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SAN ANTONIO — Second-line treatment with imlunestrant improved progression-free survival compared with standard endocrine monotherapy in patients with advanced estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer who had ESR1 mutations, according to recent findings from the EMBER-3 trial.

This progression-free survival benefit with imlunestrant did not extend to the overall population, but a combination of imlunestrant plus abemaciclib did lead to a significant improvement in progression-free survival compared with imlunestrant alone, regardless of patients’ ESR1 mutation status.

Lead author Komal Jhaveri, MD, a breast oncologist at Memorial Sloan Kettering Cancer Center in New York City, called the findings “encouraging.”

The phase 3 results raise the possibility of a second-line all-oral targeted therapy option for patients with ER–positive, HER2–negative advanced breast cancer, said Jhaveri, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024, which were published simultaneously in The New England Journal of Medicine.

However, outside experts provided a note of caution that the trial design may limit how relevant the findings are to clinical practice.

First-line treatment for advanced ER–positive, HER2–negative breast cancer includes an aromatase inhibitor, such as exemestane, and a CDK4/6 inhibitor, such as abemaciclib. However, an ESR1 mutation may develop, which can undermine the effectiveness of the aromatase inhibitor. These patients may swap in a selective estrogen receptor degrader (SERD) — typically, the injectable fulvestrant — in place of the aromatase inhibitor.

Over the past several years, researchers have searched for a better agent than fulvestrant because this injectable drug has limited efficacy in patients with ESR1 mutations, and the monthly intramuscular shots are painful and inconvenient for patients.

The oral SERD imlunestrant is one such candidate.

The EMBER-3 trial initially randomized 661 patients after progression/recurrence evenly to either imlunestrant monotherapy (400 mg once daily) or a standard treatment arm that included either exemestane or fulvestrant, with 90% of these patients receiving fulvestrant. Investigators added a third combination arm shortly after the trial started, which included 213 patients who received imlunestrant plus abemaciclib.

About 60% of the overall population had received prior CDK4/6 inhibitors, primarily palbociclib and ribociclib. About 37% of the study population had ESR1 mutations.

Among patients with ESR1 mutations, imlunestrant monotherapy led to a significant improvement in median progression-free survival of 5.5 months vs 3.8 months in the standard care arm (P < .001). Among all patients, however, progression-free survival was no different between the two arms — 5.6 months in the imlunestrant group vs 5.5 months in the standard care group.

When comparing the two treatment arms in the overall population, the median progression-free survival was significantly better in patients who received imlunestrant plus abemaciclib — 9.4 months vs 5.5 months in the imlunestrant group (hazard ratio [HR] for progression or death, 0.57; P < .001). The progression-free survival benefit held across most patient subgroups, regardless of ESR1 mutation status, as well as among patients who had received a CDK4/6 inhibitor previously.

Data from other studies presented at SABCS indicate that another SERD, elacestrant, in combination with abemaciclib, may provide a similar progression-free survival benefit in this patient population. Elacestrant was approved by the US Food and Drug Administration (FDA) in January 2023 for second-line treatment of patients with advanced breast cancer and ESR1 mutations.

The EMBER trial also reported early overall survival findings. Although immature, overall survival trends favored imlunestrant over the standard treatment. The estimated overall survival at 18 months was 77% in the imlunestrant group and 58.6% in the standard therapy group among patients with ESR1 mutations (HR, 0.55), and 78.6% in the imlunestrant group vs 71.8% in the standard-therapy group for all patients (HR, 0.69).

Common all-grade adverse events with imlunestrant vs standard therapy included fatigue (22.6% vs 13.3%), diarrhea (21.4% vs 11.7%), and nausea (17% vs 13%). Grade 3 or higher anemia and neutropenia were low and similar in both arms.

All-grade diarrhea (86%) and nausea (49%) were more common with the combination of imlunestrant and abemaciclib.

The incidence of grade 3 or higher events was 17% with imlunestrant monotherapy, 21% for standard treatment, and 49% for imlunestrant plus abemaciclib.

EMBER-3 discussant Harold Burstein, MD, PhD, a breast oncologist at the Dana-Farber Cancer Institute, Boston, said that, overall, oral SERDs are starting to “break out from the ESR1 mutation box,” perhaps reflecting the idea that an agent more active than fulvestrant in combination with a non-cross–resistant CDK4/6 inhibitor like abemaciclib might lead to a better long-term outcome, regardless of ESR1 status.

A major limit of EMBER-3, however, is that it did not compare imlunestrant/abemaciclib with fulvestrant/abemaciclib, which would have been a true standard-of-care control, said Burstein.

Kathy Miller, MD, a breast oncologist at Indiana University, Indianapolis, agreed.

She was also concerned about the use of monotherapy in the standard care arm.

“Monotherapy hormone therapy is not what people would be treated with,” Miller said. Patients would typically get fulvestrant with either a targeted therapy or everolimus.

Without appropriate controls, “the data are impossible to interpret” in the context of current practice, Miller told Medscape Medical News.

Eli Lilly, maker of imlunestrant, funded, designed, and largely conducted the trial. Jhaveri is a consultant and researcher for the company. Burstein and Miller had no disclosures. Miller is an editorial advisor for Medscape Oncology.
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Second-line treatment with imlunestrant improved progression-free survival compared with standard endocrine monotherapy in patients with advanced estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer who had ESR1 mutations, according to recent findings from the EMBER-3 trial.

This progression-free survival benefit with imlunestrant did not extend to the overall population, but a combination of imlunestrant plus abemaciclib did lead to a significant improvement in progression-free survival compared with imlunestrant alone, regardless of patients’ ESR1 mutation status.

Lead author Komal Jhaveri, MD, a breast oncologist at Memorial Sloan Kettering Cancer Center in New York City, called the findings “encouraging.”

The phase 3 results raise the possibility of a second-line all-oral targeted therapy option for patients with ER–positive, HER2–negative advanced breast cancer, said Jhaveri, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024, which were published simultaneously in The New England Journal of Medicine.

However, outside experts provided a note of caution that the trial design may limit how relevant the findings are to clinical practice.

First-line treatment for advanced ER–positive, HER2–negative breast cancer includes an aromatase inhibitor, such as exemestane, and a CDK4/6 inhibitor, such as abemaciclib. However, an ESR1 mutation may develop, which can undermine the effectiveness of the aromatase inhibitor. These patients may swap in a selective estrogen receptor degrader (SERD) — typically, the injectable fulvestrant — in place of the aromatase inhibitor.

Over the past several years, researchers have searched for a better agent than fulvestrant because this injectable drug has limited efficacy in patients with ESR1 mutations, and the monthly intramuscular shots are painful and inconvenient for patients.

The oral SERD imlunestrant is one such candidate.

The EMBER-3 trial initially randomized 661 patients after progression/recurrence evenly to either imlunestrant monotherapy (400 mg once daily) or a standard treatment arm that included either exemestane or fulvestrant, with 90% of these patients receiving fulvestrant. Investigators added a third combination arm shortly after the trial started, which included 213 patients who received imlunestrant plus abemaciclib.

About 60% of the overall population had received prior CDK4/6 inhibitors, primarily palbociclib and ribociclib. About 37% of the study population had ESR1 mutations.

Among patients with ESR1 mutations, imlunestrant monotherapy led to a significant improvement in median progression-free survival of 5.5 months vs 3.8 months in the standard care arm (P < .001). Among all patients, however, progression-free survival was no different between the two arms — 5.6 months in the imlunestrant group vs 5.5 months in the standard care group.

When comparing the two treatment arms in the overall population, the median progression-free survival was significantly better in patients who received imlunestrant plus abemaciclib — 9.4 months vs 5.5 months in the imlunestrant group (hazard ratio [HR] for progression or death, 0.57; P < .001). The progression-free survival benefit held across most patient subgroups, regardless of ESR1 mutation status, as well as among patients who had received a CDK4/6 inhibitor previously.

Data from other studies presented at SABCS indicate that another SERD, elacestrant, in combination with abemaciclib, may provide a similar progression-free survival benefit in this patient population. Elacestrant was approved by the US Food and Drug Administration (FDA) in January 2023 for second-line treatment of patients with advanced breast cancer and ESR1 mutations.

The EMBER trial also reported early overall survival findings. Although immature, overall survival trends favored imlunestrant over the standard treatment. The estimated overall survival at 18 months was 77% in the imlunestrant group and 58.6% in the standard therapy group among patients with ESR1 mutations (HR, 0.55), and 78.6% in the imlunestrant group vs 71.8% in the standard-therapy group for all patients (HR, 0.69).

Common all-grade adverse events with imlunestrant vs standard therapy included fatigue (22.6% vs 13.3%), diarrhea (21.4% vs 11.7%), and nausea (17% vs 13%). Grade 3 or higher anemia and neutropenia were low and similar in both arms.

All-grade diarrhea (86%) and nausea (49%) were more common with the combination of imlunestrant and abemaciclib.

The incidence of grade 3 or higher events was 17% with imlunestrant monotherapy, 21% for standard treatment, and 49% for imlunestrant plus abemaciclib.

EMBER-3 discussant Harold Burstein, MD, PhD, a breast oncologist at the Dana-Farber Cancer Institute, Boston, said that, overall, oral SERDs are starting to “break out from the ESR1 mutation box,” perhaps reflecting the idea that an agent more active than fulvestrant in combination with a non-cross–resistant CDK4/6 inhibitor like abemaciclib might lead to a better long-term outcome, regardless of ESR1 status.

A major limit of EMBER-3, however, is that it did not compare imlunestrant/abemaciclib with fulvestrant/abemaciclib, which would have been a true standard-of-care control, said Burstein.

Kathy Miller, MD, a breast oncologist at Indiana University, Indianapolis, agreed.

She was also concerned about the use of monotherapy in the standard care arm.

“Monotherapy hormone therapy is not what people would be treated with,” Miller said. Patients would typically get fulvestrant with either a targeted therapy or everolimus.

Without appropriate controls, “the data are impossible to interpret” in the context of current practice, Miller told Medscape Medical News.

Eli Lilly, maker of imlunestrant, funded, designed, and largely conducted the trial. Jhaveri is a consultant and researcher for the company. Burstein and Miller had no disclosures. Miller is an editorial advisor for Medscape Oncology.
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Second-line treatment with imlunestrant improved progression-free survival compared with standard endocrine monotherapy in patients with advanced estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer who had ESR1 mutations, according to recent findings from the EMBER-3 trial.

