Dermatology News

Vedolizumab (Entyvio) and ustekinumab (Stelara) appear to be equally effective for extraintestinal manifestation (EIM) of inflammatory bowel disease (IBD), according to results of a retrospective study published online in Digestive and Liver Disease.

Between 25% and 40% of patients with IBD experience EIM, which reduces quality of life, according to the Crohn’s & Colitis Foundation. EIM commonly involves the joints, skin, bones, eyes, kidney, and liver. Anemia is another extraintestinal complication.

Until now, it’s been unclear whether vedolizumab and ustekinumab are equally effective for treating EIM.

Vedolizumab specifically targets the gastrointestinal tract, a potential disadvantage in reducing EIM, while ustekinumab is thought to have a systemic effect, a potential treatment advantage, Moran Livne-Margolin, MD, and colleagues, Chaim Sheba Medical Center, Ramat Gan, Israel, point out.

To investigate, they included 111 adults with IBD who were treated at the medical center between 2015 and 2021 – 53 with vedolizumab and 58 with ustekinumab. Before starting treatment, all of them had active EIM, most commonly arthralgia (84%).

After 6 weeks of treatment, 66% of patients in both groups had a clinical response to their intestinal disease.

After 14 and 26 weeks of treatment, clinical response rates were 59% and 50%, respectively, with vedolizumab, and 48% and 41%, respectively, with ustekinumab.

Over 52 weeks, both biologics were equally effective against the intestinal disease, with clinical response rates of 42% with vedolizumab and 44% with ustekinumab.

A similar pattern emerged when looking at improvement in EIM.

At week 6, 44% of patients taking vedolizumab and 35% taking ustekinumab had improvement in EIM, with no significant difference between the two biologics (P = .4).

At week 14, rates of improvement in EIM were 43% for vedolizumab and 33% for ustekinumab (P = .39); at 26 weeks, rates were 39% and 33%, respectively (P = .6); and at 52 weeks, rates were 34% and 36% (P = .9).

Researchers also found a significant positive correlation between improvement of the intestinal disease and clinical improvement of EIM at each time point.

Ustekinumab is usually preferred in patients with EIM, Dr. Livne-Margolin and colleagues note. But their findings “may raise some questions whether ustekinumab is, in fact, a better choice in those specific patients.”

Limitations of the study include its retrospective design and small cohort size.

Additionally, vedolizumab is given intravenously in the clinic and mandates patients to have a routine checkup every 1-2 months, whereas ustekinumab can be given at home. As a result, data were missing on some of the patients treated with ustekinumab during the follow-up.

Another limitation is that most of the patients had articular complaints with a small presentation of other EIM.

Also, most of the patients had Crohn’s disease, with only one patient with ulcerative colitis in the ustekinumab group, compared with 12 in the vedolizumab group.

Finally, patients treated with ustekinumab had more experience with anti-TNF treatment, compared with the vedolizumab group, which might have influenced the results with a negative bias toward ustekinumab.

The study had no specific funding. Three authors have disclosed relationships with Janssen, which makes ustekinumab.

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

Vedolizumab (Entyvio) and ustekinumab (Stelara) appear to be equally effective for extraintestinal manifestation (EIM) of inflammatory bowel disease (IBD), according to results of a retrospective study published online in Digestive and Liver Disease.

Between 25% and 40% of patients with IBD experience EIM, which reduces quality of life, according to the Crohn’s & Colitis Foundation. EIM commonly involves the joints, skin, bones, eyes, kidney, and liver. Anemia is another extraintestinal complication.

Until now, it’s been unclear whether vedolizumab and ustekinumab are equally effective for treating EIM.

Vedolizumab specifically targets the gastrointestinal tract, a potential disadvantage in reducing EIM, while ustekinumab is thought to have a systemic effect, a potential treatment advantage, Moran Livne-Margolin, MD, and colleagues, Chaim Sheba Medical Center, Ramat Gan, Israel, point out.

To investigate, they included 111 adults with IBD who were treated at the medical center between 2015 and 2021 – 53 with vedolizumab and 58 with ustekinumab. Before starting treatment, all of them had active EIM, most commonly arthralgia (84%).

After 6 weeks of treatment, 66% of patients in both groups had a clinical response to their intestinal disease.

After 14 and 26 weeks of treatment, clinical response rates were 59% and 50%, respectively, with vedolizumab, and 48% and 41%, respectively, with ustekinumab.

Over 52 weeks, both biologics were equally effective against the intestinal disease, with clinical response rates of 42% with vedolizumab and 44% with ustekinumab.

A similar pattern emerged when looking at improvement in EIM.

At week 6, 44% of patients taking vedolizumab and 35% taking ustekinumab had improvement in EIM, with no significant difference between the two biologics (P = .4).

At week 14, rates of improvement in EIM were 43% for vedolizumab and 33% for ustekinumab (P = .39); at 26 weeks, rates were 39% and 33%, respectively (P = .6); and at 52 weeks, rates were 34% and 36% (P = .9).

Researchers also found a significant positive correlation between improvement of the intestinal disease and clinical improvement of EIM at each time point.

Ustekinumab is usually preferred in patients with EIM, Dr. Livne-Margolin and colleagues note. But their findings “may raise some questions whether ustekinumab is, in fact, a better choice in those specific patients.”

Limitations of the study include its retrospective design and small cohort size.

Additionally, vedolizumab is given intravenously in the clinic and mandates patients to have a routine checkup every 1-2 months, whereas ustekinumab can be given at home. As a result, data were missing on some of the patients treated with ustekinumab during the follow-up.

Another limitation is that most of the patients had articular complaints with a small presentation of other EIM.

Also, most of the patients had Crohn’s disease, with only one patient with ulcerative colitis in the ustekinumab group, compared with 12 in the vedolizumab group.

Finally, patients treated with ustekinumab had more experience with anti-TNF treatment, compared with the vedolizumab group, which might have influenced the results with a negative bias toward ustekinumab.

The study had no specific funding. Three authors have disclosed relationships with Janssen, which makes ustekinumab.

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

Vedolizumab (Entyvio) and ustekinumab (Stelara) appear to be equally effective for extraintestinal manifestation (EIM) of inflammatory bowel disease (IBD), according to results of a retrospective study published online in Digestive and Liver Disease.

Between 25% and 40% of patients with IBD experience EIM, which reduces quality of life, according to the Crohn’s & Colitis Foundation. EIM commonly involves the joints, skin, bones, eyes, kidney, and liver. Anemia is another extraintestinal complication.

Until now, it’s been unclear whether vedolizumab and ustekinumab are equally effective for treating EIM.

