Doug Brunk

Low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers are safe to pair with botulinum neurotoxin type A and soft-tissue fillers during the same treatment session, results from a 6-year, single-center review showed.

“These treatments can be complementary in single-session treatments and can offer increased convenience for both patients and physicians,” primary study author Jordan V. Wang, MD, MBE, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

To date, limited studies have demonstrated the safety of pairing botulinum neurotoxin type A and soft-tissue fillers with laser and other energy-based devices during the same treatment session on the same day, said Dr. Wang, medical research director at the Laser & Skin Surgery Center of New York. “Some concerns remain, though, regarding patient safety and efficacy,” he said. “Data on single-session treatment with low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers and either botulinum neurotoxin or fillers are lacking.”

In a retrospective review of electronic medical records conducted from May 2015 to April 2021, Dr. Wang, Roy G. Geronemus, MD, and Carolyn Kushner, MD evaluated patients who received a single-session facial treatment with either BoNT-A or soft-tissue fillers and the low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers (Clear+Brilliant Perméa and Original, Solta, Pleasanton, Calif.). Safety was assessed by documenting adverse events related to the spread of BoNT-A and fillers or laser treatment of filled areas within 4 weeks.

Adverse events they looked for related to botulinum neurotoxin use included eyelid ptosis; neck weakness or spasms; impairments in chewing, swallowing, speech, and respiration; and prescriptions of apraclonidine eye drops. Filler-related adverse events they looked for included product migration, unexpected loss of filler volume, vascular occlusion, acute pain, necrosis, blindness, and burn. “For both, we looked at hospital or emergency room transfers or admissions and referrals to ENT or ophthalmology,” Dr. Wang said.

During the 6-year study period, 525 patients had 1,562 single-session laser treatments with a mean 46.4 units of BoNT-A, and 398 patients had 1,237 single-session treatments with a mean 1.6 soft-tissue filler syringes. Among those who received BoNT-A, most (93%) were female, their mean age was 51 years, and 99% were treated with a 1,927-nm wavelength at a medium setting in 87% of cases. The top five injection sites were glabella (82%), forehead (69%), periorbital area (64%), neck (40%), and jawline and/or masseters (13%).

The researchers noted one case (0.06%) where apraclonidine eye drops were prescribed for ptosis. The patient had undergone eight other single-session treatments without issue. There were no other documented adverse events directly related to spread of BoNT-A. According to Dr. Wang, this rate of ptosis is lower than the incidence with BoNT-A alone in two landmark trials studying its effects on glabellar lines, which was reported as 5.4% and 1.0%.

Among the 398 patients who received soft-tissue fillers, most (94%) were female, their mean age was 54 years, and 99% were treated with a 1927nm wavelength at a medium setting in 97% of cases. The top five injection sites were cheeks and/or tear troughs (89%), perioral area and/or marionette lines (77%), lips (34%), nasolabial folds (19%), and temples (11%), and the mean number of filler syringes per treatment was 1.6. Slightly more than half (51%) had 1 session, while the remainder had 2 to greater than 10 sessions. The researchers observed no documented adverse events related to spread of fillers or laser treatment of filled areas.

“This laser is a low-powered device that creates small, superficial, and transient microchannels, which likely contributes to the safety of single-session treatments with cosmetic injectables,” Dr. Wang said. However, prospective studies are needed to further validate these results, he added.

“With this very mild laser, it is not surprising that combined treatment had no effect,” said Eric F. Bernstein, MD, MSE, director of the Main Line Center for Laser Surgery in Ardmore, Pa., who was asked to comment on the study results. “There have been numerous anecdotal reports of spreading of botulinum toxin effect to areas not in the target area for treatment following a variety of lasers, including the more powerful version of the laser used in this study. In addition, spread following vascular and other lasers has been reported,” he noted

The laser used in this study, Dr. Bernstein continued, “is low powered and emits a wavelength that is very superficially absorbed, resulting in injury to the stratum corneum, superficial epidermis, or possibly the very superficial dermis, and is often used by physician extenders and not physicians – although I suspect this is not the case in the current study. One can have a reasonable degree of confidence when combining this laser with injectables, but these results cannot be extrapolated to other devices.”

The abstract received the annual ASDS Carruthers Award during the meeting. Dr. Wang reported that he is a consultant or advisor to Allergan, Alastin, AVAVA, Cynosure, Lutronic, Novoxel, Sofwave, and Solta. Dr. Bernstein reported having received research funding from Cynosure, Candela, and Acclaro. He also has received consulting fees from Cynosure and holds ownership interest in Candela, Novoxel, OnSite, Joylux, and Acclaro and has served on the advisory board for Novoxel, Cynosure, and Acclaro.

Low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers are safe to pair with botulinum neurotoxin type A and soft-tissue fillers during the same treatment session, results from a 6-year, single-center review showed.

“These treatments can be complementary in single-session treatments and can offer increased convenience for both patients and physicians,” primary study author Jordan V. Wang, MD, MBE, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

To date, limited studies have demonstrated the safety of pairing botulinum neurotoxin type A and soft-tissue fillers with laser and other energy-based devices during the same treatment session on the same day, said Dr. Wang, medical research director at the Laser & Skin Surgery Center of New York. “Some concerns remain, though, regarding patient safety and efficacy,” he said. “Data on single-session treatment with low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers and either botulinum neurotoxin or fillers are lacking.”

In a retrospective review of electronic medical records conducted from May 2015 to April 2021, Dr. Wang, Roy G. Geronemus, MD, and Carolyn Kushner, MD evaluated patients who received a single-session facial treatment with either BoNT-A or soft-tissue fillers and the low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers (Clear+Brilliant Perméa and Original, Solta, Pleasanton, Calif.). Safety was assessed by documenting adverse events related to the spread of BoNT-A and fillers or laser treatment of filled areas within 4 weeks.

Adverse events they looked for related to botulinum neurotoxin use included eyelid ptosis; neck weakness or spasms; impairments in chewing, swallowing, speech, and respiration; and prescriptions of apraclonidine eye drops. Filler-related adverse events they looked for included product migration, unexpected loss of filler volume, vascular occlusion, acute pain, necrosis, blindness, and burn. “For both, we looked at hospital or emergency room transfers or admissions and referrals to ENT or ophthalmology,” Dr. Wang said.

During the 6-year study period, 525 patients had 1,562 single-session laser treatments with a mean 46.4 units of BoNT-A, and 398 patients had 1,237 single-session treatments with a mean 1.6 soft-tissue filler syringes. Among those who received BoNT-A, most (93%) were female, their mean age was 51 years, and 99% were treated with a 1,927-nm wavelength at a medium setting in 87% of cases. The top five injection sites were glabella (82%), forehead (69%), periorbital area (64%), neck (40%), and jawline and/or masseters (13%).

The researchers noted one case (0.06%) where apraclonidine eye drops were prescribed for ptosis. The patient had undergone eight other single-session treatments without issue. There were no other documented adverse events directly related to spread of BoNT-A. According to Dr. Wang, this rate of ptosis is lower than the incidence with BoNT-A alone in two landmark trials studying its effects on glabellar lines, which was reported as 5.4% and 1.0%.

Among the 398 patients who received soft-tissue fillers, most (94%) were female, their mean age was 54 years, and 99% were treated with a 1927nm wavelength at a medium setting in 97% of cases. The top five injection sites were cheeks and/or tear troughs (89%), perioral area and/or marionette lines (77%), lips (34%), nasolabial folds (19%), and temples (11%), and the mean number of filler syringes per treatment was 1.6. Slightly more than half (51%) had 1 session, while the remainder had 2 to greater than 10 sessions. The researchers observed no documented adverse events related to spread of fillers or laser treatment of filled areas.

“This laser is a low-powered device that creates small, superficial, and transient microchannels, which likely contributes to the safety of single-session treatments with cosmetic injectables,” Dr. Wang said. However, prospective studies are needed to further validate these results, he added.

“With this very mild laser, it is not surprising that combined treatment had no effect,” said Eric F. Bernstein, MD, MSE, director of the Main Line Center for Laser Surgery in Ardmore, Pa., who was asked to comment on the study results. “There have been numerous anecdotal reports of spreading of botulinum toxin effect to areas not in the target area for treatment following a variety of lasers, including the more powerful version of the laser used in this study. In addition, spread following vascular and other lasers has been reported,” he noted

The laser used in this study, Dr. Bernstein continued, “is low powered and emits a wavelength that is very superficially absorbed, resulting in injury to the stratum corneum, superficial epidermis, or possibly the very superficial dermis, and is often used by physician extenders and not physicians – although I suspect this is not the case in the current study. One can have a reasonable degree of confidence when combining this laser with injectables, but these results cannot be extrapolated to other devices.”

The abstract received the annual ASDS Carruthers Award during the meeting. Dr. Wang reported that he is a consultant or advisor to Allergan, Alastin, AVAVA, Cynosure, Lutronic, Novoxel, Sofwave, and Solta. Dr. Bernstein reported having received research funding from Cynosure, Candela, and Acclaro. He also has received consulting fees from Cynosure and holds ownership interest in Candela, Novoxel, OnSite, Joylux, and Acclaro and has served on the advisory board for Novoxel, Cynosure, and Acclaro.

Low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers are safe to pair with botulinum neurotoxin type A and soft-tissue fillers during the same treatment session, results from a 6-year, single-center review showed.

“These treatments can be complementary in single-session treatments and can offer increased convenience for both patients and physicians,” primary study author Jordan V. Wang, MD, MBE, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

To date, limited studies have demonstrated the safety of pairing botulinum neurotoxin type A and soft-tissue fillers with laser and other energy-based devices during the same treatment session on the same day, said Dr. Wang, medical research director at the Laser & Skin Surgery Center of New York. “Some concerns remain, though, regarding patient safety and efficacy,” he said. “Data on single-session treatment with low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers and either botulinum neurotoxin or fillers are lacking.”

In a retrospective review of electronic medical records conducted from May 2015 to April 2021, Dr. Wang, Roy G. Geronemus, MD, and Carolyn Kushner, MD evaluated patients who received a single-session facial treatment with either BoNT-A or soft-tissue fillers and the low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers (Clear+Brilliant Perméa and Original, Solta, Pleasanton, Calif.). Safety was assessed by documenting adverse events related to the spread of BoNT-A and fillers or laser treatment of filled areas within 4 weeks.

Adverse events they looked for related to botulinum neurotoxin use included eyelid ptosis; neck weakness or spasms; impairments in chewing, swallowing, speech, and respiration; and prescriptions of apraclonidine eye drops. Filler-related adverse events they looked for included product migration, unexpected loss of filler volume, vascular occlusion, acute pain, necrosis, blindness, and burn. “For both, we looked at hospital or emergency room transfers or admissions and referrals to ENT or ophthalmology,” Dr. Wang said.

During the 6-year study period, 525 patients had 1,562 single-session laser treatments with a mean 46.4 units of BoNT-A, and 398 patients had 1,237 single-session treatments with a mean 1.6 soft-tissue filler syringes. Among those who received BoNT-A, most (93%) were female, their mean age was 51 years, and 99% were treated with a 1,927-nm wavelength at a medium setting in 87% of cases. The top five injection sites were glabella (82%), forehead (69%), periorbital area (64%), neck (40%), and jawline and/or masseters (13%).

