It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.

Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.

Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.

The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.

InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.

Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”

Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”

Smart pens: How large is the market?

Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.

She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.

Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”

But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”

Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.

Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”

As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”

In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
 

Emerging field: “I think they’re here to stay”

The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.

The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.

Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.

Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.

For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.

Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.

Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.

“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”

Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
 

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

Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.

Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.

Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.

The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.

InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.

Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”

Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”

Smart pens: How large is the market?

Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.

She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.

Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”

But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”

Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.

Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”

As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”

In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
 

Emerging field: “I think they’re here to stay”

The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.

The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.

Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.

Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.

For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.

Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.

Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.

“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”

Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
 

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

Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.

Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.

Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.

The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.

InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.

Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”

Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”

Smart pens: How large is the market?

Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.

She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.

Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”

But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”

Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.

Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”

As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”

In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
 

Emerging field: “I think they’re here to stay”

The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.

The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.

Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.

Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.

For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.

Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.

Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.

“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”

Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
 

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

In 1993 I graduated from medical school. That same year Betaseron (interferon beta-1b) came to market as the first treatment specifically approved for multiple sclerosis (MS). This was a groundbreaker at the time, as there’d been little besides steroids and other potent immunosuppressants to try. Now we had a real drug to offer patients.

The demand for Betaseron was huge, so much so that a lottery system was used to determine which patients would get it first, as there simply wasn’t enough to go around. In the next several years a few more agents jumped into the ring – Avonex (interferon beta-1a), Copaxone (glatiramer acetate), Novantrone (mitoxantrone), and Rebif (interferon beta-1a) – before things went quiet for a while.

In 2006 the first monoclonal antibody for MS – Tysabri (natalizumab) – came out, then almost just as quickly vanished again, not returning until 2009.

Since then we’ve had a gradual explosion of new treatments for MS – like watching kernels become popcorn – first one, then two, then a deluge filling up the basket.

So here we are, approaching the end of 2020, with a remarkable collection of monoclonal antibodies, S1P modulators, fumarates, immunosuppressants, and one symptomatic treatment, many of which weren’t even imagined in 1993. Not to mention the original ABCR (Avonex, Betaseron, Copaxone, Rebif) agents, though they’re riding into the sunset.

A friend and I were talking about this remarkable success story. MS certainly hasn’t been cured, but its treatments have had a dramatic improvement in efficacy over the last quarter century.

He made a point though: that this selection of treatments may be relegating MS from the province of a general neurologist to that of the fellowship-trained MS subspecialist.

Not that that is such a bad thing, as MS is a very challenging disease. But the point is well taken. As treatments become increasingly complicated, and numerous, it becomes harder to know which one is best. Most of us likely choose orals first and monoclonal antibodies second, but the question of “which one?” arises for each category. They each have their own risks, side effects, initiation protocols, and peculiarities. In a disease of heterogeneous presentations and courses, there are no clear data on which agent to start first for what patient type. To a general neurologist, also juggling migraines, strokes, Parkinson’s disease, dementia, and neuropathy (and many other disorders) in the course of a day, it becomes tricky to keep up on such.

At some point do general neurologists become a victim of this success? Maybe, but probably not. Just as there are more general practitioners than neurologists, there are more general neurologists than MS subspecialists. Their knowledge and training should be reserved for those patients not responding to our first- (and second-) line treatments, presentations that are atypical, and more complex issues outside the scope of those of us practicing whatever-comes-to-the-door neurology.

It would, however, be nice to have a good consensus on how to best use this array of treatments. Solid guidelines, breaking disease subtypes and treatments down by patient types, drugs, and mechanisms of action, would help those of us on the neurology frontlines to better care for those who need us.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

In 1993 I graduated from medical school. That same year Betaseron (interferon beta-1b) came to market as the first treatment specifically approved for multiple sclerosis (MS). This was a groundbreaker at the time, as there’d been little besides steroids and other potent immunosuppressants to try. Now we had a real drug to offer patients.

The demand for Betaseron was huge, so much so that a lottery system was used to determine which patients would get it first, as there simply wasn’t enough to go around. In the next several years a few more agents jumped into the ring – Avonex (interferon beta-1a), Copaxone (glatiramer acetate), Novantrone (mitoxantrone), and Rebif (interferon beta-1a) – before things went quiet for a while.

In 2006 the first monoclonal antibody for MS – Tysabri (natalizumab) – came out, then almost just as quickly vanished again, not returning until 2009.

Since then we’ve had a gradual explosion of new treatments for MS – like watching kernels become popcorn – first one, then two, then a deluge filling up the basket.

So here we are, approaching the end of 2020, with a remarkable collection of monoclonal antibodies, S1P modulators, fumarates, immunosuppressants, and one symptomatic treatment, many of which weren’t even imagined in 1993. Not to mention the original ABCR (Avonex, Betaseron, Copaxone, Rebif) agents, though they’re riding into the sunset.

A friend and I were talking about this remarkable success story. MS certainly hasn’t been cured, but its treatments have had a dramatic improvement in efficacy over the last quarter century.

He made a point though: that this selection of treatments may be relegating MS from the province of a general neurologist to that of the fellowship-trained MS subspecialist.

Not that that is such a bad thing, as MS is a very challenging disease. But the point is well taken. As treatments become increasingly complicated, and numerous, it becomes harder to know which one is best. Most of us likely choose orals first and monoclonal antibodies second, but the question of “which one?” arises for each category. They each have their own risks, side effects, initiation protocols, and peculiarities. In a disease of heterogeneous presentations and courses, there are no clear data on which agent to start first for what patient type. To a general neurologist, also juggling migraines, strokes, Parkinson’s disease, dementia, and neuropathy (and many other disorders) in the course of a day, it becomes tricky to keep up on such.

At some point do general neurologists become a victim of this success? Maybe, but probably not. Just as there are more general practitioners than neurologists, there are more general neurologists than MS subspecialists. Their knowledge and training should be reserved for those patients not responding to our first- (and second-) line treatments, presentations that are atypical, and more complex issues outside the scope of those of us practicing whatever-comes-to-the-door neurology.

It would, however, be nice to have a good consensus on how to best use this array of treatments. Solid guidelines, breaking disease subtypes and treatments down by patient types, drugs, and mechanisms of action, would help those of us on the neurology frontlines to better care for those who need us.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

In 1993 I graduated from medical school. That same year Betaseron (interferon beta-1b) came to market as the first treatment specifically approved for multiple sclerosis (MS). This was a groundbreaker at the time, as there’d been little besides steroids and other potent immunosuppressants to try. Now we had a real drug to offer patients.

