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Moderate-to-severe atopic dermatitis: Long-term safety and effectiveness of tralokinumab
Key clinical point: Tralokinumab was well tolerated and maintained long-term disease control for up to 2 years in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: In the safety analysis set (n = 1174), the exposure-adjusted incidence rate of adverse events (AE) was 237.8 events/100 patient-years of exposure and 71.9% of participants reported ≥1 AE of mostly mild or moderate severity. In the efficacy analysis set (n = 345), 82.5% of patients treated with tralokinumab for 2 years maintained ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from the 2-year post hoc interim analysis of the ongoing, 5-year open-label extension trial, ECZTEND, including adult participants with moderate-to-severe AD from previous parent trials who received 300 mg tralokinumab every 2 weeks with or without topical corticosteroids.
Disclosures: The ECZTEND trial was sponsored by LEO Pharma A/S. Three authors declared being employees of LEO Pharma, and other authors reported ties with several sources, including LEO Pharma.
Source: Blauvelt A et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 (Jul 18). Doi: 10.1016/j.jaad.2022.07.019
Key clinical point: Tralokinumab was well tolerated and maintained long-term disease control for up to 2 years in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: In the safety analysis set (n = 1174), the exposure-adjusted incidence rate of adverse events (AE) was 237.8 events/100 patient-years of exposure and 71.9% of participants reported ≥1 AE of mostly mild or moderate severity. In the efficacy analysis set (n = 345), 82.5% of patients treated with tralokinumab for 2 years maintained ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from the 2-year post hoc interim analysis of the ongoing, 5-year open-label extension trial, ECZTEND, including adult participants with moderate-to-severe AD from previous parent trials who received 300 mg tralokinumab every 2 weeks with or without topical corticosteroids.
Disclosures: The ECZTEND trial was sponsored by LEO Pharma A/S. Three authors declared being employees of LEO Pharma, and other authors reported ties with several sources, including LEO Pharma.
Source: Blauvelt A et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 (Jul 18). Doi: 10.1016/j.jaad.2022.07.019
Key clinical point: Tralokinumab was well tolerated and maintained long-term disease control for up to 2 years in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: In the safety analysis set (n = 1174), the exposure-adjusted incidence rate of adverse events (AE) was 237.8 events/100 patient-years of exposure and 71.9% of participants reported ≥1 AE of mostly mild or moderate severity. In the efficacy analysis set (n = 345), 82.5% of patients treated with tralokinumab for 2 years maintained ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from the 2-year post hoc interim analysis of the ongoing, 5-year open-label extension trial, ECZTEND, including adult participants with moderate-to-severe AD from previous parent trials who received 300 mg tralokinumab every 2 weeks with or without topical corticosteroids.
Disclosures: The ECZTEND trial was sponsored by LEO Pharma A/S. Three authors declared being employees of LEO Pharma, and other authors reported ties with several sources, including LEO Pharma.
Source: Blauvelt A et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 (Jul 18). Doi: 10.1016/j.jaad.2022.07.019
Abrocitinib more promising than dupilumab in moderate-to-severe atopic dermatitis
Key clinical point: Abrocitinib was more effective than dupilumab in inducing early itch reduction and controlling disease severity in adults with moderate-to-severe atopic dermatitis (AD) on background topical therapy.
Major finding: A significantly higher proportion of patients in the abrocitinib vs dupilumab group achieved ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 (48% vs 26%; P < .0001) and ≥90% improvement in the Eczema Area and Severity Index at week 4 (29% vs 15%; P < .0001). Treatment-emergent adverse events were more frequent in the abrocitinib vs dupilumab group (74% vs 65%).
Study details: Findings are from a phase 3 trial including 727 adults with moderate-to-severe AD who showed inadequate response to medicated topical therapy and were randomly assigned to receive oral abrocitinib or subcutaneous dupilumab for 26 weeks.
Disclosures: This study was funded by Pfizer. Seven authors declared being current or former employees or shareholders of Pfizer or Pfizer Pharma. The other authors reported ties with several sources.
Source: Reich K et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282 (Jul 23). Doi: 10.1016/S0140-6736(22)01199-0
Key clinical point: Abrocitinib was more effective than dupilumab in inducing early itch reduction and controlling disease severity in adults with moderate-to-severe atopic dermatitis (AD) on background topical therapy.
Major finding: A significantly higher proportion of patients in the abrocitinib vs dupilumab group achieved ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 (48% vs 26%; P < .0001) and ≥90% improvement in the Eczema Area and Severity Index at week 4 (29% vs 15%; P < .0001). Treatment-emergent adverse events were more frequent in the abrocitinib vs dupilumab group (74% vs 65%).
Study details: Findings are from a phase 3 trial including 727 adults with moderate-to-severe AD who showed inadequate response to medicated topical therapy and were randomly assigned to receive oral abrocitinib or subcutaneous dupilumab for 26 weeks.
Disclosures: This study was funded by Pfizer. Seven authors declared being current or former employees or shareholders of Pfizer or Pfizer Pharma. The other authors reported ties with several sources.
Source: Reich K et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282 (Jul 23). Doi: 10.1016/S0140-6736(22)01199-0
Key clinical point: Abrocitinib was more effective than dupilumab in inducing early itch reduction and controlling disease severity in adults with moderate-to-severe atopic dermatitis (AD) on background topical therapy.
Major finding: A significantly higher proportion of patients in the abrocitinib vs dupilumab group achieved ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 (48% vs 26%; P < .0001) and ≥90% improvement in the Eczema Area and Severity Index at week 4 (29% vs 15%; P < .0001). Treatment-emergent adverse events were more frequent in the abrocitinib vs dupilumab group (74% vs 65%).
Study details: Findings are from a phase 3 trial including 727 adults with moderate-to-severe AD who showed inadequate response to medicated topical therapy and were randomly assigned to receive oral abrocitinib or subcutaneous dupilumab for 26 weeks.
Disclosures: This study was funded by Pfizer. Seven authors declared being current or former employees or shareholders of Pfizer or Pfizer Pharma. The other authors reported ties with several sources.
Source: Reich K et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282 (Jul 23). Doi: 10.1016/S0140-6736(22)01199-0
Intralesional Human Papillomavirus Vaccine Therapy for Recalcitrant Plantar Wart Triggers Gout Flare
To the Editor:
There is increasing evidence supporting the use of the human papillomavirus (HPV) vaccine in the treatment of recalcitrant common warts.1 We describe a potential complication associated with HPV vaccine treatment of warts that would be of interest to dermatologists.
A 70-year-old woman presented with a plantar wart measuring 6 mm in diameter at the base of the right hallux of 5 years’ duration. Prior failed therapies for wart removal included multiple paring treatments, cryotherapy, and topical salicylic acid 40% to 60%. The patient had no notable comorbidities; no history of gout; and no known risk factors for gout, such as hypertension, renal insufficiency, diuretic use, obesity, family history, or trauma.
Prior reports cited effective treatment of recalcitrant warts with recombinant HPV vaccines, both intralesionally1 and intramuscularly.2,3 With this knowledge in mind, we administered an intralesional injection with 0.1-mL recombinant HPV 9-valent vaccine to the patient’s plantar wart. Gradual erythema and swelling of the right first metatarsophalangeal joint developed over the next 7 days. Synovial fluid analysis demonstrated negatively birefringent crystals. The patient commenced treatment with colchicine and indomethacin and improved over the next 5 days. The wart resolved 3 months later and required no further treatment.