The researchers noted one case (0.06%) where apraclonidine eye drops were prescribed for ptosis. The patient had undergone eight other single-session treatments without issue. There were no other documented adverse events directly related to spread of BoNT-A. According to Dr. Wang, this rate of ptosis is lower than the incidence with BoNT-A alone in two landmark trials studying its effects on glabellar lines, which was reported as 5.4% and 1.0%.

Among the 398 patients who received soft-tissue fillers, most (94%) were female, their mean age was 54 years, and 99% were treated with a 1927nm wavelength at a medium setting in 97% of cases. The top five injection sites were cheeks and/or tear troughs (89%), perioral area and/or marionette lines (77%), lips (34%), nasolabial folds (19%), and temples (11%), and the mean number of filler syringes per treatment was 1.6. Slightly more than half (51%) had 1 session, while the remainder had 2 to greater than 10 sessions. The researchers observed no documented adverse events related to spread of fillers or laser treatment of filled areas.

“This laser is a low-powered device that creates small, superficial, and transient microchannels, which likely contributes to the safety of single-session treatments with cosmetic injectables,” Dr. Wang said. However, prospective studies are needed to further validate these results, he added.

“With this very mild laser, it is not surprising that combined treatment had no effect,” said Eric F. Bernstein, MD, MSE, director of the Main Line Center for Laser Surgery in Ardmore, Pa., who was asked to comment on the study results. “There have been numerous anecdotal reports of spreading of botulinum toxin effect to areas not in the target area for treatment following a variety of lasers, including the more powerful version of the laser used in this study. In addition, spread following vascular and other lasers has been reported,” he noted

The laser used in this study, Dr. Bernstein continued, “is low powered and emits a wavelength that is very superficially absorbed, resulting in injury to the stratum corneum, superficial epidermis, or possibly the very superficial dermis, and is often used by physician extenders and not physicians – although I suspect this is not the case in the current study. One can have a reasonable degree of confidence when combining this laser with injectables, but these results cannot be extrapolated to other devices.”

The abstract received the annual ASDS Carruthers Award during the meeting. Dr. Wang reported that he is a consultant or advisor to Allergan, Alastin, AVAVA, Cynosure, Lutronic, Novoxel, Sofwave, and Solta. Dr. Bernstein reported having received research funding from Cynosure, Candela, and Acclaro. He also has received consulting fees from Cynosure and holds ownership interest in Candela, Novoxel, OnSite, Joylux, and Acclaro and has served on the advisory board for Novoxel, Cynosure, and Acclaro.

Use of vascular lasers in the Medicare population is increasing, primarily among dermatologists. In addition, as a proportion of Medicare charges submitted that were reimbursed, the highest reimbursements were for dermatologists and those in the Western geographic region.

Those are among the key findings from an analysis that aimed to characterize trends in use and reimbursement patterns of vascular lasers in the Medicare-insured population.

“There are several modalities for vascular laser treatment, including the pulse dye laser, the frequency doubled KTP laser, and others,” presenting author Partik Singh, MD, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “Laser treatment of vascular lesions may sometimes be covered by insurance, depending on the indication, but little is known about how and which clinicians are taking advantage of this covered treatment.”

Dr. Singh, a 2nd-year dermatology resident at the University of Rochester Medical Center, and coauthor Mara Weinstein Velez, MD, extracted data from the 2012-2018 Medicare Public Use File, which includes 100% fee-for-service, non–Medicare Advantage claims based on CPT codes, yet no information on patient data, clinical context, or indications. Outcomes of interest were total vascular laser claims per year, annual vascular laser claims per clinician, annual clinicians using vascular lasers, accepted reimbursements defined by the allowed charge or the submitted charge to Medicare, and clinical specialties and geographic location.

The researchers found that more than half of clinicians who used vascular lasers during the study period were dermatologists (55%), followed by general surgeons (6%), family practice/internal medicine physicians (5% each) and various others. Use of vascular lasers among all clinicians increased 10.5% annually during the study period, from 3,786 to 6,883, and was most pronounced among dermatologists, whose use increased 18.4% annually, from 1,878 to 5,182. “Nondermatologists did not have a big change in their overall utilization rate, but they did have a steady utilization of vascular lasers, roughly at almost 2,000 claims per year,” Dr. Singh said.

The researchers also observed that the use of vascular lasers on a per-clinician basis increased 7.4% annually among all clinicians during the study period, from 77.3 to 118.7. This was mostly driven by dermatologists, whose per-clinician use increased 10.4% annually, from 81.7 to 148.7. Use by nondermatologists remained about stable, with just a 0.1% increase annually, from 73.4 to 74. In addition, the number of clinicians who billed for vascular laser procedures increased 2.9% annually between 2012 and 2018, from 49 to 58. This growth was driven mostly by dermatologists, who increased their billing for vascular laser procedures by 7.2% annually, from 23 to 35 clinicians.

In other findings, dermatologists were reimbursed at 68.3% of submitted charges, compared with 59.3% of charges submitted by other clinicians (P = .0001), and reimbursement rates were greatest in the Western geographic region of the United States vs. the Northeast, Midwest, and Southern regions (73.1% vs. 50.2%, 65.4%, and 55.3%, respectively; P < .0001).

“Use of vascular lasers is increasing primarily among dermatologists, though there is steady use of these procedures by nondermatologists,” Dr. Singh concluded. “Medicare charges were more often fully reimbursed when billed by dermatologists and those in the Western U.S., perhaps suggesting a better familiarity with appropriate indications and better administrative resources for coverage of vascular laser procedures.”

After the meeting, Dr. Singh acknowledged certain limitations of the analysis, including the fact that it “was limited only to Medicare Part B fee-for-service claims, not including Medicare Advantage,” he told this news organization. “Our conclusions do not necessarily hold true for Medicaid or commercial insurers, for instance. Moreover, this dataset doesn’t provide patient-specific information, such as the indication for the procedure. Further studies are needed to characterize utilization of various lasers in not only Medicare beneficiaries, but also those with Medicaid, private insurance, and patients paying out-of-pocket. Additionally, study is also needed to explain why these differences in reimbursement hold true.”

The researchers reported having no relevant financial disclosures.

[email protected]

Use of vascular lasers in the Medicare population is increasing, primarily among dermatologists. In addition, as a proportion of Medicare charges submitted that were reimbursed, the highest reimbursements were for dermatologists and those in the Western geographic region.

Those are among the key findings from an analysis that aimed to characterize trends in use and reimbursement patterns of vascular lasers in the Medicare-insured population.

“There are several modalities for vascular laser treatment, including the pulse dye laser, the frequency doubled KTP laser, and others,” presenting author Partik Singh, MD, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “Laser treatment of vascular lesions may sometimes be covered by insurance, depending on the indication, but little is known about how and which clinicians are taking advantage of this covered treatment.”

Dr. Singh, a 2nd-year dermatology resident at the University of Rochester Medical Center, and coauthor Mara Weinstein Velez, MD, extracted data from the 2012-2018 Medicare Public Use File, which includes 100% fee-for-service, non–Medicare Advantage claims based on CPT codes, yet no information on patient data, clinical context, or indications. Outcomes of interest were total vascular laser claims per year, annual vascular laser claims per clinician, annual clinicians using vascular lasers, accepted reimbursements defined by the allowed charge or the submitted charge to Medicare, and clinical specialties and geographic location.

The researchers found that more than half of clinicians who used vascular lasers during the study period were dermatologists (55%), followed by general surgeons (6%), family practice/internal medicine physicians (5% each) and various others. Use of vascular lasers among all clinicians increased 10.5% annually during the study period, from 3,786 to 6,883, and was most pronounced among dermatologists, whose use increased 18.4% annually, from 1,878 to 5,182. “Nondermatologists did not have a big change in their overall utilization rate, but they did have a steady utilization of vascular lasers, roughly at almost 2,000 claims per year,” Dr. Singh said.

The researchers also observed that the use of vascular lasers on a per-clinician basis increased 7.4% annually among all clinicians during the study period, from 77.3 to 118.7. This was mostly driven by dermatologists, whose per-clinician use increased 10.4% annually, from 81.7 to 148.7. Use by nondermatologists remained about stable, with just a 0.1% increase annually, from 73.4 to 74. In addition, the number of clinicians who billed for vascular laser procedures increased 2.9% annually between 2012 and 2018, from 49 to 58. This growth was driven mostly by dermatologists, who increased their billing for vascular laser procedures by 7.2% annually, from 23 to 35 clinicians.

In other findings, dermatologists were reimbursed at 68.3% of submitted charges, compared with 59.3% of charges submitted by other clinicians (P = .0001), and reimbursement rates were greatest in the Western geographic region of the United States vs. the Northeast, Midwest, and Southern regions (73.1% vs. 50.2%, 65.4%, and 55.3%, respectively; P < .0001).

“Use of vascular lasers is increasing primarily among dermatologists, though there is steady use of these procedures by nondermatologists,” Dr. Singh concluded. “Medicare charges were more often fully reimbursed when billed by dermatologists and those in the Western U.S., perhaps suggesting a better familiarity with appropriate indications and better administrative resources for coverage of vascular laser procedures.”

After the meeting, Dr. Singh acknowledged certain limitations of the analysis, including the fact that it “was limited only to Medicare Part B fee-for-service claims, not including Medicare Advantage,” he told this news organization. “Our conclusions do not necessarily hold true for Medicaid or commercial insurers, for instance. Moreover, this dataset doesn’t provide patient-specific information, such as the indication for the procedure. Further studies are needed to characterize utilization of various lasers in not only Medicare beneficiaries, but also those with Medicaid, private insurance, and patients paying out-of-pocket. Additionally, study is also needed to explain why these differences in reimbursement hold true.”

The researchers reported having no relevant financial disclosures.

[email protected]

Use of vascular lasers in the Medicare population is increasing, primarily among dermatologists. In addition, as a proportion of Medicare charges submitted that were reimbursed, the highest reimbursements were for dermatologists and those in the Western geographic region.

Those are among the key findings from an analysis that aimed to characterize trends in use and reimbursement patterns of vascular lasers in the Medicare-insured population.

“There are several modalities for vascular laser treatment, including the pulse dye laser, the frequency doubled KTP laser, and others,” presenting author Partik Singh, MD, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “Laser treatment of vascular lesions may sometimes be covered by insurance, depending on the indication, but little is known about how and which clinicians are taking advantage of this covered treatment.”

Dr. Singh, a 2nd-year dermatology resident at the University of Rochester Medical Center, and coauthor Mara Weinstein Velez, MD, extracted data from the 2012-2018 Medicare Public Use File, which includes 100% fee-for-service, non–Medicare Advantage claims based on CPT codes, yet no information on patient data, clinical context, or indications. Outcomes of interest were total vascular laser claims per year, annual vascular laser claims per clinician, annual clinicians using vascular lasers, accepted reimbursements defined by the allowed charge or the submitted charge to Medicare, and clinical specialties and geographic location.

