At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.

In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).

Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Courtesy The Feinstein Institutes

Potential alternative to meds

“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.

Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.

Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.

Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.

“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.

The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.

The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
 

Promising findings

At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.

By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.

In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.

The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.

Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”

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

At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.

In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).

Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Courtesy The Feinstein Institutes

Potential alternative to meds

“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.

Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.

Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.

Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.

“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.

The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.

The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
 

Promising findings

At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.

By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.

In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.

The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.

Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”

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

At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.

In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).

Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Courtesy The Feinstein Institutes

Potential alternative to meds

“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.

Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.

Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.

Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.

“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.

The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.

The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
 

Promising findings

At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.

By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.

In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.

The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.

Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”

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

A poor-quality human liver, rejected by all transplant centers, was treated outside the body for 3 days using a perfusion machine that simulated some functions of the human body and has been successfully transplanted into a patient with advanced cirrhosis.

The 62-year-old patient rapidly returned to normal quality of life and at the 1-year follow-up had no signs of liver damage, such as rejection or bile duct injury, according to the report published in Nature Biotechnology.

The study team was led by Pierre-Alain Clavien, MD, PhD, with the department of surgery and transplantation, Swiss Hepato-Pancreato-Biliary and Transplant Center, University Hospital Zürich, and the Wyss Zürich Translational Center, ETH Zürich and University of Zürich.
 

Expanding the viability window

Livers for transplant are routinely preserved in a static cold solution and implanted within a few hours. Most centers limit the time in the cold solution to 12 hours as the organ’s viability drops quickly after that time.

“This inaugural clinical success opens new horizons in clinical research and promises an extended time window of up to 10 days for assessment of viability of donor organs as well as converting an urgent and highly demanding surgery into an elective procedure,” the authors wrote.

The Liver4Life team, made up of physicians, engineers, and biochemists, developed the complex perfusion machine. Features of the machine, which mimics human body functions, include automated remote control of all key parameters. A pump mimics the heart, an oxygenator replaces the lungs, and a dialysis unit performs as kidneys would. Hormone and nutrient infusions take over the work of the intestines and pancreas. The machine also moves the liver to the rhythm of simulated breathing.

The team had to solve factors that limit viability for any solid organ outside the body over a few hours including hemolysis, hemodynamic stability, glucose control, pathologic glycogen deposition and perfusate quality and dilution.

Additionally, because the organ would be under machine perfusion for several days, the scientists also had to address pressure necrosis.
 

History behind the procedure

The process started in 2015 with the support of the Wyss Zürich Translational Center, with the goal of long-term ex situ machine perfusion of injured liver grafts.

As part of the agreement from the Swiss regulatory authority (the Federal Office of Public Health) the process would be used only if the organ was rejected by all transplant centers, the recipient had no other options for a donor liver, and if the organ met a rigorous bar for viability.

On May 19, 2021, the team was offered a liver graft from a 29-year-old female donor who had an invasive abdominal desmoid fibromatosis associated with chronic intra-abdominal abscesses and recurrent sepsis episodes from multiresistant bacteria. The donor needed long-term multiple medications and parenteral nutrition. Additionally, there was a 4-cm tumor in segment 1 of the liver.

The liver was refused by all other centers, “primarily because it required diagnostic workup of the liver lesion, which was not immediately possible, and because of the ongoing sepsis in the donor with multiresistant microorganisms,” the authors wrote.

The team removed the liver, and the graft was connected to the Wyss perfusion device for normothermic (37 °C) ex situ perfusion after 4 hours of cold preservation.

A 62-year-old male potential recipient on the official national transplant list, had earlier agreed to be considered for receiving a graft preserved ex situ in the Wyss machine.

The patient was fully informed about the process and the presence of a benign lesion in the graft and accepted the transplantation procedure. The patient had advanced cirrhosis, severe portal hypertension, and multiple and recurrent hepatocellular carcinoma (HCC).
 

Recipient had ‘near-zero’ chance to get a liver in time

The authors wrote that the patient had “a near-zero chance to receive a graft in time.”

For patients with HCC in Switzerland, the wait for liver transplant is longer than a year and no living-donor options were available.

The transplant operation took 5 hours and 26 minutes and blood loss was limited (600 mL). No transfusion was required. The patient was extubated in the operating room, transferred to the ICU, and discharged 12 days later.

Because a biopsy showed no detectable liver injury or rejection, and based on previous evidence of lower immunogenicity in perfused livers and kidneys, the researchers chose a reduced immunosuppressive regimen with quickly tapering steroids. The steroids were completely discontinued 6 weeks after surgery.

The authors wrote: “In our experience, the absence or very low degree of reperfusion injury seen in our transplant is observed only in living donation, where ‘close-to-perfect’ livers from healthy young donors are transplanted immediately as both donors and recipient are operated in parallel.”

In a press release, the team said the next step is to assess the procedure in other patients in a multicenter study.

Dr. Clavien and several coauthors affiliated with ETH (the Swiss Federal Institute of Technology in Zürich) and the University of Zürich have applied for patents on this new perfusion technology. No other authors have any competing interest.

A poor-quality human liver, rejected by all transplant centers, was treated outside the body for 3 days using a perfusion machine that simulated some functions of the human body and has been successfully transplanted into a patient with advanced cirrhosis.

The 62-year-old patient rapidly returned to normal quality of life and at the 1-year follow-up had no signs of liver damage, such as rejection or bile duct injury, according to the report published in Nature Biotechnology.

The study team was led by Pierre-Alain Clavien, MD, PhD, with the department of surgery and transplantation, Swiss Hepato-Pancreato-Biliary and Transplant Center, University Hospital Zürich, and the Wyss Zürich Translational Center, ETH Zürich and University of Zürich.
 

Expanding the viability window

Livers for transplant are routinely preserved in a static cold solution and implanted within a few hours. Most centers limit the time in the cold solution to 12 hours as the organ’s viability drops quickly after that time.

“This inaugural clinical success opens new horizons in clinical research and promises an extended time window of up to 10 days for assessment of viability of donor organs as well as converting an urgent and highly demanding surgery into an elective procedure,” the authors wrote.

The Liver4Life team, made up of physicians, engineers, and biochemists, developed the complex perfusion machine. Features of the machine, which mimics human body functions, include automated remote control of all key parameters. A pump mimics the heart, an oxygenator replaces the lungs, and a dialysis unit performs as kidneys would. Hormone and nutrient infusions take over the work of the intestines and pancreas. The machine also moves the liver to the rhythm of simulated breathing.

The team had to solve factors that limit viability for any solid organ outside the body over a few hours including hemolysis, hemodynamic stability, glucose control, pathologic glycogen deposition and perfusate quality and dilution.

Additionally, because the organ would be under machine perfusion for several days, the scientists also had to address pressure necrosis.
 

History behind the procedure

The process started in 2015 with the support of the Wyss Zürich Translational Center, with the goal of long-term ex situ machine perfusion of injured liver grafts.

As part of the agreement from the Swiss regulatory authority (the Federal Office of Public Health) the process would be used only if the organ was rejected by all transplant centers, the recipient had no other options for a donor liver, and if the organ met a rigorous bar for viability.

On May 19, 2021, the team was offered a liver graft from a 29-year-old female donor who had an invasive abdominal desmoid fibromatosis associated with chronic intra-abdominal abscesses and recurrent sepsis episodes from multiresistant bacteria. The donor needed long-term multiple medications and parenteral nutrition. Additionally, there was a 4-cm tumor in segment 1 of the liver.

The liver was refused by all other centers, “primarily because it required diagnostic workup of the liver lesion, which was not immediately possible, and because of the ongoing sepsis in the donor with multiresistant microorganisms,” the authors wrote.

The team removed the liver, and the graft was connected to the Wyss perfusion device for normothermic (37 °C) ex situ perfusion after 4 hours of cold preservation.

A 62-year-old male potential recipient on the official national transplant list, had earlier agreed to be considered for receiving a graft preserved ex situ in the Wyss machine.

The patient was fully informed about the process and the presence of a benign lesion in the graft and accepted the transplantation procedure. The patient had advanced cirrhosis, severe portal hypertension, and multiple and recurrent hepatocellular carcinoma (HCC).
 

Recipient had ‘near-zero’ chance to get a liver in time

The authors wrote that the patient had “a near-zero chance to receive a graft in time.”

For patients with HCC in Switzerland, the wait for liver transplant is longer than a year and no living-donor options were available.

The transplant operation took 5 hours and 26 minutes and blood loss was limited (600 mL). No transfusion was required. The patient was extubated in the operating room, transferred to the ICU, and discharged 12 days later.

Because a biopsy showed no detectable liver injury or rejection, and based on previous evidence of lower immunogenicity in perfused livers and kidneys, the researchers chose a reduced immunosuppressive regimen with quickly tapering steroids. The steroids were completely discontinued 6 weeks after surgery.

The authors wrote: “In our experience, the absence or very low degree of reperfusion injury seen in our transplant is observed only in living donation, where ‘close-to-perfect’ livers from healthy young donors are transplanted immediately as both donors and recipient are operated in parallel.”

In a press release, the team said the next step is to assess the procedure in other patients in a multicenter study.

Dr. Clavien and several coauthors affiliated with ETH (the Swiss Federal Institute of Technology in Zürich) and the University of Zürich have applied for patents on this new perfusion technology. No other authors have any competing interest.

A poor-quality human liver, rejected by all transplant centers, was treated outside the body for 3 days using a perfusion machine that simulated some functions of the human body and has been successfully transplanted into a patient with advanced cirrhosis.

The 62-year-old patient rapidly returned to normal quality of life and at the 1-year follow-up had no signs of liver damage, such as rejection or bile duct injury, according to the report published in Nature Biotechnology.

The study team was led by Pierre-Alain Clavien, MD, PhD, with the department of surgery and transplantation, Swiss Hepato-Pancreato-Biliary and Transplant Center, University Hospital Zürich, and the Wyss Zürich Translational Center, ETH Zürich and University of Zürich.
 

Expanding the viability window

Livers for transplant are routinely preserved in a static cold solution and implanted within a few hours. Most centers limit the time in the cold solution to 12 hours as the organ’s viability drops quickly after that time.

“This inaugural clinical success opens new horizons in clinical research and promises an extended time window of up to 10 days for assessment of viability of donor organs as well as converting an urgent and highly demanding surgery into an elective procedure,” the authors wrote.

The Liver4Life team, made up of physicians, engineers, and biochemists, developed the complex perfusion machine. Features of the machine, which mimics human body functions, include automated remote control of all key parameters. A pump mimics the heart, an oxygenator replaces the lungs, and a dialysis unit performs as kidneys would. Hormone and nutrient infusions take over the work of the intestines and pancreas. The machine also moves the liver to the rhythm of simulated breathing.

The team had to solve factors that limit viability for any solid organ outside the body over a few hours including hemolysis, hemodynamic stability, glucose control, pathologic glycogen deposition and perfusate quality and dilution.

Additionally, because the organ would be under machine perfusion for several days, the scientists also had to address pressure necrosis.
 

History behind the procedure

The process started in 2015 with the support of the Wyss Zürich Translational Center, with the goal of long-term ex situ machine perfusion of injured liver grafts.

As part of the agreement from the Swiss regulatory authority (the Federal Office of Public Health) the process would be used only if the organ was rejected by all transplant centers, the recipient had no other options for a donor liver, and if the organ met a rigorous bar for viability.

On May 19, 2021, the team was offered a liver graft from a 29-year-old female donor who had an invasive abdominal desmoid fibromatosis associated with chronic intra-abdominal abscesses and recurrent sepsis episodes from multiresistant bacteria. The donor needed long-term multiple medications and parenteral nutrition. Additionally, there was a 4-cm tumor in segment 1 of the liver.

The liver was refused by all other centers, “primarily because it required diagnostic workup of the liver lesion, which was not immediately possible, and because of the ongoing sepsis in the donor with multiresistant microorganisms,” the authors wrote.

The team removed the liver, and the graft was connected to the Wyss perfusion device for normothermic (37 °C) ex situ perfusion after 4 hours of cold preservation.

A 62-year-old male potential recipient on the official national transplant list, had earlier agreed to be considered for receiving a graft preserved ex situ in the Wyss machine.

The patient was fully informed about the process and the presence of a benign lesion in the graft and accepted the transplantation procedure. The patient had advanced cirrhosis, severe portal hypertension, and multiple and recurrent hepatocellular carcinoma (HCC).
 

Recipient had ‘near-zero’ chance to get a liver in time

The authors wrote that the patient had “a near-zero chance to receive a graft in time.”

For patients with HCC in Switzerland, the wait for liver transplant is longer than a year and no living-donor options were available.

The transplant operation took 5 hours and 26 minutes and blood loss was limited (600 mL). No transfusion was required. The patient was extubated in the operating room, transferred to the ICU, and discharged 12 days later.

Because a biopsy showed no detectable liver injury or rejection, and based on previous evidence of lower immunogenicity in perfused livers and kidneys, the researchers chose a reduced immunosuppressive regimen with quickly tapering steroids. The steroids were completely discontinued 6 weeks after surgery.

The authors wrote: “In our experience, the absence or very low degree of reperfusion injury seen in our transplant is observed only in living donation, where ‘close-to-perfect’ livers from healthy young donors are transplanted immediately as both donors and recipient are operated in parallel.”

In a press release, the team said the next step is to assess the procedure in other patients in a multicenter study.

Dr. Clavien and several coauthors affiliated with ETH (the Swiss Federal Institute of Technology in Zürich) and the University of Zürich have applied for patents on this new perfusion technology. No other authors have any competing interest.

NEW ORLEANS – Adult patients who completed an intensive outpatient program (IOP) for post-traumatic stress disorder were significantly less likely over the following year to require inpatient or emergency psychiatric treatment, according to a new study released at the annual meeting of the American Psychiatric Association.

In an analysis of 256 individuals, over the 12 months before they joined the IOP, 28.7% and 24.8% had inpatient and emergency department encounters, respectively, according to the researchers. Afterward, those numbers fell to 15.9% (P < .01) and 18.2% (P = .04), respectively.

“Engagement in IOP for patients with PTSD may help avoid the need for higher levels of care such as residential or inpatient treatment,” Nathan Lingafelter, MD, a psychiatrist and researcher at Kaiser Permanente in Oakland, Calif., said in an interview.

Dr. Lingafelter described IOP programs as typically “offering patients a combination of individual therapy, group therapy, and medication management all at an increased frequency of about 3 half-days per week. IOPs are thought to be helpful in helping patients with severe symptoms while they are still in the community – i.e., living in their homes, with their families, occasionally still working at reduced time.”

While other studies have examined the effects of IOP, “the existing literature focuses on how IOP reduces symptoms, rather than looking at how IOP involvement might be associated with patients utilizing different acute care resources,” he said. “Prior studies have also been conducted mostly in veteran populations and in populations with less diversity than our population in Oakland.”

For the new study, researchers tracked 256 IOP participants (83% female; mean age = 39; 44% White, 27% Black, 14% Hispanic, and 7% Asian). The wide majority – 85% – had comorbid depressive disorders.

“Patients are assigned a case manager when they enter the program who they can meet with individually, and they spend time attending group therapy sessions. Patients are also able to meet with a psychiatrist to discuss medications,” Dr. Lingafelter said. “A major component in both the group and individual therapy is helping patients identify which kind of interventions work for them and what we can do now that will help. IOP can really help clarify for patients what their trauma responses are and how to start treatments that actually fit their symptoms.”

The subjects had a mean 0.3 psychiatric encounters in the year before joining the program and 0.2 in the year after (P < .01). Their mean emergency department visits related to mental health fell from 0.5 to 0.3 (P = .03).

The study has limitations. Participants took part in IOP therapy from 2017 to 2018, before the pandemic disrupted mental health treatment. It does not examine whether medication use changed after IOP treatment. It is retrospective and doesn’t confirm that IOP had any positive effect.
 

