The fluid, evolving nature of perioperative medicine lends itself to a lively literature review and research update, according to Steven L. Cohn, MD, SFHM, a presenter of “ ‘A Whole New World’ of Perioperative Medicine: The 2018 Update” on Monday, April 9, at HM18.

The perioperative medicine update has been a fixture at the SHM annual conference for several years and provides an opportunity to highlight articles that may affect practice, said Dr. Cohn of the University of Miami in an interview. “Our goals are to familiarize the attendees with this new data so they are aware, so they can review the key articles in detail on their own, and so they can then apply the new information in their clinical practices,” he said.

The agenda for the session involves a presentation of 10-15 articles published since HM17. Dr. Cohn and presenter Paul J. Grant, MD, SFHM, the director of the consultative and perioperative medicine program and an associate chief medical information officer at Michigan Medicine, Ann Arbor, will briefly review the objectives and methods of each study before moving on to focus primarily on the result and conclusions.

“The top take-home message is to try to keep up with the perioperative literature, particularly in cardiology, because the evidence base keeps expanding and changing,” said Dr. Cohn. “This session is designed to deliver new information and also to stimulate the attendees to periodically review the literature on their own during the year,” he said.

This year’s collection of articles will address a range of topics, Dr. Cohn said, but he highlighted several articles “that will be thought provoking and potentially impact clinical practice regarding perioperative surveillance with the new fifth generation high sensitivity troponin assay and management of myocardial injury after noncardiac surgery. In particular, results from the MANAGE trial that was presented as a late-breaking trial at the American College of Cardiology meeting in March will be of interest to anyone involved in perioperative medicine,” he noted.

Dr. Cohn and Dr. Grant had no relevant financial conflicts to disclose.

“A Whole New World” of Perioperative Medicine: The 2018 Update
Monday, April 9, 2:00-2:40 p.m.
Crystal Ballroom G2/C-F

The fluid, evolving nature of perioperative medicine lends itself to a lively literature review and research update, according to Steven L. Cohn, MD, SFHM, a presenter of “ ‘A Whole New World’ of Perioperative Medicine: The 2018 Update” on Monday, April 9, at HM18.

The perioperative medicine update has been a fixture at the SHM annual conference for several years and provides an opportunity to highlight articles that may affect practice, said Dr. Cohn of the University of Miami in an interview. “Our goals are to familiarize the attendees with this new data so they are aware, so they can review the key articles in detail on their own, and so they can then apply the new information in their clinical practices,” he said.

The agenda for the session involves a presentation of 10-15 articles published since HM17. Dr. Cohn and presenter Paul J. Grant, MD, SFHM, the director of the consultative and perioperative medicine program and an associate chief medical information officer at Michigan Medicine, Ann Arbor, will briefly review the objectives and methods of each study before moving on to focus primarily on the result and conclusions.

“The top take-home message is to try to keep up with the perioperative literature, particularly in cardiology, because the evidence base keeps expanding and changing,” said Dr. Cohn. “This session is designed to deliver new information and also to stimulate the attendees to periodically review the literature on their own during the year,” he said.

This year’s collection of articles will address a range of topics, Dr. Cohn said, but he highlighted several articles “that will be thought provoking and potentially impact clinical practice regarding perioperative surveillance with the new fifth generation high sensitivity troponin assay and management of myocardial injury after noncardiac surgery. In particular, results from the MANAGE trial that was presented as a late-breaking trial at the American College of Cardiology meeting in March will be of interest to anyone involved in perioperative medicine,” he noted.

Dr. Cohn and Dr. Grant had no relevant financial conflicts to disclose.

“A Whole New World” of Perioperative Medicine: The 2018 Update
Monday, April 9, 2:00-2:40 p.m.
Crystal Ballroom G2/C-F

The fluid, evolving nature of perioperative medicine lends itself to a lively literature review and research update, according to Steven L. Cohn, MD, SFHM, a presenter of “ ‘A Whole New World’ of Perioperative Medicine: The 2018 Update” on Monday, April 9, at HM18.

The perioperative medicine update has been a fixture at the SHM annual conference for several years and provides an opportunity to highlight articles that may affect practice, said Dr. Cohn of the University of Miami in an interview. “Our goals are to familiarize the attendees with this new data so they are aware, so they can review the key articles in detail on their own, and so they can then apply the new information in their clinical practices,” he said.

The agenda for the session involves a presentation of 10-15 articles published since HM17. Dr. Cohn and presenter Paul J. Grant, MD, SFHM, the director of the consultative and perioperative medicine program and an associate chief medical information officer at Michigan Medicine, Ann Arbor, will briefly review the objectives and methods of each study before moving on to focus primarily on the result and conclusions.

“The top take-home message is to try to keep up with the perioperative literature, particularly in cardiology, because the evidence base keeps expanding and changing,” said Dr. Cohn. “This session is designed to deliver new information and also to stimulate the attendees to periodically review the literature on their own during the year,” he said.

This year’s collection of articles will address a range of topics, Dr. Cohn said, but he highlighted several articles “that will be thought provoking and potentially impact clinical practice regarding perioperative surveillance with the new fifth generation high sensitivity troponin assay and management of myocardial injury after noncardiac surgery. In particular, results from the MANAGE trial that was presented as a late-breaking trial at the American College of Cardiology meeting in March will be of interest to anyone involved in perioperative medicine,” he noted.

Dr. Cohn and Dr. Grant had no relevant financial conflicts to disclose.

“A Whole New World” of Perioperative Medicine: The 2018 Update
Monday, April 9, 2:00-2:40 p.m.
Crystal Ballroom G2/C-F

Although many physicians resist change, learning how to embrace change and making it work for you are keys to a long, successful practice in hospital medicine, said Thomas McIlraith, MD, SFHM, CLHM, immediate past chairman, department of hospital medicine, and immediate past treasurer of the board of directors of Mercy Medical Group in Sacramento, Calif.

During his Monday, April 9, session, “Scaling Up Your Hospital Medicine Group,” he will share what it was like to work through significant changes as the chair of a department that grew in 12 years from 12 hospitalists – averaging fewer than 100 patients per day – to 84 hospitalists averaging more than 500 patients per day.

“I will be discussing my experiences but relating some universal truths about leadership in hospital medicine that can be applied to all areas of hospital medicine and how to manage change in an environment where change is constant,” said Dr. McIlraith, who will share key lessons that he learned. “I will break it down into the cultural, personal, and structural aspects of thriving in this dynamic environment.”

Dr. McIlraith hopes that attendees will come away with a good understanding of what he dubs the “authority/accountability” equation in physician leadership. “This is a principle that is used to assess what is expected of you in order to be successful as a leader, and if your ‘authority’ is commensurate with your ‘accountability,’ ” he said. “The authority piece of the equation takes many forms: resources, personnel, reporting structure, clerical support, and so forth. The key is to make sure that the authority/accountably equation is balanced not only for you but also for your subordinates.”

One example of an imbalanced authority/accountability equation that he’ll discuss in some detail is becoming a figurehead, in which accountability exists without the necessary authority. “If you end up in that position, get out,” Dr. McIlraith said. He will also discuss an example of where the authority/accountability equation is tipped in the opposite direction, with disastrous consequences.

Dr. McIlraith and Kimberly Bell, MD, who will also present at this session, aim to make it interactive. Dr. Bell currently serves as the divisional director of the CHI Franciscan Inpatient Team located in Tacoma, Wash. “We both have a wealth of experience to offer, but we are not the only ones in attendance who have wisdom to share,” Dr. McIlraith said.

Another goal of this session is to help attendees identify other hospital medicine leaders in comparable situations for the purpose of networking outside of the meeting. The session, although aimed at physician leaders, will be relevant to all hospitalists.