The researchers found that more than half of clinicians who used vascular lasers during the study period were dermatologists (55%), followed by general surgeons (6%), family practice/internal medicine physicians (5% each) and various others. Use of vascular lasers among all clinicians increased 10.5% annually during the study period, from 3,786 to 6,883, and was most pronounced among dermatologists, whose use increased 18.4% annually, from 1,878 to 5,182. “Nondermatologists did not have a big change in their overall utilization rate, but they did have a steady utilization of vascular lasers, roughly at almost 2,000 claims per year,” Dr. Singh said.

The researchers also observed that the use of vascular lasers on a per-clinician basis increased 7.4% annually among all clinicians during the study period, from 77.3 to 118.7. This was mostly driven by dermatologists, whose per-clinician use increased 10.4% annually, from 81.7 to 148.7. Use by nondermatologists remained about stable, with just a 0.1% increase annually, from 73.4 to 74. In addition, the number of clinicians who billed for vascular laser procedures increased 2.9% annually between 2012 and 2018, from 49 to 58. This growth was driven mostly by dermatologists, who increased their billing for vascular laser procedures by 7.2% annually, from 23 to 35 clinicians.

In other findings, dermatologists were reimbursed at 68.3% of submitted charges, compared with 59.3% of charges submitted by other clinicians (P = .0001), and reimbursement rates were greatest in the Western geographic region of the United States vs. the Northeast, Midwest, and Southern regions (73.1% vs. 50.2%, 65.4%, and 55.3%, respectively; P < .0001).

“Use of vascular lasers is increasing primarily among dermatologists, though there is steady use of these procedures by nondermatologists,” Dr. Singh concluded. “Medicare charges were more often fully reimbursed when billed by dermatologists and those in the Western U.S., perhaps suggesting a better familiarity with appropriate indications and better administrative resources for coverage of vascular laser procedures.”

After the meeting, Dr. Singh acknowledged certain limitations of the analysis, including the fact that it “was limited only to Medicare Part B fee-for-service claims, not including Medicare Advantage,” he told this news organization. “Our conclusions do not necessarily hold true for Medicaid or commercial insurers, for instance. Moreover, this dataset doesn’t provide patient-specific information, such as the indication for the procedure. Further studies are needed to characterize utilization of various lasers in not only Medicare beneficiaries, but also those with Medicaid, private insurance, and patients paying out-of-pocket. Additionally, study is also needed to explain why these differences in reimbursement hold true.”

The researchers reported having no relevant financial disclosures.

[email protected]

There is an increased incidence of locally staged Merkel cell carcinoma (MCC) among patients who live in rural areas of the United States, compared with those in urban and metropolitan areas, yet overall survival is worse in rural areas.

This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”

The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.

A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”

Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.

Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”

The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.

[email protected]

There is an increased incidence of locally staged Merkel cell carcinoma (MCC) among patients who live in rural areas of the United States, compared with those in urban and metropolitan areas, yet overall survival is worse in rural areas.

This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”

The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.

A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”

Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.

Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”

The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.

[email protected]

There is an increased incidence of locally staged Merkel cell carcinoma (MCC) among patients who live in rural areas of the United States, compared with those in urban and metropolitan areas, yet overall survival is worse in rural areas.

This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”

The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.

A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”

Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.

Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”

The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.

[email protected]

The clinical presentation of atopic dermatitis (AD) in skin of color varies widely, which may create a challenge for clinicians.

“We see very heterogenous and broad clinical presentations across the diverse patient populations that we see,” Andrew F. Alexis, MD, MPH, said at the Revolutionizing Atopic Dermatitis symposium. “Some of these differences might be related to population variations in skin barrier function, immunologic factors, genetic factors, and environmental factors, which all interplay to produce variations in the clinical presentation and overall impact of AD. Many nongenetic factors also contribute to differences that we see, including some socioeconomic and other factors that feed into health disparities.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, discussed four main clinical features of AD in skin of color.
 

Erythema is less visible because it is masked by pigment

“There can be some masking of the redness and alteration of that color such that it doesn’t look bright red as it would in the background of lightly pigmented skin,” Dr. Alexis said. “Instead, the [AD lesions] have shades of grayish-red or grayish-brown or reddish-brown. It’s important to recognize this clinical presentation and look carefully and assess the patient – not just visually but with palpation and take into consideration symptomatology so that you don’t fall into the trap of calling an AD lesion postinflammatory hyperpigmentation. It’s also helpful to isolate the islands of normal or nonlesional skin and contrast that with the areas of lesional skin, to get a sense of how active and inflamed the areas are. Palpation really helps to appreciate the elevation of the lesions that are involved.”

Follicular accentuation

Morphological variants common in skin of color include the follicular variant or micropapular variant of AD. “You might just see a collection of papules that are 1-2 mm in size and pruritic and in typical sites of predilection [for] eczema,” he said. Prurigo nodularis–like lesions or prurigo nodularis in association with AD are also seen more frequently in skin of color.

Lichenification

The lichenoid variant of AD is characterized by a violaceous hue and other features that resemble lichen planus and has been reported to be more common in individuals of African descent. A prospective study of about 1,000 patients with AD seen over 2 years at a dermatology clinic in southeastern Nigeria found that 54% of patients had papular lichenoid lesions. In addition, 51% had elevated blood eosinophil counts, especially those with severe disease.

Dr. Alexis added that psoriasiform features have been reported in studies of East Asian populations with AD. These plaques may be more well demarcated and have clinical and histologic features that resemble psoriasis.
 

Dyspigmentation

One common feature across the spectrum of patients with skin of color “is the risk of longstanding pigmentary sequelae in the form of hyperpigmentation or hypopigmentation,” said Dr. Alexis, who is also vice chair for diversity and inclusion for the department of dermatology at Weill Cornell Medicine. “In very severe longstanding areas with chronic excoriation to the point of breaking of the skin, eroding of the skin, causing permanent damage to the melanocytes, dyspigmentation that resembles vitiligo can be seen. We can also see hypopigmentation as a consequence of topical corticosteroids, particularly those that are class I or class II and are used for prolonged periods of time.”

Dr. Alexis noted that delays in treatment and undertreatment can contribute to a higher risk of pigmentary and other long-term sequelae. “New therapies show promise in improving outcomes in AD patients with skin of color. When it comes to therapeutic responses, there are some post hoc studies that have investigated potential differences in safety and efficacy of the agents that have been recently approved. We clearly need more data to better understand if there are potential racial or ethnic differences.”

Dr. Alexis reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Atopic dermatitis (AD) is highly heterogenous, with tremendous variations in extent, qualities of eczema, symptom complex, and physical presentation. Prior studies have reported disparities of care delivered to racial and ethnic minorities in the United States, as well as higher susceptibility to AD and odds of persistent disease into adulthood from child-onset AD. Recognizing some differences in presentation of AD in patients with skin of color is important as we select our therapeutic interventions, including assessing new treatments being added to our armamentarium. Erythema may be harder to notice in darker skin, but attempting to blanch the skin with pressure can help to assess the color and inflammation. Appreciating lichenoid changes, including papular and “micropapular” AD, and psoriasiform-like thickening in certain patients (reportedly more common in East Asian populations) are important as well. And dyspigmentation is an important aspect of the disease presentation and patient and parental concern, given both hypopigmentaton and hyperpigmentation commonly seen over the course of AD.

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

The clinical presentation of atopic dermatitis (AD) in skin of color varies widely, which may create a challenge for clinicians.

“We see very heterogenous and broad clinical presentations across the diverse patient populations that we see,” Andrew F. Alexis, MD, MPH, said at the Revolutionizing Atopic Dermatitis symposium. “Some of these differences might be related to population variations in skin barrier function, immunologic factors, genetic factors, and environmental factors, which all interplay to produce variations in the clinical presentation and overall impact of AD. Many nongenetic factors also contribute to differences that we see, including some socioeconomic and other factors that feed into health disparities.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, discussed four main clinical features of AD in skin of color.
 

Erythema is less visible because it is masked by pigment

“There can be some masking of the redness and alteration of that color such that it doesn’t look bright red as it would in the background of lightly pigmented skin,” Dr. Alexis said. “Instead, the [AD lesions] have shades of grayish-red or grayish-brown or reddish-brown. It’s important to recognize this clinical presentation and look carefully and assess the patient – not just visually but with palpation and take into consideration symptomatology so that you don’t fall into the trap of calling an AD lesion postinflammatory hyperpigmentation. It’s also helpful to isolate the islands of normal or nonlesional skin and contrast that with the areas of lesional skin, to get a sense of how active and inflamed the areas are. Palpation really helps to appreciate the elevation of the lesions that are involved.”

Follicular accentuation

Morphological variants common in skin of color include the follicular variant or micropapular variant of AD. “You might just see a collection of papules that are 1-2 mm in size and pruritic and in typical sites of predilection [for] eczema,” he said. Prurigo nodularis–like lesions or prurigo nodularis in association with AD are also seen more frequently in skin of color.

Lichenification

The lichenoid variant of AD is characterized by a violaceous hue and other features that resemble lichen planus and has been reported to be more common in individuals of African descent. A prospective study of about 1,000 patients with AD seen over 2 years at a dermatology clinic in southeastern Nigeria found that 54% of patients had papular lichenoid lesions. In addition, 51% had elevated blood eosinophil counts, especially those with severe disease.

Dr. Alexis added that psoriasiform features have been reported in studies of East Asian populations with AD. These plaques may be more well demarcated and have clinical and histologic features that resemble psoriasis.
 

Dyspigmentation

One common feature across the spectrum of patients with skin of color “is the risk of longstanding pigmentary sequelae in the form of hyperpigmentation or hypopigmentation,” said Dr. Alexis, who is also vice chair for diversity and inclusion for the department of dermatology at Weill Cornell Medicine. “In very severe longstanding areas with chronic excoriation to the point of breaking of the skin, eroding of the skin, causing permanent damage to the melanocytes, dyspigmentation that resembles vitiligo can be seen. We can also see hypopigmentation as a consequence of topical corticosteroids, particularly those that are class I or class II and are used for prolonged periods of time.”

Dr. Alexis noted that delays in treatment and undertreatment can contribute to a higher risk of pigmentary and other long-term sequelae. “New therapies show promise in improving outcomes in AD patients with skin of color. When it comes to therapeutic responses, there are some post hoc studies that have investigated potential differences in safety and efficacy of the agents that have been recently approved. We clearly need more data to better understand if there are potential racial or ethnic differences.”

Dr. Alexis reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Atopic dermatitis (AD) is highly heterogenous, with tremendous variations in extent, qualities of eczema, symptom complex, and physical presentation. Prior studies have reported disparities of care delivered to racial and ethnic minorities in the United States, as well as higher susceptibility to AD and odds of persistent disease into adulthood from child-onset AD. Recognizing some differences in presentation of AD in patients with skin of color is important as we select our therapeutic interventions, including assessing new treatments being added to our armamentarium. Erythema may be harder to notice in darker skin, but attempting to blanch the skin with pressure can help to assess the color and inflammation. Appreciating lichenoid changes, including papular and “micropapular” AD, and psoriasiform-like thickening in certain patients (reportedly more common in East Asian populations) are important as well. And dyspigmentation is an important aspect of the disease presentation and patient and parental concern, given both hypopigmentaton and hyperpigmentation commonly seen over the course of AD.

