), bone pain (5%, n=3), diarrhea (5%, n=3), myalgia (5%, n=3), headache (3%, n=2), hypertension (3%, n=2), and injection site erythema (3%, n=2).
Dr Platzbecker said luspatercept was generally safe and well-tolerated in these studies. And the results of these trials supported the initiation of a phase 3 study (MEDALIST, NCT02631070) in patients with lower-risk MDS. 
*Data in the abstract differ from data presented at the meeting.
COPENHAGEN—Results from a pair of phase 2 trials suggest luspatercept can produce erythroid responses and enable transfusion independence in patients with lower-risk myelodysplastic syndromes (MDS).
In a 3-month base study, 51% of patients treated with luspatercept had an erythroid response, and 35% achieved transfusion independence.
In an ongoing extension study, 81% of luspatercept-treated patients have had an erythroid response, and 50% have achieved transfusion independence.
The majority of adverse events in both trials were grade 1 and 2.
Uwe Platzbecker, MD, of the University Hospital in Dresden, Germany, presented these results at the 21st Congress of the European Hematology Association (abstract S131*). The studies were sponsored by Acceleron Pharma, Inc.
Luspatercept (formerly ACE-536) is a modified activin receptor type IIB fusion protein that increases red blood cell (RBC) levels by targeting molecules in the TGF-β superfamily. Acceleron and Celgene are developing luspatercept to treat anemia in patients with rare blood disorders.
The phase 2 base study was a dose-escalation trial in which MDS patients received luspatercept for 3 months. In the ongoing extension study, patients from the base study are receiving luspatercept for an additional 24 months.
In both studies, patients with high transfusion burden (≥4 RBC units/8 weeks) and those with low transfusion burden (<4 RBC units/8 weeks) received luspatercept once every 3 weeks.
Base study
This study included 58 patients with a median age of 71.5 (range, 27-90). Their median time since diagnosis was 2.4 years (range, 0-14). Seventeen percent of patients had prior lenalidomide treatment, and 66% had previously received erythropoiesis-stimulating agents (ESAs).
In patients with low transfusion burden (n=19), the median hemoglobin at baseline was 8.7 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=39), the median number of RBC units transfused per 8 weeks was 6 (range, 4-18).
Patients received luspatercept subcutaneously every 3 weeks for up to 5 doses. The study included 7 dose-escalation cohorts (n=27, 0.125 to 1.75 mg/kg) and an expansion cohort (n=31, 1.0 to 1.75 mg/kg).
The primary outcome measure was the proportion of patients who had an erythroid response. In non-transfusion-dependent patients, an erythroid response was defined as a hemoglobin increase of at least 1.5 g/dL from baseline for at least 14 days.
In transfusion-dependent patients, an erythroid response was defined as a reduction of at least 4 RBC units transfused or a reduction of at least 50% of RBC units transfused compared to pretreatment.
Fifty-one percent (25/49) of patients treated at the higher dose levels had an erythroid response. And 35% (14/40) of transfused patients treated at the higher dose levels were transfusion independent for at least 8 weeks.
Extension study
This study includes 32 patients with a median age of 71.5 (range, 29-90). Their median time since diagnosis was 2.9 years (range, 0-14). Nineteen percent of patients had prior lenalidomide treatment, and 59% had previously received ESAs.
In patients with low transfusion burden (n=13), the median hemoglobin at baseline was 8.5 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=19), the median number of RBC units transfused per 8 weeks was 6 (range, 4-14).
In this ongoing study, patients are receiving luspatercept (1.0 to 1.75 mg/kg) subcutaneously every 3 weeks for an additional 24 months.
At last follow-up (March 4, 2016), 81% (26/32) of patients had an erythroid response. And 50% (11/22) of patients who were transfused prior to study initiation achieved transfusion independence for at least 8 weeks (range, 9-80+ weeks).