Scaling Up Your Hospital Medicine Group
Monday, 1:35-2:35 p.m.
Grand Ballroom 7B

Although many physicians resist change, learning how to embrace change and making it work for you are keys to a long, successful practice in hospital medicine, said Thomas McIlraith, MD, SFHM, CLHM, immediate past chairman, department of hospital medicine, and immediate past treasurer of the board of directors of Mercy Medical Group in Sacramento, Calif.

During his Monday, April 9, session, “Scaling Up Your Hospital Medicine Group,” he will share what it was like to work through significant changes as the chair of a department that grew in 12 years from 12 hospitalists – averaging fewer than 100 patients per day – to 84 hospitalists averaging more than 500 patients per day.

“I will be discussing my experiences but relating some universal truths about leadership in hospital medicine that can be applied to all areas of hospital medicine and how to manage change in an environment where change is constant,” said Dr. McIlraith, who will share key lessons that he learned. “I will break it down into the cultural, personal, and structural aspects of thriving in this dynamic environment.”

Dr. McIlraith hopes that attendees will come away with a good understanding of what he dubs the “authority/accountability” equation in physician leadership. “This is a principle that is used to assess what is expected of you in order to be successful as a leader, and if your ‘authority’ is commensurate with your ‘accountability,’ ” he said. “The authority piece of the equation takes many forms: resources, personnel, reporting structure, clerical support, and so forth. The key is to make sure that the authority/accountably equation is balanced not only for you but also for your subordinates.”

One example of an imbalanced authority/accountability equation that he’ll discuss in some detail is becoming a figurehead, in which accountability exists without the necessary authority. “If you end up in that position, get out,” Dr. McIlraith said. He will also discuss an example of where the authority/accountability equation is tipped in the opposite direction, with disastrous consequences.

Dr. McIlraith and Kimberly Bell, MD, who will also present at this session, aim to make it interactive. Dr. Bell currently serves as the divisional director of the CHI Franciscan Inpatient Team located in Tacoma, Wash. “We both have a wealth of experience to offer, but we are not the only ones in attendance who have wisdom to share,” Dr. McIlraith said.

Another goal of this session is to help attendees identify other hospital medicine leaders in comparable situations for the purpose of networking outside of the meeting. The session, although aimed at physician leaders, will be relevant to all hospitalists.

Scaling Up Your Hospital Medicine Group
Monday, 1:35-2:35 p.m.
Grand Ballroom 7B

Although many physicians resist change, learning how to embrace change and making it work for you are keys to a long, successful practice in hospital medicine, said Thomas McIlraith, MD, SFHM, CLHM, immediate past chairman, department of hospital medicine, and immediate past treasurer of the board of directors of Mercy Medical Group in Sacramento, Calif.

During his Monday, April 9, session, “Scaling Up Your Hospital Medicine Group,” he will share what it was like to work through significant changes as the chair of a department that grew in 12 years from 12 hospitalists – averaging fewer than 100 patients per day – to 84 hospitalists averaging more than 500 patients per day.

“I will be discussing my experiences but relating some universal truths about leadership in hospital medicine that can be applied to all areas of hospital medicine and how to manage change in an environment where change is constant,” said Dr. McIlraith, who will share key lessons that he learned. “I will break it down into the cultural, personal, and structural aspects of thriving in this dynamic environment.”

Dr. McIlraith hopes that attendees will come away with a good understanding of what he dubs the “authority/accountability” equation in physician leadership. “This is a principle that is used to assess what is expected of you in order to be successful as a leader, and if your ‘authority’ is commensurate with your ‘accountability,’ ” he said. “The authority piece of the equation takes many forms: resources, personnel, reporting structure, clerical support, and so forth. The key is to make sure that the authority/accountably equation is balanced not only for you but also for your subordinates.”

One example of an imbalanced authority/accountability equation that he’ll discuss in some detail is becoming a figurehead, in which accountability exists without the necessary authority. “If you end up in that position, get out,” Dr. McIlraith said. He will also discuss an example of where the authority/accountability equation is tipped in the opposite direction, with disastrous consequences.

Dr. McIlraith and Kimberly Bell, MD, who will also present at this session, aim to make it interactive. Dr. Bell currently serves as the divisional director of the CHI Franciscan Inpatient Team located in Tacoma, Wash. “We both have a wealth of experience to offer, but we are not the only ones in attendance who have wisdom to share,” Dr. McIlraith said.

Another goal of this session is to help attendees identify other hospital medicine leaders in comparable situations for the purpose of networking outside of the meeting. The session, although aimed at physician leaders, will be relevant to all hospitalists.

Scaling Up Your Hospital Medicine Group
Monday, 1:35-2:35 p.m.
Grand Ballroom 7B

About 6 years ago, members of the Society of Hospital Medicine’s Academic Hospitalist Committee got together to try to answer a question: How do we meet the mentoring needs of junior hospitalists?

One answer was inspired by the singles social scene. “Speed mentoring,” modeled after speed dating, became a thing at the Society of Hospital Medicine’s annual meeting in 2013, and it has remained popular going into this year, its 6th appearance.

Joanna Bonsall, MD, PhD, SFHM, assistant professor of medicine at Emory University, Atlanta, has been a part of coordinating the event since the beginning.

“We tried it out for the first year, and it was wildly successful,” she said. “The feedback was enormous, so we’ve continued it ever since.”

Hospitalists looking for mentoring time with senior hospitalists submit their curriculum vitae and a question they’d like to have answered. Then they’re paired with three mentors who have expertise in that field, meeting with each for 15 minutes.

For instance, someone asking – How can I improve my teaching skills with medical students? – would be paired with veteran hospitalists known for their education skills. In its first year, there were 12 slots available. It has since expanded, and this year, there are 20 slots. Registration closed a month before the annual conference.

About 6 years ago, members of the Society of Hospital Medicine’s Academic Hospitalist Committee got together to try to answer a question: How do we meet the mentoring needs of junior hospitalists?

One answer was inspired by the singles social scene. “Speed mentoring,” modeled after speed dating, became a thing at the Society of Hospital Medicine’s annual meeting in 2013, and it has remained popular going into this year, its 6th appearance.

Joanna Bonsall, MD, PhD, SFHM, assistant professor of medicine at Emory University, Atlanta, has been a part of coordinating the event since the beginning.

“We tried it out for the first year, and it was wildly successful,” she said. “The feedback was enormous, so we’ve continued it ever since.”

Hospitalists looking for mentoring time with senior hospitalists submit their curriculum vitae and a question they’d like to have answered. Then they’re paired with three mentors who have expertise in that field, meeting with each for 15 minutes.

For instance, someone asking – How can I improve my teaching skills with medical students? – would be paired with veteran hospitalists known for their education skills. In its first year, there were 12 slots available. It has since expanded, and this year, there are 20 slots. Registration closed a month before the annual conference.

About 6 years ago, members of the Society of Hospital Medicine’s Academic Hospitalist Committee got together to try to answer a question: How do we meet the mentoring needs of junior hospitalists?

One answer was inspired by the singles social scene. “Speed mentoring,” modeled after speed dating, became a thing at the Society of Hospital Medicine’s annual meeting in 2013, and it has remained popular going into this year, its 6th appearance.

Joanna Bonsall, MD, PhD, SFHM, assistant professor of medicine at Emory University, Atlanta, has been a part of coordinating the event since the beginning.

“We tried it out for the first year, and it was wildly successful,” she said. “The feedback was enormous, so we’ve continued it ever since.”

Hospitalists looking for mentoring time with senior hospitalists submit their curriculum vitae and a question they’d like to have answered. Then they’re paired with three mentors who have expertise in that field, meeting with each for 15 minutes.

