TOPLINE:

Certain stimulants prescribed for attention-deficit/hyperactivity disorder (ADHD) are associated with a decreased risk for psychiatric and nonpsychiatric hospitalization and suicide, new data from a national cohort study showed.

METHODOLOGY:

• Investigators used various medical and administrative databases in Sweden to identify individuals aged 16-65 years who were diagnosed with ADHD between January 2006 and December 2021.
• Participants were followed for up to 15 years (mean duration, 7 years) from date of diagnosis until death, emigration, or end of data linkage in December 2021.
• Researchers wanted to explore the link between ADHD meds and psychiatric hospitalization, nonpsychiatric hospitalization, and suicidal behavior.

TAKEAWAY:

• The cohort included 221,700 individuals with ADHD (mean age, 25 years; 54% male), and 56% had a psychiatric comorbidity such as an anxiety or stress-related disorder (24%), and depression or bipolar disorder (20%).
• Investigators found significantly lower risk for psychiatric hospitalization for the several medications. These included amphetamine (adjusted hazard ratio [aHR], 0.74), lisdexamphetamine (aHR, 0.80), dexamphetamine (aHR, 0.88), methylphenidate (aHR, 0.93), and polytherapy (aHR, 0.85). All but atomoxetine was significant at the P < .001 level.
• ADHD medications associated with a significantly lower risk for nonpsychiatric hospitalization included amphetamine (aHR, 0.62), lisdexamphetamine (aHR, 0.64), polytherapy (aHR, 0.67), dexamphetamine (aHR, 0.72), methylphenidate (aHR, 0.80), and atomoxetine (aHR, 0.84). All but atomoxetine was significant at the P < .001 level.
• Use of dexamphetamine (aHR, 0.69; P < .001), lisdexamphetamine (aHR, 0.76; P = .43), polytherapy (aHR, 0.85; P = .02), and methylphenidate (aHR, 0.92; P = .007) were associated with a significantly lower risk for suicidal behavior.

IN PRACTICE:

“Although concerns have been raised about the potential of amphetamines and methylphenidate for increasing the risk of adverse psychiatric outcomes, such as psychosis and mania, our results show that overall, the net effect on psychiatric outcomes is positive,” study authors wrote.

SOURCE:

Heidi Taipale, PhD, of Karolinska Institutet, led the study, which was published online in JAMA Network Open. 

LIMITATIONS:

Due to the use of nationwide registers, there was a lack of detailed clinical data, including type and severity of symptoms. There was also no data on nonpharmacologic treatments.

DISCLOSURES:

The study was funded by the AFA Insurance Agency. Dr. Taipale reported receiving personal fees from Gedeon Richter, Janssen, Lundbeck, and Otsuka and grants from Janssen and Eli Lilly outside of the submitted work. Other disclosures are noted in the original article.

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

TOPLINE:

Certain stimulants prescribed for attention-deficit/hyperactivity disorder (ADHD) are associated with a decreased risk for psychiatric and nonpsychiatric hospitalization and suicide, new data from a national cohort study showed.

METHODOLOGY:

• Investigators used various medical and administrative databases in Sweden to identify individuals aged 16-65 years who were diagnosed with ADHD between January 2006 and December 2021.
• Participants were followed for up to 15 years (mean duration, 7 years) from date of diagnosis until death, emigration, or end of data linkage in December 2021.
• Researchers wanted to explore the link between ADHD meds and psychiatric hospitalization, nonpsychiatric hospitalization, and suicidal behavior.

TAKEAWAY:

• The cohort included 221,700 individuals with ADHD (mean age, 25 years; 54% male), and 56% had a psychiatric comorbidity such as an anxiety or stress-related disorder (24%), and depression or bipolar disorder (20%).
• Investigators found significantly lower risk for psychiatric hospitalization for the several medications. These included amphetamine (adjusted hazard ratio [aHR], 0.74), lisdexamphetamine (aHR, 0.80), dexamphetamine (aHR, 0.88), methylphenidate (aHR, 0.93), and polytherapy (aHR, 0.85). All but atomoxetine was significant at the P < .001 level.
• ADHD medications associated with a significantly lower risk for nonpsychiatric hospitalization included amphetamine (aHR, 0.62), lisdexamphetamine (aHR, 0.64), polytherapy (aHR, 0.67), dexamphetamine (aHR, 0.72), methylphenidate (aHR, 0.80), and atomoxetine (aHR, 0.84). All but atomoxetine was significant at the P < .001 level.
• Use of dexamphetamine (aHR, 0.69; P < .001), lisdexamphetamine (aHR, 0.76; P = .43), polytherapy (aHR, 0.85; P = .02), and methylphenidate (aHR, 0.92; P = .007) were associated with a significantly lower risk for suicidal behavior.

IN PRACTICE:

“Although concerns have been raised about the potential of amphetamines and methylphenidate for increasing the risk of adverse psychiatric outcomes, such as psychosis and mania, our results show that overall, the net effect on psychiatric outcomes is positive,” study authors wrote.

SOURCE:

Heidi Taipale, PhD, of Karolinska Institutet, led the study, which was published online in JAMA Network Open. 

LIMITATIONS:

Due to the use of nationwide registers, there was a lack of detailed clinical data, including type and severity of symptoms. There was also no data on nonpharmacologic treatments.

DISCLOSURES:

The study was funded by the AFA Insurance Agency. Dr. Taipale reported receiving personal fees from Gedeon Richter, Janssen, Lundbeck, and Otsuka and grants from Janssen and Eli Lilly outside of the submitted work. Other disclosures are noted in the original article.

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

TOPLINE:

Certain stimulants prescribed for attention-deficit/hyperactivity disorder (ADHD) are associated with a decreased risk for psychiatric and nonpsychiatric hospitalization and suicide, new data from a national cohort study showed.

METHODOLOGY:

• Investigators used various medical and administrative databases in Sweden to identify individuals aged 16-65 years who were diagnosed with ADHD between January 2006 and December 2021.
• Participants were followed for up to 15 years (mean duration, 7 years) from date of diagnosis until death, emigration, or end of data linkage in December 2021.
• Researchers wanted to explore the link between ADHD meds and psychiatric hospitalization, nonpsychiatric hospitalization, and suicidal behavior.

TAKEAWAY:

• The cohort included 221,700 individuals with ADHD (mean age, 25 years; 54% male), and 56% had a psychiatric comorbidity such as an anxiety or stress-related disorder (24%), and depression or bipolar disorder (20%).
• Investigators found significantly lower risk for psychiatric hospitalization for the several medications. These included amphetamine (adjusted hazard ratio [aHR], 0.74), lisdexamphetamine (aHR, 0.80), dexamphetamine (aHR, 0.88), methylphenidate (aHR, 0.93), and polytherapy (aHR, 0.85). All but atomoxetine was significant at the P < .001 level.
• ADHD medications associated with a significantly lower risk for nonpsychiatric hospitalization included amphetamine (aHR, 0.62), lisdexamphetamine (aHR, 0.64), polytherapy (aHR, 0.67), dexamphetamine (aHR, 0.72), methylphenidate (aHR, 0.80), and atomoxetine (aHR, 0.84). All but atomoxetine was significant at the P < .001 level.
• Use of dexamphetamine (aHR, 0.69; P < .001), lisdexamphetamine (aHR, 0.76; P = .43), polytherapy (aHR, 0.85; P = .02), and methylphenidate (aHR, 0.92; P = .007) were associated with a significantly lower risk for suicidal behavior.

IN PRACTICE:

“Although concerns have been raised about the potential of amphetamines and methylphenidate for increasing the risk of adverse psychiatric outcomes, such as psychosis and mania, our results show that overall, the net effect on psychiatric outcomes is positive,” study authors wrote.

SOURCE:

Heidi Taipale, PhD, of Karolinska Institutet, led the study, which was published online in JAMA Network Open. 

LIMITATIONS:

Due to the use of nationwide registers, there was a lack of detailed clinical data, including type and severity of symptoms. There was also no data on nonpharmacologic treatments.

DISCLOSURES:

The study was funded by the AFA Insurance Agency. Dr. Taipale reported receiving personal fees from Gedeon Richter, Janssen, Lundbeck, and Otsuka and grants from Janssen and Eli Lilly outside of the submitted work. Other disclosures are noted in the original article.

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

A few weeks ago I stumbled upon a two-sentence blurb in a pediatric newsletter summarizing the results of a study comparing the chemical profile of infant body odor with that of postpubertal adolescents. The investigators found that, not surprisingly, the smell of the chemical constituents wafting from babies was more appealing than that emanating from sweaty teenagers. I quickly moved on to the next blurb hoping to find something I hadn’t already experienced or figured out on my own.

But, as I navigated through the rest of my day filled with pickleball, bicycling, and the smell of home-cooked food, something about that study of body odor nagged at me. Who had funded that voyage into the obvious? Were my tax dollars involved? Had I been duped by some alleged nonprofit that had promised my donation would save lives or at least ameliorate suffering? Finally, as the sun dipped below the horizon, my curiosity got the best of me and I searched out the original study. Within minutes I fell down a rabbit hole into the cavernous world of odor science.

Having had zero experience in this niche field, I was amazed at the lengths to which these German odor investigators had gone to analyze the chemicals on and around their subjects. Just trying to ensure that materials and microclimates in the experimental environment were scent-free was a heroic effort. There was “Mono-trap sampling of volatiles, followed by thermodesorption-comprehensive gas chromatography, and time of flight-mass spectrometry analysis.” There were graphs and charts galore. This is serious science, folks. However, they still use the abbreviation “BO” freely, just as I learned to do in junior high. And, in some situations, the investigators relied on the observation of a panel of trained human sniffers to assess the detection threshold and the degree of pleasantness.

Ultimately, the authors’ conclusion was “sexual maturation coincides with changes in body odor chemical composition. Whether those changes explain differences in parental olfactory perception needs to be determined in future studies.” Again, no surprises here.

Exhausted by my venture into the realm of odor science, I finally found the answer to my burning question. The study was supported by the German Research Foundation and the European Union. Phew! Not on my nickel.

Lest you think that I believe any investigation into the potential role of smell in our health and well-being is pure bunk, let me make it clear that I think the role of odor detection is one of the least well-studied and potentially most valuable areas of medical research. Having had one family tell me that their black lab had twice successfully “diagnosed” their pre-verbal child’s ear infection (which I confirmed with an otoscope and the tympanic membrane was intact) I have been keenly interested in the role of animal-assisted diagnosis.