The demand for Betaseron was huge, so much so that a lottery system was used to determine which patients would get it first, as there simply wasn’t enough to go around. In the next several years a few more agents jumped into the ring – Avonex (interferon beta-1a), Copaxone (glatiramer acetate), Novantrone (mitoxantrone), and Rebif (interferon beta-1a) – before things went quiet for a while.

In 2006 the first monoclonal antibody for MS – Tysabri (natalizumab) – came out, then almost just as quickly vanished again, not returning until 2009.

Since then we’ve had a gradual explosion of new treatments for MS – like watching kernels become popcorn – first one, then two, then a deluge filling up the basket.

So here we are, approaching the end of 2020, with a remarkable collection of monoclonal antibodies, S1P modulators, fumarates, immunosuppressants, and one symptomatic treatment, many of which weren’t even imagined in 1993. Not to mention the original ABCR (Avonex, Betaseron, Copaxone, Rebif) agents, though they’re riding into the sunset.

A friend and I were talking about this remarkable success story. MS certainly hasn’t been cured, but its treatments have had a dramatic improvement in efficacy over the last quarter century.

He made a point though: that this selection of treatments may be relegating MS from the province of a general neurologist to that of the fellowship-trained MS subspecialist.

Not that that is such a bad thing, as MS is a very challenging disease. But the point is well taken. As treatments become increasingly complicated, and numerous, it becomes harder to know which one is best. Most of us likely choose orals first and monoclonal antibodies second, but the question of “which one?” arises for each category. They each have their own risks, side effects, initiation protocols, and peculiarities. In a disease of heterogeneous presentations and courses, there are no clear data on which agent to start first for what patient type. To a general neurologist, also juggling migraines, strokes, Parkinson’s disease, dementia, and neuropathy (and many other disorders) in the course of a day, it becomes tricky to keep up on such.

At some point do general neurologists become a victim of this success? Maybe, but probably not. Just as there are more general practitioners than neurologists, there are more general neurologists than MS subspecialists. Their knowledge and training should be reserved for those patients not responding to our first- (and second-) line treatments, presentations that are atypical, and more complex issues outside the scope of those of us practicing whatever-comes-to-the-door neurology.

It would, however, be nice to have a good consensus on how to best use this array of treatments. Solid guidelines, breaking disease subtypes and treatments down by patient types, drugs, and mechanisms of action, would help those of us on the neurology frontlines to better care for those who need us.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

Gusacitinib, a novel oral inhibitor of multiple inflammatory pathways, achieved rapid and clinically meaningful improvement in corticosteroid-refractory moderate to severe chronic hand eczema in a phase 2b, randomized trial, Howard Sofen, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

The once-daily drug proved effective for this challenging condition, regardless of whether an individual’s chronic hand eczema was driven chiefly by irritant contact dermatitis, allergic contact dermatitis, or atopic dermatitis, added Dr. Sofen, medical director of Dermatology Research Associates, Los Angeles, and chief of the dermatology division at LA County/Olive View Medical Center.

Gusacitinib is a once-daily oral inhibitor of Janus kinase 1, 2, and 3, tyrosine kinase 2, and spleen tyrosine kinase (SYK). As such, it targets the Th1, Th2, Th17, and Th22 cytokine pathways, as well as SYK-mediated interleukin-17 signaling of keratinocyte proliferation and differentiation. Thus, its spectrum of activity makes it a candidate for the treatment of a variety of other inflammatory dermatologic diseases, although chronic hand eczema alone affects an estimated 7 million Americans, the dermatologist noted.

The phase 2b, double-blind, 16-week, multicenter, randomized trial included 97 patients who were randomized to oral gusacitinib as monotherapy at 40 or 80 mg once daily or placebo. All participants had chronic hand eczema of more than 6 months duration that was refractory to potent or superpotent topical and/or systemic steroids. Participants were split 60/40 between those with severe chronic hand eczema, defined by a baseline score on the 0-4 Physician’s Global Assessment scale, and moderate disease, with a PGA of 3.

The primary endpoint was the percent improvement in modified total lesion severity score (mTLSS) at week 16 from a mean baseline of 13.2. A clearcut dose response was evident: Gusacitinib at 80 mg/day achieved a 69.5% decrease, while 40 mg brought a 40% reduction, which wasn’t significantly better than the 33.5% decrease in placebo-treated controls.

The rapidity of response was noteworthy in these steroid-refractory patients. The 80-mg group showed significant separation from placebo by 2 weeks, with a mean 40.1% reduction in mTLSS versus 13.6% with placebo.

The secondary endpoint was achievement of a PGA score of 0 or 1 – that is, clear or almost clear – with a 2-grade improvement over placebo. This was achieved in 31.3% of patients assigned to the higher dose of gusacitinib at week 16, a success rate fivefold higher than the 6.3% rate in controls. The two groups separated on this endpoint at week 2, the first assessment. At week 8 there was an eightfold difference in response: 25% in patients on gusacitinib at 80 mg, 3.1% with placebo.

The other secondary endpoint was improvement in itch as measured by the mTLSS pruritus 0-3 subscore. As for the other outcomes, the improvement in itch was rapid. At week 2, patients on gusacitinib at 80 mg averaged a 43.1% reduction from their baseline pruritus score, compared with 4.6% with placebo. At week 16, the reductions were 65.7% and 29.8%, respectively.

Both doses of gusacitinib were well tolerated, according to Dr. Sofer. No thromboembolic events, major adverse cardiovascular events, or opportunistic infections occurred during the short 16-week study. The drug’s safety profile was consistent with what’s been seen in a collective gusacitinib clinical trial experience totaling more than 350 patients: mild to moderate nasopharyngitis, headache, asymptomatic elevations in creatine phosphokinase, and a slight increase in HDL cholesterol accompanied by a small reduction in LDL cholesterol.

Dr. Sofen reported receiving research funding from and serving as a consultant to Asana BioSciences, the study sponsor, as well as more than half a dozen other pharmaceutical companies.

[email protected]

Gusacitinib, a novel oral inhibitor of multiple inflammatory pathways, achieved rapid and clinically meaningful improvement in corticosteroid-refractory moderate to severe chronic hand eczema in a phase 2b, randomized trial, Howard Sofen, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

The once-daily drug proved effective for this challenging condition, regardless of whether an individual’s chronic hand eczema was driven chiefly by irritant contact dermatitis, allergic contact dermatitis, or atopic dermatitis, added Dr. Sofen, medical director of Dermatology Research Associates, Los Angeles, and chief of the dermatology division at LA County/Olive View Medical Center.