Vedolizumab specifically targets the gastrointestinal tract, a potential disadvantage in reducing EIM, while ustekinumab is thought to have a systemic effect, a potential treatment advantage, Moran Livne-Margolin, MD, and colleagues, Chaim Sheba Medical Center, Ramat Gan, Israel, point out.

To investigate, they included 111 adults with IBD who were treated at the medical center between 2015 and 2021 – 53 with vedolizumab and 58 with ustekinumab. Before starting treatment, all of them had active EIM, most commonly arthralgia (84%).

After 6 weeks of treatment, 66% of patients in both groups had a clinical response to their intestinal disease.

After 14 and 26 weeks of treatment, clinical response rates were 59% and 50%, respectively, with vedolizumab, and 48% and 41%, respectively, with ustekinumab.

Over 52 weeks, both biologics were equally effective against the intestinal disease, with clinical response rates of 42% with vedolizumab and 44% with ustekinumab.

A similar pattern emerged when looking at improvement in EIM.

At week 6, 44% of patients taking vedolizumab and 35% taking ustekinumab had improvement in EIM, with no significant difference between the two biologics (P = .4).

At week 14, rates of improvement in EIM were 43% for vedolizumab and 33% for ustekinumab (P = .39); at 26 weeks, rates were 39% and 33%, respectively (P = .6); and at 52 weeks, rates were 34% and 36% (P = .9).

Researchers also found a significant positive correlation between improvement of the intestinal disease and clinical improvement of EIM at each time point.

Ustekinumab is usually preferred in patients with EIM, Dr. Livne-Margolin and colleagues note. But their findings “may raise some questions whether ustekinumab is, in fact, a better choice in those specific patients.”

Limitations of the study include its retrospective design and small cohort size.

Additionally, vedolizumab is given intravenously in the clinic and mandates patients to have a routine checkup every 1-2 months, whereas ustekinumab can be given at home. As a result, data were missing on some of the patients treated with ustekinumab during the follow-up.

Another limitation is that most of the patients had articular complaints with a small presentation of other EIM.

Also, most of the patients had Crohn’s disease, with only one patient with ulcerative colitis in the ustekinumab group, compared with 12 in the vedolizumab group.

Finally, patients treated with ustekinumab had more experience with anti-TNF treatment, compared with the vedolizumab group, which might have influenced the results with a negative bias toward ustekinumab.

The study had no specific funding. Three authors have disclosed relationships with Janssen, which makes ustekinumab.

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

DENVER – Use of subcutaneous ropivacaine for Mohs surgery in highly vascularized anatomical regions such as the nose results in significantly shorter duration of anesthesia compared with less vascularized regions such as the shin, results from a single-center study showed.

Ropivacaine is a long-acting anesthetic that may be used as a substitute for the more commonly local anesthetics such as lidocaine or bupivacaine in dermatologic surgery, lead study author Kira Minkis, MD, PhD, told this news organization following the annual meeting of the American Society for Dermatologic Surgery, where the study results were presented during an oral abstract session. By comparison, ropivacaine has been reported to have a faster onset, similar duration in the range of 6-14 hours, less pain upon injection, and inherent vasoconstrictive properties.

“With tumescent anesthesia, studies have previously shown that the rate and absorption of anesthetics is influenced by the site of administration,” said Dr. Minkis, director of Mohs and dermatologic surgery at Weill Cornell Medicine, New York. “In studies comparing absorption of local anesthetics in tumescent anesthesia by regions that differ in vascularity, peak serum concentrations are greater and rise more rapidly after use in the head and neck compared to the trunk and extremities. However, no studies to date have compared the duration of ropivacaine in highly vascularized tissue or compared duration between regions that differ in vascularity.” The aim of the study, she noted, was to characterize the difference in duration of ropivacaine’s effects between anatomic regions of rich and comparably poor vascularity, such as the face and extremities, respectively.

Dr. Minkis and her colleagues recruited 17 women and 12 men with a mean age of 72 years who underwent Mohs surgery on the nose or the shin at Weill Cornell Medicine. Patients were anesthetized at each site with a subcutaneous injection of 0.5 mL of ropivacaine, 0.2%. Sensation was determined by pinprick prior to injection, at baseline, and every 15 minutes until sensation returned or surgery concluded. The primary endpoint was time to return of pinprick sensation.

The researchers found that the duration of ropivacaine was significantly shorter on the nose (a median of 60 minutes) than on the shin (a median of 210 minutes). In fact, the upper limit of the range of duration at the shin was not determinable because 22 of the 29 (76%) of participants did not regain sensation on the shin prior to leaving the surgical suite and concluding the study. The proportion of study participants who regained sensation within 1 hour was 76% among those who were treated on the nose vs. 3% of those who were treated on the shin (P < .0001).

“With durations of up to 6-14 hours reported, our results indicate a strikingly shorter duration of local anesthesia in highly vascularized tissue,” Dr. Minkis said. “The brevity of local anesthesia is even more surprising given the intrinsic vasoconstrictive properties of ropivacaine. Often, we co-administer epinephrine to achieve vasoconstriction and reduce local blood flow, thus prolonging local concentrations of the anesthetic with the added benefit of reducing bleeding during surgery. The short duration we’ve observed in our study is emphasized in using a potent, long-acting local anesthetic with vasoconstrictive properties that otherwise should attenuate the effects of high local vascularity.”

In other findings, patients with history of hypertension were more likely to regain sensation on the nose by 60 minutes but this did not reach statistical significance (P = .079). Other comorbidities including underlying anxiety/depression, diabetes, and kidney disease did not significantly impact duration of ropivacaine action on the nose. The same held true for patients who were treated on the shin.

“We highlight an inconsistency between the reported duration of a long-lasting local anesthetic and the short-lived anesthesia experienced by our patients in a highly vascularized region,” Dr. Minkis said. “In practice, adjunctive use of a long-acting anesthetic to prolong anesthesia is common, which may provide relief from multiple injections of shorter-acting lidocaine. However, the duration of Mohs surgery can be unpredictable. Extended wait times between stages may exceed the duration we’ve observed in this study.”

In addition, she continued, “pain is frequently reported on postoperative days 0 to 3, leading some to recommend the use of long-acting local anesthetics to prevent overprescription or a gap in pain coverage. This emphasizes a gap in effective pain control, but also an opportunity to improve our patients’ surgical and recovery experiences.”

 

Impact on practice

Keith L. Duffy, MD, associate professor of dermatology at the University of Utah, Salt Lake City, who was asked to comment on the study, said that in light of current local anesthetic shortages and back orders, “we dermatologic surgeons have been experimenting with different anesthetics and concentrations that we can use in our patients. Ropivacaine may become the anesthetic of choice for many of our practices given its inherent properties.”

