A medical journal is retracting a paper after a psychiatrist alleged that the managing editor closely copied and published her withdrawn work and claimed it for his own.

In addition, the managing editor, Gary VandenBos, PhD, has resigned at the journal’s request, according to an email sent to the paper’s original author, psychiatrist Amy Barnhorst, MD, vice chair for community mental health at the University of California, Davis, and coauthor and UC Davis colleague Rocco Pallin, MPH.

Dr. Barnhorst shared emails – from the journal’s publisher, Springer Publishing Company, and from the editor in chief, Morgan Sammons, PhD – with this news organization.

The retraction is the end of a saga that began when Dr. Barnhorst and Dr. Pallin submitted a paper, at Dr. VandenBos’s request, to the Journal of Health Service Psychology, published by Springer.

As previously reported by this news organization, Dr. Barnhorst and Dr. Pallin eventually decided to withdraw the paper and were later notified by Dr. VandenBos that he’d published a similar article under his own authorship. Michael O. Miller, a retired judge who trained as a psychologist, was listed as a coauthor.

Dr. VandenBos did not acknowledge how heavily his paper borrowed from the withdrawn article by Dr. Barnhorst and Dr. Pallin The two women – acknowledged experts in the article’s subject matter on how physicians can talk to patients about gun violence – immediately notified Dr. Sammons and Springer Publishing when they saw the published piece, saying they believed it plagiarized their original submission.

According to the e-mail Springer sent to Dr. Barnhorst, the publisher investigated and said that it would “be retracting the article shortly.”

The retraction notice will state: “The Editor in Chief and the authors, Dr. VandenBos and Mr. Miller, have retracted this article, as it significantly overlaps with an unpublished manuscript by Amy Barnhorst and Rocco Pallin.” It also states that “[Dr.] VandenBos accepts full responsibility for the overlap.”

The original article will still be available, but it will be marked as “retracted” and feature a link to the retraction notice.

Dr. Barnhorst, who garnered at least 40,000 likes when she tweeted about the alleged theft of her work, said in an interview that she and Dr. Pallin are “glad to see that the investigation is complete and the retraction has been issued.”

“At least we can now submit it to a new journal in a version that appropriately represents our work and expertise,” said Dr. Barnhorst. “I still have no idea how or why this happened, nor how much of it was intentional and on whose part, but I guess I never will!”

Editor removed

When contacted by this news organization to comment on the retraction and removal of Dr. VandenBos as managing editor, Dr. Sammons said it was not possible because, “I treat such correspondence as confidential.”

Dr. Sammons said he could “confirm that our investigation is reaching its conclusion and my colleagues at Springer Nature would be happy to contact you when we can provide a further update.”

Springer spokesperson Anne Korn also would not comment beyond saying, “The conclusion of our investigation is still in progress and may take a little additional time.”  

In the letter sent to Dr. Barnhorst and Dr. Pallin, Dr. Sammons said he had “asked for and accepted the resignation of Dr. VandenBos,” and that the resignation will be announced “in the upcoming print issue of our journal.”

Dr. Sammons said he also notified the dean of the University of Arizona College of Law that Mr. Miller, who held a position at the school, was not aware of the original submission by the two women. Even so, the school suspended Mr. Miller’s academic appointment, according to Dr. Sammons’ letter.

The editor in chief also said that, while “[Dr.] VandenBos’ errors were substantial and had substantial consequences, my investigation did not find any intent to plagiarize your work.”

He apologized again to Dr. Barnhorst and Dr. Pallin, though, adding, “I and my associate editors have initiated a revision of our publications processes to ensure that errors such as the above do not occur in the future, and I apologize again that this lapse affected you and your scholarly work.”

A version of this article first appeared on Medscape.com.

A medical journal is retracting a paper after a psychiatrist alleged that the managing editor closely copied and published her withdrawn work and claimed it for his own.

In addition, the managing editor, Gary VandenBos, PhD, has resigned at the journal’s request, according to an email sent to the paper’s original author, psychiatrist Amy Barnhorst, MD, vice chair for community mental health at the University of California, Davis, and coauthor and UC Davis colleague Rocco Pallin, MPH.

Dr. Barnhorst shared emails – from the journal’s publisher, Springer Publishing Company, and from the editor in chief, Morgan Sammons, PhD – with this news organization.

The retraction is the end of a saga that began when Dr. Barnhorst and Dr. Pallin submitted a paper, at Dr. VandenBos’s request, to the Journal of Health Service Psychology, published by Springer.

As previously reported by this news organization, Dr. Barnhorst and Dr. Pallin eventually decided to withdraw the paper and were later notified by Dr. VandenBos that he’d published a similar article under his own authorship. Michael O. Miller, a retired judge who trained as a psychologist, was listed as a coauthor.

Dr. VandenBos did not acknowledge how heavily his paper borrowed from the withdrawn article by Dr. Barnhorst and Dr. Pallin The two women – acknowledged experts in the article’s subject matter on how physicians can talk to patients about gun violence – immediately notified Dr. Sammons and Springer Publishing when they saw the published piece, saying they believed it plagiarized their original submission.

According to the e-mail Springer sent to Dr. Barnhorst, the publisher investigated and said that it would “be retracting the article shortly.”

The retraction notice will state: “The Editor in Chief and the authors, Dr. VandenBos and Mr. Miller, have retracted this article, as it significantly overlaps with an unpublished manuscript by Amy Barnhorst and Rocco Pallin.” It also states that “[Dr.] VandenBos accepts full responsibility for the overlap.”

The original article will still be available, but it will be marked as “retracted” and feature a link to the retraction notice.

Dr. Barnhorst, who garnered at least 40,000 likes when she tweeted about the alleged theft of her work, said in an interview that she and Dr. Pallin are “glad to see that the investigation is complete and the retraction has been issued.”

“At least we can now submit it to a new journal in a version that appropriately represents our work and expertise,” said Dr. Barnhorst. “I still have no idea how or why this happened, nor how much of it was intentional and on whose part, but I guess I never will!”

Editor removed

When contacted by this news organization to comment on the retraction and removal of Dr. VandenBos as managing editor, Dr. Sammons said it was not possible because, “I treat such correspondence as confidential.”

Dr. Sammons said he could “confirm that our investigation is reaching its conclusion and my colleagues at Springer Nature would be happy to contact you when we can provide a further update.”

Springer spokesperson Anne Korn also would not comment beyond saying, “The conclusion of our investigation is still in progress and may take a little additional time.”  

In the letter sent to Dr. Barnhorst and Dr. Pallin, Dr. Sammons said he had “asked for and accepted the resignation of Dr. VandenBos,” and that the resignation will be announced “in the upcoming print issue of our journal.”

Dr. Sammons said he also notified the dean of the University of Arizona College of Law that Mr. Miller, who held a position at the school, was not aware of the original submission by the two women. Even so, the school suspended Mr. Miller’s academic appointment, according to Dr. Sammons’ letter.

The editor in chief also said that, while “[Dr.] VandenBos’ errors were substantial and had substantial consequences, my investigation did not find any intent to plagiarize your work.”

He apologized again to Dr. Barnhorst and Dr. Pallin, though, adding, “I and my associate editors have initiated a revision of our publications processes to ensure that errors such as the above do not occur in the future, and I apologize again that this lapse affected you and your scholarly work.”

A version of this article first appeared on Medscape.com.

A medical journal is retracting a paper after a psychiatrist alleged that the managing editor closely copied and published her withdrawn work and claimed it for his own.

In addition, the managing editor, Gary VandenBos, PhD, has resigned at the journal’s request, according to an email sent to the paper’s original author, psychiatrist Amy Barnhorst, MD, vice chair for community mental health at the University of California, Davis, and coauthor and UC Davis colleague Rocco Pallin, MPH.

Dr. Barnhorst shared emails – from the journal’s publisher, Springer Publishing Company, and from the editor in chief, Morgan Sammons, PhD – with this news organization.

The retraction is the end of a saga that began when Dr. Barnhorst and Dr. Pallin submitted a paper, at Dr. VandenBos’s request, to the Journal of Health Service Psychology, published by Springer.

As previously reported by this news organization, Dr. Barnhorst and Dr. Pallin eventually decided to withdraw the paper and were later notified by Dr. VandenBos that he’d published a similar article under his own authorship. Michael O. Miller, a retired judge who trained as a psychologist, was listed as a coauthor.

Dr. VandenBos did not acknowledge how heavily his paper borrowed from the withdrawn article by Dr. Barnhorst and Dr. Pallin The two women – acknowledged experts in the article’s subject matter on how physicians can talk to patients about gun violence – immediately notified Dr. Sammons and Springer Publishing when they saw the published piece, saying they believed it plagiarized their original submission.

According to the e-mail Springer sent to Dr. Barnhorst, the publisher investigated and said that it would “be retracting the article shortly.”

The retraction notice will state: “The Editor in Chief and the authors, Dr. VandenBos and Mr. Miller, have retracted this article, as it significantly overlaps with an unpublished manuscript by Amy Barnhorst and Rocco Pallin.” It also states that “[Dr.] VandenBos accepts full responsibility for the overlap.”

The original article will still be available, but it will be marked as “retracted” and feature a link to the retraction notice.

Dr. Barnhorst, who garnered at least 40,000 likes when she tweeted about the alleged theft of her work, said in an interview that she and Dr. Pallin are “glad to see that the investigation is complete and the retraction has been issued.”

“At least we can now submit it to a new journal in a version that appropriately represents our work and expertise,” said Dr. Barnhorst. “I still have no idea how or why this happened, nor how much of it was intentional and on whose part, but I guess I never will!”

Editor removed

When contacted by this news organization to comment on the retraction and removal of Dr. VandenBos as managing editor, Dr. Sammons said it was not possible because, “I treat such correspondence as confidential.”

Dr. Sammons said he could “confirm that our investigation is reaching its conclusion and my colleagues at Springer Nature would be happy to contact you when we can provide a further update.”

Springer spokesperson Anne Korn also would not comment beyond saying, “The conclusion of our investigation is still in progress and may take a little additional time.”  

In the letter sent to Dr. Barnhorst and Dr. Pallin, Dr. Sammons said he had “asked for and accepted the resignation of Dr. VandenBos,” and that the resignation will be announced “in the upcoming print issue of our journal.”

Dr. Sammons said he also notified the dean of the University of Arizona College of Law that Mr. Miller, who held a position at the school, was not aware of the original submission by the two women. Even so, the school suspended Mr. Miller’s academic appointment, according to Dr. Sammons’ letter.

The editor in chief also said that, while “[Dr.] VandenBos’ errors were substantial and had substantial consequences, my investigation did not find any intent to plagiarize your work.”

He apologized again to Dr. Barnhorst and Dr. Pallin, though, adding, “I and my associate editors have initiated a revision of our publications processes to ensure that errors such as the above do not occur in the future, and I apologize again that this lapse affected you and your scholarly work.”

A version of this article first appeared on Medscape.com.

Immunization of people 70 and older with the Pfizer/BioNTech COVID-19 vaccine in Israel was associated with a precipitous drop in need for mechanical ventilation, new evidence reveals.

Compared with residents younger than 50 – so far vaccinated at lower rates than those of the higher-risk older people – Israelis 70 and older were 67% less likely to require mechanical ventilation for SARS-CoV-2 infection in February 2021 compared with October-December 2020.

“This study provides preliminary evidence at the population level for the reduction in risk for severe COVID-19, as manifested by need for mechanical ventilation, after vaccination with the Pfizer-BioNTech COVID-19 vaccine,” wrote lead author Ehud Rinott, department of public health, faculty of health sciences, Ben-Gurion University of the Negev in Beer-Sheva, Israel, and colleagues.

The study was published online Feb. 26, 2021, in Morbidity and Mortality Weekly Report.

The progress of COVID-19 vaccination across Israel presents researchers with a unique opportunity to study effectiveness on a population level. In this study, 84% of residents 70 and older received two-dose vaccinations. In contrast, only 10% of people in Israel younger than 50 received the same vaccine coverage.

Along with senior author Yair Lewis, MD, PhD, and coauthor Ilan Youngster, MD, Mr. Rinott compared mechanical ventilation rates between Oct. 2, 2020, and Feb. 9, 2021. They found that the ratio of people 70 and older compared with those younger than 50 requiring mechanical ventilation changed from 5.8:1 to 1.9:1 between these periods. This translates to the 67% decrease.

The study offers a “real-world” look at vaccination effectiveness, adding to more controlled evidence from clinical trials. “Achieving high vaccination coverage through intensive vaccination campaigns has the potential to substantially reduce COVID-19-associated morbidity and mortality,” the researchers wrote.

Israel started a national vaccination program on Dec. 20, 2020, targeting high-risk residents including people 60 and older, health care workers, and those with relevant comorbidities. At the same time, in addition to immunization, Israel has used strategies like stay-at-home orders, school closures, mask mandates, and more.

Potential limitations include a limited ability to account for the effect of the stay-at-home orders, spread of virus variants, and other concomitant factors; a potential for a delayed reporting of cases; and variability in mitigation measures by age group.

Dr. Youngster reported receipt of consulting fees from MyBiotix Ltd.

A version of this article first appeared on Medscape.com.

Immunization of people 70 and older with the Pfizer/BioNTech COVID-19 vaccine in Israel was associated with a precipitous drop in need for mechanical ventilation, new evidence reveals.

Compared with residents younger than 50 – so far vaccinated at lower rates than those of the higher-risk older people – Israelis 70 and older were 67% less likely to require mechanical ventilation for SARS-CoV-2 infection in February 2021 compared with October-December 2020.

“This study provides preliminary evidence at the population level for the reduction in risk for severe COVID-19, as manifested by need for mechanical ventilation, after vaccination with the Pfizer-BioNTech COVID-19 vaccine,” wrote lead author Ehud Rinott, department of public health, faculty of health sciences, Ben-Gurion University of the Negev in Beer-Sheva, Israel, and colleagues.

The study was published online Feb. 26, 2021, in Morbidity and Mortality Weekly Report.

The progress of COVID-19 vaccination across Israel presents researchers with a unique opportunity to study effectiveness on a population level. In this study, 84% of residents 70 and older received two-dose vaccinations. In contrast, only 10% of people in Israel younger than 50 received the same vaccine coverage.

Along with senior author Yair Lewis, MD, PhD, and coauthor Ilan Youngster, MD, Mr. Rinott compared mechanical ventilation rates between Oct. 2, 2020, and Feb. 9, 2021. They found that the ratio of people 70 and older compared with those younger than 50 requiring mechanical ventilation changed from 5.8:1 to 1.9:1 between these periods. This translates to the 67% decrease.

The study offers a “real-world” look at vaccination effectiveness, adding to more controlled evidence from clinical trials. “Achieving high vaccination coverage through intensive vaccination campaigns has the potential to substantially reduce COVID-19-associated morbidity and mortality,” the researchers wrote.

Israel started a national vaccination program on Dec. 20, 2020, targeting high-risk residents including people 60 and older, health care workers, and those with relevant comorbidities. At the same time, in addition to immunization, Israel has used strategies like stay-at-home orders, school closures, mask mandates, and more.

Potential limitations include a limited ability to account for the effect of the stay-at-home orders, spread of virus variants, and other concomitant factors; a potential for a delayed reporting of cases; and variability in mitigation measures by age group.

Dr. Youngster reported receipt of consulting fees from MyBiotix Ltd.

A version of this article first appeared on Medscape.com.

Immunization of people 70 and older with the Pfizer/BioNTech COVID-19 vaccine in Israel was associated with a precipitous drop in need for mechanical ventilation, new evidence reveals.

Compared with residents younger than 50 – so far vaccinated at lower rates than those of the higher-risk older people – Israelis 70 and older were 67% less likely to require mechanical ventilation for SARS-CoV-2 infection in February 2021 compared with October-December 2020.

“This study provides preliminary evidence at the population level for the reduction in risk for severe COVID-19, as manifested by need for mechanical ventilation, after vaccination with the Pfizer-BioNTech COVID-19 vaccine,” wrote lead author Ehud Rinott, department of public health, faculty of health sciences, Ben-Gurion University of the Negev in Beer-Sheva, Israel, and colleagues.