This progression-free survival benefit with imlunestrant did not extend to the overall population, but a combination of imlunestrant plus abemaciclib did lead to a significant improvement in progression-free survival compared with imlunestrant alone, regardless of patients’ ESR1 mutation status.

Lead author Komal Jhaveri, MD, a breast oncologist at Memorial Sloan Kettering Cancer Center in New York City, called the findings “encouraging.”

The phase 3 results raise the possibility of a second-line all-oral targeted therapy option for patients with ER–positive, HER2–negative advanced breast cancer, said Jhaveri, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024, which were published simultaneously in The New England Journal of Medicine.

However, outside experts provided a note of caution that the trial design may limit how relevant the findings are to clinical practice.

First-line treatment for advanced ER–positive, HER2–negative breast cancer includes an aromatase inhibitor, such as exemestane, and a CDK4/6 inhibitor, such as abemaciclib. However, an ESR1 mutation may develop, which can undermine the effectiveness of the aromatase inhibitor. These patients may swap in a selective estrogen receptor degrader (SERD) — typically, the injectable fulvestrant — in place of the aromatase inhibitor.

Over the past several years, researchers have searched for a better agent than fulvestrant because this injectable drug has limited efficacy in patients with ESR1 mutations, and the monthly intramuscular shots are painful and inconvenient for patients.

The oral SERD imlunestrant is one such candidate.

The EMBER-3 trial initially randomized 661 patients after progression/recurrence evenly to either imlunestrant monotherapy (400 mg once daily) or a standard treatment arm that included either exemestane or fulvestrant, with 90% of these patients receiving fulvestrant. Investigators added a third combination arm shortly after the trial started, which included 213 patients who received imlunestrant plus abemaciclib.

About 60% of the overall population had received prior CDK4/6 inhibitors, primarily palbociclib and ribociclib. About 37% of the study population had ESR1 mutations.

Among patients with ESR1 mutations, imlunestrant monotherapy led to a significant improvement in median progression-free survival of 5.5 months vs 3.8 months in the standard care arm (P < .001). Among all patients, however, progression-free survival was no different between the two arms — 5.6 months in the imlunestrant group vs 5.5 months in the standard care group.

When comparing the two treatment arms in the overall population, the median progression-free survival was significantly better in patients who received imlunestrant plus abemaciclib — 9.4 months vs 5.5 months in the imlunestrant group (hazard ratio [HR] for progression or death, 0.57; P < .001). The progression-free survival benefit held across most patient subgroups, regardless of ESR1 mutation status, as well as among patients who had received a CDK4/6 inhibitor previously.

Data from other studies presented at SABCS indicate that another SERD, elacestrant, in combination with abemaciclib, may provide a similar progression-free survival benefit in this patient population. Elacestrant was approved by the US Food and Drug Administration (FDA) in January 2023 for second-line treatment of patients with advanced breast cancer and ESR1 mutations.

The EMBER trial also reported early overall survival findings. Although immature, overall survival trends favored imlunestrant over the standard treatment. The estimated overall survival at 18 months was 77% in the imlunestrant group and 58.6% in the standard therapy group among patients with ESR1 mutations (HR, 0.55), and 78.6% in the imlunestrant group vs 71.8% in the standard-therapy group for all patients (HR, 0.69).

Common all-grade adverse events with imlunestrant vs standard therapy included fatigue (22.6% vs 13.3%), diarrhea (21.4% vs 11.7%), and nausea (17% vs 13%). Grade 3 or higher anemia and neutropenia were low and similar in both arms.

All-grade diarrhea (86%) and nausea (49%) were more common with the combination of imlunestrant and abemaciclib.

The incidence of grade 3 or higher events was 17% with imlunestrant monotherapy, 21% for standard treatment, and 49% for imlunestrant plus abemaciclib.

EMBER-3 discussant Harold Burstein, MD, PhD, a breast oncologist at the Dana-Farber Cancer Institute, Boston, said that, overall, oral SERDs are starting to “break out from the ESR1 mutation box,” perhaps reflecting the idea that an agent more active than fulvestrant in combination with a non-cross–resistant CDK4/6 inhibitor like abemaciclib might lead to a better long-term outcome, regardless of ESR1 status.

A major limit of EMBER-3, however, is that it did not compare imlunestrant/abemaciclib with fulvestrant/abemaciclib, which would have been a true standard-of-care control, said Burstein.

Kathy Miller, MD, a breast oncologist at Indiana University, Indianapolis, agreed.

She was also concerned about the use of monotherapy in the standard care arm.

“Monotherapy hormone therapy is not what people would be treated with,” Miller said. Patients would typically get fulvestrant with either a targeted therapy or everolimus.

Without appropriate controls, “the data are impossible to interpret” in the context of current practice, Miller told Medscape Medical News.

Eli Lilly, maker of imlunestrant, funded, designed, and largely conducted the trial. Jhaveri is a consultant and researcher for the company. Burstein and Miller had no disclosures. Miller is an editorial advisor for Medscape Oncology.
 

A version of this article appeared on Medscape.com.

NEW YORK CITY — The total body skin examination with or without dermatoscopy might eventually be marginalized by noninvasive technologies that greatly reduce the need for biopsy while increasing sensitivity and specificity, according to an expert describing four such technologies now in routine use at his own institution.

For skin cancer screening, existing and coming technologies represent “the future of dermatology,” but “we can and should be [already] trying to incorporate these into routine practice,” said Jonathan Ungar, MD, assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York City.

 

Technologies such as electrical impedance spectroscopy (EIS), optical coherence tomography (OCT), and reflectance confocal microscopy (RCM) have immediate utility for improving skin cancer detection with fewer biopsies, but this is just the beginning, according to Ungar, who is also medical director of the Kimberly and Eric J. Waldman Melanoma and Skin Cancer Center at Mount Sinai, New York City.

“There is going to be a day when we are not cutting to make a diagnosis,” he said during a presentation at the 27th Annual Winter Symposium — Advances in Medical and Surgical Dermatology (MSWS) 2024.

 

Four Noninvasive Tools Are in Routine Use

Each of these technologies, along with total body photography (TBP), is currently in use at Mount Sinai as well as other tertiary centers to improve diagnostic accuracy at the same time they reduce invasive tests. The initial excitement about these technologies was based on their potential to avoid biopsy in cosmetically sensitive areas, but Ungar suggested that wider application is being driven by better rates of detection, less morbidity, and improved patient satisfaction.

Patients are happy to avoid invasive procedures whenever they can, Ungar noted. In addition to concern about pain or discomfort and a small but measurable risk for infection, patients face a wound that requires healing and the potential for an enduring scar whether the histology is positive for a malignancy.

While none of the four technologies Ungar outlined typically provide a yes or no answer regarding the presence of a malignancy, they do improve diagnostic accuracy with a lower rate of biopsy.

 

Each Noninvasive Tool Reduces Biopsy Rates

In the case of EIS, for example, the impedance of a painless and harmless electrical current directed into the skin with a handheld probe differentiates normal from abnormal skin through an EIS algorithm. Ungar said it does not require training. A result negative for an abnormality has about a 90% predictive value, and it means that a biopsy can be avoided if there are no other reasons for suspicion.

With a price estimated in the thousands of dollars, the device and software are “not so expensive,” particularly when the tool results in fewer biopsies, Ungar noted.

OCT has a similar profile. Again, used as an adjunct to other types of evaluations, including a history and visual inspection, this helps in modulating suspicion of malignancy. In published studies, OCT has proven superior to dermatoscopy for cancer detection. Citing a 14-study meta-analysis, Ungar said that the sensitivity of OCT for melanoma exceeds, and the specificity approaches, 90%. For basal cell cancers, it is even better.

RCM involves directing a laser into the skin to detect abnormal cells that reflect light. It enables visualization of the skin by layers to the papillary dermis in a detail that is comparable with histology, according to Ungar. Imaging performed with the device used at Mount Sinai (VivaScope 1500, Caliber Imaging & Diagnostics) is reimbursed by Medicare.

Once comfortable with the technology, scanning and interpretation take slightly more time than that required of EIS or OCT, but, like the others, it is painless and helpful for determining whether further evaluation is needed, according to Ungar.

“It is extremely useful in reducing the number of biopsies,” whether melanoma or basal cell malignancies, he said.

 

Total Body Photograph Helps With Serial Screens

While not specifically a diagnostic tool, TBP can also play a role in reducing biopsies through its highly efficient ability to document the evolution of lesions over time.

As its name implies, essentially the entire body surface is captured by multiple cameras mounted in a circle around the patient. Unlike sequential photos that require far more time to take and store and are challenging to organize and retrieve, the device used at Mount Sinai (Vectra Wb180 1360, Canfield Scientific) can complete the photos in about 2 minutes.

Software for organizing and storing the photos, to which dermatoscope images of individual lesions can be attached if helpful, results in efficient retrieval of photos at sequential visits for evaluating change in any specific lesion.

“It is very easy to use,” according to Ungar, who noted that although the underlying idea is not, the technology of taking, storing, and retrieving photographs has been “perhaps perfected” with this approach.

 

Noninvasive Screening Training Is Appropriate

Year after year, dermatology residents undergo intensive instruction to master the traditional methods of skin examination with the naked eye and the help of a dermatoscope, but Ungar considers the noninvasive tools to be another step forward. They lower miss rates while reducing the need for histopathology.

Adding these new technologies to routine patient care resonates for many experts, even if the protocols of when to use with the tool are not well established.

Angela J. Lamb, MD, an associate professor of dermatology at Mount Sinai, who has been following the work of Ungar with interest, sees merit in his argument. Not surprisingly, she thinks that any approach shown to boost skin cancer detection is something that deserves attention, but she thinks the effort to safely eliminate biopsies with a low likelihood of a positive finding cannot be ignored.

“Patients want to avoid biopsies when they can,” Lamb told this news organization, and she does not think this is limited to biopsies on the face or other cosmetically sensitive areas.

As a result, she said that she does see the rationale for incorporating the newer technologies into routine care and called this an “important” effort to improve the patient experience as well as reduce missed lesions.

Ungar reported financial relationships with AbbVie, Bristol-Myers Squibb, Castle Biosciences, Dermavant, Janssen Pharmaceuticals, Menlo Therapeutics, Mitsubishi Tanabe Pharma America, and UCB. Lamb reported no potential conflicts of interest.

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

NEW YORK CITY — The total body skin examination with or without dermatoscopy might eventually be marginalized by noninvasive technologies that greatly reduce the need for biopsy while increasing sensitivity and specificity, according to an expert describing four such technologies now in routine use at his own institution.