The duration of anesthetic effects by anatomic location in this study is “actually more impressive than I would have suspected as a practicing Mohs surgeon. The results of this study will immediately impact my Mohs surgery clinic,” he said, adding that he hoped that Dr. Minkis and others “will expand on this study to include more patients, different anesthetics, and more anatomic locations.”

Dr. Minkis acknowledged certain limitations of the study, including its single-center design and the fact that there were too few observations of medical and clinical characteristics for subgroup analysis.

She and Dr. Duffy reported having no financial disclosures.

DENVER – Use of subcutaneous ropivacaine for Mohs surgery in highly vascularized anatomical regions such as the nose results in significantly shorter duration of anesthesia compared with less vascularized regions such as the shin, results from a single-center study showed.

Ropivacaine is a long-acting anesthetic that may be used as a substitute for the more commonly local anesthetics such as lidocaine or bupivacaine in dermatologic surgery, lead study author Kira Minkis, MD, PhD, told this news organization following the annual meeting of the American Society for Dermatologic Surgery, where the study results were presented during an oral abstract session. By comparison, ropivacaine has been reported to have a faster onset, similar duration in the range of 6-14 hours, less pain upon injection, and inherent vasoconstrictive properties.

“With tumescent anesthesia, studies have previously shown that the rate and absorption of anesthetics is influenced by the site of administration,” said Dr. Minkis, director of Mohs and dermatologic surgery at Weill Cornell Medicine, New York. “In studies comparing absorption of local anesthetics in tumescent anesthesia by regions that differ in vascularity, peak serum concentrations are greater and rise more rapidly after use in the head and neck compared to the trunk and extremities. However, no studies to date have compared the duration of ropivacaine in highly vascularized tissue or compared duration between regions that differ in vascularity.” The aim of the study, she noted, was to characterize the difference in duration of ropivacaine’s effects between anatomic regions of rich and comparably poor vascularity, such as the face and extremities, respectively.

Dr. Minkis and her colleagues recruited 17 women and 12 men with a mean age of 72 years who underwent Mohs surgery on the nose or the shin at Weill Cornell Medicine. Patients were anesthetized at each site with a subcutaneous injection of 0.5 mL of ropivacaine, 0.2%. Sensation was determined by pinprick prior to injection, at baseline, and every 15 minutes until sensation returned or surgery concluded. The primary endpoint was time to return of pinprick sensation.

The researchers found that the duration of ropivacaine was significantly shorter on the nose (a median of 60 minutes) than on the shin (a median of 210 minutes). In fact, the upper limit of the range of duration at the shin was not determinable because 22 of the 29 (76%) of participants did not regain sensation on the shin prior to leaving the surgical suite and concluding the study. The proportion of study participants who regained sensation within 1 hour was 76% among those who were treated on the nose vs. 3% of those who were treated on the shin (P < .0001).

“With durations of up to 6-14 hours reported, our results indicate a strikingly shorter duration of local anesthesia in highly vascularized tissue,” Dr. Minkis said. “The brevity of local anesthesia is even more surprising given the intrinsic vasoconstrictive properties of ropivacaine. Often, we co-administer epinephrine to achieve vasoconstriction and reduce local blood flow, thus prolonging local concentrations of the anesthetic with the added benefit of reducing bleeding during surgery. The short duration we’ve observed in our study is emphasized in using a potent, long-acting local anesthetic with vasoconstrictive properties that otherwise should attenuate the effects of high local vascularity.”

In other findings, patients with history of hypertension were more likely to regain sensation on the nose by 60 minutes but this did not reach statistical significance (P = .079). Other comorbidities including underlying anxiety/depression, diabetes, and kidney disease did not significantly impact duration of ropivacaine action on the nose. The same held true for patients who were treated on the shin.

“We highlight an inconsistency between the reported duration of a long-lasting local anesthetic and the short-lived anesthesia experienced by our patients in a highly vascularized region,” Dr. Minkis said. “In practice, adjunctive use of a long-acting anesthetic to prolong anesthesia is common, which may provide relief from multiple injections of shorter-acting lidocaine. However, the duration of Mohs surgery can be unpredictable. Extended wait times between stages may exceed the duration we’ve observed in this study.”

In addition, she continued, “pain is frequently reported on postoperative days 0 to 3, leading some to recommend the use of long-acting local anesthetics to prevent overprescription or a gap in pain coverage. This emphasizes a gap in effective pain control, but also an opportunity to improve our patients’ surgical and recovery experiences.”

 

Impact on practice

Keith L. Duffy, MD, associate professor of dermatology at the University of Utah, Salt Lake City, who was asked to comment on the study, said that in light of current local anesthetic shortages and back orders, “we dermatologic surgeons have been experimenting with different anesthetics and concentrations that we can use in our patients. Ropivacaine may become the anesthetic of choice for many of our practices given its inherent properties.”

The duration of anesthetic effects by anatomic location in this study is “actually more impressive than I would have suspected as a practicing Mohs surgeon. The results of this study will immediately impact my Mohs surgery clinic,” he said, adding that he hoped that Dr. Minkis and others “will expand on this study to include more patients, different anesthetics, and more anatomic locations.”

Dr. Minkis acknowledged certain limitations of the study, including its single-center design and the fact that there were too few observations of medical and clinical characteristics for subgroup analysis.

She and Dr. Duffy reported having no financial disclosures.

DENVER – Use of subcutaneous ropivacaine for Mohs surgery in highly vascularized anatomical regions such as the nose results in significantly shorter duration of anesthesia compared with less vascularized regions such as the shin, results from a single-center study showed.

Ropivacaine is a long-acting anesthetic that may be used as a substitute for the more commonly local anesthetics such as lidocaine or bupivacaine in dermatologic surgery, lead study author Kira Minkis, MD, PhD, told this news organization following the annual meeting of the American Society for Dermatologic Surgery, where the study results were presented during an oral abstract session. By comparison, ropivacaine has been reported to have a faster onset, similar duration in the range of 6-14 hours, less pain upon injection, and inherent vasoconstrictive properties.

“With tumescent anesthesia, studies have previously shown that the rate and absorption of anesthetics is influenced by the site of administration,” said Dr. Minkis, director of Mohs and dermatologic surgery at Weill Cornell Medicine, New York. “In studies comparing absorption of local anesthetics in tumescent anesthesia by regions that differ in vascularity, peak serum concentrations are greater and rise more rapidly after use in the head and neck compared to the trunk and extremities. However, no studies to date have compared the duration of ropivacaine in highly vascularized tissue or compared duration between regions that differ in vascularity.” The aim of the study, she noted, was to characterize the difference in duration of ropivacaine’s effects between anatomic regions of rich and comparably poor vascularity, such as the face and extremities, respectively.