Prophylactic quadrivalent HPV vaccines have shown efficacy in treating HPV-associated precancerous and cancerous lesions.4 Case reports have suggested that HPV vaccines may be an effective treatment option for recalcitrant warts,1-3,5 especially in cases that do not respond to traditional treatment. It is possible that the mechanism of wart treatment involves overlap in the antigenic epitopes of the HPV types targeted by the vaccine vs the HPV types responsible for causing warts.2 Papillomaviruslike particles, based on the L1 capsid protein, can induce a specific CD8+ activation signal, leading to a vaccine-induced cytotoxic T-cell response that targets the wart cells with HPV-like antigens.6 The HPV vaccine contains aluminium, which has been shown to activate NLRP3 inflammasome,5 which may trigger gout by increasing monosodium urate crystal deposition via IL-1β production.7 This may lead to an increased risk for gout flares, an adverse effect of the HPV vaccine. This finding is supported by other studies of aluminium-containing vaccines that show an association with gout.6 It is noted that these vaccines are mostly delivered intramuscularly or subcutaneously in some cases.
We reported a case of gout triggered by intralesional HPV vaccine treatment of warts. It is unclear whether the gout was induced by the vaccine itself or whether it was due to trauma caused by the intralesional injection near the joint space. Based on our findings, we recommend that patients receiving intralesional injections for wart treatment be advised of this potential adverse effect, especially if they have risk factors for gout or have a history of gout.
- Nofal A, Marei A, Ibrahim AM et al. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020;82:94-100.
- Venugopal SS, Murrell DF. Recalcitrant cutaneous warts treated with recombinant quadrivalent human papillomavirus vaccine (types 6, 11, 16, and 18) in a developmentally delayed, 31-year-old white man. Arch Dermatol. 2010;146:475-477.
- Daniel BS, Murrell DF. Complete resolution of chronic multiple verruca vulgaris treated with quadrivalent human papillomavirus vaccine. JAMA Dermatol. 2013;149:370-372.
- Kenter GG, Welters MJ, Valentijn AR, et al. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia. N Engl J Med. 2009;361:1838-1847.
- Eisenbarth SC, Colegio OR, O’Connor W, et al. Crucial role for the NALP3 inflammasome in the immunostimulatory properties of aluminium adjuvants. Nature. 2008;453:1122-1166.
- Bellone S, El-Sahwi K, Cocco E, et al. Human papillomavirus type 16 (HPV-16) virus-like particle L1-specific CD8+ cytotoxic T lymphocytes (CTLs) are equally effective as E7-specific CD8+ CTLs in killing autologous HPV-16-positive tumor cells in cervical cancer patients: implications for L1 dendritic cell-based therapeutic vaccines. J Virol. 2009;83:6779-6789.
- Yokose C, McCormick N, Chen C, et al. Risk of gout flares after vaccination: a prospective case cross-over study. Ann Rheum Dis. 2019;78:1601-1604.
To the Editor:
There is increasing evidence supporting the use of the human papillomavirus (HPV) vaccine in the treatment of recalcitrant common warts.1 We describe a potential complication associated with HPV vaccine treatment of warts that would be of interest to dermatologists.
A 70-year-old woman presented with a plantar wart measuring 6 mm in diameter at the base of the right hallux of 5 years’ duration. Prior failed therapies for wart removal included multiple paring treatments, cryotherapy, and topical salicylic acid 40% to 60%. The patient had no notable comorbidities; no history of gout; and no known risk factors for gout, such as hypertension, renal insufficiency, diuretic use, obesity, family history, or trauma.
Prior reports cited effective treatment of recalcitrant warts with recombinant HPV vaccines, both intralesionally1 and intramuscularly.2,3 With this knowledge in mind, we administered an intralesional injection with 0.1-mL recombinant HPV 9-valent vaccine to the patient’s plantar wart. Gradual erythema and swelling of the right first metatarsophalangeal joint developed over the next 7 days. Synovial fluid analysis demonstrated negatively birefringent crystals. The patient commenced treatment with colchicine and indomethacin and improved over the next 5 days. The wart resolved 3 months later and required no further treatment.
Prophylactic quadrivalent HPV vaccines have shown efficacy in treating HPV-associated precancerous and cancerous lesions.4 Case reports have suggested that HPV vaccines may be an effective treatment option for recalcitrant warts,1-3,5 especially in cases that do not respond to traditional treatment. It is possible that the mechanism of wart treatment involves overlap in the antigenic epitopes of the HPV types targeted by the vaccine vs the HPV types responsible for causing warts.2 Papillomaviruslike particles, based on the L1 capsid protein, can induce a specific CD8+ activation signal, leading to a vaccine-induced cytotoxic T-cell response that targets the wart cells with HPV-like antigens.6 The HPV vaccine contains aluminium, which has been shown to activate NLRP3 inflammasome,5 which may trigger gout by increasing monosodium urate crystal deposition via IL-1β production.7 This may lead to an increased risk for gout flares, an adverse effect of the HPV vaccine. This finding is supported by other studies of aluminium-containing vaccines that show an association with gout.6 It is noted that these vaccines are mostly delivered intramuscularly or subcutaneously in some cases.
We reported a case of gout triggered by intralesional HPV vaccine treatment of warts. It is unclear whether the gout was induced by the vaccine itself or whether it was due to trauma caused by the intralesional injection near the joint space. Based on our findings, we recommend that patients receiving intralesional injections for wart treatment be advised of this potential adverse effect, especially if they have risk factors for gout or have a history of gout.
To the Editor:
There is increasing evidence supporting the use of the human papillomavirus (HPV) vaccine in the treatment of recalcitrant common warts.1 We describe a potential complication associated with HPV vaccine treatment of warts that would be of interest to dermatologists.
A 70-year-old woman presented with a plantar wart measuring 6 mm in diameter at the base of the right hallux of 5 years’ duration. Prior failed therapies for wart removal included multiple paring treatments, cryotherapy, and topical salicylic acid 40% to 60%. The patient had no notable comorbidities; no history of gout; and no known risk factors for gout, such as hypertension, renal insufficiency, diuretic use, obesity, family history, or trauma.
Prior reports cited effective treatment of recalcitrant warts with recombinant HPV vaccines, both intralesionally1 and intramuscularly.2,3 With this knowledge in mind, we administered an intralesional injection with 0.1-mL recombinant HPV 9-valent vaccine to the patient’s plantar wart. Gradual erythema and swelling of the right first metatarsophalangeal joint developed over the next 7 days. Synovial fluid analysis demonstrated negatively birefringent crystals. The patient commenced treatment with colchicine and indomethacin and improved over the next 5 days. The wart resolved 3 months later and required no further treatment.
Prophylactic quadrivalent HPV vaccines have shown efficacy in treating HPV-associated precancerous and cancerous lesions.4 Case reports have suggested that HPV vaccines may be an effective treatment option for recalcitrant warts,1-3,5 especially in cases that do not respond to traditional treatment. It is possible that the mechanism of wart treatment involves overlap in the antigenic epitopes of the HPV types targeted by the vaccine vs the HPV types responsible for causing warts.2 Papillomaviruslike particles, based on the L1 capsid protein, can induce a specific CD8+ activation signal, leading to a vaccine-induced cytotoxic T-cell response that targets the wart cells with HPV-like antigens.6 The HPV vaccine contains aluminium, which has been shown to activate NLRP3 inflammasome,5 which may trigger gout by increasing monosodium urate crystal deposition via IL-1β production.7 This may lead to an increased risk for gout flares, an adverse effect of the HPV vaccine. This finding is supported by other studies of aluminium-containing vaccines that show an association with gout.6 It is noted that these vaccines are mostly delivered intramuscularly or subcutaneously in some cases.