For skin cancer screening, existing and coming technologies represent “the future of dermatology,” but “we can and should be [already] trying to incorporate these into routine practice,” said Jonathan Ungar, MD, assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York City.

 

Technologies such as electrical impedance spectroscopy (EIS), optical coherence tomography (OCT), and reflectance confocal microscopy (RCM) have immediate utility for improving skin cancer detection with fewer biopsies, but this is just the beginning, according to Ungar, who is also medical director of the Kimberly and Eric J. Waldman Melanoma and Skin Cancer Center at Mount Sinai, New York City.

“There is going to be a day when we are not cutting to make a diagnosis,” he said during a presentation at the 27th Annual Winter Symposium — Advances in Medical and Surgical Dermatology (MSWS) 2024.

 

Four Noninvasive Tools Are in Routine Use

Each of these technologies, along with total body photography (TBP), is currently in use at Mount Sinai as well as other tertiary centers to improve diagnostic accuracy at the same time they reduce invasive tests. The initial excitement about these technologies was based on their potential to avoid biopsy in cosmetically sensitive areas, but Ungar suggested that wider application is being driven by better rates of detection, less morbidity, and improved patient satisfaction.

Patients are happy to avoid invasive procedures whenever they can, Ungar noted. In addition to concern about pain or discomfort and a small but measurable risk for infection, patients face a wound that requires healing and the potential for an enduring scar whether the histology is positive for a malignancy.

While none of the four technologies Ungar outlined typically provide a yes or no answer regarding the presence of a malignancy, they do improve diagnostic accuracy with a lower rate of biopsy.

 

Each Noninvasive Tool Reduces Biopsy Rates

In the case of EIS, for example, the impedance of a painless and harmless electrical current directed into the skin with a handheld probe differentiates normal from abnormal skin through an EIS algorithm. Ungar said it does not require training. A result negative for an abnormality has about a 90% predictive value, and it means that a biopsy can be avoided if there are no other reasons for suspicion.

With a price estimated in the thousands of dollars, the device and software are “not so expensive,” particularly when the tool results in fewer biopsies, Ungar noted.

OCT has a similar profile. Again, used as an adjunct to other types of evaluations, including a history and visual inspection, this helps in modulating suspicion of malignancy. In published studies, OCT has proven superior to dermatoscopy for cancer detection. Citing a 14-study meta-analysis, Ungar said that the sensitivity of OCT for melanoma exceeds, and the specificity approaches, 90%. For basal cell cancers, it is even better.

RCM involves directing a laser into the skin to detect abnormal cells that reflect light. It enables visualization of the skin by layers to the papillary dermis in a detail that is comparable with histology, according to Ungar. Imaging performed with the device used at Mount Sinai (VivaScope 1500, Caliber Imaging & Diagnostics) is reimbursed by Medicare.

Once comfortable with the technology, scanning and interpretation take slightly more time than that required of EIS or OCT, but, like the others, it is painless and helpful for determining whether further evaluation is needed, according to Ungar.

“It is extremely useful in reducing the number of biopsies,” whether melanoma or basal cell malignancies, he said.

 

Total Body Photograph Helps With Serial Screens

While not specifically a diagnostic tool, TBP can also play a role in reducing biopsies through its highly efficient ability to document the evolution of lesions over time.

As its name implies, essentially the entire body surface is captured by multiple cameras mounted in a circle around the patient. Unlike sequential photos that require far more time to take and store and are challenging to organize and retrieve, the device used at Mount Sinai (Vectra Wb180 1360, Canfield Scientific) can complete the photos in about 2 minutes.

Software for organizing and storing the photos, to which dermatoscope images of individual lesions can be attached if helpful, results in efficient retrieval of photos at sequential visits for evaluating change in any specific lesion.

“It is very easy to use,” according to Ungar, who noted that although the underlying idea is not, the technology of taking, storing, and retrieving photographs has been “perhaps perfected” with this approach.

 

Noninvasive Screening Training Is Appropriate

Year after year, dermatology residents undergo intensive instruction to master the traditional methods of skin examination with the naked eye and the help of a dermatoscope, but Ungar considers the noninvasive tools to be another step forward. They lower miss rates while reducing the need for histopathology.

Adding these new technologies to routine patient care resonates for many experts, even if the protocols of when to use with the tool are not well established.

Angela J. Lamb, MD, an associate professor of dermatology at Mount Sinai, who has been following the work of Ungar with interest, sees merit in his argument. Not surprisingly, she thinks that any approach shown to boost skin cancer detection is something that deserves attention, but she thinks the effort to safely eliminate biopsies with a low likelihood of a positive finding cannot be ignored.

“Patients want to avoid biopsies when they can,” Lamb told this news organization, and she does not think this is limited to biopsies on the face or other cosmetically sensitive areas.

As a result, she said that she does see the rationale for incorporating the newer technologies into routine care and called this an “important” effort to improve the patient experience as well as reduce missed lesions.

Ungar reported financial relationships with AbbVie, Bristol-Myers Squibb, Castle Biosciences, Dermavant, Janssen Pharmaceuticals, Menlo Therapeutics, Mitsubishi Tanabe Pharma America, and UCB. Lamb reported no potential conflicts of interest.

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

NEW YORK CITY — The total body skin examination with or without dermatoscopy might eventually be marginalized by noninvasive technologies that greatly reduce the need for biopsy while increasing sensitivity and specificity, according to an expert describing four such technologies now in routine use at his own institution.

For skin cancer screening, existing and coming technologies represent “the future of dermatology,” but “we can and should be [already] trying to incorporate these into routine practice,” said Jonathan Ungar, MD, assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York City.

 

Technologies such as electrical impedance spectroscopy (EIS), optical coherence tomography (OCT), and reflectance confocal microscopy (RCM) have immediate utility for improving skin cancer detection with fewer biopsies, but this is just the beginning, according to Ungar, who is also medical director of the Kimberly and Eric J. Waldman Melanoma and Skin Cancer Center at Mount Sinai, New York City.

“There is going to be a day when we are not cutting to make a diagnosis,” he said during a presentation at the 27th Annual Winter Symposium — Advances in Medical and Surgical Dermatology (MSWS) 2024.

 

Four Noninvasive Tools Are in Routine Use

Each of these technologies, along with total body photography (TBP), is currently in use at Mount Sinai as well as other tertiary centers to improve diagnostic accuracy at the same time they reduce invasive tests. The initial excitement about these technologies was based on their potential to avoid biopsy in cosmetically sensitive areas, but Ungar suggested that wider application is being driven by better rates of detection, less morbidity, and improved patient satisfaction.

Patients are happy to avoid invasive procedures whenever they can, Ungar noted. In addition to concern about pain or discomfort and a small but measurable risk for infection, patients face a wound that requires healing and the potential for an enduring scar whether the histology is positive for a malignancy.

While none of the four technologies Ungar outlined typically provide a yes or no answer regarding the presence of a malignancy, they do improve diagnostic accuracy with a lower rate of biopsy.

 

Each Noninvasive Tool Reduces Biopsy Rates

In the case of EIS, for example, the impedance of a painless and harmless electrical current directed into the skin with a handheld probe differentiates normal from abnormal skin through an EIS algorithm. Ungar said it does not require training. A result negative for an abnormality has about a 90% predictive value, and it means that a biopsy can be avoided if there are no other reasons for suspicion.

With a price estimated in the thousands of dollars, the device and software are “not so expensive,” particularly when the tool results in fewer biopsies, Ungar noted.

OCT has a similar profile. Again, used as an adjunct to other types of evaluations, including a history and visual inspection, this helps in modulating suspicion of malignancy. In published studies, OCT has proven superior to dermatoscopy for cancer detection. Citing a 14-study meta-analysis, Ungar said that the sensitivity of OCT for melanoma exceeds, and the specificity approaches, 90%. For basal cell cancers, it is even better.

RCM involves directing a laser into the skin to detect abnormal cells that reflect light. It enables visualization of the skin by layers to the papillary dermis in a detail that is comparable with histology, according to Ungar. Imaging performed with the device used at Mount Sinai (VivaScope 1500, Caliber Imaging & Diagnostics) is reimbursed by Medicare.

Once comfortable with the technology, scanning and interpretation take slightly more time than that required of EIS or OCT, but, like the others, it is painless and helpful for determining whether further evaluation is needed, according to Ungar.

“It is extremely useful in reducing the number of biopsies,” whether melanoma or basal cell malignancies, he said.

 

Total Body Photograph Helps With Serial Screens

While not specifically a diagnostic tool, TBP can also play a role in reducing biopsies through its highly efficient ability to document the evolution of lesions over time.

As its name implies, essentially the entire body surface is captured by multiple cameras mounted in a circle around the patient. Unlike sequential photos that require far more time to take and store and are challenging to organize and retrieve, the device used at Mount Sinai (Vectra Wb180 1360, Canfield Scientific) can complete the photos in about 2 minutes.

Software for organizing and storing the photos, to which dermatoscope images of individual lesions can be attached if helpful, results in efficient retrieval of photos at sequential visits for evaluating change in any specific lesion.

“It is very easy to use,” according to Ungar, who noted that although the underlying idea is not, the technology of taking, storing, and retrieving photographs has been “perhaps perfected” with this approach.

 

Noninvasive Screening Training Is Appropriate

Year after year, dermatology residents undergo intensive instruction to master the traditional methods of skin examination with the naked eye and the help of a dermatoscope, but Ungar considers the noninvasive tools to be another step forward. They lower miss rates while reducing the need for histopathology.

Adding these new technologies to routine patient care resonates for many experts, even if the protocols of when to use with the tool are not well established.

Angela J. Lamb, MD, an associate professor of dermatology at Mount Sinai, who has been following the work of Ungar with interest, sees merit in his argument. Not surprisingly, she thinks that any approach shown to boost skin cancer detection is something that deserves attention, but she thinks the effort to safely eliminate biopsies with a low likelihood of a positive finding cannot be ignored.

“Patients want to avoid biopsies when they can,” Lamb told this news organization, and she does not think this is limited to biopsies on the face or other cosmetically sensitive areas.

As a result, she said that she does see the rationale for incorporating the newer technologies into routine care and called this an “important” effort to improve the patient experience as well as reduce missed lesions.

Ungar reported financial relationships with AbbVie, Bristol-Myers Squibb, Castle Biosciences, Dermavant, Janssen Pharmaceuticals, Menlo Therapeutics, Mitsubishi Tanabe Pharma America, and UCB. Lamb reported no potential conflicts of interest.

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

TOPLINE:

InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.