The study was published online Feb. 26, 2021, in Morbidity and Mortality Weekly Report.

The progress of COVID-19 vaccination across Israel presents researchers with a unique opportunity to study effectiveness on a population level. In this study, 84% of residents 70 and older received two-dose vaccinations. In contrast, only 10% of people in Israel younger than 50 received the same vaccine coverage.

Along with senior author Yair Lewis, MD, PhD, and coauthor Ilan Youngster, MD, Mr. Rinott compared mechanical ventilation rates between Oct. 2, 2020, and Feb. 9, 2021. They found that the ratio of people 70 and older compared with those younger than 50 requiring mechanical ventilation changed from 5.8:1 to 1.9:1 between these periods. This translates to the 67% decrease.

The study offers a “real-world” look at vaccination effectiveness, adding to more controlled evidence from clinical trials. “Achieving high vaccination coverage through intensive vaccination campaigns has the potential to substantially reduce COVID-19-associated morbidity and mortality,” the researchers wrote.

Israel started a national vaccination program on Dec. 20, 2020, targeting high-risk residents including people 60 and older, health care workers, and those with relevant comorbidities. At the same time, in addition to immunization, Israel has used strategies like stay-at-home orders, school closures, mask mandates, and more.

Potential limitations include a limited ability to account for the effect of the stay-at-home orders, spread of virus variants, and other concomitant factors; a potential for a delayed reporting of cases; and variability in mitigation measures by age group.

Dr. Youngster reported receipt of consulting fees from MyBiotix Ltd.

A version of this article first appeared on Medscape.com.

Remote interventions using an Internet-based app and telephone outreach to engage patients with osteoarthritis to self-manage their disease have demonstrated the potential to improve some symptoms, at least in the short term, showing the potential for tools to interact with OA patients without having them come into an office or clinic.

ponsulak/Thinkstock

Remote interaction using these two forms of telemedicine – one a sophisticated digital platform, the other using a device that’s been around for almost 150 years – may have greater utility for keeping physicians connected with their OA patients during the COVID-19 pandemic, OA experts said in an interview.

“This is certainly relevant during the pandemic, but this has been of high interest for years as well, as researchers and clinicians have been seeking the best ways to reach patients with these types of programs,” said Kelli Allen, PhD, a research health scientist at the University of North Carolina at Chapel Hill.

Two separate studies evaluated the telemedicine platforms. In JAMA Internal Medicine, researchers reported that telephone-based cognitive-behavioral therapy (CBT) for patients aged 60 and older with OA and insomnia led to improved sleep, fatigue and, to a lesser extent, pain, in a randomized, controlled trial with 327 patients.

A separate randomized, controlled trial of 105 OA patients at the University of Nottingham (England), published in JAMA Network Open, reported that users of a smartphone-based exercise intervention app had greater improvements in pain and function than did controls.

“I think these two studies represent a first step in terms of moving forward, and certainly the interventions could be refined and potentially combined together for patients in the future,” said C. Kent Kwoh, MD, director of the University of Arizona Arthritis Center in Tucson.

Phone-based CBT study

The telephone-based CBT study consisted of two groups: the CBT group (n = 163) who completed six 20- to 30-minute telephone calls over 8 weeks, kept daily diaries, and received tailored educational materials and an education-only group (n = 164). At 2 months after treatment, Insomnia Severity Index scores decreased 8.1 points on average in the CBT group versus 4.8 points in the education-only patients (P < .001).

That variation between the intervention group and controls was sustained out to a year: 7.7 points lower than baseline versus 4.7 points lower. At the same time point, 56.3% of the CBT group remained in remission with Insomnia Severity Index scores less than 7 versus 25.8% of controls. Fatigue outcomes were similarly disparate between the groups.

Pain outcomes were a different story, however. “Post treatment, significant differences were observed for pain, but these differences were not sustained at 12-month follow-up,” first author Susan M. McCurry, PhD, a clinical psychologist and faculty member at the University of Washington, Seattle, and colleagues wrote.

“I think their positive findings illustrate that remotely delivered interventions can be ‘low tech’ and still effective,” Dr. Allen said of the CBT phone study. She noted that complete case data were available for 282 of 327 patients. “The high rate of session attendance suggests that they chose a delivery modality appropriate for their target patient group.”

The scalability of the telephone model is noteworthy, Dr. Kwoh said. “Having a telemedicine intervention that could be scaled a little more easily rather than an in-person intervention, and having individualized treatment, that’s beneficial, as is targeting two symptoms that are very bothersome and burdensome to patients with OA: insomnia and fatigue.” Following patients out to 12 months is a strength of the study, he added.
 

Smartphone app–based exercise study

The U.K. study evaluated 6-week outcomes of 48 patients with knee OA who used a proprietary app-based exercise program (Joint Academy) and 57 controls who used traditional self-management. The app provided daily exercises and texts, along with email and smartphone reminders. The app was derived from the Better Management of Patients with OA program initiated in Sweden in 2008 that used OA treatment guidelines for education and exercise in person in primary care clinics.

App users showed a 1.5-point reduction in numeric rating scale (NRS) pain score at 6 weeks versus virtually no change in controls (P < .001). In terms of secondary outcomes, pain scores improved 2.2 points on average for app users versus 1.2 for controls (P = .02), with similar improvements recorded in both stiffness and physical function.

Average change in the 30-second sit-to-stand test measured 4.5 for the app users and 1.2 for the usual-care group (P < .001). The study found no difference between the two groups in changes in temporal summation, conditional pain modulation, or Arthritis Research UK Musculoskeletal Health Questionnaire scores.

First author Sameer Akram Gohir, MSc, PhD, and colleagues wrote that the reasons for differences in outcomes between app users and controls aren’t clear. “The superior outcome in the intervention group may depend on the content and context in the app, including a combination of standardized exercises and information, as well as using a digital delivery system.”

Data gathering was cut short because of COVID-19 restrictions in the United Kingdom, as 27 patients missed their in-person follow-up visits. That was one shortcoming of the study, Dr. Kwoh noted.

“Given the caveats certainly they were able to show robust changes in terms of decreased pain, and also improvement in a variety of performance measures. Certainly this may be beneficial – we don’t know – in terms of cost-effectiveness, but it may be beneficial for insurance companies to adapt such a program,” he said, adding that future studies into the cost effectiveness of the digital platform would be in order.

“Certainly, if this program were to decrease physician visits or postpone the need for joint replacement for individuals, then it could be certainly very cost effective,” Dr. Kwoh said.

The completion rate among patients in the study – almost 90% – was “impressive,” Dr. Allen said. “However, this is a relatively short-term study, and I think an important question for future research is whether patients continue with this level of engagement for a longer period of time.”

Dr. McCurry had no relevant financial relationships to disclose. The CBT phone study received funding from the Public Health Service and the National Institute on Aging. Coauthors disclosed relationships with Campbell Alliance Group, Mapi Research Trust, and Pfizer. Dr. Gohir reported no relevant financial relationships. The study received funding from the Versus Arthritis UK Plan Center, the National Institute for Health Research Nottingham Biomedical Research Center, and Pfizer Global. The Joint Academy provided software for the study. A coauthor reported a financial relationships with Pfizer. Dr. Kwoh said that in the past year he has consulted for Express Scripts, Kolon Tissue Gene, LG Chem, and Regeneron. In the past year, he also received institutional grants for clinical trials from AbbVie, Cumberland, Eicos, Eli Lilly, GlaxoSmithKline, Mitsubishi, and Pfizer. Dr. Allen had no relevant financial relationships to disclose.

Remote interventions using an Internet-based app and telephone outreach to engage patients with osteoarthritis to self-manage their disease have demonstrated the potential to improve some symptoms, at least in the short term, showing the potential for tools to interact with OA patients without having them come into an office or clinic.

ponsulak/Thinkstock

Remote interaction using these two forms of telemedicine – one a sophisticated digital platform, the other using a device that’s been around for almost 150 years – may have greater utility for keeping physicians connected with their OA patients during the COVID-19 pandemic, OA experts said in an interview.

“This is certainly relevant during the pandemic, but this has been of high interest for years as well, as researchers and clinicians have been seeking the best ways to reach patients with these types of programs,” said Kelli Allen, PhD, a research health scientist at the University of North Carolina at Chapel Hill.

Two separate studies evaluated the telemedicine platforms. In JAMA Internal Medicine, researchers reported that telephone-based cognitive-behavioral therapy (CBT) for patients aged 60 and older with OA and insomnia led to improved sleep, fatigue and, to a lesser extent, pain, in a randomized, controlled trial with 327 patients.

A separate randomized, controlled trial of 105 OA patients at the University of Nottingham (England), published in JAMA Network Open, reported that users of a smartphone-based exercise intervention app had greater improvements in pain and function than did controls.

“I think these two studies represent a first step in terms of moving forward, and certainly the interventions could be refined and potentially combined together for patients in the future,” said C. Kent Kwoh, MD, director of the University of Arizona Arthritis Center in Tucson.

Phone-based CBT study

The telephone-based CBT study consisted of two groups: the CBT group (n = 163) who completed six 20- to 30-minute telephone calls over 8 weeks, kept daily diaries, and received tailored educational materials and an education-only group (n = 164). At 2 months after treatment, Insomnia Severity Index scores decreased 8.1 points on average in the CBT group versus 4.8 points in the education-only patients (P < .001).

That variation between the intervention group and controls was sustained out to a year: 7.7 points lower than baseline versus 4.7 points lower. At the same time point, 56.3% of the CBT group remained in remission with Insomnia Severity Index scores less than 7 versus 25.8% of controls. Fatigue outcomes were similarly disparate between the groups.

Pain outcomes were a different story, however. “Post treatment, significant differences were observed for pain, but these differences were not sustained at 12-month follow-up,” first author Susan M. McCurry, PhD, a clinical psychologist and faculty member at the University of Washington, Seattle, and colleagues wrote.

“I think their positive findings illustrate that remotely delivered interventions can be ‘low tech’ and still effective,” Dr. Allen said of the CBT phone study. She noted that complete case data were available for 282 of 327 patients. “The high rate of session attendance suggests that they chose a delivery modality appropriate for their target patient group.”

The scalability of the telephone model is noteworthy, Dr. Kwoh said. “Having a telemedicine intervention that could be scaled a little more easily rather than an in-person intervention, and having individualized treatment, that’s beneficial, as is targeting two symptoms that are very bothersome and burdensome to patients with OA: insomnia and fatigue.” Following patients out to 12 months is a strength of the study, he added.
 

Smartphone app–based exercise study

The U.K. study evaluated 6-week outcomes of 48 patients with knee OA who used a proprietary app-based exercise program (Joint Academy) and 57 controls who used traditional self-management. The app provided daily exercises and texts, along with email and smartphone reminders. The app was derived from the Better Management of Patients with OA program initiated in Sweden in 2008 that used OA treatment guidelines for education and exercise in person in primary care clinics.

App users showed a 1.5-point reduction in numeric rating scale (NRS) pain score at 6 weeks versus virtually no change in controls (P < .001). In terms of secondary outcomes, pain scores improved 2.2 points on average for app users versus 1.2 for controls (P = .02), with similar improvements recorded in both stiffness and physical function.

Average change in the 30-second sit-to-stand test measured 4.5 for the app users and 1.2 for the usual-care group (P < .001). The study found no difference between the two groups in changes in temporal summation, conditional pain modulation, or Arthritis Research UK Musculoskeletal Health Questionnaire scores.

First author Sameer Akram Gohir, MSc, PhD, and colleagues wrote that the reasons for differences in outcomes between app users and controls aren’t clear. “The superior outcome in the intervention group may depend on the content and context in the app, including a combination of standardized exercises and information, as well as using a digital delivery system.”

Data gathering was cut short because of COVID-19 restrictions in the United Kingdom, as 27 patients missed their in-person follow-up visits. That was one shortcoming of the study, Dr. Kwoh noted.

“Given the caveats certainly they were able to show robust changes in terms of decreased pain, and also improvement in a variety of performance measures. Certainly this may be beneficial – we don’t know – in terms of cost-effectiveness, but it may be beneficial for insurance companies to adapt such a program,” he said, adding that future studies into the cost effectiveness of the digital platform would be in order.

“Certainly, if this program were to decrease physician visits or postpone the need for joint replacement for individuals, then it could be certainly very cost effective,” Dr. Kwoh said.

The completion rate among patients in the study – almost 90% – was “impressive,” Dr. Allen said. “However, this is a relatively short-term study, and I think an important question for future research is whether patients continue with this level of engagement for a longer period of time.”

Dr. McCurry had no relevant financial relationships to disclose. The CBT phone study received funding from the Public Health Service and the National Institute on Aging. Coauthors disclosed relationships with Campbell Alliance Group, Mapi Research Trust, and Pfizer. Dr. Gohir reported no relevant financial relationships. The study received funding from the Versus Arthritis UK Plan Center, the National Institute for Health Research Nottingham Biomedical Research Center, and Pfizer Global. The Joint Academy provided software for the study. A coauthor reported a financial relationships with Pfizer. Dr. Kwoh said that in the past year he has consulted for Express Scripts, Kolon Tissue Gene, LG Chem, and Regeneron. In the past year, he also received institutional grants for clinical trials from AbbVie, Cumberland, Eicos, Eli Lilly, GlaxoSmithKline, Mitsubishi, and Pfizer. Dr. Allen had no relevant financial relationships to disclose.

Remote interventions using an Internet-based app and telephone outreach to engage patients with osteoarthritis to self-manage their disease have demonstrated the potential to improve some symptoms, at least in the short term, showing the potential for tools to interact with OA patients without having them come into an office or clinic.

ponsulak/Thinkstock

Remote interaction using these two forms of telemedicine – one a sophisticated digital platform, the other using a device that’s been around for almost 150 years – may have greater utility for keeping physicians connected with their OA patients during the COVID-19 pandemic, OA experts said in an interview.

“This is certainly relevant during the pandemic, but this has been of high interest for years as well, as researchers and clinicians have been seeking the best ways to reach patients with these types of programs,” said Kelli Allen, PhD, a research health scientist at the University of North Carolina at Chapel Hill.

Two separate studies evaluated the telemedicine platforms. In JAMA Internal Medicine, researchers reported that telephone-based cognitive-behavioral therapy (CBT) for patients aged 60 and older with OA and insomnia led to improved sleep, fatigue and, to a lesser extent, pain, in a randomized, controlled trial with 327 patients.

A separate randomized, controlled trial of 105 OA patients at the University of Nottingham (England), published in JAMA Network Open, reported that users of a smartphone-based exercise intervention app had greater improvements in pain and function than did controls.

“I think these two studies represent a first step in terms of moving forward, and certainly the interventions could be refined and potentially combined together for patients in the future,” said C. Kent Kwoh, MD, director of the University of Arizona Arthritis Center in Tucson.

Phone-based CBT study

The telephone-based CBT study consisted of two groups: the CBT group (n = 163) who completed six 20- to 30-minute telephone calls over 8 weeks, kept daily diaries, and received tailored educational materials and an education-only group (n = 164). At 2 months after treatment, Insomnia Severity Index scores decreased 8.1 points on average in the CBT group versus 4.8 points in the education-only patients (P < .001).

That variation between the intervention group and controls was sustained out to a year: 7.7 points lower than baseline versus 4.7 points lower. At the same time point, 56.3% of the CBT group remained in remission with Insomnia Severity Index scores less than 7 versus 25.8% of controls. Fatigue outcomes were similarly disparate between the groups.

Pain outcomes were a different story, however. “Post treatment, significant differences were observed for pain, but these differences were not sustained at 12-month follow-up,” first author Susan M. McCurry, PhD, a clinical psychologist and faculty member at the University of Washington, Seattle, and colleagues wrote.

“I think their positive findings illustrate that remotely delivered interventions can be ‘low tech’ and still effective,” Dr. Allen said of the CBT phone study. She noted that complete case data were available for 282 of 327 patients. “The high rate of session attendance suggests that they chose a delivery modality appropriate for their target patient group.”