Dr. Minkis and her colleagues recruited 17 women and 12 men with a mean age of 72 years who underwent Mohs surgery on the nose or the shin at Weill Cornell Medicine. Patients were anesthetized at each site with a subcutaneous injection of 0.5 mL of ropivacaine, 0.2%. Sensation was determined by pinprick prior to injection, at baseline, and every 15 minutes until sensation returned or surgery concluded. The primary endpoint was time to return of pinprick sensation.

The researchers found that the duration of ropivacaine was significantly shorter on the nose (a median of 60 minutes) than on the shin (a median of 210 minutes). In fact, the upper limit of the range of duration at the shin was not determinable because 22 of the 29 (76%) of participants did not regain sensation on the shin prior to leaving the surgical suite and concluding the study. The proportion of study participants who regained sensation within 1 hour was 76% among those who were treated on the nose vs. 3% of those who were treated on the shin (P < .0001).

“With durations of up to 6-14 hours reported, our results indicate a strikingly shorter duration of local anesthesia in highly vascularized tissue,” Dr. Minkis said. “The brevity of local anesthesia is even more surprising given the intrinsic vasoconstrictive properties of ropivacaine. Often, we co-administer epinephrine to achieve vasoconstriction and reduce local blood flow, thus prolonging local concentrations of the anesthetic with the added benefit of reducing bleeding during surgery. The short duration we’ve observed in our study is emphasized in using a potent, long-acting local anesthetic with vasoconstrictive properties that otherwise should attenuate the effects of high local vascularity.”

In other findings, patients with history of hypertension were more likely to regain sensation on the nose by 60 minutes but this did not reach statistical significance (P = .079). Other comorbidities including underlying anxiety/depression, diabetes, and kidney disease did not significantly impact duration of ropivacaine action on the nose. The same held true for patients who were treated on the shin.

“We highlight an inconsistency between the reported duration of a long-lasting local anesthetic and the short-lived anesthesia experienced by our patients in a highly vascularized region,” Dr. Minkis said. “In practice, adjunctive use of a long-acting anesthetic to prolong anesthesia is common, which may provide relief from multiple injections of shorter-acting lidocaine. However, the duration of Mohs surgery can be unpredictable. Extended wait times between stages may exceed the duration we’ve observed in this study.”

In addition, she continued, “pain is frequently reported on postoperative days 0 to 3, leading some to recommend the use of long-acting local anesthetics to prevent overprescription or a gap in pain coverage. This emphasizes a gap in effective pain control, but also an opportunity to improve our patients’ surgical and recovery experiences.”

 

Impact on practice

Keith L. Duffy, MD, associate professor of dermatology at the University of Utah, Salt Lake City, who was asked to comment on the study, said that in light of current local anesthetic shortages and back orders, “we dermatologic surgeons have been experimenting with different anesthetics and concentrations that we can use in our patients. Ropivacaine may become the anesthetic of choice for many of our practices given its inherent properties.”

The duration of anesthetic effects by anatomic location in this study is “actually more impressive than I would have suspected as a practicing Mohs surgeon. The results of this study will immediately impact my Mohs surgery clinic,” he said, adding that he hoped that Dr. Minkis and others “will expand on this study to include more patients, different anesthetics, and more anatomic locations.”

Dr. Minkis acknowledged certain limitations of the study, including its single-center design and the fact that there were too few observations of medical and clinical characteristics for subgroup analysis.

She and Dr. Duffy reported having no financial disclosures.

DENVER – One expert’s clinical experience suggests that Ellacor, a dermal microcoring device that became available in the United States in October 2022, is an effective treatment for facial wrinkles and tightening.

“It’s early yet, but I have treated dozens of patients with this device, and they have been happy with the results,” Mathew M. Avram, MD, JD, said at the annual meeting of the American Society for Dermatologic Surgery. “This is a new technique that offers the ability to remove a significant amount of damaged, lax skin without concern for scarring,” he said.

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the first-in-class device is cleared by the Food and Drug Administration for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. It features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“It doesn’t do anything equivalent to a facelift, but the concept is a facelift by thousands of micro-punch excisions,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “Rather than pulling up the skin and lifting it and cutting the excess skin like we do with a facelift, we are creating thousands of smaller-scale tissue removals with immediate closures to do the same thing. The micro-cores are about the size of a 22-gauge needle and there is no scarring due to the small size of these tissue extractions.”

The device features needle cartridges capable of excising up to 24,000 cores per treatment. According to data from Cytrellis, the manufacturer, the equivalent of about 2 inches of skin can be removed during the procedure, which typically takes fewer than 30 minutes to perform. “There is no heat whatsoever,” Dr. Avram said. “In my experience, it especially helps with jawline definition, the lower medial cheek excess skin, and accordion lines in that area.”

In a pivotal trial of the device, 51 patients with mid to lower face wrinkles (moderately deep or deep wrinkles with well-defined edges) were treated 2-3 times with 7%-8% skin removal and up to a 5-mm needle coring depth). The investigators found that 40% of study participants achieved an improvement of 2 grades on the Lemperle Wrinkle Severity Scale and that the rate of overall satisfaction (slightly, somewhat, and extremely satisfied) was 86%.

In addition, 90% showed improvement of treated sites on the Global Aesthetic Improvement Scale, and 70% were comfortable enough to go out in public or return to work 3 days after treatment. Common side effects that can occur immediately post treatment include redness, swelling, and pinpoint bleeding, which typically clear in a few days.

Dr. Avram, immediate past president of the ASDS, has posted videos to his Instagram feed that show him treating patients with the Ellacor device and he admits that the procedure looks painful. “There are all these tear emojis and people cursing me out,” he said, referring to responses from his Instagram followers.

Proper local anesthesia prior to treatment is key. “I perform nerve blocks and infiltrate the skin,” he said. “You have to cover the whole treatment area. If you don’t, then it’s going to hurt. The average pain score is 1.9 out of 10. The highest pain score I’ve gotten from a patient is a 3 out of 10.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton, and has ownership and/or shareholder interest in Cytrellis.

DENVER – One expert’s clinical experience suggests that Ellacor, a dermal microcoring device that became available in the United States in October 2022, is an effective treatment for facial wrinkles and tightening.

“It’s early yet, but I have treated dozens of patients with this device, and they have been happy with the results,” Mathew M. Avram, MD, JD, said at the annual meeting of the American Society for Dermatologic Surgery. “This is a new technique that offers the ability to remove a significant amount of damaged, lax skin without concern for scarring,” he said.