METHODOLOGY:

• The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
• IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
• The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.

TAKEAWAY:

• The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
• The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
• The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
• Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).

IN PRACTICE:

“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.

SOURCE:

The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.

LIMITATIONS:

The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.

DISCLOSURES:

The investigators reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.

METHODOLOGY:

• The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
• IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
• The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.

TAKEAWAY:

• The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
• The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
• The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
• Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).

IN PRACTICE:

“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.

SOURCE:

The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.

LIMITATIONS:

The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.

DISCLOSURES:

The investigators reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.

METHODOLOGY:

• The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
• IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
• The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.

TAKEAWAY:

• The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
• The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
• The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
• Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).

IN PRACTICE:

“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.

SOURCE:

The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.

LIMITATIONS:

The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.

DISCLOSURES:

The investigators reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.   
 

The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy. 
 

The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations. 
 

In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.  
 

The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.  
 

However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed. 
 

The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.  
 

The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.  
 

In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.” 
 

Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”

The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.   
 

The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy. 
 

The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations. 
 

In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.  
 

The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.  
 

However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed. 
 

The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.  
 

The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.  
 

In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.” 
 

Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”

The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.   
 

The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy. 
 

The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations. 
 

In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.  
 

The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.  
 

However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed. 
 

The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.  
 

The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.  
 

In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.” 
 

Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”

TOPLINE:

A survey of dermatologists reveals hypertrophic or traumatic scars, acne, and hyperhidrosis as the top pediatric cosmetic concerns, and vascular lasers, laser hair removal, and lasers for pigmentation among the most common treatments.

METHODOLOGY:

• An anonymous online survey conducted with SurveyMonkey targeted healthcare providers who routinely used lasers to treat cutaneous conditions in pediatric patients.
• The survey included members of the Society for Pediatric Dermatology and the American Society for Laser Medicine and Surgery and Surgery, as well as fellowship directors and current fellows of the American Society for Dermatologic Surgery.
• A total of 85 practitioners responded to the survey, with 86% answering all questions; respondents primarily included pediatric dermatologists (77.65%), general dermatologists (18.82%), cosmetic dermatologists (8.24%), and dermatologic/Mohs surgeons (1.18%).

TAKEAWAY:

• Hypertrophic or traumatic scars ranked as the most frequently treated pediatric cosmetic condition (95.29%), followed by acne (89.41%), axillary and facial hyperhidrosis (77.65%), hypertrichosis/hirsutism (67.06%), and pigmented lesion removal (64.71%).
• The most common procedures performed were vascular lasers (77.65%), laser hair removal (50.59%), lasers for pigmentation (28.24%), neuromodulators (25.88%), and laser skin resurfacing (22.35%).
• Additional treatments respondents performed included chemical peels (20.00%), radiofrequency microneedling (16.47%), soft tissue fillers (4.71%), and cryolipolysis/body contouring (4.17%).
• About 50% of respondents said they would start cosmetic treatment of acne, and about 66% said they would start laser hair removal treatment between the ages of 12 and 15 years.

IN PRACTICE:

Noting that the survey results provided insight into the types of cosmetic procedures being performed for pediatric patients, the authors wrote, “These interventions can play a significant role in addressing the emotional and social challenges faced by pediatric patients with cosmetic concerns, allowing them to navigate social interactions more confidently and positively.” Before any procedure, they added, “It is important that any comorbid conditions be addressed,” they added, and “ethical considerations regarding informed consent, patient autonomy, and long-term consequences should be carefully weighed, given the vulnerable nature of pediatric patients.”

SOURCE:

The study was led by Lauren Hoffman, MD, who practices dermatology in Great Neck, New York. It was published online in December 2024 in Dermatologic Surgery.

LIMITATIONS:

The study was subjective in nature and had a small sample size, and the exact number of survey recipients was unclear, hindering an accurate calculation of the response rate. The absolute number of responses accounted for a small portion of the total memberships of the participating societies. Also, the data collection periods varied among the three academic societies, and dermatologists’ practice types may have influenced the range and nature of treated conditions.

DISCLOSURES:

The authors did not disclose funding information. They declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A survey of dermatologists reveals hypertrophic or traumatic scars, acne, and hyperhidrosis as the top pediatric cosmetic concerns, and vascular lasers, laser hair removal, and lasers for pigmentation among the most common treatments.

METHODOLOGY:

• An anonymous online survey conducted with SurveyMonkey targeted healthcare providers who routinely used lasers to treat cutaneous conditions in pediatric patients.
• The survey included members of the Society for Pediatric Dermatology and the American Society for Laser Medicine and Surgery and Surgery, as well as fellowship directors and current fellows of the American Society for Dermatologic Surgery.
• A total of 85 practitioners responded to the survey, with 86% answering all questions; respondents primarily included pediatric dermatologists (77.65%), general dermatologists (18.82%), cosmetic dermatologists (8.24%), and dermatologic/Mohs surgeons (1.18%).

TAKEAWAY:

• Hypertrophic or traumatic scars ranked as the most frequently treated pediatric cosmetic condition (95.29%), followed by acne (89.41%), axillary and facial hyperhidrosis (77.65%), hypertrichosis/hirsutism (67.06%), and pigmented lesion removal (64.71%).
• The most common procedures performed were vascular lasers (77.65%), laser hair removal (50.59%), lasers for pigmentation (28.24%), neuromodulators (25.88%), and laser skin resurfacing (22.35%).
• Additional treatments respondents performed included chemical peels (20.00%), radiofrequency microneedling (16.47%), soft tissue fillers (4.71%), and cryolipolysis/body contouring (4.17%).
• About 50% of respondents said they would start cosmetic treatment of acne, and about 66% said they would start laser hair removal treatment between the ages of 12 and 15 years.

IN PRACTICE:

Noting that the survey results provided insight into the types of cosmetic procedures being performed for pediatric patients, the authors wrote, “These interventions can play a significant role in addressing the emotional and social challenges faced by pediatric patients with cosmetic concerns, allowing them to navigate social interactions more confidently and positively.” Before any procedure, they added, “It is important that any comorbid conditions be addressed,” they added, and “ethical considerations regarding informed consent, patient autonomy, and long-term consequences should be carefully weighed, given the vulnerable nature of pediatric patients.”

SOURCE:

The study was led by Lauren Hoffman, MD, who practices dermatology in Great Neck, New York. It was published online in December 2024 in Dermatologic Surgery.

LIMITATIONS:

The study was subjective in nature and had a small sample size, and the exact number of survey recipients was unclear, hindering an accurate calculation of the response rate. The absolute number of responses accounted for a small portion of the total memberships of the participating societies. Also, the data collection periods varied among the three academic societies, and dermatologists’ practice types may have influenced the range and nature of treated conditions.

DISCLOSURES:

The authors did not disclose funding information. They declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A survey of dermatologists reveals hypertrophic or traumatic scars, acne, and hyperhidrosis as the top pediatric cosmetic concerns, and vascular lasers, laser hair removal, and lasers for pigmentation among the most common treatments.

METHODOLOGY:

• An anonymous online survey conducted with SurveyMonkey targeted healthcare providers who routinely used lasers to treat cutaneous conditions in pediatric patients.
• The survey included members of the Society for Pediatric Dermatology and the American Society for Laser Medicine and Surgery and Surgery, as well as fellowship directors and current fellows of the American Society for Dermatologic Surgery.
• A total of 85 practitioners responded to the survey, with 86% answering all questions; respondents primarily included pediatric dermatologists (77.65%), general dermatologists (18.82%), cosmetic dermatologists (8.24%), and dermatologic/Mohs surgeons (1.18%).

TAKEAWAY:

• Hypertrophic or traumatic scars ranked as the most frequently treated pediatric cosmetic condition (95.29%), followed by acne (89.41%), axillary and facial hyperhidrosis (77.65%), hypertrichosis/hirsutism (67.06%), and pigmented lesion removal (64.71%).
• The most common procedures performed were vascular lasers (77.65%), laser hair removal (50.59%), lasers for pigmentation (28.24%), neuromodulators (25.88%), and laser skin resurfacing (22.35%).
• Additional treatments respondents performed included chemical peels (20.00%), radiofrequency microneedling (16.47%), soft tissue fillers (4.71%), and cryolipolysis/body contouring (4.17%).
• About 50% of respondents said they would start cosmetic treatment of acne, and about 66% said they would start laser hair removal treatment between the ages of 12 and 15 years.

IN PRACTICE:

Noting that the survey results provided insight into the types of cosmetic procedures being performed for pediatric patients, the authors wrote, “These interventions can play a significant role in addressing the emotional and social challenges faced by pediatric patients with cosmetic concerns, allowing them to navigate social interactions more confidently and positively.” Before any procedure, they added, “It is important that any comorbid conditions be addressed,” they added, and “ethical considerations regarding informed consent, patient autonomy, and long-term consequences should be carefully weighed, given the vulnerable nature of pediatric patients.”

SOURCE:

The study was led by Lauren Hoffman, MD, who practices dermatology in Great Neck, New York. It was published online in December 2024 in Dermatologic Surgery.

LIMITATIONS:

The study was subjective in nature and had a small sample size, and the exact number of survey recipients was unclear, hindering an accurate calculation of the response rate. The absolute number of responses accounted for a small portion of the total memberships of the participating societies. Also, the data collection periods varied among the three academic societies, and dermatologists’ practice types may have influenced the range and nature of treated conditions.

DISCLOSURES:

The authors did not disclose funding information. They declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

SAN DIEGO — The multiple myeloma (MM) drug daratumumab (Darzalex), an anti-CD38 monoclonal antibody, dramatically reduced progression to active MM or death in patients with high-risk smoldering MM (SMM), a landmark randomized, open-label, phase 3 study found.

Among 390 patients with SMM (194 assigned to daratumumab and 196 to active monitoring), progression to active MM or death over a follow-up of 65.2 (0-76.6) months was 51% lower in the daratumumab group vs active monitoring (34.5% vs 50.5%, hazard ratio [HR], 0.49; 95% CI, 0.36-0.67; P < .0001), researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting and in a simultaneous publication in the New England Journal of Medicine.

Rahul Banerjee, MD, an assistant professor with the University of Washington and Fred Hutchinson Cancer Center, both in Seattle, who wasn’t involved with the research, said the study “is a big deal, and I suspect this will ultimately lead to an FDA [Food and Drug Administration] approval for daratumumab in this setting. If using daratumumab up-front can prevent further myeloma and therefore make patients live longer, this would be immediately adopted at many practices.”