The scalability of the telephone model is noteworthy, Dr. Kwoh said. “Having a telemedicine intervention that could be scaled a little more easily rather than an in-person intervention, and having individualized treatment, that’s beneficial, as is targeting two symptoms that are very bothersome and burdensome to patients with OA: insomnia and fatigue.” Following patients out to 12 months is a strength of the study, he added.
 

Smartphone app–based exercise study

The U.K. study evaluated 6-week outcomes of 48 patients with knee OA who used a proprietary app-based exercise program (Joint Academy) and 57 controls who used traditional self-management. The app provided daily exercises and texts, along with email and smartphone reminders. The app was derived from the Better Management of Patients with OA program initiated in Sweden in 2008 that used OA treatment guidelines for education and exercise in person in primary care clinics.

App users showed a 1.5-point reduction in numeric rating scale (NRS) pain score at 6 weeks versus virtually no change in controls (P < .001). In terms of secondary outcomes, pain scores improved 2.2 points on average for app users versus 1.2 for controls (P = .02), with similar improvements recorded in both stiffness and physical function.

Average change in the 30-second sit-to-stand test measured 4.5 for the app users and 1.2 for the usual-care group (P < .001). The study found no difference between the two groups in changes in temporal summation, conditional pain modulation, or Arthritis Research UK Musculoskeletal Health Questionnaire scores.

First author Sameer Akram Gohir, MSc, PhD, and colleagues wrote that the reasons for differences in outcomes between app users and controls aren’t clear. “The superior outcome in the intervention group may depend on the content and context in the app, including a combination of standardized exercises and information, as well as using a digital delivery system.”

Data gathering was cut short because of COVID-19 restrictions in the United Kingdom, as 27 patients missed their in-person follow-up visits. That was one shortcoming of the study, Dr. Kwoh noted.

“Given the caveats certainly they were able to show robust changes in terms of decreased pain, and also improvement in a variety of performance measures. Certainly this may be beneficial – we don’t know – in terms of cost-effectiveness, but it may be beneficial for insurance companies to adapt such a program,” he said, adding that future studies into the cost effectiveness of the digital platform would be in order.

“Certainly, if this program were to decrease physician visits or postpone the need for joint replacement for individuals, then it could be certainly very cost effective,” Dr. Kwoh said.

The completion rate among patients in the study – almost 90% – was “impressive,” Dr. Allen said. “However, this is a relatively short-term study, and I think an important question for future research is whether patients continue with this level of engagement for a longer period of time.”

Dr. McCurry had no relevant financial relationships to disclose. The CBT phone study received funding from the Public Health Service and the National Institute on Aging. Coauthors disclosed relationships with Campbell Alliance Group, Mapi Research Trust, and Pfizer. Dr. Gohir reported no relevant financial relationships. The study received funding from the Versus Arthritis UK Plan Center, the National Institute for Health Research Nottingham Biomedical Research Center, and Pfizer Global. The Joint Academy provided software for the study. A coauthor reported a financial relationships with Pfizer. Dr. Kwoh said that in the past year he has consulted for Express Scripts, Kolon Tissue Gene, LG Chem, and Regeneron. In the past year, he also received institutional grants for clinical trials from AbbVie, Cumberland, Eicos, Eli Lilly, GlaxoSmithKline, Mitsubishi, and Pfizer. Dr. Allen had no relevant financial relationships to disclose.

Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1 year.

In a double-blind, placebo-controlled, food challenge (DBPCFC) of some 36 peanut-allergic children (mean age 2.2 years, range 1-4 years), those who were randomly assigned to receive peanut sublingual immunotherapy (PNSLIT) showed significant desensitization compared with those who received placebo.

In addition, there was a “strong potential” for sustained unresponsiveness at 3 months for the toddlers who received the active treatment.

The findings were presented in a late breaking oral abstract session at the 2021 American Academy of Allergy, Asthma & Immunology virtual annual meeting (Abstract L2).

“A year ago, the Food and Drug Administration approved the oral agent Palforzia (peanut allergen powder) for the treatment of peanut allergy in children 4 and older, and it is a great option, but I think what we have learned over time is that this approach is not for everybody,” Edwin H. Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, said in an interview.

Palforzia is a powder that is mixed in food like yogurt or pudding which the child then eats daily, according to a rigorous schedule. But Palforzia treatment presents some difficulties.

“Palforzia requires getting the powder dose, mixing it with food, like pudding or apple sauce, then eating it, which can take up to 30 minutes depending on age and kids’ cooperation. It tastes and smells like peanut which can cause aversion. Kids have to refrain from exercise or strenuous activity for at least 30 minutes before and after dosing and have to be observed for up to 2 hours post dose for symptoms,” Dr. Kim said.

“It’s a great drug, but the treatment could be overly difficult for certain families to be able to do, and in some cases the side effects may be more than certain patients are able or willing to handle, so there is a real urgent need for alternative approaches,” Dr. Kim said. “SLIT is several drops under the tongue, held for 2 minutes, swallowed and done.”

In the current placebo-controlled study, he and his group tested the feasibility, efficacy, and safety of the sublingual approach to peanut allergy in children age 4 years and younger.

Both groups were similar with regard to gender, race, ethnicity, atopic history, peanut skin prick test, and qualifying DBPCFC, and all children were previously allergic with positive blood and skin tests, with a positive reaction during baseline food challenge, thus proving the allergy and establishing the baseline threshold.

“We have learned from some studies, for instance the DEVIL and LEAP studies, that strongly suggest that the immune systems in younger patients may be more amenable to change, and there may be some justification for early intervention,” he said.

“Based on both of those ideas, we wanted to take our sublingual approach, which we have shown to have a pretty good efficacy in older children, and bring it down to this younger group and see if it still could have the same efficacy and also maintain what seems to be a very good safety signal.”

The researchers randomly assigned the children to receive PNSLIT at a daily maintenance dose of 4 mg peanut protein (n = 19) or to receive placebo (n = 17) for 36 months.

“There was a 5- to 6-month buildup period where the SLIT dose was increased every 1-2 weeks up to the target dose of 4 mg, and then the final dose of 4 mg was continued through to the end of the study,” Dr. Kim noted.

Over a total of 20,593 potential dosing days, the children took 91.2% of SLIT doses and 93.5% of placebo doses.

At the end of the 3-year study period, the children were challenged by DBPCFC with up to 4,333 mg of peanut protein.

Sustained unresponsiveness was assessed by an identical DBPCFC after discontinuation of the immunotherapy for 3 months.

Cumulative tolerated dose increased from a median of 143 mg to 4,443 mg in the PNSLIT group, compared with a median of 43 mg to 143 mg in the placebo group (P < .0001).

Fourteen of the children receiving PNSLIT, and none of the children receiving placebo, passed the desensitization food challenge. Twelve of the children receiving PNSLIT and two of the children receiving placebo passed the sustained unresponsiveness challenge.

Children who underwent the immunotherapy saw a decrease in their peanut skin prick test from 10 mm to 3.25 mm, compared to an increase from 11.5 mm to 12 mm with placebo (P < .0001).

The most common side effect reported was itching or irritation in the mouth. Most side effects resolved on their own, although some patients used an antihistamine. Getting children as young as 1 to hold the dose under their tongue was a challenge in some instances, but it eventually worked out, Dr. Kim said.

“It took a lot of work from the parents as well as from our research coordinators in trying to train these young kids to, first of all, allow us to put the peanut medication in the mouth and then to try as best as possible to keep it in their mouth for up to 2 minutes, but the families involved in our study were very dedicated and so we were able to get through that,” he said.
 

Study merits larger numbers

“Among the 36 who completed the 3 years of therapy, the authors report significant rates of desensitization among treated children compared with those receiving placebo. Furthermore, this effect was persistent for at least 3 months after stopping therapy in a subgroup of the children,” said Leonard B. Bacharier, MD, director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, Tenn.

“Overall, these findings suggest the promise of peanut SLIT, which should be studied in larger numbers of preschool children,” Dr. Bacharier, who was not part of the study, said in an interview.

Jonathan A. Bernstein, MD, professor of medicine, University of Cincinnati, agreed.

“It’s a well-designed study, it’s small, but it’s promising,” Dr. Bernstein, who was not involved with the study, said in an interview.

“They did show that most of the patients who got the sublingual therapy were able to get to the target dose and develop tolerance, so I think it’s promising. We know that this stuff works. This is just more data from a well-controlled study in a younger population,” he said.

“We do OIT [oral immunotherapy] and sublingual but we don’t do it in such young children in our practice. The youngest is 3 years old, because they have to understand what is going on and cooperate. If they don’t cooperate it’s not possible.”

Dr. Kim reported financial relationships with DBV Technologies, Kenota Health, Ukko, Aimmune Therapeutics, ALK, AllerGenis, Belhaven Pharma, Duke Clinical Research Institute, Nutricia, NIH/NIAID, NIH/NCCIH, NIH/Immune Tolerance Network, FARE, and the Wallace Foundation. Dr. Bacharier and Dr. Bernstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1 year.

In a double-blind, placebo-controlled, food challenge (DBPCFC) of some 36 peanut-allergic children (mean age 2.2 years, range 1-4 years), those who were randomly assigned to receive peanut sublingual immunotherapy (PNSLIT) showed significant desensitization compared with those who received placebo.

In addition, there was a “strong potential” for sustained unresponsiveness at 3 months for the toddlers who received the active treatment.

The findings were presented in a late breaking oral abstract session at the 2021 American Academy of Allergy, Asthma & Immunology virtual annual meeting (Abstract L2).

“A year ago, the Food and Drug Administration approved the oral agent Palforzia (peanut allergen powder) for the treatment of peanut allergy in children 4 and older, and it is a great option, but I think what we have learned over time is that this approach is not for everybody,” Edwin H. Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, said in an interview.

Palforzia is a powder that is mixed in food like yogurt or pudding which the child then eats daily, according to a rigorous schedule. But Palforzia treatment presents some difficulties.

“Palforzia requires getting the powder dose, mixing it with food, like pudding or apple sauce, then eating it, which can take up to 30 minutes depending on age and kids’ cooperation. It tastes and smells like peanut which can cause aversion. Kids have to refrain from exercise or strenuous activity for at least 30 minutes before and after dosing and have to be observed for up to 2 hours post dose for symptoms,” Dr. Kim said.

“It’s a great drug, but the treatment could be overly difficult for certain families to be able to do, and in some cases the side effects may be more than certain patients are able or willing to handle, so there is a real urgent need for alternative approaches,” Dr. Kim said. “SLIT is several drops under the tongue, held for 2 minutes, swallowed and done.”

In the current placebo-controlled study, he and his group tested the feasibility, efficacy, and safety of the sublingual approach to peanut allergy in children age 4 years and younger.

Both groups were similar with regard to gender, race, ethnicity, atopic history, peanut skin prick test, and qualifying DBPCFC, and all children were previously allergic with positive blood and skin tests, with a positive reaction during baseline food challenge, thus proving the allergy and establishing the baseline threshold.

“We have learned from some studies, for instance the DEVIL and LEAP studies, that strongly suggest that the immune systems in younger patients may be more amenable to change, and there may be some justification for early intervention,” he said.

“Based on both of those ideas, we wanted to take our sublingual approach, which we have shown to have a pretty good efficacy in older children, and bring it down to this younger group and see if it still could have the same efficacy and also maintain what seems to be a very good safety signal.”

The researchers randomly assigned the children to receive PNSLIT at a daily maintenance dose of 4 mg peanut protein (n = 19) or to receive placebo (n = 17) for 36 months.

“There was a 5- to 6-month buildup period where the SLIT dose was increased every 1-2 weeks up to the target dose of 4 mg, and then the final dose of 4 mg was continued through to the end of the study,” Dr. Kim noted.

Over a total of 20,593 potential dosing days, the children took 91.2% of SLIT doses and 93.5% of placebo doses.

At the end of the 3-year study period, the children were challenged by DBPCFC with up to 4,333 mg of peanut protein.

Sustained unresponsiveness was assessed by an identical DBPCFC after discontinuation of the immunotherapy for 3 months.

Cumulative tolerated dose increased from a median of 143 mg to 4,443 mg in the PNSLIT group, compared with a median of 43 mg to 143 mg in the placebo group (P < .0001).

Fourteen of the children receiving PNSLIT, and none of the children receiving placebo, passed the desensitization food challenge. Twelve of the children receiving PNSLIT and two of the children receiving placebo passed the sustained unresponsiveness challenge.

Children who underwent the immunotherapy saw a decrease in their peanut skin prick test from 10 mm to 3.25 mm, compared to an increase from 11.5 mm to 12 mm with placebo (P < .0001).

The most common side effect reported was itching or irritation in the mouth. Most side effects resolved on their own, although some patients used an antihistamine. Getting children as young as 1 to hold the dose under their tongue was a challenge in some instances, but it eventually worked out, Dr. Kim said.

“It took a lot of work from the parents as well as from our research coordinators in trying to train these young kids to, first of all, allow us to put the peanut medication in the mouth and then to try as best as possible to keep it in their mouth for up to 2 minutes, but the families involved in our study were very dedicated and so we were able to get through that,” he said.
 

Study merits larger numbers

“Among the 36 who completed the 3 years of therapy, the authors report significant rates of desensitization among treated children compared with those receiving placebo. Furthermore, this effect was persistent for at least 3 months after stopping therapy in a subgroup of the children,” said Leonard B. Bacharier, MD, director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, Tenn.

“Overall, these findings suggest the promise of peanut SLIT, which should be studied in larger numbers of preschool children,” Dr. Bacharier, who was not part of the study, said in an interview.

Jonathan A. Bernstein, MD, professor of medicine, University of Cincinnati, agreed.

“It’s a well-designed study, it’s small, but it’s promising,” Dr. Bernstein, who was not involved with the study, said in an interview.

“They did show that most of the patients who got the sublingual therapy were able to get to the target dose and develop tolerance, so I think it’s promising. We know that this stuff works. This is just more data from a well-controlled study in a younger population,” he said.

“We do OIT [oral immunotherapy] and sublingual but we don’t do it in such young children in our practice. The youngest is 3 years old, because they have to understand what is going on and cooperate. If they don’t cooperate it’s not possible.”

Dr. Kim reported financial relationships with DBV Technologies, Kenota Health, Ukko, Aimmune Therapeutics, ALK, AllerGenis, Belhaven Pharma, Duke Clinical Research Institute, Nutricia, NIH/NIAID, NIH/NCCIH, NIH/Immune Tolerance Network, FARE, and the Wallace Foundation. Dr. Bacharier and Dr. Bernstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1 year.

In a double-blind, placebo-controlled, food challenge (DBPCFC) of some 36 peanut-allergic children (mean age 2.2 years, range 1-4 years), those who were randomly assigned to receive peanut sublingual immunotherapy (PNSLIT) showed significant desensitization compared with those who received placebo.

In addition, there was a “strong potential” for sustained unresponsiveness at 3 months for the toddlers who received the active treatment.

The findings were presented in a late breaking oral abstract session at the 2021 American Academy of Allergy, Asthma & Immunology virtual annual meeting (Abstract L2).

“A year ago, the Food and Drug Administration approved the oral agent Palforzia (peanut allergen powder) for the treatment of peanut allergy in children 4 and older, and it is a great option, but I think what we have learned over time is that this approach is not for everybody,” Edwin H. Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, said in an interview.

Palforzia is a powder that is mixed in food like yogurt or pudding which the child then eats daily, according to a rigorous schedule. But Palforzia treatment presents some difficulties.

“Palforzia requires getting the powder dose, mixing it with food, like pudding or apple sauce, then eating it, which can take up to 30 minutes depending on age and kids’ cooperation. It tastes and smells like peanut which can cause aversion. Kids have to refrain from exercise or strenuous activity for at least 30 minutes before and after dosing and have to be observed for up to 2 hours post dose for symptoms,” Dr. Kim said.

“It’s a great drug, but the treatment could be overly difficult for certain families to be able to do, and in some cases the side effects may be more than certain patients are able or willing to handle, so there is a real urgent need for alternative approaches,” Dr. Kim said. “SLIT is several drops under the tongue, held for 2 minutes, swallowed and done.”