If you also have wondered whether you could write off your pedigreed Portuguese Water Dog as an office expense, I would direct you to an article titled “Canine olfactory detection and its relevance to medical detection.” The authors note that there is some evidence of dogs successfully alerting physicians to Parkinson’s disease, some cancers, malaria, and COVID-19, among others. However, they caution that the reliability is, in most cases, not of a quality that would be helpful on a larger scale.

I can understand the reasons for their caution. However, from my own personal experience, I am completely confident that I can diagnose strep throat by smell, sometimes simply on opening the examination room door. My false-positive rate over 40 years of practice is zero. Of course I still test and, not surprisingly, my false-negative rate is nothing to brag about. However, if a dog can produce even close to my zero false negative with a given disease, that information is valuable and suggests that we should be pointing the odor investigators and their tool box of skills in that direction. I’m pretty sure we don’t need them to dig much deeper into why babies smell better than teenagers.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A few weeks ago I stumbled upon a two-sentence blurb in a pediatric newsletter summarizing the results of a study comparing the chemical profile of infant body odor with that of postpubertal adolescents. The investigators found that, not surprisingly, the smell of the chemical constituents wafting from babies was more appealing than that emanating from sweaty teenagers. I quickly moved on to the next blurb hoping to find something I hadn’t already experienced or figured out on my own.

But, as I navigated through the rest of my day filled with pickleball, bicycling, and the smell of home-cooked food, something about that study of body odor nagged at me. Who had funded that voyage into the obvious? Were my tax dollars involved? Had I been duped by some alleged nonprofit that had promised my donation would save lives or at least ameliorate suffering? Finally, as the sun dipped below the horizon, my curiosity got the best of me and I searched out the original study. Within minutes I fell down a rabbit hole into the cavernous world of odor science.

Having had zero experience in this niche field, I was amazed at the lengths to which these German odor investigators had gone to analyze the chemicals on and around their subjects. Just trying to ensure that materials and microclimates in the experimental environment were scent-free was a heroic effort. There was “Mono-trap sampling of volatiles, followed by thermodesorption-comprehensive gas chromatography, and time of flight-mass spectrometry analysis.” There were graphs and charts galore. This is serious science, folks. However, they still use the abbreviation “BO” freely, just as I learned to do in junior high. And, in some situations, the investigators relied on the observation of a panel of trained human sniffers to assess the detection threshold and the degree of pleasantness.

Ultimately, the authors’ conclusion was “sexual maturation coincides with changes in body odor chemical composition. Whether those changes explain differences in parental olfactory perception needs to be determined in future studies.” Again, no surprises here.

Exhausted by my venture into the realm of odor science, I finally found the answer to my burning question. The study was supported by the German Research Foundation and the European Union. Phew! Not on my nickel.

Lest you think that I believe any investigation into the potential role of smell in our health and well-being is pure bunk, let me make it clear that I think the role of odor detection is one of the least well-studied and potentially most valuable areas of medical research. Having had one family tell me that their black lab had twice successfully “diagnosed” their pre-verbal child’s ear infection (which I confirmed with an otoscope and the tympanic membrane was intact) I have been keenly interested in the role of animal-assisted diagnosis.

If you also have wondered whether you could write off your pedigreed Portuguese Water Dog as an office expense, I would direct you to an article titled “Canine olfactory detection and its relevance to medical detection.” The authors note that there is some evidence of dogs successfully alerting physicians to Parkinson’s disease, some cancers, malaria, and COVID-19, among others. However, they caution that the reliability is, in most cases, not of a quality that would be helpful on a larger scale.

I can understand the reasons for their caution. However, from my own personal experience, I am completely confident that I can diagnose strep throat by smell, sometimes simply on opening the examination room door. My false-positive rate over 40 years of practice is zero. Of course I still test and, not surprisingly, my false-negative rate is nothing to brag about. However, if a dog can produce even close to my zero false negative with a given disease, that information is valuable and suggests that we should be pointing the odor investigators and their tool box of skills in that direction. I’m pretty sure we don’t need them to dig much deeper into why babies smell better than teenagers.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A few weeks ago I stumbled upon a two-sentence blurb in a pediatric newsletter summarizing the results of a study comparing the chemical profile of infant body odor with that of postpubertal adolescents. The investigators found that, not surprisingly, the smell of the chemical constituents wafting from babies was more appealing than that emanating from sweaty teenagers. I quickly moved on to the next blurb hoping to find something I hadn’t already experienced or figured out on my own.

But, as I navigated through the rest of my day filled with pickleball, bicycling, and the smell of home-cooked food, something about that study of body odor nagged at me. Who had funded that voyage into the obvious? Were my tax dollars involved? Had I been duped by some alleged nonprofit that had promised my donation would save lives or at least ameliorate suffering? Finally, as the sun dipped below the horizon, my curiosity got the best of me and I searched out the original study. Within minutes I fell down a rabbit hole into the cavernous world of odor science.

Having had zero experience in this niche field, I was amazed at the lengths to which these German odor investigators had gone to analyze the chemicals on and around their subjects. Just trying to ensure that materials and microclimates in the experimental environment were scent-free was a heroic effort. There was “Mono-trap sampling of volatiles, followed by thermodesorption-comprehensive gas chromatography, and time of flight-mass spectrometry analysis.” There were graphs and charts galore. This is serious science, folks. However, they still use the abbreviation “BO” freely, just as I learned to do in junior high. And, in some situations, the investigators relied on the observation of a panel of trained human sniffers to assess the detection threshold and the degree of pleasantness.

Ultimately, the authors’ conclusion was “sexual maturation coincides with changes in body odor chemical composition. Whether those changes explain differences in parental olfactory perception needs to be determined in future studies.” Again, no surprises here.

Exhausted by my venture into the realm of odor science, I finally found the answer to my burning question. The study was supported by the German Research Foundation and the European Union. Phew! Not on my nickel.

Lest you think that I believe any investigation into the potential role of smell in our health and well-being is pure bunk, let me make it clear that I think the role of odor detection is one of the least well-studied and potentially most valuable areas of medical research. Having had one family tell me that their black lab had twice successfully “diagnosed” their pre-verbal child’s ear infection (which I confirmed with an otoscope and the tympanic membrane was intact) I have been keenly interested in the role of animal-assisted diagnosis.

If you also have wondered whether you could write off your pedigreed Portuguese Water Dog as an office expense, I would direct you to an article titled “Canine olfactory detection and its relevance to medical detection.” The authors note that there is some evidence of dogs successfully alerting physicians to Parkinson’s disease, some cancers, malaria, and COVID-19, among others. However, they caution that the reliability is, in most cases, not of a quality that would be helpful on a larger scale.

I can understand the reasons for their caution. However, from my own personal experience, I am completely confident that I can diagnose strep throat by smell, sometimes simply on opening the examination room door. My false-positive rate over 40 years of practice is zero. Of course I still test and, not surprisingly, my false-negative rate is nothing to brag about. However, if a dog can produce even close to my zero false negative with a given disease, that information is valuable and suggests that we should be pointing the odor investigators and their tool box of skills in that direction. I’m pretty sure we don’t need them to dig much deeper into why babies smell better than teenagers.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

SAN DIEGO — A novel formulation of polidocanol, an injectable synthetic non-ionic detergent that is approved by the US Food and Drug Administration (FDA) for sclerotherapy, may have a role in excess submental fat reduction, results from a phase 2b trial demonstrated.

The solution, also known as 10XB101, “has been demonstrated to cause adipolysis,” Kavita Darji, MD, an American Society for Dermatologic Surgery (ASDS) cosmetic and dermatologic laser surgery fellow at a practice in San Diego, said during a late-breaking session at the annual meeting of the American Academy of Dermatology. “It shows less inflammation and release of cytokines TNF-alpha and MCP-1 by macrophages than deoxycholic acid, which is currently used for submental fat reduction.”

Dr. Darji

In a phase 2b clinical trial conducted at four sites, investigators enrolled 51 patients and assigned them to one of four dose cohorts: 2%, 3%, or 4.5% 10XB101, or vehicle. Each treatment consisted of up to 50 injections at 0.2 mL per injection, and they were administered up to six times 4 weeks apart. Study endpoints included a composite of the Clinician Submental Fat Score (CSFS) and Patient Submental Fat Score (PSFS) on a 0-4–point scale. The researchers graded local skin reactions such as erythema, edema, tenderness on palpation, bruising, pain, and burning/stinging as 0 (none), 1 (mild), 2 (moderate), or 3 (severe). They also obtained lab tests and performed electrocardiograms.

Dr. Darji and colleagues analyzed two populations: the intent to treat (ITT) population, which included all 51 enrolled subjects who received any injection of the test agent, and a completer population of 40 subjects. “These patients had at least four treatments or completed the treatments per protocol, completed the 4 weeks after final treatment assessments, or did not have any significant protocol deviations that would impact the evaluation of efficacy,” she explained.

To compare how 10XB101 performed compared with deoxycholic acid (Kybella), which is approved by the FDA to improve the appearance of moderate to severe submental fat, the researchers drew from pooled findings of Refine 1 and 2, in which adults received up to six treatment sessions with deoxycholic acid or placebo.

The ITT analysis of the 3% and 4.5% 10XB101 dose groups showed about a fourfold increase in a 2-grade or better improvement in the composite endpoint relative to the pooled findings of deoxycholic acid (62% vs. 16%, respectively). In addition, 80% of the completer population achieved a 2-grade improvement in the composite endpoint. “Importantly, 10% to 33% also received a 3-grade improvement, depending on the dose they were assigned to,” Dr. Darji said.

On average, patients in both cohorts achieved a 1-grade improvement after two treatments, and about 50% achieved a 2-grade improvement after four treatments — which is consistent with a more rapid onset when compared with deoxycholic acid, she said.

Both study endpoints were achieved by 31% of patients in the ITT group vs. 33% of completers, respectively, with the 2% dose; 62% vs. 80% with the 3% dose; and 54% vs. 79% for the 4.5% dose. “This is a 2- to 5-times increase in success” when compared with the results of deoxycholic acid in the published pooled analysis, Dr. Darji said. The researchers measured adverse events by spontaneous and elicited reports and by assessments of recorded local skin reactions. They found that 80% of all measured local skin reactions rated as 0 while 98% of all measured local skin reactions rated as a 0 or 1. One myocardial infarction occurred, which was mild and resolved. This case was not related to the study drug, Dr. Darji said in an interview after the meeting. Otherwise, no safety laboratory or ECG signals were noted.