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the first-in-class device is cleared by the Food and Drug Administration for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. It features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“It doesn’t do anything equivalent to a facelift, but the concept is a facelift by thousands of micro-punch excisions,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “Rather than pulling up the skin and lifting it and cutting the excess skin like we do with a facelift, we are creating thousands of smaller-scale tissue removals with immediate closures to do the same thing. The micro-cores are about the size of a 22-gauge needle and there is no scarring due to the small size of these tissue extractions.”

The device features needle cartridges capable of excising up to 24,000 cores per treatment. According to data from Cytrellis, the manufacturer, the equivalent of about 2 inches of skin can be removed during the procedure, which typically takes fewer than 30 minutes to perform. “There is no heat whatsoever,” Dr. Avram said. “In my experience, it especially helps with jawline definition, the lower medial cheek excess skin, and accordion lines in that area.”

In a pivotal trial of the device, 51 patients with mid to lower face wrinkles (moderately deep or deep wrinkles with well-defined edges) were treated 2-3 times with 7%-8% skin removal and up to a 5-mm needle coring depth). The investigators found that 40% of study participants achieved an improvement of 2 grades on the Lemperle Wrinkle Severity Scale and that the rate of overall satisfaction (slightly, somewhat, and extremely satisfied) was 86%.

In addition, 90% showed improvement of treated sites on the Global Aesthetic Improvement Scale, and 70% were comfortable enough to go out in public or return to work 3 days after treatment. Common side effects that can occur immediately post treatment include redness, swelling, and pinpoint bleeding, which typically clear in a few days.

Dr. Avram, immediate past president of the ASDS, has posted videos to his Instagram feed that show him treating patients with the Ellacor device and he admits that the procedure looks painful. “There are all these tear emojis and people cursing me out,” he said, referring to responses from his Instagram followers.

Proper local anesthesia prior to treatment is key. “I perform nerve blocks and infiltrate the skin,” he said. “You have to cover the whole treatment area. If you don’t, then it’s going to hurt. The average pain score is 1.9 out of 10. The highest pain score I’ve gotten from a patient is a 3 out of 10.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton, and has ownership and/or shareholder interest in Cytrellis.

DENVER – One expert’s clinical experience suggests that Ellacor, a dermal microcoring device that became available in the United States in October 2022, is an effective treatment for facial wrinkles and tightening.

“It’s early yet, but I have treated dozens of patients with this device, and they have been happy with the results,” Mathew M. Avram, MD, JD, said at the annual meeting of the American Society for Dermatologic Surgery. “This is a new technique that offers the ability to remove a significant amount of damaged, lax skin without concern for scarring,” he said.

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the first-in-class device is cleared by the Food and Drug Administration for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. It features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“It doesn’t do anything equivalent to a facelift, but the concept is a facelift by thousands of micro-punch excisions,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “Rather than pulling up the skin and lifting it and cutting the excess skin like we do with a facelift, we are creating thousands of smaller-scale tissue removals with immediate closures to do the same thing. The micro-cores are about the size of a 22-gauge needle and there is no scarring due to the small size of these tissue extractions.”

The device features needle cartridges capable of excising up to 24,000 cores per treatment. According to data from Cytrellis, the manufacturer, the equivalent of about 2 inches of skin can be removed during the procedure, which typically takes fewer than 30 minutes to perform. “There is no heat whatsoever,” Dr. Avram said. “In my experience, it especially helps with jawline definition, the lower medial cheek excess skin, and accordion lines in that area.”

In a pivotal trial of the device, 51 patients with mid to lower face wrinkles (moderately deep or deep wrinkles with well-defined edges) were treated 2-3 times with 7%-8% skin removal and up to a 5-mm needle coring depth). The investigators found that 40% of study participants achieved an improvement of 2 grades on the Lemperle Wrinkle Severity Scale and that the rate of overall satisfaction (slightly, somewhat, and extremely satisfied) was 86%.

In addition, 90% showed improvement of treated sites on the Global Aesthetic Improvement Scale, and 70% were comfortable enough to go out in public or return to work 3 days after treatment. Common side effects that can occur immediately post treatment include redness, swelling, and pinpoint bleeding, which typically clear in a few days.

Dr. Avram, immediate past president of the ASDS, has posted videos to his Instagram feed that show him treating patients with the Ellacor device and he admits that the procedure looks painful. “There are all these tear emojis and people cursing me out,” he said, referring to responses from his Instagram followers.

Proper local anesthesia prior to treatment is key. “I perform nerve blocks and infiltrate the skin,” he said. “You have to cover the whole treatment area. If you don’t, then it’s going to hurt. The average pain score is 1.9 out of 10. The highest pain score I’ve gotten from a patient is a 3 out of 10.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton, and has ownership and/or shareholder interest in Cytrellis.

Doctor, doctor, gimme the news. I got a bad case of misidentifying you

There are a lot of medical specialties out there. A lot. Everything from allergists to urologists, with something like 150 subspecialties grouped in among the larger specialties. Can you name every one? Do you know what they do?

The point is, telling a patient or anyone in the general public that you’re an ophthalmologist may not be as helpful as you might think, if a recent study is to be believed. In a survey of 204 adults, conducted at the Minnesota State Fair of all places, researchers asked volunteers to define 14 different specialties, as well as five medical seniority titles.

Minerva Studio/ThinkStock

The results were less than stellar. While more than 90% of people correctly defined what cardiologists and dermatologists do, 6 of the other 12 specialists were correctly identified by less than half of those surveyed. Nephrology was at the bottom, correctly identified by just 20% of the fair-attending public, followed by internists (21%), intensivists (29%), hospitalists (31%), pulmonologists (43%), and neonatologists at 48%. The hospitalists are particularly concerning. They’re doctors, but in hospitals. How hard is that? (Yes, it’s obviously more complicated than that, but still.)

The general public didn’t fare much better when it came to correctly lining up the order of progression from medical student to attending. Just 12% managed to place all five in the correct order of med student, intern, senior resident, fellow, then attending, with senior resident proving especially troublesome. More than 40% put senior resident at the end, compared with 27% for attending. Which does make a certain amount of sense, since it has senior in the name.

While the results speak for themselves – maybe elaborate on what the heck your fancy title actually means – it’s too bad the researchers didn’t throw in something really tricky. If two-thirds of the population can’t identify a hospitalist, just imagine how many people would misidentify an otolaryngologist.
 

Beach-to-table sand could fight obesity

People are always looking for the new weight loss solution. Whether it’s to just look good in a new pair of jeans or reduce the risk of cardiovascular disease, there are millions of diets and exercise routines out here. We’re here to tell you that the next new therapy to reduce fat comes from a very unsuspecting place: Sand.

David Stanley

Like sand from the beach and desert, sand? Well, yes and no.