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

The clinical presentation of atopic dermatitis (AD) in skin of color varies widely, which may create a challenge for clinicians.

“We see very heterogenous and broad clinical presentations across the diverse patient populations that we see,” Andrew F. Alexis, MD, MPH, said at the Revolutionizing Atopic Dermatitis symposium. “Some of these differences might be related to population variations in skin barrier function, immunologic factors, genetic factors, and environmental factors, which all interplay to produce variations in the clinical presentation and overall impact of AD. Many nongenetic factors also contribute to differences that we see, including some socioeconomic and other factors that feed into health disparities.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, discussed four main clinical features of AD in skin of color.
 

Erythema is less visible because it is masked by pigment

“There can be some masking of the redness and alteration of that color such that it doesn’t look bright red as it would in the background of lightly pigmented skin,” Dr. Alexis said. “Instead, the [AD lesions] have shades of grayish-red or grayish-brown or reddish-brown. It’s important to recognize this clinical presentation and look carefully and assess the patient – not just visually but with palpation and take into consideration symptomatology so that you don’t fall into the trap of calling an AD lesion postinflammatory hyperpigmentation. It’s also helpful to isolate the islands of normal or nonlesional skin and contrast that with the areas of lesional skin, to get a sense of how active and inflamed the areas are. Palpation really helps to appreciate the elevation of the lesions that are involved.”

Follicular accentuation

Morphological variants common in skin of color include the follicular variant or micropapular variant of AD. “You might just see a collection of papules that are 1-2 mm in size and pruritic and in typical sites of predilection [for] eczema,” he said. Prurigo nodularis–like lesions or prurigo nodularis in association with AD are also seen more frequently in skin of color.

Lichenification

The lichenoid variant of AD is characterized by a violaceous hue and other features that resemble lichen planus and has been reported to be more common in individuals of African descent. A prospective study of about 1,000 patients with AD seen over 2 years at a dermatology clinic in southeastern Nigeria found that 54% of patients had papular lichenoid lesions. In addition, 51% had elevated blood eosinophil counts, especially those with severe disease.

Dr. Alexis added that psoriasiform features have been reported in studies of East Asian populations with AD. These plaques may be more well demarcated and have clinical and histologic features that resemble psoriasis.
 

Dyspigmentation

One common feature across the spectrum of patients with skin of color “is the risk of longstanding pigmentary sequelae in the form of hyperpigmentation or hypopigmentation,” said Dr. Alexis, who is also vice chair for diversity and inclusion for the department of dermatology at Weill Cornell Medicine. “In very severe longstanding areas with chronic excoriation to the point of breaking of the skin, eroding of the skin, causing permanent damage to the melanocytes, dyspigmentation that resembles vitiligo can be seen. We can also see hypopigmentation as a consequence of topical corticosteroids, particularly those that are class I or class II and are used for prolonged periods of time.”

Dr. Alexis noted that delays in treatment and undertreatment can contribute to a higher risk of pigmentary and other long-term sequelae. “New therapies show promise in improving outcomes in AD patients with skin of color. When it comes to therapeutic responses, there are some post hoc studies that have investigated potential differences in safety and efficacy of the agents that have been recently approved. We clearly need more data to better understand if there are potential racial or ethnic differences.”

Dr. Alexis reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Atopic dermatitis (AD) is highly heterogenous, with tremendous variations in extent, qualities of eczema, symptom complex, and physical presentation. Prior studies have reported disparities of care delivered to racial and ethnic minorities in the United States, as well as higher susceptibility to AD and odds of persistent disease into adulthood from child-onset AD. Recognizing some differences in presentation of AD in patients with skin of color is important as we select our therapeutic interventions, including assessing new treatments being added to our armamentarium. Erythema may be harder to notice in darker skin, but attempting to blanch the skin with pressure can help to assess the color and inflammation. Appreciating lichenoid changes, including papular and “micropapular” AD, and psoriasiform-like thickening in certain patients (reportedly more common in East Asian populations) are important as well. And dyspigmentation is an important aspect of the disease presentation and patient and parental concern, given both hypopigmentaton and hyperpigmentation commonly seen over the course of AD.

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

Responses to abrocitinib treatment among patients with moderate to severe atopic dermatitis (AD) showed dose-dependent consistency across age groups and was comparable in patients aged 51 years and older, results from a post hoc analysis of four trials showed.

Abrocitinib (Cibinqo) is an oral, once-daily, Janus kinase 1 selective inhibitor that has shown good efficacy and safety as monotherapy or combined with topical therapy for treatment of patients with moderate to severe AD. The agent was approved in mid-December in Europe for the treatment of moderate to severe AD in adults who are candidates for systemic therapy and is currently under review by the Food and Drug Administration.

“We know that responses to, and adverse events associated with, systemic therapies may vary among patients of different ages,” Andrew F. Alexis, MD, MPH, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “The efficacy and safety of abrocitinib monotherapy were previously evaluated in adolescent and adult subpopulations from controlled clinical trials in patients with moderate to severe AD. The objective of the current study was to assess the impact of age on short-term responses to abrocitinib treatment in patients with moderate to severe AD.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, and colleagues performed a post hoc analysis across four randomized, double-blind studies that was stratified by age group: 12-17 years, 18-40 years, 41-50 years, and 51 years and older. Efficacy data were assessed separately for patients in the monotherapy pool and in the JADE COMPARE trial. The monotherapy pool included patients from one phase 2b study and two phase 3 studies who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo monotherapy for 12 weeks (JADE-MONO-1 and JADE-MONO-2).

The JADE COMPARE pool included patients who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo, plus medicated topical therapy for 16 weeks. Data from patients in all four trials were pooled for the analysis of treatment-emergent adverse events. Efficacy points analyzed were the Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear), a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75), or Peak Pruritus Numeric Rating Scale score (PP-NRS4) at week 12 for the monotherapy pool and at week 16 for COMPARE.

In the monotherapy pool, the proportions of patients ages 12-17 years, 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response at 12 weeks were 31.3%, 40.2%, 43.8%, and 50.8% (abrocitinib 200 mg); 22%, 23.7%, 22.4%, and 40.8% (abrocitinib 100 mg); and 8.7%, 8%, 3.3%, and 10% (placebo).

In JADE COMPARE, the proportions of patients aged 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response were 50%, 53.2%, and 34.8% (abrocitinib 200 mg); 36.9%, 37.1%, and 26.1% (abrocitinib 100 mg); and 12%, 11.8%, and 16.7% (placebo) at 16 weeks. Similar trends were observed for EASI-75 and PP-NRS4 responses at 12 weeks.

Across all age groups, the most common treatment-emergent adverse events were infections/infestations and gastrointestinal effects; most cases were mild or moderate. Nausea was more frequent in the two younger age groups and was dose related: For abrocitinib 200 mg and abrocitinib 100 mg, respectively, the rates of nausea were 18.8% and 7.8% in patients aged 12-17 years; 17.1% and 6.4% in patients aged 18-40 years; and 7.1% and 3.3% in patients aged 51 and older.

“Efficacy responses in patients 51 years of age and older were comparable to those in other age groups,” concluded Dr. Alexis, vice chair for diversity and inclusion in the department of dermatology at Weill Cornell. “The safety profile was consistent across age ranges and was similar to that reported previously.”

The investigators found that treatment response to abrocitinib “in the absence or presence of medicated topical therapy was fairly consistent across age groups, showed similar dose-dependency, and importantly, did not show reduced efficacy in older adults as measured by lesional severity, extent, and itch at 4 months,” said Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study.

“Furthermore, the safety profile was consistent across all adults, though notably, nausea was more common among younger age groups, highlighting an area of future investigation,” he added. “Overall, these data show that abrocitinib is associated with similar short-term responses across adulthood and underscore the importance of the JAK-STAT pathway in the underlying pathophysiology of AD in different age groups. It will be interesting to see how these data reflect the real-world setting with both short- and long-term outcomes in a heterogeneous patient population.”

In the interview, Dr. Chovatiya said, “the next frontier in personalized therapy for AD involves deeper clinical phenotyping of our patients and a better understanding of how efficacy and safety vary across patient groups.” For example, he noted, “AD in earlier versus later adulthood may be associated with different clinical signs, symptoms, comorbidities, and other measures of patient burden, and thus, may be associated with different treatment responses to systemic therapy.”  

Dr. Alexis disclosed that he has served as an adviser to, or has received consulting fees from, Leo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Beiersdorf, Valeant, L’Oréal, BMS, Bausch Health, UCB, Vyne, Arcutis, Janssen, Allergan, Almirall, AbbVie, Sol-Gel, and Amgen.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme.

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

Responses to abrocitinib treatment among patients with moderate to severe atopic dermatitis (AD) showed dose-dependent consistency across age groups and was comparable in patients aged 51 years and older, results from a post hoc analysis of four trials showed.

Abrocitinib (Cibinqo) is an oral, once-daily, Janus kinase 1 selective inhibitor that has shown good efficacy and safety as monotherapy or combined with topical therapy for treatment of patients with moderate to severe AD. The agent was approved in mid-December in Europe for the treatment of moderate to severe AD in adults who are candidates for systemic therapy and is currently under review by the Food and Drug Administration.

“We know that responses to, and adverse events associated with, systemic therapies may vary among patients of different ages,” Andrew F. Alexis, MD, MPH, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “The efficacy and safety of abrocitinib monotherapy were previously evaluated in adolescent and adult subpopulations from controlled clinical trials in patients with moderate to severe AD. The objective of the current study was to assess the impact of age on short-term responses to abrocitinib treatment in patients with moderate to severe AD.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, and colleagues performed a post hoc analysis across four randomized, double-blind studies that was stratified by age group: 12-17 years, 18-40 years, 41-50 years, and 51 years and older. Efficacy data were assessed separately for patients in the monotherapy pool and in the JADE COMPARE trial. The monotherapy pool included patients from one phase 2b study and two phase 3 studies who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo monotherapy for 12 weeks (JADE-MONO-1 and JADE-MONO-2).

The JADE COMPARE pool included patients who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo, plus medicated topical therapy for 16 weeks. Data from patients in all four trials were pooled for the analysis of treatment-emergent adverse events. Efficacy points analyzed were the Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear), a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75), or Peak Pruritus Numeric Rating Scale score (PP-NRS4) at week 12 for the monotherapy pool and at week 16 for COMPARE.

In the monotherapy pool, the proportions of patients ages 12-17 years, 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response at 12 weeks were 31.3%, 40.2%, 43.8%, and 50.8% (abrocitinib 200 mg); 22%, 23.7%, 22.4%, and 40.8% (abrocitinib 100 mg); and 8.7%, 8%, 3.3%, and 10% (placebo).

In JADE COMPARE, the proportions of patients aged 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response were 50%, 53.2%, and 34.8% (abrocitinib 200 mg); 36.9%, 37.1%, and 26.1% (abrocitinib 100 mg); and 12%, 11.8%, and 16.7% (placebo) at 16 weeks. Similar trends were observed for EASI-75 and PP-NRS4 responses at 12 weeks.