As study first author Meletios Athanasios Dimopoulos, MD, of National and Kapodistrian University of Athens and Alexandra General Hospital in Greece, noted at a news briefing, SMM is common, affecting 0.5% of the population aged over 40, per a 2023 Iceland study.

“Standard practice is close follow-up without immediate intervention. However, this oftentimes ends in organ tissue damage, and hypercalcemia, bone lesions, renal impairment, and anemia,” Dimopoulos said.

According to him, researchers launched the AQUILA study in light of indications that daratumumab may benefit patients with intermediate- and high-risk SMM.

For the study, researchers recruited patients from 2017 to 2019 in 23 countries with confirmed high-risk SMM for ≤ 5 years (median age, 64 [31-86] years; 47%-49% men; 83% White).

In the daratumumab group, the drug was administered in 28-day cycles until cycle 39, 36 months, or disease progression, whichever came first (median treatment duration, 38 months [35 months]).

At 5 years, progression-free survival (PFS) — the primary endpoint — was 63.1% (daratumumab) and 40.8% (active monitoring). Researchers estimated 60-month PFS rates at 63.1% and 40.8%, respectively, and overall response rates were 63.4% vs 2.0% (P < .0001), respectively.

The 60-month overall survival rates were 93.0% and 86.9% (HR, 0.52; 95% CI, 0.27-0.98) with 15 deaths in the daratumumab and 26 in the active monitoring group.

“During the follow-up period, there was continuous improvement in favor of the daratumumab arm,” Dimopoulos said. “Even after treatment was discontinued at 3 years, or even at 5 or 6 years, there was a continuous benefit from treatment with daratumumab.”

By clinical cutoff in May 2024, 65% of patients taking daratumumab had finished 39 cycles/3 years of treatment vs 40.8% in the active monitoring group. Progressive disease was the most common reason that patients stopped treatment (21.8% and 41.8% of patients in the groups, respectively).

Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 40.4% (daratumumab) and 30.1% (active monitoring) of patients. The most common was hypertension (5.7% and 4.6%, respectively).

In the daratumumab group, 5.7% discontinued therapy because of TEAEs, which the researchers described as a “low” number, and fatal TEAEs were similar in both groups (1.0% and 2.0%, respectively).

Banerjee said that “one theoretical risk of using daratumumab monotherapy to treat perceived high-risk SMM is that if the patient actually has active multiple myeloma, you are undertreating them. For anyone with HR-SMM, active multiple myeloma must be completely ruled out. I always insist on both a PET-CT and a whole-body MRI to evaluate the bone marrow comprehensively.”

For now, Banerjee said, clinicians should wait for the US Food and Drug Administration approval before prescribing daratumumab for high-risk SMM.

Are there alternatives to reduce the risk for SMM turning into MM? “Generally, I advise close observation in most cases, but we do have clinical trials in this space,” Banerjee said. “Technically, it is possible to consider lenalidomide monotherapy in SMM based on the results of a large phase 3 study. But lenalidomide is expensive and has many side effects. Insurance companies often won’t cover it fully, and patients almost always have at least one side effect.”

Also, he added, “only half of patients saw their high-risk SMM disease burden drop. Lenalidomide also has a clear link to rare, delayed toxicities such as second primary malignancies, which makes us nervous.”

Janssen Pharmaceuticals, the maker of daratumumab, funded the study. Dimopoulos disclosed ties with Sanofi, Regeneron, Menarini, Takeda, GSK, BMS, Janssen Pharmaceuticals, BeiGene, Swixx, AstraZeneca, and Amgen. Banerjee disclosed ties with AbbVie, Adaptive, BMS, Caribou, Genentech/Roche, GSK, Karyopharm Therapeutics, Legend, Johnson & Johnson, Novartis, Pack, Pfizer, Prothena, Sanofi Pasteur, and SparkCures. Some other authors reported various and multiple disclosures, including ties with Janssen Pharmaceuticals.

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

SAN DIEGO — The multiple myeloma (MM) drug daratumumab (Darzalex), an anti-CD38 monoclonal antibody, dramatically reduced progression to active MM or death in patients with high-risk smoldering MM (SMM), a landmark randomized, open-label, phase 3 study found.

Among 390 patients with SMM (194 assigned to daratumumab and 196 to active monitoring), progression to active MM or death over a follow-up of 65.2 (0-76.6) months was 51% lower in the daratumumab group vs active monitoring (34.5% vs 50.5%, hazard ratio [HR], 0.49; 95% CI, 0.36-0.67; P < .0001), researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting and in a simultaneous publication in the New England Journal of Medicine.

Rahul Banerjee, MD, an assistant professor with the University of Washington and Fred Hutchinson Cancer Center, both in Seattle, who wasn’t involved with the research, said the study “is a big deal, and I suspect this will ultimately lead to an FDA [Food and Drug Administration] approval for daratumumab in this setting. If using daratumumab up-front can prevent further myeloma and therefore make patients live longer, this would be immediately adopted at many practices.”

As study first author Meletios Athanasios Dimopoulos, MD, of National and Kapodistrian University of Athens and Alexandra General Hospital in Greece, noted at a news briefing, SMM is common, affecting 0.5% of the population aged over 40, per a 2023 Iceland study.

“Standard practice is close follow-up without immediate intervention. However, this oftentimes ends in organ tissue damage, and hypercalcemia, bone lesions, renal impairment, and anemia,” Dimopoulos said.

According to him, researchers launched the AQUILA study in light of indications that daratumumab may benefit patients with intermediate- and high-risk SMM.

For the study, researchers recruited patients from 2017 to 2019 in 23 countries with confirmed high-risk SMM for ≤ 5 years (median age, 64 [31-86] years; 47%-49% men; 83% White).

In the daratumumab group, the drug was administered in 28-day cycles until cycle 39, 36 months, or disease progression, whichever came first (median treatment duration, 38 months [35 months]).

At 5 years, progression-free survival (PFS) — the primary endpoint — was 63.1% (daratumumab) and 40.8% (active monitoring). Researchers estimated 60-month PFS rates at 63.1% and 40.8%, respectively, and overall response rates were 63.4% vs 2.0% (P < .0001), respectively.

The 60-month overall survival rates were 93.0% and 86.9% (HR, 0.52; 95% CI, 0.27-0.98) with 15 deaths in the daratumumab and 26 in the active monitoring group.

“During the follow-up period, there was continuous improvement in favor of the daratumumab arm,” Dimopoulos said. “Even after treatment was discontinued at 3 years, or even at 5 or 6 years, there was a continuous benefit from treatment with daratumumab.”

By clinical cutoff in May 2024, 65% of patients taking daratumumab had finished 39 cycles/3 years of treatment vs 40.8% in the active monitoring group. Progressive disease was the most common reason that patients stopped treatment (21.8% and 41.8% of patients in the groups, respectively).

Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 40.4% (daratumumab) and 30.1% (active monitoring) of patients. The most common was hypertension (5.7% and 4.6%, respectively).

In the daratumumab group, 5.7% discontinued therapy because of TEAEs, which the researchers described as a “low” number, and fatal TEAEs were similar in both groups (1.0% and 2.0%, respectively).

Banerjee said that “one theoretical risk of using daratumumab monotherapy to treat perceived high-risk SMM is that if the patient actually has active multiple myeloma, you are undertreating them. For anyone with HR-SMM, active multiple myeloma must be completely ruled out. I always insist on both a PET-CT and a whole-body MRI to evaluate the bone marrow comprehensively.”

For now, Banerjee said, clinicians should wait for the US Food and Drug Administration approval before prescribing daratumumab for high-risk SMM.

Are there alternatives to reduce the risk for SMM turning into MM? “Generally, I advise close observation in most cases, but we do have clinical trials in this space,” Banerjee said. “Technically, it is possible to consider lenalidomide monotherapy in SMM based on the results of a large phase 3 study. But lenalidomide is expensive and has many side effects. Insurance companies often won’t cover it fully, and patients almost always have at least one side effect.”

Also, he added, “only half of patients saw their high-risk SMM disease burden drop. Lenalidomide also has a clear link to rare, delayed toxicities such as second primary malignancies, which makes us nervous.”

Janssen Pharmaceuticals, the maker of daratumumab, funded the study. Dimopoulos disclosed ties with Sanofi, Regeneron, Menarini, Takeda, GSK, BMS, Janssen Pharmaceuticals, BeiGene, Swixx, AstraZeneca, and Amgen. Banerjee disclosed ties with AbbVie, Adaptive, BMS, Caribou, Genentech/Roche, GSK, Karyopharm Therapeutics, Legend, Johnson & Johnson, Novartis, Pack, Pfizer, Prothena, Sanofi Pasteur, and SparkCures. Some other authors reported various and multiple disclosures, including ties with Janssen Pharmaceuticals.

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

SAN DIEGO — The multiple myeloma (MM) drug daratumumab (Darzalex), an anti-CD38 monoclonal antibody, dramatically reduced progression to active MM or death in patients with high-risk smoldering MM (SMM), a landmark randomized, open-label, phase 3 study found.

Among 390 patients with SMM (194 assigned to daratumumab and 196 to active monitoring), progression to active MM or death over a follow-up of 65.2 (0-76.6) months was 51% lower in the daratumumab group vs active monitoring (34.5% vs 50.5%, hazard ratio [HR], 0.49; 95% CI, 0.36-0.67; P < .0001), researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting and in a simultaneous publication in the New England Journal of Medicine.

Rahul Banerjee, MD, an assistant professor with the University of Washington and Fred Hutchinson Cancer Center, both in Seattle, who wasn’t involved with the research, said the study “is a big deal, and I suspect this will ultimately lead to an FDA [Food and Drug Administration] approval for daratumumab in this setting. If using daratumumab up-front can prevent further myeloma and therefore make patients live longer, this would be immediately adopted at many practices.”

As study first author Meletios Athanasios Dimopoulos, MD, of National and Kapodistrian University of Athens and Alexandra General Hospital in Greece, noted at a news briefing, SMM is common, affecting 0.5% of the population aged over 40, per a 2023 Iceland study.

“Standard practice is close follow-up without immediate intervention. However, this oftentimes ends in organ tissue damage, and hypercalcemia, bone lesions, renal impairment, and anemia,” Dimopoulos said.

According to him, researchers launched the AQUILA study in light of indications that daratumumab may benefit patients with intermediate- and high-risk SMM.

For the study, researchers recruited patients from 2017 to 2019 in 23 countries with confirmed high-risk SMM for ≤ 5 years (median age, 64 [31-86] years; 47%-49% men; 83% White).