The research involved engineered porous silica particles made from sand that are designed to have a high surface area. Investigators used a two-step GI model in which gastric digestion was modeled for 30 minutes, followed by a 60-minute intestinal phase, to show that the porous silica particles helped prevent fat and sugar adsorption within the GI tract.

By mimicking the gastrointestinal environment during digestion of a high-fat, high-carb meal, the researchers found that the porous silica created an “anti-obesity effect” by restricting the adsorption of those fats and carbohydrates.

Okay, but how is that on the tummy? Much gentler on the stomach than a drug such as orlistat, said senior researcher Paul Joyce, PhD, of the University of South Australia, Adelaide, who noted the lack of effective therapies without side effects, such as bloating, diarrhea, and abdominal pain, that deter people from treatment.

Obesity affects over 1.9 billion people worldwide, so the researchers think this could be a breakthrough. Reducing obesity may be one of the most preventable ways to reduce the risk of type 2 diabetes, heart disease, and other weight-related chronic conditions. A treatment solution this simple could be the answer to this global health crisis.

Who would have thought the solution would be as simple as sand? But how would the sand get in our stomachs? Do we sprinkle it on our food? Mix it in during cooking? Or will the sand come in pill form? We sure hope it’s that third one.
 

I am Reliebo. I am here to help you

Halloween is almost here, and the LOTME staff has been trying to make the office look as scary as possible: Headless vampires, ghost clowns, Ted Cruz, gray tombstones, pink hearts, green clovers, red balloons. Wait a second, those last three are Lucky Charms marshmallows, aren’t they? We’ll use those some other time.

University of Tsukuba

What are we not using to decorate? Well, besides marshmallows from cereal, we’re not using Reliebo. That’s what we’re not using. Reliebo is a cute little fuzzy robot, and is not at all scary. Reliebo was designed to be the opposite of scary. Reliebo “may reduce fear as well as alleviate the perception of pain during medical treatments, including vaccinations,” senior author Fumihide Tanaka, PhD, of the University of Tsukuba (Japan) said in a written statement.

The soft, fur-covered robot contains small airbags that can inflate in response to hand movements. When study participants were subjected to a moderate heat stimulus on one arm, those who held the robot with the other arm experienced less pain than those who did not have a Reliebo.

The results also were encouraging when Dr. Tanaka and associates measured the levels of oxytocin and cortisol (biomarkers for stress) from the subjects’ saliva samples and evaluated their fear of injections and their psychological state before and after the experiments.

After looking at that photo of Reliebo for a while, though, we have to admit that we’re having a bit of a rethink about its cuteness. Is it cute, or weird-looking? An office full of fuzzy little inflating robots just could be seriously creepy. Please don’t tell the rest of the staff about this. We want to surprise them on Monday.

Doctor, doctor, gimme the news. I got a bad case of misidentifying you

There are a lot of medical specialties out there. A lot. Everything from allergists to urologists, with something like 150 subspecialties grouped in among the larger specialties. Can you name every one? Do you know what they do?

The point is, telling a patient or anyone in the general public that you’re an ophthalmologist may not be as helpful as you might think, if a recent study is to be believed. In a survey of 204 adults, conducted at the Minnesota State Fair of all places, researchers asked volunteers to define 14 different specialties, as well as five medical seniority titles.

Minerva Studio/ThinkStock

The results were less than stellar. While more than 90% of people correctly defined what cardiologists and dermatologists do, 6 of the other 12 specialists were correctly identified by less than half of those surveyed. Nephrology was at the bottom, correctly identified by just 20% of the fair-attending public, followed by internists (21%), intensivists (29%), hospitalists (31%), pulmonologists (43%), and neonatologists at 48%. The hospitalists are particularly concerning. They’re doctors, but in hospitals. How hard is that? (Yes, it’s obviously more complicated than that, but still.)

The general public didn’t fare much better when it came to correctly lining up the order of progression from medical student to attending. Just 12% managed to place all five in the correct order of med student, intern, senior resident, fellow, then attending, with senior resident proving especially troublesome. More than 40% put senior resident at the end, compared with 27% for attending. Which does make a certain amount of sense, since it has senior in the name.

While the results speak for themselves – maybe elaborate on what the heck your fancy title actually means – it’s too bad the researchers didn’t throw in something really tricky. If two-thirds of the population can’t identify a hospitalist, just imagine how many people would misidentify an otolaryngologist.
 

Beach-to-table sand could fight obesity

People are always looking for the new weight loss solution. Whether it’s to just look good in a new pair of jeans or reduce the risk of cardiovascular disease, there are millions of diets and exercise routines out here. We’re here to tell you that the next new therapy to reduce fat comes from a very unsuspecting place: Sand.

David Stanley

Like sand from the beach and desert, sand? Well, yes and no.

The research involved engineered porous silica particles made from sand that are designed to have a high surface area. Investigators used a two-step GI model in which gastric digestion was modeled for 30 minutes, followed by a 60-minute intestinal phase, to show that the porous silica particles helped prevent fat and sugar adsorption within the GI tract.

By mimicking the gastrointestinal environment during digestion of a high-fat, high-carb meal, the researchers found that the porous silica created an “anti-obesity effect” by restricting the adsorption of those fats and carbohydrates.

Okay, but how is that on the tummy? Much gentler on the stomach than a drug such as orlistat, said senior researcher Paul Joyce, PhD, of the University of South Australia, Adelaide, who noted the lack of effective therapies without side effects, such as bloating, diarrhea, and abdominal pain, that deter people from treatment.

Obesity affects over 1.9 billion people worldwide, so the researchers think this could be a breakthrough. Reducing obesity may be one of the most preventable ways to reduce the risk of type 2 diabetes, heart disease, and other weight-related chronic conditions. A treatment solution this simple could be the answer to this global health crisis.

Who would have thought the solution would be as simple as sand? But how would the sand get in our stomachs? Do we sprinkle it on our food? Mix it in during cooking? Or will the sand come in pill form? We sure hope it’s that third one.
 

I am Reliebo. I am here to help you

Halloween is almost here, and the LOTME staff has been trying to make the office look as scary as possible: Headless vampires, ghost clowns, Ted Cruz, gray tombstones, pink hearts, green clovers, red balloons. Wait a second, those last three are Lucky Charms marshmallows, aren’t they? We’ll use those some other time.

University of Tsukuba

What are we not using to decorate? Well, besides marshmallows from cereal, we’re not using Reliebo. That’s what we’re not using. Reliebo is a cute little fuzzy robot, and is not at all scary. Reliebo was designed to be the opposite of scary. Reliebo “may reduce fear as well as alleviate the perception of pain during medical treatments, including vaccinations,” senior author Fumihide Tanaka, PhD, of the University of Tsukuba (Japan) said in a written statement.