Multiple benefits of IOP

In an interview, Deborah C. Beidel, PhD, director of UCF RESTORES at the University of Central Florida, Orlando, said IOP has several advantages as a treatment for PTSD. Her clinic, which focuses on PTSD treatment for military veterans, has used the approach to treat hundreds of people.

“First, IOPs can address the stigma that surrounds mental health treatment. If you have a physical injury, you take time off from work to go to physical therapy, which is time-limited. If you have a stress injury, why not do the same? Take a few weeks, get it treated, and get back to work,” she said. “The second reason is that the most effective treatment for PTSD is exposure therapy, which is more effective when treatment sessions occur in a daily as opposed to a weekly or monthly time frame. Third, from a cost and feasibility perspective, an intensive program could reduce overall medical costs and get people back to work sooner.”

The new study is “definitely useful” since it examines the impact of IOP over a longer term, Dr. Beidel said. This kind of data “can influence policy, particularly with insurance companies. If we can build the evidence that short, intensive treatment produces better long-term outcomes, insurance companies will be more likely to pay for the IOP.”

The University of Central Florida program is funded by federal research grants and state funding, she said. “When we calculate the cost, it comes to about $10,000 in therapy time plus an average of about $3,000 in travel related costs – transportation, lodging, meals – for those who travel from out of state for our program.”

What’s next? “Further study is needed to characterize whether these findings are applicable to other practice settings, including virtual treatment programs; the long-term durability of these findings; and whether similar patterns of reduced resource use extend to non–mental health–specific care utilization,” said Dr. Lingafelter, the study’s lead author.

No study funding and no author disclosures were reported. Dr. Beidel disclosed IOP-related research support from the U.S. Army Medical Research and Development Command–Military Operational Medicine Research Program.

NEW ORLEANS – Adult patients who completed an intensive outpatient program (IOP) for post-traumatic stress disorder were significantly less likely over the following year to require inpatient or emergency psychiatric treatment, according to a new study released at the annual meeting of the American Psychiatric Association.

In an analysis of 256 individuals, over the 12 months before they joined the IOP, 28.7% and 24.8% had inpatient and emergency department encounters, respectively, according to the researchers. Afterward, those numbers fell to 15.9% (P < .01) and 18.2% (P = .04), respectively.

“Engagement in IOP for patients with PTSD may help avoid the need for higher levels of care such as residential or inpatient treatment,” Nathan Lingafelter, MD, a psychiatrist and researcher at Kaiser Permanente in Oakland, Calif., said in an interview.

Dr. Lingafelter described IOP programs as typically “offering patients a combination of individual therapy, group therapy, and medication management all at an increased frequency of about 3 half-days per week. IOPs are thought to be helpful in helping patients with severe symptoms while they are still in the community – i.e., living in their homes, with their families, occasionally still working at reduced time.”

While other studies have examined the effects of IOP, “the existing literature focuses on how IOP reduces symptoms, rather than looking at how IOP involvement might be associated with patients utilizing different acute care resources,” he said. “Prior studies have also been conducted mostly in veteran populations and in populations with less diversity than our population in Oakland.”

For the new study, researchers tracked 256 IOP participants (83% female; mean age = 39; 44% White, 27% Black, 14% Hispanic, and 7% Asian). The wide majority – 85% – had comorbid depressive disorders.

“Patients are assigned a case manager when they enter the program who they can meet with individually, and they spend time attending group therapy sessions. Patients are also able to meet with a psychiatrist to discuss medications,” Dr. Lingafelter said. “A major component in both the group and individual therapy is helping patients identify which kind of interventions work for them and what we can do now that will help. IOP can really help clarify for patients what their trauma responses are and how to start treatments that actually fit their symptoms.”

The subjects had a mean 0.3 psychiatric encounters in the year before joining the program and 0.2 in the year after (P < .01). Their mean emergency department visits related to mental health fell from 0.5 to 0.3 (P = .03).

The study has limitations. Participants took part in IOP therapy from 2017 to 2018, before the pandemic disrupted mental health treatment. It does not examine whether medication use changed after IOP treatment. It is retrospective and doesn’t confirm that IOP had any positive effect.
 

Multiple benefits of IOP

In an interview, Deborah C. Beidel, PhD, director of UCF RESTORES at the University of Central Florida, Orlando, said IOP has several advantages as a treatment for PTSD. Her clinic, which focuses on PTSD treatment for military veterans, has used the approach to treat hundreds of people.

“First, IOPs can address the stigma that surrounds mental health treatment. If you have a physical injury, you take time off from work to go to physical therapy, which is time-limited. If you have a stress injury, why not do the same? Take a few weeks, get it treated, and get back to work,” she said. “The second reason is that the most effective treatment for PTSD is exposure therapy, which is more effective when treatment sessions occur in a daily as opposed to a weekly or monthly time frame. Third, from a cost and feasibility perspective, an intensive program could reduce overall medical costs and get people back to work sooner.”

The new study is “definitely useful” since it examines the impact of IOP over a longer term, Dr. Beidel said. This kind of data “can influence policy, particularly with insurance companies. If we can build the evidence that short, intensive treatment produces better long-term outcomes, insurance companies will be more likely to pay for the IOP.”

The University of Central Florida program is funded by federal research grants and state funding, she said. “When we calculate the cost, it comes to about $10,000 in therapy time plus an average of about $3,000 in travel related costs – transportation, lodging, meals – for those who travel from out of state for our program.”

What’s next? “Further study is needed to characterize whether these findings are applicable to other practice settings, including virtual treatment programs; the long-term durability of these findings; and whether similar patterns of reduced resource use extend to non–mental health–specific care utilization,” said Dr. Lingafelter, the study’s lead author.

No study funding and no author disclosures were reported. Dr. Beidel disclosed IOP-related research support from the U.S. Army Medical Research and Development Command–Military Operational Medicine Research Program.

NEW ORLEANS – Adult patients who completed an intensive outpatient program (IOP) for post-traumatic stress disorder were significantly less likely over the following year to require inpatient or emergency psychiatric treatment, according to a new study released at the annual meeting of the American Psychiatric Association.

In an analysis of 256 individuals, over the 12 months before they joined the IOP, 28.7% and 24.8% had inpatient and emergency department encounters, respectively, according to the researchers. Afterward, those numbers fell to 15.9% (P < .01) and 18.2% (P = .04), respectively.

“Engagement in IOP for patients with PTSD may help avoid the need for higher levels of care such as residential or inpatient treatment,” Nathan Lingafelter, MD, a psychiatrist and researcher at Kaiser Permanente in Oakland, Calif., said in an interview.

Dr. Lingafelter described IOP programs as typically “offering patients a combination of individual therapy, group therapy, and medication management all at an increased frequency of about 3 half-days per week. IOPs are thought to be helpful in helping patients with severe symptoms while they are still in the community – i.e., living in their homes, with their families, occasionally still working at reduced time.”

While other studies have examined the effects of IOP, “the existing literature focuses on how IOP reduces symptoms, rather than looking at how IOP involvement might be associated with patients utilizing different acute care resources,” he said. “Prior studies have also been conducted mostly in veteran populations and in populations with less diversity than our population in Oakland.”

For the new study, researchers tracked 256 IOP participants (83% female; mean age = 39; 44% White, 27% Black, 14% Hispanic, and 7% Asian). The wide majority – 85% – had comorbid depressive disorders.

“Patients are assigned a case manager when they enter the program who they can meet with individually, and they spend time attending group therapy sessions. Patients are also able to meet with a psychiatrist to discuss medications,” Dr. Lingafelter said. “A major component in both the group and individual therapy is helping patients identify which kind of interventions work for them and what we can do now that will help. IOP can really help clarify for patients what their trauma responses are and how to start treatments that actually fit their symptoms.”

The subjects had a mean 0.3 psychiatric encounters in the year before joining the program and 0.2 in the year after (P < .01). Their mean emergency department visits related to mental health fell from 0.5 to 0.3 (P = .03).

The study has limitations. Participants took part in IOP therapy from 2017 to 2018, before the pandemic disrupted mental health treatment. It does not examine whether medication use changed after IOP treatment. It is retrospective and doesn’t confirm that IOP had any positive effect.
 

Multiple benefits of IOP

In an interview, Deborah C. Beidel, PhD, director of UCF RESTORES at the University of Central Florida, Orlando, said IOP has several advantages as a treatment for PTSD. Her clinic, which focuses on PTSD treatment for military veterans, has used the approach to treat hundreds of people.

“First, IOPs can address the stigma that surrounds mental health treatment. If you have a physical injury, you take time off from work to go to physical therapy, which is time-limited. If you have a stress injury, why not do the same? Take a few weeks, get it treated, and get back to work,” she said. “The second reason is that the most effective treatment for PTSD is exposure therapy, which is more effective when treatment sessions occur in a daily as opposed to a weekly or monthly time frame. Third, from a cost and feasibility perspective, an intensive program could reduce overall medical costs and get people back to work sooner.”

The new study is “definitely useful” since it examines the impact of IOP over a longer term, Dr. Beidel said. This kind of data “can influence policy, particularly with insurance companies. If we can build the evidence that short, intensive treatment produces better long-term outcomes, insurance companies will be more likely to pay for the IOP.”

The University of Central Florida program is funded by federal research grants and state funding, she said. “When we calculate the cost, it comes to about $10,000 in therapy time plus an average of about $3,000 in travel related costs – transportation, lodging, meals – for those who travel from out of state for our program.”

What’s next? “Further study is needed to characterize whether these findings are applicable to other practice settings, including virtual treatment programs; the long-term durability of these findings; and whether similar patterns of reduced resource use extend to non–mental health–specific care utilization,” said Dr. Lingafelter, the study’s lead author.

No study funding and no author disclosures were reported. Dr. Beidel disclosed IOP-related research support from the U.S. Army Medical Research and Development Command–Military Operational Medicine Research Program.

As the number of people reporting persistent, and sometimes debilitating, symptoms from COVID-19 increases, researchers have struggled to pinpoint exactly how common so-called “long COVID” is, as well as how to clearly define exactly who has it or who is likely to get it.

Now, Centers for Disease Control and Prevention researchers have concluded that one in five adults aged 18 and older have at least one health condition that might be related to their previous COVID-19 illness; that number goes up to one in four among those 65 and older. Their data was published in the CDC’s Morbidity and Mortality Weekly Report.

The conditions associated with what’s been officially termed postacute sequelae of COVID-19, or PASC, include kidney failure, blood clots, other vascular issues, respiratory issues, heart problems, mental health or neurologic problems, and musculoskeletal conditions. But none of those conditions is unique to long COVID.

Another new study, published in The Lancet Digital Health, is trying to help better characterize what long COVID is, and what it isn’t.

The research team, supported by the National Institutes of Health, used machine learning techniques to analyze electronic health record data to identify new information about long COVID and detect patterns that could help identify those likely to develop it.
 

CDC data

The CDC team came to its conclusions by evaluating the EHRs of more than 353,000 adults who were diagnosed with COVID-19 or got a positive test result, then comparing those records with 1.6 million patients who had a medical visit in the same month without a positive test result or a COVID-19 diagnosis.

They looked at data from March 2020 to November 2021, tagging 26 conditions often linked to post-COVID issues.

Overall, more than 38% of the COVID patients and 16% of those without COVID had at least one of these 26 conditions. They assessed the absolute risk difference between the patients and the non-COVID patients who developed one of the conditions, finding a 20.8–percentage point difference for those 18-64, yielding the one in five figure, and a 26.9–percentage point difference for those 65 and above, translating to about one in four.

“These findings suggest the need for increased awareness for post-COVID conditions so that improved post-COVID care and management of patients who survived COVID-19 can be developed and implemented,” said study author Lara Bull-Otterson, PhD, MPH, colead of data analytics at the Healthcare Data Advisory Unit of the CDC.
 

Pinpointing long COVID characteristics

Long COVID is difficult to identify, because many of its symptoms are similar to those of other conditions, so researchers are looking for better ways to characterize it to help improve both diagnosis and treatment.

Researchers on the Lancet study evaluated data from the National COVID Cohort Collaborative, N3C, a national NIH database that includes information from more than 8 million people. The team looked at the health records of 98,000 adult COVID patients and used that information, along with data from about nearly 600 long-COVID patients treated at three long-COVID clinics, to create three machine learning models for identifying long-COVID patients.

The models aimed to identify long-COVID patients in three groups: all patients, those hospitalized with COVID, and those with COVID but not hospitalized. The models were judged by the researchers to be accurate because those identified at risk for long COVID from the database were similar to those actually treated for long COVID at the clinics.

“Our algorithm is not intended to diagnose long COVID,” said lead author Emily Pfaff, PhD, research assistant professor of medicine at the University of North Carolina at Chapel Hill. “Rather, it is intended to identify patients in EHR data who ‘look like’ patients seen by physicians for long COVID.’’

Next, the researchers say, they will incorporate the new patterns they found with a diagnosis code for COVID and include it in the models to further test their accuracy. The models could also be used to help recruit patients for clinical trials, the researchers say.
 

Perspective and caveats

The figures of one in five and one in four found by the CDC researchers don’t surprise David Putrino, PT, PhD, director of rehabilitation innovation for Mount Sinai Health System in New York and director of its Abilities Research Center, which cares for long-COVID patients.

“Those numbers are high and it’s alarming,” he said. “But we’ve been sounding the alarm for quite some time, and we’ve been assuming that about one in five end up with long COVID.”

He does see a limitation to the CDC research – that some symptoms could have emerged later, and some in the control group could have had an undiagnosed COVID infection and gone on to develop long COVID.

As for machine learning, “this is something we need to approach with caution,” Dr. Putrino said. “There are a lot of variables we don’t understand about long COVID,’’ and that could result in spurious conclusions.

“Although I am supportive of this work going on, I am saying, ‘Scrutinize the tools with a grain of salt.’ Electronic records, Dr. Putrino points out, include information that the doctors enter, not what the patient says.

Dr. Pfaff responds: “It is entirely appropriate to approach both machine learning and EHR data with relevant caveats in mind. There are many clinical factors that are not recorded in the EHR, and the EHR is not representative of all persons with long COVID.” Those data can only reflect those who seek care for a condition, a natural limitation.

When it comes to algorithms, they are limited by data they have access to, such as the electronic health records in this research. However, the immense size and diversity in the data used “does allow us to make some assertations with much more confidence than if we were using data from a single or small number of health care systems,” she said.

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

As the number of people reporting persistent, and sometimes debilitating, symptoms from COVID-19 increases, researchers have struggled to pinpoint exactly how common so-called “long COVID” is, as well as how to clearly define exactly who has it or who is likely to get it.

Now, Centers for Disease Control and Prevention researchers have concluded that one in five adults aged 18 and older have at least one health condition that might be related to their previous COVID-19 illness; that number goes up to one in four among those 65 and older. Their data was published in the CDC’s Morbidity and Mortality Weekly Report.

The conditions associated with what’s been officially termed postacute sequelae of COVID-19, or PASC, include kidney failure, blood clots, other vascular issues, respiratory issues, heart problems, mental health or neurologic problems, and musculoskeletal conditions. But none of those conditions is unique to long COVID.

Another new study, published in The Lancet Digital Health, is trying to help better characterize what long COVID is, and what it isn’t.

The research team, supported by the National Institutes of Health, used machine learning techniques to analyze electronic health record data to identify new information about long COVID and detect patterns that could help identify those likely to develop it.
 

CDC data

The CDC team came to its conclusions by evaluating the EHRs of more than 353,000 adults who were diagnosed with COVID-19 or got a positive test result, then comparing those records with 1.6 million patients who had a medical visit in the same month without a positive test result or a COVID-19 diagnosis.

They looked at data from March 2020 to November 2021, tagging 26 conditions often linked to post-COVID issues.