Gusacitinib is a once-daily oral inhibitor of Janus kinase 1, 2, and 3, tyrosine kinase 2, and spleen tyrosine kinase (SYK). As such, it targets the Th1, Th2, Th17, and Th22 cytokine pathways, as well as SYK-mediated interleukin-17 signaling of keratinocyte proliferation and differentiation. Thus, its spectrum of activity makes it a candidate for the treatment of a variety of other inflammatory dermatologic diseases, although chronic hand eczema alone affects an estimated 7 million Americans, the dermatologist noted.

The phase 2b, double-blind, 16-week, multicenter, randomized trial included 97 patients who were randomized to oral gusacitinib as monotherapy at 40 or 80 mg once daily or placebo. All participants had chronic hand eczema of more than 6 months duration that was refractory to potent or superpotent topical and/or systemic steroids. Participants were split 60/40 between those with severe chronic hand eczema, defined by a baseline score on the 0-4 Physician’s Global Assessment scale, and moderate disease, with a PGA of 3.

The primary endpoint was the percent improvement in modified total lesion severity score (mTLSS) at week 16 from a mean baseline of 13.2. A clearcut dose response was evident: Gusacitinib at 80 mg/day achieved a 69.5% decrease, while 40 mg brought a 40% reduction, which wasn’t significantly better than the 33.5% decrease in placebo-treated controls.

The rapidity of response was noteworthy in these steroid-refractory patients. The 80-mg group showed significant separation from placebo by 2 weeks, with a mean 40.1% reduction in mTLSS versus 13.6% with placebo.

The secondary endpoint was achievement of a PGA score of 0 or 1 – that is, clear or almost clear – with a 2-grade improvement over placebo. This was achieved in 31.3% of patients assigned to the higher dose of gusacitinib at week 16, a success rate fivefold higher than the 6.3% rate in controls. The two groups separated on this endpoint at week 2, the first assessment. At week 8 there was an eightfold difference in response: 25% in patients on gusacitinib at 80 mg, 3.1% with placebo.

The other secondary endpoint was improvement in itch as measured by the mTLSS pruritus 0-3 subscore. As for the other outcomes, the improvement in itch was rapid. At week 2, patients on gusacitinib at 80 mg averaged a 43.1% reduction from their baseline pruritus score, compared with 4.6% with placebo. At week 16, the reductions were 65.7% and 29.8%, respectively.

Both doses of gusacitinib were well tolerated, according to Dr. Sofer. No thromboembolic events, major adverse cardiovascular events, or opportunistic infections occurred during the short 16-week study. The drug’s safety profile was consistent with what’s been seen in a collective gusacitinib clinical trial experience totaling more than 350 patients: mild to moderate nasopharyngitis, headache, asymptomatic elevations in creatine phosphokinase, and a slight increase in HDL cholesterol accompanied by a small reduction in LDL cholesterol.

Dr. Sofen reported receiving research funding from and serving as a consultant to Asana BioSciences, the study sponsor, as well as more than half a dozen other pharmaceutical companies.

[email protected]

Gusacitinib, a novel oral inhibitor of multiple inflammatory pathways, achieved rapid and clinically meaningful improvement in corticosteroid-refractory moderate to severe chronic hand eczema in a phase 2b, randomized trial, Howard Sofen, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

The once-daily drug proved effective for this challenging condition, regardless of whether an individual’s chronic hand eczema was driven chiefly by irritant contact dermatitis, allergic contact dermatitis, or atopic dermatitis, added Dr. Sofen, medical director of Dermatology Research Associates, Los Angeles, and chief of the dermatology division at LA County/Olive View Medical Center.

Gusacitinib is a once-daily oral inhibitor of Janus kinase 1, 2, and 3, tyrosine kinase 2, and spleen tyrosine kinase (SYK). As such, it targets the Th1, Th2, Th17, and Th22 cytokine pathways, as well as SYK-mediated interleukin-17 signaling of keratinocyte proliferation and differentiation. Thus, its spectrum of activity makes it a candidate for the treatment of a variety of other inflammatory dermatologic diseases, although chronic hand eczema alone affects an estimated 7 million Americans, the dermatologist noted.

The phase 2b, double-blind, 16-week, multicenter, randomized trial included 97 patients who were randomized to oral gusacitinib as monotherapy at 40 or 80 mg once daily or placebo. All participants had chronic hand eczema of more than 6 months duration that was refractory to potent or superpotent topical and/or systemic steroids. Participants were split 60/40 between those with severe chronic hand eczema, defined by a baseline score on the 0-4 Physician’s Global Assessment scale, and moderate disease, with a PGA of 3.

The primary endpoint was the percent improvement in modified total lesion severity score (mTLSS) at week 16 from a mean baseline of 13.2. A clearcut dose response was evident: Gusacitinib at 80 mg/day achieved a 69.5% decrease, while 40 mg brought a 40% reduction, which wasn’t significantly better than the 33.5% decrease in placebo-treated controls.

The rapidity of response was noteworthy in these steroid-refractory patients. The 80-mg group showed significant separation from placebo by 2 weeks, with a mean 40.1% reduction in mTLSS versus 13.6% with placebo.

The secondary endpoint was achievement of a PGA score of 0 or 1 – that is, clear or almost clear – with a 2-grade improvement over placebo. This was achieved in 31.3% of patients assigned to the higher dose of gusacitinib at week 16, a success rate fivefold higher than the 6.3% rate in controls. The two groups separated on this endpoint at week 2, the first assessment. At week 8 there was an eightfold difference in response: 25% in patients on gusacitinib at 80 mg, 3.1% with placebo.

The other secondary endpoint was improvement in itch as measured by the mTLSS pruritus 0-3 subscore. As for the other outcomes, the improvement in itch was rapid. At week 2, patients on gusacitinib at 80 mg averaged a 43.1% reduction from their baseline pruritus score, compared with 4.6% with placebo. At week 16, the reductions were 65.7% and 29.8%, respectively.

Both doses of gusacitinib were well tolerated, according to Dr. Sofer. No thromboembolic events, major adverse cardiovascular events, or opportunistic infections occurred during the short 16-week study. The drug’s safety profile was consistent with what’s been seen in a collective gusacitinib clinical trial experience totaling more than 350 patients: mild to moderate nasopharyngitis, headache, asymptomatic elevations in creatine phosphokinase, and a slight increase in HDL cholesterol accompanied by a small reduction in LDL cholesterol.