The soft, fur-covered robot contains small airbags that can inflate in response to hand movements. When study participants were subjected to a moderate heat stimulus on one arm, those who held the robot with the other arm experienced less pain than those who did not have a Reliebo.

The results also were encouraging when Dr. Tanaka and associates measured the levels of oxytocin and cortisol (biomarkers for stress) from the subjects’ saliva samples and evaluated their fear of injections and their psychological state before and after the experiments.

After looking at that photo of Reliebo for a while, though, we have to admit that we’re having a bit of a rethink about its cuteness. Is it cute, or weird-looking? An office full of fuzzy little inflating robots just could be seriously creepy. Please don’t tell the rest of the staff about this. We want to surprise them on Monday.

Doctor, doctor, gimme the news. I got a bad case of misidentifying you

There are a lot of medical specialties out there. A lot. Everything from allergists to urologists, with something like 150 subspecialties grouped in among the larger specialties. Can you name every one? Do you know what they do?

The point is, telling a patient or anyone in the general public that you’re an ophthalmologist may not be as helpful as you might think, if a recent study is to be believed. In a survey of 204 adults, conducted at the Minnesota State Fair of all places, researchers asked volunteers to define 14 different specialties, as well as five medical seniority titles.

Minerva Studio/ThinkStock

The results were less than stellar. While more than 90% of people correctly defined what cardiologists and dermatologists do, 6 of the other 12 specialists were correctly identified by less than half of those surveyed. Nephrology was at the bottom, correctly identified by just 20% of the fair-attending public, followed by internists (21%), intensivists (29%), hospitalists (31%), pulmonologists (43%), and neonatologists at 48%. The hospitalists are particularly concerning. They’re doctors, but in hospitals. How hard is that? (Yes, it’s obviously more complicated than that, but still.)

The general public didn’t fare much better when it came to correctly lining up the order of progression from medical student to attending. Just 12% managed to place all five in the correct order of med student, intern, senior resident, fellow, then attending, with senior resident proving especially troublesome. More than 40% put senior resident at the end, compared with 27% for attending. Which does make a certain amount of sense, since it has senior in the name.

While the results speak for themselves – maybe elaborate on what the heck your fancy title actually means – it’s too bad the researchers didn’t throw in something really tricky. If two-thirds of the population can’t identify a hospitalist, just imagine how many people would misidentify an otolaryngologist.
 

Beach-to-table sand could fight obesity

People are always looking for the new weight loss solution. Whether it’s to just look good in a new pair of jeans or reduce the risk of cardiovascular disease, there are millions of diets and exercise routines out here. We’re here to tell you that the next new therapy to reduce fat comes from a very unsuspecting place: Sand.

David Stanley

Like sand from the beach and desert, sand? Well, yes and no.

The research involved engineered porous silica particles made from sand that are designed to have a high surface area. Investigators used a two-step GI model in which gastric digestion was modeled for 30 minutes, followed by a 60-minute intestinal phase, to show that the porous silica particles helped prevent fat and sugar adsorption within the GI tract.

By mimicking the gastrointestinal environment during digestion of a high-fat, high-carb meal, the researchers found that the porous silica created an “anti-obesity effect” by restricting the adsorption of those fats and carbohydrates.

Okay, but how is that on the tummy? Much gentler on the stomach than a drug such as orlistat, said senior researcher Paul Joyce, PhD, of the University of South Australia, Adelaide, who noted the lack of effective therapies without side effects, such as bloating, diarrhea, and abdominal pain, that deter people from treatment.

Obesity affects over 1.9 billion people worldwide, so the researchers think this could be a breakthrough. Reducing obesity may be one of the most preventable ways to reduce the risk of type 2 diabetes, heart disease, and other weight-related chronic conditions. A treatment solution this simple could be the answer to this global health crisis.

Who would have thought the solution would be as simple as sand? But how would the sand get in our stomachs? Do we sprinkle it on our food? Mix it in during cooking? Or will the sand come in pill form? We sure hope it’s that third one.
 

I am Reliebo. I am here to help you

Halloween is almost here, and the LOTME staff has been trying to make the office look as scary as possible: Headless vampires, ghost clowns, Ted Cruz, gray tombstones, pink hearts, green clovers, red balloons. Wait a second, those last three are Lucky Charms marshmallows, aren’t they? We’ll use those some other time.

University of Tsukuba

What are we not using to decorate? Well, besides marshmallows from cereal, we’re not using Reliebo. That’s what we’re not using. Reliebo is a cute little fuzzy robot, and is not at all scary. Reliebo was designed to be the opposite of scary. Reliebo “may reduce fear as well as alleviate the perception of pain during medical treatments, including vaccinations,” senior author Fumihide Tanaka, PhD, of the University of Tsukuba (Japan) said in a written statement.

The soft, fur-covered robot contains small airbags that can inflate in response to hand movements. When study participants were subjected to a moderate heat stimulus on one arm, those who held the robot with the other arm experienced less pain than those who did not have a Reliebo.

The results also were encouraging when Dr. Tanaka and associates measured the levels of oxytocin and cortisol (biomarkers for stress) from the subjects’ saliva samples and evaluated their fear of injections and their psychological state before and after the experiments.

After looking at that photo of Reliebo for a while, though, we have to admit that we’re having a bit of a rethink about its cuteness. Is it cute, or weird-looking? An office full of fuzzy little inflating robots just could be seriously creepy. Please don’t tell the rest of the staff about this. We want to surprise them on Monday.

MONTREAL – Remote assessment of atopic dermatitis (AD) severity is possible through the use of patient-provided clinical photos – opening a new avenue for improving access for patients, as well as the possibility of conducting remote clinical trials that would be less expensive and less burdensome for participants, according to investigators, who presented the study at the annual meeting of the International Society of Atopic Dermatitis.

Still, practical barriers need to be addressed, particularly the problem of image quality, noted study investigator Aviël Ragamin, MD, from the department of dermatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.

“Good-quality images are crucial, [and] in our study, patients didn’t have any incentive to provide images because they had already received their medical consultation,” he explained. He suggested that this problem could be overcome by providing technical support for patients and compensation for trial participants.

The study included 87 children (median age, 7 years), who were assessed for AD severity at an academic outpatient clinic. The in-person visit included assessment with the Eczema Area and Severity Index (EASI) score, as well as the collection of whole-body clinical images. Parents were then asked to return home and to provide their own clinical images and self-administered EASI assessments of their child for comparison. Four raters were asked to rate all images twice and to compare in-clinic and self-administered EASI scores based on the images.

At the in-clinic visit, the median EASI score of the group was 8.8. The majority of patients had moderate (46.6%) or severe (14.8%) AD. Roughly 40% of the patients had darker skin (Fitzpatrick skin types IV–VI).