Overall, more than 38% of the COVID patients and 16% of those without COVID had at least one of these 26 conditions. They assessed the absolute risk difference between the patients and the non-COVID patients who developed one of the conditions, finding a 20.8–percentage point difference for those 18-64, yielding the one in five figure, and a 26.9–percentage point difference for those 65 and above, translating to about one in four.

“These findings suggest the need for increased awareness for post-COVID conditions so that improved post-COVID care and management of patients who survived COVID-19 can be developed and implemented,” said study author Lara Bull-Otterson, PhD, MPH, colead of data analytics at the Healthcare Data Advisory Unit of the CDC.
 

Pinpointing long COVID characteristics

Long COVID is difficult to identify, because many of its symptoms are similar to those of other conditions, so researchers are looking for better ways to characterize it to help improve both diagnosis and treatment.

Researchers on the Lancet study evaluated data from the National COVID Cohort Collaborative, N3C, a national NIH database that includes information from more than 8 million people. The team looked at the health records of 98,000 adult COVID patients and used that information, along with data from about nearly 600 long-COVID patients treated at three long-COVID clinics, to create three machine learning models for identifying long-COVID patients.

The models aimed to identify long-COVID patients in three groups: all patients, those hospitalized with COVID, and those with COVID but not hospitalized. The models were judged by the researchers to be accurate because those identified at risk for long COVID from the database were similar to those actually treated for long COVID at the clinics.

“Our algorithm is not intended to diagnose long COVID,” said lead author Emily Pfaff, PhD, research assistant professor of medicine at the University of North Carolina at Chapel Hill. “Rather, it is intended to identify patients in EHR data who ‘look like’ patients seen by physicians for long COVID.’’

Next, the researchers say, they will incorporate the new patterns they found with a diagnosis code for COVID and include it in the models to further test their accuracy. The models could also be used to help recruit patients for clinical trials, the researchers say.
 

Perspective and caveats

The figures of one in five and one in four found by the CDC researchers don’t surprise David Putrino, PT, PhD, director of rehabilitation innovation for Mount Sinai Health System in New York and director of its Abilities Research Center, which cares for long-COVID patients.

“Those numbers are high and it’s alarming,” he said. “But we’ve been sounding the alarm for quite some time, and we’ve been assuming that about one in five end up with long COVID.”

He does see a limitation to the CDC research – that some symptoms could have emerged later, and some in the control group could have had an undiagnosed COVID infection and gone on to develop long COVID.

As for machine learning, “this is something we need to approach with caution,” Dr. Putrino said. “There are a lot of variables we don’t understand about long COVID,’’ and that could result in spurious conclusions.

“Although I am supportive of this work going on, I am saying, ‘Scrutinize the tools with a grain of salt.’ Electronic records, Dr. Putrino points out, include information that the doctors enter, not what the patient says.

Dr. Pfaff responds: “It is entirely appropriate to approach both machine learning and EHR data with relevant caveats in mind. There are many clinical factors that are not recorded in the EHR, and the EHR is not representative of all persons with long COVID.” Those data can only reflect those who seek care for a condition, a natural limitation.

When it comes to algorithms, they are limited by data they have access to, such as the electronic health records in this research. However, the immense size and diversity in the data used “does allow us to make some assertations with much more confidence than if we were using data from a single or small number of health care systems,” she said.

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

As the number of people reporting persistent, and sometimes debilitating, symptoms from COVID-19 increases, researchers have struggled to pinpoint exactly how common so-called “long COVID” is, as well as how to clearly define exactly who has it or who is likely to get it.

Now, Centers for Disease Control and Prevention researchers have concluded that one in five adults aged 18 and older have at least one health condition that might be related to their previous COVID-19 illness; that number goes up to one in four among those 65 and older. Their data was published in the CDC’s Morbidity and Mortality Weekly Report.

The conditions associated with what’s been officially termed postacute sequelae of COVID-19, or PASC, include kidney failure, blood clots, other vascular issues, respiratory issues, heart problems, mental health or neurologic problems, and musculoskeletal conditions. But none of those conditions is unique to long COVID.

Another new study, published in The Lancet Digital Health, is trying to help better characterize what long COVID is, and what it isn’t.

The research team, supported by the National Institutes of Health, used machine learning techniques to analyze electronic health record data to identify new information about long COVID and detect patterns that could help identify those likely to develop it.
 

CDC data

The CDC team came to its conclusions by evaluating the EHRs of more than 353,000 adults who were diagnosed with COVID-19 or got a positive test result, then comparing those records with 1.6 million patients who had a medical visit in the same month without a positive test result or a COVID-19 diagnosis.

They looked at data from March 2020 to November 2021, tagging 26 conditions often linked to post-COVID issues.

Overall, more than 38% of the COVID patients and 16% of those without COVID had at least one of these 26 conditions. They assessed the absolute risk difference between the patients and the non-COVID patients who developed one of the conditions, finding a 20.8–percentage point difference for those 18-64, yielding the one in five figure, and a 26.9–percentage point difference for those 65 and above, translating to about one in four.

“These findings suggest the need for increased awareness for post-COVID conditions so that improved post-COVID care and management of patients who survived COVID-19 can be developed and implemented,” said study author Lara Bull-Otterson, PhD, MPH, colead of data analytics at the Healthcare Data Advisory Unit of the CDC.
 

Pinpointing long COVID characteristics

Long COVID is difficult to identify, because many of its symptoms are similar to those of other conditions, so researchers are looking for better ways to characterize it to help improve both diagnosis and treatment.

Researchers on the Lancet study evaluated data from the National COVID Cohort Collaborative, N3C, a national NIH database that includes information from more than 8 million people. The team looked at the health records of 98,000 adult COVID patients and used that information, along with data from about nearly 600 long-COVID patients treated at three long-COVID clinics, to create three machine learning models for identifying long-COVID patients.

The models aimed to identify long-COVID patients in three groups: all patients, those hospitalized with COVID, and those with COVID but not hospitalized. The models were judged by the researchers to be accurate because those identified at risk for long COVID from the database were similar to those actually treated for long COVID at the clinics.

“Our algorithm is not intended to diagnose long COVID,” said lead author Emily Pfaff, PhD, research assistant professor of medicine at the University of North Carolina at Chapel Hill. “Rather, it is intended to identify patients in EHR data who ‘look like’ patients seen by physicians for long COVID.’’

Next, the researchers say, they will incorporate the new patterns they found with a diagnosis code for COVID and include it in the models to further test their accuracy. The models could also be used to help recruit patients for clinical trials, the researchers say.
 

Perspective and caveats

The figures of one in five and one in four found by the CDC researchers don’t surprise David Putrino, PT, PhD, director of rehabilitation innovation for Mount Sinai Health System in New York and director of its Abilities Research Center, which cares for long-COVID patients.

“Those numbers are high and it’s alarming,” he said. “But we’ve been sounding the alarm for quite some time, and we’ve been assuming that about one in five end up with long COVID.”

He does see a limitation to the CDC research – that some symptoms could have emerged later, and some in the control group could have had an undiagnosed COVID infection and gone on to develop long COVID.

As for machine learning, “this is something we need to approach with caution,” Dr. Putrino said. “There are a lot of variables we don’t understand about long COVID,’’ and that could result in spurious conclusions.

“Although I am supportive of this work going on, I am saying, ‘Scrutinize the tools with a grain of salt.’ Electronic records, Dr. Putrino points out, include information that the doctors enter, not what the patient says.

Dr. Pfaff responds: “It is entirely appropriate to approach both machine learning and EHR data with relevant caveats in mind. There are many clinical factors that are not recorded in the EHR, and the EHR is not representative of all persons with long COVID.” Those data can only reflect those who seek care for a condition, a natural limitation.

When it comes to algorithms, they are limited by data they have access to, such as the electronic health records in this research. However, the immense size and diversity in the data used “does allow us to make some assertations with much more confidence than if we were using data from a single or small number of health care systems,” she said.

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

To the Editor:

Albendazole is a commonly prescribed anthelmintic that typically is well tolerated. Its broadest application is in developing countries that have a high rate of endemic nematode infection.^1,2 Albendazole belongs to the benzimidazole class of anthelmintic chemotherapeutic agents that function by inhibiting microtubule dynamics, resulting in cytotoxic antimitotic effects.³ Benzimidazoles (eg, albendazole, mebendazole) have a binding affinity for helminthic β-tubulin that is 25- to 400-times greater than their binding affinity for the mammalian counterpart.⁴ Consequently, benzimidazoles generally are afforded a very broad therapeutic index for helminthic infection.

A 53-year-old man presented to the emergency department (ED) after an episode of syncope and sudden hair loss. At presentation he had a fever (temperature, 103 °F [39.4 °C]), a heart rate of 120 bpm, and pancytopenia (white blood cell count, 0.4×10³/μL [reference range, 4.0–10.0×10³/μL]; hemoglobin, 7.0 g/dL [reference range, 11.2–15.7 g/dL]; platelet count, 100×10³/μL [reference range, 150–400×10³/μL]). A toxicology screen was positive for cocaine, opiates, and benzodiazepines. The blood alcohol concentration was 126 mg/dL.

The patient reported severe gastrointestinal (GI) distress and diarrhea for the last year as well as a 25-lb weight loss. He discussed his belief that his GI symptoms were due to a parasite he had acquired the year prior; however, he reported that an exhaustive outpatient GI workup had been negative. Two weeks before presentation to our ED, the patient presented to another ED with stomach upset and was given a dose of albendazole. Perceiving alleviation of his symptoms, he purchased 2 bottles of veterinary albendazole online and consumed 113,000 mg—approximately 300 times the standard dose of 400 mg.

A dermatologic examination in our ED demonstrated reticulated violaceous patches on the face and severe alopecia with preferential sparing of the occipital scalp (Figure 1). Photographs taken by the patient on his phone from a week prior to presentation showed no facial dyschromia or signs of hair loss. A punch biopsy of the chin demonstrated perivascular and perifollicular dermatitis with eosinophils, most consistent with a drug reaction.

To the Editor:

Albendazole is a commonly prescribed anthelmintic that typically is well tolerated. Its broadest application is in developing countries that have a high rate of endemic nematode infection.^1,2 Albendazole belongs to the benzimidazole class of anthelmintic chemotherapeutic agents that function by inhibiting microtubule dynamics, resulting in cytotoxic antimitotic effects.³ Benzimidazoles (eg, albendazole, mebendazole) have a binding affinity for helminthic β-tubulin that is 25- to 400-times greater than their binding affinity for the mammalian counterpart.⁴ Consequently, benzimidazoles generally are afforded a very broad therapeutic index for helminthic infection.

A 53-year-old man presented to the emergency department (ED) after an episode of syncope and sudden hair loss. At presentation he had a fever (temperature, 103 °F [39.4 °C]), a heart rate of 120 bpm, and pancytopenia (white blood cell count, 0.4×10³/μL [reference range, 4.0–10.0×10³/μL]; hemoglobin, 7.0 g/dL [reference range, 11.2–15.7 g/dL]; platelet count, 100×10³/μL [reference range, 150–400×10³/μL]). A toxicology screen was positive for cocaine, opiates, and benzodiazepines. The blood alcohol concentration was 126 mg/dL.

The patient reported severe gastrointestinal (GI) distress and diarrhea for the last year as well as a 25-lb weight loss. He discussed his belief that his GI symptoms were due to a parasite he had acquired the year prior; however, he reported that an exhaustive outpatient GI workup had been negative. Two weeks before presentation to our ED, the patient presented to another ED with stomach upset and was given a dose of albendazole. Perceiving alleviation of his symptoms, he purchased 2 bottles of veterinary albendazole online and consumed 113,000 mg—approximately 300 times the standard dose of 400 mg.

A dermatologic examination in our ED demonstrated reticulated violaceous patches on the face and severe alopecia with preferential sparing of the occipital scalp (Figure 1). Photographs taken by the patient on his phone from a week prior to presentation showed no facial dyschromia or signs of hair loss. A punch biopsy of the chin demonstrated perivascular and perifollicular dermatitis with eosinophils, most consistent with a drug reaction.

To the Editor:

Albendazole is a commonly prescribed anthelmintic that typically is well tolerated. Its broadest application is in developing countries that have a high rate of endemic nematode infection.^1,2 Albendazole belongs to the benzimidazole class of anthelmintic chemotherapeutic agents that function by inhibiting microtubule dynamics, resulting in cytotoxic antimitotic effects.³ Benzimidazoles (eg, albendazole, mebendazole) have a binding affinity for helminthic β-tubulin that is 25- to 400-times greater than their binding affinity for the mammalian counterpart.⁴ Consequently, benzimidazoles generally are afforded a very broad therapeutic index for helminthic infection.

A 53-year-old man presented to the emergency department (ED) after an episode of syncope and sudden hair loss. At presentation he had a fever (temperature, 103 °F [39.4 °C]), a heart rate of 120 bpm, and pancytopenia (white blood cell count, 0.4×10³/μL [reference range, 4.0–10.0×10³/μL]; hemoglobin, 7.0 g/dL [reference range, 11.2–15.7 g/dL]; platelet count, 100×10³/μL [reference range, 150–400×10³/μL]). A toxicology screen was positive for cocaine, opiates, and benzodiazepines. The blood alcohol concentration was 126 mg/dL.

The patient reported severe gastrointestinal (GI) distress and diarrhea for the last year as well as a 25-lb weight loss. He discussed his belief that his GI symptoms were due to a parasite he had acquired the year prior; however, he reported that an exhaustive outpatient GI workup had been negative. Two weeks before presentation to our ED, the patient presented to another ED with stomach upset and was given a dose of albendazole. Perceiving alleviation of his symptoms, he purchased 2 bottles of veterinary albendazole online and consumed 113,000 mg—approximately 300 times the standard dose of 400 mg.

A dermatologic examination in our ED demonstrated reticulated violaceous patches on the face and severe alopecia with preferential sparing of the occipital scalp (Figure 1). Photographs taken by the patient on his phone from a week prior to presentation showed no facial dyschromia or signs of hair loss. A punch biopsy of the chin demonstrated perivascular and perifollicular dermatitis with eosinophils, most consistent with a drug reaction.

A 5-year cervical screening interval is as safe and effective for women who test negative for human papillomavirus (HPV) as are 3-year intervals, according to a new ‘real life’ study led by King’s College London (KCL) with researchers from the University of Manchester, and the NHS, on behalf of the HPV pilot steering group.

The study, published in The BMJ, used data from the HPV screening pilot to assess rates of detection of high-grade cervical intraepithelial neoplasia (CIN3+) and of cervical cancer following a negative HPV test. It confirmed that 5-yearly screening prevents as many cancers as screening at 3-year intervals, even in women who are not vaccinated against HPV.
 

Change to primary HPV testing since 2019 

Before 2019, the NHS cervical screening program conducted cytology testing first, testing for HPV only if abnormalities were found. In 2019, following reporting of early results of the HPV pilot by the same researchers, the program in England switched to testing for HPV first, on the grounds that since having HPV infection comes before having abnormal cells, HPV testing would detect more women at risk of cervical cancer.

Following the switch to primary HPV testing, the same screening intervals were retained, meaning 3-yearly screening for those aged 24-49 years and testing every 5 years for women aged 50-64 years, or 3 years if they tested positive. However, the National Screening Committee had recommended that invites should be changed from 3 to 5 years for those in the under-50 age group found not to have high-risk HPV at their routine screening test.

For the latest study, funded by Cancer Research UK, the steering group researchers analyzed details for more than 1.3 million women who had attended screening for two rounds of the HPV screening pilot, the first from 2013 to 2016, with a follow-up to the end of 2019. By this time, the data set had doubled in size from the pilot study, and results had been linked with the national cancer registry.