In the current placebo-controlled study, he and his group tested the feasibility, efficacy, and safety of the sublingual approach to peanut allergy in children age 4 years and younger.

Both groups were similar with regard to gender, race, ethnicity, atopic history, peanut skin prick test, and qualifying DBPCFC, and all children were previously allergic with positive blood and skin tests, with a positive reaction during baseline food challenge, thus proving the allergy and establishing the baseline threshold.

“We have learned from some studies, for instance the DEVIL and LEAP studies, that strongly suggest that the immune systems in younger patients may be more amenable to change, and there may be some justification for early intervention,” he said.

“Based on both of those ideas, we wanted to take our sublingual approach, which we have shown to have a pretty good efficacy in older children, and bring it down to this younger group and see if it still could have the same efficacy and also maintain what seems to be a very good safety signal.”

The researchers randomly assigned the children to receive PNSLIT at a daily maintenance dose of 4 mg peanut protein (n = 19) or to receive placebo (n = 17) for 36 months.

“There was a 5- to 6-month buildup period where the SLIT dose was increased every 1-2 weeks up to the target dose of 4 mg, and then the final dose of 4 mg was continued through to the end of the study,” Dr. Kim noted.

Over a total of 20,593 potential dosing days, the children took 91.2% of SLIT doses and 93.5% of placebo doses.

At the end of the 3-year study period, the children were challenged by DBPCFC with up to 4,333 mg of peanut protein.

Sustained unresponsiveness was assessed by an identical DBPCFC after discontinuation of the immunotherapy for 3 months.

Cumulative tolerated dose increased from a median of 143 mg to 4,443 mg in the PNSLIT group, compared with a median of 43 mg to 143 mg in the placebo group (P < .0001).

Fourteen of the children receiving PNSLIT, and none of the children receiving placebo, passed the desensitization food challenge. Twelve of the children receiving PNSLIT and two of the children receiving placebo passed the sustained unresponsiveness challenge.

Children who underwent the immunotherapy saw a decrease in their peanut skin prick test from 10 mm to 3.25 mm, compared to an increase from 11.5 mm to 12 mm with placebo (P < .0001).

The most common side effect reported was itching or irritation in the mouth. Most side effects resolved on their own, although some patients used an antihistamine. Getting children as young as 1 to hold the dose under their tongue was a challenge in some instances, but it eventually worked out, Dr. Kim said.

“It took a lot of work from the parents as well as from our research coordinators in trying to train these young kids to, first of all, allow us to put the peanut medication in the mouth and then to try as best as possible to keep it in their mouth for up to 2 minutes, but the families involved in our study were very dedicated and so we were able to get through that,” he said.
 

Study merits larger numbers

“Among the 36 who completed the 3 years of therapy, the authors report significant rates of desensitization among treated children compared with those receiving placebo. Furthermore, this effect was persistent for at least 3 months after stopping therapy in a subgroup of the children,” said Leonard B. Bacharier, MD, director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, Tenn.

“Overall, these findings suggest the promise of peanut SLIT, which should be studied in larger numbers of preschool children,” Dr. Bacharier, who was not part of the study, said in an interview.

Jonathan A. Bernstein, MD, professor of medicine, University of Cincinnati, agreed.

“It’s a well-designed study, it’s small, but it’s promising,” Dr. Bernstein, who was not involved with the study, said in an interview.

“They did show that most of the patients who got the sublingual therapy were able to get to the target dose and develop tolerance, so I think it’s promising. We know that this stuff works. This is just more data from a well-controlled study in a younger population,” he said.

“We do OIT [oral immunotherapy] and sublingual but we don’t do it in such young children in our practice. The youngest is 3 years old, because they have to understand what is going on and cooperate. If they don’t cooperate it’s not possible.”

Dr. Kim reported financial relationships with DBV Technologies, Kenota Health, Ukko, Aimmune Therapeutics, ALK, AllerGenis, Belhaven Pharma, Duke Clinical Research Institute, Nutricia, NIH/NIAID, NIH/NCCIH, NIH/Immune Tolerance Network, FARE, and the Wallace Foundation. Dr. Bacharier and Dr. Bernstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

As Jade Myers set out to help create the virtual platform for SHM Converge, she was aware, through surveys and other communication, that the top wish of members of the Society of Hospital Medicine was an extensive and interactive educational experience.

“People really wanted to get back to the in-person conference,” said Ms. Myers, SHM’s director of meetings. “While we couldn’t do that, we can provide the same caliber and as robust an experience from an educational perspective as we would for an in-person activity.”

That has required significant revamping of the virtual platform compared to the platform for last year’s annual conference. In 2020, there was only one session running live at a time. This year, there will be 12 sessions running at the same time. There will also be more opportunities for networking, as well as other features for enjoyment and a sense of calm.

Here are some features of the SHM Converge platform:

• A host segment to kick-start each day, with an introduction of the day’s sessions and events.
• Nine didactic educational sessions at any given time. These sessions will include a live chat for peer-to-peer engagement, as well as questions and answers throughout the session to continue the discussion between speakers and participants.
• Three workshops at any given time. These sessions – on topics such as communication, gender equity, and clinical guidelines – will provide an opportunity for dynamic small-group discussion.
• A scientific abstract poster competition and reception, with an e-gallery of about 700 posters, providing a networking opportunity and highlighting emerging scientific and clinical cases.
• Special Interest Forums, in the form of live, interactive Zoom conferences. There will be 25 forums, which are designed to build community and facilitate collaboration.
• A variety of games, including trivia and a word scramble.
• Personalized profiles with information such as “Hospitalist in Training,” or “Committee Member.” These will be visible to other attendees to make it easier for people to connect when they have something in common.
• Early- and Mid-Career Speed Mentorship, in which a mentor and mentee can interact one-on-one, with each mentee able to meet with two mentors, with pairings designed for the best mentorship experience.
• Sessions on wellness and resilience.

“People are kind of Zoom fatigued,” Ms. Myers said, “so we’re trying to meet their needs while also offering an opportunity for respite, because our attendees are on the front lines right now, and they’re dealing with all types of fatigue and challenging times.”

The annual conference was on target for a banner year in 2020 before the COVID-19 pandemic forced the cancellation of the in-person conference in San Diego, and SHM Converge is a product of planning that began then, as organizers started considering a virtual event.

“In 2020, we were slated to have the largest conference in person that we have ever had,” said Hayleigh Scott, SHM’s meeting projects manager. “San Diego was going to be our really big year.”

But attendance at last year’s virtual conference was a fraction of what was expected at the in-person conference. This year, that seems poised to improve. There will be many more offerings, with more than 125 AMA PRA Category 1 Credits™ and 45 Maintenance of Certification points possible, Ms. Myers said. Because attendees won’t have to worry about being in two places at once, it will be possible to secure more CME credits at SHM Converge than at any previous SHM annual conference, she said.

The volume of content will be a heavy load on SHM personnel. Last year, three society staff members were on hand at each session to make sure it ran smoothly and to answer questions. With 12 sessions running simultaneously this year, many more staff members will need to be involved. But that is not unfamiliar for the society during meeting week, Ms. Myers said.

“We’re going to need to pull from pretty much our entire staff in order to make this conference happen, which is exciting and daunting,” she said. “It’s always been an all-hands-on-deck program and this is going to be more similar to an in-person conference in that way.”

As Jade Myers set out to help create the virtual platform for SHM Converge, she was aware, through surveys and other communication, that the top wish of members of the Society of Hospital Medicine was an extensive and interactive educational experience.

“People really wanted to get back to the in-person conference,” said Ms. Myers, SHM’s director of meetings. “While we couldn’t do that, we can provide the same caliber and as robust an experience from an educational perspective as we would for an in-person activity.”

That has required significant revamping of the virtual platform compared to the platform for last year’s annual conference. In 2020, there was only one session running live at a time. This year, there will be 12 sessions running at the same time. There will also be more opportunities for networking, as well as other features for enjoyment and a sense of calm.

Here are some features of the SHM Converge platform:

• A host segment to kick-start each day, with an introduction of the day’s sessions and events.
• Nine didactic educational sessions at any given time. These sessions will include a live chat for peer-to-peer engagement, as well as questions and answers throughout the session to continue the discussion between speakers and participants.
• Three workshops at any given time. These sessions – on topics such as communication, gender equity, and clinical guidelines – will provide an opportunity for dynamic small-group discussion.
• A scientific abstract poster competition and reception, with an e-gallery of about 700 posters, providing a networking opportunity and highlighting emerging scientific and clinical cases.
• Special Interest Forums, in the form of live, interactive Zoom conferences. There will be 25 forums, which are designed to build community and facilitate collaboration.
• A variety of games, including trivia and a word scramble.
• Personalized profiles with information such as “Hospitalist in Training,” or “Committee Member.” These will be visible to other attendees to make it easier for people to connect when they have something in common.
• Early- and Mid-Career Speed Mentorship, in which a mentor and mentee can interact one-on-one, with each mentee able to meet with two mentors, with pairings designed for the best mentorship experience.
• Sessions on wellness and resilience.

“People are kind of Zoom fatigued,” Ms. Myers said, “so we’re trying to meet their needs while also offering an opportunity for respite, because our attendees are on the front lines right now, and they’re dealing with all types of fatigue and challenging times.”

The annual conference was on target for a banner year in 2020 before the COVID-19 pandemic forced the cancellation of the in-person conference in San Diego, and SHM Converge is a product of planning that began then, as organizers started considering a virtual event.

“In 2020, we were slated to have the largest conference in person that we have ever had,” said Hayleigh Scott, SHM’s meeting projects manager. “San Diego was going to be our really big year.”

But attendance at last year’s virtual conference was a fraction of what was expected at the in-person conference. This year, that seems poised to improve. There will be many more offerings, with more than 125 AMA PRA Category 1 Credits™ and 45 Maintenance of Certification points possible, Ms. Myers said. Because attendees won’t have to worry about being in two places at once, it will be possible to secure more CME credits at SHM Converge than at any previous SHM annual conference, she said.

The volume of content will be a heavy load on SHM personnel. Last year, three society staff members were on hand at each session to make sure it ran smoothly and to answer questions. With 12 sessions running simultaneously this year, many more staff members will need to be involved. But that is not unfamiliar for the society during meeting week, Ms. Myers said.

“We’re going to need to pull from pretty much our entire staff in order to make this conference happen, which is exciting and daunting,” she said. “It’s always been an all-hands-on-deck program and this is going to be more similar to an in-person conference in that way.”

As Jade Myers set out to help create the virtual platform for SHM Converge, she was aware, through surveys and other communication, that the top wish of members of the Society of Hospital Medicine was an extensive and interactive educational experience.

“People really wanted to get back to the in-person conference,” said Ms. Myers, SHM’s director of meetings. “While we couldn’t do that, we can provide the same caliber and as robust an experience from an educational perspective as we would for an in-person activity.”

That has required significant revamping of the virtual platform compared to the platform for last year’s annual conference. In 2020, there was only one session running live at a time. This year, there will be 12 sessions running at the same time. There will also be more opportunities for networking, as well as other features for enjoyment and a sense of calm.

Here are some features of the SHM Converge platform:

• A host segment to kick-start each day, with an introduction of the day’s sessions and events.
• Nine didactic educational sessions at any given time. These sessions will include a live chat for peer-to-peer engagement, as well as questions and answers throughout the session to continue the discussion between speakers and participants.
• Three workshops at any given time. These sessions – on topics such as communication, gender equity, and clinical guidelines – will provide an opportunity for dynamic small-group discussion.
• A scientific abstract poster competition and reception, with an e-gallery of about 700 posters, providing a networking opportunity and highlighting emerging scientific and clinical cases.
• Special Interest Forums, in the form of live, interactive Zoom conferences. There will be 25 forums, which are designed to build community and facilitate collaboration.
• A variety of games, including trivia and a word scramble.
• Personalized profiles with information such as “Hospitalist in Training,” or “Committee Member.” These will be visible to other attendees to make it easier for people to connect when they have something in common.
• Early- and Mid-Career Speed Mentorship, in which a mentor and mentee can interact one-on-one, with each mentee able to meet with two mentors, with pairings designed for the best mentorship experience.
• Sessions on wellness and resilience.

“People are kind of Zoom fatigued,” Ms. Myers said, “so we’re trying to meet their needs while also offering an opportunity for respite, because our attendees are on the front lines right now, and they’re dealing with all types of fatigue and challenging times.”

The annual conference was on target for a banner year in 2020 before the COVID-19 pandemic forced the cancellation of the in-person conference in San Diego, and SHM Converge is a product of planning that began then, as organizers started considering a virtual event.

“In 2020, we were slated to have the largest conference in person that we have ever had,” said Hayleigh Scott, SHM’s meeting projects manager. “San Diego was going to be our really big year.”

But attendance at last year’s virtual conference was a fraction of what was expected at the in-person conference. This year, that seems poised to improve. There will be many more offerings, with more than 125 AMA PRA Category 1 Credits™ and 45 Maintenance of Certification points possible, Ms. Myers said. Because attendees won’t have to worry about being in two places at once, it will be possible to secure more CME credits at SHM Converge than at any previous SHM annual conference, she said.

The volume of content will be a heavy load on SHM personnel. Last year, three society staff members were on hand at each session to make sure it ran smoothly and to answer questions. With 12 sessions running simultaneously this year, many more staff members will need to be involved. But that is not unfamiliar for the society during meeting week, Ms. Myers said.

“We’re going to need to pull from pretty much our entire staff in order to make this conference happen, which is exciting and daunting,” she said. “It’s always been an all-hands-on-deck program and this is going to be more similar to an in-person conference in that way.”

With dozens and dozens of sessions on the SHM Converge program, picking what to go to can feel virtually impossible.

The editorial board of The Hospitalist is here to help. With knowledge in an array of subspecialties – and experience in attending many SHM annual conferences, they have pointed out sessions they consider “must see,” whether based on the importance of the topic, the entertainment aspect, or the dynamic qualities of the speakers.

Here are their selections:
 

Ilaria Gadalla, DMSc, PA-C, physician assistant department chair, South University, West Palm Beach, Fla.

What You Say, What They Hear: Conversations with Your Hospital C-suite (Tuesday, May 4, 1:40 p.m. to 2:40 p.m.)

“As a department leader, developing my communication skills is always an area I seek to improve,” Dr. Gadalla said. “Tips to help with interpreting the audience and tailoring presentations for receptive feedback are invaluable tools.”

Hiring the Right Hospitalist: The Other Kind of Choosing Wisely (Wednesday, May 5, 2 p.m. to 3 p.m.)

“[This] is also an interesting session – selection criteria in the age of virtual interviewing is challenging,” she said. “I look forward to benefiting from my colleagues’ experience to enhance my leadership style.”

Shyam Odeti, MD, SFHM, FAAFP, MBA, hospitalist at Ballad Health, Johnson City, Tenn.

Understanding High-Value Care: Cost, Rationing, Overuse, and Underuse: Workshop (Tuesday May 4, 1:40 p.m. to 2:40 p.m.)

“Health care in the U.S. is expensive, and we have to pay utmost attention to the cost while providing the highest-quality medical care and service to sustain the health care,” Dr. Odeti said. “I am excited about this workshop organized by Dr. Justin Glasgow, Dr. Sarah Baron, Dr. Mona Krouss, and Dr. Harry Cho. I have known these leaders in the health care quality and patient safety arena over several years and their immense contributions to their organizations and the quality improvement special interest group of SHM. This workshop will help us understand how to define value in health care, implement high-value care, and eliminate low-value care.”

Hospitalists Piloting the Twin Engines of the Mid-Revenue Cycle Ship: A Primer on Utilization Management and Clinical Documentation Improvement (Thursday, May 6, 2:30 p.m. to 3:30 p.m.)