In findings limited to the 3% dose of 10XB101, mild bruising occurred in 8% of patients at postinjection visit 2, 18% of those at postinjection visit 3, 20% of those at postinjection visit 4, and in 20% of those at postinjection visit 5. Reports of mild pain/burning/stinging occurred in 8% of patients at postinjection visit 2 but at no other subsequent visits. Meanwhile, edema occurred in 42% of patients at postinjection visit 2, 45% of those at postinjection visit 3, 50% of those at postinjection visits 4 and 5, and 38% of those at postinjection visit 6.

“Patients resumed normal activity within 1-3 days and had fewer side effects that lasted longer than 30 days,” Dr. Darji concluded, adding that the results “imply a potential opportunity to expand the treatment to other anatomic areas, which is a future direction.”

One of the session moderators, Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center, Portland, noted that the study was not a head-to-head trial of polidocanol vs. deoxycholic acid, so he cautioned against drawing strong conclusions about the comparative data presented.

Asked to comment on the results Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, said that 10XB101 “showed excellent efficacy with much fewer adverse events when compared to what we found in studies with Kybella, the only currently FDA-approved injection for submental fat reduction.”

Dr. Green

In addition, “much less pain after injection was to me the most obvious differentiator between this and Kybella studies. I look forward to seeing if larger studies confirm the efficacy and safety from this phase 2 study, as 10XB101 has potential to be a more effective, and safer option to reduce submental fat,” he added. He was not involved with the study.

Dr. Darji reported having no disclosures. Mitchel P. Goldman, MD, the study’s lead investigator, is a minority investor in 10XBio, which is developing 10XB101. Dr. Blauvelt and Dr. Green disclosed conflicts of interest from many pharmaceutical companies.

SAN DIEGO — A novel formulation of polidocanol, an injectable synthetic non-ionic detergent that is approved by the US Food and Drug Administration (FDA) for sclerotherapy, may have a role in excess submental fat reduction, results from a phase 2b trial demonstrated.

The solution, also known as 10XB101, “has been demonstrated to cause adipolysis,” Kavita Darji, MD, an American Society for Dermatologic Surgery (ASDS) cosmetic and dermatologic laser surgery fellow at a practice in San Diego, said during a late-breaking session at the annual meeting of the American Academy of Dermatology. “It shows less inflammation and release of cytokines TNF-alpha and MCP-1 by macrophages than deoxycholic acid, which is currently used for submental fat reduction.”

Dr. Darji

In a phase 2b clinical trial conducted at four sites, investigators enrolled 51 patients and assigned them to one of four dose cohorts: 2%, 3%, or 4.5% 10XB101, or vehicle. Each treatment consisted of up to 50 injections at 0.2 mL per injection, and they were administered up to six times 4 weeks apart. Study endpoints included a composite of the Clinician Submental Fat Score (CSFS) and Patient Submental Fat Score (PSFS) on a 0-4–point scale. The researchers graded local skin reactions such as erythema, edema, tenderness on palpation, bruising, pain, and burning/stinging as 0 (none), 1 (mild), 2 (moderate), or 3 (severe). They also obtained lab tests and performed electrocardiograms.

Dr. Darji and colleagues analyzed two populations: the intent to treat (ITT) population, which included all 51 enrolled subjects who received any injection of the test agent, and a completer population of 40 subjects. “These patients had at least four treatments or completed the treatments per protocol, completed the 4 weeks after final treatment assessments, or did not have any significant protocol deviations that would impact the evaluation of efficacy,” she explained.

To compare how 10XB101 performed compared with deoxycholic acid (Kybella), which is approved by the FDA to improve the appearance of moderate to severe submental fat, the researchers drew from pooled findings of Refine 1 and 2, in which adults received up to six treatment sessions with deoxycholic acid or placebo.

The ITT analysis of the 3% and 4.5% 10XB101 dose groups showed about a fourfold increase in a 2-grade or better improvement in the composite endpoint relative to the pooled findings of deoxycholic acid (62% vs. 16%, respectively). In addition, 80% of the completer population achieved a 2-grade improvement in the composite endpoint. “Importantly, 10% to 33% also received a 3-grade improvement, depending on the dose they were assigned to,” Dr. Darji said.

On average, patients in both cohorts achieved a 1-grade improvement after two treatments, and about 50% achieved a 2-grade improvement after four treatments — which is consistent with a more rapid onset when compared with deoxycholic acid, she said.

Both study endpoints were achieved by 31% of patients in the ITT group vs. 33% of completers, respectively, with the 2% dose; 62% vs. 80% with the 3% dose; and 54% vs. 79% for the 4.5% dose. “This is a 2- to 5-times increase in success” when compared with the results of deoxycholic acid in the published pooled analysis, Dr. Darji said. The researchers measured adverse events by spontaneous and elicited reports and by assessments of recorded local skin reactions. They found that 80% of all measured local skin reactions rated as 0 while 98% of all measured local skin reactions rated as a 0 or 1. One myocardial infarction occurred, which was mild and resolved. This case was not related to the study drug, Dr. Darji said in an interview after the meeting. Otherwise, no safety laboratory or ECG signals were noted.

In findings limited to the 3% dose of 10XB101, mild bruising occurred in 8% of patients at postinjection visit 2, 18% of those at postinjection visit 3, 20% of those at postinjection visit 4, and in 20% of those at postinjection visit 5. Reports of mild pain/burning/stinging occurred in 8% of patients at postinjection visit 2 but at no other subsequent visits. Meanwhile, edema occurred in 42% of patients at postinjection visit 2, 45% of those at postinjection visit 3, 50% of those at postinjection visits 4 and 5, and 38% of those at postinjection visit 6.

“Patients resumed normal activity within 1-3 days and had fewer side effects that lasted longer than 30 days,” Dr. Darji concluded, adding that the results “imply a potential opportunity to expand the treatment to other anatomic areas, which is a future direction.”

One of the session moderators, Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center, Portland, noted that the study was not a head-to-head trial of polidocanol vs. deoxycholic acid, so he cautioned against drawing strong conclusions about the comparative data presented.

Asked to comment on the results Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, said that 10XB101 “showed excellent efficacy with much fewer adverse events when compared to what we found in studies with Kybella, the only currently FDA-approved injection for submental fat reduction.”

Dr. Green

In addition, “much less pain after injection was to me the most obvious differentiator between this and Kybella studies. I look forward to seeing if larger studies confirm the efficacy and safety from this phase 2 study, as 10XB101 has potential to be a more effective, and safer option to reduce submental fat,” he added. He was not involved with the study.

Dr. Darji reported having no disclosures. Mitchel P. Goldman, MD, the study’s lead investigator, is a minority investor in 10XBio, which is developing 10XB101. Dr. Blauvelt and Dr. Green disclosed conflicts of interest from many pharmaceutical companies.

SAN DIEGO — A novel formulation of polidocanol, an injectable synthetic non-ionic detergent that is approved by the US Food and Drug Administration (FDA) for sclerotherapy, may have a role in excess submental fat reduction, results from a phase 2b trial demonstrated.

The solution, also known as 10XB101, “has been demonstrated to cause adipolysis,” Kavita Darji, MD, an American Society for Dermatologic Surgery (ASDS) cosmetic and dermatologic laser surgery fellow at a practice in San Diego, said during a late-breaking session at the annual meeting of the American Academy of Dermatology. “It shows less inflammation and release of cytokines TNF-alpha and MCP-1 by macrophages than deoxycholic acid, which is currently used for submental fat reduction.”

Dr. Darji

In a phase 2b clinical trial conducted at four sites, investigators enrolled 51 patients and assigned them to one of four dose cohorts: 2%, 3%, or 4.5% 10XB101, or vehicle. Each treatment consisted of up to 50 injections at 0.2 mL per injection, and they were administered up to six times 4 weeks apart. Study endpoints included a composite of the Clinician Submental Fat Score (CSFS) and Patient Submental Fat Score (PSFS) on a 0-4–point scale. The researchers graded local skin reactions such as erythema, edema, tenderness on palpation, bruising, pain, and burning/stinging as 0 (none), 1 (mild), 2 (moderate), or 3 (severe). They also obtained lab tests and performed electrocardiograms.

Dr. Darji and colleagues analyzed two populations: the intent to treat (ITT) population, which included all 51 enrolled subjects who received any injection of the test agent, and a completer population of 40 subjects. “These patients had at least four treatments or completed the treatments per protocol, completed the 4 weeks after final treatment assessments, or did not have any significant protocol deviations that would impact the evaluation of efficacy,” she explained.

To compare how 10XB101 performed compared with deoxycholic acid (Kybella), which is approved by the FDA to improve the appearance of moderate to severe submental fat, the researchers drew from pooled findings of Refine 1 and 2, in which adults received up to six treatment sessions with deoxycholic acid or placebo.

The ITT analysis of the 3% and 4.5% 10XB101 dose groups showed about a fourfold increase in a 2-grade or better improvement in the composite endpoint relative to the pooled findings of deoxycholic acid (62% vs. 16%, respectively). In addition, 80% of the completer population achieved a 2-grade improvement in the composite endpoint. “Importantly, 10% to 33% also received a 3-grade improvement, depending on the dose they were assigned to,” Dr. Darji said.

On average, patients in both cohorts achieved a 1-grade improvement after two treatments, and about 50% achieved a 2-grade improvement after four treatments — which is consistent with a more rapid onset when compared with deoxycholic acid, she said.

Both study endpoints were achieved by 31% of patients in the ITT group vs. 33% of completers, respectively, with the 2% dose; 62% vs. 80% with the 3% dose; and 54% vs. 79% for the 4.5% dose. “This is a 2- to 5-times increase in success” when compared with the results of deoxycholic acid in the published pooled analysis, Dr. Darji said. The researchers measured adverse events by spontaneous and elicited reports and by assessments of recorded local skin reactions. They found that 80% of all measured local skin reactions rated as 0 while 98% of all measured local skin reactions rated as a 0 or 1. One myocardial infarction occurred, which was mild and resolved. This case was not related to the study drug, Dr. Darji said in an interview after the meeting. Otherwise, no safety laboratory or ECG signals were noted.