Dr. Sofen reported receiving research funding from and serving as a consultant to Asana BioSciences, the study sponsor, as well as more than half a dozen other pharmaceutical companies.

[email protected]

The FDA issued an emergency use authorization Tuesday for the first self-testing COVID-19 kit to use at home, which provides results in about 30 minutes.

The Lucira COVID-19 All-In-One Test-Kit is a single-use test that has a nasal swab to collect samples for people ages 14 and older. It’s available only by prescription, which can be given by a doctor who suspects a patient may have contracted the coronavirus.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn, MD, said in the statement.

The test kit can also be used in doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a health care professional if the patient is under age 14.

After using the nasal swab, the test works by swirling the sample in a vial and then placing it in the provided test unit, according to the FDA. Within 30 minutes, the results appear on the unit’s light-up display. People who receive a positive result should self-isolate and seek care from their doctor. Those who test negative but have COVID-like symptoms should follow up with their doctor, since a negative result doesn’t necessarily mean they don’t have the coronavirus.

Testing is still a key part of controlling the spread of the coronavirus, Reuters reports. The United States surpassed 11 million infections Sunday, only 8 days after passing 10 million cases.

With the at-home testing kit, public health officials still need to track and monitor results. As part of the emergency use authorization, the FDA requires doctors who prescribe the tests to report all results to public health authorities based on local, state, and federal requirements. Lucira Health, the test maker, also created box labeling and instructions to help doctors to report results.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

This article first appeared on WebMD.com.

The FDA issued an emergency use authorization Tuesday for the first self-testing COVID-19 kit to use at home, which provides results in about 30 minutes.

The Lucira COVID-19 All-In-One Test-Kit is a single-use test that has a nasal swab to collect samples for people ages 14 and older. It’s available only by prescription, which can be given by a doctor who suspects a patient may have contracted the coronavirus.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn, MD, said in the statement.

The test kit can also be used in doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a health care professional if the patient is under age 14.

After using the nasal swab, the test works by swirling the sample in a vial and then placing it in the provided test unit, according to the FDA. Within 30 minutes, the results appear on the unit’s light-up display. People who receive a positive result should self-isolate and seek care from their doctor. Those who test negative but have COVID-like symptoms should follow up with their doctor, since a negative result doesn’t necessarily mean they don’t have the coronavirus.

Testing is still a key part of controlling the spread of the coronavirus, Reuters reports. The United States surpassed 11 million infections Sunday, only 8 days after passing 10 million cases.

With the at-home testing kit, public health officials still need to track and monitor results. As part of the emergency use authorization, the FDA requires doctors who prescribe the tests to report all results to public health authorities based on local, state, and federal requirements. Lucira Health, the test maker, also created box labeling and instructions to help doctors to report results.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

This article first appeared on WebMD.com.

The FDA issued an emergency use authorization Tuesday for the first self-testing COVID-19 kit to use at home, which provides results in about 30 minutes.

The Lucira COVID-19 All-In-One Test-Kit is a single-use test that has a nasal swab to collect samples for people ages 14 and older. It’s available only by prescription, which can be given by a doctor who suspects a patient may have contracted the coronavirus.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn, MD, said in the statement.

The test kit can also be used in doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a health care professional if the patient is under age 14.

After using the nasal swab, the test works by swirling the sample in a vial and then placing it in the provided test unit, according to the FDA. Within 30 minutes, the results appear on the unit’s light-up display. People who receive a positive result should self-isolate and seek care from their doctor. Those who test negative but have COVID-like symptoms should follow up with their doctor, since a negative result doesn’t necessarily mean they don’t have the coronavirus.

Testing is still a key part of controlling the spread of the coronavirus, Reuters reports. The United States surpassed 11 million infections Sunday, only 8 days after passing 10 million cases.

With the at-home testing kit, public health officials still need to track and monitor results. As part of the emergency use authorization, the FDA requires doctors who prescribe the tests to report all results to public health authorities based on local, state, and federal requirements. Lucira Health, the test maker, also created box labeling and instructions to help doctors to report results.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

This article first appeared on WebMD.com.

The full 5-year results of a long-term extension study of tildrakizumab for psoriasis show a high rate of sustained disease control coupled with a favorable safety profile during more than 5,400 patient-years of prospective follow-up, Diamont Thaçi, MD, PhD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

For example, 89% of patients who had a PASI-75 response on the 100-mg dose of tildrakizumab (Ilumya) – the dose approved in the United States – at week 28 in the parent reSURFACE 1 and reSURFACE 2 trials maintained their PASI-75 response throughout the next 4½ years in the long-term extension study, as did 93% of those with a week 28 PASI-75 response on 200 mg, a dose approved elsewhere, said Dr. Thaçi, professor of dermatology and director of the Comprehensive Center for Inflammation Medicine at Lübeck (Germany) University.

The same held true for PASI-90, a response achieved by 71% of participants on 100 mg of tildrakizumab at week 28 and 66% at week 244, and by 73% of those on the 200-mg dose at week 28 and 70% at 5 years. A PASI-100 response was documented at week 28 in 29% of patients on the lower dose and 37% of those on 200 mg, with week 244 PASI-100 rates of 33% and 41%, respectively.

The long-term extension study enrolled 622 patients with moderate to severe chronic plaque psoriasis with at least a PASI-75 response to 100 mg or 200 mg of the humanized monoclonal antibody interleukin-23p19 inhibitor at week 28 in reSURFACE 1 or 2, or who were partial or nonresponders to etanercept in reSURFACE 2 and were then switched to tildrakizumab at 200 mg. Five hundred and forty-five of the 622 patients (88%) completed the full 5 years of the extension study.

Very few patients left the study because of loss of efficacy or adverse events. Indeed, the exposure-adjusted rate of drug-related serious adverse events was 0.8 cases per 100 patient-years at tildrakizumab 100 mg and 0.5 per 100 patient-years at 200 mg. Moreover, the rates of drug-related serious adverse events leading to treatment continuation were 0.3 and 0.2 per 100 patient-years at the 100-mg and 200-mg doses. Rates of treatment-emergent severe infection were 1.2 and 1.3 per 100 patient-years on the lower and higher doses. Major adverse cardiovascular events occurred at rates of 0.5 and 0.7 cases per 100 patient-years.

“I think the adverse events are generally similar to what has been seen with other biologics, but slightly less with tildrakizumab. Registries will provide a clearer picture. What’s interesting is that even if you double the dosage you don’t see an increase in side effects,” Dr. Thaçi said.