Dr Platzbecker noted that, in both studies, erythroid responses were observed whether or not patients previously received ESAs and regardless of patients’ baseline erythropoietin levels.
Safety
There were three grade 3 adverse events that were possibly or probably related to luspatercept—an increase in blast cell count, myalgia, and worsening of general condition.
Adverse events that were possibly or probably related to luspatercept and occurred in at least 2 patients were fatigue (7%, n=4), bone pain (5%, n=3), diarrhea (5%, n=3), myalgia (5%, n=3), headache (3%, n=2), hypertension (3%, n=2), and injection site erythema (3%, n=2).
Dr Platzbecker said luspatercept was generally safe and well-tolerated in these studies. And the results of these trials supported the initiation of a phase 3 study (MEDALIST, NCT02631070) in patients with lower-risk MDS.
*Data in the abstract differ from data presented at the meeting.
COPENHAGEN—Results from a pair of phase 2 trials suggest luspatercept can produce erythroid responses and enable transfusion independence in patients with lower-risk myelodysplastic syndromes (MDS).
In a 3-month base study, 51% of patients treated with luspatercept had an erythroid response, and 35% achieved transfusion independence.
In an ongoing extension study, 81% of luspatercept-treated patients have had an erythroid response, and 50% have achieved transfusion independence.
The majority of adverse events in both trials were grade 1 and 2.
Uwe Platzbecker, MD, of the University Hospital in Dresden, Germany, presented these results at the 21st Congress of the European Hematology Association (abstract S131*). The studies were sponsored by Acceleron Pharma, Inc.
Luspatercept (formerly ACE-536) is a modified activin receptor type IIB fusion protein that increases red blood cell (RBC) levels by targeting molecules in the TGF-β superfamily. Acceleron and Celgene are developing luspatercept to treat anemia in patients with rare blood disorders.
The phase 2 base study was a dose-escalation trial in which MDS patients received luspatercept for 3 months. In the ongoing extension study, patients from the base study are receiving luspatercept for an additional 24 months.
In both studies, patients with high transfusion burden (≥4 RBC units/8 weeks) and those with low transfusion burden (<4 RBC units/8 weeks) received luspatercept once every 3 weeks.
Base study
This study included 58 patients with a median age of 71.5 (range, 27-90). Their median time since diagnosis was 2.4 years (range, 0-14). Seventeen percent of patients had prior lenalidomide treatment, and 66% had previously received erythropoiesis-stimulating agents (ESAs).
In patients with low transfusion burden (n=19), the median hemoglobin at baseline was 8.7 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=39), the median number of RBC units transfused per 8 weeks was 6 (range, 4-18).
Patients received luspatercept subcutaneously every 3 weeks for up to 5 doses. The study included 7 dose-escalation cohorts (n=27, 0.125 to 1.75 mg/kg) and an expansion cohort (n=31, 1.0 to 1.75 mg/kg).
The primary outcome measure was the proportion of patients who had an erythroid response. In non-transfusion-dependent patients, an erythroid response was defined as a hemoglobin increase of at least 1.5 g/dL from baseline for at least 14 days.
In transfusion-dependent patients, an erythroid response was defined as a reduction of at least 4 RBC units transfused or a reduction of at least 50% of RBC units transfused compared to pretreatment.
Fifty-one percent (25/49) of patients treated at the higher dose levels had an erythroid response. And 35% (14/40) of transfused patients treated at the higher dose levels were transfusion independent for at least 8 weeks.
Extension study
This study includes 32 patients with a median age of 71.5 (range, 29-90). Their median time since diagnosis was 2.9 years (range, 0-14). Nineteen percent of patients had prior lenalidomide treatment, and 59% had previously received ESAs.
In patients with low transfusion burden (n=13), the median hemoglobin at baseline was 8.5 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=19), the median number of RBC units transfused per 8 weeks was 6 (range, 4-14).