Across all age groups, the most common treatment-emergent adverse events were infections/infestations and gastrointestinal effects; most cases were mild or moderate. Nausea was more frequent in the two younger age groups and was dose related: For abrocitinib 200 mg and abrocitinib 100 mg, respectively, the rates of nausea were 18.8% and 7.8% in patients aged 12-17 years; 17.1% and 6.4% in patients aged 18-40 years; and 7.1% and 3.3% in patients aged 51 and older.

“Efficacy responses in patients 51 years of age and older were comparable to those in other age groups,” concluded Dr. Alexis, vice chair for diversity and inclusion in the department of dermatology at Weill Cornell. “The safety profile was consistent across age ranges and was similar to that reported previously.”

The investigators found that treatment response to abrocitinib “in the absence or presence of medicated topical therapy was fairly consistent across age groups, showed similar dose-dependency, and importantly, did not show reduced efficacy in older adults as measured by lesional severity, extent, and itch at 4 months,” said Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study.

“Furthermore, the safety profile was consistent across all adults, though notably, nausea was more common among younger age groups, highlighting an area of future investigation,” he added. “Overall, these data show that abrocitinib is associated with similar short-term responses across adulthood and underscore the importance of the JAK-STAT pathway in the underlying pathophysiology of AD in different age groups. It will be interesting to see how these data reflect the real-world setting with both short- and long-term outcomes in a heterogeneous patient population.”

In the interview, Dr. Chovatiya said, “the next frontier in personalized therapy for AD involves deeper clinical phenotyping of our patients and a better understanding of how efficacy and safety vary across patient groups.” For example, he noted, “AD in earlier versus later adulthood may be associated with different clinical signs, symptoms, comorbidities, and other measures of patient burden, and thus, may be associated with different treatment responses to systemic therapy.”  

Dr. Alexis disclosed that he has served as an adviser to, or has received consulting fees from, Leo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Beiersdorf, Valeant, L’Oréal, BMS, Bausch Health, UCB, Vyne, Arcutis, Janssen, Allergan, Almirall, AbbVie, Sol-Gel, and Amgen.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme.

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

Responses to abrocitinib treatment among patients with moderate to severe atopic dermatitis (AD) showed dose-dependent consistency across age groups and was comparable in patients aged 51 years and older, results from a post hoc analysis of four trials showed.

Abrocitinib (Cibinqo) is an oral, once-daily, Janus kinase 1 selective inhibitor that has shown good efficacy and safety as monotherapy or combined with topical therapy for treatment of patients with moderate to severe AD. The agent was approved in mid-December in Europe for the treatment of moderate to severe AD in adults who are candidates for systemic therapy and is currently under review by the Food and Drug Administration.

“We know that responses to, and adverse events associated with, systemic therapies may vary among patients of different ages,” Andrew F. Alexis, MD, MPH, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “The efficacy and safety of abrocitinib monotherapy were previously evaluated in adolescent and adult subpopulations from controlled clinical trials in patients with moderate to severe AD. The objective of the current study was to assess the impact of age on short-term responses to abrocitinib treatment in patients with moderate to severe AD.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, and colleagues performed a post hoc analysis across four randomized, double-blind studies that was stratified by age group: 12-17 years, 18-40 years, 41-50 years, and 51 years and older. Efficacy data were assessed separately for patients in the monotherapy pool and in the JADE COMPARE trial. The monotherapy pool included patients from one phase 2b study and two phase 3 studies who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo monotherapy for 12 weeks (JADE-MONO-1 and JADE-MONO-2).

The JADE COMPARE pool included patients who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo, plus medicated topical therapy for 16 weeks. Data from patients in all four trials were pooled for the analysis of treatment-emergent adverse events. Efficacy points analyzed were the Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear), a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75), or Peak Pruritus Numeric Rating Scale score (PP-NRS4) at week 12 for the monotherapy pool and at week 16 for COMPARE.

In the monotherapy pool, the proportions of patients ages 12-17 years, 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response at 12 weeks were 31.3%, 40.2%, 43.8%, and 50.8% (abrocitinib 200 mg); 22%, 23.7%, 22.4%, and 40.8% (abrocitinib 100 mg); and 8.7%, 8%, 3.3%, and 10% (placebo).

In JADE COMPARE, the proportions of patients aged 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response were 50%, 53.2%, and 34.8% (abrocitinib 200 mg); 36.9%, 37.1%, and 26.1% (abrocitinib 100 mg); and 12%, 11.8%, and 16.7% (placebo) at 16 weeks. Similar trends were observed for EASI-75 and PP-NRS4 responses at 12 weeks.

Across all age groups, the most common treatment-emergent adverse events were infections/infestations and gastrointestinal effects; most cases were mild or moderate. Nausea was more frequent in the two younger age groups and was dose related: For abrocitinib 200 mg and abrocitinib 100 mg, respectively, the rates of nausea were 18.8% and 7.8% in patients aged 12-17 years; 17.1% and 6.4% in patients aged 18-40 years; and 7.1% and 3.3% in patients aged 51 and older.

“Efficacy responses in patients 51 years of age and older were comparable to those in other age groups,” concluded Dr. Alexis, vice chair for diversity and inclusion in the department of dermatology at Weill Cornell. “The safety profile was consistent across age ranges and was similar to that reported previously.”

The investigators found that treatment response to abrocitinib “in the absence or presence of medicated topical therapy was fairly consistent across age groups, showed similar dose-dependency, and importantly, did not show reduced efficacy in older adults as measured by lesional severity, extent, and itch at 4 months,” said Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study.

“Furthermore, the safety profile was consistent across all adults, though notably, nausea was more common among younger age groups, highlighting an area of future investigation,” he added. “Overall, these data show that abrocitinib is associated with similar short-term responses across adulthood and underscore the importance of the JAK-STAT pathway in the underlying pathophysiology of AD in different age groups. It will be interesting to see how these data reflect the real-world setting with both short- and long-term outcomes in a heterogeneous patient population.”

In the interview, Dr. Chovatiya said, “the next frontier in personalized therapy for AD involves deeper clinical phenotyping of our patients and a better understanding of how efficacy and safety vary across patient groups.” For example, he noted, “AD in earlier versus later adulthood may be associated with different clinical signs, symptoms, comorbidities, and other measures of patient burden, and thus, may be associated with different treatment responses to systemic therapy.”  

Dr. Alexis disclosed that he has served as an adviser to, or has received consulting fees from, Leo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Beiersdorf, Valeant, L’Oréal, BMS, Bausch Health, UCB, Vyne, Arcutis, Janssen, Allergan, Almirall, AbbVie, Sol-Gel, and Amgen.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme.

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

Adult atopic dermatitis (AD) patients with sleep disorders had higher levels of the inflammatory biomarker C-reactive protein (CRP), as well as a higher risk of developing adverse cardiovascular outcomes and mortality, results from a large cohort analysis showed.

“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”

To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.

The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).

To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”

Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).

“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.

Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”

“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”

Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.

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

Adult atopic dermatitis (AD) patients with sleep disorders had higher levels of the inflammatory biomarker C-reactive protein (CRP), as well as a higher risk of developing adverse cardiovascular outcomes and mortality, results from a large cohort analysis showed.

“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”

To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.

The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).

To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”

Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).

“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.

Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”

“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”

Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.

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

Adult atopic dermatitis (AD) patients with sleep disorders had higher levels of the inflammatory biomarker C-reactive protein (CRP), as well as a higher risk of developing adverse cardiovascular outcomes and mortality, results from a large cohort analysis showed.

“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”

To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.

The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).

To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”

Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).

“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.

Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”

“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”

Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.

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

The number of adverse events involving vascular necrosis and vision changes following injection of dermal fillers increased from 2014 to 2020, results from a large database analysis showed.

“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”

Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.

In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.

When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.

Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.

“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”

Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”

Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.

“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”

The researchers reported having no financial disclosures.

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

The number of adverse events involving vascular necrosis and vision changes following injection of dermal fillers increased from 2014 to 2020, results from a large database analysis showed.

“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”

Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.

In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.

When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.

Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.

“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”

Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”

Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.

“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”

The researchers reported having no financial disclosures.

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

The number of adverse events involving vascular necrosis and vision changes following injection of dermal fillers increased from 2014 to 2020, results from a large database analysis showed.

“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”

Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.

In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.

When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.

Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.

“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”

Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”

Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.

“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”

The researchers reported having no financial disclosures.

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

Microneedling is a safe and effective adjuvant to topical therapies for melasma, with optimal results typically seen at 12 weeks, results from a combined systematic review and meta-analysis suggest.

“Microneedling has a similar efficacy to other drug delivery methods, such as CO₂ laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”

For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.

Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.

Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”

A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO₂ laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.

In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.

A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.

The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.

Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”

In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.

Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”

The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”

Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.

[email protected]

Microneedling is a safe and effective adjuvant to topical therapies for melasma, with optimal results typically seen at 12 weeks, results from a combined systematic review and meta-analysis suggest.

“Microneedling has a similar efficacy to other drug delivery methods, such as CO₂ laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”

For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.

Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.

Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”

A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO₂ laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.

In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.

A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.

The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.

Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”

In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.

Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”

The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”

Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.

[email protected]

Microneedling is a safe and effective adjuvant to topical therapies for melasma, with optimal results typically seen at 12 weeks, results from a combined systematic review and meta-analysis suggest.

“Microneedling has a similar efficacy to other drug delivery methods, such as CO₂ laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”

For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.

Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.

Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”

A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO₂ laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.

In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.

A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.

The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.

Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”

In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.

Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”

The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”

Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.

[email protected]

Will my child outgrow the eczema?

That is perhaps the No. 1 atopic dermatitis–related question that Lawrence F. Eichenfield, MD, fields from parents in his role as chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego.

The answer “is pretty tricky,” he said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We used to say, ‘yeah, your kid will probably outgrow the disease,’ but we now have good data that show there are variable courses.”

Using data from the birth study cohort known as the Avon Longitudinal Study of Parents and Children, researchers in the United Kingdom investigated the existence of different longitudinal phenotypes of AD among 9,894 children. They found that 58% of the children in the cohort were unaffected or had transient AD, while 12.9% had early-onset/early-resolving AD. The remaining AD phenotypes consisted of 7%-8% patients each (early-onset persistent, early-onset late-resolving, mid-onset resolving, and late-onset resolving).

“There have been several studies that looked at the natural course of AD,” said Dr. Eichenfield, distinguished professor of dermatology and pediatrics at the University of California, San Diego. “A cohort study from Thailand showed that 50% of patients with childhood AD lost their AD diagnosis about 5 years into it, while there was an increase in allergic rhino-conjunctivitis and asthma, similar to what’s been seen in atopic march studies,” he noted.

A separate group of investigators analyzed records from The Health Improvement Network in the UK to determine the prevalence of AD among more than 8 million patients seen in primary care between 1994 and 2013. They found that the cumulative lifetime prevalence of atopic eczema was 9.9% and the highest rates of active disease were among children and older adults. “The takeaway was markedly inconsistent in terms of whether AD went away over time or increased over time, so it’s really not especially helpful prevalence data,” Dr. Eichenfield said. “Overall, you have a high prevalence in the first years of life, it decreases, and it may increase again when people are 60 years and older. Whether that’s truly AD or xerotic eczema isn’t known in this data set.”

A separate meta-analysis of 17 studies reported that 26% of adults with AD said they had adult-onset disease, which is characterized by more atopy, more foot dermatitis, and less flexural involvement.