Asked what happens when a tildrakizumab responder stops taking the monoclonal antibody, he replied, “This is something very interesting we see with the IL-23 inhibitors: The disease comes back very slowly. It takes months, and sometimes years, for the patient to lose the PASI-75 or even the PASI-90 response. But we still consider that continuous treatment is probably the better way to go because we cannot be sure who will lose or regain response. At the moment we don’t have a biomarker to tell us what we should do in our daily practice.”

Dr. Thaçi reported serving as an adviser to and paid investigator for Almirall, the study sponsor, and approximately 20 other pharmaceutical companies.

[email protected]

The full 5-year results of a long-term extension study of tildrakizumab for psoriasis show a high rate of sustained disease control coupled with a favorable safety profile during more than 5,400 patient-years of prospective follow-up, Diamont Thaçi, MD, PhD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

For example, 89% of patients who had a PASI-75 response on the 100-mg dose of tildrakizumab (Ilumya) – the dose approved in the United States – at week 28 in the parent reSURFACE 1 and reSURFACE 2 trials maintained their PASI-75 response throughout the next 4½ years in the long-term extension study, as did 93% of those with a week 28 PASI-75 response on 200 mg, a dose approved elsewhere, said Dr. Thaçi, professor of dermatology and director of the Comprehensive Center for Inflammation Medicine at Lübeck (Germany) University.

The same held true for PASI-90, a response achieved by 71% of participants on 100 mg of tildrakizumab at week 28 and 66% at week 244, and by 73% of those on the 200-mg dose at week 28 and 70% at 5 years. A PASI-100 response was documented at week 28 in 29% of patients on the lower dose and 37% of those on 200 mg, with week 244 PASI-100 rates of 33% and 41%, respectively.

The long-term extension study enrolled 622 patients with moderate to severe chronic plaque psoriasis with at least a PASI-75 response to 100 mg or 200 mg of the humanized monoclonal antibody interleukin-23p19 inhibitor at week 28 in reSURFACE 1 or 2, or who were partial or nonresponders to etanercept in reSURFACE 2 and were then switched to tildrakizumab at 200 mg. Five hundred and forty-five of the 622 patients (88%) completed the full 5 years of the extension study.

Very few patients left the study because of loss of efficacy or adverse events. Indeed, the exposure-adjusted rate of drug-related serious adverse events was 0.8 cases per 100 patient-years at tildrakizumab 100 mg and 0.5 per 100 patient-years at 200 mg. Moreover, the rates of drug-related serious adverse events leading to treatment continuation were 0.3 and 0.2 per 100 patient-years at the 100-mg and 200-mg doses. Rates of treatment-emergent severe infection were 1.2 and 1.3 per 100 patient-years on the lower and higher doses. Major adverse cardiovascular events occurred at rates of 0.5 and 0.7 cases per 100 patient-years.

“I think the adverse events are generally similar to what has been seen with other biologics, but slightly less with tildrakizumab. Registries will provide a clearer picture. What’s interesting is that even if you double the dosage you don’t see an increase in side effects,” Dr. Thaçi said.

Asked what happens when a tildrakizumab responder stops taking the monoclonal antibody, he replied, “This is something very interesting we see with the IL-23 inhibitors: The disease comes back very slowly. It takes months, and sometimes years, for the patient to lose the PASI-75 or even the PASI-90 response. But we still consider that continuous treatment is probably the better way to go because we cannot be sure who will lose or regain response. At the moment we don’t have a biomarker to tell us what we should do in our daily practice.”

Dr. Thaçi reported serving as an adviser to and paid investigator for Almirall, the study sponsor, and approximately 20 other pharmaceutical companies.

[email protected]

The full 5-year results of a long-term extension study of tildrakizumab for psoriasis show a high rate of sustained disease control coupled with a favorable safety profile during more than 5,400 patient-years of prospective follow-up, Diamont Thaçi, MD, PhD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

For example, 89% of patients who had a PASI-75 response on the 100-mg dose of tildrakizumab (Ilumya) – the dose approved in the United States – at week 28 in the parent reSURFACE 1 and reSURFACE 2 trials maintained their PASI-75 response throughout the next 4½ years in the long-term extension study, as did 93% of those with a week 28 PASI-75 response on 200 mg, a dose approved elsewhere, said Dr. Thaçi, professor of dermatology and director of the Comprehensive Center for Inflammation Medicine at Lübeck (Germany) University.

The same held true for PASI-90, a response achieved by 71% of participants on 100 mg of tildrakizumab at week 28 and 66% at week 244, and by 73% of those on the 200-mg dose at week 28 and 70% at 5 years. A PASI-100 response was documented at week 28 in 29% of patients on the lower dose and 37% of those on 200 mg, with week 244 PASI-100 rates of 33% and 41%, respectively.

The long-term extension study enrolled 622 patients with moderate to severe chronic plaque psoriasis with at least a PASI-75 response to 100 mg or 200 mg of the humanized monoclonal antibody interleukin-23p19 inhibitor at week 28 in reSURFACE 1 or 2, or who were partial or nonresponders to etanercept in reSURFACE 2 and were then switched to tildrakizumab at 200 mg. Five hundred and forty-five of the 622 patients (88%) completed the full 5 years of the extension study.

Very few patients left the study because of loss of efficacy or adverse events. Indeed, the exposure-adjusted rate of drug-related serious adverse events was 0.8 cases per 100 patient-years at tildrakizumab 100 mg and 0.5 per 100 patient-years at 200 mg. Moreover, the rates of drug-related serious adverse events leading to treatment continuation were 0.3 and 0.2 per 100 patient-years at the 100-mg and 200-mg doses. Rates of treatment-emergent severe infection were 1.2 and 1.3 per 100 patient-years on the lower and higher doses. Major adverse cardiovascular events occurred at rates of 0.5 and 0.7 cases per 100 patient-years.

“I think the adverse events are generally similar to what has been seen with other biologics, but slightly less with tildrakizumab. Registries will provide a clearer picture. What’s interesting is that even if you double the dosage you don’t see an increase in side effects,” Dr. Thaçi said.

Asked what happens when a tildrakizumab responder stops taking the monoclonal antibody, he replied, “This is something very interesting we see with the IL-23 inhibitors: The disease comes back very slowly. It takes months, and sometimes years, for the patient to lose the PASI-75 or even the PASI-90 response. But we still consider that continuous treatment is probably the better way to go because we cannot be sure who will lose or regain response. At the moment we don’t have a biomarker to tell us what we should do in our daily practice.”

