Atopic Dermatitis

Key clinical point: Onset and persistence of atopic dermatitis (AD) in children is associated with delinquent behaviors during childhood and adolescence.

Major finding: AD in children aged 5 years (adjusted odds ratio [aOR] 1.31; 95% CI 1.04-1.64) or 9 years (aOR 1.38; 95% CI 1.14-1.67) was associated with ≥75th percentile of mean delinquent behavior scores at age 9 or 15 years. At 9 years of age, a 1-year history of AD was associated with smoking at age 15 years (aOR 1.46; 95% CI 1.00-2.13), damaging property (aOR 1.38; 95% CI 1.08-1.77), cheating on a test (aOR 1.62; 95% CI 1.17-2.26), and school suspension (aOR 1.36; 95% CI 1.08-1.71).

Study details: Findings are from the prospective, longitudinal birth cohort Fragile Families and Child Wellbeing Study including 4,898 children aged 1, 3, 5, 9, or 15 years, of which 16.4%, 17.5%, and 16% of children aged 5, 9, and 15 years, respectively, had AD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Manjunath J et al. Arch Dermatol Res. 2022 (Jan 10). Doi: 10.1007/s00403-021-02314-y.

Key clinical point: Onset and persistence of atopic dermatitis (AD) in children is associated with delinquent behaviors during childhood and adolescence.

Major finding: AD in children aged 5 years (adjusted odds ratio [aOR] 1.31; 95% CI 1.04-1.64) or 9 years (aOR 1.38; 95% CI 1.14-1.67) was associated with ≥75th percentile of mean delinquent behavior scores at age 9 or 15 years. At 9 years of age, a 1-year history of AD was associated with smoking at age 15 years (aOR 1.46; 95% CI 1.00-2.13), damaging property (aOR 1.38; 95% CI 1.08-1.77), cheating on a test (aOR 1.62; 95% CI 1.17-2.26), and school suspension (aOR 1.36; 95% CI 1.08-1.71).

Study details: Findings are from the prospective, longitudinal birth cohort Fragile Families and Child Wellbeing Study including 4,898 children aged 1, 3, 5, 9, or 15 years, of which 16.4%, 17.5%, and 16% of children aged 5, 9, and 15 years, respectively, had AD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Manjunath J et al. Arch Dermatol Res. 2022 (Jan 10). Doi: 10.1007/s00403-021-02314-y.

Key clinical point: Onset and persistence of atopic dermatitis (AD) in children is associated with delinquent behaviors during childhood and adolescence.

Major finding: AD in children aged 5 years (adjusted odds ratio [aOR] 1.31; 95% CI 1.04-1.64) or 9 years (aOR 1.38; 95% CI 1.14-1.67) was associated with ≥75th percentile of mean delinquent behavior scores at age 9 or 15 years. At 9 years of age, a 1-year history of AD was associated with smoking at age 15 years (aOR 1.46; 95% CI 1.00-2.13), damaging property (aOR 1.38; 95% CI 1.08-1.77), cheating on a test (aOR 1.62; 95% CI 1.17-2.26), and school suspension (aOR 1.36; 95% CI 1.08-1.71).

Study details: Findings are from the prospective, longitudinal birth cohort Fragile Families and Child Wellbeing Study including 4,898 children aged 1, 3, 5, 9, or 15 years, of which 16.4%, 17.5%, and 16% of children aged 5, 9, and 15 years, respectively, had AD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Manjunath J et al. Arch Dermatol Res. 2022 (Jan 10). Doi: 10.1007/s00403-021-02314-y.

Key clinical point: Patients with atopic dermatitis (AD) showed a significantly higher risk of contracting COVID-19 infection irrespective of comorbidities and other demographic factors.

Major finding: Patients with vs. without AD were more likely to have a diagnosis of COVID-19 (4.2% vs. 2.8%; P < .001) with AD remaining significantly associated with COVID-19 even after adjusting for demographic factors and comorbidities (odds ratio 1.29; P < .001).