In the daratumumab group, the drug was administered in 28-day cycles until cycle 39, 36 months, or disease progression, whichever came first (median treatment duration, 38 months [35 months]).

At 5 years, progression-free survival (PFS) — the primary endpoint — was 63.1% (daratumumab) and 40.8% (active monitoring). Researchers estimated 60-month PFS rates at 63.1% and 40.8%, respectively, and overall response rates were 63.4% vs 2.0% (P < .0001), respectively.

The 60-month overall survival rates were 93.0% and 86.9% (HR, 0.52; 95% CI, 0.27-0.98) with 15 deaths in the daratumumab and 26 in the active monitoring group.

“During the follow-up period, there was continuous improvement in favor of the daratumumab arm,” Dimopoulos said. “Even after treatment was discontinued at 3 years, or even at 5 or 6 years, there was a continuous benefit from treatment with daratumumab.”

By clinical cutoff in May 2024, 65% of patients taking daratumumab had finished 39 cycles/3 years of treatment vs 40.8% in the active monitoring group. Progressive disease was the most common reason that patients stopped treatment (21.8% and 41.8% of patients in the groups, respectively).

Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 40.4% (daratumumab) and 30.1% (active monitoring) of patients. The most common was hypertension (5.7% and 4.6%, respectively).

In the daratumumab group, 5.7% discontinued therapy because of TEAEs, which the researchers described as a “low” number, and fatal TEAEs were similar in both groups (1.0% and 2.0%, respectively).

Banerjee said that “one theoretical risk of using daratumumab monotherapy to treat perceived high-risk SMM is that if the patient actually has active multiple myeloma, you are undertreating them. For anyone with HR-SMM, active multiple myeloma must be completely ruled out. I always insist on both a PET-CT and a whole-body MRI to evaluate the bone marrow comprehensively.”

For now, Banerjee said, clinicians should wait for the US Food and Drug Administration approval before prescribing daratumumab for high-risk SMM.

Are there alternatives to reduce the risk for SMM turning into MM? “Generally, I advise close observation in most cases, but we do have clinical trials in this space,” Banerjee said. “Technically, it is possible to consider lenalidomide monotherapy in SMM based on the results of a large phase 3 study. But lenalidomide is expensive and has many side effects. Insurance companies often won’t cover it fully, and patients almost always have at least one side effect.”

Also, he added, “only half of patients saw their high-risk SMM disease burden drop. Lenalidomide also has a clear link to rare, delayed toxicities such as second primary malignancies, which makes us nervous.”

Janssen Pharmaceuticals, the maker of daratumumab, funded the study. Dimopoulos disclosed ties with Sanofi, Regeneron, Menarini, Takeda, GSK, BMS, Janssen Pharmaceuticals, BeiGene, Swixx, AstraZeneca, and Amgen. Banerjee disclosed ties with AbbVie, Adaptive, BMS, Caribou, Genentech/Roche, GSK, Karyopharm Therapeutics, Legend, Johnson & Johnson, Novartis, Pack, Pfizer, Prothena, Sanofi Pasteur, and SparkCures. Some other authors reported various and multiple disclosures, including ties with Janssen Pharmaceuticals.

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

The Food and Drug Administration (FDA) has approved nemolizumab for moderate to severe atopic dermatitis inadequately controlled with topical therapies in patients aged 12 years and older, according to a press release from the manufacturer, Galderma. 

Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company. 

Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids. 

At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.

At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies. 

In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.

Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively). 

Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.

According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.

In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.

ARCADIA is funded by Galderma.

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

The Food and Drug Administration (FDA) has approved nemolizumab for moderate to severe atopic dermatitis inadequately controlled with topical therapies in patients aged 12 years and older, according to a press release from the manufacturer, Galderma. 

Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company. 

Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids. 

At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.

At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies. 

In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.

Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively). 

Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.

According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.

In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.

ARCADIA is funded by Galderma.

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

The Food and Drug Administration (FDA) has approved nemolizumab for moderate to severe atopic dermatitis inadequately controlled with topical therapies in patients aged 12 years and older, according to a press release from the manufacturer, Galderma. 

Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company. 

Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids. 

At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.

At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies. 

In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.

Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively). 

Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.

According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.

In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.

ARCADIA is funded by Galderma.

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

SAN DIEGO — In patients with metabolic dysfunction–associated steatotic liver disease (MASLD), hypertension, and cirrhosis, certain antihypertensive medications may lead to increased risks for hepatocellular carcinoma (HCC), according to new research.

In particular, the use of calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARBs) was associated with a higher risk of developing HCC, compared with not using these medications.

About half of patients with MASLD have hypertension, and the use of antihypertensives in these patients is beneficial to reduce the risk for cardiovascular disease and complications related to MASLD, said lead author Ahmed Elhariri, MD, a research fellow at the University of Texas MD Anderson Cancer Center, Houston, who conducted the study as a research assistant in gastroenterology and hepatology at the Baylor College of Medicine, also in Houston.

However, previous studies have suggested a possible link between these medications and cancer development, “especially CCBs and breast and lung cancer,” said Elhariri, who presented the findings at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD).

 

Analyzing Potential Risks

In a case-control study, Elhariri and colleagues analyzed antihypertensive medication use among patients with MASLD-induced HCC, as defined by histology or radiology based on the Liver Imaging Reporting & Data System, and control patients with MASLD but without HCC.

Between 2020 and 2024, the research team recruited 153 newly diagnosed HCC cases with different etiologies and 170 patients with MASLD but without HCC from Baylor College of Medicine’s outpatient clinics. For this study, they selected 47 age- and sex-matched pairs, all of whom had cirrhosis. Only those with a history of hypertension were included, however. Data on risk factors of metabolic syndrome (including diabetes) and HCC were collected, along with details about medication use such as metformin and statins.

A total of 42 patients with MASLD and HCC and 39 MASLD control individuals had a history of hypertension and were treated with antihypertensive medications. The mean age was 66.5 years for the HCC group and 63.5 years for the control group, and the mean body mass index (BMI) was 31.1 for the HCC group and 31.7 for the control group.

After adjusting for age, sex, BMI, Hispanic ethnicity, and use of other medications, patients taking CCBs had an increased HCC risk (odds ratio [OR], 2.76), compared with those not taking CCBs. Patients taking ACE inhibitors or ARBs also had an increased HCC risk (OR, 2.54), compared with those not taking ACE inhibitors or ARBs.

However, there wasn’t a statistically significant difference in HCC risk among patients taking beta-blockers (OR, 0.87).

“Patients with fatty liver in the presence of metabolic syndrome, especially in the presence of cirrhosis and antihypertensives, need to have stricter surveillance for liver cancer,” Elhariri said.

“We need to carefully review blood pressure medications in patients with MASLD and cirrhosis,” he said. CCBs, ACE inhibitors, and ARBs can be replaced with beta-blockers, “which have been shown to reduce progression of cirrhosis-related complications.”

 

Considering Clinical Implications

“Although our study showed some association between the use of some commonly used antihypertensives and the risk for HCC in this high-risk population, it is based on data collected retrospectively on a small number of selected patients with advanced liver disease,” Elhariri noted.

The associations and underlying mechanisms should be studied in larger populations and prospective trials, he said. “Until we have more data with a significantly larger sample size, it’s premature to raise the concern in the general population.”

“The cardiovascular benefits of controlling blood pressure far outweigh the risk of liver cancer in patients with metabolic syndrome,” Elhariri added.

In ongoing studies, researchers are investigating ways to improve patient outcomes and reduce the negative effects of cirrhosis-associated complications among patients with MASLD and metabolic dysfunction–associated steatohepatitis (MASH), Muhammad Ali Butt, MD, a hepatology fellow at Beth Israel Lahey Hospital & Medical Center in Burlington, Massachusetts, said in an interview.

Butt, who wasn’t involved with this study, presented separate research on statins in MASH patients with cirrhosis, which indicated statistically significant decreases in portal hypertension, thrombosis, hepatorenal syndrome, hepatic encephalopathy, and mortality.

“We know patients with MASLD- and MASH-associated cirrhosis commonly have other comorbidities, including high cardiovascular risks, diabetes, and hyperlipidemia,” he said. “All of these conditions indicate patients to be on other medications such as antihypertensives or statins. It’s important to know the role these medications play, especially given the high-risk profile of these patients.”

Elhariri and Butt reported no relevant disclosures.

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

SAN DIEGO — In patients with metabolic dysfunction–associated steatotic liver disease (MASLD), hypertension, and cirrhosis, certain antihypertensive medications may lead to increased risks for hepatocellular carcinoma (HCC), according to new research.

In particular, the use of calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARBs) was associated with a higher risk of developing HCC, compared with not using these medications.

About half of patients with MASLD have hypertension, and the use of antihypertensives in these patients is beneficial to reduce the risk for cardiovascular disease and complications related to MASLD, said lead author Ahmed Elhariri, MD, a research fellow at the University of Texas MD Anderson Cancer Center, Houston, who conducted the study as a research assistant in gastroenterology and hepatology at the Baylor College of Medicine, also in Houston.

However, previous studies have suggested a possible link between these medications and cancer development, “especially CCBs and breast and lung cancer,” said Elhariri, who presented the findings at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD).

 

Analyzing Potential Risks

In a case-control study, Elhariri and colleagues analyzed antihypertensive medication use among patients with MASLD-induced HCC, as defined by histology or radiology based on the Liver Imaging Reporting & Data System, and control patients with MASLD but without HCC.

Between 2020 and 2024, the research team recruited 153 newly diagnosed HCC cases with different etiologies and 170 patients with MASLD but without HCC from Baylor College of Medicine’s outpatient clinics. For this study, they selected 47 age- and sex-matched pairs, all of whom had cirrhosis. Only those with a history of hypertension were included, however. Data on risk factors of metabolic syndrome (including diabetes) and HCC were collected, along with details about medication use such as metformin and statins.

A total of 42 patients with MASLD and HCC and 39 MASLD control individuals had a history of hypertension and were treated with antihypertensive medications. The mean age was 66.5 years for the HCC group and 63.5 years for the control group, and the mean body mass index (BMI) was 31.1 for the HCC group and 31.7 for the control group.

After adjusting for age, sex, BMI, Hispanic ethnicity, and use of other medications, patients taking CCBs had an increased HCC risk (odds ratio [OR], 2.76), compared with those not taking CCBs. Patients taking ACE inhibitors or ARBs also had an increased HCC risk (OR, 2.54), compared with those not taking ACE inhibitors or ARBs.