Dr. Eichenfield tells parents, “there’s a really good chance (depending on disease severity) that 60% to 70% of children will outgrow their eczema or most of it,” he said. “If you ask me when, I won’t tell you. The important thing is to treat it to minimize its impact. We want minimal rash, minimal itch, and minimal sleep disturbance. Sometimes I say, ‘that might improve the chance of the eczema getting better over time.’ ”

Following are four other common questions parents and patients ask him:

Can we figure out the allergies causing the eczema? “This is probably one of the most unnerving questions I get asked,” he said. “It’s a loaded question. My answer is that allergies are intertwined with AD. Searching for the secret allergy causing the atopic dermatitis is rarely successful.” Sensitization is much more common with AD, he added, meaning specific IgE testing, whether it be blood testing or skin prick testing. “The more severe your eczema is, the more chance you’ll have of real food allergy,” he said. “About 15% of milder eczema patients will have at least one food allergy, but when you get to the more moderate to severe cases, about 40% will have a true food allergy.”

Food reactions may not cause eczema, though. Food reactions can cause urticaria, angioedema, eczematous dermatitis, allergic contact dermatitis, contact urticaria, and respiratory findings. According to National Institutes of Health guidelines for food allergy, skin prick tests and serum IgE tests are recommended to assist in identification of foods that may be provoking IgE-mediated food reactions, but are not diagnostic of food allergy.

“There’s a huge literature showing that there’s a lot of food allergy testing that’s just not helpful,” he said. In one study, 89% of food challenges administered in patients who were listed as being allergic based on skin prick tests or serum IgE tests did not have a true food allergy.

“Empiric elimination diets aren’t especially useful. However, we occasionally see children who do have AD exacerbated by food allergies in the first year of life,” he said. NIH guidelines suggest that children younger than 5 years of age with moderate to severe AD be considered for food allergy evaluation for milk, egg, peanut, wheat, and soy, if at least one of the following conditions is met: the child has persistent AD in spite of optimized management and topical therapy, and/or the child has a reliable history of an immediate reaction after ingestion of a specific food.

“We do know that there are high rates of comorbid allergic processes, besides food allergy, associated with atopic dermatitis, including allergic rhinitis and asthma both in children and adults,” Dr. Eichenfield said. “I do discuss allergy triggers and their importance in the life of the individual, though not necessarily as factors in AD. There are a variety of environmental allergens and/or environmental triggers that can significantly impact AD. Recently, we have seen studies discussing air pollution and wildfires as exacerbators of AD.”

How should I bathe and moisturize? There are no standard guidelines for the frequency, type, or duration of bathing in patients with AD, he said, though in more severe disease, frequent bathing can be helpful along with standard anti-inflammatory topical medicines. “I keep my general recommendations vague,” Dr. Eichenfield said. “I do explain that we don’t want to use harsh soaps; we want to be gentle in our washing. I usually recommend daily to every other day bathing. It’s important to pat the skin dry and then apply a moisturizer. Applying a moisturizer 2-3 minutes after bathing is important and limited significant cleanser use can be helpful.”

Moisturizers and emollients are a standard of care in U.S. guidelines published in 2013 and 2014, and international guidelines, and are steroid-sparing and useful for both prevention and maintenance. “I tell parents and patients that there is no reason to avoid bathing because of AD as long as you moisturize after,” he said.

Do I have to use topical [name of drug]? “I try to explain that there is skin barrier dysfunction that stimulates the inflammatory milieu, and that inflammation in the skin or blood in AD negatively impacts skin barrier function,” Dr. Eichenfield said. “I explain that if inflammation doesn’t get better with good skin care, moisturizers, and avoidance of triggers, we need anti-inflammatory medication. Then we discuss what the options are, the significant variation in strengths of topical corticosteroids, and topical nonsteroid options.”

When he counsels parents and patients on the use of topical corticosteroids, he tells them that cortisone is a naturally-occurring metabolite, and that “we can work together to let you know how much medicine to use, and how a safe amount is a powerful tool to fix the eczema.” He often says that topical steroids “are like hammers. We have tiny hammers, like over-the-counter hydrocortisone, and sledgehammers like clobetasol. We also have ‘screwdrivers’ and ‘pliers’ with nonsteroidal topical calcineurin and PDE-4 inhibitors, which are especially useful for maintenance therapy. Topical ruxolitinib is a new medicine that we may use for patients as well. The label includes discussion of side effects from oral JAK inhibitors as well as from the drug development program, so it takes some time to talk through.”

Is it time for a stronger systemic medicine? Any conversation about this topic should support the concept that the AD is multifactorial. “We have the rash of eczema,” he said. “We have the itch. We have impact on sleep disturbance. We have the comorbidities. We have other physical changes, which can happen with bacterial infections and other immune system or cardiovascular changes. We have the impact on quality of life and impact on school and work. When we recognize that if patients have significant enough disease that it is not getting better with topicals and is having a negative impact on their lives, we can move our discussion to systemic therapy.”

When counseling patients about systemic therapy, Dr. Eichenfield will conduct a body surface area assessment and document how bad the itch is. “But I’m not just recording the information; I’m bringing it out in the room,” he said. “I’ll do a BSA assessment and say, for example, ‘oh, you have 32% of your body involved with eczema.’ I ask about sleep disturbance, to get the answer ‘out in the room.’ ” He also asks questions such as: “When was the last time your skin was last totally clear? Are there activities that you or your family don’t do because of your eczema, or that you’re living your life around it? Is there anxiety or depression?” Documenting both the impact on quality of life and the severity of disease “makes it easier to discuss systemic therapy,” Dr. Eichenfield said. “Meanwhile, as the provider, I am trying to figure out if the patient should ‘go into the topical therapy bucket’ or into the ‘systemic therapy bucket.’ ”

Counseling about systemic therapy includes shared decision-making regarding the choice of biologics versus oral JAK inhibitors versus traditional systemic agent or phototherapy. Factors to consider in the decision making include patient age, sex, severity, comorbidities, prior therapy, risk aversion, duration, medication access, and desired efficacy. “Evolving therapies can change the conversation, the questions, and the outcomes, but the overarching desired outcome is long-term disease control, minimal eczematous rash, minimal pruritus, and minimal sleep disturbance,” he said.

Dr. Eichenfield disclosed that he has served as a consultant to or investigator for AbbVie; Almirall; Arcutis; Arena; Asana; Termagant; Dermira; Forte Biosciences; Galderma Laboratories; Glenmark/Chinos; Incyte; Kyowa Kirin; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Otsuka; Pfizer; Freestone; Regeneron, and Sanofi Genzyme.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

Will my child outgrow the eczema?

That is perhaps the No. 1 atopic dermatitis–related question that Lawrence F. Eichenfield, MD, fields from parents in his role as chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego.

The answer “is pretty tricky,” he said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We used to say, ‘yeah, your kid will probably outgrow the disease,’ but we now have good data that show there are variable courses.”

Using data from the birth study cohort known as the Avon Longitudinal Study of Parents and Children, researchers in the United Kingdom investigated the existence of different longitudinal phenotypes of AD among 9,894 children. They found that 58% of the children in the cohort were unaffected or had transient AD, while 12.9% had early-onset/early-resolving AD. The remaining AD phenotypes consisted of 7%-8% patients each (early-onset persistent, early-onset late-resolving, mid-onset resolving, and late-onset resolving).

“There have been several studies that looked at the natural course of AD,” said Dr. Eichenfield, distinguished professor of dermatology and pediatrics at the University of California, San Diego. “A cohort study from Thailand showed that 50% of patients with childhood AD lost their AD diagnosis about 5 years into it, while there was an increase in allergic rhino-conjunctivitis and asthma, similar to what’s been seen in atopic march studies,” he noted.

A separate group of investigators analyzed records from The Health Improvement Network in the UK to determine the prevalence of AD among more than 8 million patients seen in primary care between 1994 and 2013. They found that the cumulative lifetime prevalence of atopic eczema was 9.9% and the highest rates of active disease were among children and older adults. “The takeaway was markedly inconsistent in terms of whether AD went away over time or increased over time, so it’s really not especially helpful prevalence data,” Dr. Eichenfield said. “Overall, you have a high prevalence in the first years of life, it decreases, and it may increase again when people are 60 years and older. Whether that’s truly AD or xerotic eczema isn’t known in this data set.”

A separate meta-analysis of 17 studies reported that 26% of adults with AD said they had adult-onset disease, which is characterized by more atopy, more foot dermatitis, and less flexural involvement.

Dr. Eichenfield tells parents, “there’s a really good chance (depending on disease severity) that 60% to 70% of children will outgrow their eczema or most of it,” he said. “If you ask me when, I won’t tell you. The important thing is to treat it to minimize its impact. We want minimal rash, minimal itch, and minimal sleep disturbance. Sometimes I say, ‘that might improve the chance of the eczema getting better over time.’ ”

Following are four other common questions parents and patients ask him:

Can we figure out the allergies causing the eczema? “This is probably one of the most unnerving questions I get asked,” he said. “It’s a loaded question. My answer is that allergies are intertwined with AD. Searching for the secret allergy causing the atopic dermatitis is rarely successful.” Sensitization is much more common with AD, he added, meaning specific IgE testing, whether it be blood testing or skin prick testing. “The more severe your eczema is, the more chance you’ll have of real food allergy,” he said. “About 15% of milder eczema patients will have at least one food allergy, but when you get to the more moderate to severe cases, about 40% will have a true food allergy.”

Food reactions may not cause eczema, though. Food reactions can cause urticaria, angioedema, eczematous dermatitis, allergic contact dermatitis, contact urticaria, and respiratory findings. According to National Institutes of Health guidelines for food allergy, skin prick tests and serum IgE tests are recommended to assist in identification of foods that may be provoking IgE-mediated food reactions, but are not diagnostic of food allergy.

“There’s a huge literature showing that there’s a lot of food allergy testing that’s just not helpful,” he said. In one study, 89% of food challenges administered in patients who were listed as being allergic based on skin prick tests or serum IgE tests did not have a true food allergy.

“Empiric elimination diets aren’t especially useful. However, we occasionally see children who do have AD exacerbated by food allergies in the first year of life,” he said. NIH guidelines suggest that children younger than 5 years of age with moderate to severe AD be considered for food allergy evaluation for milk, egg, peanut, wheat, and soy, if at least one of the following conditions is met: the child has persistent AD in spite of optimized management and topical therapy, and/or the child has a reliable history of an immediate reaction after ingestion of a specific food.

“We do know that there are high rates of comorbid allergic processes, besides food allergy, associated with atopic dermatitis, including allergic rhinitis and asthma both in children and adults,” Dr. Eichenfield said. “I do discuss allergy triggers and their importance in the life of the individual, though not necessarily as factors in AD. There are a variety of environmental allergens and/or environmental triggers that can significantly impact AD. Recently, we have seen studies discussing air pollution and wildfires as exacerbators of AD.”

How should I bathe and moisturize? There are no standard guidelines for the frequency, type, or duration of bathing in patients with AD, he said, though in more severe disease, frequent bathing can be helpful along with standard anti-inflammatory topical medicines. “I keep my general recommendations vague,” Dr. Eichenfield said. “I do explain that we don’t want to use harsh soaps; we want to be gentle in our washing. I usually recommend daily to every other day bathing. It’s important to pat the skin dry and then apply a moisturizer. Applying a moisturizer 2-3 minutes after bathing is important and limited significant cleanser use can be helpful.”