In findings limited to the 3% dose of 10XB101, mild bruising occurred in 8% of patients at postinjection visit 2, 18% of those at postinjection visit 3, 20% of those at postinjection visit 4, and in 20% of those at postinjection visit 5. Reports of mild pain/burning/stinging occurred in 8% of patients at postinjection visit 2 but at no other subsequent visits. Meanwhile, edema occurred in 42% of patients at postinjection visit 2, 45% of those at postinjection visit 3, 50% of those at postinjection visits 4 and 5, and 38% of those at postinjection visit 6.

“Patients resumed normal activity within 1-3 days and had fewer side effects that lasted longer than 30 days,” Dr. Darji concluded, adding that the results “imply a potential opportunity to expand the treatment to other anatomic areas, which is a future direction.”

One of the session moderators, Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center, Portland, noted that the study was not a head-to-head trial of polidocanol vs. deoxycholic acid, so he cautioned against drawing strong conclusions about the comparative data presented.

Asked to comment on the results Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, said that 10XB101 “showed excellent efficacy with much fewer adverse events when compared to what we found in studies with Kybella, the only currently FDA-approved injection for submental fat reduction.”

Dr. Green

In addition, “much less pain after injection was to me the most obvious differentiator between this and Kybella studies. I look forward to seeing if larger studies confirm the efficacy and safety from this phase 2 study, as 10XB101 has potential to be a more effective, and safer option to reduce submental fat,” he added. He was not involved with the study.

Dr. Darji reported having no disclosures. Mitchel P. Goldman, MD, the study’s lead investigator, is a minority investor in 10XBio, which is developing 10XB101. Dr. Blauvelt and Dr. Green disclosed conflicts of interest from many pharmaceutical companies.

CORRECTED April 16, 2024 // An earlier version of this article stated incorrect percentages of patients who never received any biologics during the study's 3-year period but improved rapidly or moderately.

Early initiation of biologics — within the first 2 months of symptom presentation — appears to have a significant impact on how rapidly patients with juvenile idiopathic arthritis (JIA) improve, according to findings presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance.

“Our study provides evidence that early use of biologics can significantly alter the disease trajectory of patients with JIA,” Mei-Sing Ong, PhD, of Harvard Medical School, Boston, told attendees. At the same time, however, not all patients who improved rapidly during a 3-year follow-up period needed biologics, a finding that Ong said the researchers are continuing to investigate.

Marinka Twilt, MD, MScE, PhD, chair of CARRA’s JIA Research Committee and a pediatric rheumatologist and clinician scientist at Alberta Children’s Hospital in Calgary, Canada, was not involved in the research but said the continued sustained remission in patients who improved rapidly is very reassuring.

Dr. Twilt

“We always wonder if initial response will be sustained or if patients tend to flare after the initial treatment,” Dr. Twilt told this news organization. “To see the sustained response up to 3 years is fantastic.” She added that it would be enlightening to see more information about patients who rapidly improved over 3 years, including whether they were still taking a [conventional disease-modifying antirheumatic drug (DMARD)] and/or biologic.

“A new diagnosis can be overwhelming for families, and this sometimes leads to step-up therapy to not overwhelm them more with information on new drugs,” Dr. Twilt said. “This study shows that an earlier start is beneficial, and this should be discussed with families early on so there is less delay in early treatment.”

Canada and many US states currently require 3 months of conventional DMARD treatment before patients can start a biologic, Dr. Twilt said, yet “this study shows the additive benefit of using a biologic within 2 months of starting a DMARD, which hopefully will lead to insurance companies adopting this threshold.”

The STOP-JIA study is a prospective observational study that compares the effectiveness of three different treatment plans for JIA. A Step-Up cohort of 257 patients received conventional antirheumatic monotherapy initially, with a biologic added at 3 months or later as needed. The Early Combination cohort of 100 patients received conventional antirheumatic therapy with a biologic from the start. The Biologic First cohort of 43 patients began taking a biologic as a first-line therapy.

In previously reported results of the study at 12 months’ follow-up, there was no significant difference between the Step-Up and Biologic First groups, but there were significant differences between the Step-Up and Early Combination groups. Significantly more patients in the Early Combination group (58.8%) than in the Step-Up group (42.8%) had inactive disease, based on the clinical Juvenile Arthritis Disease Activity Score 10 (cJADAS-10) (P = .03). Similarly, 81% of Early Combination patients achieved the American College of Rheumatology 70% improvement criteria, compared with 62% of the Step-Up patients (P = .01).

To learn whether the timing of starting a biologic influenced the disease trajectory over time, the researchers compared subgroups of patients with similar trajectories.

“Assessing treatment outcomes at a single point in time does not give us a complete picture of the effects of treatment on disease trajectory, which is an important outcome given that JIA is characterized by a relapsing-remitting course,” Dr. Ong told attendees.

Patients were sorted in the slow, moderate, or rapid improvement trajectories. In previously reported data at 12 months’ follow-up, patients’ odds of achieving rapid improvement were 3.6 times greater if they had started a biologic within 3 months.

This study compared patients’ trajectories over 3 years in the 259 patients (65% of the original cohort) who had at least one cJADAS-10 assessment in each year of follow-up. Most patients (66.8%) were in the rapid improvement class, with 25.9% in the moderate improvement class and 7.3% in the slow improvement class.

Patients in the rapid improvement group achieved inactive disease (cJADAS-10 of 2.5 or less) within 1 year and maintained inactive disease through the second and third years. The moderate and low improvement groups both had higher disease activity at baseline, but the moderate group continued to improve in years 2 and 3, with minimal disease by year 3, on the basis of the cJADAS-10 scores of 2.5-5. The slow group continued to experience moderate disease activity during years 2 and 3.

The findings also revealed that the earlier patients began a biologic, the more likely they were to be in the rapid improvement group than the slow improvement group. Participants who started a biologic in the first month had more than five times greater odds of being in the rapid improvement group than in the slow improvement group (odds ratio [OR], 5.33; P = .017).

Those who started a biologic in the second month were also more likely to be in the rapid improvement group (OR, 2.67; P = .032). For those who began a biologic by the third month, the odds of improving rapidly were not statistically significant, though Ong noted that could have been because of the small sample size. There was also no significant difference between those who improved moderately vs slowly based on when a biologic was initiated.

It would be helpful to learn whether any of the patients in the rapid improvement group were able to stop medications or whether they all continued treatment during the 3 years of follow-up, Dr. Twilt said. “Does early treatment with biologics not only lead to early remission after initiation but also to the possibility of stopping treatment earlier and remaining in remission?” she asked.

The researchers also found that not all patients needed biologics to end up in the rapid improvement group. Among patients who never received any biologics during the 3-year period, 83% improved rapidly and 17% improved moderately. Yet the researchers identified no significant differences in demographics or clinical factors between patients who received biologics and those who did not.

“The fact that there is a group of patients in the rapid response group who never need a biologic is of great interest, as we always want to treat patients early with the medications they need, but we also want to avoid overtreating patients,” Dr. Twilt said. It’s important to find out what differentiates those patients and whether it is possible to predict which patients do not need biologics early on, she said.

Dr. Ong said the research team is working to develop machine learning methods to improve risk stratification in hopes of addressing that question.

Dr. Ong and Dr. Twilt reported no disclosures. The research was funded by CARRA and the Patient-Centered Outcomes Research Institute.
 

A version of this article appeared on Medscape.com .

CORRECTED April 16, 2024 // An earlier version of this article stated incorrect percentages of patients who never received any biologics during the study's 3-year period but improved rapidly or moderately.

Early initiation of biologics — within the first 2 months of symptom presentation — appears to have a significant impact on how rapidly patients with juvenile idiopathic arthritis (JIA) improve, according to findings presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance.

“Our study provides evidence that early use of biologics can significantly alter the disease trajectory of patients with JIA,” Mei-Sing Ong, PhD, of Harvard Medical School, Boston, told attendees. At the same time, however, not all patients who improved rapidly during a 3-year follow-up period needed biologics, a finding that Ong said the researchers are continuing to investigate.

Marinka Twilt, MD, MScE, PhD, chair of CARRA’s JIA Research Committee and a pediatric rheumatologist and clinician scientist at Alberta Children’s Hospital in Calgary, Canada, was not involved in the research but said the continued sustained remission in patients who improved rapidly is very reassuring.

Dr. Twilt

“We always wonder if initial response will be sustained or if patients tend to flare after the initial treatment,” Dr. Twilt told this news organization. “To see the sustained response up to 3 years is fantastic.” She added that it would be enlightening to see more information about patients who rapidly improved over 3 years, including whether they were still taking a [conventional disease-modifying antirheumatic drug (DMARD)] and/or biologic.

“A new diagnosis can be overwhelming for families, and this sometimes leads to step-up therapy to not overwhelm them more with information on new drugs,” Dr. Twilt said. “This study shows that an earlier start is beneficial, and this should be discussed with families early on so there is less delay in early treatment.”

Canada and many US states currently require 3 months of conventional DMARD treatment before patients can start a biologic, Dr. Twilt said, yet “this study shows the additive benefit of using a biologic within 2 months of starting a DMARD, which hopefully will lead to insurance companies adopting this threshold.”

The STOP-JIA study is a prospective observational study that compares the effectiveness of three different treatment plans for JIA. A Step-Up cohort of 257 patients received conventional antirheumatic monotherapy initially, with a biologic added at 3 months or later as needed. The Early Combination cohort of 100 patients received conventional antirheumatic therapy with a biologic from the start. The Biologic First cohort of 43 patients began taking a biologic as a first-line therapy.

In previously reported results of the study at 12 months’ follow-up, there was no significant difference between the Step-Up and Biologic First groups, but there were significant differences between the Step-Up and Early Combination groups. Significantly more patients in the Early Combination group (58.8%) than in the Step-Up group (42.8%) had inactive disease, based on the clinical Juvenile Arthritis Disease Activity Score 10 (cJADAS-10) (P = .03). Similarly, 81% of Early Combination patients achieved the American College of Rheumatology 70% improvement criteria, compared with 62% of the Step-Up patients (P = .01).

To learn whether the timing of starting a biologic influenced the disease trajectory over time, the researchers compared subgroups of patients with similar trajectories.

“Assessing treatment outcomes at a single point in time does not give us a complete picture of the effects of treatment on disease trajectory, which is an important outcome given that JIA is characterized by a relapsing-remitting course,” Dr. Ong told attendees.

Patients were sorted in the slow, moderate, or rapid improvement trajectories. In previously reported data at 12 months’ follow-up, patients’ odds of achieving rapid improvement were 3.6 times greater if they had started a biologic within 3 months.