In this ongoing study, patients are receiving luspatercept (1.0 to 1.75 mg/kg) subcutaneously every 3 weeks for an additional 24 months.
At last follow-up (March 4, 2016), 81% (26/32) of patients had an erythroid response. And 50% (11/22) of patients who were transfused prior to study initiation achieved transfusion independence for at least 8 weeks (range, 9-80+ weeks).
Dr Platzbecker noted that, in both studies, erythroid responses were observed whether or not patients previously received ESAs and regardless of patients’ baseline erythropoietin levels.
Safety
There were three grade 3 adverse events that were possibly or probably related to luspatercept—an increase in blast cell count, myalgia, and worsening of general condition.
Adverse events that were possibly or probably related to luspatercept and occurred in at least 2 patients were fatigue (7%, n=4), bone pain (5%, n=3), diarrhea (5%, n=3), myalgia (5%, n=3), headache (3%, n=2), hypertension (3%, n=2), and injection site erythema (3%, n=2).
Dr Platzbecker said luspatercept was generally safe and well-tolerated in these studies. And the results of these trials supported the initiation of a phase 3 study (MEDALIST, NCT02631070) in patients with lower-risk MDS.
*Data in the abstract differ from data presented at the meeting.
Team describes method of targeting LSCs in BC-CML
Photo courtesy of
UC San Diego Health
New research has revealed a method of targeting leukemia stem cells (LSCs) in blast crisis chronic myeloid leukemia (BC-CML).
For this study, investigators used human cells and mouse models to define the role of ADAR1, an RNA editing enzyme, in BC-CML.
The team discovered how ADAR1 promotes LSC generation and identified a small molecule that can disrupt this process to fight BC-CML.
Catriona Jamieson, MD, PhD, of the University of California, San Diego, and her colleagues described this work in Cell Stem Cell.
“In this study, we showed that cancer stem cells co-opt an RNA editing system to clone themselves,” Dr Jamieson said. “What’s more, we found a method to dial it down.”
The investigators knew that ADAR1 can edit the sequence of microRNAs. By swapping out just one microRNA building block for another, ADAR1 alters the carefully orchestrated system cells use to control which genes are turned on or off at which times.
ADAR1 is also known to promote cancer progression and resistance to therapy. But Dr Jamieson’s team wanted to determine ADAR1’s role in governing LSCs.
The investigators conducted experiments with human BC-CML cells and mouse models of BC-CML. And they found that increased JAK2 signaling and BCR-ABL1 amplification activate ADAR1 in BC-CML cells. Then, hyper-ADAR1 editing slows down microRNAs known as let-7.
Ultimately, this activity increases cellular regeneration, turning white blood cell precursors into LSCs. And LSCs promote BC-CML.
After learning how the ADAR1 system works, Dr Jamieson and her colleagues looked for a way to stop it.
By inhibiting ADAR1 with a small-molecule compound known as 8-Aza, the investigators were able to counter ADAR1’s effect on LSC self-renewal and restore let-7.
Treatment with 8-Aza reduced self-renewal of BC-CML cells by approximately 40%, when compared to untreated cells.
“Based on this research, we believe that detecting ADAR1 activity will be important for predicting cancer progression,” Dr Jamieson said.
“In addition, inhibiting this enzyme represents a unique therapeutic vulnerability in cancer stem cells with active inflammatory signaling that may respond to pharmacologic inhibitors of inflammation sensitivity or selective ADAR1 inhibitors that are currently being developed.”
Photo courtesy of
UC San Diego Health
New research has revealed a method of targeting leukemia stem cells (LSCs) in blast crisis chronic myeloid leukemia (BC-CML).
For this study, investigators used human cells and mouse models to define the role of ADAR1, an RNA editing enzyme, in BC-CML.
The team discovered how ADAR1 promotes LSC generation and identified a small molecule that can disrupt this process to fight BC-CML.
Catriona Jamieson, MD, PhD, of the University of California, San Diego, and her colleagues described this work in Cell Stem Cell.