Moisturizers and emollients are a standard of care in U.S. guidelines published in 2013 and 2014, and international guidelines, and are steroid-sparing and useful for both prevention and maintenance. “I tell parents and patients that there is no reason to avoid bathing because of AD as long as you moisturize after,” he said.

Do I have to use topical [name of drug]? “I try to explain that there is skin barrier dysfunction that stimulates the inflammatory milieu, and that inflammation in the skin or blood in AD negatively impacts skin barrier function,” Dr. Eichenfield said. “I explain that if inflammation doesn’t get better with good skin care, moisturizers, and avoidance of triggers, we need anti-inflammatory medication. Then we discuss what the options are, the significant variation in strengths of topical corticosteroids, and topical nonsteroid options.”

When he counsels parents and patients on the use of topical corticosteroids, he tells them that cortisone is a naturally-occurring metabolite, and that “we can work together to let you know how much medicine to use, and how a safe amount is a powerful tool to fix the eczema.” He often says that topical steroids “are like hammers. We have tiny hammers, like over-the-counter hydrocortisone, and sledgehammers like clobetasol. We also have ‘screwdrivers’ and ‘pliers’ with nonsteroidal topical calcineurin and PDE-4 inhibitors, which are especially useful for maintenance therapy. Topical ruxolitinib is a new medicine that we may use for patients as well. The label includes discussion of side effects from oral JAK inhibitors as well as from the drug development program, so it takes some time to talk through.”

Is it time for a stronger systemic medicine? Any conversation about this topic should support the concept that the AD is multifactorial. “We have the rash of eczema,” he said. “We have the itch. We have impact on sleep disturbance. We have the comorbidities. We have other physical changes, which can happen with bacterial infections and other immune system or cardiovascular changes. We have the impact on quality of life and impact on school and work. When we recognize that if patients have significant enough disease that it is not getting better with topicals and is having a negative impact on their lives, we can move our discussion to systemic therapy.”

When counseling patients about systemic therapy, Dr. Eichenfield will conduct a body surface area assessment and document how bad the itch is. “But I’m not just recording the information; I’m bringing it out in the room,” he said. “I’ll do a BSA assessment and say, for example, ‘oh, you have 32% of your body involved with eczema.’ I ask about sleep disturbance, to get the answer ‘out in the room.’ ” He also asks questions such as: “When was the last time your skin was last totally clear? Are there activities that you or your family don’t do because of your eczema, or that you’re living your life around it? Is there anxiety or depression?” Documenting both the impact on quality of life and the severity of disease “makes it easier to discuss systemic therapy,” Dr. Eichenfield said. “Meanwhile, as the provider, I am trying to figure out if the patient should ‘go into the topical therapy bucket’ or into the ‘systemic therapy bucket.’ ”

Counseling about systemic therapy includes shared decision-making regarding the choice of biologics versus oral JAK inhibitors versus traditional systemic agent or phototherapy. Factors to consider in the decision making include patient age, sex, severity, comorbidities, prior therapy, risk aversion, duration, medication access, and desired efficacy. “Evolving therapies can change the conversation, the questions, and the outcomes, but the overarching desired outcome is long-term disease control, minimal eczematous rash, minimal pruritus, and minimal sleep disturbance,” he said.

Dr. Eichenfield disclosed that he has served as a consultant to or investigator for AbbVie; Almirall; Arcutis; Arena; Asana; Termagant; Dermira; Forte Biosciences; Galderma Laboratories; Glenmark/Chinos; Incyte; Kyowa Kirin; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Otsuka; Pfizer; Freestone; Regeneron, and Sanofi Genzyme.

MedscapeLive and this news organization are owned by the same parent company.

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Will my child outgrow the eczema?

That is perhaps the No. 1 atopic dermatitis–related question that Lawrence F. Eichenfield, MD, fields from parents in his role as chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego.

The answer “is pretty tricky,” he said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We used to say, ‘yeah, your kid will probably outgrow the disease,’ but we now have good data that show there are variable courses.”

Using data from the birth study cohort known as the Avon Longitudinal Study of Parents and Children, researchers in the United Kingdom investigated the existence of different longitudinal phenotypes of AD among 9,894 children. They found that 58% of the children in the cohort were unaffected or had transient AD, while 12.9% had early-onset/early-resolving AD. The remaining AD phenotypes consisted of 7%-8% patients each (early-onset persistent, early-onset late-resolving, mid-onset resolving, and late-onset resolving).

“There have been several studies that looked at the natural course of AD,” said Dr. Eichenfield, distinguished professor of dermatology and pediatrics at the University of California, San Diego. “A cohort study from Thailand showed that 50% of patients with childhood AD lost their AD diagnosis about 5 years into it, while there was an increase in allergic rhino-conjunctivitis and asthma, similar to what’s been seen in atopic march studies,” he noted.

A separate group of investigators analyzed records from The Health Improvement Network in the UK to determine the prevalence of AD among more than 8 million patients seen in primary care between 1994 and 2013. They found that the cumulative lifetime prevalence of atopic eczema was 9.9% and the highest rates of active disease were among children and older adults. “The takeaway was markedly inconsistent in terms of whether AD went away over time or increased over time, so it’s really not especially helpful prevalence data,” Dr. Eichenfield said. “Overall, you have a high prevalence in the first years of life, it decreases, and it may increase again when people are 60 years and older. Whether that’s truly AD or xerotic eczema isn’t known in this data set.”

A separate meta-analysis of 17 studies reported that 26% of adults with AD said they had adult-onset disease, which is characterized by more atopy, more foot dermatitis, and less flexural involvement.

Dr. Eichenfield tells parents, “there’s a really good chance (depending on disease severity) that 60% to 70% of children will outgrow their eczema or most of it,” he said. “If you ask me when, I won’t tell you. The important thing is to treat it to minimize its impact. We want minimal rash, minimal itch, and minimal sleep disturbance. Sometimes I say, ‘that might improve the chance of the eczema getting better over time.’ ”

Following are four other common questions parents and patients ask him:

Can we figure out the allergies causing the eczema? “This is probably one of the most unnerving questions I get asked,” he said. “It’s a loaded question. My answer is that allergies are intertwined with AD. Searching for the secret allergy causing the atopic dermatitis is rarely successful.” Sensitization is much more common with AD, he added, meaning specific IgE testing, whether it be blood testing or skin prick testing. “The more severe your eczema is, the more chance you’ll have of real food allergy,” he said. “About 15% of milder eczema patients will have at least one food allergy, but when you get to the more moderate to severe cases, about 40% will have a true food allergy.”

Food reactions may not cause eczema, though. Food reactions can cause urticaria, angioedema, eczematous dermatitis, allergic contact dermatitis, contact urticaria, and respiratory findings. According to National Institutes of Health guidelines for food allergy, skin prick tests and serum IgE tests are recommended to assist in identification of foods that may be provoking IgE-mediated food reactions, but are not diagnostic of food allergy.

“There’s a huge literature showing that there’s a lot of food allergy testing that’s just not helpful,” he said. In one study, 89% of food challenges administered in patients who were listed as being allergic based on skin prick tests or serum IgE tests did not have a true food allergy.

“Empiric elimination diets aren’t especially useful. However, we occasionally see children who do have AD exacerbated by food allergies in the first year of life,” he said. NIH guidelines suggest that children younger than 5 years of age with moderate to severe AD be considered for food allergy evaluation for milk, egg, peanut, wheat, and soy, if at least one of the following conditions is met: the child has persistent AD in spite of optimized management and topical therapy, and/or the child has a reliable history of an immediate reaction after ingestion of a specific food.

“We do know that there are high rates of comorbid allergic processes, besides food allergy, associated with atopic dermatitis, including allergic rhinitis and asthma both in children and adults,” Dr. Eichenfield said. “I do discuss allergy triggers and their importance in the life of the individual, though not necessarily as factors in AD. There are a variety of environmental allergens and/or environmental triggers that can significantly impact AD. Recently, we have seen studies discussing air pollution and wildfires as exacerbators of AD.”

How should I bathe and moisturize? There are no standard guidelines for the frequency, type, or duration of bathing in patients with AD, he said, though in more severe disease, frequent bathing can be helpful along with standard anti-inflammatory topical medicines. “I keep my general recommendations vague,” Dr. Eichenfield said. “I do explain that we don’t want to use harsh soaps; we want to be gentle in our washing. I usually recommend daily to every other day bathing. It’s important to pat the skin dry and then apply a moisturizer. Applying a moisturizer 2-3 minutes after bathing is important and limited significant cleanser use can be helpful.”

Moisturizers and emollients are a standard of care in U.S. guidelines published in 2013 and 2014, and international guidelines, and are steroid-sparing and useful for both prevention and maintenance. “I tell parents and patients that there is no reason to avoid bathing because of AD as long as you moisturize after,” he said.

Do I have to use topical [name of drug]? “I try to explain that there is skin barrier dysfunction that stimulates the inflammatory milieu, and that inflammation in the skin or blood in AD negatively impacts skin barrier function,” Dr. Eichenfield said. “I explain that if inflammation doesn’t get better with good skin care, moisturizers, and avoidance of triggers, we need anti-inflammatory medication. Then we discuss what the options are, the significant variation in strengths of topical corticosteroids, and topical nonsteroid options.”

When he counsels parents and patients on the use of topical corticosteroids, he tells them that cortisone is a naturally-occurring metabolite, and that “we can work together to let you know how much medicine to use, and how a safe amount is a powerful tool to fix the eczema.” He often says that topical steroids “are like hammers. We have tiny hammers, like over-the-counter hydrocortisone, and sledgehammers like clobetasol. We also have ‘screwdrivers’ and ‘pliers’ with nonsteroidal topical calcineurin and PDE-4 inhibitors, which are especially useful for maintenance therapy. Topical ruxolitinib is a new medicine that we may use for patients as well. The label includes discussion of side effects from oral JAK inhibitors as well as from the drug development program, so it takes some time to talk through.”

Is it time for a stronger systemic medicine? Any conversation about this topic should support the concept that the AD is multifactorial. “We have the rash of eczema,” he said. “We have the itch. We have impact on sleep disturbance. We have the comorbidities. We have other physical changes, which can happen with bacterial infections and other immune system or cardiovascular changes. We have the impact on quality of life and impact on school and work. When we recognize that if patients have significant enough disease that it is not getting better with topicals and is having a negative impact on their lives, we can move our discussion to systemic therapy.”