For instance, someone asking – How can I improve my teaching skills with medical students? – would be paired with veteran hospitalists known for their education skills. In its first year, there were 12 slots available. It has since expanded, and this year, there are 20 slots. Registration closed a month before the annual conference.

Welcome to Hospital Medicine 2018 (HM18), the largest conference ever held specifically for hospital medicine. The Society of Hospital Medicine (SHM) is proud that HM18 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, acute care providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM18 demonstrates your commitment to not only the specialty of hospital medicine but also to the patients you serve.

This year’s renowned speakers will present important sessions addressing the rapidly evolving health care landscape. To open the main conference on April 9, Kate Goodrich, MD, MHS, chief medical officer and director of the Centers for Medicare & Medicaid Services’ Center for Clinical Standards and Quality, and a practicing hospitalist, will present her featured address, “Payment Reform is Here: What Hospitalists Need to Know.” You will also hear from the president of SHM, Ron Greeno, MD, FCCP, MHM, about the state of hospital medicine.

On April 9, be sure to attend one of SHM’s Special Interest Forums, where you can choose to network and connect with other hospitalists interested in the same things you are. There are 29 forums from which to choose. On April 10, SHM will open the first-ever International Hospital Medicine Lounge. We hope to welcome more than 100 hospitalists from around the world to HM18.

On April 11, HM18 concludes with the closing keynote, titled “Hospitalists as Drivers of Innovation and System Change: Are We Doing Enough?” presented by Robert M. Wachter, MD, MHM, chief of the department of medicine at the University of California, San Francisco, and the author of “Hospital Medicine” and “The Digital Doctor.”

Please make sure to download the HM18 At Hand meeting app, a wonderful resource for every HM18 attendee that puts the meeting at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.

Don’t miss the opportunity to meet one on one with members of SHM’s Board of Directors, who will be available in the SHM Pavilion, located in the Exhibit Hall, during scheduled visit times. Please consult the Meet the Board schedule in the HM18 At Hand app for further information.

On behalf of the SHM Board of Directors and staff, welcome to HM18 and to Orlando. Through this conference’s rich selection of educational opportunities, research offerings, and networking events, SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, continuing to empower hospitalists and revolutionize patient care.

Dr. Wellikson is CEO of SHM.

Welcome to Hospital Medicine 2018 (HM18), the largest conference ever held specifically for hospital medicine. The Society of Hospital Medicine (SHM) is proud that HM18 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, acute care providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM18 demonstrates your commitment to not only the specialty of hospital medicine but also to the patients you serve.

This year’s renowned speakers will present important sessions addressing the rapidly evolving health care landscape. To open the main conference on April 9, Kate Goodrich, MD, MHS, chief medical officer and director of the Centers for Medicare & Medicaid Services’ Center for Clinical Standards and Quality, and a practicing hospitalist, will present her featured address, “Payment Reform is Here: What Hospitalists Need to Know.” You will also hear from the president of SHM, Ron Greeno, MD, FCCP, MHM, about the state of hospital medicine.

On April 9, be sure to attend one of SHM’s Special Interest Forums, where you can choose to network and connect with other hospitalists interested in the same things you are. There are 29 forums from which to choose. On April 10, SHM will open the first-ever International Hospital Medicine Lounge. We hope to welcome more than 100 hospitalists from around the world to HM18.

On April 11, HM18 concludes with the closing keynote, titled “Hospitalists as Drivers of Innovation and System Change: Are We Doing Enough?” presented by Robert M. Wachter, MD, MHM, chief of the department of medicine at the University of California, San Francisco, and the author of “Hospital Medicine” and “The Digital Doctor.”

Please make sure to download the HM18 At Hand meeting app, a wonderful resource for every HM18 attendee that puts the meeting at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.

Don’t miss the opportunity to meet one on one with members of SHM’s Board of Directors, who will be available in the SHM Pavilion, located in the Exhibit Hall, during scheduled visit times. Please consult the Meet the Board schedule in the HM18 At Hand app for further information.

On behalf of the SHM Board of Directors and staff, welcome to HM18 and to Orlando. Through this conference’s rich selection of educational opportunities, research offerings, and networking events, SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, continuing to empower hospitalists and revolutionize patient care.

Dr. Wellikson is CEO of SHM.

Welcome to Hospital Medicine 2018 (HM18), the largest conference ever held specifically for hospital medicine. The Society of Hospital Medicine (SHM) is proud that HM18 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, acute care providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM18 demonstrates your commitment to not only the specialty of hospital medicine but also to the patients you serve.

This year’s renowned speakers will present important sessions addressing the rapidly evolving health care landscape. To open the main conference on April 9, Kate Goodrich, MD, MHS, chief medical officer and director of the Centers for Medicare & Medicaid Services’ Center for Clinical Standards and Quality, and a practicing hospitalist, will present her featured address, “Payment Reform is Here: What Hospitalists Need to Know.” You will also hear from the president of SHM, Ron Greeno, MD, FCCP, MHM, about the state of hospital medicine.

On April 9, be sure to attend one of SHM’s Special Interest Forums, where you can choose to network and connect with other hospitalists interested in the same things you are. There are 29 forums from which to choose. On April 10, SHM will open the first-ever International Hospital Medicine Lounge. We hope to welcome more than 100 hospitalists from around the world to HM18.

On April 11, HM18 concludes with the closing keynote, titled “Hospitalists as Drivers of Innovation and System Change: Are We Doing Enough?” presented by Robert M. Wachter, MD, MHM, chief of the department of medicine at the University of California, San Francisco, and the author of “Hospital Medicine” and “The Digital Doctor.”

Please make sure to download the HM18 At Hand meeting app, a wonderful resource for every HM18 attendee that puts the meeting at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.

Don’t miss the opportunity to meet one on one with members of SHM’s Board of Directors, who will be available in the SHM Pavilion, located in the Exhibit Hall, during scheduled visit times. Please consult the Meet the Board schedule in the HM18 At Hand app for further information.

On behalf of the SHM Board of Directors and staff, welcome to HM18 and to Orlando. Through this conference’s rich selection of educational opportunities, research offerings, and networking events, SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, continuing to empower hospitalists and revolutionize patient care.

Dr. Wellikson is CEO of SHM.

The charge of the Annual Conference Committee is to develop the content for the SHM Annual Conference and pre-courses, including topics, speakers, and learning objectives. The 2018 Annual Conference Committee is composed of the following SHM members:

Course Director

Kathleen M. Finn, MD, MPhil, SFHM
Massachusetts General Hospital

Assistant Course Director​

Dustin T. Smith, MD, SFHM
Emory University School of Medicine

Committee Members

Joshua Allen-Dicker, MD, MPH, FHM
Beth Israel Deaconess Medical Center

Daniel Fang, MD
Stanford School of Medicine

Margaret C. Fang, MD, MPH, FHM
University of California, San Francisco

Leonard Feldman, MD, SFHM, FAAP, FACP
Johns Hopkins Hospital

Nick Fitterman, MD, SFHM
Northwell Health

Prateek Gandiga, MD
Georgetown University Hospital

Laura Nell Hodo, MD, FHM
Icahn School of Medicine at Mount Sinai & Kravis Children’s Hospital

Akshata Hopkins, MD, FHM
Johns Hopkins All Children’s Hospital

Michael Janjigian, MD
Bellevue Hospital Center

Benji K. Mathews, MD, SFHM
HealthPartners & University of Minnesota Medical School