However, there wasn’t a statistically significant difference in HCC risk among patients taking beta-blockers (OR, 0.87).

“Patients with fatty liver in the presence of metabolic syndrome, especially in the presence of cirrhosis and antihypertensives, need to have stricter surveillance for liver cancer,” Elhariri said.

“We need to carefully review blood pressure medications in patients with MASLD and cirrhosis,” he said. CCBs, ACE inhibitors, and ARBs can be replaced with beta-blockers, “which have been shown to reduce progression of cirrhosis-related complications.”

 

Considering Clinical Implications

“Although our study showed some association between the use of some commonly used antihypertensives and the risk for HCC in this high-risk population, it is based on data collected retrospectively on a small number of selected patients with advanced liver disease,” Elhariri noted.

The associations and underlying mechanisms should be studied in larger populations and prospective trials, he said. “Until we have more data with a significantly larger sample size, it’s premature to raise the concern in the general population.”

“The cardiovascular benefits of controlling blood pressure far outweigh the risk of liver cancer in patients with metabolic syndrome,” Elhariri added.

In ongoing studies, researchers are investigating ways to improve patient outcomes and reduce the negative effects of cirrhosis-associated complications among patients with MASLD and metabolic dysfunction–associated steatohepatitis (MASH), Muhammad Ali Butt, MD, a hepatology fellow at Beth Israel Lahey Hospital & Medical Center in Burlington, Massachusetts, said in an interview.

Butt, who wasn’t involved with this study, presented separate research on statins in MASH patients with cirrhosis, which indicated statistically significant decreases in portal hypertension, thrombosis, hepatorenal syndrome, hepatic encephalopathy, and mortality.

“We know patients with MASLD- and MASH-associated cirrhosis commonly have other comorbidities, including high cardiovascular risks, diabetes, and hyperlipidemia,” he said. “All of these conditions indicate patients to be on other medications such as antihypertensives or statins. It’s important to know the role these medications play, especially given the high-risk profile of these patients.”

Elhariri and Butt reported no relevant disclosures.

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

SAN DIEGO — In patients with metabolic dysfunction–associated steatotic liver disease (MASLD), hypertension, and cirrhosis, certain antihypertensive medications may lead to increased risks for hepatocellular carcinoma (HCC), according to new research.

In particular, the use of calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARBs) was associated with a higher risk of developing HCC, compared with not using these medications.

About half of patients with MASLD have hypertension, and the use of antihypertensives in these patients is beneficial to reduce the risk for cardiovascular disease and complications related to MASLD, said lead author Ahmed Elhariri, MD, a research fellow at the University of Texas MD Anderson Cancer Center, Houston, who conducted the study as a research assistant in gastroenterology and hepatology at the Baylor College of Medicine, also in Houston.

However, previous studies have suggested a possible link between these medications and cancer development, “especially CCBs and breast and lung cancer,” said Elhariri, who presented the findings at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD).

 

Analyzing Potential Risks

In a case-control study, Elhariri and colleagues analyzed antihypertensive medication use among patients with MASLD-induced HCC, as defined by histology or radiology based on the Liver Imaging Reporting & Data System, and control patients with MASLD but without HCC.

Between 2020 and 2024, the research team recruited 153 newly diagnosed HCC cases with different etiologies and 170 patients with MASLD but without HCC from Baylor College of Medicine’s outpatient clinics. For this study, they selected 47 age- and sex-matched pairs, all of whom had cirrhosis. Only those with a history of hypertension were included, however. Data on risk factors of metabolic syndrome (including diabetes) and HCC were collected, along with details about medication use such as metformin and statins.

A total of 42 patients with MASLD and HCC and 39 MASLD control individuals had a history of hypertension and were treated with antihypertensive medications. The mean age was 66.5 years for the HCC group and 63.5 years for the control group, and the mean body mass index (BMI) was 31.1 for the HCC group and 31.7 for the control group.

After adjusting for age, sex, BMI, Hispanic ethnicity, and use of other medications, patients taking CCBs had an increased HCC risk (odds ratio [OR], 2.76), compared with those not taking CCBs. Patients taking ACE inhibitors or ARBs also had an increased HCC risk (OR, 2.54), compared with those not taking ACE inhibitors or ARBs.

However, there wasn’t a statistically significant difference in HCC risk among patients taking beta-blockers (OR, 0.87).

“Patients with fatty liver in the presence of metabolic syndrome, especially in the presence of cirrhosis and antihypertensives, need to have stricter surveillance for liver cancer,” Elhariri said.

“We need to carefully review blood pressure medications in patients with MASLD and cirrhosis,” he said. CCBs, ACE inhibitors, and ARBs can be replaced with beta-blockers, “which have been shown to reduce progression of cirrhosis-related complications.”

 

Considering Clinical Implications

“Although our study showed some association between the use of some commonly used antihypertensives and the risk for HCC in this high-risk population, it is based on data collected retrospectively on a small number of selected patients with advanced liver disease,” Elhariri noted.

The associations and underlying mechanisms should be studied in larger populations and prospective trials, he said. “Until we have more data with a significantly larger sample size, it’s premature to raise the concern in the general population.”

“The cardiovascular benefits of controlling blood pressure far outweigh the risk of liver cancer in patients with metabolic syndrome,” Elhariri added.

In ongoing studies, researchers are investigating ways to improve patient outcomes and reduce the negative effects of cirrhosis-associated complications among patients with MASLD and metabolic dysfunction–associated steatohepatitis (MASH), Muhammad Ali Butt, MD, a hepatology fellow at Beth Israel Lahey Hospital & Medical Center in Burlington, Massachusetts, said in an interview.

Butt, who wasn’t involved with this study, presented separate research on statins in MASH patients with cirrhosis, which indicated statistically significant decreases in portal hypertension, thrombosis, hepatorenal syndrome, hepatic encephalopathy, and mortality.

“We know patients with MASLD- and MASH-associated cirrhosis commonly have other comorbidities, including high cardiovascular risks, diabetes, and hyperlipidemia,” he said. “All of these conditions indicate patients to be on other medications such as antihypertensives or statins. It’s important to know the role these medications play, especially given the high-risk profile of these patients.”

Elhariri and Butt reported no relevant disclosures.

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

NEW YORK CITY — Instructions on wound healing often involve disturbing photographs of severe diabetic ulcers, angry autoimmune blistering, and oozing lesions produced by uncommon genetic disorders, but whether or not they are dramatic, day-to-day dermatologic wound care relies on both the basics as well as novel approaches, according to a well-known wound treatment expert.

Wound repair is relevant to any specialty involved in invasive interventions, but dermatologists are at ground zero and should have commensurate skills, suggested Robert S. Kirsner, MD, PhD, director of the Wound Clinic at Jackson Memorial Hospital and chair of the Department of Dermatology and Cutaneous Surgery at the University of Miami, Florida.

“We as a specialty make and repair more wounds than any other specialty,” said Kirsner, who provided data to make his point. In a table he showed, the number of wound repairs made annually by dermatologists was several-fold higher than surgeons, the next highest group, and the numbers declined rapidly from there. 

Speaking at the 27th Annual Winter Symposium – Advances in Medical and Surgical Dermatology (MSWS) 2024, Kirsner offered an array of clinical pearls, reinforced some basics, and pointed to well-supported strategies he believes are too often overlooked.

Drugs Repurposed for Wound Healing

Of the clinical pearls, he spoke of the repurposing of several agents for wound care. His first example was the monoclonal antibody dupilumab, which inhibits interleukin-4 (IL-4) and IL-13 signaling, to heal selected patients with leg ulcers. The potential of this drug for wound healing was based on a patient with a leg ulcer who presented with concomitant prurigo nodularis and biliary cirrhosis. When offered for the comorbidities, dupilumab provided a “dramatic” benefit with regard to the wound, according to Kirsner. 

The explanation for the response is that IL-4 and IL-13 have been found to be upregulated in some patients with leg ulcers. Based on numerous cases, Kirsner spoke of a phenotype of nonhealing leg ulcers from which elevated IL-4 and IL-13 can be isolated; these are the candidates for adding dupilumab to wound care, he said.

Topical beta-blockade is another example of a therapy repurposed for wound healing, according to Kirsner. He said beta-blockers are already a standard of care for burn wounds, but the mechanism is relevant in other wound types.

Several studies have looked at this phenomenon, with experimental studies showing that skin healing is impaired when beta-2 receptors are agonized but accelerated when blocked. 

 

Beta-Blockade Accelerates Wound Healing 

A recent review of these mechanisms in soft-tissue wound healing pointed to an anti-inflammatory effect, acceleration of keratinocyte migration, pro-reepithelization effects, and inhibition of bacterial virulence. Beta-blockers were first implicated as mediators of wound healing more than a decade ago, but Kirsner indicated that there is now more attention to this therapy within a comprehensive approach in difficult cases.

Although not specific to wound healing, the potential for teprotumumab to improve control of pretibial myxedema is another example of a repurposed therapy for a challenging skin disease. Teprotumumab, a monoclonal antibody that targets the insulin-like growth factor-1 (IGF-1) receptor, is approved for active thyroid eye disease, but Kirsner cited data showing compelling evidence of benefit in this cutaneous complication of Graves disease.

As for basics, Kirsner devoted some time to emphasizing the importance of compression therapy for improving leg vascularization. This is not something to just consider; rather, he thinks it is part of standard practice. “Compress all leg ulcers,” was Kirsner’s simple message.

Citing encouraging work in identifying targetable molecular events in wound healing, Kirsner suggested that treatment might be increasingly guided by biomarkers. He pointed to ongoing work to characterize wound exudate as a source of biomarkers.

“The discarded dressing contains a wealth of information,” he said, referring to cell types and proteins, such as growth factors. He thinks that the ongoing studies of exudate, which have shown that molecular processes detected at the periphery are often different than those at the focal site of injury, have substantial promise for identifying new treatment targets.

 

Virtual Reality to Address Pain

From a practical standpoint, Kirsner looked to a well-studied but still underused adjunct to wound debridement and surgical repair: the distraction offered by relatively low-priced virtual reality systems. He described it as a simple way to help patients keep their minds off the pain. It is not a new idea and has been studied for this use numerous times, and the evidence of benefit is essentially uniform, according to Kirsner.

He said effective and sophisticated systems can now be purchased for just hundreds of dollars, and no training is needed. Indeed, he said pediatric patients can typically explain how the system works if the clinician does not know.

“If you can enhance their experience [during wound repair], you can make their lives and your life better,” he said. 