This study compared patients’ trajectories over 3 years in the 259 patients (65% of the original cohort) who had at least one cJADAS-10 assessment in each year of follow-up. Most patients (66.8%) were in the rapid improvement class, with 25.9% in the moderate improvement class and 7.3% in the slow improvement class.

Patients in the rapid improvement group achieved inactive disease (cJADAS-10 of 2.5 or less) within 1 year and maintained inactive disease through the second and third years. The moderate and low improvement groups both had higher disease activity at baseline, but the moderate group continued to improve in years 2 and 3, with minimal disease by year 3, on the basis of the cJADAS-10 scores of 2.5-5. The slow group continued to experience moderate disease activity during years 2 and 3.

The findings also revealed that the earlier patients began a biologic, the more likely they were to be in the rapid improvement group than the slow improvement group. Participants who started a biologic in the first month had more than five times greater odds of being in the rapid improvement group than in the slow improvement group (odds ratio [OR], 5.33; P = .017).

Those who started a biologic in the second month were also more likely to be in the rapid improvement group (OR, 2.67; P = .032). For those who began a biologic by the third month, the odds of improving rapidly were not statistically significant, though Ong noted that could have been because of the small sample size. There was also no significant difference between those who improved moderately vs slowly based on when a biologic was initiated.

It would be helpful to learn whether any of the patients in the rapid improvement group were able to stop medications or whether they all continued treatment during the 3 years of follow-up, Dr. Twilt said. “Does early treatment with biologics not only lead to early remission after initiation but also to the possibility of stopping treatment earlier and remaining in remission?” she asked.

The researchers also found that not all patients needed biologics to end up in the rapid improvement group. Among patients who never received any biologics during the 3-year period, 83% improved rapidly and 17% improved moderately. Yet the researchers identified no significant differences in demographics or clinical factors between patients who received biologics and those who did not.

“The fact that there is a group of patients in the rapid response group who never need a biologic is of great interest, as we always want to treat patients early with the medications they need, but we also want to avoid overtreating patients,” Dr. Twilt said. It’s important to find out what differentiates those patients and whether it is possible to predict which patients do not need biologics early on, she said.

Dr. Ong said the research team is working to develop machine learning methods to improve risk stratification in hopes of addressing that question.

Dr. Ong and Dr. Twilt reported no disclosures. The research was funded by CARRA and the Patient-Centered Outcomes Research Institute.
 

A version of this article appeared on Medscape.com .

CORRECTED April 16, 2024 // An earlier version of this article stated incorrect percentages of patients who never received any biologics during the study's 3-year period but improved rapidly or moderately.

Early initiation of biologics — within the first 2 months of symptom presentation — appears to have a significant impact on how rapidly patients with juvenile idiopathic arthritis (JIA) improve, according to findings presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance.

“Our study provides evidence that early use of biologics can significantly alter the disease trajectory of patients with JIA,” Mei-Sing Ong, PhD, of Harvard Medical School, Boston, told attendees. At the same time, however, not all patients who improved rapidly during a 3-year follow-up period needed biologics, a finding that Ong said the researchers are continuing to investigate.

Marinka Twilt, MD, MScE, PhD, chair of CARRA’s JIA Research Committee and a pediatric rheumatologist and clinician scientist at Alberta Children’s Hospital in Calgary, Canada, was not involved in the research but said the continued sustained remission in patients who improved rapidly is very reassuring.

Dr. Twilt

“We always wonder if initial response will be sustained or if patients tend to flare after the initial treatment,” Dr. Twilt told this news organization. “To see the sustained response up to 3 years is fantastic.” She added that it would be enlightening to see more information about patients who rapidly improved over 3 years, including whether they were still taking a [conventional disease-modifying antirheumatic drug (DMARD)] and/or biologic.

“A new diagnosis can be overwhelming for families, and this sometimes leads to step-up therapy to not overwhelm them more with information on new drugs,” Dr. Twilt said. “This study shows that an earlier start is beneficial, and this should be discussed with families early on so there is less delay in early treatment.”

Canada and many US states currently require 3 months of conventional DMARD treatment before patients can start a biologic, Dr. Twilt said, yet “this study shows the additive benefit of using a biologic within 2 months of starting a DMARD, which hopefully will lead to insurance companies adopting this threshold.”

The STOP-JIA study is a prospective observational study that compares the effectiveness of three different treatment plans for JIA. A Step-Up cohort of 257 patients received conventional antirheumatic monotherapy initially, with a biologic added at 3 months or later as needed. The Early Combination cohort of 100 patients received conventional antirheumatic therapy with a biologic from the start. The Biologic First cohort of 43 patients began taking a biologic as a first-line therapy.

In previously reported results of the study at 12 months’ follow-up, there was no significant difference between the Step-Up and Biologic First groups, but there were significant differences between the Step-Up and Early Combination groups. Significantly more patients in the Early Combination group (58.8%) than in the Step-Up group (42.8%) had inactive disease, based on the clinical Juvenile Arthritis Disease Activity Score 10 (cJADAS-10) (P = .03). Similarly, 81% of Early Combination patients achieved the American College of Rheumatology 70% improvement criteria, compared with 62% of the Step-Up patients (P = .01).

To learn whether the timing of starting a biologic influenced the disease trajectory over time, the researchers compared subgroups of patients with similar trajectories.

“Assessing treatment outcomes at a single point in time does not give us a complete picture of the effects of treatment on disease trajectory, which is an important outcome given that JIA is characterized by a relapsing-remitting course,” Dr. Ong told attendees.

Patients were sorted in the slow, moderate, or rapid improvement trajectories. In previously reported data at 12 months’ follow-up, patients’ odds of achieving rapid improvement were 3.6 times greater if they had started a biologic within 3 months.

This study compared patients’ trajectories over 3 years in the 259 patients (65% of the original cohort) who had at least one cJADAS-10 assessment in each year of follow-up. Most patients (66.8%) were in the rapid improvement class, with 25.9% in the moderate improvement class and 7.3% in the slow improvement class.

Patients in the rapid improvement group achieved inactive disease (cJADAS-10 of 2.5 or less) within 1 year and maintained inactive disease through the second and third years. The moderate and low improvement groups both had higher disease activity at baseline, but the moderate group continued to improve in years 2 and 3, with minimal disease by year 3, on the basis of the cJADAS-10 scores of 2.5-5. The slow group continued to experience moderate disease activity during years 2 and 3.

The findings also revealed that the earlier patients began a biologic, the more likely they were to be in the rapid improvement group than the slow improvement group. Participants who started a biologic in the first month had more than five times greater odds of being in the rapid improvement group than in the slow improvement group (odds ratio [OR], 5.33; P = .017).

Those who started a biologic in the second month were also more likely to be in the rapid improvement group (OR, 2.67; P = .032). For those who began a biologic by the third month, the odds of improving rapidly were not statistically significant, though Ong noted that could have been because of the small sample size. There was also no significant difference between those who improved moderately vs slowly based on when a biologic was initiated.

It would be helpful to learn whether any of the patients in the rapid improvement group were able to stop medications or whether they all continued treatment during the 3 years of follow-up, Dr. Twilt said. “Does early treatment with biologics not only lead to early remission after initiation but also to the possibility of stopping treatment earlier and remaining in remission?” she asked.

The researchers also found that not all patients needed biologics to end up in the rapid improvement group. Among patients who never received any biologics during the 3-year period, 83% improved rapidly and 17% improved moderately. Yet the researchers identified no significant differences in demographics or clinical factors between patients who received biologics and those who did not.

“The fact that there is a group of patients in the rapid response group who never need a biologic is of great interest, as we always want to treat patients early with the medications they need, but we also want to avoid overtreating patients,” Dr. Twilt said. It’s important to find out what differentiates those patients and whether it is possible to predict which patients do not need biologics early on, she said.

Dr. Ong said the research team is working to develop machine learning methods to improve risk stratification in hopes of addressing that question.

Dr. Ong and Dr. Twilt reported no disclosures. The research was funded by CARRA and the Patient-Centered Outcomes Research Institute.
 

A version of this article appeared on Medscape.com .

TOPLINE:

Despite concerns about malpractice risk among physicians, investigators found no successful malpractice litigation related to active surveillance as a management strategy for low-risk cancers.

METHODOLOGY:

• Although practice guidelines from the National Comprehensive Cancer Network consider active surveillance an effective strategy for managing low-risk cancers, some physicians have been hesitant to incorporate it into their practice because of concerns about potential litigation.
• Researchers used Westlaw Edge and LexisNexis Advance databases to identify malpractice trends involving active surveillance related to thyroid, prostate, kidney, and  or  from 1990 to 2022.
• Data included unpublished cases, trial orders, jury verdicts, and administrative decisions.
• Researchers identified 201 malpractice cases across all low-risk cancers in the initial screening. Out of these, only five cases, all , involved active surveillance as the point of allegation.

TAKEAWAY:

• Out of the five prostate cancer cases, two involved incarcerated patients with Gleason 6 very-low-risk prostate adenocarcinoma that was managed with active surveillance by their urologists.
• In these two cases, the patients claimed that active surveillance violated their 8th Amendment right to be free from cruel or unusual punishment. In both cases, there was no metastasis or spread detected and the court determined active surveillance management was performed under national standards.
• The other three cases involved litigation claiming that active surveillance was not explicitly recommended as a treatment option for patients who all had very-low-risk prostate adenocarcinoma and had reported negligence from an intervention ( or cryoablation). However, all cases had documented informed consent for active surveillance.
• No relevant cases were found relating to active surveillance in any other type of cancer, whether in an initial diagnosis or recurrence.

IN PRACTICE:

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” study coauthor Timothy Daskivich, MD, assistant professor of surgery at Cedars-Sinai Medical Center, Los Angeles, said in a statement . “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study.”

SOURCE:

This study, led by Samuel Chang, JD, with Athene Law LLP, San Francisco, was recently published in Annals of Surgery.

LIMITATIONS:

The Westlaw and Lexis databases may not contain all cases or decisions issued by a state regulatory agency, like a medical board. Federal and state decisions from lower courts may not be published and available. Also, settlements outside of court or suits filed and not pursued were not included in the data.

DISCLOSURES:

The researchers did not provide any disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite concerns about malpractice risk among physicians, investigators found no successful malpractice litigation related to active surveillance as a management strategy for low-risk cancers.