Heather Nye, MD, PhD, SFHM
University of California, San Francisco

James C. Pile, MD, SFHM
Cleveland Clinic

Linda Prieto, MD, FHM
Morton Plant Hospital

Amith Skandhan, MD, FHM
Southeast Alabama Medical Center

Barbara Slawski, MD, MS, SFHM
Medical College of Wisconsin

Daniel I. Steinberg, MD, FHM
Beth Israel Medical Center

Amanda Trask, MBA, MHA, FACHE, SFHM
Catholic Health Initiatives

Rohit Uppal, MD, MBA, SFHM
TeamHealth

Christopher M. Whinney, MD, FACP, FHM
Cleveland Clinic Lerner College of Medicine

Surinder Yadav, MD, SFHM
CEP America

The charge of the Annual Conference Committee is to develop the content for the SHM Annual Conference and pre-courses, including topics, speakers, and learning objectives. The 2018 Annual Conference Committee is composed of the following SHM members:

Course Director

Kathleen M. Finn, MD, MPhil, SFHM
Massachusetts General Hospital

Assistant Course Director​

Dustin T. Smith, MD, SFHM
Emory University School of Medicine

Committee Members

Joshua Allen-Dicker, MD, MPH, FHM
Beth Israel Deaconess Medical Center

Daniel Fang, MD
Stanford School of Medicine

Margaret C. Fang, MD, MPH, FHM
University of California, San Francisco

Leonard Feldman, MD, SFHM, FAAP, FACP
Johns Hopkins Hospital

Nick Fitterman, MD, SFHM
Northwell Health

Prateek Gandiga, MD
Georgetown University Hospital

Laura Nell Hodo, MD, FHM
Icahn School of Medicine at Mount Sinai & Kravis Children’s Hospital

Akshata Hopkins, MD, FHM
Johns Hopkins All Children’s Hospital

Michael Janjigian, MD
Bellevue Hospital Center

Benji K. Mathews, MD, SFHM
HealthPartners & University of Minnesota Medical School

Heather Nye, MD, PhD, SFHM
University of California, San Francisco

James C. Pile, MD, SFHM
Cleveland Clinic

Linda Prieto, MD, FHM
Morton Plant Hospital

Amith Skandhan, MD, FHM
Southeast Alabama Medical Center

Barbara Slawski, MD, MS, SFHM
Medical College of Wisconsin

Daniel I. Steinberg, MD, FHM
Beth Israel Medical Center

Amanda Trask, MBA, MHA, FACHE, SFHM
Catholic Health Initiatives

Rohit Uppal, MD, MBA, SFHM
TeamHealth

Christopher M. Whinney, MD, FACP, FHM
Cleveland Clinic Lerner College of Medicine

Surinder Yadav, MD, SFHM
CEP America

The charge of the Annual Conference Committee is to develop the content for the SHM Annual Conference and pre-courses, including topics, speakers, and learning objectives. The 2018 Annual Conference Committee is composed of the following SHM members:

Course Director

Kathleen M. Finn, MD, MPhil, SFHM
Massachusetts General Hospital

Assistant Course Director​

Dustin T. Smith, MD, SFHM
Emory University School of Medicine

Committee Members

Joshua Allen-Dicker, MD, MPH, FHM
Beth Israel Deaconess Medical Center

Daniel Fang, MD
Stanford School of Medicine

Margaret C. Fang, MD, MPH, FHM
University of California, San Francisco

Leonard Feldman, MD, SFHM, FAAP, FACP
Johns Hopkins Hospital

Nick Fitterman, MD, SFHM
Northwell Health

Prateek Gandiga, MD
Georgetown University Hospital

Laura Nell Hodo, MD, FHM
Icahn School of Medicine at Mount Sinai & Kravis Children’s Hospital

Akshata Hopkins, MD, FHM
Johns Hopkins All Children’s Hospital

Michael Janjigian, MD
Bellevue Hospital Center

Benji K. Mathews, MD, SFHM
HealthPartners & University of Minnesota Medical School

Heather Nye, MD, PhD, SFHM
University of California, San Francisco

James C. Pile, MD, SFHM
Cleveland Clinic

Linda Prieto, MD, FHM
Morton Plant Hospital

Amith Skandhan, MD, FHM
Southeast Alabama Medical Center

Barbara Slawski, MD, MS, SFHM
Medical College of Wisconsin

Daniel I. Steinberg, MD, FHM
Beth Israel Medical Center

Amanda Trask, MBA, MHA, FACHE, SFHM
Catholic Health Initiatives

Rohit Uppal, MD, MBA, SFHM
TeamHealth

Christopher M. Whinney, MD, FACP, FHM
Cleveland Clinic Lerner College of Medicine

Surinder Yadav, MD, SFHM
CEP America

Image from NIAID

LISBON—Preliminary data from a phase 1 trial suggest UCART19 can serve as a bridge to transplant in adults with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL).

This “universal,” donor-derived, chimeric antigen receptor (CAR) T-cell therapy produced complete responses (CRs) in 6 of 9 patients treated.

Five of the patients who were negative for minimal residual disease (MRD) proceeded to allogeneic hematopoietic stem cell transplant (allo-HSCT).

Two of the 5 patients were still alive and in MRD-negative remission at last follow-up, but 1 had relapsed and 2 died.

A total of 4 patients died in this trial—1 from a dose-limiting toxicity (DLT), 1 from progressive disease, 1 from infection, and 1 from pulmonary hemorrhage.

“These early results for UCART19 are very encouraging, both in terms of manageable safety and the impressive complete molecular remission rate in these hard-to-treat adult patients with R/R B-ALL,” said principal investigator Reuben Benjamin, MBBS, PhD, a consultant hematologist at King’s College London in the UK.

Dr Benjamin presented these results, from the CALM trial, at the 44th Annual Meeting of the EBMT (abstract OS10-4*).

The CALM trial is sponsored by Servier. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co-developed by Servier and Pfizer.

Patients and treatment

Dr Benjamin presented results in 9 patients with R/R B-ALL who had a median age of 23 (range, 18-49).

All patients had morphological disease or an MRD level of at least 1 x 10^-3 (via flow cytometry and/or qPCR) at baseline. The median disease burden was 8% (range, 0-95).

Four patients had received 1 to 3 prior therapies, and 5 had received 4 or more prior treatments. Six patients had prior inotuzumab ozogamicin, 2 had prior blinatumomab, and 7 had prior allo-HSCT. The median time to relapse after allo-HSCT was 5.9 months (range, 4.1-11).

Patients underwent lymphodepletion with fludarabine, cyclophosphamide, and alemtuzumab (n=8) or fludarabine and cyclophosphamide (n=1).

They received UCART19 at 2 dose levels—6 x 10⁶ total cells (n=6) or 6 to 8 x 10⁷ total cells (n=3).

Toxicity

There were 2 DLTs, 1 at each dose level. At the lower dose, the DLT was grade 4 cytokine release syndrome (CRS) associated with grade 5 neutropenic sepsis. The patient with this DLT died at day 15 post-infusion.

At the higher dose level, the DLT was grade 4 prolonged cytopenia associated with infection and pulmonary hemorrhage. This patient died at day 82 post-infusion, 19 days after undergoing allo-HSCT.

In all, 8 patients had CRS. One patient had grade 1, 6 had grade 2, and 1 had grade 4 CRS. Seven patients had complete resolution of CRS.

Two patients had neurotoxic events, both grade 1.

Three patients had prolonged cytopenia, all grade 4. This was defined as persistent neutropenia and/or thrombocytopenia beyond day 42 after UCART19 infusion, except if the patient had >5% bone marrow blasts.

Two patients had neutropenic sepsis, grade 4 and grade 5.

Three patients had cytomegalovirus infection, all grade 2. Two patients had adenovirus infection, grade 1 and grade 3.

One patient had grade 1 acute cutaneous graft-versus-host disease.