When counseling patients about systemic therapy, Dr. Eichenfield will conduct a body surface area assessment and document how bad the itch is. “But I’m not just recording the information; I’m bringing it out in the room,” he said. “I’ll do a BSA assessment and say, for example, ‘oh, you have 32% of your body involved with eczema.’ I ask about sleep disturbance, to get the answer ‘out in the room.’ ” He also asks questions such as: “When was the last time your skin was last totally clear? Are there activities that you or your family don’t do because of your eczema, or that you’re living your life around it? Is there anxiety or depression?” Documenting both the impact on quality of life and the severity of disease “makes it easier to discuss systemic therapy,” Dr. Eichenfield said. “Meanwhile, as the provider, I am trying to figure out if the patient should ‘go into the topical therapy bucket’ or into the ‘systemic therapy bucket.’ ”

Counseling about systemic therapy includes shared decision-making regarding the choice of biologics versus oral JAK inhibitors versus traditional systemic agent or phototherapy. Factors to consider in the decision making include patient age, sex, severity, comorbidities, prior therapy, risk aversion, duration, medication access, and desired efficacy. “Evolving therapies can change the conversation, the questions, and the outcomes, but the overarching desired outcome is long-term disease control, minimal eczematous rash, minimal pruritus, and minimal sleep disturbance,” he said.

Dr. Eichenfield disclosed that he has served as a consultant to or investigator for AbbVie; Almirall; Arcutis; Arena; Asana; Termagant; Dermira; Forte Biosciences; Galderma Laboratories; Glenmark/Chinos; Incyte; Kyowa Kirin; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Otsuka; Pfizer; Freestone; Regeneron, and Sanofi Genzyme.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

According to Iltefat H. Hamzavi, MD, the initial clinical assessment for hidradenitis suppurativa (HS) includes posing two questions to patients: Have you had outbreaks of boils during the past 6 months? Where and how many boils have you had?

If the answer to the first question is “yes” and the patient has had at least two boils in intertriginous areas, that person likely has HS, a disease of apocrine gland–bearing skin that occurs in 1%-4% of people, has a higher prevalence in Blacks, compared with Whites, and affects more women than men by a 3:1 ratio.

“Current treatments offer limited efficacy, and the disease is chronic and recurrent,” Dr. Hamzavi, of the department of dermatology at Henry Ford Health System, Detroit, said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “You often see nodules, abscesses, fistulae, and scarring,” with all different skin types represented in the majority of patients.

Typical HS lesions appear as inflamed nodules, abscesses, draining fistulas, and scars as well as double-headed “tombstone” comedones, he said. These are typically located in the axilla, intermammary folds, in the groin, around the genitals, and on the buttocks. Atypical lesions can also occur – often folliculitis and open comedones in locations such as the waistline, the neck, and behind the ears.

The differential diagnosis is wide-ranging and includes bacterial abscess, inflamed cyst, folliculitis, pilonidal sinus, cellulitis, and cutaneous Crohn’s disease. Pain may appear out of proportion to the physical examination.

“There is a window of opportunity to treat HS, early in the disease process,” Dr. Hamzavi said. “There are no definitive cures for HS but lots of treatment options.”

According to clinical management guidelines published by the United States and Canadian Hidradenitis Suppurativa Foundations, options for moderate stage disease include antibiotics, antiandrogens, retinoids, immunosuppression/biologics, deroofing, and limited excision with primary closure. Options for severe disease include radical excision.

“HS requires a mix of medical and procedural treatments based on the number of nodules,” Dr. Hamzavi said. “Because the disease has so many different phases, there is no perfect outcome measure yet, but progress is being made.”

In 2018, an effort to develop a consensus core outcome set of domains regarding what to measure in clinical trials of HS was launched; it is known as the Hidradenitis Suppurativa Core Outcomes Set International Collaboration (HISTORIC). It was formed as a collaboration between the International Dermatology Outcome Measures (IDEOM) initiative, the Cochrane Skin Group – Core Outcome Set Initiative (CSG-COUSIN), and Zealand University Hospital, Roskilde.

HISTORIC is now part of the partnership with CSG-COUSIN and this work continues onward. Core domains as defined by the group include pain, physical signs, HS-specific quality of life, global assessment, and disease progression. “For now, we are mostly using some objective measures and some patient-reported outcomes with the addition of ultrasound in some centers,” Dr. Hamzavi said.

He underscored the importance of lifestyle modifications in patients with HS, including smoking cessation and weight loss, as well as decreasing pressure/friction on lesions, using warm compresses, and modifying diet. “This generally involves a low-inflammatory diet: Low carbohydrate, low dairy, and higher protein content, but there is much work needed to understand the role of diet in HS,” he said.

“This is a tough disease, but the compassion you offer these patients will be paid back to you a thousandfold. They tend to be some of the happiest and most appreciative patients you will ever have in your practice.”

Dr. Hamzavi disclosed that he has been a clinical investigator for Clinuvel, Incyte, Pfizer, Avita, and Ferndale Labs. He has also been a consultant for Pfizer, AbbVie, Novartis, and Aclaris, and has received a grant from Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

According to Iltefat H. Hamzavi, MD, the initial clinical assessment for hidradenitis suppurativa (HS) includes posing two questions to patients: Have you had outbreaks of boils during the past 6 months? Where and how many boils have you had?

If the answer to the first question is “yes” and the patient has had at least two boils in intertriginous areas, that person likely has HS, a disease of apocrine gland–bearing skin that occurs in 1%-4% of people, has a higher prevalence in Blacks, compared with Whites, and affects more women than men by a 3:1 ratio.

“Current treatments offer limited efficacy, and the disease is chronic and recurrent,” Dr. Hamzavi, of the department of dermatology at Henry Ford Health System, Detroit, said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “You often see nodules, abscesses, fistulae, and scarring,” with all different skin types represented in the majority of patients.

Typical HS lesions appear as inflamed nodules, abscesses, draining fistulas, and scars as well as double-headed “tombstone” comedones, he said. These are typically located in the axilla, intermammary folds, in the groin, around the genitals, and on the buttocks. Atypical lesions can also occur – often folliculitis and open comedones in locations such as the waistline, the neck, and behind the ears.

The differential diagnosis is wide-ranging and includes bacterial abscess, inflamed cyst, folliculitis, pilonidal sinus, cellulitis, and cutaneous Crohn’s disease. Pain may appear out of proportion to the physical examination.

“There is a window of opportunity to treat HS, early in the disease process,” Dr. Hamzavi said. “There are no definitive cures for HS but lots of treatment options.”

According to clinical management guidelines published by the United States and Canadian Hidradenitis Suppurativa Foundations, options for moderate stage disease include antibiotics, antiandrogens, retinoids, immunosuppression/biologics, deroofing, and limited excision with primary closure. Options for severe disease include radical excision.

“HS requires a mix of medical and procedural treatments based on the number of nodules,” Dr. Hamzavi said. “Because the disease has so many different phases, there is no perfect outcome measure yet, but progress is being made.”

In 2018, an effort to develop a consensus core outcome set of domains regarding what to measure in clinical trials of HS was launched; it is known as the Hidradenitis Suppurativa Core Outcomes Set International Collaboration (HISTORIC). It was formed as a collaboration between the International Dermatology Outcome Measures (IDEOM) initiative, the Cochrane Skin Group – Core Outcome Set Initiative (CSG-COUSIN), and Zealand University Hospital, Roskilde.

HISTORIC is now part of the partnership with CSG-COUSIN and this work continues onward. Core domains as defined by the group include pain, physical signs, HS-specific quality of life, global assessment, and disease progression. “For now, we are mostly using some objective measures and some patient-reported outcomes with the addition of ultrasound in some centers,” Dr. Hamzavi said.

He underscored the importance of lifestyle modifications in patients with HS, including smoking cessation and weight loss, as well as decreasing pressure/friction on lesions, using warm compresses, and modifying diet. “This generally involves a low-inflammatory diet: Low carbohydrate, low dairy, and higher protein content, but there is much work needed to understand the role of diet in HS,” he said.

“This is a tough disease, but the compassion you offer these patients will be paid back to you a thousandfold. They tend to be some of the happiest and most appreciative patients you will ever have in your practice.”

Dr. Hamzavi disclosed that he has been a clinical investigator for Clinuvel, Incyte, Pfizer, Avita, and Ferndale Labs. He has also been a consultant for Pfizer, AbbVie, Novartis, and Aclaris, and has received a grant from Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

According to Iltefat H. Hamzavi, MD, the initial clinical assessment for hidradenitis suppurativa (HS) includes posing two questions to patients: Have you had outbreaks of boils during the past 6 months? Where and how many boils have you had?

If the answer to the first question is “yes” and the patient has had at least two boils in intertriginous areas, that person likely has HS, a disease of apocrine gland–bearing skin that occurs in 1%-4% of people, has a higher prevalence in Blacks, compared with Whites, and affects more women than men by a 3:1 ratio.

“Current treatments offer limited efficacy, and the disease is chronic and recurrent,” Dr. Hamzavi, of the department of dermatology at Henry Ford Health System, Detroit, said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “You often see nodules, abscesses, fistulae, and scarring,” with all different skin types represented in the majority of patients.

Typical HS lesions appear as inflamed nodules, abscesses, draining fistulas, and scars as well as double-headed “tombstone” comedones, he said. These are typically located in the axilla, intermammary folds, in the groin, around the genitals, and on the buttocks. Atypical lesions can also occur – often folliculitis and open comedones in locations such as the waistline, the neck, and behind the ears.

The differential diagnosis is wide-ranging and includes bacterial abscess, inflamed cyst, folliculitis, pilonidal sinus, cellulitis, and cutaneous Crohn’s disease. Pain may appear out of proportion to the physical examination.

“There is a window of opportunity to treat HS, early in the disease process,” Dr. Hamzavi said. “There are no definitive cures for HS but lots of treatment options.”

According to clinical management guidelines published by the United States and Canadian Hidradenitis Suppurativa Foundations, options for moderate stage disease include antibiotics, antiandrogens, retinoids, immunosuppression/biologics, deroofing, and limited excision with primary closure. Options for severe disease include radical excision.

“HS requires a mix of medical and procedural treatments based on the number of nodules,” Dr. Hamzavi said. “Because the disease has so many different phases, there is no perfect outcome measure yet, but progress is being made.”

In 2018, an effort to develop a consensus core outcome set of domains regarding what to measure in clinical trials of HS was launched; it is known as the Hidradenitis Suppurativa Core Outcomes Set International Collaboration (HISTORIC). It was formed as a collaboration between the International Dermatology Outcome Measures (IDEOM) initiative, the Cochrane Skin Group – Core Outcome Set Initiative (CSG-COUSIN), and Zealand University Hospital, Roskilde.

HISTORIC is now part of the partnership with CSG-COUSIN and this work continues onward. Core domains as defined by the group include pain, physical signs, HS-specific quality of life, global assessment, and disease progression. “For now, we are mostly using some objective measures and some patient-reported outcomes with the addition of ultrasound in some centers,” Dr. Hamzavi said.

He underscored the importance of lifestyle modifications in patients with HS, including smoking cessation and weight loss, as well as decreasing pressure/friction on lesions, using warm compresses, and modifying diet. “This generally involves a low-inflammatory diet: Low carbohydrate, low dairy, and higher protein content, but there is much work needed to understand the role of diet in HS,” he said.

“This is a tough disease, but the compassion you offer these patients will be paid back to you a thousandfold. They tend to be some of the happiest and most appreciative patients you will ever have in your practice.”

Dr. Hamzavi disclosed that he has been a clinical investigator for Clinuvel, Incyte, Pfizer, Avita, and Ferndale Labs. He has also been a consultant for Pfizer, AbbVie, Novartis, and Aclaris, and has received a grant from Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]