Joshua Zeichner, MD, associate professor of dermatology at Mount Sinai Hospital in New York City, concurred that the evidence supports this approach and is easy to do. “I am in favor of anything that improves the experience of the patient,” said Zeichner, who chaired the portion of the meeting during which Kirsner spoke. 

Kirsner said he practices what he preaches. “I routinely employ virtual reality for simple surgical procedures or processes that patients might find unpleasant,” he said. He acknowledged that clinicians might have heard this message before, but he believes those who have not yet introduced this into their practice should consider it.

Kirsner has reported no relevant financial relationships. Zeichner has reported serving as a consultant for Beiersdorf. 

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

NEW YORK CITY — Instructions on wound healing often involve disturbing photographs of severe diabetic ulcers, angry autoimmune blistering, and oozing lesions produced by uncommon genetic disorders, but whether or not they are dramatic, day-to-day dermatologic wound care relies on both the basics as well as novel approaches, according to a well-known wound treatment expert.

Wound repair is relevant to any specialty involved in invasive interventions, but dermatologists are at ground zero and should have commensurate skills, suggested Robert S. Kirsner, MD, PhD, director of the Wound Clinic at Jackson Memorial Hospital and chair of the Department of Dermatology and Cutaneous Surgery at the University of Miami, Florida.

“We as a specialty make and repair more wounds than any other specialty,” said Kirsner, who provided data to make his point. In a table he showed, the number of wound repairs made annually by dermatologists was several-fold higher than surgeons, the next highest group, and the numbers declined rapidly from there. 

Speaking at the 27th Annual Winter Symposium – Advances in Medical and Surgical Dermatology (MSWS) 2024, Kirsner offered an array of clinical pearls, reinforced some basics, and pointed to well-supported strategies he believes are too often overlooked.

Drugs Repurposed for Wound Healing

Of the clinical pearls, he spoke of the repurposing of several agents for wound care. His first example was the monoclonal antibody dupilumab, which inhibits interleukin-4 (IL-4) and IL-13 signaling, to heal selected patients with leg ulcers. The potential of this drug for wound healing was based on a patient with a leg ulcer who presented with concomitant prurigo nodularis and biliary cirrhosis. When offered for the comorbidities, dupilumab provided a “dramatic” benefit with regard to the wound, according to Kirsner. 

The explanation for the response is that IL-4 and IL-13 have been found to be upregulated in some patients with leg ulcers. Based on numerous cases, Kirsner spoke of a phenotype of nonhealing leg ulcers from which elevated IL-4 and IL-13 can be isolated; these are the candidates for adding dupilumab to wound care, he said.

Topical beta-blockade is another example of a therapy repurposed for wound healing, according to Kirsner. He said beta-blockers are already a standard of care for burn wounds, but the mechanism is relevant in other wound types.

Several studies have looked at this phenomenon, with experimental studies showing that skin healing is impaired when beta-2 receptors are agonized but accelerated when blocked. 

 

Beta-Blockade Accelerates Wound Healing 

A recent review of these mechanisms in soft-tissue wound healing pointed to an anti-inflammatory effect, acceleration of keratinocyte migration, pro-reepithelization effects, and inhibition of bacterial virulence. Beta-blockers were first implicated as mediators of wound healing more than a decade ago, but Kirsner indicated that there is now more attention to this therapy within a comprehensive approach in difficult cases.

Although not specific to wound healing, the potential for teprotumumab to improve control of pretibial myxedema is another example of a repurposed therapy for a challenging skin disease. Teprotumumab, a monoclonal antibody that targets the insulin-like growth factor-1 (IGF-1) receptor, is approved for active thyroid eye disease, but Kirsner cited data showing compelling evidence of benefit in this cutaneous complication of Graves disease.

As for basics, Kirsner devoted some time to emphasizing the importance of compression therapy for improving leg vascularization. This is not something to just consider; rather, he thinks it is part of standard practice. “Compress all leg ulcers,” was Kirsner’s simple message.

Citing encouraging work in identifying targetable molecular events in wound healing, Kirsner suggested that treatment might be increasingly guided by biomarkers. He pointed to ongoing work to characterize wound exudate as a source of biomarkers.

“The discarded dressing contains a wealth of information,” he said, referring to cell types and proteins, such as growth factors. He thinks that the ongoing studies of exudate, which have shown that molecular processes detected at the periphery are often different than those at the focal site of injury, have substantial promise for identifying new treatment targets.

 

Virtual Reality to Address Pain

From a practical standpoint, Kirsner looked to a well-studied but still underused adjunct to wound debridement and surgical repair: the distraction offered by relatively low-priced virtual reality systems. He described it as a simple way to help patients keep their minds off the pain. It is not a new idea and has been studied for this use numerous times, and the evidence of benefit is essentially uniform, according to Kirsner.

He said effective and sophisticated systems can now be purchased for just hundreds of dollars, and no training is needed. Indeed, he said pediatric patients can typically explain how the system works if the clinician does not know.

“If you can enhance their experience [during wound repair], you can make their lives and your life better,” he said. 

Joshua Zeichner, MD, associate professor of dermatology at Mount Sinai Hospital in New York City, concurred that the evidence supports this approach and is easy to do. “I am in favor of anything that improves the experience of the patient,” said Zeichner, who chaired the portion of the meeting during which Kirsner spoke. 

Kirsner said he practices what he preaches. “I routinely employ virtual reality for simple surgical procedures or processes that patients might find unpleasant,” he said. He acknowledged that clinicians might have heard this message before, but he believes those who have not yet introduced this into their practice should consider it.

Kirsner has reported no relevant financial relationships. Zeichner has reported serving as a consultant for Beiersdorf. 

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

NEW YORK CITY — Instructions on wound healing often involve disturbing photographs of severe diabetic ulcers, angry autoimmune blistering, and oozing lesions produced by uncommon genetic disorders, but whether or not they are dramatic, day-to-day dermatologic wound care relies on both the basics as well as novel approaches, according to a well-known wound treatment expert.

Wound repair is relevant to any specialty involved in invasive interventions, but dermatologists are at ground zero and should have commensurate skills, suggested Robert S. Kirsner, MD, PhD, director of the Wound Clinic at Jackson Memorial Hospital and chair of the Department of Dermatology and Cutaneous Surgery at the University of Miami, Florida.

“We as a specialty make and repair more wounds than any other specialty,” said Kirsner, who provided data to make his point. In a table he showed, the number of wound repairs made annually by dermatologists was several-fold higher than surgeons, the next highest group, and the numbers declined rapidly from there. 

Speaking at the 27th Annual Winter Symposium – Advances in Medical and Surgical Dermatology (MSWS) 2024, Kirsner offered an array of clinical pearls, reinforced some basics, and pointed to well-supported strategies he believes are too often overlooked.

Drugs Repurposed for Wound Healing

Of the clinical pearls, he spoke of the repurposing of several agents for wound care. His first example was the monoclonal antibody dupilumab, which inhibits interleukin-4 (IL-4) and IL-13 signaling, to heal selected patients with leg ulcers. The potential of this drug for wound healing was based on a patient with a leg ulcer who presented with concomitant prurigo nodularis and biliary cirrhosis. When offered for the comorbidities, dupilumab provided a “dramatic” benefit with regard to the wound, according to Kirsner. 

The explanation for the response is that IL-4 and IL-13 have been found to be upregulated in some patients with leg ulcers. Based on numerous cases, Kirsner spoke of a phenotype of nonhealing leg ulcers from which elevated IL-4 and IL-13 can be isolated; these are the candidates for adding dupilumab to wound care, he said.

Topical beta-blockade is another example of a therapy repurposed for wound healing, according to Kirsner. He said beta-blockers are already a standard of care for burn wounds, but the mechanism is relevant in other wound types.

Several studies have looked at this phenomenon, with experimental studies showing that skin healing is impaired when beta-2 receptors are agonized but accelerated when blocked. 

 

Beta-Blockade Accelerates Wound Healing 

A recent review of these mechanisms in soft-tissue wound healing pointed to an anti-inflammatory effect, acceleration of keratinocyte migration, pro-reepithelization effects, and inhibition of bacterial virulence. Beta-blockers were first implicated as mediators of wound healing more than a decade ago, but Kirsner indicated that there is now more attention to this therapy within a comprehensive approach in difficult cases.

Although not specific to wound healing, the potential for teprotumumab to improve control of pretibial myxedema is another example of a repurposed therapy for a challenging skin disease. Teprotumumab, a monoclonal antibody that targets the insulin-like growth factor-1 (IGF-1) receptor, is approved for active thyroid eye disease, but Kirsner cited data showing compelling evidence of benefit in this cutaneous complication of Graves disease.

As for basics, Kirsner devoted some time to emphasizing the importance of compression therapy for improving leg vascularization. This is not something to just consider; rather, he thinks it is part of standard practice. “Compress all leg ulcers,” was Kirsner’s simple message.

Citing encouraging work in identifying targetable molecular events in wound healing, Kirsner suggested that treatment might be increasingly guided by biomarkers. He pointed to ongoing work to characterize wound exudate as a source of biomarkers.

“The discarded dressing contains a wealth of information,” he said, referring to cell types and proteins, such as growth factors. He thinks that the ongoing studies of exudate, which have shown that molecular processes detected at the periphery are often different than those at the focal site of injury, have substantial promise for identifying new treatment targets.

 

Virtual Reality to Address Pain

From a practical standpoint, Kirsner looked to a well-studied but still underused adjunct to wound debridement and surgical repair: the distraction offered by relatively low-priced virtual reality systems. He described it as a simple way to help patients keep their minds off the pain. It is not a new idea and has been studied for this use numerous times, and the evidence of benefit is essentially uniform, according to Kirsner.

He said effective and sophisticated systems can now be purchased for just hundreds of dollars, and no training is needed. Indeed, he said pediatric patients can typically explain how the system works if the clinician does not know.

“If you can enhance their experience [during wound repair], you can make their lives and your life better,” he said. 

Joshua Zeichner, MD, associate professor of dermatology at Mount Sinai Hospital in New York City, concurred that the evidence supports this approach and is easy to do. “I am in favor of anything that improves the experience of the patient,” said Zeichner, who chaired the portion of the meeting during which Kirsner spoke. 

Kirsner said he practices what he preaches. “I routinely employ virtual reality for simple surgical procedures or processes that patients might find unpleasant,” he said. He acknowledged that clinicians might have heard this message before, but he believes those who have not yet introduced this into their practice should consider it.

Kirsner has reported no relevant financial relationships. Zeichner has reported serving as a consultant for Beiersdorf. 

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