Efficacy

Six of 9 patients achieved a CR, and 5 were MRD-negative by flow cytometry or qPCR. All 5 patients proceeded to allo-HSCT.

After transplant, 2 patients were still MRD-negative at 8 months, 1 patient relapsed after 6 months, and 2 patients died while MRD-negative. The deaths were due to infection and pulmonary hemorrhage.

Two other deaths were due to a DLT (neutropenic sepsis associated with CRS) and progressive disease.

Of the 5 patients who are alive, 2 are still MRD-negative after allo-HSCT. One of these patients relapsed after the first UCART19 infusion, received a second infusion, and achieved an MRD-negative CR that enabled transplant.

The remaining 3 patients who are still alive did not undergo transplant. One of these patients relapsed after achieving MRD-positive remission, and 1 relapsed after MRD-negative remission. The third patient relapsed and received a second UCART19 infusion. This patient has yet to respond to the second infusion but has minimal follow-up.

Recruitment in this study is ongoing at the higher dose level—6 to 8 x 10⁷ total cells.

*Data in the abstract were updated in the presentation.

Image from NIAID

LISBON—Preliminary data from a phase 1 trial suggest UCART19 can serve as a bridge to transplant in adults with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL).

This “universal,” donor-derived, chimeric antigen receptor (CAR) T-cell therapy produced complete responses (CRs) in 6 of 9 patients treated.

Five of the patients who were negative for minimal residual disease (MRD) proceeded to allogeneic hematopoietic stem cell transplant (allo-HSCT).

Two of the 5 patients were still alive and in MRD-negative remission at last follow-up, but 1 had relapsed and 2 died.

A total of 4 patients died in this trial—1 from a dose-limiting toxicity (DLT), 1 from progressive disease, 1 from infection, and 1 from pulmonary hemorrhage.

“These early results for UCART19 are very encouraging, both in terms of manageable safety and the impressive complete molecular remission rate in these hard-to-treat adult patients with R/R B-ALL,” said principal investigator Reuben Benjamin, MBBS, PhD, a consultant hematologist at King’s College London in the UK.

Dr Benjamin presented these results, from the CALM trial, at the 44th Annual Meeting of the EBMT (abstract OS10-4*).

The CALM trial is sponsored by Servier. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co-developed by Servier and Pfizer.

Patients and treatment

Dr Benjamin presented results in 9 patients with R/R B-ALL who had a median age of 23 (range, 18-49).

All patients had morphological disease or an MRD level of at least 1 x 10^-3 (via flow cytometry and/or qPCR) at baseline. The median disease burden was 8% (range, 0-95).

Four patients had received 1 to 3 prior therapies, and 5 had received 4 or more prior treatments. Six patients had prior inotuzumab ozogamicin, 2 had prior blinatumomab, and 7 had prior allo-HSCT. The median time to relapse after allo-HSCT was 5.9 months (range, 4.1-11).

Patients underwent lymphodepletion with fludarabine, cyclophosphamide, and alemtuzumab (n=8) or fludarabine and cyclophosphamide (n=1).

They received UCART19 at 2 dose levels—6 x 10⁶ total cells (n=6) or 6 to 8 x 10⁷ total cells (n=3).

Toxicity

There were 2 DLTs, 1 at each dose level. At the lower dose, the DLT was grade 4 cytokine release syndrome (CRS) associated with grade 5 neutropenic sepsis. The patient with this DLT died at day 15 post-infusion.

At the higher dose level, the DLT was grade 4 prolonged cytopenia associated with infection and pulmonary hemorrhage. This patient died at day 82 post-infusion, 19 days after undergoing allo-HSCT.

In all, 8 patients had CRS. One patient had grade 1, 6 had grade 2, and 1 had grade 4 CRS. Seven patients had complete resolution of CRS.

Two patients had neurotoxic events, both grade 1.

Three patients had prolonged cytopenia, all grade 4. This was defined as persistent neutropenia and/or thrombocytopenia beyond day 42 after UCART19 infusion, except if the patient had >5% bone marrow blasts.

Two patients had neutropenic sepsis, grade 4 and grade 5.

Three patients had cytomegalovirus infection, all grade 2. Two patients had adenovirus infection, grade 1 and grade 3.

One patient had grade 1 acute cutaneous graft-versus-host disease.

Efficacy

Six of 9 patients achieved a CR, and 5 were MRD-negative by flow cytometry or qPCR. All 5 patients proceeded to allo-HSCT.

After transplant, 2 patients were still MRD-negative at 8 months, 1 patient relapsed after 6 months, and 2 patients died while MRD-negative. The deaths were due to infection and pulmonary hemorrhage.

Two other deaths were due to a DLT (neutropenic sepsis associated with CRS) and progressive disease.

Of the 5 patients who are alive, 2 are still MRD-negative after allo-HSCT. One of these patients relapsed after the first UCART19 infusion, received a second infusion, and achieved an MRD-negative CR that enabled transplant.

The remaining 3 patients who are still alive did not undergo transplant. One of these patients relapsed after achieving MRD-positive remission, and 1 relapsed after MRD-negative remission. The third patient relapsed and received a second UCART19 infusion. This patient has yet to respond to the second infusion but has minimal follow-up.

Recruitment in this study is ongoing at the higher dose level—6 to 8 x 10⁷ total cells.

*Data in the abstract were updated in the presentation.

Image from NIAID

LISBON—Preliminary data from a phase 1 trial suggest UCART19 can serve as a bridge to transplant in adults with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL).

This “universal,” donor-derived, chimeric antigen receptor (CAR) T-cell therapy produced complete responses (CRs) in 6 of 9 patients treated.

Five of the patients who were negative for minimal residual disease (MRD) proceeded to allogeneic hematopoietic stem cell transplant (allo-HSCT).

Two of the 5 patients were still alive and in MRD-negative remission at last follow-up, but 1 had relapsed and 2 died.

A total of 4 patients died in this trial—1 from a dose-limiting toxicity (DLT), 1 from progressive disease, 1 from infection, and 1 from pulmonary hemorrhage.

“These early results for UCART19 are very encouraging, both in terms of manageable safety and the impressive complete molecular remission rate in these hard-to-treat adult patients with R/R B-ALL,” said principal investigator Reuben Benjamin, MBBS, PhD, a consultant hematologist at King’s College London in the UK.

Dr Benjamin presented these results, from the CALM trial, at the 44th Annual Meeting of the EBMT (abstract OS10-4*).

The CALM trial is sponsored by Servier. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co-developed by Servier and Pfizer.

Patients and treatment

Dr Benjamin presented results in 9 patients with R/R B-ALL who had a median age of 23 (range, 18-49).

All patients had morphological disease or an MRD level of at least 1 x 10^-3 (via flow cytometry and/or qPCR) at baseline. The median disease burden was 8% (range, 0-95).

Four patients had received 1 to 3 prior therapies, and 5 had received 4 or more prior treatments. Six patients had prior inotuzumab ozogamicin, 2 had prior blinatumomab, and 7 had prior allo-HSCT. The median time to relapse after allo-HSCT was 5.9 months (range, 4.1-11).

Patients underwent lymphodepletion with fludarabine, cyclophosphamide, and alemtuzumab (n=8) or fludarabine and cyclophosphamide (n=1).

They received UCART19 at 2 dose levels—6 x 10⁶ total cells (n=6) or 6 to 8 x 10⁷ total cells (n=3).

Toxicity

There were 2 DLTs, 1 at each dose level. At the lower dose, the DLT was grade 4 cytokine release syndrome (CRS) associated with grade 5 neutropenic sepsis. The patient with this DLT died at day 15 post-infusion.

At the higher dose level, the DLT was grade 4 prolonged cytopenia associated with infection and pulmonary hemorrhage. This patient died at day 82 post-infusion, 19 days after undergoing allo-HSCT.