We reported a case of gout triggered by intralesional HPV vaccine treatment of warts. It is unclear whether the gout was induced by the vaccine itself or whether it was due to trauma caused by the intralesional injection near the joint space. Based on our findings, we recommend that patients receiving intralesional injections for wart treatment be advised of this potential adverse effect, especially if they have risk factors for gout or have a history of gout.
- Nofal A, Marei A, Ibrahim AM et al. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020;82:94-100.
- Venugopal SS, Murrell DF. Recalcitrant cutaneous warts treated with recombinant quadrivalent human papillomavirus vaccine (types 6, 11, 16, and 18) in a developmentally delayed, 31-year-old white man. Arch Dermatol. 2010;146:475-477.
- Daniel BS, Murrell DF. Complete resolution of chronic multiple verruca vulgaris treated with quadrivalent human papillomavirus vaccine. JAMA Dermatol. 2013;149:370-372.
- Kenter GG, Welters MJ, Valentijn AR, et al. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia. N Engl J Med. 2009;361:1838-1847.
- Eisenbarth SC, Colegio OR, O’Connor W, et al. Crucial role for the NALP3 inflammasome in the immunostimulatory properties of aluminium adjuvants. Nature. 2008;453:1122-1166.
- Bellone S, El-Sahwi K, Cocco E, et al. Human papillomavirus type 16 (HPV-16) virus-like particle L1-specific CD8+ cytotoxic T lymphocytes (CTLs) are equally effective as E7-specific CD8+ CTLs in killing autologous HPV-16-positive tumor cells in cervical cancer patients: implications for L1 dendritic cell-based therapeutic vaccines. J Virol. 2009;83:6779-6789.
- Yokose C, McCormick N, Chen C, et al. Risk of gout flares after vaccination: a prospective case cross-over study. Ann Rheum Dis. 2019;78:1601-1604.
- Nofal A, Marei A, Ibrahim AM et al. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020;82:94-100.
- Venugopal SS, Murrell DF. Recalcitrant cutaneous warts treated with recombinant quadrivalent human papillomavirus vaccine (types 6, 11, 16, and 18) in a developmentally delayed, 31-year-old white man. Arch Dermatol. 2010;146:475-477.
- Daniel BS, Murrell DF. Complete resolution of chronic multiple verruca vulgaris treated with quadrivalent human papillomavirus vaccine. JAMA Dermatol. 2013;149:370-372.
- Kenter GG, Welters MJ, Valentijn AR, et al. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia. N Engl J Med. 2009;361:1838-1847.
- Eisenbarth SC, Colegio OR, O’Connor W, et al. Crucial role for the NALP3 inflammasome in the immunostimulatory properties of aluminium adjuvants. Nature. 2008;453:1122-1166.
- Bellone S, El-Sahwi K, Cocco E, et al. Human papillomavirus type 16 (HPV-16) virus-like particle L1-specific CD8+ cytotoxic T lymphocytes (CTLs) are equally effective as E7-specific CD8+ CTLs in killing autologous HPV-16-positive tumor cells in cervical cancer patients: implications for L1 dendritic cell-based therapeutic vaccines. J Virol. 2009;83:6779-6789.
- Yokose C, McCormick N, Chen C, et al. Risk of gout flares after vaccination: a prospective case cross-over study. Ann Rheum Dis. 2019;78:1601-1604.
Practice Points
- Human papillomavirus (HPV) vaccines are increasingly used for recalcitrant warts.
- We describe an unreported adverse effect of gout flare following HPV vaccine treatment of plantar wart.
Vitamin D supplements during pregnancy may protect infants from atopic eczema
according to results of a clinical trial.
“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.
“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.
The study also was published in the British Journal of Dermatology.
Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.
The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.
Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.
The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.
The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.
Infants appear to be protected up to 1 year of age
Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.
After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).
The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.
The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.
At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).
The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.
Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.
“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.
The results are mixed, though, she noted.
“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.
“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.
“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”
The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to results of a clinical trial.
“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.
“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.
The study also was published in the British Journal of Dermatology.
Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.
The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.
Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.
The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.
The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.
Infants appear to be protected up to 1 year of age
Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.
After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).
The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.
The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.
At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).
The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.
Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.
“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.
The results are mixed, though, she noted.
“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.
“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.
“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”
The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to results of a clinical trial.
“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.
“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.
The study also was published in the British Journal of Dermatology.
Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.
The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.
Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.
The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.
The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.
Infants appear to be protected up to 1 year of age
Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.
After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).
The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.
The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.
At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).
The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.
Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.
“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.
The results are mixed, though, she noted.
“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.
“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.
“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”
The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM SID 2022
Commentary: Conditions Associated with AD, August 2022
Atopic dermatitis (AD) is truly a fascinating disease! Despite the thousands of scientific manuscripts published on AD, more novel insights keep coming about the clinical manifestations and risk factors of this condition. This month is no exception.
In a cross-sectional observational study of 502 Finnish patients with AD, Salava and colleagues found that severe AD was associated with older age, male sex, early age of disease onset, higher body mass index, history of smoking, concomitant asthma, palmar hyperlinearity, hand dermatitis, history of contact allergy, and history of elevated immunoglobulin E levels. Some of these findings are correlated with each other. For example, palmar hyperlinearity was previously found to be a sign associated with early-onset AD in conjunction with Filaggrin loss-of-function mutations and atopic comorbidities.1,2 The association of AD with increased body mass index is consistent with previous studies that found associations of AD with overweight and obesity.3 In some instances, more severe AD may precede or lead to the association, eg, asthma and hand dermatitis. These results highlight the heterogeneity and complexity of AD, especially in moderate-to-severe disease.
AD is also associated with heterogeneous triggers. In clinical practice, we commonly see patients who consider food a potential trigger for AD. To better understand the role of food-triggered AD, Li and colleagues performed a retrospective study of 372 pediatric patients with AD. They found that more than half of the children with mild, moderate, and severe AD had an immunoglobulin E–mediated food allergy. Nevertheless, food-triggered AD occurred in only 3% of patients with AD. These results are doubly important because they indicate that clinicians should address food allergies to holistically improve the health of patients with AD. On the other hand, food is rarely a reproducible trigger of AD and appropriate treatment should generally not be withheld in favor of testing for food triggers of AD.
That said, it is important to address cutaneous and extra-cutaneous infections that occur in patients with AD to prevent worsening of AD and serious sequelae of infection. Indeed, Han and colleagues examined data from the Korean National Health Insurance Service, a nationwide population-based registry including 70,205 patients with AD and an unspecified number of control patients without AD. They found that AD was associated with significantly higher odds of molluscum contagiosum, impetigo, chickenpox, otitis media, eczema herpeticum, viral warts, and viral conjunctivitis. These results are consistent with previous studies from my research group showing higher rates of these and other infections.4-8 Anecdotally, I have seen all of these occur commonly in patients with AD, and in many instances these conditions worsen the underlying AD, eg, impetigo and eczema herpeticum.