“In this study, we showed that cancer stem cells co-opt an RNA editing system to clone themselves,” Dr Jamieson said. “What’s more, we found a method to dial it down.”
The investigators knew that ADAR1 can edit the sequence of microRNAs. By swapping out just one microRNA building block for another, ADAR1 alters the carefully orchestrated system cells use to control which genes are turned on or off at which times.
ADAR1 is also known to promote cancer progression and resistance to therapy. But Dr Jamieson’s team wanted to determine ADAR1’s role in governing LSCs.
The investigators conducted experiments with human BC-CML cells and mouse models of BC-CML. And they found that increased JAK2 signaling and BCR-ABL1 amplification activate ADAR1 in BC-CML cells. Then, hyper-ADAR1 editing slows down microRNAs known as let-7.
Ultimately, this activity increases cellular regeneration, turning white blood cell precursors into LSCs. And LSCs promote BC-CML.
After learning how the ADAR1 system works, Dr Jamieson and her colleagues looked for a way to stop it.
By inhibiting ADAR1 with a small-molecule compound known as 8-Aza, the investigators were able to counter ADAR1’s effect on LSC self-renewal and restore let-7.
Treatment with 8-Aza reduced self-renewal of BC-CML cells by approximately 40%, when compared to untreated cells.
“Based on this research, we believe that detecting ADAR1 activity will be important for predicting cancer progression,” Dr Jamieson said.
“In addition, inhibiting this enzyme represents a unique therapeutic vulnerability in cancer stem cells with active inflammatory signaling that may respond to pharmacologic inhibitors of inflammation sensitivity or selective ADAR1 inhibitors that are currently being developed.”
Photo courtesy of
UC San Diego Health
New research has revealed a method of targeting leukemia stem cells (LSCs) in blast crisis chronic myeloid leukemia (BC-CML).
For this study, investigators used human cells and mouse models to define the role of ADAR1, an RNA editing enzyme, in BC-CML.
The team discovered how ADAR1 promotes LSC generation and identified a small molecule that can disrupt this process to fight BC-CML.
Catriona Jamieson, MD, PhD, of the University of California, San Diego, and her colleagues described this work in Cell Stem Cell.
“In this study, we showed that cancer stem cells co-opt an RNA editing system to clone themselves,” Dr Jamieson said. “What’s more, we found a method to dial it down.”
The investigators knew that ADAR1 can edit the sequence of microRNAs. By swapping out just one microRNA building block for another, ADAR1 alters the carefully orchestrated system cells use to control which genes are turned on or off at which times.
ADAR1 is also known to promote cancer progression and resistance to therapy. But Dr Jamieson’s team wanted to determine ADAR1’s role in governing LSCs.
The investigators conducted experiments with human BC-CML cells and mouse models of BC-CML. And they found that increased JAK2 signaling and BCR-ABL1 amplification activate ADAR1 in BC-CML cells. Then, hyper-ADAR1 editing slows down microRNAs known as let-7.
Ultimately, this activity increases cellular regeneration, turning white blood cell precursors into LSCs. And LSCs promote BC-CML.
After learning how the ADAR1 system works, Dr Jamieson and her colleagues looked for a way to stop it.
By inhibiting ADAR1 with a small-molecule compound known as 8-Aza, the investigators were able to counter ADAR1’s effect on LSC self-renewal and restore let-7.
Treatment with 8-Aza reduced self-renewal of BC-CML cells by approximately 40%, when compared to untreated cells.
“Based on this research, we believe that detecting ADAR1 activity will be important for predicting cancer progression,” Dr Jamieson said.
“In addition, inhibiting this enzyme represents a unique therapeutic vulnerability in cancer stem cells with active inflammatory signaling that may respond to pharmacologic inhibitors of inflammation sensitivity or selective ADAR1 inhibitors that are currently being developed.”
FDA grants drug breakthrough designation to treat GVHD
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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD).