“The business of running hospitals carries with it many financial challenges,” Dr. Odeti said. “The intersection of tremendous fixed overhead and the vagaries of payer behavior is the cause. The COVID-19 pandemic and its devastating impact have compounded the problem. Hospitalists are natural institution leaders who are fundamental in overcoming this impasse through taking command and piloting the twin-engine ship of utilization management and clinical documentation improvement. These two domains working in synergy with experienced pilots are critical to attaining both high-quality care and the long-term viability of our health care systems. Dr. Aziz Ansari has been an expert in this domain and a highly sought-after speaker at SHM annual conferences. His sessions are incredibly captivating and educational.”

Harry Cho, MD, FACP, SFHM, chief value officer at NYC Health+ Hospitals

Medical Jeopardy (Thursday, May 6, 2:30 p.m. to 3:10 p.m.)

“[I am] always looking forward to a fun-filled session for medical learning with this fantastic group of facilitators,” Dr. Cho said.

Back to the Future - Things I Wish I Knew Earlier in my Career (Wednesday, May 5, 3:50 p.m. to 4:30 p.m.)

“Listening to Brad Sharpe brings me back to the days in training, eagerly absorbing every pearl of wisdom from mentors,” he said.

Marina Farah, MD, MHA, performance improvement consultant, FarahMD Consulting, Corvallis, Ore.

James Kim, MD, associate professor of medicine, Emory University, Atlanta

Health Equity and Disparities in Hospitalized Patients (Tuesday, May 4, 3:30 p.m. to 4:10 p.m. )

“[Kimberly Manning, MD] is an amazing speaker, and I know that this is a topic that she can speak about both eloquently and passionately,” Dr. Kim said. “She has been advocating for her patients at Grady for years and so this is something that she has first-hand experience about.”

Top 5 Clinical Practice Guidelines Every Hospitalist Needs to Know: Workshop (Wednesday, May 5, 3:50 p.m. to 4:50 p.m. )

“This sounds like a high-yield session,” he said. “For busy clinicians, being able to know what guidelines should affect your daily practice is extremely important.”

Lonika Sood, MD, MHPE, FACP, FHM, clinical education director of internal medicine, Washington State University, Spokane

Anika Kumar, MD, FAAP, FHM, assistant professor of pediatrics, Cleveland Clinic Lerner College of Medicine

Fireside Chat: Story-telling and the Nocturnist in Pediatrics (Tuesday, May 4, 3:30 p.m. to 4:50 p.m.)

“I look forward to their discussion about storytelling and the role narrative medicine plays in patient care, especially pediatrics,” Dr. Kumar said.

Febrile Infant Update (Thursday, May 6, 3:10 p.m. to 3:50 p.m.)

“This clinical update session with Dr. Russell McCulloh will be exciting, as caring for febrile infants is bread-and-butter pediatric hospital medicine,” she said. “And this update will help review new research in this diagnosis.”

Kranthi Sitammagari, MD, FACP, CHCQM-PHYADV, director of clinical operations, quality, and patient experience, Atrium Health Hospitalist Group, Monroe, N.C.

Any session in the “Clinical Updates” and “Quality” tracks

“I would recommend ‘Clinical Updates’ and ‘Quality’ sessions, as they are so close to my practice and I look forward to those sessions,” Dr. Sitammagari said. “Clinical Updates provide the latest updates in clinical practice which is very useful for everyday patient management for hospitalists. Quality sessions discuss innovative ways to improve the quality of hospitalist practice.”

Raman Palabindala, MD, SFHM, medical director of utilization management, University of Mississippi Medical Center, Jackson

Medical Jeopardy (Thursday, May 6, 2:30 p.m. to 3:10 p.m.)

“I will always promote my fun event, Medical Jeopardy (Dr. Palabindala is a moderator). It is going to be a challenge between three great attendings from three great organizations across the country to win the national Jeopardy competition. Not only will you learn a lot, but you also will have a lot of fun. I am sure it is going to be more entertaining this time, given virtual play.”

LAMA’s DRAMA: Left AMA – Documentation & Rules of AMA (Friday, May 7, 3:30 p.m. to 4:30 p.m.)

“I also recommend the talk by Dr. Medarametla not just for the title LAMA DRAMA (for ‘left against medical advice’),” he said. “We all need to learn this one to the core and I am sure he will deliver the most engaging presentation.”

With dozens and dozens of sessions on the SHM Converge program, picking what to go to can feel virtually impossible.

The editorial board of The Hospitalist is here to help. With knowledge in an array of subspecialties – and experience in attending many SHM annual conferences, they have pointed out sessions they consider “must see,” whether based on the importance of the topic, the entertainment aspect, or the dynamic qualities of the speakers.

Here are their selections:
 

Ilaria Gadalla, DMSc, PA-C, physician assistant department chair, South University, West Palm Beach, Fla.

What You Say, What They Hear: Conversations with Your Hospital C-suite (Tuesday, May 4, 1:40 p.m. to 2:40 p.m.)

“As a department leader, developing my communication skills is always an area I seek to improve,” Dr. Gadalla said. “Tips to help with interpreting the audience and tailoring presentations for receptive feedback are invaluable tools.”

Hiring the Right Hospitalist: The Other Kind of Choosing Wisely (Wednesday, May 5, 2 p.m. to 3 p.m.)

“[This] is also an interesting session – selection criteria in the age of virtual interviewing is challenging,” she said. “I look forward to benefiting from my colleagues’ experience to enhance my leadership style.”

Shyam Odeti, MD, SFHM, FAAFP, MBA, hospitalist at Ballad Health, Johnson City, Tenn.

Understanding High-Value Care: Cost, Rationing, Overuse, and Underuse: Workshop (Tuesday May 4, 1:40 p.m. to 2:40 p.m.)

“Health care in the U.S. is expensive, and we have to pay utmost attention to the cost while providing the highest-quality medical care and service to sustain the health care,” Dr. Odeti said. “I am excited about this workshop organized by Dr. Justin Glasgow, Dr. Sarah Baron, Dr. Mona Krouss, and Dr. Harry Cho. I have known these leaders in the health care quality and patient safety arena over several years and their immense contributions to their organizations and the quality improvement special interest group of SHM. This workshop will help us understand how to define value in health care, implement high-value care, and eliminate low-value care.”

Hospitalists Piloting the Twin Engines of the Mid-Revenue Cycle Ship: A Primer on Utilization Management and Clinical Documentation Improvement (Thursday, May 6, 2:30 p.m. to 3:30 p.m.)

“The business of running hospitals carries with it many financial challenges,” Dr. Odeti said. “The intersection of tremendous fixed overhead and the vagaries of payer behavior is the cause. The COVID-19 pandemic and its devastating impact have compounded the problem. Hospitalists are natural institution leaders who are fundamental in overcoming this impasse through taking command and piloting the twin-engine ship of utilization management and clinical documentation improvement. These two domains working in synergy with experienced pilots are critical to attaining both high-quality care and the long-term viability of our health care systems. Dr. Aziz Ansari has been an expert in this domain and a highly sought-after speaker at SHM annual conferences. His sessions are incredibly captivating and educational.”

Harry Cho, MD, FACP, SFHM, chief value officer at NYC Health+ Hospitals

Medical Jeopardy (Thursday, May 6, 2:30 p.m. to 3:10 p.m.)

“[I am] always looking forward to a fun-filled session for medical learning with this fantastic group of facilitators,” Dr. Cho said.

Back to the Future - Things I Wish I Knew Earlier in my Career (Wednesday, May 5, 3:50 p.m. to 4:30 p.m.)

“Listening to Brad Sharpe brings me back to the days in training, eagerly absorbing every pearl of wisdom from mentors,” he said.

Marina Farah, MD, MHA, performance improvement consultant, FarahMD Consulting, Corvallis, Ore.

James Kim, MD, associate professor of medicine, Emory University, Atlanta

Health Equity and Disparities in Hospitalized Patients (Tuesday, May 4, 3:30 p.m. to 4:10 p.m. )

“[Kimberly Manning, MD] is an amazing speaker, and I know that this is a topic that she can speak about both eloquently and passionately,” Dr. Kim said. “She has been advocating for her patients at Grady for years and so this is something that she has first-hand experience about.”

Top 5 Clinical Practice Guidelines Every Hospitalist Needs to Know: Workshop (Wednesday, May 5, 3:50 p.m. to 4:50 p.m. )

“This sounds like a high-yield session,” he said. “For busy clinicians, being able to know what guidelines should affect your daily practice is extremely important.”

Lonika Sood, MD, MHPE, FACP, FHM, clinical education director of internal medicine, Washington State University, Spokane

Anika Kumar, MD, FAAP, FHM, assistant professor of pediatrics, Cleveland Clinic Lerner College of Medicine

Fireside Chat: Story-telling and the Nocturnist in Pediatrics (Tuesday, May 4, 3:30 p.m. to 4:50 p.m.)

“I look forward to their discussion about storytelling and the role narrative medicine plays in patient care, especially pediatrics,” Dr. Kumar said.

Febrile Infant Update (Thursday, May 6, 3:10 p.m. to 3:50 p.m.)

“This clinical update session with Dr. Russell McCulloh will be exciting, as caring for febrile infants is bread-and-butter pediatric hospital medicine,” she said. “And this update will help review new research in this diagnosis.”

Kranthi Sitammagari, MD, FACP, CHCQM-PHYADV, director of clinical operations, quality, and patient experience, Atrium Health Hospitalist Group, Monroe, N.C.

Any session in the “Clinical Updates” and “Quality” tracks

“I would recommend ‘Clinical Updates’ and ‘Quality’ sessions, as they are so close to my practice and I look forward to those sessions,” Dr. Sitammagari said. “Clinical Updates provide the latest updates in clinical practice which is very useful for everyday patient management for hospitalists. Quality sessions discuss innovative ways to improve the quality of hospitalist practice.”

Raman Palabindala, MD, SFHM, medical director of utilization management, University of Mississippi Medical Center, Jackson

Medical Jeopardy (Thursday, May 6, 2:30 p.m. to 3:10 p.m.)

“I will always promote my fun event, Medical Jeopardy (Dr. Palabindala is a moderator). It is going to be a challenge between three great attendings from three great organizations across the country to win the national Jeopardy competition. Not only will you learn a lot, but you also will have a lot of fun. I am sure it is going to be more entertaining this time, given virtual play.”

LAMA’s DRAMA: Left AMA – Documentation & Rules of AMA (Friday, May 7, 3:30 p.m. to 4:30 p.m.)

“I also recommend the talk by Dr. Medarametla not just for the title LAMA DRAMA (for ‘left against medical advice’),” he said. “We all need to learn this one to the core and I am sure he will deliver the most engaging presentation.”

With dozens and dozens of sessions on the SHM Converge program, picking what to go to can feel virtually impossible.

The editorial board of The Hospitalist is here to help. With knowledge in an array of subspecialties – and experience in attending many SHM annual conferences, they have pointed out sessions they consider “must see,” whether based on the importance of the topic, the entertainment aspect, or the dynamic qualities of the speakers.

Here are their selections:
 

Ilaria Gadalla, DMSc, PA-C, physician assistant department chair, South University, West Palm Beach, Fla.

What You Say, What They Hear: Conversations with Your Hospital C-suite (Tuesday, May 4, 1:40 p.m. to 2:40 p.m.)

“As a department leader, developing my communication skills is always an area I seek to improve,” Dr. Gadalla said. “Tips to help with interpreting the audience and tailoring presentations for receptive feedback are invaluable tools.”

Hiring the Right Hospitalist: The Other Kind of Choosing Wisely (Wednesday, May 5, 2 p.m. to 3 p.m.)

“[This] is also an interesting session – selection criteria in the age of virtual interviewing is challenging,” she said. “I look forward to benefiting from my colleagues’ experience to enhance my leadership style.”

Shyam Odeti, MD, SFHM, FAAFP, MBA, hospitalist at Ballad Health, Johnson City, Tenn.

Understanding High-Value Care: Cost, Rationing, Overuse, and Underuse: Workshop (Tuesday May 4, 1:40 p.m. to 2:40 p.m.)

“Health care in the U.S. is expensive, and we have to pay utmost attention to the cost while providing the highest-quality medical care and service to sustain the health care,” Dr. Odeti said. “I am excited about this workshop organized by Dr. Justin Glasgow, Dr. Sarah Baron, Dr. Mona Krouss, and Dr. Harry Cho. I have known these leaders in the health care quality and patient safety arena over several years and their immense contributions to their organizations and the quality improvement special interest group of SHM. This workshop will help us understand how to define value in health care, implement high-value care, and eliminate low-value care.”

Hospitalists Piloting the Twin Engines of the Mid-Revenue Cycle Ship: A Primer on Utilization Management and Clinical Documentation Improvement (Thursday, May 6, 2:30 p.m. to 3:30 p.m.)

“The business of running hospitals carries with it many financial challenges,” Dr. Odeti said. “The intersection of tremendous fixed overhead and the vagaries of payer behavior is the cause. The COVID-19 pandemic and its devastating impact have compounded the problem. Hospitalists are natural institution leaders who are fundamental in overcoming this impasse through taking command and piloting the twin-engine ship of utilization management and clinical documentation improvement. These two domains working in synergy with experienced pilots are critical to attaining both high-quality care and the long-term viability of our health care systems. Dr. Aziz Ansari has been an expert in this domain and a highly sought-after speaker at SHM annual conferences. His sessions are incredibly captivating and educational.”

Harry Cho, MD, FACP, SFHM, chief value officer at NYC Health+ Hospitals

Medical Jeopardy (Thursday, May 6, 2:30 p.m. to 3:10 p.m.)

“[I am] always looking forward to a fun-filled session for medical learning with this fantastic group of facilitators,” Dr. Cho said.

Back to the Future - Things I Wish I Knew Earlier in my Career (Wednesday, May 5, 3:50 p.m. to 4:30 p.m.)

“Listening to Brad Sharpe brings me back to the days in training, eagerly absorbing every pearl of wisdom from mentors,” he said.

Marina Farah, MD, MHA, performance improvement consultant, FarahMD Consulting, Corvallis, Ore.

James Kim, MD, associate professor of medicine, Emory University, Atlanta

Health Equity and Disparities in Hospitalized Patients (Tuesday, May 4, 3:30 p.m. to 4:10 p.m. )

“[Kimberly Manning, MD] is an amazing speaker, and I know that this is a topic that she can speak about both eloquently and passionately,” Dr. Kim said. “She has been advocating for her patients at Grady for years and so this is something that she has first-hand experience about.”

Top 5 Clinical Practice Guidelines Every Hospitalist Needs to Know: Workshop (Wednesday, May 5, 3:50 p.m. to 4:50 p.m. )

“This sounds like a high-yield session,” he said. “For busy clinicians, being able to know what guidelines should affect your daily practice is extremely important.”

Lonika Sood, MD, MHPE, FACP, FHM, clinical education director of internal medicine, Washington State University, Spokane

Anika Kumar, MD, FAAP, FHM, assistant professor of pediatrics, Cleveland Clinic Lerner College of Medicine

Fireside Chat: Story-telling and the Nocturnist in Pediatrics (Tuesday, May 4, 3:30 p.m. to 4:50 p.m.)

“I look forward to their discussion about storytelling and the role narrative medicine plays in patient care, especially pediatrics,” Dr. Kumar said.

Febrile Infant Update (Thursday, May 6, 3:10 p.m. to 3:50 p.m.)

“This clinical update session with Dr. Russell McCulloh will be exciting, as caring for febrile infants is bread-and-butter pediatric hospital medicine,” she said. “And this update will help review new research in this diagnosis.”

Kranthi Sitammagari, MD, FACP, CHCQM-PHYADV, director of clinical operations, quality, and patient experience, Atrium Health Hospitalist Group, Monroe, N.C.

Any session in the “Clinical Updates” and “Quality” tracks

“I would recommend ‘Clinical Updates’ and ‘Quality’ sessions, as they are so close to my practice and I look forward to those sessions,” Dr. Sitammagari said. “Clinical Updates provide the latest updates in clinical practice which is very useful for everyday patient management for hospitalists. Quality sessions discuss innovative ways to improve the quality of hospitalist practice.”