The above-mentioned studies highlight the heterogeneity and complexity of AD, especially moderate-to-severe disease. Elsawi and colleagues conducted a survey-based study of 1065 adults with AD and found that moderate-to-severe AD was associated with increased patient burden, increased time spent managing AD symptoms, and comorbid depression. In addition, time spent managing AD symptoms was in and of itself a predictor of increased patient burden. These results underscore the many unmet needs that remain in the management of AD, with substantial patient burden from inadequate treatment as well as the inherent burden from the treatments themselves.
Additional References
1. Meng L, Wang L, Tang H, et al. Filaggrin gene mutation c.3321delA is associated with various clinical features of atopic dermatitis in the Chinese Han population. PloS One. 2014;9:e98235. Doi: 10.1371/journal.pone.0098235
2. Weidinger S, Illig T, Baurecht H, et al. Loss-of-function variations within the filaggrin gene predispose for atopic dermatitis with allergic sensitizations. J Allergy Clin Immunol. 2006;118:214-219. Doi: 10.1016/j.jaci.2006.05.004
3. Zhang A, Silverberg JI. Association of atopic dermatitis with being overweight and obese: a systematic review and metaanalysis. J Am Acad Dermatol. 2015;72:606-616.e4. Doi: 10.1016/j.jaad.2014.12.013
4. Narla S, Silverberg JI. Association between childhood atopic dermatitis and cutaneous, extracutaneous and systemic infections. Br J Dermatol. 2018;178:1467-1468. Doi: 10.1111/bjd.16482
5. Narla S, Silverberg JI. Association between atopic dermatitis and serious cutaneous, multiorgan and systemic infections in US adults. Anb Allergy Asthma Immunol. 2018;120:66-72e11. Doi: 10.1016/j.anai.2017.10.019
6. Ren Z, Silverberg JI. Association of atopic dermatitis with bacterial, fungal, viral, and sexually transmitted skin infections. Dermatitis. 2020;31:157-164. Doi: 10.1097/DER.0000000000000526
7. Serrano L, Patel KR, Silverberg JI. Association between atopic dermatitis and extracutaneous bacterial and mycobacterial infections: a systematic review and meta-analysis. J Acad Am Acad Dermatol. 2019;80:904-912. Doi: 10.1016/j.jaad.2018.11.028
8. Silverberg JI, Silverberg NB. Childhood atopic dermatitis and warts are associated with increased risk of infection: a US population-based study. J Allergy Clin Immunol. 2014;133:1041-1047. Doi: 10.1016/j.jaci.2013.08.012
Atopic dermatitis (AD) is truly a fascinating disease! Despite the thousands of scientific manuscripts published on AD, more novel insights keep coming about the clinical manifestations and risk factors of this condition. This month is no exception.
In a cross-sectional observational study of 502 Finnish patients with AD, Salava and colleagues found that severe AD was associated with older age, male sex, early age of disease onset, higher body mass index, history of smoking, concomitant asthma, palmar hyperlinearity, hand dermatitis, history of contact allergy, and history of elevated immunoglobulin E levels. Some of these findings are correlated with each other. For example, palmar hyperlinearity was previously found to be a sign associated with early-onset AD in conjunction with Filaggrin loss-of-function mutations and atopic comorbidities.1,2 The association of AD with increased body mass index is consistent with previous studies that found associations of AD with overweight and obesity.3 In some instances, more severe AD may precede or lead to the association, eg, asthma and hand dermatitis. These results highlight the heterogeneity and complexity of AD, especially in moderate-to-severe disease.
AD is also associated with heterogeneous triggers. In clinical practice, we commonly see patients who consider food a potential trigger for AD. To better understand the role of food-triggered AD, Li and colleagues performed a retrospective study of 372 pediatric patients with AD. They found that more than half of the children with mild, moderate, and severe AD had an immunoglobulin E–mediated food allergy. Nevertheless, food-triggered AD occurred in only 3% of patients with AD. These results are doubly important because they indicate that clinicians should address food allergies to holistically improve the health of patients with AD. On the other hand, food is rarely a reproducible trigger of AD and appropriate treatment should generally not be withheld in favor of testing for food triggers of AD.
That said, it is important to address cutaneous and extra-cutaneous infections that occur in patients with AD to prevent worsening of AD and serious sequelae of infection. Indeed, Han and colleagues examined data from the Korean National Health Insurance Service, a nationwide population-based registry including 70,205 patients with AD and an unspecified number of control patients without AD. They found that AD was associated with significantly higher odds of molluscum contagiosum, impetigo, chickenpox, otitis media, eczema herpeticum, viral warts, and viral conjunctivitis. These results are consistent with previous studies from my research group showing higher rates of these and other infections.4-8 Anecdotally, I have seen all of these occur commonly in patients with AD, and in many instances these conditions worsen the underlying AD, eg, impetigo and eczema herpeticum.
The above-mentioned studies highlight the heterogeneity and complexity of AD, especially moderate-to-severe disease. Elsawi and colleagues conducted a survey-based study of 1065 adults with AD and found that moderate-to-severe AD was associated with increased patient burden, increased time spent managing AD symptoms, and comorbid depression. In addition, time spent managing AD symptoms was in and of itself a predictor of increased patient burden. These results underscore the many unmet needs that remain in the management of AD, with substantial patient burden from inadequate treatment as well as the inherent burden from the treatments themselves.
Additional References
1. Meng L, Wang L, Tang H, et al. Filaggrin gene mutation c.3321delA is associated with various clinical features of atopic dermatitis in the Chinese Han population. PloS One. 2014;9:e98235. Doi: 10.1371/journal.pone.0098235
2. Weidinger S, Illig T, Baurecht H, et al. Loss-of-function variations within the filaggrin gene predispose for atopic dermatitis with allergic sensitizations. J Allergy Clin Immunol. 2006;118:214-219. Doi: 10.1016/j.jaci.2006.05.004
3. Zhang A, Silverberg JI. Association of atopic dermatitis with being overweight and obese: a systematic review and metaanalysis. J Am Acad Dermatol. 2015;72:606-616.e4. Doi: 10.1016/j.jaad.2014.12.013
4. Narla S, Silverberg JI. Association between childhood atopic dermatitis and cutaneous, extracutaneous and systemic infections. Br J Dermatol. 2018;178:1467-1468. Doi: 10.1111/bjd.16482
5. Narla S, Silverberg JI. Association between atopic dermatitis and serious cutaneous, multiorgan and systemic infections in US adults. Anb Allergy Asthma Immunol. 2018;120:66-72e11. Doi: 10.1016/j.anai.2017.10.019
6. Ren Z, Silverberg JI. Association of atopic dermatitis with bacterial, fungal, viral, and sexually transmitted skin infections. Dermatitis. 2020;31:157-164. Doi: 10.1097/DER.0000000000000526
7. Serrano L, Patel KR, Silverberg JI. Association between atopic dermatitis and extracutaneous bacterial and mycobacterial infections: a systematic review and meta-analysis. J Acad Am Acad Dermatol. 2019;80:904-912. Doi: 10.1016/j.jaad.2018.11.028
8. Silverberg JI, Silverberg NB. Childhood atopic dermatitis and warts are associated with increased risk of infection: a US population-based study. J Allergy Clin Immunol. 2014;133:1041-1047. Doi: 10.1016/j.jaci.2013.08.012
Atopic dermatitis (AD) is truly a fascinating disease! Despite the thousands of scientific manuscripts published on AD, more novel insights keep coming about the clinical manifestations and risk factors of this condition. This month is no exception.