Ruxolitinib is a JAK1/2 inhibitor that is already FDA-approved to treat patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
The drug is also approved to treat patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
Ruxolitinib is marketed as Jakafi by Incyte in the US and as Jakavi by Novartis outside the US.
“Receiving breakthrough therapy designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, MD, Incyte’s chief medical officer.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
Photo from Business Wire
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD).
Ruxolitinib is a JAK1/2 inhibitor that is already FDA-approved to treat patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
The drug is also approved to treat patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
Ruxolitinib is marketed as Jakafi by Incyte in the US and as Jakavi by Novartis outside the US.
“Receiving breakthrough therapy designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, MD, Incyte’s chief medical officer.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
Photo from Business Wire
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD).
Ruxolitinib is a JAK1/2 inhibitor that is already FDA-approved to treat patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
The drug is also approved to treat patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
Ruxolitinib is marketed as Jakafi by Incyte in the US and as Jakavi by Novartis outside the US.
“Receiving breakthrough therapy designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, MD, Incyte’s chief medical officer.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
Company recalls blood collection system
Photo by Charles Haymond
Haemonetics Corporation is recalling all lots of the Leukotrap RC System with RC2D Filter (re-order numbers 129-62 and 129-63) distributed since April 14, 2016.
The company says using these lots of the blood collection system may result in a higher-than-expected level of leukocytes in transfused blood.
Earlier this month, Haemonetics recalled 3 lots of the Leukotrap RC System with RC2D Filter due to reports of higher-than-expected residual white blood cells.
Since then, the company has received additional reports related to other lots.
Blood products that have been processed with the lots distributed since April 14, 2016, should not be re-filtered and should be labeled as non-leukoreduced, unless individual units have been tested and found suitable to be labeled as leukoreduced.
Continued use of these lots will require customers to verify that each unit labeled as leukoreduced was tested and meets standards for residual white blood cells acceptable to the US Food and Drug Administration.
Customers who want to return unused product to Haemonetics should contact their local customer service representative.
Photo by Charles Haymond
Haemonetics Corporation is recalling all lots of the Leukotrap RC System with RC2D Filter (re-order numbers 129-62 and 129-63) distributed since April 14, 2016.
The company says using these lots of the blood collection system may result in a higher-than-expected level of leukocytes in transfused blood.
Earlier this month, Haemonetics recalled 3 lots of the Leukotrap RC System with RC2D Filter due to reports of higher-than-expected residual white blood cells.
Since then, the company has received additional reports related to other lots.
Blood products that have been processed with the lots distributed since April 14, 2016, should not be re-filtered and should be labeled as non-leukoreduced, unless individual units have been tested and found suitable to be labeled as leukoreduced.
Continued use of these lots will require customers to verify that each unit labeled as leukoreduced was tested and meets standards for residual white blood cells acceptable to the US Food and Drug Administration.
Customers who want to return unused product to Haemonetics should contact their local customer service representative.
Photo by Charles Haymond
Haemonetics Corporation is recalling all lots of the Leukotrap RC System with RC2D Filter (re-order numbers 129-62 and 129-63) distributed since April 14, 2016.
The company says using these lots of the blood collection system may result in a higher-than-expected level of leukocytes in transfused blood.
Earlier this month, Haemonetics recalled 3 lots of the Leukotrap RC System with RC2D Filter due to reports of higher-than-expected residual white blood cells.
Since then, the company has received additional reports related to other lots.
Blood products that have been processed with the lots distributed since April 14, 2016, should not be re-filtered and should be labeled as non-leukoreduced, unless individual units have been tested and found suitable to be labeled as leukoreduced.
Continued use of these lots will require customers to verify that each unit labeled as leukoreduced was tested and meets standards for residual white blood cells acceptable to the US Food and Drug Administration.
Customers who want to return unused product to Haemonetics should contact their local customer service representative.