Raman Palabindala, MD, SFHM, medical director of utilization management, University of Mississippi Medical Center, Jackson

Medical Jeopardy (Thursday, May 6, 2:30 p.m. to 3:10 p.m.)

“I will always promote my fun event, Medical Jeopardy (Dr. Palabindala is a moderator). It is going to be a challenge between three great attendings from three great organizations across the country to win the national Jeopardy competition. Not only will you learn a lot, but you also will have a lot of fun. I am sure it is going to be more entertaining this time, given virtual play.”

LAMA’s DRAMA: Left AMA – Documentation & Rules of AMA (Friday, May 7, 3:30 p.m. to 4:30 p.m.)

“I also recommend the talk by Dr. Medarametla not just for the title LAMA DRAMA (for ‘left against medical advice’),” he said. “We all need to learn this one to the core and I am sure he will deliver the most engaging presentation.”

Ingrid Pinzon, MD, FACP, was working as a medical assistant to a physician a decade ago when she heard the doctor prescribe ibuprofen to a woman who was in the latter stages of pregnancy. Dr. Pinzon was a doctor, having received her education and training in Colombia, but because she had emigrated to the United States and hadn’t yet completed her certification and training here, she was not recognized yet as an American physician.

But she knew that ibuprofen was not recommended during late-term pregnancy, and she was alarmed. She informed the physician of the mistake. The doctor headed to Google, Dr. Pinzon said, and called the patient to rescind the ibuprofen prescription. But she soon fired Dr. Pinzon, seemingly for having had the courage to speak up.

Dr. Pinzon, now medical director of care coordination at Emory Johns Creek Hospital in Atlanta, will describe her experience as an immigrant physician in the Society of Hospital Medicine Converge session: “A Walk in Our Shoes: Immigrant Physicians Sharing Their Stories.” She will be joined by Patricia O’Brien, MD, PhD, FAAP, a pediatric hospitalist in Tampa; Manpreet Malik, MD, a hospitalist at Emory University; and Benji Mathews, MD, SFHM, FACP, chief of hospital medicine at HealthPartners and associate professor at the University of Minnesota.

They will describe their struggles to find their way in the United States, along with the satisfaction of having hard work pay off with better lives for themselves and their families. And together, they’ll provide a variety of narratives that will show, contrary to how many Americans view immigrants, how the experiences of immigrants don’t follow the same path, but each one carves out a path of his or her own.

“The thrust of this is really storytelling, along with putting into context what we can do to help our hospitalist brothers and sisters who are immigrants, and shining the light on it,” Dr. O’Brien said.

Dr. Pinzon was working as a doctor for the Colombian government when she began receiving threats from soldiers in a guerrilla army, which didn’t agree with her alignment with the government. One day, a guerrilla soldier threatened her and her two daughters – aged 5 and 11 at the time – and accurately described her daughters’ whereabouts.

Less than a week later, she and her daughters flew from Bogota to the United States, never to return to Colombia.

“I dropped everything I had when I came here,” she said. An immigration attorney initially recommended that she marry an American man in order to stay in the United States. When Dr. Pinzon declined, they pursued political asylum, and she received it less than a year later.

For 3 years, she worked jobs as assistants in medical offices and in other jobs, well below her education level, as she guided her daughters through school and went through the U.S. medical certification process. She was besieged by doubt constantly, she said.

“I cried for 3 years in a row,” she said. “I wanted to go back to my country. I didn’t want to stay here.”

Finally, she did her medical residency between 2011 and 2014, and got a job with Emory. Her daughters are grown, and one is a doctor in general surgery residency. Dr. Pinzon said she is happy to care for patients, particularly those who are Spanish-speaking and struggle as she did. But she often encounters patients who don’t hide that they dislike her accent.

“I will mute the TV and I will say: ‘I have a strong accent and so I want to make sure communication is clear,’ ” she said. “We have to prove ourselves all of the time. I feel like I have to prove myself to my patients that I’m a good doctor all of the time.” American-born doctors, she added, “shouldn’t take for granted what they already have.”

Dr. O’Brien grew up in Ireland, but in the late 1980s, the country was in a serious recession, with unemployment close to 20%, and her father applied for residency in Canada and the United States. They were accepted in Canada first, and moved there in 1988. A few years later, her parents moved them to Florida.

“They knew in order for us to do well, we had to go abroad,” she said. Dr. O’Brien went to college, medical school and graduate school in Florida, and completed residency in Cincinnati. Feeling the tug of her birthplace, she moved back to Ireland and worked there for a couple years.

“I never really wanted to leave because it was my home,” she said. While there, she came to a new-found appreciation for the U.S. health care system. It’s true that, in Ireland, everyone is insured, but there long wait times – for example, up to 2 years for a sedated nonurgent MRI for a child. She once had to send a patient to Dublin in a taxi with a nurse because an ambulance was unavailable.

“After going back to Ireland, where – I honestly thought I was going to go back and settle there – I realized how visionary my parents were in moving us,” Dr. O’Brien said. “This system in the U.S., there are lot of things broken about it, but we have all the resources.”

She moved back to the United States in August 2016, during a period of anti-immigrant rhetoric.

Nonetheless, Dr. O’Brien said she is happy to be here despite the lack of tolerance she sees in a minority of the U.S. population.

“Have a bit of sensitivity toward your provider. Maybe they speak with an accent. Maybe they don’t speak English perfectly. Maybe they have a different skin color. But their intention is good and it’s to help you and improve your health,” she said.

Ingrid Pinzon, MD, FACP, was working as a medical assistant to a physician a decade ago when she heard the doctor prescribe ibuprofen to a woman who was in the latter stages of pregnancy. Dr. Pinzon was a doctor, having received her education and training in Colombia, but because she had emigrated to the United States and hadn’t yet completed her certification and training here, she was not recognized yet as an American physician.

But she knew that ibuprofen was not recommended during late-term pregnancy, and she was alarmed. She informed the physician of the mistake. The doctor headed to Google, Dr. Pinzon said, and called the patient to rescind the ibuprofen prescription. But she soon fired Dr. Pinzon, seemingly for having had the courage to speak up.

Dr. Pinzon, now medical director of care coordination at Emory Johns Creek Hospital in Atlanta, will describe her experience as an immigrant physician in the Society of Hospital Medicine Converge session: “A Walk in Our Shoes: Immigrant Physicians Sharing Their Stories.” She will be joined by Patricia O’Brien, MD, PhD, FAAP, a pediatric hospitalist in Tampa; Manpreet Malik, MD, a hospitalist at Emory University; and Benji Mathews, MD, SFHM, FACP, chief of hospital medicine at HealthPartners and associate professor at the University of Minnesota.

They will describe their struggles to find their way in the United States, along with the satisfaction of having hard work pay off with better lives for themselves and their families. And together, they’ll provide a variety of narratives that will show, contrary to how many Americans view immigrants, how the experiences of immigrants don’t follow the same path, but each one carves out a path of his or her own.

“The thrust of this is really storytelling, along with putting into context what we can do to help our hospitalist brothers and sisters who are immigrants, and shining the light on it,” Dr. O’Brien said.

Dr. Pinzon was working as a doctor for the Colombian government when she began receiving threats from soldiers in a guerrilla army, which didn’t agree with her alignment with the government. One day, a guerrilla soldier threatened her and her two daughters – aged 5 and 11 at the time – and accurately described her daughters’ whereabouts.

Less than a week later, she and her daughters flew from Bogota to the United States, never to return to Colombia.

“I dropped everything I had when I came here,” she said. An immigration attorney initially recommended that she marry an American man in order to stay in the United States. When Dr. Pinzon declined, they pursued political asylum, and she received it less than a year later.

For 3 years, she worked jobs as assistants in medical offices and in other jobs, well below her education level, as she guided her daughters through school and went through the U.S. medical certification process. She was besieged by doubt constantly, she said.

“I cried for 3 years in a row,” she said. “I wanted to go back to my country. I didn’t want to stay here.”

Finally, she did her medical residency between 2011 and 2014, and got a job with Emory. Her daughters are grown, and one is a doctor in general surgery residency. Dr. Pinzon said she is happy to care for patients, particularly those who are Spanish-speaking and struggle as she did. But she often encounters patients who don’t hide that they dislike her accent.

“I will mute the TV and I will say: ‘I have a strong accent and so I want to make sure communication is clear,’ ” she said. “We have to prove ourselves all of the time. I feel like I have to prove myself to my patients that I’m a good doctor all of the time.” American-born doctors, she added, “shouldn’t take for granted what they already have.”

Dr. O’Brien grew up in Ireland, but in the late 1980s, the country was in a serious recession, with unemployment close to 20%, and her father applied for residency in Canada and the United States. They were accepted in Canada first, and moved there in 1988. A few years later, her parents moved them to Florida.

“They knew in order for us to do well, we had to go abroad,” she said. Dr. O’Brien went to college, medical school and graduate school in Florida, and completed residency in Cincinnati. Feeling the tug of her birthplace, she moved back to Ireland and worked there for a couple years.

“I never really wanted to leave because it was my home,” she said. While there, she came to a new-found appreciation for the U.S. health care system. It’s true that, in Ireland, everyone is insured, but there long wait times – for example, up to 2 years for a sedated nonurgent MRI for a child. She once had to send a patient to Dublin in a taxi with a nurse because an ambulance was unavailable.

“After going back to Ireland, where – I honestly thought I was going to go back and settle there – I realized how visionary my parents were in moving us,” Dr. O’Brien said. “This system in the U.S., there are lot of things broken about it, but we have all the resources.”

She moved back to the United States in August 2016, during a period of anti-immigrant rhetoric.

Nonetheless, Dr. O’Brien said she is happy to be here despite the lack of tolerance she sees in a minority of the U.S. population.

“Have a bit of sensitivity toward your provider. Maybe they speak with an accent. Maybe they don’t speak English perfectly. Maybe they have a different skin color. But their intention is good and it’s to help you and improve your health,” she said.

Ingrid Pinzon, MD, FACP, was working as a medical assistant to a physician a decade ago when she heard the doctor prescribe ibuprofen to a woman who was in the latter stages of pregnancy. Dr. Pinzon was a doctor, having received her education and training in Colombia, but because she had emigrated to the United States and hadn’t yet completed her certification and training here, she was not recognized yet as an American physician.

But she knew that ibuprofen was not recommended during late-term pregnancy, and she was alarmed. She informed the physician of the mistake. The doctor headed to Google, Dr. Pinzon said, and called the patient to rescind the ibuprofen prescription. But she soon fired Dr. Pinzon, seemingly for having had the courage to speak up.

Dr. Pinzon, now medical director of care coordination at Emory Johns Creek Hospital in Atlanta, will describe her experience as an immigrant physician in the Society of Hospital Medicine Converge session: “A Walk in Our Shoes: Immigrant Physicians Sharing Their Stories.” She will be joined by Patricia O’Brien, MD, PhD, FAAP, a pediatric hospitalist in Tampa; Manpreet Malik, MD, a hospitalist at Emory University; and Benji Mathews, MD, SFHM, FACP, chief of hospital medicine at HealthPartners and associate professor at the University of Minnesota.

They will describe their struggles to find their way in the United States, along with the satisfaction of having hard work pay off with better lives for themselves and their families. And together, they’ll provide a variety of narratives that will show, contrary to how many Americans view immigrants, how the experiences of immigrants don’t follow the same path, but each one carves out a path of his or her own.

“The thrust of this is really storytelling, along with putting into context what we can do to help our hospitalist brothers and sisters who are immigrants, and shining the light on it,” Dr. O’Brien said.

Dr. Pinzon was working as a doctor for the Colombian government when she began receiving threats from soldiers in a guerrilla army, which didn’t agree with her alignment with the government. One day, a guerrilla soldier threatened her and her two daughters – aged 5 and 11 at the time – and accurately described her daughters’ whereabouts.

Less than a week later, she and her daughters flew from Bogota to the United States, never to return to Colombia.

“I dropped everything I had when I came here,” she said. An immigration attorney initially recommended that she marry an American man in order to stay in the United States. When Dr. Pinzon declined, they pursued political asylum, and she received it less than a year later.

For 3 years, she worked jobs as assistants in medical offices and in other jobs, well below her education level, as she guided her daughters through school and went through the U.S. medical certification process. She was besieged by doubt constantly, she said.

“I cried for 3 years in a row,” she said. “I wanted to go back to my country. I didn’t want to stay here.”

Finally, she did her medical residency between 2011 and 2014, and got a job with Emory. Her daughters are grown, and one is a doctor in general surgery residency. Dr. Pinzon said she is happy to care for patients, particularly those who are Spanish-speaking and struggle as she did. But she often encounters patients who don’t hide that they dislike her accent.

“I will mute the TV and I will say: ‘I have a strong accent and so I want to make sure communication is clear,’ ” she said. “We have to prove ourselves all of the time. I feel like I have to prove myself to my patients that I’m a good doctor all of the time.” American-born doctors, she added, “shouldn’t take for granted what they already have.”

Dr. O’Brien grew up in Ireland, but in the late 1980s, the country was in a serious recession, with unemployment close to 20%, and her father applied for residency in Canada and the United States. They were accepted in Canada first, and moved there in 1988. A few years later, her parents moved them to Florida.

“They knew in order for us to do well, we had to go abroad,” she said. Dr. O’Brien went to college, medical school and graduate school in Florida, and completed residency in Cincinnati. Feeling the tug of her birthplace, she moved back to Ireland and worked there for a couple years.

“I never really wanted to leave because it was my home,” she said. While there, she came to a new-found appreciation for the U.S. health care system. It’s true that, in Ireland, everyone is insured, but there long wait times – for example, up to 2 years for a sedated nonurgent MRI for a child. She once had to send a patient to Dublin in a taxi with a nurse because an ambulance was unavailable.

“After going back to Ireland, where – I honestly thought I was going to go back and settle there – I realized how visionary my parents were in moving us,” Dr. O’Brien said. “This system in the U.S., there are lot of things broken about it, but we have all the resources.”

She moved back to the United States in August 2016, during a period of anti-immigrant rhetoric.

Nonetheless, Dr. O’Brien said she is happy to be here despite the lack of tolerance she sees in a minority of the U.S. population.

“Have a bit of sensitivity toward your provider. Maybe they speak with an accent. Maybe they don’t speak English perfectly. Maybe they have a different skin color. But their intention is good and it’s to help you and improve your health,” she said.

An overview of five important advances in pulmonary and critical care medicine are on the agenda for the “Update in Pulmonary and Critical Care” session on Tuesday, May 4, at the virtual 2021 SHM Converge conference.

“I hope this session gives attendees a nice, broad look at advances both in the intensive care unit and in general pulmonary medicine,” said James Walter, MD, of Northwestern Medicine in Chicago, who serves as director of the session.

On the critical care medicine side, Dr. Walter will review the latest research on the efficacy of ascorbic acid in treating patients with severe sepsis and septic shock. “There was a lot of excitement and some skepticism about early results promising a really large treatment effect in giving critically ill patients with sepsis large doses of vitamin C,” Dr. Walter said. The last year has produced some high-quality randomized trials that have contributed to a better understanding of the potential effects ascorbic acid in sepsis can have, he noted.

Dr. Walter, who is also medical director of the Northwestern Lung Rescue Program, intends to discuss what he believes is a definitive trial regarding the benefit of preemptively starting critically ill patients with acute kidney injury on renal replacement therapy instead of waiting until there are specific clinical signs. “This has been another area of uncertainty in critical care and I think we finally have a very definitive answer with this high quality, randomized, controlled trial that I plan to review,” he said.

Though he said there have been a number of important advances in pulmonary medicine over the past year, Dr. Walter will highlight just two.

Up until recently, the antifibrotics nintedanib and pirfenidone have mostly been used in patients with idiopathic pulmonary fibrosis. However, recent research suggests there may be a potential benefit to using these drugs in patients with fibrotic lung disease outside of idiopathic pulmonary fibrosis. “I think this is an important advance for hospital medicine providers to be aware of,” said Dr. Walter.