Dr. Thaçi reported serving as an adviser to and paid investigator for Almirall, the study sponsor, and approximately 20 other pharmaceutical companies.

[email protected]

The first nationwide study of severe immune-related adverse events among cancer patients treated with immune checkpoint inhibitors helps identify those at elevated risk. The findings were reported at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

“Immune-related adverse events are a very serious side effect of immune checkpoint inhibitor therapy, and as this therapy has become more common for treating advanced cancers, the incidence of immune-related adverse events has increased as well,” said presenting author William Murphy, a dual MD and MBA student at Harvard Medical School and Harvard Business School, both in Boston.

“However, because there is no ICD code for immune-related adverse events, it’s very difficult to study them at a population level. Most of the current literature around the incidence of immune-related adverse events and factors that are predictive of incidence are based on clinical trials and small studies,” Mr. Murphy noted.

He and his colleagues analyzed claims data from a U.S. nationwide health insurance plan for 14,378 patients who had a primary cancer and received at least one administration of an immune checkpoint inhibitor – an inhibitor of PD-1, PD-L1, or CTLA4 – during 2011-2019.

Over 19,117 patient-years of follow-up, 504 patients (3.5%) developed a severe immune-related adverse event (irAE), defined as one occurring within 2 years of their treatment and requiring inpatient hospitalization and new immunosuppression.

The incidence of severe irAEs per patient treatment year was 2.6% overall, rising from 0% in 2011 to 3.7% in 2016.

In multivariate analysis, patients had an elevated risk of severe irAEs if they received combination immunotherapy as compared with monotherapy (odds ratio, 2.44; P < .001).

On the other hand, risk fell with advancing age (OR, 0.98 per additional year; P < .001). And risk was lower for patients with melanoma (OR, 0.70; P = .01), renal cell carcinoma (OR, 0.71; P = .03), and other cancers (OR, 0.50; P < .001), compared with lung cancer.

Sex, geographic region, income, employment status, and comorbidity were not significantly associated with the risk of severe irAEs.

“We hope that patients and providers can use this evidence from a nationwide study of severe irAEs to guide treatment and management decisions,” Mr. Murphy concluded.
 

Real-world evidence

“As the use of immune checkpoint inhibitors increases for patients with a variety of different tumor types, there is increasing need for population-level evidence for patients treated outside of clinical trials,” said Allison Betof Warner, MD, PhD, an assistant attending physician with the melanoma service at Memorial Sloan Kettering Cancer Center in New York.

“This is a well-conducted study with an innovative approach to using real-world evidence to examine immune-related adverse events,” she added.

To her knowledge, it is the first study to look at multiple cancers for which immunotherapy is approved, Dr. Betof Warner said. This approach resulted in a large patient sample, giving power to detect differences between groups.

“The authors’ finding that combination immunotherapy is associated with more severe irAEs is in line with our clinical experience and other data sets, and the data regarding increased odds of severe irAEs in younger patients and those with lung cancer raise interesting biological questions about the etiology of irAEs,” Dr. Betof Warner noted.

However, certain factors complicate interpretation of the study’s findings, she cautioned. One such factor is requiring hospitalization to define an irAE.

“Practice patterns regarding hospitalization vary quite widely from center to center. For example, in some centers, all patients with immune-mediated colitis are hospitalized, whereas in others, these patients are managed predominantly in the outpatient setting, even in cases of high-grade toxicity,” she explained. “Practice patterns have also changed drastically over time as oncologists have grown more comfortable managing immune-related adverse events.”

Another factor is potential confounding. For example, patients with melanoma are more likely to receive combination immunotherapy given its longstanding approval for this cancer, whereas it is comparatively new for other cancers. Also, age may differ across cancers.

“The data the authors have provided are a great starting point, but I think further analysis is needed before these observations can be validated and integrated into practice,” Dr. Betof Warner concluded.

This study did not receive any specific funding. Mr. Murphy and Dr. Betof Warner disclosed no relevant conflicts of interest.

SOURCE: Murphy W et al. SITC 2020, Abstract 854.

The first nationwide study of severe immune-related adverse events among cancer patients treated with immune checkpoint inhibitors helps identify those at elevated risk. The findings were reported at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

“Immune-related adverse events are a very serious side effect of immune checkpoint inhibitor therapy, and as this therapy has become more common for treating advanced cancers, the incidence of immune-related adverse events has increased as well,” said presenting author William Murphy, a dual MD and MBA student at Harvard Medical School and Harvard Business School, both in Boston.

“However, because there is no ICD code for immune-related adverse events, it’s very difficult to study them at a population level. Most of the current literature around the incidence of immune-related adverse events and factors that are predictive of incidence are based on clinical trials and small studies,” Mr. Murphy noted.

He and his colleagues analyzed claims data from a U.S. nationwide health insurance plan for 14,378 patients who had a primary cancer and received at least one administration of an immune checkpoint inhibitor – an inhibitor of PD-1, PD-L1, or CTLA4 – during 2011-2019.

Over 19,117 patient-years of follow-up, 504 patients (3.5%) developed a severe immune-related adverse event (irAE), defined as one occurring within 2 years of their treatment and requiring inpatient hospitalization and new immunosuppression.

The incidence of severe irAEs per patient treatment year was 2.6% overall, rising from 0% in 2011 to 3.7% in 2016.

In multivariate analysis, patients had an elevated risk of severe irAEs if they received combination immunotherapy as compared with monotherapy (odds ratio, 2.44; P < .001).

On the other hand, risk fell with advancing age (OR, 0.98 per additional year; P < .001). And risk was lower for patients with melanoma (OR, 0.70; P = .01), renal cell carcinoma (OR, 0.71; P = .03), and other cancers (OR, 0.50; P < .001), compared with lung cancer.

Sex, geographic region, income, employment status, and comorbidity were not significantly associated with the risk of severe irAEs.

“We hope that patients and providers can use this evidence from a nationwide study of severe irAEs to guide treatment and management decisions,” Mr. Murphy concluded.
 

Real-world evidence

“As the use of immune checkpoint inhibitors increases for patients with a variety of different tumor types, there is increasing need for population-level evidence for patients treated outside of clinical trials,” said Allison Betof Warner, MD, PhD, an assistant attending physician with the melanoma service at Memorial Sloan Kettering Cancer Center in New York.

“This is a well-conducted study with an innovative approach to using real-world evidence to examine immune-related adverse events,” she added.