They confirmed that HPV testing was more accurate than a cytology test, irrespective of whether the HPV test assay was DNA- or mRNA-based. With HPV testing, the risk of subsequent cytological changes more than halved overall. Eligible women under 50 who had a negative HPV screen in the first round had a much lower risk of detection of CIN3+ in the second round, with a rate of 1.21 in 1,000, compared with 4.52 in 1,000 after a negative cytology test.
 

Data support extension of the testing interval

“The study confirms that women in this age group are much less likely to develop clinically relevant cervical lesions and cervical cancer, 3 years after a negative HPV screen, compared with a negative smear test,” the researchers said.

They suggested that most women do not need to be screened as frequently as the current program allows, and that the data support an extension of the screening intervals, regardless of the test assay used, to 5 years after a negative HPV test in women aged 25-49 years, and even longer for women aged 50 years and older.

However, the screening interval for HPV-positive women who have negative HPV tests at early recall should be kept at 3 years, they said.

“These results are very reassuring,” said lead author Matejka Rebolj, PhD, senior epidemiologist at KCL. “They build on previous research that shows that following the introduction of HPV testing for cervical screening, a 5-year interval is at least as safe as the previous 3-year interval. Changing to 5-yearly screening will mean we can prevent just as many cancers as before, while allowing for fewer screens.”

Michelle Mitchell, Cancer Research UK’s chief executive, said: “This large study shows that offering cervical screening using HPV testing effectively prevents cervical cancer, without having to be screened as often. This builds on findings from years of research showing HPV testing is more accurate at predicting who is at risk of developing cervical cancer compared to the previous way of testing. As changes to the screening [programs] are made, they will be monitored to help ensure that cervical screening is as effective as possible for all who take part.”
 

If HPV is present, testing interval should remain every 3 years

Responding to the study, Theresa Freeman-Wang, MBChB, consultant gynecologist, president of the British Society for Colposcopy and Cervical Pathology, and spokesperson for the Royal College of Obstetricians and Gynaecologists, told this news organization: “England, Scotland, and Wales and many other countries now use HPV primary screening, which is much better at assessing risk than previous methods. HPV testing is more sensitive and accurate, so changes are picked up earlier.

“Studies have confirmed that if someone is HPV negative (i.e., HPV is not present in the screen test), intervals between tests can very safely be increased from 3 to 5 years. 

“If HPV is present, then the program will automatically look for any abnormal cells. If there are no abnormalities, the woman will be advised to have a repeat screen test in a year. If the HPV remains present over 3 successive years or if abnormal cells are detected at any stage, she will be referred for a more detailed screening examination called a colposcopy.

“It’s important that with any change like this, there is clear information available to explain what these changes mean.

“We have an effective cervical screening program in the UK that has significantly reduced the number of cases and deaths from this preventable cancer. 

“HPV screening every 5 years is safe and to be fully effective it is vital that women take up the invitation for cervical screening when called.”

A version of this article first appeared on Medscape UK.

A 5-year cervical screening interval is as safe and effective for women who test negative for human papillomavirus (HPV) as are 3-year intervals, according to a new ‘real life’ study led by King’s College London (KCL) with researchers from the University of Manchester, and the NHS, on behalf of the HPV pilot steering group.

The study, published in The BMJ, used data from the HPV screening pilot to assess rates of detection of high-grade cervical intraepithelial neoplasia (CIN3+) and of cervical cancer following a negative HPV test. It confirmed that 5-yearly screening prevents as many cancers as screening at 3-year intervals, even in women who are not vaccinated against HPV.
 

Change to primary HPV testing since 2019 

Before 2019, the NHS cervical screening program conducted cytology testing first, testing for HPV only if abnormalities were found. In 2019, following reporting of early results of the HPV pilot by the same researchers, the program in England switched to testing for HPV first, on the grounds that since having HPV infection comes before having abnormal cells, HPV testing would detect more women at risk of cervical cancer.

Following the switch to primary HPV testing, the same screening intervals were retained, meaning 3-yearly screening for those aged 24-49 years and testing every 5 years for women aged 50-64 years, or 3 years if they tested positive. However, the National Screening Committee had recommended that invites should be changed from 3 to 5 years for those in the under-50 age group found not to have high-risk HPV at their routine screening test.

For the latest study, funded by Cancer Research UK, the steering group researchers analyzed details for more than 1.3 million women who had attended screening for two rounds of the HPV screening pilot, the first from 2013 to 2016, with a follow-up to the end of 2019. By this time, the data set had doubled in size from the pilot study, and results had been linked with the national cancer registry.

They confirmed that HPV testing was more accurate than a cytology test, irrespective of whether the HPV test assay was DNA- or mRNA-based. With HPV testing, the risk of subsequent cytological changes more than halved overall. Eligible women under 50 who had a negative HPV screen in the first round had a much lower risk of detection of CIN3+ in the second round, with a rate of 1.21 in 1,000, compared with 4.52 in 1,000 after a negative cytology test.
 

Data support extension of the testing interval

“The study confirms that women in this age group are much less likely to develop clinically relevant cervical lesions and cervical cancer, 3 years after a negative HPV screen, compared with a negative smear test,” the researchers said.

They suggested that most women do not need to be screened as frequently as the current program allows, and that the data support an extension of the screening intervals, regardless of the test assay used, to 5 years after a negative HPV test in women aged 25-49 years, and even longer for women aged 50 years and older.

However, the screening interval for HPV-positive women who have negative HPV tests at early recall should be kept at 3 years, they said.

“These results are very reassuring,” said lead author Matejka Rebolj, PhD, senior epidemiologist at KCL. “They build on previous research that shows that following the introduction of HPV testing for cervical screening, a 5-year interval is at least as safe as the previous 3-year interval. Changing to 5-yearly screening will mean we can prevent just as many cancers as before, while allowing for fewer screens.”

Michelle Mitchell, Cancer Research UK’s chief executive, said: “This large study shows that offering cervical screening using HPV testing effectively prevents cervical cancer, without having to be screened as often. This builds on findings from years of research showing HPV testing is more accurate at predicting who is at risk of developing cervical cancer compared to the previous way of testing. As changes to the screening [programs] are made, they will be monitored to help ensure that cervical screening is as effective as possible for all who take part.”
 

If HPV is present, testing interval should remain every 3 years

Responding to the study, Theresa Freeman-Wang, MBChB, consultant gynecologist, president of the British Society for Colposcopy and Cervical Pathology, and spokesperson for the Royal College of Obstetricians and Gynaecologists, told this news organization: “England, Scotland, and Wales and many other countries now use HPV primary screening, which is much better at assessing risk than previous methods. HPV testing is more sensitive and accurate, so changes are picked up earlier.

“Studies have confirmed that if someone is HPV negative (i.e., HPV is not present in the screen test), intervals between tests can very safely be increased from 3 to 5 years. 

“If HPV is present, then the program will automatically look for any abnormal cells. If there are no abnormalities, the woman will be advised to have a repeat screen test in a year. If the HPV remains present over 3 successive years or if abnormal cells are detected at any stage, she will be referred for a more detailed screening examination called a colposcopy.

“It’s important that with any change like this, there is clear information available to explain what these changes mean.

“We have an effective cervical screening program in the UK that has significantly reduced the number of cases and deaths from this preventable cancer. 

“HPV screening every 5 years is safe and to be fully effective it is vital that women take up the invitation for cervical screening when called.”

A version of this article first appeared on Medscape UK.

A 5-year cervical screening interval is as safe and effective for women who test negative for human papillomavirus (HPV) as are 3-year intervals, according to a new ‘real life’ study led by King’s College London (KCL) with researchers from the University of Manchester, and the NHS, on behalf of the HPV pilot steering group.

The study, published in The BMJ, used data from the HPV screening pilot to assess rates of detection of high-grade cervical intraepithelial neoplasia (CIN3+) and of cervical cancer following a negative HPV test. It confirmed that 5-yearly screening prevents as many cancers as screening at 3-year intervals, even in women who are not vaccinated against HPV.
 

Change to primary HPV testing since 2019 

Before 2019, the NHS cervical screening program conducted cytology testing first, testing for HPV only if abnormalities were found. In 2019, following reporting of early results of the HPV pilot by the same researchers, the program in England switched to testing for HPV first, on the grounds that since having HPV infection comes before having abnormal cells, HPV testing would detect more women at risk of cervical cancer.

Following the switch to primary HPV testing, the same screening intervals were retained, meaning 3-yearly screening for those aged 24-49 years and testing every 5 years for women aged 50-64 years, or 3 years if they tested positive. However, the National Screening Committee had recommended that invites should be changed from 3 to 5 years for those in the under-50 age group found not to have high-risk HPV at their routine screening test.

For the latest study, funded by Cancer Research UK, the steering group researchers analyzed details for more than 1.3 million women who had attended screening for two rounds of the HPV screening pilot, the first from 2013 to 2016, with a follow-up to the end of 2019. By this time, the data set had doubled in size from the pilot study, and results had been linked with the national cancer registry.

They confirmed that HPV testing was more accurate than a cytology test, irrespective of whether the HPV test assay was DNA- or mRNA-based. With HPV testing, the risk of subsequent cytological changes more than halved overall. Eligible women under 50 who had a negative HPV screen in the first round had a much lower risk of detection of CIN3+ in the second round, with a rate of 1.21 in 1,000, compared with 4.52 in 1,000 after a negative cytology test.
 

Data support extension of the testing interval

“The study confirms that women in this age group are much less likely to develop clinically relevant cervical lesions and cervical cancer, 3 years after a negative HPV screen, compared with a negative smear test,” the researchers said.

They suggested that most women do not need to be screened as frequently as the current program allows, and that the data support an extension of the screening intervals, regardless of the test assay used, to 5 years after a negative HPV test in women aged 25-49 years, and even longer for women aged 50 years and older.

However, the screening interval for HPV-positive women who have negative HPV tests at early recall should be kept at 3 years, they said.

“These results are very reassuring,” said lead author Matejka Rebolj, PhD, senior epidemiologist at KCL. “They build on previous research that shows that following the introduction of HPV testing for cervical screening, a 5-year interval is at least as safe as the previous 3-year interval. Changing to 5-yearly screening will mean we can prevent just as many cancers as before, while allowing for fewer screens.”

Michelle Mitchell, Cancer Research UK’s chief executive, said: “This large study shows that offering cervical screening using HPV testing effectively prevents cervical cancer, without having to be screened as often. This builds on findings from years of research showing HPV testing is more accurate at predicting who is at risk of developing cervical cancer compared to the previous way of testing. As changes to the screening [programs] are made, they will be monitored to help ensure that cervical screening is as effective as possible for all who take part.”
 

If HPV is present, testing interval should remain every 3 years

Responding to the study, Theresa Freeman-Wang, MBChB, consultant gynecologist, president of the British Society for Colposcopy and Cervical Pathology, and spokesperson for the Royal College of Obstetricians and Gynaecologists, told this news organization: “England, Scotland, and Wales and many other countries now use HPV primary screening, which is much better at assessing risk than previous methods. HPV testing is more sensitive and accurate, so changes are picked up earlier.

“Studies have confirmed that if someone is HPV negative (i.e., HPV is not present in the screen test), intervals between tests can very safely be increased from 3 to 5 years. 

“If HPV is present, then the program will automatically look for any abnormal cells. If there are no abnormalities, the woman will be advised to have a repeat screen test in a year. If the HPV remains present over 3 successive years or if abnormal cells are detected at any stage, she will be referred for a more detailed screening examination called a colposcopy.

“It’s important that with any change like this, there is clear information available to explain what these changes mean.

“We have an effective cervical screening program in the UK that has significantly reduced the number of cases and deaths from this preventable cancer. 

“HPV screening every 5 years is safe and to be fully effective it is vital that women take up the invitation for cervical screening when called.”

A version of this article first appeared on Medscape UK.

To the Editor:

A 59-year-old man was referred to our clinic for a rash, fever, and night sweats following treatment for metastatic seminoma with cisplatin and etoposide. Physical examination revealed indurated erythematous papules and plaques on the trunk and upper and lower extremities, some with annular or arcuate configuration with trailing scale (Figure, A). A skin biopsy demonstrated mild papillary dermal edema with a mixed infiltrate of mononuclear cells, neutrophils, eosinophils, mast cells, lymphocytes, and karyorrhectic debris without evidence of leukocytoclastic vasculitis. The histopathologic differential diagnosis included a histiocytoid variant of Sweet syndrome (SS), and our patient’s rapid clinical response to corticosteroids supported this diagnosis.

With a relapsing and remitting course over 3 years, the rash eventually evolved into more edematous papules and plaques (Figure, B), and a repeat biopsy 3 years later was consistent with classic SS. Although the patient's condition improved with prednisone, attempts to taper prednisone invariably resulted in relapse. Multiple steroid-sparing agents were trialed over the course of 3 years including dapsone and mycophenolate mofetil, both of which resulted in hypersensitivity drug eruptions. Colchicine and methotrexate were ineffective. Thalidomide strongly was considered but ultimately was avoided due to substantial existing neuropathy associated with his prior chemotherapy for metastatic seminoma.

Four years after the initial diagnosis of SS, our patient presented with dyspnea and weight loss. Computed tomography revealed a nearly confluent miliary pattern of nodularity in the lungs. A wedge biopsy demonstrated pneumonitis with intra-alveolar fibrin and neutrophils with a notable absence of granulomatous inflammation. Fungal and acid-fast bacilli staining as well as tissue cultures were negative. He had a history of Mycobacterium kansasii pulmonary infection treated 18 months prior; however, in this instance, the histopathology, negative microbial cultures, and rapid steroid responsiveness were consistent with pulmonary involvement of SS. Over the ensuing 2 years, the patient developed worsening of his chronic anemia. He was diagnosed with myelodysplastic syndrome (MDS) by bone marrow biopsy, despite having a normal bone marrow biopsy more than 3 years prior to evaluate his anemia. At this time, thalidomide was initiated at 50 mg daily leading to notable improvement in his SS symptoms; however, he developed worsening neuropathy resulting in the discontinuation of this treatment 2 months later. An investigational combination of vosaroxin and azacytidine was used to treat his MDS, resulting in normalization of blood counts and remission from SS.

Sweet syndrome may occur in the setting of undiagnosed cancer or may signal the return of a previously treated malignancy. The first description of SS associated with solid tumors was in a patient with testicular cancer,¹ which prompted continuous surveillance for recurrent seminoma in our patient, though none was found. Hematologic malignancies, as well as MDS, often are associated with SS.² In our patient, multiple atypical features linked the development of SS to the ultimate presentation of MDS. The initial finding of a histiocytoid variant has been described in a case series of 9 patients with chronic relapsing SS who eventually developed MDS with latency of up to 7 years. The histopathology in these cases evolved over time to that of classic neutrophilic SS.³ Pulmonary involvement of SS is another interesting aspect of our case. In one analysis, 18 of 34 (53%) cases with pulmonary involvement featured hematologic pathology, including myelodysplasia and acute leukemia.⁴

In our patient, SS preceded the clinical manifestation of MDS by 6 years. A similar phenomenon has been described in a patient with SS that preceded myelodysplasia by 30 months and was recalcitrant to numerous steroid-sparing therapies except thalidomide, despite the persistence of myelodysplasia. Tapering thalidomide, however, resulted in recurrence of SS lesions in that patient.⁵ In another case, resolution of myelodysplasia from azacytidine treatment was associated with remission from SS.⁶

Our case represents a confluence of atypical features that seem to define myelodysplasia-associated SS, including the initial presentation with a clinically atypical histiocytoid variant, chronic relapsing and remitting course, and extracutaneous involvement of the lungs. These findings should prompt surveillance for hematologic malignancy or myelodysplasia. Serial bone marrow biopsies were required to evaluate persistent anemia before the histopathologic findings of MDS became apparent in our patient. Thalidomide was an effective treatment for the cutaneous manifestations in our patient and should be considered as a steroid-sparing agent in the treatment of recalcitrant SS. Despite the discontinuation of thalidomide therapy, effective control of our patient’s myelodysplasia with chemotherapy has kept him in remission from SS for more than 7 years of follow-up, suggesting a causal relationship between these disorders.