In all, 8 patients had CRS. One patient had grade 1, 6 had grade 2, and 1 had grade 4 CRS. Seven patients had complete resolution of CRS.

Two patients had neurotoxic events, both grade 1.

Three patients had prolonged cytopenia, all grade 4. This was defined as persistent neutropenia and/or thrombocytopenia beyond day 42 after UCART19 infusion, except if the patient had >5% bone marrow blasts.

Two patients had neutropenic sepsis, grade 4 and grade 5.

Three patients had cytomegalovirus infection, all grade 2. Two patients had adenovirus infection, grade 1 and grade 3.

One patient had grade 1 acute cutaneous graft-versus-host disease.

Efficacy

Six of 9 patients achieved a CR, and 5 were MRD-negative by flow cytometry or qPCR. All 5 patients proceeded to allo-HSCT.

After transplant, 2 patients were still MRD-negative at 8 months, 1 patient relapsed after 6 months, and 2 patients died while MRD-negative. The deaths were due to infection and pulmonary hemorrhage.

Two other deaths were due to a DLT (neutropenic sepsis associated with CRS) and progressive disease.

Of the 5 patients who are alive, 2 are still MRD-negative after allo-HSCT. One of these patients relapsed after the first UCART19 infusion, received a second infusion, and achieved an MRD-negative CR that enabled transplant.

The remaining 3 patients who are still alive did not undergo transplant. One of these patients relapsed after achieving MRD-positive remission, and 1 relapsed after MRD-negative remission. The third patient relapsed and received a second UCART19 infusion. This patient has yet to respond to the second infusion but has minimal follow-up.

Recruitment in this study is ongoing at the higher dose level—6 to 8 x 10⁷ total cells.

*Data in the abstract were updated in the presentation.

SHM’s new recommendations to improve opioid prescribing for acute, noncancer pain in hospitalized adults will be the focus of Monday (April 9) morning’s session, “Opioids: What Now?”

Many patients who wind up on opioids for chronic pain start on the medications in an acute pain setting, said presenter Shoshana J. Herzig, MD, MPH, director of hospital medicine research at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston.

“Our prescribing patterns in the setting of acute pain meaningfully impact downstream outcomes and prescribing practices,” she said. “The degree of importance related to this topic often is underestimated by hospitalists, because we think of it as a more straightforward situation – prescribing for acute pain. In reality, there are nuances to it, and we have data to show that it’s not done well a lot of the time. It’s a big problem.”

Beth Israel Deaconess Media Services

During the session, “we’re going to do a case-based review that highlights the main points of the SHM consensus statement, just published in the Journal of Hospital Medicine [April issue],” Dr. Herzig said. She led the working group that developed the consensus statement. It features 16 suggestions to help hospital-based physicians appropriately employ opioids as part of their acute pain management strategies.

The copresenter will be Teryl K. Nuckols, MD, FHM, associate professor of medicine at the University of California, Los Angeles, and director of the division of internal medicine and associate professor of medicine at Cedars-Sinai Medical Center, Los Angeles. Dr. Nuckols was senior author of the JHM articles.

The presentation will assess the state of opioid prescribing in hospitalized patients and the challenges to acute pain management in hospitalized adults and explain how to improve prescribing practices to prevent opioid-related adverse events, opioid-use disorder, and long-term opioid use. Dr. Herzig and Dr. Nuckols will discuss how their group developed the new consensus statement by culling the key points from other physician group guidelines and present several case studies for interactive discussion to showcase the consensus statement suggestions. They also will go over topics in need of future research.

“We hope that attending the session and reading over the consensus statement will help to improve the appropriateness as well as the safety of opioid prescribing in the setting of acute pain in the hospital and help physicians recognize common pitfalls,” Dr. Herzig said. These include not remembering to combine opioids with nonopioid-based pharmacologic therapy; inappropriately continuing a patient on intravenous opioids when oral opioids, which have a lower risk of adverse outcomes, would suffice; and being able to identify patients at increased risk for opioid-related adverse events for whom a dose reduction or increased monitoring may be warranted.

Opioids: What Now?​​
Monday, April​ 10:35-11:35 a.m.
Crystal Ballroom G1/A&B

SHM’s new recommendations to improve opioid prescribing for acute, noncancer pain in hospitalized adults will be the focus of Monday (April 9) morning’s session, “Opioids: What Now?”

Many patients who wind up on opioids for chronic pain start on the medications in an acute pain setting, said presenter Shoshana J. Herzig, MD, MPH, director of hospital medicine research at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston.

“Our prescribing patterns in the setting of acute pain meaningfully impact downstream outcomes and prescribing practices,” she said. “The degree of importance related to this topic often is underestimated by hospitalists, because we think of it as a more straightforward situation – prescribing for acute pain. In reality, there are nuances to it, and we have data to show that it’s not done well a lot of the time. It’s a big problem.”

Beth Israel Deaconess Media Services

During the session, “we’re going to do a case-based review that highlights the main points of the SHM consensus statement, just published in the Journal of Hospital Medicine [April issue],” Dr. Herzig said. She led the working group that developed the consensus statement. It features 16 suggestions to help hospital-based physicians appropriately employ opioids as part of their acute pain management strategies.

The copresenter will be Teryl K. Nuckols, MD, FHM, associate professor of medicine at the University of California, Los Angeles, and director of the division of internal medicine and associate professor of medicine at Cedars-Sinai Medical Center, Los Angeles. Dr. Nuckols was senior author of the JHM articles.

The presentation will assess the state of opioid prescribing in hospitalized patients and the challenges to acute pain management in hospitalized adults and explain how to improve prescribing practices to prevent opioid-related adverse events, opioid-use disorder, and long-term opioid use. Dr. Herzig and Dr. Nuckols will discuss how their group developed the new consensus statement by culling the key points from other physician group guidelines and present several case studies for interactive discussion to showcase the consensus statement suggestions. They also will go over topics in need of future research.

“We hope that attending the session and reading over the consensus statement will help to improve the appropriateness as well as the safety of opioid prescribing in the setting of acute pain in the hospital and help physicians recognize common pitfalls,” Dr. Herzig said. These include not remembering to combine opioids with nonopioid-based pharmacologic therapy; inappropriately continuing a patient on intravenous opioids when oral opioids, which have a lower risk of adverse outcomes, would suffice; and being able to identify patients at increased risk for opioid-related adverse events for whom a dose reduction or increased monitoring may be warranted.

Opioids: What Now?​​
Monday, April​ 10:35-11:35 a.m.
Crystal Ballroom G1/A&B

SHM’s new recommendations to improve opioid prescribing for acute, noncancer pain in hospitalized adults will be the focus of Monday (April 9) morning’s session, “Opioids: What Now?”

Many patients who wind up on opioids for chronic pain start on the medications in an acute pain setting, said presenter Shoshana J. Herzig, MD, MPH, director of hospital medicine research at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston.

“Our prescribing patterns in the setting of acute pain meaningfully impact downstream outcomes and prescribing practices,” she said. “The degree of importance related to this topic often is underestimated by hospitalists, because we think of it as a more straightforward situation – prescribing for acute pain. In reality, there are nuances to it, and we have data to show that it’s not done well a lot of the time. It’s a big problem.”

Beth Israel Deaconess Media Services

During the session, “we’re going to do a case-based review that highlights the main points of the SHM consensus statement, just published in the Journal of Hospital Medicine [April issue],” Dr. Herzig said. She led the working group that developed the consensus statement. It features 16 suggestions to help hospital-based physicians appropriately employ opioids as part of their acute pain management strategies.