Using Spearman rank correlation of 1,534 in-clinic and 425 patient-provided images, the study found good inter- and intra-rater reliability for clinical image assessment and strong agreement between images and the in-clinic EASI scores. The top outliers in the assessment were individuals with either darker skin or significant postinflammatory hyperpigmentation, which are “the most difficult cases to rate, based on images,” Dr. Ragamin noted.

There was only moderate correlation between the in-clinic and self-administered EASI scores, with a significant number of patients either underestimating or overestimating their AD severity, he added.

Overall, the main problem with remote assessment seems to be the feasibility of patients providing images, said Dr. Ragamin. Only 36.8% of parents provided any images at all, and of these, 1 of 5 were deemed too blurry, leaving just 13 for final assessment, he explained.

“Pragmatically, it’s tricky,” said Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, who was asked to comment on the study. “It takes long enough to do an EASI score in person, let alone looking through blurry pictures that take too long to load into your electronic medical record. We know it works, but when our hospital went virtual [during the COVID pandemic] ... most of my patients with chronic eczema weren’t even sending me pictures.”

Regarding the utility of remote, full-body photography in clinical practice, he said, “There’s too many feasibility hoops to jump through at this point. The most promise I see is for clinical trials, where it’s hard to get people to come in.”

Dr. Ragamin and Dr. Drucker have disclosed no relevant financial relationships.

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

MONTREAL – Remote assessment of atopic dermatitis (AD) severity is possible through the use of patient-provided clinical photos – opening a new avenue for improving access for patients, as well as the possibility of conducting remote clinical trials that would be less expensive and less burdensome for participants, according to investigators, who presented the study at the annual meeting of the International Society of Atopic Dermatitis.

Still, practical barriers need to be addressed, particularly the problem of image quality, noted study investigator Aviël Ragamin, MD, from the department of dermatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.

“Good-quality images are crucial, [and] in our study, patients didn’t have any incentive to provide images because they had already received their medical consultation,” he explained. He suggested that this problem could be overcome by providing technical support for patients and compensation for trial participants.

The study included 87 children (median age, 7 years), who were assessed for AD severity at an academic outpatient clinic. The in-person visit included assessment with the Eczema Area and Severity Index (EASI) score, as well as the collection of whole-body clinical images. Parents were then asked to return home and to provide their own clinical images and self-administered EASI assessments of their child for comparison. Four raters were asked to rate all images twice and to compare in-clinic and self-administered EASI scores based on the images.

At the in-clinic visit, the median EASI score of the group was 8.8. The majority of patients had moderate (46.6%) or severe (14.8%) AD. Roughly 40% of the patients had darker skin (Fitzpatrick skin types IV–VI).

Using Spearman rank correlation of 1,534 in-clinic and 425 patient-provided images, the study found good inter- and intra-rater reliability for clinical image assessment and strong agreement between images and the in-clinic EASI scores. The top outliers in the assessment were individuals with either darker skin or significant postinflammatory hyperpigmentation, which are “the most difficult cases to rate, based on images,” Dr. Ragamin noted.

There was only moderate correlation between the in-clinic and self-administered EASI scores, with a significant number of patients either underestimating or overestimating their AD severity, he added.

Overall, the main problem with remote assessment seems to be the feasibility of patients providing images, said Dr. Ragamin. Only 36.8% of parents provided any images at all, and of these, 1 of 5 were deemed too blurry, leaving just 13 for final assessment, he explained.

“Pragmatically, it’s tricky,” said Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, who was asked to comment on the study. “It takes long enough to do an EASI score in person, let alone looking through blurry pictures that take too long to load into your electronic medical record. We know it works, but when our hospital went virtual [during the COVID pandemic] ... most of my patients with chronic eczema weren’t even sending me pictures.”

Regarding the utility of remote, full-body photography in clinical practice, he said, “There’s too many feasibility hoops to jump through at this point. The most promise I see is for clinical trials, where it’s hard to get people to come in.”

Dr. Ragamin and Dr. Drucker have disclosed no relevant financial relationships.

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

MONTREAL – Remote assessment of atopic dermatitis (AD) severity is possible through the use of patient-provided clinical photos – opening a new avenue for improving access for patients, as well as the possibility of conducting remote clinical trials that would be less expensive and less burdensome for participants, according to investigators, who presented the study at the annual meeting of the International Society of Atopic Dermatitis.

Still, practical barriers need to be addressed, particularly the problem of image quality, noted study investigator Aviël Ragamin, MD, from the department of dermatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.

“Good-quality images are crucial, [and] in our study, patients didn’t have any incentive to provide images because they had already received their medical consultation,” he explained. He suggested that this problem could be overcome by providing technical support for patients and compensation for trial participants.

The study included 87 children (median age, 7 years), who were assessed for AD severity at an academic outpatient clinic. The in-person visit included assessment with the Eczema Area and Severity Index (EASI) score, as well as the collection of whole-body clinical images. Parents were then asked to return home and to provide their own clinical images and self-administered EASI assessments of their child for comparison. Four raters were asked to rate all images twice and to compare in-clinic and self-administered EASI scores based on the images.

At the in-clinic visit, the median EASI score of the group was 8.8. The majority of patients had moderate (46.6%) or severe (14.8%) AD. Roughly 40% of the patients had darker skin (Fitzpatrick skin types IV–VI).

Using Spearman rank correlation of 1,534 in-clinic and 425 patient-provided images, the study found good inter- and intra-rater reliability for clinical image assessment and strong agreement between images and the in-clinic EASI scores. The top outliers in the assessment were individuals with either darker skin or significant postinflammatory hyperpigmentation, which are “the most difficult cases to rate, based on images,” Dr. Ragamin noted.

There was only moderate correlation between the in-clinic and self-administered EASI scores, with a significant number of patients either underestimating or overestimating their AD severity, he added.

Overall, the main problem with remote assessment seems to be the feasibility of patients providing images, said Dr. Ragamin. Only 36.8% of parents provided any images at all, and of these, 1 of 5 were deemed too blurry, leaving just 13 for final assessment, he explained.

“Pragmatically, it’s tricky,” said Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, who was asked to comment on the study. “It takes long enough to do an EASI score in person, let alone looking through blurry pictures that take too long to load into your electronic medical record. We know it works, but when our hospital went virtual [during the COVID pandemic] ... most of my patients with chronic eczema weren’t even sending me pictures.”

Regarding the utility of remote, full-body photography in clinical practice, he said, “There’s too many feasibility hoops to jump through at this point. The most promise I see is for clinical trials, where it’s hard to get people to come in.”

Dr. Ragamin and Dr. Drucker have disclosed no relevant financial relationships.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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