To the Editor:

A 59-year-old man was referred to our clinic for a rash, fever, and night sweats following treatment for metastatic seminoma with cisplatin and etoposide. Physical examination revealed indurated erythematous papules and plaques on the trunk and upper and lower extremities, some with annular or arcuate configuration with trailing scale (Figure, A). A skin biopsy demonstrated mild papillary dermal edema with a mixed infiltrate of mononuclear cells, neutrophils, eosinophils, mast cells, lymphocytes, and karyorrhectic debris without evidence of leukocytoclastic vasculitis. The histopathologic differential diagnosis included a histiocytoid variant of Sweet syndrome (SS), and our patient’s rapid clinical response to corticosteroids supported this diagnosis.

With a relapsing and remitting course over 3 years, the rash eventually evolved into more edematous papules and plaques (Figure, B), and a repeat biopsy 3 years later was consistent with classic SS. Although the patient's condition improved with prednisone, attempts to taper prednisone invariably resulted in relapse. Multiple steroid-sparing agents were trialed over the course of 3 years including dapsone and mycophenolate mofetil, both of which resulted in hypersensitivity drug eruptions. Colchicine and methotrexate were ineffective. Thalidomide strongly was considered but ultimately was avoided due to substantial existing neuropathy associated with his prior chemotherapy for metastatic seminoma.

Four years after the initial diagnosis of SS, our patient presented with dyspnea and weight loss. Computed tomography revealed a nearly confluent miliary pattern of nodularity in the lungs. A wedge biopsy demonstrated pneumonitis with intra-alveolar fibrin and neutrophils with a notable absence of granulomatous inflammation. Fungal and acid-fast bacilli staining as well as tissue cultures were negative. He had a history of Mycobacterium kansasii pulmonary infection treated 18 months prior; however, in this instance, the histopathology, negative microbial cultures, and rapid steroid responsiveness were consistent with pulmonary involvement of SS. Over the ensuing 2 years, the patient developed worsening of his chronic anemia. He was diagnosed with myelodysplastic syndrome (MDS) by bone marrow biopsy, despite having a normal bone marrow biopsy more than 3 years prior to evaluate his anemia. At this time, thalidomide was initiated at 50 mg daily leading to notable improvement in his SS symptoms; however, he developed worsening neuropathy resulting in the discontinuation of this treatment 2 months later. An investigational combination of vosaroxin and azacytidine was used to treat his MDS, resulting in normalization of blood counts and remission from SS.

Sweet syndrome may occur in the setting of undiagnosed cancer or may signal the return of a previously treated malignancy. The first description of SS associated with solid tumors was in a patient with testicular cancer,¹ which prompted continuous surveillance for recurrent seminoma in our patient, though none was found. Hematologic malignancies, as well as MDS, often are associated with SS.² In our patient, multiple atypical features linked the development of SS to the ultimate presentation of MDS. The initial finding of a histiocytoid variant has been described in a case series of 9 patients with chronic relapsing SS who eventually developed MDS with latency of up to 7 years. The histopathology in these cases evolved over time to that of classic neutrophilic SS.³ Pulmonary involvement of SS is another interesting aspect of our case. In one analysis, 18 of 34 (53%) cases with pulmonary involvement featured hematologic pathology, including myelodysplasia and acute leukemia.⁴

In our patient, SS preceded the clinical manifestation of MDS by 6 years. A similar phenomenon has been described in a patient with SS that preceded myelodysplasia by 30 months and was recalcitrant to numerous steroid-sparing therapies except thalidomide, despite the persistence of myelodysplasia. Tapering thalidomide, however, resulted in recurrence of SS lesions in that patient.⁵ In another case, resolution of myelodysplasia from azacytidine treatment was associated with remission from SS.⁶

Our case represents a confluence of atypical features that seem to define myelodysplasia-associated SS, including the initial presentation with a clinically atypical histiocytoid variant, chronic relapsing and remitting course, and extracutaneous involvement of the lungs. These findings should prompt surveillance for hematologic malignancy or myelodysplasia. Serial bone marrow biopsies were required to evaluate persistent anemia before the histopathologic findings of MDS became apparent in our patient. Thalidomide was an effective treatment for the cutaneous manifestations in our patient and should be considered as a steroid-sparing agent in the treatment of recalcitrant SS. Despite the discontinuation of thalidomide therapy, effective control of our patient’s myelodysplasia with chemotherapy has kept him in remission from SS for more than 7 years of follow-up, suggesting a causal relationship between these disorders.

To the Editor:

A 59-year-old man was referred to our clinic for a rash, fever, and night sweats following treatment for metastatic seminoma with cisplatin and etoposide. Physical examination revealed indurated erythematous papules and plaques on the trunk and upper and lower extremities, some with annular or arcuate configuration with trailing scale (Figure, A). A skin biopsy demonstrated mild papillary dermal edema with a mixed infiltrate of mononuclear cells, neutrophils, eosinophils, mast cells, lymphocytes, and karyorrhectic debris without evidence of leukocytoclastic vasculitis. The histopathologic differential diagnosis included a histiocytoid variant of Sweet syndrome (SS), and our patient’s rapid clinical response to corticosteroids supported this diagnosis.

With a relapsing and remitting course over 3 years, the rash eventually evolved into more edematous papules and plaques (Figure, B), and a repeat biopsy 3 years later was consistent with classic SS. Although the patient's condition improved with prednisone, attempts to taper prednisone invariably resulted in relapse. Multiple steroid-sparing agents were trialed over the course of 3 years including dapsone and mycophenolate mofetil, both of which resulted in hypersensitivity drug eruptions. Colchicine and methotrexate were ineffective. Thalidomide strongly was considered but ultimately was avoided due to substantial existing neuropathy associated with his prior chemotherapy for metastatic seminoma.

Four years after the initial diagnosis of SS, our patient presented with dyspnea and weight loss. Computed tomography revealed a nearly confluent miliary pattern of nodularity in the lungs. A wedge biopsy demonstrated pneumonitis with intra-alveolar fibrin and neutrophils with a notable absence of granulomatous inflammation. Fungal and acid-fast bacilli staining as well as tissue cultures were negative. He had a history of Mycobacterium kansasii pulmonary infection treated 18 months prior; however, in this instance, the histopathology, negative microbial cultures, and rapid steroid responsiveness were consistent with pulmonary involvement of SS. Over the ensuing 2 years, the patient developed worsening of his chronic anemia. He was diagnosed with myelodysplastic syndrome (MDS) by bone marrow biopsy, despite having a normal bone marrow biopsy more than 3 years prior to evaluate his anemia. At this time, thalidomide was initiated at 50 mg daily leading to notable improvement in his SS symptoms; however, he developed worsening neuropathy resulting in the discontinuation of this treatment 2 months later. An investigational combination of vosaroxin and azacytidine was used to treat his MDS, resulting in normalization of blood counts and remission from SS.

Sweet syndrome may occur in the setting of undiagnosed cancer or may signal the return of a previously treated malignancy. The first description of SS associated with solid tumors was in a patient with testicular cancer,¹ which prompted continuous surveillance for recurrent seminoma in our patient, though none was found. Hematologic malignancies, as well as MDS, often are associated with SS.² In our patient, multiple atypical features linked the development of SS to the ultimate presentation of MDS. The initial finding of a histiocytoid variant has been described in a case series of 9 patients with chronic relapsing SS who eventually developed MDS with latency of up to 7 years. The histopathology in these cases evolved over time to that of classic neutrophilic SS.³ Pulmonary involvement of SS is another interesting aspect of our case. In one analysis, 18 of 34 (53%) cases with pulmonary involvement featured hematologic pathology, including myelodysplasia and acute leukemia.⁴

In our patient, SS preceded the clinical manifestation of MDS by 6 years. A similar phenomenon has been described in a patient with SS that preceded myelodysplasia by 30 months and was recalcitrant to numerous steroid-sparing therapies except thalidomide, despite the persistence of myelodysplasia. Tapering thalidomide, however, resulted in recurrence of SS lesions in that patient.⁵ In another case, resolution of myelodysplasia from azacytidine treatment was associated with remission from SS.⁶

Our case represents a confluence of atypical features that seem to define myelodysplasia-associated SS, including the initial presentation with a clinically atypical histiocytoid variant, chronic relapsing and remitting course, and extracutaneous involvement of the lungs. These findings should prompt surveillance for hematologic malignancy or myelodysplasia. Serial bone marrow biopsies were required to evaluate persistent anemia before the histopathologic findings of MDS became apparent in our patient. Thalidomide was an effective treatment for the cutaneous manifestations in our patient and should be considered as a steroid-sparing agent in the treatment of recalcitrant SS. Despite the discontinuation of thalidomide therapy, effective control of our patient’s myelodysplasia with chemotherapy has kept him in remission from SS for more than 7 years of follow-up, suggesting a causal relationship between these disorders.

The number of general internists choosing a career in hospital medicine jumped from 25% to 40% over 10 years, according to data from the American Board of Internal Medicine.

In a new study, published in Annals of Internal Medicine, researchers from ABIM reviewed certification data from 67,902 general internists, accounting for 80% of all general internists certified in the United States from 1990 to 2017.

The researchers also used data from Medicare fee-for-service claims from 2008-2018 to measure and categorize practice setting types. The claims were from patients aged 65 years or older with at least 20 evaluation and management visits each year. Practice settings were categorized as hospitalist, outpatient, or mixed.

“ABIM is always working to understand the real-life experience of physicians, and this project grew out of that sort of analysis,” lead author Bradley M. Gray, PhD, a health services researcher at ABIM in Philadelphia, said in an interview. “We wanted to better understand practice setting, because that relates to the kinds of questions that we ask on our certifying exams. When we did this, we noticed a trend toward hospital medicine.”

Overall, the percentages of general internists in hospitalist practice and outpatient-only practice increased during the study period, from 25% to 40% and from 23% to 38%, respectively. By contrast, the percentage of general internists in a mixed-practice setting decreased from 52% to 23%, a 56% decline. Most of the physicians who left the mixed practice setting switched to outpatient-only practices.

Among the internists certified in 2017, 71% practiced as hospitalists, compared with 8% practicing as outpatient-only physicians. Most physicians remained in their original choice of practice setting. For physicians certified in 1999 and 2012, 86% and 85%, respectively, of those who chose hospitalist medicine remained in the hospital setting 5 years later, as did 95% of outpatient physicians, but only 57% of mixed-practice physicians.

The shift to outpatient practice among senior physicians offset the potential decline in outpatient primary care resulting from the increased choice of hospitalist medicine by new internists, the researchers noted.

The study findings were limited by several factors, including the reliance on Medicare fee-for-service claims, the researchers noted.

“We were surprised by both the dramatic shift toward hospital medicine by new physicians and the shift to outpatient only (an extreme category) for more senior physicians,” Dr. Gray said in an interview.

The shift toward outpatient practice among older physicians may be driven by convenience, said Dr. Gray. “I suspect that it is more efficient to specialize in terms of practice setting. Only seeing patients in the outpatient setting means that you don’t have to travel to the hospital, which can be time consuming.

“Also, with fewer new physicians going into primary care, older physicians need to focus on outpatient visits. This could be problematic in the future as more senior physicians retire and are replaced by new physicians who focus on hospital care,” which could lead to more shortages in primary care physicians, he explained.

The trend toward hospital medicine as a career has been going on since before the pandemic, said Dr. Gray. “I don’t think the pandemic will ultimately impact this trend. That said, at least in the short run, there may have been a decreased demand for primary care, but that is just my speculation. As more data flow in we will be able to answer this question more directly.”

Next steps for research included digging deeper into the data to understand the nature of conditions facing hospitalists, Dr. Gray said.
 

Implications for primary care

“This study provides an updated snapshot of the popularity of hospital medicine,” said Bradley A. Sharpe, MD, of the division of hospital medicine at the University of California, San Francisco. “It is also important to conduct this study now as health systems think about the challenge of providing high-quality primary care with a rapidly decreasing number of internists choosing to practice outpatient medicine.” Dr. Sharpe was not involved in the study.

“The most surprising finding to me was not the increase in general internists focusing on hospital medicine, but the amount of the increase; it is remarkable that nearly three quarters of general internists are choosing to practice as hospitalists,” Dr. Sharpe noted.

“I think there are a number of key factors at play,” he said. “First, as hospital medicine as a field is now more than 25 years old, hospitals and health systems have evolved to create hospital medicine jobs that are interesting, engaging, rewarding (financially and otherwise), doable, and sustainable. Second, being an outpatient internist is incredibly challenging; multiple studies have shown that it is essentially impossible to complete the evidence-based preventive care for a panel of patients on top of everything else. We know burnout rates are often higher among primary care and family medicine providers. On top of that, the expansion of electronic health records and patient access has led to a massive increase in messages to providers; this has been shown to be associated with burnout.”

The potential impact of the pandemic on physicians’ choices and the trend toward hospital medicine is an interested question, Dr. Sharpe said. The current study showed only trends through 2017.

“To be honest, I think it is difficult to predict,” he said. “Hospitalists shouldered much of the burden of COVID care nationally and burnout rates are high. One could imagine the extra work (as well as concern for personal safety) could lead to fewer providers choosing hospital medicine.

“At the same time, the pandemic has driven many of us to reflect on life and our values and what is important and, through that lens, providers might choose hospital medicine as a more sustainable, do-able, rewarding, and enjoyable career choice,” Dr. Sharpe emphasized.

“Additional research could explore the drivers of this clear trend toward hospital medicine. Determining what is motivating this trend could help hospitals and health systems ensure they have the right workforce for the future and, in particular, how to create outpatient positions that are attractive and rewarding,” he said.

The study received no outside funding. The researchers and Dr. Sharpe disclosed no relevant financial relationships.

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

The number of general internists choosing a career in hospital medicine jumped from 25% to 40% over 10 years, according to data from the American Board of Internal Medicine.

In a new study, published in Annals of Internal Medicine, researchers from ABIM reviewed certification data from 67,902 general internists, accounting for 80% of all general internists certified in the United States from 1990 to 2017.

The researchers also used data from Medicare fee-for-service claims from 2008-2018 to measure and categorize practice setting types. The claims were from patients aged 65 years or older with at least 20 evaluation and management visits each year. Practice settings were categorized as hospitalist, outpatient, or mixed.

“ABIM is always working to understand the real-life experience of physicians, and this project grew out of that sort of analysis,” lead author Bradley M. Gray, PhD, a health services researcher at ABIM in Philadelphia, said in an interview. “We wanted to better understand practice setting, because that relates to the kinds of questions that we ask on our certifying exams. When we did this, we noticed a trend toward hospital medicine.”

Overall, the percentages of general internists in hospitalist practice and outpatient-only practice increased during the study period, from 25% to 40% and from 23% to 38%, respectively. By contrast, the percentage of general internists in a mixed-practice setting decreased from 52% to 23%, a 56% decline. Most of the physicians who left the mixed practice setting switched to outpatient-only practices.

Among the internists certified in 2017, 71% practiced as hospitalists, compared with 8% practicing as outpatient-only physicians. Most physicians remained in their original choice of practice setting. For physicians certified in 1999 and 2012, 86% and 85%, respectively, of those who chose hospitalist medicine remained in the hospital setting 5 years later, as did 95% of outpatient physicians, but only 57% of mixed-practice physicians.

The shift to outpatient practice among senior physicians offset the potential decline in outpatient primary care resulting from the increased choice of hospitalist medicine by new internists, the researchers noted.

The study findings were limited by several factors, including the reliance on Medicare fee-for-service claims, the researchers noted.