METHODOLOGY:

• Although practice guidelines from the National Comprehensive Cancer Network consider active surveillance an effective strategy for managing low-risk cancers, some physicians have been hesitant to incorporate it into their practice because of concerns about potential litigation.
• Researchers used Westlaw Edge and LexisNexis Advance databases to identify malpractice trends involving active surveillance related to thyroid, prostate, kidney, and  or  from 1990 to 2022.
• Data included unpublished cases, trial orders, jury verdicts, and administrative decisions.
• Researchers identified 201 malpractice cases across all low-risk cancers in the initial screening. Out of these, only five cases, all , involved active surveillance as the point of allegation.

TAKEAWAY:

• Out of the five prostate cancer cases, two involved incarcerated patients with Gleason 6 very-low-risk prostate adenocarcinoma that was managed with active surveillance by their urologists.
• In these two cases, the patients claimed that active surveillance violated their 8th Amendment right to be free from cruel or unusual punishment. In both cases, there was no metastasis or spread detected and the court determined active surveillance management was performed under national standards.
• The other three cases involved litigation claiming that active surveillance was not explicitly recommended as a treatment option for patients who all had very-low-risk prostate adenocarcinoma and had reported negligence from an intervention ( or cryoablation). However, all cases had documented informed consent for active surveillance.
• No relevant cases were found relating to active surveillance in any other type of cancer, whether in an initial diagnosis or recurrence.

IN PRACTICE:

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” study coauthor Timothy Daskivich, MD, assistant professor of surgery at Cedars-Sinai Medical Center, Los Angeles, said in a statement . “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study.”

SOURCE:

This study, led by Samuel Chang, JD, with Athene Law LLP, San Francisco, was recently published in Annals of Surgery.

LIMITATIONS:

The Westlaw and Lexis databases may not contain all cases or decisions issued by a state regulatory agency, like a medical board. Federal and state decisions from lower courts may not be published and available. Also, settlements outside of court or suits filed and not pursued were not included in the data.

DISCLOSURES:

The researchers did not provide any disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite concerns about malpractice risk among physicians, investigators found no successful malpractice litigation related to active surveillance as a management strategy for low-risk cancers.

METHODOLOGY:

• Although practice guidelines from the National Comprehensive Cancer Network consider active surveillance an effective strategy for managing low-risk cancers, some physicians have been hesitant to incorporate it into their practice because of concerns about potential litigation.
• Researchers used Westlaw Edge and LexisNexis Advance databases to identify malpractice trends involving active surveillance related to thyroid, prostate, kidney, and  or  from 1990 to 2022.
• Data included unpublished cases, trial orders, jury verdicts, and administrative decisions.
• Researchers identified 201 malpractice cases across all low-risk cancers in the initial screening. Out of these, only five cases, all , involved active surveillance as the point of allegation.

TAKEAWAY:

• Out of the five prostate cancer cases, two involved incarcerated patients with Gleason 6 very-low-risk prostate adenocarcinoma that was managed with active surveillance by their urologists.
• In these two cases, the patients claimed that active surveillance violated their 8th Amendment right to be free from cruel or unusual punishment. In both cases, there was no metastasis or spread detected and the court determined active surveillance management was performed under national standards.
• The other three cases involved litigation claiming that active surveillance was not explicitly recommended as a treatment option for patients who all had very-low-risk prostate adenocarcinoma and had reported negligence from an intervention ( or cryoablation). However, all cases had documented informed consent for active surveillance.
• No relevant cases were found relating to active surveillance in any other type of cancer, whether in an initial diagnosis or recurrence.

IN PRACTICE:

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” study coauthor Timothy Daskivich, MD, assistant professor of surgery at Cedars-Sinai Medical Center, Los Angeles, said in a statement . “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study.”

SOURCE:

This study, led by Samuel Chang, JD, with Athene Law LLP, San Francisco, was recently published in Annals of Surgery.

LIMITATIONS:

The Westlaw and Lexis databases may not contain all cases or decisions issued by a state regulatory agency, like a medical board. Federal and state decisions from lower courts may not be published and available. Also, settlements outside of court or suits filed and not pursued were not included in the data.

DISCLOSURES:

The researchers did not provide any disclosures.

A version of this article appeared on Medscape.com.

Each January, the AGA Nominating Committee meets to complete a very important task — namely, selection of new members of AGA’s Governing Board, pending approval by the membership.

Having served on this committee in the past, I can attest to how challenging a task it is to select these leaders from such a talented and committed pool of candidates, each of whom have served the organization in numerous impactful roles over the course of many years.

University of Michigan

This year’s recently announced additions to the Governing Board, who will assume their roles this summer, include Dr. Byron Cryer (incoming Vice President), Dr. Shahnaz Sultan (Clinical Research Councillor), and Dr. Jonathan Rosenberg (Practice Councillor). I have had the pleasure of working with each of them over the years from my very early days at AGA and am confident that AGA will continue to thrive under their leadership. Please join me in congratulating Byron, Shahnaz, and Jonathan on their new roles!

In this month’s issue of GIHN, we highlight a phase 3 RCT from NEJM demonstrating the efficacy of seladelpar, an alternative to ursodeoxycholic acid in patients with PBC with refractory pruritus. From the CGH Practice Management section, Dr. Michelle Kim (Cleveland Clinic) and colleagues provide helpful tips on how to optimize EHR use in GI practice, including by incorporating novel tools based on AI, natural language processing, and speech recognition. In our April Member Spotlight, we are excited to feature gastroenterologist and stand-up comedienne Dr. Shida Haghighat of UCLA, who shares her passion for addressing health disparities and highlights how humor helped her cope with the demands of medical training. We hope you enjoy these, and all the stories included in our April issue.
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

Each January, the AGA Nominating Committee meets to complete a very important task — namely, selection of new members of AGA’s Governing Board, pending approval by the membership.

Having served on this committee in the past, I can attest to how challenging a task it is to select these leaders from such a talented and committed pool of candidates, each of whom have served the organization in numerous impactful roles over the course of many years.

University of Michigan

This year’s recently announced additions to the Governing Board, who will assume their roles this summer, include Dr. Byron Cryer (incoming Vice President), Dr. Shahnaz Sultan (Clinical Research Councillor), and Dr. Jonathan Rosenberg (Practice Councillor). I have had the pleasure of working with each of them over the years from my very early days at AGA and am confident that AGA will continue to thrive under their leadership. Please join me in congratulating Byron, Shahnaz, and Jonathan on their new roles!

In this month’s issue of GIHN, we highlight a phase 3 RCT from NEJM demonstrating the efficacy of seladelpar, an alternative to ursodeoxycholic acid in patients with PBC with refractory pruritus. From the CGH Practice Management section, Dr. Michelle Kim (Cleveland Clinic) and colleagues provide helpful tips on how to optimize EHR use in GI practice, including by incorporating novel tools based on AI, natural language processing, and speech recognition. In our April Member Spotlight, we are excited to feature gastroenterologist and stand-up comedienne Dr. Shida Haghighat of UCLA, who shares her passion for addressing health disparities and highlights how humor helped her cope with the demands of medical training. We hope you enjoy these, and all the stories included in our April issue.
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

Each January, the AGA Nominating Committee meets to complete a very important task — namely, selection of new members of AGA’s Governing Board, pending approval by the membership.

Having served on this committee in the past, I can attest to how challenging a task it is to select these leaders from such a talented and committed pool of candidates, each of whom have served the organization in numerous impactful roles over the course of many years.

University of Michigan

This year’s recently announced additions to the Governing Board, who will assume their roles this summer, include Dr. Byron Cryer (incoming Vice President), Dr. Shahnaz Sultan (Clinical Research Councillor), and Dr. Jonathan Rosenberg (Practice Councillor). I have had the pleasure of working with each of them over the years from my very early days at AGA and am confident that AGA will continue to thrive under their leadership. Please join me in congratulating Byron, Shahnaz, and Jonathan on their new roles!

In this month’s issue of GIHN, we highlight a phase 3 RCT from NEJM demonstrating the efficacy of seladelpar, an alternative to ursodeoxycholic acid in patients with PBC with refractory pruritus. From the CGH Practice Management section, Dr. Michelle Kim (Cleveland Clinic) and colleagues provide helpful tips on how to optimize EHR use in GI practice, including by incorporating novel tools based on AI, natural language processing, and speech recognition. In our April Member Spotlight, we are excited to feature gastroenterologist and stand-up comedienne Dr. Shida Haghighat of UCLA, who shares her passion for addressing health disparities and highlights how humor helped her cope with the demands of medical training. We hope you enjoy these, and all the stories included in our April issue.
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

Growing up in a household where GI issues dominated conversations, it’s no surprise that Shida Haghighat, MD, chose gastroenterology as her area of study in medicine.

She watched her father suffer from the complications of Crohn’s disease and her brother struggle with irritable bowel syndrome. “We always needed to know where the nearest bathroom was. I grew up with that around me, and I was always just fascinated by the gut and the digestive system,” said Dr. Haghighat, who just finished up her fellowship at the University of Miami and is now a gastroenterologist at University of California, Los Angeles. She also serves as social media editor for AGA’s Gastro Hep Advances.

University of Miami

As she got to know the personalities of the GI department in the first year of medical school, “I realized that our senses of humor and personalities kind of aligned, and I was like, ‘Oh yeah, this is where I’m supposed to be,’ ” said Dr. Haghighat, who can be found on X @DoctorShida.

Humor is something Dr. Haghighat has reached for throughout her life and career. She eventually channeled her gift for satire onto the stage and the internet, as a stand-up comedian. In an interview with GI & Hepatology News, she spoke about the connection between GI medicine and humor, and the creative ways she has helped promote cancer screening in underserved populations.
 

Q: What practice challenges have you faced in your career?

Dr. Haghighat: I trained in a county hospital, so I’ve always worked with underserved and vulnerable populations. One of the challenges has been just navigation of care, especially as it pertains to cancer diagnoses or cancer screening. A lot of the time, patients don’t understand why they have to do a test or something invasive like a colonoscopy for symptoms they don’t have. 

Q: A focus of yours has been improving uptake of screening in underserved communities. Please talk about the work you’ve done in this area.

Dr. Haghighat: I was at Los Angeles General Medical Center — a county hospital in Los Angeles — for residency, where we treated underserved, uninsured patients. I noticed in our primary care clinics a very low uptake of colon cancer screening. Patients didn’t want to bring the stool tests back or get colonoscopies. I surveyed a bunch of the patients and asked: How can we make colon cancer screening easier for you? About a third of the patients said, “If I can do it in the clinic before I go home, that would be great.”