Study details: Findings are from a case-control cohort, All of Us, including 11,752 patients with AD who were matched with 47,008 healthy controls.

Disclosures: This study did not report any funding. The authors declared no conflicts of interest.

Source: Fan R et al. JAAD Int. 2021 (Dec 27). Doi: 10.1016/j.jdin.2021.12.007.

Key clinical point: Patients with atopic dermatitis (AD) showed a significantly higher risk of contracting COVID-19 infection irrespective of comorbidities and other demographic factors.

Major finding: Patients with vs. without AD were more likely to have a diagnosis of COVID-19 (4.2% vs. 2.8%; P < .001) with AD remaining significantly associated with COVID-19 even after adjusting for demographic factors and comorbidities (odds ratio 1.29; P < .001).

Study details: Findings are from a case-control cohort, All of Us, including 11,752 patients with AD who were matched with 47,008 healthy controls.

Disclosures: This study did not report any funding. The authors declared no conflicts of interest.

Source: Fan R et al. JAAD Int. 2021 (Dec 27). Doi: 10.1016/j.jdin.2021.12.007.

Key clinical point: Patients with atopic dermatitis (AD) showed a significantly higher risk of contracting COVID-19 infection irrespective of comorbidities and other demographic factors.

Major finding: Patients with vs. without AD were more likely to have a diagnosis of COVID-19 (4.2% vs. 2.8%; P < .001) with AD remaining significantly associated with COVID-19 even after adjusting for demographic factors and comorbidities (odds ratio 1.29; P < .001).

Study details: Findings are from a case-control cohort, All of Us, including 11,752 patients with AD who were matched with 47,008 healthy controls.

Disclosures: This study did not report any funding. The authors declared no conflicts of interest.

Source: Fan R et al. JAAD Int. 2021 (Dec 27). Doi: 10.1016/j.jdin.2021.12.007.

Key clinical point: Some patients with atopic dermatitis (AD) who failed to achieve ≥75% improvement in Eczema Area and Severity Index (EASI)-75 and Investigator’s Global Assessment score of 0/1 (IGA 0/1) after initial 16-week treatment with dupilumab seemed to benefit from continued long-term treatment.

Major finding: Among patients with a suboptimal 16-week response to dupilumab, 91% achieved EASI-75 by week 100 with 49% of patients receiving initial dupilumab once weekly and 45% on every 2 weeks achieving IGA 0/1 at week 100.

Study details: Findings are a post hoc analysis of 100-week data from dupilumab open-label extension study including 391 adults with moderate-to-severe AD who received 300 mg dupilumab weekly after showing suboptimal response with weekly or every 2 weeks dosing in the parent study.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared serving as a consultants, speakers, and investigators or receiving funding and honoraria from various sources. Some of the authors declared being present/former employees or shareholders of Regeneron Pharmaceuticals or Sanofi Genzyme.

Source: Armstrong A et al. Dermatol Ther (Heidelb). 2021 (Dec 13). Doi: 10.1007/s13555-021-00643-4.

Key clinical point: Some patients with atopic dermatitis (AD) who failed to achieve ≥75% improvement in Eczema Area and Severity Index (EASI)-75 and Investigator’s Global Assessment score of 0/1 (IGA 0/1) after initial 16-week treatment with dupilumab seemed to benefit from continued long-term treatment.

Major finding: Among patients with a suboptimal 16-week response to dupilumab, 91% achieved EASI-75 by week 100 with 49% of patients receiving initial dupilumab once weekly and 45% on every 2 weeks achieving IGA 0/1 at week 100.

Study details: Findings are a post hoc analysis of 100-week data from dupilumab open-label extension study including 391 adults with moderate-to-severe AD who received 300 mg dupilumab weekly after showing suboptimal response with weekly or every 2 weeks dosing in the parent study.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared serving as a consultants, speakers, and investigators or receiving funding and honoraria from various sources. Some of the authors declared being present/former employees or shareholders of Regeneron Pharmaceuticals or Sanofi Genzyme.