“We were surprised by both the dramatic shift toward hospital medicine by new physicians and the shift to outpatient only (an extreme category) for more senior physicians,” Dr. Gray said in an interview.

The shift toward outpatient practice among older physicians may be driven by convenience, said Dr. Gray. “I suspect that it is more efficient to specialize in terms of practice setting. Only seeing patients in the outpatient setting means that you don’t have to travel to the hospital, which can be time consuming.

“Also, with fewer new physicians going into primary care, older physicians need to focus on outpatient visits. This could be problematic in the future as more senior physicians retire and are replaced by new physicians who focus on hospital care,” which could lead to more shortages in primary care physicians, he explained.

The trend toward hospital medicine as a career has been going on since before the pandemic, said Dr. Gray. “I don’t think the pandemic will ultimately impact this trend. That said, at least in the short run, there may have been a decreased demand for primary care, but that is just my speculation. As more data flow in we will be able to answer this question more directly.”

Next steps for research included digging deeper into the data to understand the nature of conditions facing hospitalists, Dr. Gray said.
 

Implications for primary care

“This study provides an updated snapshot of the popularity of hospital medicine,” said Bradley A. Sharpe, MD, of the division of hospital medicine at the University of California, San Francisco. “It is also important to conduct this study now as health systems think about the challenge of providing high-quality primary care with a rapidly decreasing number of internists choosing to practice outpatient medicine.” Dr. Sharpe was not involved in the study.

“The most surprising finding to me was not the increase in general internists focusing on hospital medicine, but the amount of the increase; it is remarkable that nearly three quarters of general internists are choosing to practice as hospitalists,” Dr. Sharpe noted.

“I think there are a number of key factors at play,” he said. “First, as hospital medicine as a field is now more than 25 years old, hospitals and health systems have evolved to create hospital medicine jobs that are interesting, engaging, rewarding (financially and otherwise), doable, and sustainable. Second, being an outpatient internist is incredibly challenging; multiple studies have shown that it is essentially impossible to complete the evidence-based preventive care for a panel of patients on top of everything else. We know burnout rates are often higher among primary care and family medicine providers. On top of that, the expansion of electronic health records and patient access has led to a massive increase in messages to providers; this has been shown to be associated with burnout.”

The potential impact of the pandemic on physicians’ choices and the trend toward hospital medicine is an interested question, Dr. Sharpe said. The current study showed only trends through 2017.

“To be honest, I think it is difficult to predict,” he said. “Hospitalists shouldered much of the burden of COVID care nationally and burnout rates are high. One could imagine the extra work (as well as concern for personal safety) could lead to fewer providers choosing hospital medicine.

“At the same time, the pandemic has driven many of us to reflect on life and our values and what is important and, through that lens, providers might choose hospital medicine as a more sustainable, do-able, rewarding, and enjoyable career choice,” Dr. Sharpe emphasized.

“Additional research could explore the drivers of this clear trend toward hospital medicine. Determining what is motivating this trend could help hospitals and health systems ensure they have the right workforce for the future and, in particular, how to create outpatient positions that are attractive and rewarding,” he said.

The study received no outside funding. The researchers and Dr. Sharpe disclosed no relevant financial relationships.

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

The number of general internists choosing a career in hospital medicine jumped from 25% to 40% over 10 years, according to data from the American Board of Internal Medicine.

In a new study, published in Annals of Internal Medicine, researchers from ABIM reviewed certification data from 67,902 general internists, accounting for 80% of all general internists certified in the United States from 1990 to 2017.

The researchers also used data from Medicare fee-for-service claims from 2008-2018 to measure and categorize practice setting types. The claims were from patients aged 65 years or older with at least 20 evaluation and management visits each year. Practice settings were categorized as hospitalist, outpatient, or mixed.

“ABIM is always working to understand the real-life experience of physicians, and this project grew out of that sort of analysis,” lead author Bradley M. Gray, PhD, a health services researcher at ABIM in Philadelphia, said in an interview. “We wanted to better understand practice setting, because that relates to the kinds of questions that we ask on our certifying exams. When we did this, we noticed a trend toward hospital medicine.”

Overall, the percentages of general internists in hospitalist practice and outpatient-only practice increased during the study period, from 25% to 40% and from 23% to 38%, respectively. By contrast, the percentage of general internists in a mixed-practice setting decreased from 52% to 23%, a 56% decline. Most of the physicians who left the mixed practice setting switched to outpatient-only practices.

Among the internists certified in 2017, 71% practiced as hospitalists, compared with 8% practicing as outpatient-only physicians. Most physicians remained in their original choice of practice setting. For physicians certified in 1999 and 2012, 86% and 85%, respectively, of those who chose hospitalist medicine remained in the hospital setting 5 years later, as did 95% of outpatient physicians, but only 57% of mixed-practice physicians.

The shift to outpatient practice among senior physicians offset the potential decline in outpatient primary care resulting from the increased choice of hospitalist medicine by new internists, the researchers noted.

The study findings were limited by several factors, including the reliance on Medicare fee-for-service claims, the researchers noted.

“We were surprised by both the dramatic shift toward hospital medicine by new physicians and the shift to outpatient only (an extreme category) for more senior physicians,” Dr. Gray said in an interview.

The shift toward outpatient practice among older physicians may be driven by convenience, said Dr. Gray. “I suspect that it is more efficient to specialize in terms of practice setting. Only seeing patients in the outpatient setting means that you don’t have to travel to the hospital, which can be time consuming.

“Also, with fewer new physicians going into primary care, older physicians need to focus on outpatient visits. This could be problematic in the future as more senior physicians retire and are replaced by new physicians who focus on hospital care,” which could lead to more shortages in primary care physicians, he explained.

The trend toward hospital medicine as a career has been going on since before the pandemic, said Dr. Gray. “I don’t think the pandemic will ultimately impact this trend. That said, at least in the short run, there may have been a decreased demand for primary care, but that is just my speculation. As more data flow in we will be able to answer this question more directly.”

Next steps for research included digging deeper into the data to understand the nature of conditions facing hospitalists, Dr. Gray said.
 

Implications for primary care

“This study provides an updated snapshot of the popularity of hospital medicine,” said Bradley A. Sharpe, MD, of the division of hospital medicine at the University of California, San Francisco. “It is also important to conduct this study now as health systems think about the challenge of providing high-quality primary care with a rapidly decreasing number of internists choosing to practice outpatient medicine.” Dr. Sharpe was not involved in the study.

“The most surprising finding to me was not the increase in general internists focusing on hospital medicine, but the amount of the increase; it is remarkable that nearly three quarters of general internists are choosing to practice as hospitalists,” Dr. Sharpe noted.

“I think there are a number of key factors at play,” he said. “First, as hospital medicine as a field is now more than 25 years old, hospitals and health systems have evolved to create hospital medicine jobs that are interesting, engaging, rewarding (financially and otherwise), doable, and sustainable. Second, being an outpatient internist is incredibly challenging; multiple studies have shown that it is essentially impossible to complete the evidence-based preventive care for a panel of patients on top of everything else. We know burnout rates are often higher among primary care and family medicine providers. On top of that, the expansion of electronic health records and patient access has led to a massive increase in messages to providers; this has been shown to be associated with burnout.”

The potential impact of the pandemic on physicians’ choices and the trend toward hospital medicine is an interested question, Dr. Sharpe said. The current study showed only trends through 2017.

“To be honest, I think it is difficult to predict,” he said. “Hospitalists shouldered much of the burden of COVID care nationally and burnout rates are high. One could imagine the extra work (as well as concern for personal safety) could lead to fewer providers choosing hospital medicine.

“At the same time, the pandemic has driven many of us to reflect on life and our values and what is important and, through that lens, providers might choose hospital medicine as a more sustainable, do-able, rewarding, and enjoyable career choice,” Dr. Sharpe emphasized.

“Additional research could explore the drivers of this clear trend toward hospital medicine. Determining what is motivating this trend could help hospitals and health systems ensure they have the right workforce for the future and, in particular, how to create outpatient positions that are attractive and rewarding,” he said.

The study received no outside funding. The researchers and Dr. Sharpe disclosed no relevant financial relationships.

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

The full results on Lilly’s tirzepatide for obesity will likely dominate the headlines from the annual scientific sessions of the American Diabetes Association, but the conference program is jam-packed with new findings – and new paradigms – in both type 1 and type 2 diabetes management and prevention.

Taking place June 3-7 both in person – for the first time in 3 years – in New Orleans, and virtually, the “hybrid” meeting is mandating COVID-19 vaccination and mask wearing for all on-site attendees.

CrackerClips/Thinkstock

A major topic will be new findings and thinking in the treatment of type 2 diabetes, including the new twincretin tirzepatide, as well as discussions about the role of weight loss and the concept of “remission.” In type 1 diabetes, sessions will examine intervention trials to prevent progression, progress in islet transplantation, and the latest findings in diabetes technology.

Other key conference themes include the often interrelated topics of disparities, mental health, and COVID-19.

“I think that the scientific planning committee has put together a really outstanding program this year, covering the entire spectrum of diabetes care and research and translation for both type 1 and type 2 diabetes,” Scientific Planning Committee Chair Dana Dabelea, MD, PhD, professor of epidemiology and pediatrics at the University of Colorado Anschutz Medical Campus, Aurora, told this news organization.
 

Tirzepatide: The next big thing?

The presentation likely to generate the most buzz will take place Saturday morning, with the full detailed results from Lilly’s phase 3 SURMOUNT-1 trial of its dual-incretin tirzepatide for weight loss in people with obesity or overweight with at least one comorbidity but not diabetes.

Top-line results released by Lilly in April 2022 showed that the drug induced weight loss of up to 22%. Tirzepatide was approved May 13 by the Food and Drug Administration for type 2 diabetes under the brand name Mounjaro. It is not approved for weight loss.  

“Certainly the general public will latch on to this idea that there is a drug they can lose 22% of their weight on,” Robert A. Gabbay, MD, PhD, ADA chief science and medical officer, told this news organization. “It’s hard to comment on a press release, so that’s why this presentation is going to be key.”

Another tirzepatide analysis, this one comparing its use to insulin glargine on kidney outcomes in participants with diabetes in the pivotal SURPASS-4 study, will be presented as an ADA Presidents’ Select Abstract on Friday afternoon.

“I think tirzepatide could be the great new thing, but I think we need to know a little bit more. Weight loss seems to be better than with glucagon-like peptide-1 (GLP-1) receptor agonists. Renal outcomes are important. Next will be to see if it has cardiovascular benefit. It makes one think about its use versus GLP-1 agonists,” Dr. Gabbay said.
 

Managing type 2 diabetes: Shifting paradigms

With the emergence of tirzepatide and other pharmacologic agents with benefits beyond glucose lowering, there has been much discussion in recent years about alternatives to the current metformin monotherapy first, stepwise approach to managing type 2 diabetes.

As has been done previously, on Monday afternoon, there will be a joint ADA/European Association for the Study of Diabetes (EASD) session during which a draft of the latest update will be presented on the management of hyperglycemia in type 2 diabetes. The final version will be presented at the EASD meeting in September.

While it won’t include tirzepatide, as the drug is not yet approved in Europe, there will be discussion about the role of weight loss goals in type 2 diabetes management, Dr. Gabbay said.

The concept of a 15% weight loss as a primary treatment goal of type 2 diabetes management is a new focus, initiated at the EASD 2021 annual meeting and published in The Lancet.

“With tirzepatide becoming available, there’s the opportunity for more significant weight loss. So, there’s been this debate, starting with the somewhat controversial opinion piece in Lancet ... Maybe it was stating things a bit too far but it certainly got everyone in the field thinking. You’ll see that come up in lots of places at this meeting,” Dr. Gabbay said.

Indeed, those sessions include a Sunday morning symposium titled: “Obesity Management as a Primary Treatment Goal for Type 2 Diabetes – It’s Time for a Paradigm Shift,” in which speakers will address both lifestyle and pharmacologic intervention. On Saturday afternoon, two speakers will debate the question: “Weighing the Evidence – Should Obesity Be the Primary Target of Treatment in Type 2 Diabetes?” Yet another session on Sunday afternoon, will cover “Incorporating Weight Management Strategies for Obesity Into Type 2 Diabetes Care – Medical Management and Surgery.”

 

From weight loss to type 2 diabetes ‘remission’?

Related to the issue of weight loss as first-line therapy is the concept of type 2 diabetes “remission.” “There is a school of thought that says early in the course of disease we probably want to be a lot more aggressive because there’s a greater chance of putting someone into remission,” Dr. Gabbay noted. “The opportunities for remission after someone has had diabetes for a number of years are relatively low.” 

In September 2021, ADA, along with EASD, the Endocrine Society, and Diabetes UK, published a joint consensus statement aiming to standardize use of the term “remission” in type 2 diabetes.  

At the ADA meeting, a symposium on Monday afternoon, titled, “Definition and Interpretation of Remission in Type 2 Diabetes,” will cover lifestyle, pharmacotherapy, and metabolic surgery approaches. One noteworthy talk in that session will address the question: “Can Type 2 Diabetes Remission Be Diagnosed While Glucose-Lowering Drugs Are Being Used?”

Asked how all of this – tirzepatide, weight loss, and “remission” – might play out clinically, Dr. Dabelea replied: “We are still debating the strategy. That’s why we’re having the scientific talks.

“I think they will be very interesting and very well-attended, but there isn’t a strategy yet ... The important thing is we have these ‘miracle drugs,’ if you want, and once we’ve learned all we need to know about how they act and who we should target, perhaps next year we can talk about a strategy.”
 

Type 1 diabetes: Progress in preventing, treating, and ... curing?

Type 1 diabetes also will be well represented at the conference, with topics covering prevention, treatment, and progress toward a cure. On Saturday afternoon, a symposium will cover data from a trial of low-dose IL-2 in people with recently diagnosed type 1 diabetes, while a Friday afternoon symposium will address “Emerging Approaches to Beta Cell Replacement.”

On Saturday afternoon, a symposium will provide an update on islet cell transplantation, including immune tolerance strategies, while an oral abstract session will cover “Clinical Outcomes in Islet and Pancreas Transplantation.” And on Monday afternoon, yet another symposium will examine “Emerging Data on Therapies to Treat the Underlying Autoimmunity in Type 1 Diabetes.”

As usual, there will also be numerous presentations on the latest in diabetes technology. Particularly noteworthy among these will be an oral abstract presentation on Monday afternoon, “The CREATE Trial: Randomized Clinical Trial Comparing Open-Source Automated Insulin Delivery With Sensor Augmented Pump Therapy in Type 1 Diabetes,” and results from the insulin-only “bionic pancreas” pivotal randomized clinical trial on Friday afternoon.   

“I’m happy to see a plethora of studies in type 1 diabetes. Dr. Dabelea said. “As with tirzepatide in type 2 diabetes, we are witnessing discoveries and we need to have some time to really understand the results, understand who are they targeting, who is going to benefit, and then move into a strategy.”

However, she added, in both type 1 and type 2 diabetes, “we’re seeing these disparities [where] these novel technologies and therapeutics are not getting to the people who need them most,” which brings up another major meeting theme, health disparities.
 

Overlapping themes: Disparities, mental health, and COVID-19

The topics of health disparities in diabetes prevention, management, and care and promoting health equity, as well as the impact of COVID-19, are “certainly timely this year,” said Dr. Dabelea.

At least eight meeting sessions will address various aspects of disparity, including a Friday afternoon symposium, “Race, Racism, and Diabetes Research,” a Saturday morning oral presentation on “Mitigating Disparities in the Screening and Diagnosis of Diabetes,” and on Monday morning, the symposium “Disparities in the Use of Diabetes Medications and Technologies.”

A related topic, insulin access, will be addressed in a Friday morning “mini-symposium” that will cover the issue from U.S. and international perspectives, including humanitarian crisis situations. Related to that, on Sunday afternoon a panel will discuss the Ukraine situation specifically.