So, I started this initiative called “Go Before You Go.” We would ask patients, “Hey, do you need to go to the bathroom right now, if you can?” Our nurses handed them the stool test to do in the bathroom before they left the clinic after their doctor visits.

We saw really good results with that. Surprisingly, a lot of people can go on demand. We saw increased screening rates, and that quality improvement project went on to win multiple first place awards in research competitions. So that’s what got me interested, and that’s where I had my beginnings of increasing preventative services in underserved communities on the ground.
 

Q: Can you discuss some health disparity studies you’ve done in this area?

Dr. Haghighat: As a GI at Jackson Memorial Hospital in Miami, I was seeing cancer disparities firsthand every day. I wanted to approach these disparities from a research funding standpoint on a federal level. I was particularly interested in gastric cancer because it’s not common enough in the United States to warrant universal screening, but it’s very common among certain racial and ethnic minorities, which would warrant targeted screening.

I evaluated cancer funding allocation from the National Cancer Institute among the most common cancers in the United States and found that cancer afflicting a higher proportion of racial and ethnic minorities was receiving lower funding. One of those cancers was stomach cancer. This study basically highlighted that, to decrease these disparities, a top-down policy approach is necessary to distribute cancer research funding equitably across these groups. 

A lot of stomach cancer comes from a bacteria called Helicobacter pylori, which can be more prevalent in certain countries. In another study, I looked at country of birth as a risk factor for stomach cancer, specifically for gastric intestinal metaplasia, which is a precursor for gastric cancer . 

We found that country of birth is a key risk factor for gastric intestinal metaplasia and that it should be incorporated into risk stratification for targeted screening. 
 

Q: Outside of medicine, you perform as a stand-up comedian. You have a popular satirical alias on social media. How did you get interested in stand-up comedy?

Dr. Haghighat: I gave my medical school’s commencement speech, and I had sprinkled a few jokes in there. Afterward, multiple people approached me and said, “You should really consider stand-up comedy. Your timing and delivery are great.” A few months later, I started my intern year in Los Angeles and simultaneously took stand-up comedy classes. I started performing at local clubs around town throughout residency, and I had two or three good sets that I could rely on. And so that’s how I got into stand-up comedy.

My intern year is also when I started this social media satire account. It was a way to cope with the anxieties and stress of residency. Before I knew it, the account gained multitudes of followers, doctors, and other medical professionals. And I joke that the more hours I work in a week, the more memes I make, the more posts I make. It’s kind of a creative outlet for me after a long day.
 

Q: What types of things do you talk about during your stand-up act?

Dr. Haghighat: A lot of it is about growing up in an immigrant household as a first-generation Iranian American. One of my favorite jokes is, my parents gave me so many options for a career. They said I could be a family doctor, a surgeon, a plastic surgeon, and if I worked hard, even a wife of a surgeon. But I talk a lot about being a woman in medicine. That always gets a lot of laughs. And now that I’ve graduated GI fellowship, I’m excited to incorporate some GI jokes because it turns out people love poop jokes.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

Denver

Cat or dog person

Dog

Best place you went on vacation

Patagonia

Favorite sport

Basketball

Favorite ice cream

Rocky Road

What song do you have to sing along with when you hear it?

Celine Dion’s My Heart Will Go On

Growing up in a household where GI issues dominated conversations, it’s no surprise that Shida Haghighat, MD, chose gastroenterology as her area of study in medicine.

She watched her father suffer from the complications of Crohn’s disease and her brother struggle with irritable bowel syndrome. “We always needed to know where the nearest bathroom was. I grew up with that around me, and I was always just fascinated by the gut and the digestive system,” said Dr. Haghighat, who just finished up her fellowship at the University of Miami and is now a gastroenterologist at University of California, Los Angeles. She also serves as social media editor for AGA’s Gastro Hep Advances.

University of Miami

As she got to know the personalities of the GI department in the first year of medical school, “I realized that our senses of humor and personalities kind of aligned, and I was like, ‘Oh yeah, this is where I’m supposed to be,’ ” said Dr. Haghighat, who can be found on X @DoctorShida.

Humor is something Dr. Haghighat has reached for throughout her life and career. She eventually channeled her gift for satire onto the stage and the internet, as a stand-up comedian. In an interview with GI & Hepatology News, she spoke about the connection between GI medicine and humor, and the creative ways she has helped promote cancer screening in underserved populations.
 

Q: What practice challenges have you faced in your career?

Dr. Haghighat: I trained in a county hospital, so I’ve always worked with underserved and vulnerable populations. One of the challenges has been just navigation of care, especially as it pertains to cancer diagnoses or cancer screening. A lot of the time, patients don’t understand why they have to do a test or something invasive like a colonoscopy for symptoms they don’t have. 

Q: A focus of yours has been improving uptake of screening in underserved communities. Please talk about the work you’ve done in this area.

Dr. Haghighat: I was at Los Angeles General Medical Center — a county hospital in Los Angeles — for residency, where we treated underserved, uninsured patients. I noticed in our primary care clinics a very low uptake of colon cancer screening. Patients didn’t want to bring the stool tests back or get colonoscopies. I surveyed a bunch of the patients and asked: How can we make colon cancer screening easier for you? About a third of the patients said, “If I can do it in the clinic before I go home, that would be great.”

So, I started this initiative called “Go Before You Go.” We would ask patients, “Hey, do you need to go to the bathroom right now, if you can?” Our nurses handed them the stool test to do in the bathroom before they left the clinic after their doctor visits.

We saw really good results with that. Surprisingly, a lot of people can go on demand. We saw increased screening rates, and that quality improvement project went on to win multiple first place awards in research competitions. So that’s what got me interested, and that’s where I had my beginnings of increasing preventative services in underserved communities on the ground.
 

Q: Can you discuss some health disparity studies you’ve done in this area?

Dr. Haghighat: As a GI at Jackson Memorial Hospital in Miami, I was seeing cancer disparities firsthand every day. I wanted to approach these disparities from a research funding standpoint on a federal level. I was particularly interested in gastric cancer because it’s not common enough in the United States to warrant universal screening, but it’s very common among certain racial and ethnic minorities, which would warrant targeted screening.

I evaluated cancer funding allocation from the National Cancer Institute among the most common cancers in the United States and found that cancer afflicting a higher proportion of racial and ethnic minorities was receiving lower funding. One of those cancers was stomach cancer. This study basically highlighted that, to decrease these disparities, a top-down policy approach is necessary to distribute cancer research funding equitably across these groups. 

A lot of stomach cancer comes from a bacteria called Helicobacter pylori, which can be more prevalent in certain countries. In another study, I looked at country of birth as a risk factor for stomach cancer, specifically for gastric intestinal metaplasia, which is a precursor for gastric cancer . 

We found that country of birth is a key risk factor for gastric intestinal metaplasia and that it should be incorporated into risk stratification for targeted screening. 
 

Q: Outside of medicine, you perform as a stand-up comedian. You have a popular satirical alias on social media. How did you get interested in stand-up comedy?

Dr. Haghighat: I gave my medical school’s commencement speech, and I had sprinkled a few jokes in there. Afterward, multiple people approached me and said, “You should really consider stand-up comedy. Your timing and delivery are great.” A few months later, I started my intern year in Los Angeles and simultaneously took stand-up comedy classes. I started performing at local clubs around town throughout residency, and I had two or three good sets that I could rely on. And so that’s how I got into stand-up comedy.

My intern year is also when I started this social media satire account. It was a way to cope with the anxieties and stress of residency. Before I knew it, the account gained multitudes of followers, doctors, and other medical professionals. And I joke that the more hours I work in a week, the more memes I make, the more posts I make. It’s kind of a creative outlet for me after a long day.
 

Q: What types of things do you talk about during your stand-up act?

Dr. Haghighat: A lot of it is about growing up in an immigrant household as a first-generation Iranian American. One of my favorite jokes is, my parents gave me so many options for a career. They said I could be a family doctor, a surgeon, a plastic surgeon, and if I worked hard, even a wife of a surgeon. But I talk a lot about being a woman in medicine. That always gets a lot of laughs. And now that I’ve graduated GI fellowship, I’m excited to incorporate some GI jokes because it turns out people love poop jokes.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

Denver

Cat or dog person

Dog

Best place you went on vacation

Patagonia

Favorite sport

Basketball

Favorite ice cream

Rocky Road

What song do you have to sing along with when you hear it?

Celine Dion’s My Heart Will Go On

Growing up in a household where GI issues dominated conversations, it’s no surprise that Shida Haghighat, MD, chose gastroenterology as her area of study in medicine.

She watched her father suffer from the complications of Crohn’s disease and her brother struggle with irritable bowel syndrome. “We always needed to know where the nearest bathroom was. I grew up with that around me, and I was always just fascinated by the gut and the digestive system,” said Dr. Haghighat, who just finished up her fellowship at the University of Miami and is now a gastroenterologist at University of California, Los Angeles. She also serves as social media editor for AGA’s Gastro Hep Advances.

University of Miami

As she got to know the personalities of the GI department in the first year of medical school, “I realized that our senses of humor and personalities kind of aligned, and I was like, ‘Oh yeah, this is where I’m supposed to be,’ ” said Dr. Haghighat, who can be found on X @DoctorShida.

Humor is something Dr. Haghighat has reached for throughout her life and career. She eventually channeled her gift for satire onto the stage and the internet, as a stand-up comedian. In an interview with GI & Hepatology News, she spoke about the connection between GI medicine and humor, and the creative ways she has helped promote cancer screening in underserved populations.
 

Q: What practice challenges have you faced in your career?

Dr. Haghighat: I trained in a county hospital, so I’ve always worked with underserved and vulnerable populations. One of the challenges has been just navigation of care, especially as it pertains to cancer diagnoses or cancer screening. A lot of the time, patients don’t understand why they have to do a test or something invasive like a colonoscopy for symptoms they don’t have. 

Q: A focus of yours has been improving uptake of screening in underserved communities. Please talk about the work you’ve done in this area.

Dr. Haghighat: I was at Los Angeles General Medical Center — a county hospital in Los Angeles — for residency, where we treated underserved, uninsured patients. I noticed in our primary care clinics a very low uptake of colon cancer screening. Patients didn’t want to bring the stool tests back or get colonoscopies. I surveyed a bunch of the patients and asked: How can we make colon cancer screening easier for you? About a third of the patients said, “If I can do it in the clinic before I go home, that would be great.”