To her knowledge, it is the first study to look at multiple cancers for which immunotherapy is approved, Dr. Betof Warner said. This approach resulted in a large patient sample, giving power to detect differences between groups.

“The authors’ finding that combination immunotherapy is associated with more severe irAEs is in line with our clinical experience and other data sets, and the data regarding increased odds of severe irAEs in younger patients and those with lung cancer raise interesting biological questions about the etiology of irAEs,” Dr. Betof Warner noted.

However, certain factors complicate interpretation of the study’s findings, she cautioned. One such factor is requiring hospitalization to define an irAE.

“Practice patterns regarding hospitalization vary quite widely from center to center. For example, in some centers, all patients with immune-mediated colitis are hospitalized, whereas in others, these patients are managed predominantly in the outpatient setting, even in cases of high-grade toxicity,” she explained. “Practice patterns have also changed drastically over time as oncologists have grown more comfortable managing immune-related adverse events.”

Another factor is potential confounding. For example, patients with melanoma are more likely to receive combination immunotherapy given its longstanding approval for this cancer, whereas it is comparatively new for other cancers. Also, age may differ across cancers.

“The data the authors have provided are a great starting point, but I think further analysis is needed before these observations can be validated and integrated into practice,” Dr. Betof Warner concluded.

This study did not receive any specific funding. Mr. Murphy and Dr. Betof Warner disclosed no relevant conflicts of interest.

SOURCE: Murphy W et al. SITC 2020, Abstract 854.

The first nationwide study of severe immune-related adverse events among cancer patients treated with immune checkpoint inhibitors helps identify those at elevated risk. The findings were reported at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

“Immune-related adverse events are a very serious side effect of immune checkpoint inhibitor therapy, and as this therapy has become more common for treating advanced cancers, the incidence of immune-related adverse events has increased as well,” said presenting author William Murphy, a dual MD and MBA student at Harvard Medical School and Harvard Business School, both in Boston.

“However, because there is no ICD code for immune-related adverse events, it’s very difficult to study them at a population level. Most of the current literature around the incidence of immune-related adverse events and factors that are predictive of incidence are based on clinical trials and small studies,” Mr. Murphy noted.

He and his colleagues analyzed claims data from a U.S. nationwide health insurance plan for 14,378 patients who had a primary cancer and received at least one administration of an immune checkpoint inhibitor – an inhibitor of PD-1, PD-L1, or CTLA4 – during 2011-2019.

Over 19,117 patient-years of follow-up, 504 patients (3.5%) developed a severe immune-related adverse event (irAE), defined as one occurring within 2 years of their treatment and requiring inpatient hospitalization and new immunosuppression.

The incidence of severe irAEs per patient treatment year was 2.6% overall, rising from 0% in 2011 to 3.7% in 2016.

In multivariate analysis, patients had an elevated risk of severe irAEs if they received combination immunotherapy as compared with monotherapy (odds ratio, 2.44; P < .001).

On the other hand, risk fell with advancing age (OR, 0.98 per additional year; P < .001). And risk was lower for patients with melanoma (OR, 0.70; P = .01), renal cell carcinoma (OR, 0.71; P = .03), and other cancers (OR, 0.50; P < .001), compared with lung cancer.

Sex, geographic region, income, employment status, and comorbidity were not significantly associated with the risk of severe irAEs.

“We hope that patients and providers can use this evidence from a nationwide study of severe irAEs to guide treatment and management decisions,” Mr. Murphy concluded.
 

Real-world evidence

“As the use of immune checkpoint inhibitors increases for patients with a variety of different tumor types, there is increasing need for population-level evidence for patients treated outside of clinical trials,” said Allison Betof Warner, MD, PhD, an assistant attending physician with the melanoma service at Memorial Sloan Kettering Cancer Center in New York.

“This is a well-conducted study with an innovative approach to using real-world evidence to examine immune-related adverse events,” she added.

To her knowledge, it is the first study to look at multiple cancers for which immunotherapy is approved, Dr. Betof Warner said. This approach resulted in a large patient sample, giving power to detect differences between groups.

“The authors’ finding that combination immunotherapy is associated with more severe irAEs is in line with our clinical experience and other data sets, and the data regarding increased odds of severe irAEs in younger patients and those with lung cancer raise interesting biological questions about the etiology of irAEs,” Dr. Betof Warner noted.

However, certain factors complicate interpretation of the study’s findings, she cautioned. One such factor is requiring hospitalization to define an irAE.

“Practice patterns regarding hospitalization vary quite widely from center to center. For example, in some centers, all patients with immune-mediated colitis are hospitalized, whereas in others, these patients are managed predominantly in the outpatient setting, even in cases of high-grade toxicity,” she explained. “Practice patterns have also changed drastically over time as oncologists have grown more comfortable managing immune-related adverse events.”

Another factor is potential confounding. For example, patients with melanoma are more likely to receive combination immunotherapy given its longstanding approval for this cancer, whereas it is comparatively new for other cancers. Also, age may differ across cancers.

“The data the authors have provided are a great starting point, but I think further analysis is needed before these observations can be validated and integrated into practice,” Dr. Betof Warner concluded.

This study did not receive any specific funding. Mr. Murphy and Dr. Betof Warner disclosed no relevant conflicts of interest.

SOURCE: Murphy W et al. SITC 2020, Abstract 854.

Death while on clozapine for schizophrenia is often associated with substandard treatment of cardiometabolic risk factors, Sharon Taub, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

“Inadequate treatment for metabolic syndrome was found to be a mortality predictor while on clozapine therapy. Patients who died were less likely to receive appropriate treatment for hyperlipidemia and type 2 diabetes, despite having been diagnosed with those conditions,” she said in presenting the results of her retrospective cohort study.

“Better preventive care, with special attention to those conditions, might prevent morbidity and improve life expectancy in this population,” concluded Dr. Taub of Geha Mental Health Center in Petah Tikva, Israel, and Tel Aviv University.

She reported on all 1,817 patients on clozapine for schizophrenia included in a large Israeli health care electronic medical records database, of whom 112, or 6.2%, died during 2 years of follow-up. Mortality while on the atypical antipsychotic was associated with a higher prevalence of hyperlipidemia, type 2 diabetes, hypertension, known ischemic heart disease, and a history of acute MI, compared with survivors.