Regarding mental health, one noteworthy session is a symposium on Saturday afternoon: “Suicide and Self-Injury – Unveiling and Addressing the Hidden Nightmare in Diabetes.”

“It’s an underrecognized problem and we’ve devoted a symposium to really drill into it. I think that’s going to be an important story for all of us to think about,” Dr. Gabbay said.

Another mental health session on Saturday afternoon will examine “Stigma in Diabetes Care – Evidence and Solutions.” Dr. Dabelea noted, “Mental health is a rising concern in the United States, especially in people with chronic diseases in the wake of the pandemic ... Of course there’s overlap in mechanisms in type 1 and type 2, but I think there are also distinct pathways.”  

COVID-19 will be somewhat less of a focus than in the past 2 years, but there will certainly still be plenty about it. A Friday morning mini-symposium will cover new findings in pathophysiology, another session on Monday afternoon will look at the impact of the pandemic on hypoglycemia risk, and COVID-19 will be the subject of several late-breaking posters on Sunday afternoon. One in particular will report a review of diabetes as a risk factor for long COVID.
 

Celebrating in person in the Big Easy

But unlike the past 2 years, COVID-19 has not kept ADA from meeting in person in 2022. “I think it’s going to be amazing ... We’re so excited to be in person and interacting,” Dr. Gabbay said.

He observed that virtual meetings – as ADA and most other medical societies have been forced into for the past 2 years during the pandemic – fail to capture “how science is advanced by the casual conversations in the hallway and collaborations and new ideas. It’s really this incredible incubator. For me, that’s the most exciting part.”

The location, New Orleans, also factors into his excitement: “What a great place to do this. It’s conducive to celebrating. It’s been a long couple of years.” 

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

The full results on Lilly’s tirzepatide for obesity will likely dominate the headlines from the annual scientific sessions of the American Diabetes Association, but the conference program is jam-packed with new findings – and new paradigms – in both type 1 and type 2 diabetes management and prevention.

Taking place June 3-7 both in person – for the first time in 3 years – in New Orleans, and virtually, the “hybrid” meeting is mandating COVID-19 vaccination and mask wearing for all on-site attendees.

CrackerClips/Thinkstock

A major topic will be new findings and thinking in the treatment of type 2 diabetes, including the new twincretin tirzepatide, as well as discussions about the role of weight loss and the concept of “remission.” In type 1 diabetes, sessions will examine intervention trials to prevent progression, progress in islet transplantation, and the latest findings in diabetes technology.

Other key conference themes include the often interrelated topics of disparities, mental health, and COVID-19.

“I think that the scientific planning committee has put together a really outstanding program this year, covering the entire spectrum of diabetes care and research and translation for both type 1 and type 2 diabetes,” Scientific Planning Committee Chair Dana Dabelea, MD, PhD, professor of epidemiology and pediatrics at the University of Colorado Anschutz Medical Campus, Aurora, told this news organization.
 

Tirzepatide: The next big thing?

The presentation likely to generate the most buzz will take place Saturday morning, with the full detailed results from Lilly’s phase 3 SURMOUNT-1 trial of its dual-incretin tirzepatide for weight loss in people with obesity or overweight with at least one comorbidity but not diabetes.

Top-line results released by Lilly in April 2022 showed that the drug induced weight loss of up to 22%. Tirzepatide was approved May 13 by the Food and Drug Administration for type 2 diabetes under the brand name Mounjaro. It is not approved for weight loss.  

“Certainly the general public will latch on to this idea that there is a drug they can lose 22% of their weight on,” Robert A. Gabbay, MD, PhD, ADA chief science and medical officer, told this news organization. “It’s hard to comment on a press release, so that’s why this presentation is going to be key.”

Another tirzepatide analysis, this one comparing its use to insulin glargine on kidney outcomes in participants with diabetes in the pivotal SURPASS-4 study, will be presented as an ADA Presidents’ Select Abstract on Friday afternoon.

“I think tirzepatide could be the great new thing, but I think we need to know a little bit more. Weight loss seems to be better than with glucagon-like peptide-1 (GLP-1) receptor agonists. Renal outcomes are important. Next will be to see if it has cardiovascular benefit. It makes one think about its use versus GLP-1 agonists,” Dr. Gabbay said.
 

Managing type 2 diabetes: Shifting paradigms

With the emergence of tirzepatide and other pharmacologic agents with benefits beyond glucose lowering, there has been much discussion in recent years about alternatives to the current metformin monotherapy first, stepwise approach to managing type 2 diabetes.

As has been done previously, on Monday afternoon, there will be a joint ADA/European Association for the Study of Diabetes (EASD) session during which a draft of the latest update will be presented on the management of hyperglycemia in type 2 diabetes. The final version will be presented at the EASD meeting in September.

While it won’t include tirzepatide, as the drug is not yet approved in Europe, there will be discussion about the role of weight loss goals in type 2 diabetes management, Dr. Gabbay said.

The concept of a 15% weight loss as a primary treatment goal of type 2 diabetes management is a new focus, initiated at the EASD 2021 annual meeting and published in The Lancet.

“With tirzepatide becoming available, there’s the opportunity for more significant weight loss. So, there’s been this debate, starting with the somewhat controversial opinion piece in Lancet ... Maybe it was stating things a bit too far but it certainly got everyone in the field thinking. You’ll see that come up in lots of places at this meeting,” Dr. Gabbay said.

Indeed, those sessions include a Sunday morning symposium titled: “Obesity Management as a Primary Treatment Goal for Type 2 Diabetes – It’s Time for a Paradigm Shift,” in which speakers will address both lifestyle and pharmacologic intervention. On Saturday afternoon, two speakers will debate the question: “Weighing the Evidence – Should Obesity Be the Primary Target of Treatment in Type 2 Diabetes?” Yet another session on Sunday afternoon, will cover “Incorporating Weight Management Strategies for Obesity Into Type 2 Diabetes Care – Medical Management and Surgery.”

 

From weight loss to type 2 diabetes ‘remission’?

Related to the issue of weight loss as first-line therapy is the concept of type 2 diabetes “remission.” “There is a school of thought that says early in the course of disease we probably want to be a lot more aggressive because there’s a greater chance of putting someone into remission,” Dr. Gabbay noted. “The opportunities for remission after someone has had diabetes for a number of years are relatively low.” 

In September 2021, ADA, along with EASD, the Endocrine Society, and Diabetes UK, published a joint consensus statement aiming to standardize use of the term “remission” in type 2 diabetes.  

At the ADA meeting, a symposium on Monday afternoon, titled, “Definition and Interpretation of Remission in Type 2 Diabetes,” will cover lifestyle, pharmacotherapy, and metabolic surgery approaches. One noteworthy talk in that session will address the question: “Can Type 2 Diabetes Remission Be Diagnosed While Glucose-Lowering Drugs Are Being Used?”

Asked how all of this – tirzepatide, weight loss, and “remission” – might play out clinically, Dr. Dabelea replied: “We are still debating the strategy. That’s why we’re having the scientific talks.

“I think they will be very interesting and very well-attended, but there isn’t a strategy yet ... The important thing is we have these ‘miracle drugs,’ if you want, and once we’ve learned all we need to know about how they act and who we should target, perhaps next year we can talk about a strategy.”
 

Type 1 diabetes: Progress in preventing, treating, and ... curing?

Type 1 diabetes also will be well represented at the conference, with topics covering prevention, treatment, and progress toward a cure. On Saturday afternoon, a symposium will cover data from a trial of low-dose IL-2 in people with recently diagnosed type 1 diabetes, while a Friday afternoon symposium will address “Emerging Approaches to Beta Cell Replacement.”

On Saturday afternoon, a symposium will provide an update on islet cell transplantation, including immune tolerance strategies, while an oral abstract session will cover “Clinical Outcomes in Islet and Pancreas Transplantation.” And on Monday afternoon, yet another symposium will examine “Emerging Data on Therapies to Treat the Underlying Autoimmunity in Type 1 Diabetes.”

As usual, there will also be numerous presentations on the latest in diabetes technology. Particularly noteworthy among these will be an oral abstract presentation on Monday afternoon, “The CREATE Trial: Randomized Clinical Trial Comparing Open-Source Automated Insulin Delivery With Sensor Augmented Pump Therapy in Type 1 Diabetes,” and results from the insulin-only “bionic pancreas” pivotal randomized clinical trial on Friday afternoon.   

“I’m happy to see a plethora of studies in type 1 diabetes. Dr. Dabelea said. “As with tirzepatide in type 2 diabetes, we are witnessing discoveries and we need to have some time to really understand the results, understand who are they targeting, who is going to benefit, and then move into a strategy.”

However, she added, in both type 1 and type 2 diabetes, “we’re seeing these disparities [where] these novel technologies and therapeutics are not getting to the people who need them most,” which brings up another major meeting theme, health disparities.
 

Overlapping themes: Disparities, mental health, and COVID-19

The topics of health disparities in diabetes prevention, management, and care and promoting health equity, as well as the impact of COVID-19, are “certainly timely this year,” said Dr. Dabelea.

At least eight meeting sessions will address various aspects of disparity, including a Friday afternoon symposium, “Race, Racism, and Diabetes Research,” a Saturday morning oral presentation on “Mitigating Disparities in the Screening and Diagnosis of Diabetes,” and on Monday morning, the symposium “Disparities in the Use of Diabetes Medications and Technologies.”

A related topic, insulin access, will be addressed in a Friday morning “mini-symposium” that will cover the issue from U.S. and international perspectives, including humanitarian crisis situations. Related to that, on Sunday afternoon a panel will discuss the Ukraine situation specifically.

Regarding mental health, one noteworthy session is a symposium on Saturday afternoon: “Suicide and Self-Injury – Unveiling and Addressing the Hidden Nightmare in Diabetes.”

“It’s an underrecognized problem and we’ve devoted a symposium to really drill into it. I think that’s going to be an important story for all of us to think about,” Dr. Gabbay said.

Another mental health session on Saturday afternoon will examine “Stigma in Diabetes Care – Evidence and Solutions.” Dr. Dabelea noted, “Mental health is a rising concern in the United States, especially in people with chronic diseases in the wake of the pandemic ... Of course there’s overlap in mechanisms in type 1 and type 2, but I think there are also distinct pathways.”  

COVID-19 will be somewhat less of a focus than in the past 2 years, but there will certainly still be plenty about it. A Friday morning mini-symposium will cover new findings in pathophysiology, another session on Monday afternoon will look at the impact of the pandemic on hypoglycemia risk, and COVID-19 will be the subject of several late-breaking posters on Sunday afternoon. One in particular will report a review of diabetes as a risk factor for long COVID.
 

Celebrating in person in the Big Easy

But unlike the past 2 years, COVID-19 has not kept ADA from meeting in person in 2022. “I think it’s going to be amazing ... We’re so excited to be in person and interacting,” Dr. Gabbay said.

He observed that virtual meetings – as ADA and most other medical societies have been forced into for the past 2 years during the pandemic – fail to capture “how science is advanced by the casual conversations in the hallway and collaborations and new ideas. It’s really this incredible incubator. For me, that’s the most exciting part.”

The location, New Orleans, also factors into his excitement: “What a great place to do this. It’s conducive to celebrating. It’s been a long couple of years.” 

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

The full results on Lilly’s tirzepatide for obesity will likely dominate the headlines from the annual scientific sessions of the American Diabetes Association, but the conference program is jam-packed with new findings – and new paradigms – in both type 1 and type 2 diabetes management and prevention.

Taking place June 3-7 both in person – for the first time in 3 years – in New Orleans, and virtually, the “hybrid” meeting is mandating COVID-19 vaccination and mask wearing for all on-site attendees.

CrackerClips/Thinkstock

A major topic will be new findings and thinking in the treatment of type 2 diabetes, including the new twincretin tirzepatide, as well as discussions about the role of weight loss and the concept of “remission.” In type 1 diabetes, sessions will examine intervention trials to prevent progression, progress in islet transplantation, and the latest findings in diabetes technology.

Other key conference themes include the often interrelated topics of disparities, mental health, and COVID-19.

“I think that the scientific planning committee has put together a really outstanding program this year, covering the entire spectrum of diabetes care and research and translation for both type 1 and type 2 diabetes,” Scientific Planning Committee Chair Dana Dabelea, MD, PhD, professor of epidemiology and pediatrics at the University of Colorado Anschutz Medical Campus, Aurora, told this news organization.
 

Tirzepatide: The next big thing?

The presentation likely to generate the most buzz will take place Saturday morning, with the full detailed results from Lilly’s phase 3 SURMOUNT-1 trial of its dual-incretin tirzepatide for weight loss in people with obesity or overweight with at least one comorbidity but not diabetes.

Top-line results released by Lilly in April 2022 showed that the drug induced weight loss of up to 22%. Tirzepatide was approved May 13 by the Food and Drug Administration for type 2 diabetes under the brand name Mounjaro. It is not approved for weight loss.  

“Certainly the general public will latch on to this idea that there is a drug they can lose 22% of their weight on,” Robert A. Gabbay, MD, PhD, ADA chief science and medical officer, told this news organization. “It’s hard to comment on a press release, so that’s why this presentation is going to be key.”

Another tirzepatide analysis, this one comparing its use to insulin glargine on kidney outcomes in participants with diabetes in the pivotal SURPASS-4 study, will be presented as an ADA Presidents’ Select Abstract on Friday afternoon.

“I think tirzepatide could be the great new thing, but I think we need to know a little bit more. Weight loss seems to be better than with glucagon-like peptide-1 (GLP-1) receptor agonists. Renal outcomes are important. Next will be to see if it has cardiovascular benefit. It makes one think about its use versus GLP-1 agonists,” Dr. Gabbay said.
 

Managing type 2 diabetes: Shifting paradigms

With the emergence of tirzepatide and other pharmacologic agents with benefits beyond glucose lowering, there has been much discussion in recent years about alternatives to the current metformin monotherapy first, stepwise approach to managing type 2 diabetes.

As has been done previously, on Monday afternoon, there will be a joint ADA/European Association for the Study of Diabetes (EASD) session during which a draft of the latest update will be presented on the management of hyperglycemia in type 2 diabetes. The final version will be presented at the EASD meeting in September.

While it won’t include tirzepatide, as the drug is not yet approved in Europe, there will be discussion about the role of weight loss goals in type 2 diabetes management, Dr. Gabbay said.

The concept of a 15% weight loss as a primary treatment goal of type 2 diabetes management is a new focus, initiated at the EASD 2021 annual meeting and published in The Lancet.

“With tirzepatide becoming available, there’s the opportunity for more significant weight loss. So, there’s been this debate, starting with the somewhat controversial opinion piece in Lancet ... Maybe it was stating things a bit too far but it certainly got everyone in the field thinking. You’ll see that come up in lots of places at this meeting,” Dr. Gabbay said.

Indeed, those sessions include a Sunday morning symposium titled: “Obesity Management as a Primary Treatment Goal for Type 2 Diabetes – It’s Time for a Paradigm Shift,” in which speakers will address both lifestyle and pharmacologic intervention. On Saturday afternoon, two speakers will debate the question: “Weighing the Evidence – Should Obesity Be the Primary Target of Treatment in Type 2 Diabetes?” Yet another session on Sunday afternoon, will cover “Incorporating Weight Management Strategies for Obesity Into Type 2 Diabetes Care – Medical Management and Surgery.”

 

From weight loss to type 2 diabetes ‘remission’?

Related to the issue of weight loss as first-line therapy is the concept of type 2 diabetes “remission.” “There is a school of thought that says early in the course of disease we probably want to be a lot more aggressive because there’s a greater chance of putting someone into remission,” Dr. Gabbay noted. “The opportunities for remission after someone has had diabetes for a number of years are relatively low.” 