In a cross-sectional observational study of 502 Finnish patients with AD, Salava and colleagues found that severe AD was associated with older age, male sex, early age of disease onset, higher body mass index, history of smoking, concomitant asthma, palmar hyperlinearity, hand dermatitis, history of contact allergy, and history of elevated immunoglobulin E levels. Some of these findings are correlated with each other. For example, palmar hyperlinearity was previously found to be a sign associated with early-onset AD in conjunction with Filaggrin loss-of-function mutations and atopic comorbidities.1,2 The association of AD with increased body mass index is consistent with previous studies that found associations of AD with overweight and obesity.3 In some instances, more severe AD may precede or lead to the association, eg, asthma and hand dermatitis. These results highlight the heterogeneity and complexity of AD, especially in moderate-to-severe disease.
AD is also associated with heterogeneous triggers. In clinical practice, we commonly see patients who consider food a potential trigger for AD. To better understand the role of food-triggered AD, Li and colleagues performed a retrospective study of 372 pediatric patients with AD. They found that more than half of the children with mild, moderate, and severe AD had an immunoglobulin E–mediated food allergy. Nevertheless, food-triggered AD occurred in only 3% of patients with AD. These results are doubly important because they indicate that clinicians should address food allergies to holistically improve the health of patients with AD. On the other hand, food is rarely a reproducible trigger of AD and appropriate treatment should generally not be withheld in favor of testing for food triggers of AD.
That said, it is important to address cutaneous and extra-cutaneous infections that occur in patients with AD to prevent worsening of AD and serious sequelae of infection. Indeed, Han and colleagues examined data from the Korean National Health Insurance Service, a nationwide population-based registry including 70,205 patients with AD and an unspecified number of control patients without AD. They found that AD was associated with significantly higher odds of molluscum contagiosum, impetigo, chickenpox, otitis media, eczema herpeticum, viral warts, and viral conjunctivitis. These results are consistent with previous studies from my research group showing higher rates of these and other infections.4-8 Anecdotally, I have seen all of these occur commonly in patients with AD, and in many instances these conditions worsen the underlying AD, eg, impetigo and eczema herpeticum.
The above-mentioned studies highlight the heterogeneity and complexity of AD, especially moderate-to-severe disease. Elsawi and colleagues conducted a survey-based study of 1065 adults with AD and found that moderate-to-severe AD was associated with increased patient burden, increased time spent managing AD symptoms, and comorbid depression. In addition, time spent managing AD symptoms was in and of itself a predictor of increased patient burden. These results underscore the many unmet needs that remain in the management of AD, with substantial patient burden from inadequate treatment as well as the inherent burden from the treatments themselves.
Additional References
1. Meng L, Wang L, Tang H, et al. Filaggrin gene mutation c.3321delA is associated with various clinical features of atopic dermatitis in the Chinese Han population. PloS One. 2014;9:e98235. Doi: 10.1371/journal.pone.0098235
2. Weidinger S, Illig T, Baurecht H, et al. Loss-of-function variations within the filaggrin gene predispose for atopic dermatitis with allergic sensitizations. J Allergy Clin Immunol. 2006;118:214-219. Doi: 10.1016/j.jaci.2006.05.004
3. Zhang A, Silverberg JI. Association of atopic dermatitis with being overweight and obese: a systematic review and metaanalysis. J Am Acad Dermatol. 2015;72:606-616.e4. Doi: 10.1016/j.jaad.2014.12.013
4. Narla S, Silverberg JI. Association between childhood atopic dermatitis and cutaneous, extracutaneous and systemic infections. Br J Dermatol. 2018;178:1467-1468. Doi: 10.1111/bjd.16482
5. Narla S, Silverberg JI. Association between atopic dermatitis and serious cutaneous, multiorgan and systemic infections in US adults. Anb Allergy Asthma Immunol. 2018;120:66-72e11. Doi: 10.1016/j.anai.2017.10.019
6. Ren Z, Silverberg JI. Association of atopic dermatitis with bacterial, fungal, viral, and sexually transmitted skin infections. Dermatitis. 2020;31:157-164. Doi: 10.1097/DER.0000000000000526
7. Serrano L, Patel KR, Silverberg JI. Association between atopic dermatitis and extracutaneous bacterial and mycobacterial infections: a systematic review and meta-analysis. J Acad Am Acad Dermatol. 2019;80:904-912. Doi: 10.1016/j.jaad.2018.11.028
8. Silverberg JI, Silverberg NB. Childhood atopic dermatitis and warts are associated with increased risk of infection: a US population-based study. J Allergy Clin Immunol. 2014;133:1041-1047. Doi: 10.1016/j.jaci.2013.08.012
Topical ruxolitinib quickly relieves atopic dermatitis itch in Black patients
“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.
AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.
Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.
Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.
FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.
Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows:
- Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
- At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
- At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
- Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.
Ruxolitinib may be an alternative to systemic immunosuppressives
Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”
Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.
“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.
Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”
The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.
“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.
All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.
A version of this article first appeared on Medscape.com.
“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.
AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.
Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.
Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.
FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.
Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows:
- Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
- At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
- At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
- Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.
Ruxolitinib may be an alternative to systemic immunosuppressives
Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”
Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.
“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.
Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”
The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.
“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.
All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.
A version of this article first appeared on Medscape.com.
“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.
AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.
Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.
Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.
FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.
Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows:
- Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
- At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
- At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
- Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.
Ruxolitinib may be an alternative to systemic immunosuppressives
Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”
Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.
“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.
Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”
The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.
“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.
All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.
A version of this article first appeared on Medscape.com.
FROM SID 2022
Cultural humility required to optimize treatment of eczema patients with skin of color
INDIANAPOLIS – Treating atopic dermatitis (AD) in children and adolescents with skin of color requires an acumen that extends well beyond the skin, said Candrice R. Heath, MD, at the annual meeting of the Society for Pediatric Dermatology.
This involves the practice of cultural humility, which Dr. Heath defined as a commitment to learn about all aspects of patients to truly understand them, including their race, access to health care, and socioeconomic status.
“We can continue to prioritize learning about all different types of skin tones and hair types, but we really have to commit to advocating for what our patients deserve in every way,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said during her presentation at the meeting.
“That means advocating for kids to have access to better housing and for increasing health literacy programs in our hospitals, so that all our patients can understand what’s happening and how to navigate the health system,” she said. “It also means increasing diversity in our clinical trials by taking a few extra moments with the patient and family of color who might be eligible to participate in a clinical trial. We have work to do.”
To illustrate her points, she discussed the case of a 6-year-old Black patient, whose parents bring him into the clinic complaining about dark marks on the skin. The areas are itchy and the doctor figures, “this is a slam dunk; this is AD,” Dr. Heath said. “You talk about the diagnosis, and you give your treatment plan.
“But the issue is, in the parking lot when the patient’s family leaves, they feel like you didn’t help them at all,” she continued. “You didn’t understand what they came in for. They didn’t receive a treatment for what they came in for, because the initial complaint was dark marks on the skin, which is postinflammatory hyperpigmentation. We know that patients are distressed by this.”