Notably, patients who died on clozapine were markedly less likely to be on indicated statin therapy for their hyperlipidemia, by a margin of 13.7% to 52.9%. Similarly, only 16.3% of those known to have type 2 diabetes who died while on clozapine were on hypoglycemic agents, compared with 67.1% of diabetic survivors. The between-group difference in the use of antihypertensive drug therapy for patients diagnosed with hypertension – 28.6% in nonsurvivors on clozapine, 40.1% in survivors – did not achieve statistical significance.

In a multivariate analysis adjusted for age, sex, and socioeconomic status, schizophrenia patients with type 2 diabetes who weren’t on hypoglycemic medication were at 695% increased risk of mortality, compared with those who were. Similarly, hyperlipidemic patients on clozapine who weren’t on a statin had a 579% increase in mortality risk.

Patients who died while on clozapine had no increased risk of use of medical services while living in the community.

This evidence of a pattern of inadequate care with regard to management of cardiometabolic risk factors in patients on clozapine is disturbing for several reasons. For one, clozapine is known to be associated with increased risk of serious side effects, including development or worsening of metabolic syndrome. Also, clozapine is an important drug in psychiatric practice: “Clozapine is the only antipsychotic indicated for refractory schizophrenia. It is highly effective in treatment-resistant disease, present in 25%-30% of individuals with schizophrenia,” Dr. Taub noted. “Clozapine is underused, mostly because of severe side effects. Its administration is often postponed.”

She reported having no financial conflicts regarding her study, which was voted by conference attendees one of the top presentations at ECNP 2020.

[email protected]

Death while on clozapine for schizophrenia is often associated with substandard treatment of cardiometabolic risk factors, Sharon Taub, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

“Inadequate treatment for metabolic syndrome was found to be a mortality predictor while on clozapine therapy. Patients who died were less likely to receive appropriate treatment for hyperlipidemia and type 2 diabetes, despite having been diagnosed with those conditions,” she said in presenting the results of her retrospective cohort study.

“Better preventive care, with special attention to those conditions, might prevent morbidity and improve life expectancy in this population,” concluded Dr. Taub of Geha Mental Health Center in Petah Tikva, Israel, and Tel Aviv University.

She reported on all 1,817 patients on clozapine for schizophrenia included in a large Israeli health care electronic medical records database, of whom 112, or 6.2%, died during 2 years of follow-up. Mortality while on the atypical antipsychotic was associated with a higher prevalence of hyperlipidemia, type 2 diabetes, hypertension, known ischemic heart disease, and a history of acute MI, compared with survivors.

Notably, patients who died on clozapine were markedly less likely to be on indicated statin therapy for their hyperlipidemia, by a margin of 13.7% to 52.9%. Similarly, only 16.3% of those known to have type 2 diabetes who died while on clozapine were on hypoglycemic agents, compared with 67.1% of diabetic survivors. The between-group difference in the use of antihypertensive drug therapy for patients diagnosed with hypertension – 28.6% in nonsurvivors on clozapine, 40.1% in survivors – did not achieve statistical significance.

In a multivariate analysis adjusted for age, sex, and socioeconomic status, schizophrenia patients with type 2 diabetes who weren’t on hypoglycemic medication were at 695% increased risk of mortality, compared with those who were. Similarly, hyperlipidemic patients on clozapine who weren’t on a statin had a 579% increase in mortality risk.

Patients who died while on clozapine had no increased risk of use of medical services while living in the community.

This evidence of a pattern of inadequate care with regard to management of cardiometabolic risk factors in patients on clozapine is disturbing for several reasons. For one, clozapine is known to be associated with increased risk of serious side effects, including development or worsening of metabolic syndrome. Also, clozapine is an important drug in psychiatric practice: “Clozapine is the only antipsychotic indicated for refractory schizophrenia. It is highly effective in treatment-resistant disease, present in 25%-30% of individuals with schizophrenia,” Dr. Taub noted. “Clozapine is underused, mostly because of severe side effects. Its administration is often postponed.”

She reported having no financial conflicts regarding her study, which was voted by conference attendees one of the top presentations at ECNP 2020.

[email protected]

Death while on clozapine for schizophrenia is often associated with substandard treatment of cardiometabolic risk factors, Sharon Taub, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

“Inadequate treatment for metabolic syndrome was found to be a mortality predictor while on clozapine therapy. Patients who died were less likely to receive appropriate treatment for hyperlipidemia and type 2 diabetes, despite having been diagnosed with those conditions,” she said in presenting the results of her retrospective cohort study.

“Better preventive care, with special attention to those conditions, might prevent morbidity and improve life expectancy in this population,” concluded Dr. Taub of Geha Mental Health Center in Petah Tikva, Israel, and Tel Aviv University.

She reported on all 1,817 patients on clozapine for schizophrenia included in a large Israeli health care electronic medical records database, of whom 112, or 6.2%, died during 2 years of follow-up. Mortality while on the atypical antipsychotic was associated with a higher prevalence of hyperlipidemia, type 2 diabetes, hypertension, known ischemic heart disease, and a history of acute MI, compared with survivors.

Notably, patients who died on clozapine were markedly less likely to be on indicated statin therapy for their hyperlipidemia, by a margin of 13.7% to 52.9%. Similarly, only 16.3% of those known to have type 2 diabetes who died while on clozapine were on hypoglycemic agents, compared with 67.1% of diabetic survivors. The between-group difference in the use of antihypertensive drug therapy for patients diagnosed with hypertension – 28.6% in nonsurvivors on clozapine, 40.1% in survivors – did not achieve statistical significance.

In a multivariate analysis adjusted for age, sex, and socioeconomic status, schizophrenia patients with type 2 diabetes who weren’t on hypoglycemic medication were at 695% increased risk of mortality, compared with those who were. Similarly, hyperlipidemic patients on clozapine who weren’t on a statin had a 579% increase in mortality risk.

Patients who died while on clozapine had no increased risk of use of medical services while living in the community.

This evidence of a pattern of inadequate care with regard to management of cardiometabolic risk factors in patients on clozapine is disturbing for several reasons. For one, clozapine is known to be associated with increased risk of serious side effects, including development or worsening of metabolic syndrome. Also, clozapine is an important drug in psychiatric practice: “Clozapine is the only antipsychotic indicated for refractory schizophrenia. It is highly effective in treatment-resistant disease, present in 25%-30% of individuals with schizophrenia,” Dr. Taub noted. “Clozapine is underused, mostly because of severe side effects. Its administration is often postponed.”

She reported having no financial conflicts regarding her study, which was voted by conference attendees one of the top presentations at ECNP 2020.

[email protected]