He will also go over some large randomized controlled trials of the use of triple therapy – a combination of a long-acting beta agonist (LABA), a long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid in one inhaler – in chronic obstructive pulmonary disease. The trials looked at whether triple inhaler therapy was beneficial compared to the typical therapies used for COPD.

The session wouldn’t be complete without a nod to COVID-19, which Dr. Walter said has significantly changed the landscape for hospital medicine providers. He plans to discuss what he considers the most impactful study – the RECOVERY trial. This study looked at the role of dexamethasone in patients with more severe manifestations of SARS-CoV-2.

“From the incredible amount of data that’s come out in the last year about COVID, I think this is probably the trial that’s changed practice the most and shown the largest therapeutic benefit of all the pharmacotherapies,” Dr. Walter said. “It’s an important one for providers to be aware of in terms of what the trial shows and how it informs which patients are most likely to benefit from dexamethasone therapy.”

Dr. Walter hopes clinicians who participate in the session will leave with these takeaways:

• Be able to summarize recent trials of ascorbic acid in sepsis and think about how to incorporate – or not – the use of vitamin C in critically ill sepsis patients.
• A thorough understanding of when renal replacement therapy should be offered to critically ill patients with acute kidney dysfunction.
• Be able to discuss the impact of antifibrotic therapy in interstitial lung diseases outside of idiopathic pulmonary fibrosis.
• An understanding of the role of triple inhaler combinations in COPD.
• Be able to explain when dexamethasone is most likely to benefit hypoxemic patients with COVID-19.

An overview of five important advances in pulmonary and critical care medicine are on the agenda for the “Update in Pulmonary and Critical Care” session on Tuesday, May 4, at the virtual 2021 SHM Converge conference.

“I hope this session gives attendees a nice, broad look at advances both in the intensive care unit and in general pulmonary medicine,” said James Walter, MD, of Northwestern Medicine in Chicago, who serves as director of the session.

On the critical care medicine side, Dr. Walter will review the latest research on the efficacy of ascorbic acid in treating patients with severe sepsis and septic shock. “There was a lot of excitement and some skepticism about early results promising a really large treatment effect in giving critically ill patients with sepsis large doses of vitamin C,” Dr. Walter said. The last year has produced some high-quality randomized trials that have contributed to a better understanding of the potential effects ascorbic acid in sepsis can have, he noted.

Dr. Walter, who is also medical director of the Northwestern Lung Rescue Program, intends to discuss what he believes is a definitive trial regarding the benefit of preemptively starting critically ill patients with acute kidney injury on renal replacement therapy instead of waiting until there are specific clinical signs. “This has been another area of uncertainty in critical care and I think we finally have a very definitive answer with this high quality, randomized, controlled trial that I plan to review,” he said.

Though he said there have been a number of important advances in pulmonary medicine over the past year, Dr. Walter will highlight just two.

Up until recently, the antifibrotics nintedanib and pirfenidone have mostly been used in patients with idiopathic pulmonary fibrosis. However, recent research suggests there may be a potential benefit to using these drugs in patients with fibrotic lung disease outside of idiopathic pulmonary fibrosis. “I think this is an important advance for hospital medicine providers to be aware of,” said Dr. Walter.

He will also go over some large randomized controlled trials of the use of triple therapy – a combination of a long-acting beta agonist (LABA), a long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid in one inhaler – in chronic obstructive pulmonary disease. The trials looked at whether triple inhaler therapy was beneficial compared to the typical therapies used for COPD.

The session wouldn’t be complete without a nod to COVID-19, which Dr. Walter said has significantly changed the landscape for hospital medicine providers. He plans to discuss what he considers the most impactful study – the RECOVERY trial. This study looked at the role of dexamethasone in patients with more severe manifestations of SARS-CoV-2.

“From the incredible amount of data that’s come out in the last year about COVID, I think this is probably the trial that’s changed practice the most and shown the largest therapeutic benefit of all the pharmacotherapies,” Dr. Walter said. “It’s an important one for providers to be aware of in terms of what the trial shows and how it informs which patients are most likely to benefit from dexamethasone therapy.”

Dr. Walter hopes clinicians who participate in the session will leave with these takeaways:

• Be able to summarize recent trials of ascorbic acid in sepsis and think about how to incorporate – or not – the use of vitamin C in critically ill sepsis patients.
• A thorough understanding of when renal replacement therapy should be offered to critically ill patients with acute kidney dysfunction.
• Be able to discuss the impact of antifibrotic therapy in interstitial lung diseases outside of idiopathic pulmonary fibrosis.
• An understanding of the role of triple inhaler combinations in COPD.
• Be able to explain when dexamethasone is most likely to benefit hypoxemic patients with COVID-19.

An overview of five important advances in pulmonary and critical care medicine are on the agenda for the “Update in Pulmonary and Critical Care” session on Tuesday, May 4, at the virtual 2021 SHM Converge conference.

“I hope this session gives attendees a nice, broad look at advances both in the intensive care unit and in general pulmonary medicine,” said James Walter, MD, of Northwestern Medicine in Chicago, who serves as director of the session.

On the critical care medicine side, Dr. Walter will review the latest research on the efficacy of ascorbic acid in treating patients with severe sepsis and septic shock. “There was a lot of excitement and some skepticism about early results promising a really large treatment effect in giving critically ill patients with sepsis large doses of vitamin C,” Dr. Walter said. The last year has produced some high-quality randomized trials that have contributed to a better understanding of the potential effects ascorbic acid in sepsis can have, he noted.

Dr. Walter, who is also medical director of the Northwestern Lung Rescue Program, intends to discuss what he believes is a definitive trial regarding the benefit of preemptively starting critically ill patients with acute kidney injury on renal replacement therapy instead of waiting until there are specific clinical signs. “This has been another area of uncertainty in critical care and I think we finally have a very definitive answer with this high quality, randomized, controlled trial that I plan to review,” he said.

Though he said there have been a number of important advances in pulmonary medicine over the past year, Dr. Walter will highlight just two.

Up until recently, the antifibrotics nintedanib and pirfenidone have mostly been used in patients with idiopathic pulmonary fibrosis. However, recent research suggests there may be a potential benefit to using these drugs in patients with fibrotic lung disease outside of idiopathic pulmonary fibrosis. “I think this is an important advance for hospital medicine providers to be aware of,” said Dr. Walter.

He will also go over some large randomized controlled trials of the use of triple therapy – a combination of a long-acting beta agonist (LABA), a long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid in one inhaler – in chronic obstructive pulmonary disease. The trials looked at whether triple inhaler therapy was beneficial compared to the typical therapies used for COPD.

The session wouldn’t be complete without a nod to COVID-19, which Dr. Walter said has significantly changed the landscape for hospital medicine providers. He plans to discuss what he considers the most impactful study – the RECOVERY trial. This study looked at the role of dexamethasone in patients with more severe manifestations of SARS-CoV-2.

“From the incredible amount of data that’s come out in the last year about COVID, I think this is probably the trial that’s changed practice the most and shown the largest therapeutic benefit of all the pharmacotherapies,” Dr. Walter said. “It’s an important one for providers to be aware of in terms of what the trial shows and how it informs which patients are most likely to benefit from dexamethasone therapy.”

Dr. Walter hopes clinicians who participate in the session will leave with these takeaways:

• Be able to summarize recent trials of ascorbic acid in sepsis and think about how to incorporate – or not – the use of vitamin C in critically ill sepsis patients.
• A thorough understanding of when renal replacement therapy should be offered to critically ill patients with acute kidney dysfunction.
• Be able to discuss the impact of antifibrotic therapy in interstitial lung diseases outside of idiopathic pulmonary fibrosis.
• An understanding of the role of triple inhaler combinations in COPD.
• Be able to explain when dexamethasone is most likely to benefit hypoxemic patients with COVID-19.

The weeks leading up to our Annual Conference always trigger certain rituals for me.

Deciding which sessions to attend feels like planning an intellectual feast mixed with an exercise in compromise, as I realize there is just no way to attend every session that I want to. Scheduling all my plans to connect over dinner and drinks with current and former colleagues is a logistical challenge I undertake with anticipation and some stress, especially when I’m the one tasked with making restaurant reservations. Thinking about how to pay for it all means digging out the rules around my CME faculty allowance, after first figuring out if I still even have a CME allowance, of course.

In the years that I am presenting, there are the last-minute emails with my co-presenters to arrange a time to run through our slides together on site. The prospect of seeing cherished colleagues and friends from SHM mixes with the fact that I know I will miss my wife and young son while I am away. Overall though, I am filled with a tremendous sense of excitement, a feeling that I enjoy in a sustained way for weeks before the meeting.

My excitement for SHM Converge is just as strong, but different in some great and important ways. The availability of on-demand content means I won’t have to choose one session over another this year – I can have my cake and eat it, too. Without the need to travel, expenses will be considerably less, and I won’t need to be away from my family.

But what I am most thrilled about when I think about SHM Converge is the content. A year of planning by our outstanding SHM staff, leadership, and Annual Conference Committee has produced a lineup of world-class speakers. Our virtual platform will offer a rich interactive and networking experience. Perennial favorite sessions, such as the Great Debate, Rapid Fire, and Update sessions will provide attendees the chance to update their core clinical knowledge across the breadth of hospital medicine.

Many aspects of health equity will be explored. Over 15 sessions and four special-interest forums covering topics such as racial and gender inequities, implicit bias, vulnerable populations, and ethics will help attendees not only understand the issues but also will show them how they can take action to make a difference.

Clinical and operational aspects of COVID-19 will also be covered at SHM Converge as speakers share the tremendous innovation, triumphs, and challenges that have taken place over the past year. Wellness and resilience are, of course, as relevant as ever, and sessions on balancing parenthood and work, learning from personal failures, and how to handle uncertainty and be resilient are among the topics that will be covered.

The essence of what we will do at SHM Converge in May is captured in our new meeting logo, an animation of nodes connecting with each other through lines that travel short and long, and intersect along the way. It’s a great representation of the togetherness, community, and mutual support that is at the core of who we are as SHM – now, more than ever. Thank you for joining us!

Dr. Steinberg is chief patient safety officer at Mount Sinai Downtown, and associate dean for quality/patient safety in GME, Mount Sinai Health System, New York. He is professor of medicine and medical education at the Icahn School of Medicine at Mount Sinai, and course director of SHM Converge.

The weeks leading up to our Annual Conference always trigger certain rituals for me.

Deciding which sessions to attend feels like planning an intellectual feast mixed with an exercise in compromise, as I realize there is just no way to attend every session that I want to. Scheduling all my plans to connect over dinner and drinks with current and former colleagues is a logistical challenge I undertake with anticipation and some stress, especially when I’m the one tasked with making restaurant reservations. Thinking about how to pay for it all means digging out the rules around my CME faculty allowance, after first figuring out if I still even have a CME allowance, of course.

In the years that I am presenting, there are the last-minute emails with my co-presenters to arrange a time to run through our slides together on site. The prospect of seeing cherished colleagues and friends from SHM mixes with the fact that I know I will miss my wife and young son while I am away. Overall though, I am filled with a tremendous sense of excitement, a feeling that I enjoy in a sustained way for weeks before the meeting.

My excitement for SHM Converge is just as strong, but different in some great and important ways. The availability of on-demand content means I won’t have to choose one session over another this year – I can have my cake and eat it, too. Without the need to travel, expenses will be considerably less, and I won’t need to be away from my family.

But what I am most thrilled about when I think about SHM Converge is the content. A year of planning by our outstanding SHM staff, leadership, and Annual Conference Committee has produced a lineup of world-class speakers. Our virtual platform will offer a rich interactive and networking experience. Perennial favorite sessions, such as the Great Debate, Rapid Fire, and Update sessions will provide attendees the chance to update their core clinical knowledge across the breadth of hospital medicine.

Many aspects of health equity will be explored. Over 15 sessions and four special-interest forums covering topics such as racial and gender inequities, implicit bias, vulnerable populations, and ethics will help attendees not only understand the issues but also will show them how they can take action to make a difference.

Clinical and operational aspects of COVID-19 will also be covered at SHM Converge as speakers share the tremendous innovation, triumphs, and challenges that have taken place over the past year. Wellness and resilience are, of course, as relevant as ever, and sessions on balancing parenthood and work, learning from personal failures, and how to handle uncertainty and be resilient are among the topics that will be covered.

The essence of what we will do at SHM Converge in May is captured in our new meeting logo, an animation of nodes connecting with each other through lines that travel short and long, and intersect along the way. It’s a great representation of the togetherness, community, and mutual support that is at the core of who we are as SHM – now, more than ever. Thank you for joining us!

Dr. Steinberg is chief patient safety officer at Mount Sinai Downtown, and associate dean for quality/patient safety in GME, Mount Sinai Health System, New York. He is professor of medicine and medical education at the Icahn School of Medicine at Mount Sinai, and course director of SHM Converge.

The weeks leading up to our Annual Conference always trigger certain rituals for me.

Deciding which sessions to attend feels like planning an intellectual feast mixed with an exercise in compromise, as I realize there is just no way to attend every session that I want to. Scheduling all my plans to connect over dinner and drinks with current and former colleagues is a logistical challenge I undertake with anticipation and some stress, especially when I’m the one tasked with making restaurant reservations. Thinking about how to pay for it all means digging out the rules around my CME faculty allowance, after first figuring out if I still even have a CME allowance, of course.

In the years that I am presenting, there are the last-minute emails with my co-presenters to arrange a time to run through our slides together on site. The prospect of seeing cherished colleagues and friends from SHM mixes with the fact that I know I will miss my wife and young son while I am away. Overall though, I am filled with a tremendous sense of excitement, a feeling that I enjoy in a sustained way for weeks before the meeting.

My excitement for SHM Converge is just as strong, but different in some great and important ways. The availability of on-demand content means I won’t have to choose one session over another this year – I can have my cake and eat it, too. Without the need to travel, expenses will be considerably less, and I won’t need to be away from my family.

But what I am most thrilled about when I think about SHM Converge is the content. A year of planning by our outstanding SHM staff, leadership, and Annual Conference Committee has produced a lineup of world-class speakers. Our virtual platform will offer a rich interactive and networking experience. Perennial favorite sessions, such as the Great Debate, Rapid Fire, and Update sessions will provide attendees the chance to update their core clinical knowledge across the breadth of hospital medicine.

Many aspects of health equity will be explored. Over 15 sessions and four special-interest forums covering topics such as racial and gender inequities, implicit bias, vulnerable populations, and ethics will help attendees not only understand the issues but also will show them how they can take action to make a difference.

Clinical and operational aspects of COVID-19 will also be covered at SHM Converge as speakers share the tremendous innovation, triumphs, and challenges that have taken place over the past year. Wellness and resilience are, of course, as relevant as ever, and sessions on balancing parenthood and work, learning from personal failures, and how to handle uncertainty and be resilient are among the topics that will be covered.

The essence of what we will do at SHM Converge in May is captured in our new meeting logo, an animation of nodes connecting with each other through lines that travel short and long, and intersect along the way. It’s a great representation of the togetherness, community, and mutual support that is at the core of who we are as SHM – now, more than ever. Thank you for joining us!

Dr. Steinberg is chief patient safety officer at Mount Sinai Downtown, and associate dean for quality/patient safety in GME, Mount Sinai Health System, New York. He is professor of medicine and medical education at the Icahn School of Medicine at Mount Sinai, and course director of SHM Converge.

The antibody-drug conjugate enfortumab vedotin is superior to chemotherapy in patients with previously treated advanced urothelial carcinoma, primary results of the EV-301 trial show.

Findings were reported at the 2021 Genitourinary Cancers Symposium (Abstract 393).

“Treatment after platinum-based chemotherapy and immune checkpoint inhibitors is challenging. Overall survival is short, and therapeutic options are also limited,” noted first author Thomas Powles, MD, a professor of genitourinary oncology and director of the Barts Cancer Centre, Queen Mary University of London. “Chemotherapy is being used as the global standard of care, but randomized trials supporting these treatment choices are actually lacking. In this setting, new therapeutic agents supported by randomized trials are needed.”