The copresenter will be Teryl K. Nuckols, MD, FHM, associate professor of medicine at the University of California, Los Angeles, and director of the division of internal medicine and associate professor of medicine at Cedars-Sinai Medical Center, Los Angeles. Dr. Nuckols was senior author of the JHM articles.

The presentation will assess the state of opioid prescribing in hospitalized patients and the challenges to acute pain management in hospitalized adults and explain how to improve prescribing practices to prevent opioid-related adverse events, opioid-use disorder, and long-term opioid use. Dr. Herzig and Dr. Nuckols will discuss how their group developed the new consensus statement by culling the key points from other physician group guidelines and present several case studies for interactive discussion to showcase the consensus statement suggestions. They also will go over topics in need of future research.

“We hope that attending the session and reading over the consensus statement will help to improve the appropriateness as well as the safety of opioid prescribing in the setting of acute pain in the hospital and help physicians recognize common pitfalls,” Dr. Herzig said. These include not remembering to combine opioids with nonopioid-based pharmacologic therapy; inappropriately continuing a patient on intravenous opioids when oral opioids, which have a lower risk of adverse outcomes, would suffice; and being able to identify patients at increased risk for opioid-related adverse events for whom a dose reduction or increased monitoring may be warranted.

Opioids: What Now?​​
Monday, April​ 10:35-11:35 a.m.
Crystal Ballroom G1/A&B

Photo from Business Wire

Two hemophilia organizations have notified the public of 5 deaths in adult patients receiving emicizumab (Hemlibra).

All 5 deaths—occurring in 2016 (n=1), 2017 (n=2), and this year (n=2)—were deemed unrelated to emicizumab by the investigator or treating physician.

The National Hemophilia Foundation and Hemophilia Federation of America reported these deaths after receiving notifications from Genentech.

The company said it has limited information about the circumstances of the deaths.

However, Genentech did say the 2016 death, 1 of the 2017 deaths, and 1 of the 2018 deaths occurred in patients receiving emicizumab via a compassionate use program.

Compassionate use of emicizumab has been available on a case-by-case basis, following a request to Roche from a patient’s treating physician, if the patient has a serious or life-threatening condition, has exhausted all other treatment options, and is unable to participate in a clinical trial.

The other death in 2017 occurred in a patient on the phase 3 HAVEN 1 trial and was reported along with the other results from that trial.

The remaining death in 2018 was in a patient receiving emicizumab via an expanded access protocol.

This protocol, which was reviewed by the US Food and Drug Administration, allowed US patients who were not participating in a clinical trial of emicizumab but who met eligibility criteria similar to key studies to have access to emicizumab prior to approval, which occurred in November 2017.

In response to the deaths, Genentech has pledged to share information on any adverse events that impact the overall benefit/risk profile of emicizumab.

“We are committed to providing timely and transparent updates on the safety profile of Hemlibra to health authorities, healthcare professionals, and the hemophilia community,” the company said.

For more information, patients and healthcare providers can call Genentech’s medical communications line at 1-800-821-8590. 

Photo from Business Wire

Two hemophilia organizations have notified the public of 5 deaths in adult patients receiving emicizumab (Hemlibra).

All 5 deaths—occurring in 2016 (n=1), 2017 (n=2), and this year (n=2)—were deemed unrelated to emicizumab by the investigator or treating physician.

The National Hemophilia Foundation and Hemophilia Federation of America reported these deaths after receiving notifications from Genentech.

The company said it has limited information about the circumstances of the deaths.

However, Genentech did say the 2016 death, 1 of the 2017 deaths, and 1 of the 2018 deaths occurred in patients receiving emicizumab via a compassionate use program.

Compassionate use of emicizumab has been available on a case-by-case basis, following a request to Roche from a patient’s treating physician, if the patient has a serious or life-threatening condition, has exhausted all other treatment options, and is unable to participate in a clinical trial.

The other death in 2017 occurred in a patient on the phase 3 HAVEN 1 trial and was reported along with the other results from that trial.

The remaining death in 2018 was in a patient receiving emicizumab via an expanded access protocol.

This protocol, which was reviewed by the US Food and Drug Administration, allowed US patients who were not participating in a clinical trial of emicizumab but who met eligibility criteria similar to key studies to have access to emicizumab prior to approval, which occurred in November 2017.

In response to the deaths, Genentech has pledged to share information on any adverse events that impact the overall benefit/risk profile of emicizumab.

“We are committed to providing timely and transparent updates on the safety profile of Hemlibra to health authorities, healthcare professionals, and the hemophilia community,” the company said.

For more information, patients and healthcare providers can call Genentech’s medical communications line at 1-800-821-8590. 

Photo from Business Wire

Two hemophilia organizations have notified the public of 5 deaths in adult patients receiving emicizumab (Hemlibra).

All 5 deaths—occurring in 2016 (n=1), 2017 (n=2), and this year (n=2)—were deemed unrelated to emicizumab by the investigator or treating physician.

The National Hemophilia Foundation and Hemophilia Federation of America reported these deaths after receiving notifications from Genentech.

The company said it has limited information about the circumstances of the deaths.

However, Genentech did say the 2016 death, 1 of the 2017 deaths, and 1 of the 2018 deaths occurred in patients receiving emicizumab via a compassionate use program.

Compassionate use of emicizumab has been available on a case-by-case basis, following a request to Roche from a patient’s treating physician, if the patient has a serious or life-threatening condition, has exhausted all other treatment options, and is unable to participate in a clinical trial.

The other death in 2017 occurred in a patient on the phase 3 HAVEN 1 trial and was reported along with the other results from that trial.

The remaining death in 2018 was in a patient receiving emicizumab via an expanded access protocol.

This protocol, which was reviewed by the US Food and Drug Administration, allowed US patients who were not participating in a clinical trial of emicizumab but who met eligibility criteria similar to key studies to have access to emicizumab prior to approval, which occurred in November 2017.

In response to the deaths, Genentech has pledged to share information on any adverse events that impact the overall benefit/risk profile of emicizumab.

“We are committed to providing timely and transparent updates on the safety profile of Hemlibra to health authorities, healthcare professionals, and the hemophilia community,” the company said.

For more information, patients and healthcare providers can call Genentech’s medical communications line at 1-800-821-8590. 

Photo by Bill Branson

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changing the terms of marketing authorization for fosaprepitant (Ivemend).

The product is already approved in the European Union (EU) for the prevention of acute and delayed nausea and vomiting associated with moderately or highly emetogenic cancer chemotherapy in adults.

Now, the CHMP is recommending that fosaprepitant be authorized for the same indication in pediatric patients age 6 months and older.

As it is in adults, fosaprepitant would be given to children as part of combination therapy.

The CHMP’s opinion on fosaprepitant will be reviewed by the European Commission (EC).

If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the EU. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.

The EC typically makes a decision within 67 days of the CHMP’s recommendation.

Merck Sharp & Dohme Corp., the company developing fosaprepitant, has conducted a phase 2 trial assessing the pharmacokinetics, pharmacodynamics, safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in children.

Patients ages 2 to 17 were randomized to receive 1 of 4 doses of fosaprepitant (0.4 mg/kg, 1.2 mg/kg, 3 mg/kg, and 5 mg/kg) or placebo in cycle 1. All patients also received ondansetron, with or without dexamethasone. Patients ages 0 to 11 were invited to participate in optional cycles 2 to 6, during which they received fosaprepitant at 3 mg/kg or 5 mg/kg.

Results from this trial have been posted on its clinicaltrials.gov page (NCT01697579).

Photo by Bill Branson

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changing the terms of marketing authorization for fosaprepitant (Ivemend).

The product is already approved in the European Union (EU) for the prevention of acute and delayed nausea and vomiting associated with moderately or highly emetogenic cancer chemotherapy in adults.