Source: Armstrong A et al. Dermatol Ther (Heidelb). 2021 (Dec 13). Doi: 10.1007/s13555-021-00643-4.

Key clinical point: Some patients with atopic dermatitis (AD) who failed to achieve ≥75% improvement in Eczema Area and Severity Index (EASI)-75 and Investigator’s Global Assessment score of 0/1 (IGA 0/1) after initial 16-week treatment with dupilumab seemed to benefit from continued long-term treatment.

Major finding: Among patients with a suboptimal 16-week response to dupilumab, 91% achieved EASI-75 by week 100 with 49% of patients receiving initial dupilumab once weekly and 45% on every 2 weeks achieving IGA 0/1 at week 100.

Study details: Findings are a post hoc analysis of 100-week data from dupilumab open-label extension study including 391 adults with moderate-to-severe AD who received 300 mg dupilumab weekly after showing suboptimal response with weekly or every 2 weeks dosing in the parent study.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared serving as a consultants, speakers, and investigators or receiving funding and honoraria from various sources. Some of the authors declared being present/former employees or shareholders of Regeneron Pharmaceuticals or Sanofi Genzyme.

Source: Armstrong A et al. Dermatol Ther (Heidelb). 2021 (Dec 13). Doi: 10.1007/s13555-021-00643-4.

Key clinical point: The combination of upadacitinib and topical corticosteroids (TCS) showed a favorable safety profile in moderate-to-severe atopic dermatitis (AD).

Major finding: Treatment-emergent adverse events (TEAE) were reported by 56% and 64% of patients receiving 15 mg upadacitinib and 30 mg upadacitinib, respectively, vs. 42% of patients receiving placebo. Mild/moderate acne was more frequent with 15 mg upadacitinib (13.2%) and 30 mg (19.8%) vs. placebo (5.6%), but did not lead to treatment discontinuation. No new safety risks or deaths were reported.

Study details: Findings are a 24-week interim safety analysis of an ongoing phase 3 Rising Up trial including 272 patients with moderate-to-severe AD with an inadequate response to systemic treatment who were randomly assigned to 15 mg upadacitinib, 30 mg upadacitinib, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speakers, consultants, and investigators or receiving honoraria, grants, funding, and scholarship from various sources. Six authors declared being employees or shareholders of AbbVie.

Source: Katoh N et al. JAAD Int. 2021 (Dec 19). Doi: 10.1016/j.jdin.2021.11.001.

Key clinical point: The combination of upadacitinib and topical corticosteroids (TCS) showed a favorable safety profile in moderate-to-severe atopic dermatitis (AD).

Major finding: Treatment-emergent adverse events (TEAE) were reported by 56% and 64% of patients receiving 15 mg upadacitinib and 30 mg upadacitinib, respectively, vs. 42% of patients receiving placebo. Mild/moderate acne was more frequent with 15 mg upadacitinib (13.2%) and 30 mg (19.8%) vs. placebo (5.6%), but did not lead to treatment discontinuation. No new safety risks or deaths were reported.

Study details: Findings are a 24-week interim safety analysis of an ongoing phase 3 Rising Up trial including 272 patients with moderate-to-severe AD with an inadequate response to systemic treatment who were randomly assigned to 15 mg upadacitinib, 30 mg upadacitinib, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speakers, consultants, and investigators or receiving honoraria, grants, funding, and scholarship from various sources. Six authors declared being employees or shareholders of AbbVie.

Source: Katoh N et al. JAAD Int. 2021 (Dec 19). Doi: 10.1016/j.jdin.2021.11.001.

Key clinical point: The combination of upadacitinib and topical corticosteroids (TCS) showed a favorable safety profile in moderate-to-severe atopic dermatitis (AD).

Major finding: Treatment-emergent adverse events (TEAE) were reported by 56% and 64% of patients receiving 15 mg upadacitinib and 30 mg upadacitinib, respectively, vs. 42% of patients receiving placebo. Mild/moderate acne was more frequent with 15 mg upadacitinib (13.2%) and 30 mg (19.8%) vs. placebo (5.6%), but did not lead to treatment discontinuation. No new safety risks or deaths were reported.