As evidence, she cited a cross-sectional study that assessed the impact of hyperpigmentation and hyperchromia on quality of life in adults, published in the Journal of the American Academy of Dermatology. People who reported the highest levels of distress were women, those with postinflammatory hyperpigmentation, those with fewer formal years of education, and those who had higher out-of-pocket spending on skin-enhancing products.
“So, when you see hyperpigmentation in your AD patients of color, acknowledge it; say, ‘I see this pigmentation change,’ ” Dr. Heath advised. “Talk about how controlling the AD with a topical steroid or other treatment option can have a positive impact on that.”
However, she added that sometimes patients have steroid phobia, possibly because they believe the topical steroids are causing the pigmentation changes, “especially in cases of hypopigmentation, so I take the time to reassure patients so that they will not be fearful about using the medication.”
Parents of patients with skin of color who have AD may harbor other “invisible” concerns during office visits, she continued, including prior experiences with dermatologists that may not have been positive, difficulty accessing pediatric dermatologists, or a general mistrust of the health care system.
“All of that is going on in the room with your patients, particularly those with skin of color and those who feel marginalized,” said Dr. Heath, who is also a faculty scholar at Temple University medical school’s office of health equity, diversity and inclusion. “Of course, we can’t fix everything. But we can commit to approaching our visits with cultural humility.”
For patients with skin of color, she pointed out, other upstream effects impact AD care and outcomes, including well-documented socioeconomic factors.
“One of the equalizing factors is that we as pediatric dermatologists can think about increasing our education regarding skin of color,” Dr. Heath said.
For example, an analysis of data from the 2002 to 2012 National Inpatient Sample found that the main risk factors for inpatient hospitalization for AD were being non-White, having lowest-quartile household income, and having Medicaid or no insurance, researchers reported in 2018.
A separate multicenter study of 1,437 mother-child pairs with known AD found that non-Hispanic Black children and Hispanic children had greater odds of persistent AD than non-Hispanic White children, according to a 2019 study. Another large prospective cohort study published in 2019 found that AD prevalence and persistence is highest in U.S. urban children who are female or Black, and urban children with AD are more likely to have poor quality of life and asthma.
A few months after that study was published, researchers reported results from an analysis of data from the 2007-2008 National Survey of Children’s Health, which found that children who perceive the neighborhood they lived in as unsafe, unsupportive, or underdeveloped had a higher prevalence of AD and a higher severity of AD. The same year, a study of the social and economic risk factors for moderate to severe AD found that Black children were more likely to come from homes with a lower household income, lower parental education attainment, lack of home ownership, and live between two residences, and have exposure to smoke.
“Disease recognition is one thing, but we also want everyone to be aware of these other factors,” she said, “because some patients do need a little bit more care and help to be able to access the medications that they need and gain access to us.”
Follicular, nummular eczema
In her clinical experience, the most common clinical variants of AD in patients with skin of color is follicular eczema. “Examine the patient, apply your hand to the affected area, and you can feel the papules beneath your fingertips,” she advised.
“That’s what I teach my residents and medical students,” she said. “If you are looking for erythema to seal your diagnosis of AD, it may not happen. You may see more of a violaceous hue and sometimes you may not find it at all, depending on the patient’s skin tone. If I find an area of normal appearing skin and then look back at the area of active skin disease, I go back and forth until I’m able to train my eye to be able to see those violaceous and erythematous hues more easily.”
Nummular eczema can also be a challenge in AD patients with skin of color.
“I like to listen to buzz words,” Dr. Heath said. “If a parent says, ‘my child has been diagnosed with ringworm multiple times,’ I zoom in on that. We know that kids can get tinea corporis, but usually not multiple times. I ask about all the things that can be associated with AD, and often we do see these nummular plaques on the skin and do some education about that. I also talk to their pediatrician or send information to that person so that they can be aware that nummular eczema is a form of AD.”
She noted that AD of the scalp may be confused with tinea capitis, especially in young Black children with moderate to severe AD. In her experience, triamcinolone 0.1% ointment works well for AD of the scalp.
She concluded her presentation by noting that there is no easy solution to treating AD in young patients with skin of color. “It’s way more than just eczema. We can help people see AD in a different way. My goal is to see the value in challenging ourselves to understand the impact of what happens outside of the exam room on these patients.”
Dr. Heath disclosed that she has served as a consultant for several pharmaceutical companies, including Regeneron, Janssen, Arcutis, Johnson and Johnson, Cassiopea, and Lilly.
INDIANAPOLIS – Treating atopic dermatitis (AD) in children and adolescents with skin of color requires an acumen that extends well beyond the skin, said Candrice R. Heath, MD, at the annual meeting of the Society for Pediatric Dermatology.
This involves the practice of cultural humility, which Dr. Heath defined as a commitment to learn about all aspects of patients to truly understand them, including their race, access to health care, and socioeconomic status.
“We can continue to prioritize learning about all different types of skin tones and hair types, but we really have to commit to advocating for what our patients deserve in every way,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said during her presentation at the meeting.
“That means advocating for kids to have access to better housing and for increasing health literacy programs in our hospitals, so that all our patients can understand what’s happening and how to navigate the health system,” she said. “It also means increasing diversity in our clinical trials by taking a few extra moments with the patient and family of color who might be eligible to participate in a clinical trial. We have work to do.”
To illustrate her points, she discussed the case of a 6-year-old Black patient, whose parents bring him into the clinic complaining about dark marks on the skin. The areas are itchy and the doctor figures, “this is a slam dunk; this is AD,” Dr. Heath said. “You talk about the diagnosis, and you give your treatment plan.
“But the issue is, in the parking lot when the patient’s family leaves, they feel like you didn’t help them at all,” she continued. “You didn’t understand what they came in for. They didn’t receive a treatment for what they came in for, because the initial complaint was dark marks on the skin, which is postinflammatory hyperpigmentation. We know that patients are distressed by this.”
As evidence, she cited a cross-sectional study that assessed the impact of hyperpigmentation and hyperchromia on quality of life in adults, published in the Journal of the American Academy of Dermatology. People who reported the highest levels of distress were women, those with postinflammatory hyperpigmentation, those with fewer formal years of education, and those who had higher out-of-pocket spending on skin-enhancing products.
“So, when you see hyperpigmentation in your AD patients of color, acknowledge it; say, ‘I see this pigmentation change,’ ” Dr. Heath advised. “Talk about how controlling the AD with a topical steroid or other treatment option can have a positive impact on that.”
However, she added that sometimes patients have steroid phobia, possibly because they believe the topical steroids are causing the pigmentation changes, “especially in cases of hypopigmentation, so I take the time to reassure patients so that they will not be fearful about using the medication.”
Parents of patients with skin of color who have AD may harbor other “invisible” concerns during office visits, she continued, including prior experiences with dermatologists that may not have been positive, difficulty accessing pediatric dermatologists, or a general mistrust of the health care system.
“All of that is going on in the room with your patients, particularly those with skin of color and those who feel marginalized,” said Dr. Heath, who is also a faculty scholar at Temple University medical school’s office of health equity, diversity and inclusion. “Of course, we can’t fix everything. But we can commit to approaching our visits with cultural humility.”
For patients with skin of color, she pointed out, other upstream effects impact AD care and outcomes, including well-documented socioeconomic factors.