Now, the CHMP is recommending that fosaprepitant be authorized for the same indication in pediatric patients age 6 months and older.

As it is in adults, fosaprepitant would be given to children as part of combination therapy.

The CHMP’s opinion on fosaprepitant will be reviewed by the European Commission (EC).

If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the EU. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.

The EC typically makes a decision within 67 days of the CHMP’s recommendation.

Merck Sharp & Dohme Corp., the company developing fosaprepitant, has conducted a phase 2 trial assessing the pharmacokinetics, pharmacodynamics, safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in children.

Patients ages 2 to 17 were randomized to receive 1 of 4 doses of fosaprepitant (0.4 mg/kg, 1.2 mg/kg, 3 mg/kg, and 5 mg/kg) or placebo in cycle 1. All patients also received ondansetron, with or without dexamethasone. Patients ages 0 to 11 were invited to participate in optional cycles 2 to 6, during which they received fosaprepitant at 3 mg/kg or 5 mg/kg.

Results from this trial have been posted on its clinicaltrials.gov page (NCT01697579).

Photo by Bill Branson

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changing the terms of marketing authorization for fosaprepitant (Ivemend).

The product is already approved in the European Union (EU) for the prevention of acute and delayed nausea and vomiting associated with moderately or highly emetogenic cancer chemotherapy in adults.

Now, the CHMP is recommending that fosaprepitant be authorized for the same indication in pediatric patients age 6 months and older.

As it is in adults, fosaprepitant would be given to children as part of combination therapy.

The CHMP’s opinion on fosaprepitant will be reviewed by the European Commission (EC).

If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the EU. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.

The EC typically makes a decision within 67 days of the CHMP’s recommendation.

Merck Sharp & Dohme Corp., the company developing fosaprepitant, has conducted a phase 2 trial assessing the pharmacokinetics, pharmacodynamics, safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in children.

Patients ages 2 to 17 were randomized to receive 1 of 4 doses of fosaprepitant (0.4 mg/kg, 1.2 mg/kg, 3 mg/kg, and 5 mg/kg) or placebo in cycle 1. All patients also received ondansetron, with or without dexamethasone. Patients ages 0 to 11 were invited to participate in optional cycles 2 to 6, during which they received fosaprepitant at 3 mg/kg or 5 mg/kg.

Results from this trial have been posted on its clinicaltrials.gov page (NCT01697579).

Clinically important traumatic brain injury (ciTBI) is uncommon in children with minor head injuries associated with isolated vomiting, said Meredith L. Borland, MD, of the Princess Margaret Hospital for Children, Perth, Australia, and her associates.

Likewise, traumatic brain injury evident on computed tomography (TBI-CT) is rare in such cases.

In a study published in Pediatrics, 19,920 eligible children younger than 18 years were enrolled in the Australasian Paediatric Head Injury Rule Study (APHIRST); 3,389 had a history of any vomiting, and 1,006 had isolated vomiting without any other clinical decision rules predictors. Results found 76 of the 172 (44%) children with a ciTBI and 123 of the 285 (43%) children with TBI-CT had any history of vomiting. When the Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) rule predictors for those with isolated vomiting – both fewer than three times (n = 662 of 1,006; 66%) and also three or more times (n = 344 of 1,006; 34%) – was applied, there was only one child with ciTBI, and there were only two children with a TBI-CT.

Within the subsample comprising 457 children younger than 2 years old with isolated vomiting out of the overall 1,006 (45%), there were none with ciTBI or TBI-CT. In the 549 (55%) children 2 years old and older with isolated vomiting, one (0.3%) had ciTBI, and two (0.6%) had TBI-CT.

In multivariate regression, signs of skull fracture, altered mental status, headache, and acting abnormally were significantly associated with ciTBI. Signs of a skull fracture, nonaccidental injury concern, headache, and acting abnormally were significantly associated with TBI-CT.

“TBI-CT is uncommon, and ciTBI is uncommon in children with minor blunt head injury when vomiting is their only sign or symptom,” Dr. Borland and her associates concluded. “In children with isolated vomiting, strategies such as observation should be considered before conducting an immediate CT scan.”

Read the full study in Pediatrics.
 

[email protected]

Clinically important traumatic brain injury (ciTBI) is uncommon in children with minor head injuries associated with isolated vomiting, said Meredith L. Borland, MD, of the Princess Margaret Hospital for Children, Perth, Australia, and her associates.

Likewise, traumatic brain injury evident on computed tomography (TBI-CT) is rare in such cases.

In a study published in Pediatrics, 19,920 eligible children younger than 18 years were enrolled in the Australasian Paediatric Head Injury Rule Study (APHIRST); 3,389 had a history of any vomiting, and 1,006 had isolated vomiting without any other clinical decision rules predictors. Results found 76 of the 172 (44%) children with a ciTBI and 123 of the 285 (43%) children with TBI-CT had any history of vomiting. When the Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) rule predictors for those with isolated vomiting – both fewer than three times (n = 662 of 1,006; 66%) and also three or more times (n = 344 of 1,006; 34%) – was applied, there was only one child with ciTBI, and there were only two children with a TBI-CT.

Within the subsample comprising 457 children younger than 2 years old with isolated vomiting out of the overall 1,006 (45%), there were none with ciTBI or TBI-CT. In the 549 (55%) children 2 years old and older with isolated vomiting, one (0.3%) had ciTBI, and two (0.6%) had TBI-CT.

In multivariate regression, signs of skull fracture, altered mental status, headache, and acting abnormally were significantly associated with ciTBI. Signs of a skull fracture, nonaccidental injury concern, headache, and acting abnormally were significantly associated with TBI-CT.

“TBI-CT is uncommon, and ciTBI is uncommon in children with minor blunt head injury when vomiting is their only sign or symptom,” Dr. Borland and her associates concluded. “In children with isolated vomiting, strategies such as observation should be considered before conducting an immediate CT scan.”

Read the full study in Pediatrics.
 

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Clinically important traumatic brain injury (ciTBI) is uncommon in children with minor head injuries associated with isolated vomiting, said Meredith L. Borland, MD, of the Princess Margaret Hospital for Children, Perth, Australia, and her associates.

Likewise, traumatic brain injury evident on computed tomography (TBI-CT) is rare in such cases.

In a study published in Pediatrics, 19,920 eligible children younger than 18 years were enrolled in the Australasian Paediatric Head Injury Rule Study (APHIRST); 3,389 had a history of any vomiting, and 1,006 had isolated vomiting without any other clinical decision rules predictors. Results found 76 of the 172 (44%) children with a ciTBI and 123 of the 285 (43%) children with TBI-CT had any history of vomiting. When the Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) rule predictors for those with isolated vomiting – both fewer than three times (n = 662 of 1,006; 66%) and also three or more times (n = 344 of 1,006; 34%) – was applied, there was only one child with ciTBI, and there were only two children with a TBI-CT.

Within the subsample comprising 457 children younger than 2 years old with isolated vomiting out of the overall 1,006 (45%), there were none with ciTBI or TBI-CT. In the 549 (55%) children 2 years old and older with isolated vomiting, one (0.3%) had ciTBI, and two (0.6%) had TBI-CT.

In multivariate regression, signs of skull fracture, altered mental status, headache, and acting abnormally were significantly associated with ciTBI. Signs of a skull fracture, nonaccidental injury concern, headache, and acting abnormally were significantly associated with TBI-CT.

“TBI-CT is uncommon, and ciTBI is uncommon in children with minor blunt head injury when vomiting is their only sign or symptom,” Dr. Borland and her associates concluded. “In children with isolated vomiting, strategies such as observation should be considered before conducting an immediate CT scan.”

Read the full study in Pediatrics.
 

[email protected]