Study details: Findings are a 24-week interim safety analysis of an ongoing phase 3 Rising Up trial including 272 patients with moderate-to-severe AD with an inadequate response to systemic treatment who were randomly assigned to 15 mg upadacitinib, 30 mg upadacitinib, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speakers, consultants, and investigators or receiving honoraria, grants, funding, and scholarship from various sources. Six authors declared being employees or shareholders of AbbVie.

Source: Katoh N et al. JAAD Int. 2021 (Dec 19). Doi: 10.1016/j.jdin.2021.11.001.

Key clinical point: Children with atopic dermatitis (AD) had higher β-glucocerebrosidase (GBA) activity and glucosyl cholesterol (GlcChol) levels than healthy controls, depicting the role of inflammation in disturbed lipid processing; however, the levels decreased after treatment with topical corticosteroids (TCS).

Major finding: Baseline GBA activity (P < .0001) and GlcChol (P < .01) levels were higher in children with AD vs. healthy controls but decreased after a 6-week TCS therapy (both P < .01). GBA activity and GlcChol levels correlated with the levels of interleukin (IL)-1α and IL-18 (P < .01 for all), and GlcChol levels were associated with disease severity (P < .05).

Study details: The study cohort was derived from a larger study involving 100 children with AD, of which 22 children with AD were matched with 17 healthy controls and 19 children with AD with 9 healthy controls for analyzing GBA activity and GlcChol levels, respectively.

Disclosures: This study was funded by the National Children's Research Centre, Dublin, Ireland. The authors declared no conflicts of interest.

Source: Kezic S et al. Br J Dermatol. 2022 (Jan 7). Doi: 10.1111/bjd.20979.

Key clinical point: Children with atopic dermatitis (AD) had higher β-glucocerebrosidase (GBA) activity and glucosyl cholesterol (GlcChol) levels than healthy controls, depicting the role of inflammation in disturbed lipid processing; however, the levels decreased after treatment with topical corticosteroids (TCS).

Major finding: Baseline GBA activity (P < .0001) and GlcChol (P < .01) levels were higher in children with AD vs. healthy controls but decreased after a 6-week TCS therapy (both P < .01). GBA activity and GlcChol levels correlated with the levels of interleukin (IL)-1α and IL-18 (P < .01 for all), and GlcChol levels were associated with disease severity (P < .05).

Study details: The study cohort was derived from a larger study involving 100 children with AD, of which 22 children with AD were matched with 17 healthy controls and 19 children with AD with 9 healthy controls for analyzing GBA activity and GlcChol levels, respectively.

Disclosures: This study was funded by the National Children's Research Centre, Dublin, Ireland. The authors declared no conflicts of interest.

Source: Kezic S et al. Br J Dermatol. 2022 (Jan 7). Doi: 10.1111/bjd.20979.

Key clinical point: Children with atopic dermatitis (AD) had higher β-glucocerebrosidase (GBA) activity and glucosyl cholesterol (GlcChol) levels than healthy controls, depicting the role of inflammation in disturbed lipid processing; however, the levels decreased after treatment with topical corticosteroids (TCS).

Major finding: Baseline GBA activity (P < .0001) and GlcChol (P < .01) levels were higher in children with AD vs. healthy controls but decreased after a 6-week TCS therapy (both P < .01). GBA activity and GlcChol levels correlated with the levels of interleukin (IL)-1α and IL-18 (P < .01 for all), and GlcChol levels were associated with disease severity (P < .05).

Study details: The study cohort was derived from a larger study involving 100 children with AD, of which 22 children with AD were matched with 17 healthy controls and 19 children with AD with 9 healthy controls for analyzing GBA activity and GlcChol levels, respectively.

Disclosures: This study was funded by the National Children's Research Centre, Dublin, Ireland. The authors declared no conflicts of interest.