“One of the equalizing factors is that we as pediatric dermatologists can think about increasing our education regarding skin of color,” Dr. Heath said.
For example, an analysis of data from the 2002 to 2012 National Inpatient Sample found that the main risk factors for inpatient hospitalization for AD were being non-White, having lowest-quartile household income, and having Medicaid or no insurance, researchers reported in 2018.
A separate multicenter study of 1,437 mother-child pairs with known AD found that non-Hispanic Black children and Hispanic children had greater odds of persistent AD than non-Hispanic White children, according to a 2019 study. Another large prospective cohort study published in 2019 found that AD prevalence and persistence is highest in U.S. urban children who are female or Black, and urban children with AD are more likely to have poor quality of life and asthma.
A few months after that study was published, researchers reported results from an analysis of data from the 2007-2008 National Survey of Children’s Health, which found that children who perceive the neighborhood they lived in as unsafe, unsupportive, or underdeveloped had a higher prevalence of AD and a higher severity of AD. The same year, a study of the social and economic risk factors for moderate to severe AD found that Black children were more likely to come from homes with a lower household income, lower parental education attainment, lack of home ownership, and live between two residences, and have exposure to smoke.
“Disease recognition is one thing, but we also want everyone to be aware of these other factors,” she said, “because some patients do need a little bit more care and help to be able to access the medications that they need and gain access to us.”
Follicular, nummular eczema
In her clinical experience, the most common clinical variants of AD in patients with skin of color is follicular eczema. “Examine the patient, apply your hand to the affected area, and you can feel the papules beneath your fingertips,” she advised.
“That’s what I teach my residents and medical students,” she said. “If you are looking for erythema to seal your diagnosis of AD, it may not happen. You may see more of a violaceous hue and sometimes you may not find it at all, depending on the patient’s skin tone. If I find an area of normal appearing skin and then look back at the area of active skin disease, I go back and forth until I’m able to train my eye to be able to see those violaceous and erythematous hues more easily.”
Nummular eczema can also be a challenge in AD patients with skin of color.
“I like to listen to buzz words,” Dr. Heath said. “If a parent says, ‘my child has been diagnosed with ringworm multiple times,’ I zoom in on that. We know that kids can get tinea corporis, but usually not multiple times. I ask about all the things that can be associated with AD, and often we do see these nummular plaques on the skin and do some education about that. I also talk to their pediatrician or send information to that person so that they can be aware that nummular eczema is a form of AD.”
She noted that AD of the scalp may be confused with tinea capitis, especially in young Black children with moderate to severe AD. In her experience, triamcinolone 0.1% ointment works well for AD of the scalp.
She concluded her presentation by noting that there is no easy solution to treating AD in young patients with skin of color. “It’s way more than just eczema. We can help people see AD in a different way. My goal is to see the value in challenging ourselves to understand the impact of what happens outside of the exam room on these patients.”
Dr. Heath disclosed that she has served as a consultant for several pharmaceutical companies, including Regeneron, Janssen, Arcutis, Johnson and Johnson, Cassiopea, and Lilly.
INDIANAPOLIS – Treating atopic dermatitis (AD) in children and adolescents with skin of color requires an acumen that extends well beyond the skin, said Candrice R. Heath, MD, at the annual meeting of the Society for Pediatric Dermatology.
This involves the practice of cultural humility, which Dr. Heath defined as a commitment to learn about all aspects of patients to truly understand them, including their race, access to health care, and socioeconomic status.
“We can continue to prioritize learning about all different types of skin tones and hair types, but we really have to commit to advocating for what our patients deserve in every way,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said during her presentation at the meeting.
“That means advocating for kids to have access to better housing and for increasing health literacy programs in our hospitals, so that all our patients can understand what’s happening and how to navigate the health system,” she said. “It also means increasing diversity in our clinical trials by taking a few extra moments with the patient and family of color who might be eligible to participate in a clinical trial. We have work to do.”
To illustrate her points, she discussed the case of a 6-year-old Black patient, whose parents bring him into the clinic complaining about dark marks on the skin. The areas are itchy and the doctor figures, “this is a slam dunk; this is AD,” Dr. Heath said. “You talk about the diagnosis, and you give your treatment plan.
“But the issue is, in the parking lot when the patient’s family leaves, they feel like you didn’t help them at all,” she continued. “You didn’t understand what they came in for. They didn’t receive a treatment for what they came in for, because the initial complaint was dark marks on the skin, which is postinflammatory hyperpigmentation. We know that patients are distressed by this.”
As evidence, she cited a cross-sectional study that assessed the impact of hyperpigmentation and hyperchromia on quality of life in adults, published in the Journal of the American Academy of Dermatology. People who reported the highest levels of distress were women, those with postinflammatory hyperpigmentation, those with fewer formal years of education, and those who had higher out-of-pocket spending on skin-enhancing products.
“So, when you see hyperpigmentation in your AD patients of color, acknowledge it; say, ‘I see this pigmentation change,’ ” Dr. Heath advised. “Talk about how controlling the AD with a topical steroid or other treatment option can have a positive impact on that.”
However, she added that sometimes patients have steroid phobia, possibly because they believe the topical steroids are causing the pigmentation changes, “especially in cases of hypopigmentation, so I take the time to reassure patients so that they will not be fearful about using the medication.”
Parents of patients with skin of color who have AD may harbor other “invisible” concerns during office visits, she continued, including prior experiences with dermatologists that may not have been positive, difficulty accessing pediatric dermatologists, or a general mistrust of the health care system.
“All of that is going on in the room with your patients, particularly those with skin of color and those who feel marginalized,” said Dr. Heath, who is also a faculty scholar at Temple University medical school’s office of health equity, diversity and inclusion. “Of course, we can’t fix everything. But we can commit to approaching our visits with cultural humility.”
For patients with skin of color, she pointed out, other upstream effects impact AD care and outcomes, including well-documented socioeconomic factors.
“One of the equalizing factors is that we as pediatric dermatologists can think about increasing our education regarding skin of color,” Dr. Heath said.
For example, an analysis of data from the 2002 to 2012 National Inpatient Sample found that the main risk factors for inpatient hospitalization for AD were being non-White, having lowest-quartile household income, and having Medicaid or no insurance, researchers reported in 2018.
A separate multicenter study of 1,437 mother-child pairs with known AD found that non-Hispanic Black children and Hispanic children had greater odds of persistent AD than non-Hispanic White children, according to a 2019 study. Another large prospective cohort study published in 2019 found that AD prevalence and persistence is highest in U.S. urban children who are female or Black, and urban children with AD are more likely to have poor quality of life and asthma.
A few months after that study was published, researchers reported results from an analysis of data from the 2007-2008 National Survey of Children’s Health, which found that children who perceive the neighborhood they lived in as unsafe, unsupportive, or underdeveloped had a higher prevalence of AD and a higher severity of AD. The same year, a study of the social and economic risk factors for moderate to severe AD found that Black children were more likely to come from homes with a lower household income, lower parental education attainment, lack of home ownership, and live between two residences, and have exposure to smoke.
“Disease recognition is one thing, but we also want everyone to be aware of these other factors,” she said, “because some patients do need a little bit more care and help to be able to access the medications that they need and gain access to us.”
Follicular, nummular eczema
In her clinical experience, the most common clinical variants of AD in patients with skin of color is follicular eczema. “Examine the patient, apply your hand to the affected area, and you can feel the papules beneath your fingertips,” she advised.