So, I started this initiative called “Go Before You Go.” We would ask patients, “Hey, do you need to go to the bathroom right now, if you can?” Our nurses handed them the stool test to do in the bathroom before they left the clinic after their doctor visits.

We saw really good results with that. Surprisingly, a lot of people can go on demand. We saw increased screening rates, and that quality improvement project went on to win multiple first place awards in research competitions. So that’s what got me interested, and that’s where I had my beginnings of increasing preventative services in underserved communities on the ground.
 

Q: Can you discuss some health disparity studies you’ve done in this area?

Dr. Haghighat: As a GI at Jackson Memorial Hospital in Miami, I was seeing cancer disparities firsthand every day. I wanted to approach these disparities from a research funding standpoint on a federal level. I was particularly interested in gastric cancer because it’s not common enough in the United States to warrant universal screening, but it’s very common among certain racial and ethnic minorities, which would warrant targeted screening.

I evaluated cancer funding allocation from the National Cancer Institute among the most common cancers in the United States and found that cancer afflicting a higher proportion of racial and ethnic minorities was receiving lower funding. One of those cancers was stomach cancer. This study basically highlighted that, to decrease these disparities, a top-down policy approach is necessary to distribute cancer research funding equitably across these groups. 

A lot of stomach cancer comes from a bacteria called Helicobacter pylori, which can be more prevalent in certain countries. In another study, I looked at country of birth as a risk factor for stomach cancer, specifically for gastric intestinal metaplasia, which is a precursor for gastric cancer . 

We found that country of birth is a key risk factor for gastric intestinal metaplasia and that it should be incorporated into risk stratification for targeted screening. 
 

Q: Outside of medicine, you perform as a stand-up comedian. You have a popular satirical alias on social media. How did you get interested in stand-up comedy?

Dr. Haghighat: I gave my medical school’s commencement speech, and I had sprinkled a few jokes in there. Afterward, multiple people approached me and said, “You should really consider stand-up comedy. Your timing and delivery are great.” A few months later, I started my intern year in Los Angeles and simultaneously took stand-up comedy classes. I started performing at local clubs around town throughout residency, and I had two or three good sets that I could rely on. And so that’s how I got into stand-up comedy.

My intern year is also when I started this social media satire account. It was a way to cope with the anxieties and stress of residency. Before I knew it, the account gained multitudes of followers, doctors, and other medical professionals. And I joke that the more hours I work in a week, the more memes I make, the more posts I make. It’s kind of a creative outlet for me after a long day.
 

Q: What types of things do you talk about during your stand-up act?

Dr. Haghighat: A lot of it is about growing up in an immigrant household as a first-generation Iranian American. One of my favorite jokes is, my parents gave me so many options for a career. They said I could be a family doctor, a surgeon, a plastic surgeon, and if I worked hard, even a wife of a surgeon. But I talk a lot about being a woman in medicine. That always gets a lot of laughs. And now that I’ve graduated GI fellowship, I’m excited to incorporate some GI jokes because it turns out people love poop jokes.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

Denver

Cat or dog person

Dog

Best place you went on vacation

Patagonia

Favorite sport

Basketball

Favorite ice cream

Rocky Road

What song do you have to sing along with when you hear it?

Celine Dion’s My Heart Will Go On

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."^[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."^[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.^[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.^[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.^[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.^[3]

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

Additional References

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."^[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."^[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.^[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.^[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.^[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.^[3]

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

Additional References

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."^[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."^[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.^[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.^[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.^[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.^[3]

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

Additional References

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

For anyone (physicians included) concerned about whether generative artificial intelligence (AI) tools will take your job, the likely answer is no—but those who use generative AI will have an advantage, according to Faranak (Fara) Kamangar, MD, Department Chair, Palo Alto Medical Foundation, who presented on AI at the 2024 Annual Meeting of the American Academy of Dermatology, San Diego, California.

Dr. Kamangar is a dermatologist and inventor of DermGPT, an AI tool created specifically to help health care providers with clinical tasks to increase productivity. According to Dr. Kamangar, “For every 8 hours of scheduled patient time, ambulatory physicians spend more than 5 hours on the [electronic health record].” Her advice is to use AI when you can to complete clinical tasks and move on.

DermGPT utilizes a learned language model that is based on dermatology knowledge acquired from more than 3000 peer-reviewed articles and texts (eg, systematic literature reviews, other published sources in the field of dermatology). Search output includes citations so that users can confirm that the answers and sources are accurate. “Still, with all of these safeguards, all AI models can create inaccuracies and it is important to proofread all content,” says Dr. Kamangar.

During her presentation, Dr. Kamangar gave the following examples of potentially useful DermGPT prompts for dermatologists:

• Can you help me write a response to a denial letter to an insurance company for upadacitinib in a patient with atopic dermatitis?
• I am seeing a patient with blisters. What is the differential diagnosis?
• I am prescribing bimekizumab. What labs do I need to check?

Other potential time-saving uses for a dermatologist include:

• prior authorization letters
• coding support
• responses to common patient messages
• letters of recommendation
• information on new treatments.

In Dr. Kamangar’s practice, they have been able to save at least 30 to 60 minutes at the end of the day that is usually spent updating the electronic health record. “This allows us to complete the clinic day much earlier and does not leave work that will spill over to the next day,” she shares. “During my workday, I have [DermGPT] open on my computer, and as clinical tasks arise, if they require more information or assistance, I turn to DermGPT to help de-escalate the task from a moderate to difficult level to an easy task that can be easily managed.”

The next stage of health technology—AI—is here, and physicians are understandably cautious. Board-certified dermatologists, dermatology residents, fellows, and medical students can try DermGPT for free at https://www.dermgpt.com/.

Dr. Kamangar is the founder of DermGPT.

Melissa Sears is the Director, Editorial, of Cutis.

For anyone (physicians included) concerned about whether generative artificial intelligence (AI) tools will take your job, the likely answer is no—but those who use generative AI will have an advantage, according to Faranak (Fara) Kamangar, MD, Department Chair, Palo Alto Medical Foundation, who presented on AI at the 2024 Annual Meeting of the American Academy of Dermatology, San Diego, California.

Dr. Kamangar is a dermatologist and inventor of DermGPT, an AI tool created specifically to help health care providers with clinical tasks to increase productivity. According to Dr. Kamangar, “For every 8 hours of scheduled patient time, ambulatory physicians spend more than 5 hours on the [electronic health record].” Her advice is to use AI when you can to complete clinical tasks and move on.

DermGPT utilizes a learned language model that is based on dermatology knowledge acquired from more than 3000 peer-reviewed articles and texts (eg, systematic literature reviews, other published sources in the field of dermatology). Search output includes citations so that users can confirm that the answers and sources are accurate. “Still, with all of these safeguards, all AI models can create inaccuracies and it is important to proofread all content,” says Dr. Kamangar.

During her presentation, Dr. Kamangar gave the following examples of potentially useful DermGPT prompts for dermatologists:

• Can you help me write a response to a denial letter to an insurance company for upadacitinib in a patient with atopic dermatitis?
• I am seeing a patient with blisters. What is the differential diagnosis?
• I am prescribing bimekizumab. What labs do I need to check?

Other potential time-saving uses for a dermatologist include:

• prior authorization letters
• coding support
• responses to common patient messages
• letters of recommendation
• information on new treatments.

In Dr. Kamangar’s practice, they have been able to save at least 30 to 60 minutes at the end of the day that is usually spent updating the electronic health record. “This allows us to complete the clinic day much earlier and does not leave work that will spill over to the next day,” she shares. “During my workday, I have [DermGPT] open on my computer, and as clinical tasks arise, if they require more information or assistance, I turn to DermGPT to help de-escalate the task from a moderate to difficult level to an easy task that can be easily managed.”

The next stage of health technology—AI—is here, and physicians are understandably cautious. Board-certified dermatologists, dermatology residents, fellows, and medical students can try DermGPT for free at https://www.dermgpt.com/.

Dr. Kamangar is the founder of DermGPT.

Melissa Sears is the Director, Editorial, of Cutis.

For anyone (physicians included) concerned about whether generative artificial intelligence (AI) tools will take your job, the likely answer is no—but those who use generative AI will have an advantage, according to Faranak (Fara) Kamangar, MD, Department Chair, Palo Alto Medical Foundation, who presented on AI at the 2024 Annual Meeting of the American Academy of Dermatology, San Diego, California.

Dr. Kamangar is a dermatologist and inventor of DermGPT, an AI tool created specifically to help health care providers with clinical tasks to increase productivity. According to Dr. Kamangar, “For every 8 hours of scheduled patient time, ambulatory physicians spend more than 5 hours on the [electronic health record].” Her advice is to use AI when you can to complete clinical tasks and move on.

DermGPT utilizes a learned language model that is based on dermatology knowledge acquired from more than 3000 peer-reviewed articles and texts (eg, systematic literature reviews, other published sources in the field of dermatology). Search output includes citations so that users can confirm that the answers and sources are accurate. “Still, with all of these safeguards, all AI models can create inaccuracies and it is important to proofread all content,” says Dr. Kamangar.

During her presentation, Dr. Kamangar gave the following examples of potentially useful DermGPT prompts for dermatologists:

• Can you help me write a response to a denial letter to an insurance company for upadacitinib in a patient with atopic dermatitis?
• I am seeing a patient with blisters. What is the differential diagnosis?
• I am prescribing bimekizumab. What labs do I need to check?

Other potential time-saving uses for a dermatologist include:

• prior authorization letters
• coding support
• responses to common patient messages
• letters of recommendation
• information on new treatments.

In Dr. Kamangar’s practice, they have been able to save at least 30 to 60 minutes at the end of the day that is usually spent updating the electronic health record. “This allows us to complete the clinic day much earlier and does not leave work that will spill over to the next day,” she shares. “During my workday, I have [DermGPT] open on my computer, and as clinical tasks arise, if they require more information or assistance, I turn to DermGPT to help de-escalate the task from a moderate to difficult level to an easy task that can be easily managed.”

The next stage of health technology—AI—is here, and physicians are understandably cautious. Board-certified dermatologists, dermatology residents, fellows, and medical students can try DermGPT for free at https://www.dermgpt.com/.

Dr. Kamangar is the founder of DermGPT.

Melissa Sears is the Director, Editorial, of Cutis.

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