Source: Kezic S et al. Br J Dermatol. 2022 (Jan 7). Doi: 10.1111/bjd.20979.

Key clinical point: Young adults with atopic dermatitis (AD) did not have lower bone mineral density (BMD) compared with healthy controls; however, early onset, longer duration of AD, and lower body mass index (BMI) increased the risk for low BMD.

Major finding: The prevalence rate of low BMD (z-score) was similar in patients with vs. without AD in both men (P = .56) and women (P = .40), with early onset of AD, longer disease duration (both P < .001), and lower BMI (P < .05) being significant risk factors for low BMD in patients with AD.

Study details: Findings are from a case-control cohort including 311 patients with AD who were matched with 8,972 healthy controls.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Kim S et al. Sci Rep. 2021;11:24228 (Dec 20). Doi: 10.1038/s41598-021-03630-z.

Key clinical point: Young adults with atopic dermatitis (AD) did not have lower bone mineral density (BMD) compared with healthy controls; however, early onset, longer duration of AD, and lower body mass index (BMI) increased the risk for low BMD.

Major finding: The prevalence rate of low BMD (z-score) was similar in patients with vs. without AD in both men (P = .56) and women (P = .40), with early onset of AD, longer disease duration (both P < .001), and lower BMI (P < .05) being significant risk factors for low BMD in patients with AD.

Study details: Findings are from a case-control cohort including 311 patients with AD who were matched with 8,972 healthy controls.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Kim S et al. Sci Rep. 2021;11:24228 (Dec 20). Doi: 10.1038/s41598-021-03630-z.

Key clinical point: Young adults with atopic dermatitis (AD) did not have lower bone mineral density (BMD) compared with healthy controls; however, early onset, longer duration of AD, and lower body mass index (BMI) increased the risk for low BMD.

Major finding: The prevalence rate of low BMD (z-score) was similar in patients with vs. without AD in both men (P = .56) and women (P = .40), with early onset of AD, longer disease duration (both P < .001), and lower BMI (P < .05) being significant risk factors for low BMD in patients with AD.

Study details: Findings are from a case-control cohort including 311 patients with AD who were matched with 8,972 healthy controls.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Kim S et al. Sci Rep. 2021;11:24228 (Dec 20). Doi: 10.1038/s41598-021-03630-z.

Key clinical point: Patients with atopic dermatitis (AD) who received dupilumab therapy experienced rapid and sustained disease control for up to 12 months after therapy initiation.

Major finding: The mean AD Control Tool score reduced from 15.8 at baseline to 6.4 and 4.4 at months 1 and 12, respectively (both P < .001). Furthermore, at month 1, with the use of concomitant AD therapies, flares and skin symptoms, such as skin pain/soreness, hot/burning feeling, and sensitivity to touch, were reduced and health-related quality of life improved with effects sustained until month 12 (all P < .001).

Study details: Findings are from a prospective, longitudinal RELIEVE-AD study including 699 patients with moderate-to-severe AD who initiated treatment with dupilumab and were followed up for 12 months.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as consultants, advisory board members, and speakers or receiving honoraria and funding from several sources. Some of the authors reported being employees or shareholders of Sanofi, Regeneron Pharmaceuticals, and others.

Source: Strober B et al. JAMA Dermatol. 2021 (Dec 15). Doi: 10.1001/jamadermatol.2021.4778.

Key clinical point: Patients with atopic dermatitis (AD) who received dupilumab therapy experienced rapid and sustained disease control for up to 12 months after therapy initiation.

Major finding: The mean AD Control Tool score reduced from 15.8 at baseline to 6.4 and 4.4 at months 1 and 12, respectively (both P < .001). Furthermore, at month 1, with the use of concomitant AD therapies, flares and skin symptoms, such as skin pain/soreness, hot/burning feeling, and sensitivity to touch, were reduced and health-related quality of life improved with effects sustained until month 12 (all P < .001).