Patients enrolled in EV-301 (NCT03474107), an international open-label, phase 3 trial, had locally advanced or metastatic urothelial carcinoma, had received platinum-based chemotherapy, and had experienced progression during or after immune checkpoint inhibitor therapy (anti–PD1/PD-L1 therapy).

The trial met its primary endpoint, showing that, relative to chemotherapy, enfortumab vedotin reduced the risk of death by 30%, giving patients nearly 4 additional months of life. The toxicity profile was similar to that seen in earlier trials and was manageable.

“Enfortumab vedotin is the first drug, beyond chemotherapy and immunotherapy, to show a significant survival advantage in previously treated urothelial cancer. This is a big step in the right direction for patients with advanced urothelial cancer, where treatment options remain quite limited,” Dr. Powles maintained.

The drug is also showing promising activity when used in the immunotherapy-treated but cisplatin-ineligible patients in the second cohort of the predecessor EV-201 trial, reported at the symposium as well (Abstract 394), he noted. “I hope that, as we move it earlier, we will show better efficacy.”

The Food and Drug Administration granted enfortumab vedotin accelerated approval as third-line therapy in 2019 on the basis of data from the EV-201 trial’s first cohort. With these new data from both trials, the manufacturers have submitted applications to convert the accelerated approval to regular approval, and to expand the current label to include cisplatin-ineligible patients.
 

Trial details

In EV-301, a total of 608 patients were randomized evenly to enfortumab vedotin (an antibody-drug conjugate that targets nectin-4, a cell-adhesion molecule highly expressed in urothelial carcinoma) or the physician’s choice among three standard chemotherapy options having similar efficacy (docetaxel, paclitaxel, or vinflunine).

“None of these chemotherapy drugs have spectacular response rates, and the overall survival is best described as modest,” Dr. Powles said.

He reported results of the trial’s planned interim analysis, which became the primary analysis because the primary endpoint was positive. Specifically, median overall survival was 12.9 months with enfortumab vedotin and 9.0 months with chemotherapy (hazard ratio, 0.70; P = .00142). Benefit was similar across most patient subgroups.

The enfortumab vedotin group also had a better median progression-free survival (5.6 vs. 3.7 months; HR, 0.62; P < .00001) and investigator-assessed overall response rate (40.6% vs. 17.9%; P < .001).

The rate of grade 3 or worse treatment-related adverse events was 51% with enfortumab vedotin and 50% with chemotherapy. The former was associated with a higher rate of grade 3 or worse maculopapular rash (7% vs. 0%), whereas the latter was associated with higher rates of grade 3 or worse decreased neutrophil count (13% vs. 6%), decreased white blood cell count (7% vs. 1%), and febrile neutropenia (6% vs. 1%).

Regarding events of special interest, enfortumab vedotin led to more grade 3 or worse skin reactions of any type (15% vs. 1%), peripheral neuropathy (5% vs. 2%), and hyperglycemia (4% vs. 0%). However, the majority of all treatment-related adverse events of special interest were mild to moderate in severity and consistent with those previously reported.

“There is a skill associated with the management of toxicity, and there is going to be a learning curve for people who haven’t used the drug before,” Dr. Powles acknowledged. “But my experience is, it’s a manageable drug, and delays and dose interruptions actually make it a relatively straightforward drug to give in the context of the profile that we’ve seen today.”
 

Level 1 evidence

“We now know that enfortumab vedotin is here to stay in the armamentarium for the treatment of urothelial cancer, adding its name to the ranks of others which have shown level 1 evidence, proof of a survival benefit in metastatic urothelial carcinoma,” commented invited discussant Arlene O. Siefker-Radtke, MD, a professor in the department of genitourinary medical oncology, University of Texas MD Anderson Cancer Center, Houston.

“I’ve been impressed not only by the activity of enfortumab vedotin in visceral and liver metastases, but also by the impact in patients with bone metastases as this appears very helpful in controlling bone pain in many patients,” she noted.

Preventing and managing toxicity requires appropriate patient selection, careful monitoring, and dose modifications, with knowledge of the agent’s adverse event profile and of factors conferring elevated risk for events, Dr. Siefker-Radtke said.

“The early evidence for enfortumab vedotin in the postimmunotherapy, platinum-ineligible group suggests that this can help treat patients with an unmet need due to their inability to receive platinum-based therapy,” she concluded. “And while it’s currently approved in the third-line setting, we are all eagerly awaiting the outcomes of the frontline studies of enfortumab vedotin combined with pembrolizumab, which showed such a promising objective response rate, as has been presented at earlier meetings.”

The trial was sponsored by Astellas Pharma and Seagen. Dr. Powles disclosed relationships with Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, and numerous other pharmaceutical and biotechnology companies. Dr. Siefker-Radtke disclosed relationships with AstraZeneca, Bavarian Nordic, Bristol-Myers Squibb, and a variety of other pharmaceutical and biotechnology companies, as well as patents, royalties, and/or other intellectual property pertaining to methods of characterizing and treating molecular subsets of muscle-invasive bladder cancer.

The antibody-drug conjugate enfortumab vedotin is superior to chemotherapy in patients with previously treated advanced urothelial carcinoma, primary results of the EV-301 trial show.

Findings were reported at the 2021 Genitourinary Cancers Symposium (Abstract 393).

“Treatment after platinum-based chemotherapy and immune checkpoint inhibitors is challenging. Overall survival is short, and therapeutic options are also limited,” noted first author Thomas Powles, MD, a professor of genitourinary oncology and director of the Barts Cancer Centre, Queen Mary University of London. “Chemotherapy is being used as the global standard of care, but randomized trials supporting these treatment choices are actually lacking. In this setting, new therapeutic agents supported by randomized trials are needed.”

Patients enrolled in EV-301 (NCT03474107), an international open-label, phase 3 trial, had locally advanced or metastatic urothelial carcinoma, had received platinum-based chemotherapy, and had experienced progression during or after immune checkpoint inhibitor therapy (anti–PD1/PD-L1 therapy).

The trial met its primary endpoint, showing that, relative to chemotherapy, enfortumab vedotin reduced the risk of death by 30%, giving patients nearly 4 additional months of life. The toxicity profile was similar to that seen in earlier trials and was manageable.

“Enfortumab vedotin is the first drug, beyond chemotherapy and immunotherapy, to show a significant survival advantage in previously treated urothelial cancer. This is a big step in the right direction for patients with advanced urothelial cancer, where treatment options remain quite limited,” Dr. Powles maintained.

The drug is also showing promising activity when used in the immunotherapy-treated but cisplatin-ineligible patients in the second cohort of the predecessor EV-201 trial, reported at the symposium as well (Abstract 394), he noted. “I hope that, as we move it earlier, we will show better efficacy.”

The Food and Drug Administration granted enfortumab vedotin accelerated approval as third-line therapy in 2019 on the basis of data from the EV-201 trial’s first cohort. With these new data from both trials, the manufacturers have submitted applications to convert the accelerated approval to regular approval, and to expand the current label to include cisplatin-ineligible patients.
 

Trial details

In EV-301, a total of 608 patients were randomized evenly to enfortumab vedotin (an antibody-drug conjugate that targets nectin-4, a cell-adhesion molecule highly expressed in urothelial carcinoma) or the physician’s choice among three standard chemotherapy options having similar efficacy (docetaxel, paclitaxel, or vinflunine).

“None of these chemotherapy drugs have spectacular response rates, and the overall survival is best described as modest,” Dr. Powles said.

He reported results of the trial’s planned interim analysis, which became the primary analysis because the primary endpoint was positive. Specifically, median overall survival was 12.9 months with enfortumab vedotin and 9.0 months with chemotherapy (hazard ratio, 0.70; P = .00142). Benefit was similar across most patient subgroups.

The enfortumab vedotin group also had a better median progression-free survival (5.6 vs. 3.7 months; HR, 0.62; P < .00001) and investigator-assessed overall response rate (40.6% vs. 17.9%; P < .001).

The rate of grade 3 or worse treatment-related adverse events was 51% with enfortumab vedotin and 50% with chemotherapy. The former was associated with a higher rate of grade 3 or worse maculopapular rash (7% vs. 0%), whereas the latter was associated with higher rates of grade 3 or worse decreased neutrophil count (13% vs. 6%), decreased white blood cell count (7% vs. 1%), and febrile neutropenia (6% vs. 1%).

Regarding events of special interest, enfortumab vedotin led to more grade 3 or worse skin reactions of any type (15% vs. 1%), peripheral neuropathy (5% vs. 2%), and hyperglycemia (4% vs. 0%). However, the majority of all treatment-related adverse events of special interest were mild to moderate in severity and consistent with those previously reported.

“There is a skill associated with the management of toxicity, and there is going to be a learning curve for people who haven’t used the drug before,” Dr. Powles acknowledged. “But my experience is, it’s a manageable drug, and delays and dose interruptions actually make it a relatively straightforward drug to give in the context of the profile that we’ve seen today.”
 

Level 1 evidence

“We now know that enfortumab vedotin is here to stay in the armamentarium for the treatment of urothelial cancer, adding its name to the ranks of others which have shown level 1 evidence, proof of a survival benefit in metastatic urothelial carcinoma,” commented invited discussant Arlene O. Siefker-Radtke, MD, a professor in the department of genitourinary medical oncology, University of Texas MD Anderson Cancer Center, Houston.

“I’ve been impressed not only by the activity of enfortumab vedotin in visceral and liver metastases, but also by the impact in patients with bone metastases as this appears very helpful in controlling bone pain in many patients,” she noted.

Preventing and managing toxicity requires appropriate patient selection, careful monitoring, and dose modifications, with knowledge of the agent’s adverse event profile and of factors conferring elevated risk for events, Dr. Siefker-Radtke said.

“The early evidence for enfortumab vedotin in the postimmunotherapy, platinum-ineligible group suggests that this can help treat patients with an unmet need due to their inability to receive platinum-based therapy,” she concluded. “And while it’s currently approved in the third-line setting, we are all eagerly awaiting the outcomes of the frontline studies of enfortumab vedotin combined with pembrolizumab, which showed such a promising objective response rate, as has been presented at earlier meetings.”

The trial was sponsored by Astellas Pharma and Seagen. Dr. Powles disclosed relationships with Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, and numerous other pharmaceutical and biotechnology companies. Dr. Siefker-Radtke disclosed relationships with AstraZeneca, Bavarian Nordic, Bristol-Myers Squibb, and a variety of other pharmaceutical and biotechnology companies, as well as patents, royalties, and/or other intellectual property pertaining to methods of characterizing and treating molecular subsets of muscle-invasive bladder cancer.

The antibody-drug conjugate enfortumab vedotin is superior to chemotherapy in patients with previously treated advanced urothelial carcinoma, primary results of the EV-301 trial show.

Findings were reported at the 2021 Genitourinary Cancers Symposium (Abstract 393).

“Treatment after platinum-based chemotherapy and immune checkpoint inhibitors is challenging. Overall survival is short, and therapeutic options are also limited,” noted first author Thomas Powles, MD, a professor of genitourinary oncology and director of the Barts Cancer Centre, Queen Mary University of London. “Chemotherapy is being used as the global standard of care, but randomized trials supporting these treatment choices are actually lacking. In this setting, new therapeutic agents supported by randomized trials are needed.”

Patients enrolled in EV-301 (NCT03474107), an international open-label, phase 3 trial, had locally advanced or metastatic urothelial carcinoma, had received platinum-based chemotherapy, and had experienced progression during or after immune checkpoint inhibitor therapy (anti–PD1/PD-L1 therapy).

The trial met its primary endpoint, showing that, relative to chemotherapy, enfortumab vedotin reduced the risk of death by 30%, giving patients nearly 4 additional months of life. The toxicity profile was similar to that seen in earlier trials and was manageable.

“Enfortumab vedotin is the first drug, beyond chemotherapy and immunotherapy, to show a significant survival advantage in previously treated urothelial cancer. This is a big step in the right direction for patients with advanced urothelial cancer, where treatment options remain quite limited,” Dr. Powles maintained.

The drug is also showing promising activity when used in the immunotherapy-treated but cisplatin-ineligible patients in the second cohort of the predecessor EV-201 trial, reported at the symposium as well (Abstract 394), he noted. “I hope that, as we move it earlier, we will show better efficacy.”

The Food and Drug Administration granted enfortumab vedotin accelerated approval as third-line therapy in 2019 on the basis of data from the EV-201 trial’s first cohort. With these new data from both trials, the manufacturers have submitted applications to convert the accelerated approval to regular approval, and to expand the current label to include cisplatin-ineligible patients.
 

Trial details

In EV-301, a total of 608 patients were randomized evenly to enfortumab vedotin (an antibody-drug conjugate that targets nectin-4, a cell-adhesion molecule highly expressed in urothelial carcinoma) or the physician’s choice among three standard chemotherapy options having similar efficacy (docetaxel, paclitaxel, or vinflunine).

“None of these chemotherapy drugs have spectacular response rates, and the overall survival is best described as modest,” Dr. Powles said.

He reported results of the trial’s planned interim analysis, which became the primary analysis because the primary endpoint was positive. Specifically, median overall survival was 12.9 months with enfortumab vedotin and 9.0 months with chemotherapy (hazard ratio, 0.70; P = .00142). Benefit was similar across most patient subgroups.

The enfortumab vedotin group also had a better median progression-free survival (5.6 vs. 3.7 months; HR, 0.62; P < .00001) and investigator-assessed overall response rate (40.6% vs. 17.9%; P < .001).

The rate of grade 3 or worse treatment-related adverse events was 51% with enfortumab vedotin and 50% with chemotherapy. The former was associated with a higher rate of grade 3 or worse maculopapular rash (7% vs. 0%), whereas the latter was associated with higher rates of grade 3 or worse decreased neutrophil count (13% vs. 6%), decreased white blood cell count (7% vs. 1%), and febrile neutropenia (6% vs. 1%).

Regarding events of special interest, enfortumab vedotin led to more grade 3 or worse skin reactions of any type (15% vs. 1%), peripheral neuropathy (5% vs. 2%), and hyperglycemia (4% vs. 0%). However, the majority of all treatment-related adverse events of special interest were mild to moderate in severity and consistent with those previously reported.

“There is a skill associated with the management of toxicity, and there is going to be a learning curve for people who haven’t used the drug before,” Dr. Powles acknowledged. “But my experience is, it’s a manageable drug, and delays and dose interruptions actually make it a relatively straightforward drug to give in the context of the profile that we’ve seen today.”
 

Level 1 evidence

“We now know that enfortumab vedotin is here to stay in the armamentarium for the treatment of urothelial cancer, adding its name to the ranks of others which have shown level 1 evidence, proof of a survival benefit in metastatic urothelial carcinoma,” commented invited discussant Arlene O. Siefker-Radtke, MD, a professor in the department of genitourinary medical oncology, University of Texas MD Anderson Cancer Center, Houston.

“I’ve been impressed not only by the activity of enfortumab vedotin in visceral and liver metastases, but also by the impact in patients with bone metastases as this appears very helpful in controlling bone pain in many patients,” she noted.

Preventing and managing toxicity requires appropriate patient selection, careful monitoring, and dose modifications, with knowledge of the agent’s adverse event profile and of factors conferring elevated risk for events, Dr. Siefker-Radtke said.

“The early evidence for enfortumab vedotin in the postimmunotherapy, platinum-ineligible group suggests that this can help treat patients with an unmet need due to their inability to receive platinum-based therapy,” she concluded. “And while it’s currently approved in the third-line setting, we are all eagerly awaiting the outcomes of the frontline studies of enfortumab vedotin combined with pembrolizumab, which showed such a promising objective response rate, as has been presented at earlier meetings.”

The trial was sponsored by Astellas Pharma and Seagen. Dr. Powles disclosed relationships with Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, and numerous other pharmaceutical and biotechnology companies. Dr. Siefker-Radtke disclosed relationships with AstraZeneca, Bavarian Nordic, Bristol-Myers Squibb, and a variety of other pharmaceutical and biotechnology companies, as well as patents, royalties, and/or other intellectual property pertaining to methods of characterizing and treating molecular subsets of muscle-invasive bladder cancer.