In September 2021, ADA, along with EASD, the Endocrine Society, and Diabetes UK, published a joint consensus statement aiming to standardize use of the term “remission” in type 2 diabetes.  

At the ADA meeting, a symposium on Monday afternoon, titled, “Definition and Interpretation of Remission in Type 2 Diabetes,” will cover lifestyle, pharmacotherapy, and metabolic surgery approaches. One noteworthy talk in that session will address the question: “Can Type 2 Diabetes Remission Be Diagnosed While Glucose-Lowering Drugs Are Being Used?”

Asked how all of this – tirzepatide, weight loss, and “remission” – might play out clinically, Dr. Dabelea replied: “We are still debating the strategy. That’s why we’re having the scientific talks.

“I think they will be very interesting and very well-attended, but there isn’t a strategy yet ... The important thing is we have these ‘miracle drugs,’ if you want, and once we’ve learned all we need to know about how they act and who we should target, perhaps next year we can talk about a strategy.”
 

Type 1 diabetes: Progress in preventing, treating, and ... curing?

Type 1 diabetes also will be well represented at the conference, with topics covering prevention, treatment, and progress toward a cure. On Saturday afternoon, a symposium will cover data from a trial of low-dose IL-2 in people with recently diagnosed type 1 diabetes, while a Friday afternoon symposium will address “Emerging Approaches to Beta Cell Replacement.”

On Saturday afternoon, a symposium will provide an update on islet cell transplantation, including immune tolerance strategies, while an oral abstract session will cover “Clinical Outcomes in Islet and Pancreas Transplantation.” And on Monday afternoon, yet another symposium will examine “Emerging Data on Therapies to Treat the Underlying Autoimmunity in Type 1 Diabetes.”

As usual, there will also be numerous presentations on the latest in diabetes technology. Particularly noteworthy among these will be an oral abstract presentation on Monday afternoon, “The CREATE Trial: Randomized Clinical Trial Comparing Open-Source Automated Insulin Delivery With Sensor Augmented Pump Therapy in Type 1 Diabetes,” and results from the insulin-only “bionic pancreas” pivotal randomized clinical trial on Friday afternoon.   

“I’m happy to see a plethora of studies in type 1 diabetes. Dr. Dabelea said. “As with tirzepatide in type 2 diabetes, we are witnessing discoveries and we need to have some time to really understand the results, understand who are they targeting, who is going to benefit, and then move into a strategy.”

However, she added, in both type 1 and type 2 diabetes, “we’re seeing these disparities [where] these novel technologies and therapeutics are not getting to the people who need them most,” which brings up another major meeting theme, health disparities.
 

Overlapping themes: Disparities, mental health, and COVID-19

The topics of health disparities in diabetes prevention, management, and care and promoting health equity, as well as the impact of COVID-19, are “certainly timely this year,” said Dr. Dabelea.

At least eight meeting sessions will address various aspects of disparity, including a Friday afternoon symposium, “Race, Racism, and Diabetes Research,” a Saturday morning oral presentation on “Mitigating Disparities in the Screening and Diagnosis of Diabetes,” and on Monday morning, the symposium “Disparities in the Use of Diabetes Medications and Technologies.”

A related topic, insulin access, will be addressed in a Friday morning “mini-symposium” that will cover the issue from U.S. and international perspectives, including humanitarian crisis situations. Related to that, on Sunday afternoon a panel will discuss the Ukraine situation specifically.

Regarding mental health, one noteworthy session is a symposium on Saturday afternoon: “Suicide and Self-Injury – Unveiling and Addressing the Hidden Nightmare in Diabetes.”

“It’s an underrecognized problem and we’ve devoted a symposium to really drill into it. I think that’s going to be an important story for all of us to think about,” Dr. Gabbay said.

Another mental health session on Saturday afternoon will examine “Stigma in Diabetes Care – Evidence and Solutions.” Dr. Dabelea noted, “Mental health is a rising concern in the United States, especially in people with chronic diseases in the wake of the pandemic ... Of course there’s overlap in mechanisms in type 1 and type 2, but I think there are also distinct pathways.”  

COVID-19 will be somewhat less of a focus than in the past 2 years, but there will certainly still be plenty about it. A Friday morning mini-symposium will cover new findings in pathophysiology, another session on Monday afternoon will look at the impact of the pandemic on hypoglycemia risk, and COVID-19 will be the subject of several late-breaking posters on Sunday afternoon. One in particular will report a review of diabetes as a risk factor for long COVID.
 

Celebrating in person in the Big Easy

But unlike the past 2 years, COVID-19 has not kept ADA from meeting in person in 2022. “I think it’s going to be amazing ... We’re so excited to be in person and interacting,” Dr. Gabbay said.

He observed that virtual meetings – as ADA and most other medical societies have been forced into for the past 2 years during the pandemic – fail to capture “how science is advanced by the casual conversations in the hallway and collaborations and new ideas. It’s really this incredible incubator. For me, that’s the most exciting part.”

The location, New Orleans, also factors into his excitement: “What a great place to do this. It’s conducive to celebrating. It’s been a long couple of years.” 

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

To the Editor:

An otherwise healthy 26-year-old man presented to our outpatient clinic with a 15- to 20-mm, shiny, friable-appearing, red umbilical nodule with clear malodorous discharge (Figure 1). The lesion developed 2 weeks prior and gradually increased in size and discomfort. The patient reported mild associated abdominal pain. He had no fever, changes in urination or bowel movements, or prior history of umbilical growths or drainage. The abdomen was tender to palpation.

Differential diagnoses included pyogenic granuloma, umbilical hernia, epidermoid cyst or abscess, and malignancy (low suspicion). A biopsy was not performed due to concern for bleeding or communication with the bowel. A complete blood cell count, comprehensive metabolic panel, and urinalysis were unremarkable except for mild leukocytosis and elevated C-reactive protein. Ultrasonography revealed a 1.4×1.3-cm inflammatory umbilical mass with no communication with the bowel. The patient was referred to the emergency department (ED) for further evaluation. Computed tomography (CT) revealed periumbilical inflammation and an associated 1-cm calcification that appeared to be connected to a potential tract from the bladder, suggestive of a urachal remnant calcification (Figure 2). The patient was diagnosed with a persistent urachal remnant, discharged home with ciprofloxacin, and scheduled for a follow-up with urology.

The patient returned to the ED 3 days later with painful umbilical bleeding (Figure 3). While there, the patient extracted a 1-cm stone from the lesion, consistent with the calcification visualized on CT scan. Computed tomographic virtual cystoscopy showed no connection between the bladder and umbilicus. He was diagnosed with an umbilical-urachal sinus. Complete surgical excision was recommended and performed by urology without complication.

We report an unusual presentation of a symptomatic urachal remnant in an adult. During embryogenesis, the urachus connects the umbilicus to the developing bladder and normally involutes during development. Incomplete regression can cause rare pathological urachal anomalies. The clinical presentation is nonspecific and differs between children and adults, with most cases presenting during infancy or childhood.¹ Pediatric urachal abnormalities often present with umbilical drainage, abdominal pain, a palpable mass, an abnormal appearance of the umbilicus, or urinary tract infections.^2,3 In adults, the most common symptoms include hematuria, pain, or dysuria. Alternatively, they may be asympomatic³ or present with periumbilical dermatitis⁴ or abscess. Rodrigues and Gandhi⁵ reported another case of a symptomatic calculus formed within a urachal remnant. Calcifications in urachal remnants are rare and usually are reported as incidental radiologic findings.

Overall, visible umbilical masses occur infrequently. In addition to urachal anomalies, the differential diagnosis includes several benign and malignant pathologies. Benign causes include epidermoid cysts, foreign body granulomas, pyogenic granulomas, abscesses, hamartomas, nevi, hemangiomas, dermatofibromas, neurofibromas, lipomas, granular cell tumors, desmoid tumors, keloid scars, omphaliths, hernias, or omphalomesenteric duct remnants.⁶ Primary malignancies (eg, skin cancers, urachal adenocarcinoma, mesenchymal tumors) or metastasis (ie, Sister Mary Joseph nodule) also can present as umbilical nodules.

The wide range of clinical presentations of urachal anomalies combined with the rarity make diagnosis difficult. Thus, it is essential to have a high index of suspicion and awareness of how they can present. Ultrasonography and CT scan are useful tools in making the diagnosis. Urachal anomalies are prone to infection or can be associated with malignancy; therefore, timely and correct diagnosis is critical. Although surgical removal is the primary treatment for urachal anomalies, it may not be the primary treatment of the other entities included in the differential diagnosis of umbilical nodules. For example, the Sister Mary Joseph nodule can be associated with various primary malignancies, which should be treated accordingly.

To the Editor:

An otherwise healthy 26-year-old man presented to our outpatient clinic with a 15- to 20-mm, shiny, friable-appearing, red umbilical nodule with clear malodorous discharge (Figure 1). The lesion developed 2 weeks prior and gradually increased in size and discomfort. The patient reported mild associated abdominal pain. He had no fever, changes in urination or bowel movements, or prior history of umbilical growths or drainage. The abdomen was tender to palpation.

Differential diagnoses included pyogenic granuloma, umbilical hernia, epidermoid cyst or abscess, and malignancy (low suspicion). A biopsy was not performed due to concern for bleeding or communication with the bowel. A complete blood cell count, comprehensive metabolic panel, and urinalysis were unremarkable except for mild leukocytosis and elevated C-reactive protein. Ultrasonography revealed a 1.4×1.3-cm inflammatory umbilical mass with no communication with the bowel. The patient was referred to the emergency department (ED) for further evaluation. Computed tomography (CT) revealed periumbilical inflammation and an associated 1-cm calcification that appeared to be connected to a potential tract from the bladder, suggestive of a urachal remnant calcification (Figure 2). The patient was diagnosed with a persistent urachal remnant, discharged home with ciprofloxacin, and scheduled for a follow-up with urology.

The patient returned to the ED 3 days later with painful umbilical bleeding (Figure 3). While there, the patient extracted a 1-cm stone from the lesion, consistent with the calcification visualized on CT scan. Computed tomographic virtual cystoscopy showed no connection between the bladder and umbilicus. He was diagnosed with an umbilical-urachal sinus. Complete surgical excision was recommended and performed by urology without complication.

We report an unusual presentation of a symptomatic urachal remnant in an adult. During embryogenesis, the urachus connects the umbilicus to the developing bladder and normally involutes during development. Incomplete regression can cause rare pathological urachal anomalies. The clinical presentation is nonspecific and differs between children and adults, with most cases presenting during infancy or childhood.¹ Pediatric urachal abnormalities often present with umbilical drainage, abdominal pain, a palpable mass, an abnormal appearance of the umbilicus, or urinary tract infections.^2,3 In adults, the most common symptoms include hematuria, pain, or dysuria. Alternatively, they may be asympomatic³ or present with periumbilical dermatitis⁴ or abscess. Rodrigues and Gandhi⁵ reported another case of a symptomatic calculus formed within a urachal remnant. Calcifications in urachal remnants are rare and usually are reported as incidental radiologic findings.

Overall, visible umbilical masses occur infrequently. In addition to urachal anomalies, the differential diagnosis includes several benign and malignant pathologies. Benign causes include epidermoid cysts, foreign body granulomas, pyogenic granulomas, abscesses, hamartomas, nevi, hemangiomas, dermatofibromas, neurofibromas, lipomas, granular cell tumors, desmoid tumors, keloid scars, omphaliths, hernias, or omphalomesenteric duct remnants.⁶ Primary malignancies (eg, skin cancers, urachal adenocarcinoma, mesenchymal tumors) or metastasis (ie, Sister Mary Joseph nodule) also can present as umbilical nodules.

The wide range of clinical presentations of urachal anomalies combined with the rarity make diagnosis difficult. Thus, it is essential to have a high index of suspicion and awareness of how they can present. Ultrasonography and CT scan are useful tools in making the diagnosis. Urachal anomalies are prone to infection or can be associated with malignancy; therefore, timely and correct diagnosis is critical. Although surgical removal is the primary treatment for urachal anomalies, it may not be the primary treatment of the other entities included in the differential diagnosis of umbilical nodules. For example, the Sister Mary Joseph nodule can be associated with various primary malignancies, which should be treated accordingly.

To the Editor:

An otherwise healthy 26-year-old man presented to our outpatient clinic with a 15- to 20-mm, shiny, friable-appearing, red umbilical nodule with clear malodorous discharge (Figure 1). The lesion developed 2 weeks prior and gradually increased in size and discomfort. The patient reported mild associated abdominal pain. He had no fever, changes in urination or bowel movements, or prior history of umbilical growths or drainage. The abdomen was tender to palpation.

Differential diagnoses included pyogenic granuloma, umbilical hernia, epidermoid cyst or abscess, and malignancy (low suspicion). A biopsy was not performed due to concern for bleeding or communication with the bowel. A complete blood cell count, comprehensive metabolic panel, and urinalysis were unremarkable except for mild leukocytosis and elevated C-reactive protein. Ultrasonography revealed a 1.4×1.3-cm inflammatory umbilical mass with no communication with the bowel. The patient was referred to the emergency department (ED) for further evaluation. Computed tomography (CT) revealed periumbilical inflammation and an associated 1-cm calcification that appeared to be connected to a potential tract from the bladder, suggestive of a urachal remnant calcification (Figure 2). The patient was diagnosed with a persistent urachal remnant, discharged home with ciprofloxacin, and scheduled for a follow-up with urology.

The patient returned to the ED 3 days later with painful umbilical bleeding (Figure 3). While there, the patient extracted a 1-cm stone from the lesion, consistent with the calcification visualized on CT scan. Computed tomographic virtual cystoscopy showed no connection between the bladder and umbilicus. He was diagnosed with an umbilical-urachal sinus. Complete surgical excision was recommended and performed by urology without complication.

We report an unusual presentation of a symptomatic urachal remnant in an adult. During embryogenesis, the urachus connects the umbilicus to the developing bladder and normally involutes during development. Incomplete regression can cause rare pathological urachal anomalies. The clinical presentation is nonspecific and differs between children and adults, with most cases presenting during infancy or childhood.¹ Pediatric urachal abnormalities often present with umbilical drainage, abdominal pain, a palpable mass, an abnormal appearance of the umbilicus, or urinary tract infections.^2,3 In adults, the most common symptoms include hematuria, pain, or dysuria. Alternatively, they may be asympomatic³ or present with periumbilical dermatitis⁴ or abscess. Rodrigues and Gandhi⁵ reported another case of a symptomatic calculus formed within a urachal remnant. Calcifications in urachal remnants are rare and usually are reported as incidental radiologic findings.

Overall, visible umbilical masses occur infrequently. In addition to urachal anomalies, the differential diagnosis includes several benign and malignant pathologies. Benign causes include epidermoid cysts, foreign body granulomas, pyogenic granulomas, abscesses, hamartomas, nevi, hemangiomas, dermatofibromas, neurofibromas, lipomas, granular cell tumors, desmoid tumors, keloid scars, omphaliths, hernias, or omphalomesenteric duct remnants.⁶ Primary malignancies (eg, skin cancers, urachal adenocarcinoma, mesenchymal tumors) or metastasis (ie, Sister Mary Joseph nodule) also can present as umbilical nodules.

The wide range of clinical presentations of urachal anomalies combined with the rarity make diagnosis difficult. Thus, it is essential to have a high index of suspicion and awareness of how they can present. Ultrasonography and CT scan are useful tools in making the diagnosis. Urachal anomalies are prone to infection or can be associated with malignancy; therefore, timely and correct diagnosis is critical. Although surgical removal is the primary treatment for urachal anomalies, it may not be the primary treatment of the other entities included in the differential diagnosis of umbilical nodules. For example, the Sister Mary Joseph nodule can be associated with various primary malignancies, which should be treated accordingly.