Study details: Findings are from a prospective, longitudinal RELIEVE-AD study including 699 patients with moderate-to-severe AD who initiated treatment with dupilumab and were followed up for 12 months.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as consultants, advisory board members, and speakers or receiving honoraria and funding from several sources. Some of the authors reported being employees or shareholders of Sanofi, Regeneron Pharmaceuticals, and others.

Source: Strober B et al. JAMA Dermatol. 2021 (Dec 15). Doi: 10.1001/jamadermatol.2021.4778.

Key clinical point: Patients with atopic dermatitis (AD) who received dupilumab therapy experienced rapid and sustained disease control for up to 12 months after therapy initiation.

Major finding: The mean AD Control Tool score reduced from 15.8 at baseline to 6.4 and 4.4 at months 1 and 12, respectively (both P < .001). Furthermore, at month 1, with the use of concomitant AD therapies, flares and skin symptoms, such as skin pain/soreness, hot/burning feeling, and sensitivity to touch, were reduced and health-related quality of life improved with effects sustained until month 12 (all P < .001).

Study details: Findings are from a prospective, longitudinal RELIEVE-AD study including 699 patients with moderate-to-severe AD who initiated treatment with dupilumab and were followed up for 12 months.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as consultants, advisory board members, and speakers or receiving honoraria and funding from several sources. Some of the authors reported being employees or shareholders of Sanofi, Regeneron Pharmaceuticals, and others.

Source: Strober B et al. JAMA Dermatol. 2021 (Dec 15). Doi: 10.1001/jamadermatol.2021.4778.

The Food and Drug Administration on Jan. 14 approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) – upadacitinib and abrocitinib – making them the first oral JAK-inhibitors available for this indication in the United States.

“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.

Olivier Le Moal/Getty Images

Upadacitinib

The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.

Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.

“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”

She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”

Abrocitinib

Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.

The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.




 

The Food and Drug Administration on Jan. 14 approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) – upadacitinib and abrocitinib – making them the first oral JAK-inhibitors available for this indication in the United States.

“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.

Olivier Le Moal/Getty Images

Upadacitinib

The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.

Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.

“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”

She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”

Abrocitinib

Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.

The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.




 

The Food and Drug Administration on Jan. 14 approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) – upadacitinib and abrocitinib – making them the first oral JAK-inhibitors available for this indication in the United States.

“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.

Olivier Le Moal/Getty Images

Upadacitinib

The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.

Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.

“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”

She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”

Abrocitinib

Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.

The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.




 

• PATIENT SATISFACTION WITH TREATMENT
• REDUCING ITCH
• BURDEN OF DISEASE IN BLACK PATIENTS
• BATHING RECOMMENDATIONS

Read More

• PATIENT SATISFACTION WITH TREATMENT
• REDUCING ITCH
• BURDEN OF DISEASE IN BLACK PATIENTS
• BATHING RECOMMENDATIONS

Read More

• PATIENT SATISFACTION WITH TREATMENT
• REDUCING ITCH
• BURDEN OF DISEASE IN BLACK PATIENTS
• BATHING RECOMMENDATIONS

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An estimated 10% of adults report hand eczema each year, but over one’s lifetime, about 15%-20% will experience the condition, which is more common among those with atopic dermatitis (AD), according to Jacob P. Thyssen, MD, PhD.

“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.

Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.

“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”

He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”

The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.

The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.

Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.

In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”

A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”

Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.

An estimated 10% of adults report hand eczema each year, but over one’s lifetime, about 15%-20% will experience the condition, which is more common among those with atopic dermatitis (AD), according to Jacob P. Thyssen, MD, PhD.

“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.

Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.

“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”

He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”

The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.

The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.

Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.

In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”

A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”

Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.

An estimated 10% of adults report hand eczema each year, but over one’s lifetime, about 15%-20% will experience the condition, which is more common among those with atopic dermatitis (AD), according to Jacob P. Thyssen, MD, PhD.

“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.

Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.

“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”

He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”

The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.

The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.

Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.

In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”

A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”

Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.