“That’s what I teach my residents and medical students,” she said. “If you are looking for erythema to seal your diagnosis of AD, it may not happen. You may see more of a violaceous hue and sometimes you may not find it at all, depending on the patient’s skin tone. If I find an area of normal appearing skin and then look back at the area of active skin disease, I go back and forth until I’m able to train my eye to be able to see those violaceous and erythematous hues more easily.”
Nummular eczema can also be a challenge in AD patients with skin of color.
“I like to listen to buzz words,” Dr. Heath said. “If a parent says, ‘my child has been diagnosed with ringworm multiple times,’ I zoom in on that. We know that kids can get tinea corporis, but usually not multiple times. I ask about all the things that can be associated with AD, and often we do see these nummular plaques on the skin and do some education about that. I also talk to their pediatrician or send information to that person so that they can be aware that nummular eczema is a form of AD.”
She noted that AD of the scalp may be confused with tinea capitis, especially in young Black children with moderate to severe AD. In her experience, triamcinolone 0.1% ointment works well for AD of the scalp.
She concluded her presentation by noting that there is no easy solution to treating AD in young patients with skin of color. “It’s way more than just eczema. We can help people see AD in a different way. My goal is to see the value in challenging ourselves to understand the impact of what happens outside of the exam room on these patients.”
Dr. Heath disclosed that she has served as a consultant for several pharmaceutical companies, including Regeneron, Janssen, Arcutis, Johnson and Johnson, Cassiopea, and Lilly.
AT SPD 2022
Atopic dermatitis and infectious cutaneous disorders: What is the link?
Key clinical point: Risk for cutaneous infectious diseases is significantly higher in adults and children with atopic dermatitis (AD) than individuals without AD, with the risk for molluscum contagiosum being the highest.
Major finding: Patients with AD vs individuals without AD were at a significantly greater risk for molluscum contagiosum (adjusted odds ratio [aOR] 5.237), followed by impetigo (aOR 2.852), chickenpox (aOR 2.251), otitis media (aOR 2.243), eczema herpeticum (aOR 1.292), viral warts (aOR 1.105), and viral conjunctivitis (aOR 1.099; all P < .001) with molluscum contagiosum having the highest comorbidity (1.06%) and shortest onset duration (77.42 days).
Study details: Findings are from a nationwide population-based study including 70,205 patients with AD and individuals without AD.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Han J-H et al. Evaluation of atopic dermatitis and cutaneous infectious disorders using sequential pattern mining: A nationwide population-based cohort study. J Clin Med. 2022;11(12):3422 (Jun 14). Doi: 10.3390/jcm11123422
Key clinical point: Risk for cutaneous infectious diseases is significantly higher in adults and children with atopic dermatitis (AD) than individuals without AD, with the risk for molluscum contagiosum being the highest.
Major finding: Patients with AD vs individuals without AD were at a significantly greater risk for molluscum contagiosum (adjusted odds ratio [aOR] 5.237), followed by impetigo (aOR 2.852), chickenpox (aOR 2.251), otitis media (aOR 2.243), eczema herpeticum (aOR 1.292), viral warts (aOR 1.105), and viral conjunctivitis (aOR 1.099; all P < .001) with molluscum contagiosum having the highest comorbidity (1.06%) and shortest onset duration (77.42 days).
Study details: Findings are from a nationwide population-based study including 70,205 patients with AD and individuals without AD.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Han J-H et al. Evaluation of atopic dermatitis and cutaneous infectious disorders using sequential pattern mining: A nationwide population-based cohort study. J Clin Med. 2022;11(12):3422 (Jun 14). Doi: 10.3390/jcm11123422
Key clinical point: Risk for cutaneous infectious diseases is significantly higher in adults and children with atopic dermatitis (AD) than individuals without AD, with the risk for molluscum contagiosum being the highest.
Major finding: Patients with AD vs individuals without AD were at a significantly greater risk for molluscum contagiosum (adjusted odds ratio [aOR] 5.237), followed by impetigo (aOR 2.852), chickenpox (aOR 2.251), otitis media (aOR 2.243), eczema herpeticum (aOR 1.292), viral warts (aOR 1.105), and viral conjunctivitis (aOR 1.099; all P < .001) with molluscum contagiosum having the highest comorbidity (1.06%) and shortest onset duration (77.42 days).
Study details: Findings are from a nationwide population-based study including 70,205 patients with AD and individuals without AD.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Han J-H et al. Evaluation of atopic dermatitis and cutaneous infectious disorders using sequential pattern mining: A nationwide population-based cohort study. J Clin Med. 2022;11(12):3422 (Jun 14). Doi: 10.3390/jcm11123422
Exposure to antibiotics in early life not linked to atopic dermatitis onset in childhood or adolescence
Key clinical point: Exposure to antibiotics in early life was not associated with an increased risk of development of atopic dermatitis (AD) from 1 year of life up to adolescence.
Major finding: Antibiotic exposure vs no exposure during the first 6 months of life (adjusted hazard ratio [aHR] 1.05; 95% CI 0.97-1.12), first year of life (aHR 1.02; 95% CI 0.97-1.07), and first 2 years of life (aHR 1.01; 95% CI 0.94-1.10) was not associated with an increased risk of development of AD.
Study details: Findings are from a retrospective study including 73,816 children aged 0-14 years, of which 34,202 were exposed to antibiotics.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Cantarutti A et al. Early-life exposure to antibiotics and subsequent development of atopic dermatitis. Expert Rev Clin Pharmacol. 2022 (Jun 20). Doi: 10.1080/17512433.2022.2092471
Key clinical point: Exposure to antibiotics in early life was not associated with an increased risk of development of atopic dermatitis (AD) from 1 year of life up to adolescence.
Major finding: Antibiotic exposure vs no exposure during the first 6 months of life (adjusted hazard ratio [aHR] 1.05; 95% CI 0.97-1.12), first year of life (aHR 1.02; 95% CI 0.97-1.07), and first 2 years of life (aHR 1.01; 95% CI 0.94-1.10) was not associated with an increased risk of development of AD.
Study details: Findings are from a retrospective study including 73,816 children aged 0-14 years, of which 34,202 were exposed to antibiotics.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Cantarutti A et al. Early-life exposure to antibiotics and subsequent development of atopic dermatitis. Expert Rev Clin Pharmacol. 2022 (Jun 20). Doi: 10.1080/17512433.2022.2092471
Key clinical point: Exposure to antibiotics in early life was not associated with an increased risk of development of atopic dermatitis (AD) from 1 year of life up to adolescence.
Major finding: Antibiotic exposure vs no exposure during the first 6 months of life (adjusted hazard ratio [aHR] 1.05; 95% CI 0.97-1.12), first year of life (aHR 1.02; 95% CI 0.97-1.07), and first 2 years of life (aHR 1.01; 95% CI 0.94-1.10) was not associated with an increased risk of development of AD.
Study details: Findings are from a retrospective study including 73,816 children aged 0-14 years, of which 34,202 were exposed to antibiotics.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Cantarutti A et al. Early-life exposure to antibiotics and subsequent development of atopic dermatitis. Expert Rev Clin Pharmacol. 2022 (Jun 20). Doi: 10.1080/17512433.2022.2092471
Pediatric atopic dermatitis: Food allergy common but AD rarely triggered by food
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028