Noninvasive vagus nerve stimulation affirms its potential to prevent migraine

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Key clinical point: Noninvasive vagus nerve stimulation (nVNS) is an effective therapeutic option for preventing migraine.

Main finding: nVNS led to a greater mean reduction in monthly migraine days from baseline (3.12 days vs. 2.29 days; P = .2329) and a higher percentage of patients achieving 50% reduction in the number of migraine days (44.87% vs. 26.81%; P = .0481) compared to sham stimulation.

Study details: Findings are from the multicenter PREMIUM II trial wherein 231 adults with episodic or chronic migraine (with or without aura) were randomly assigned to receive nVNS (n = 114) or sham stimulation (n = 117) over 12 weeks. Of these, 113 (nVNS, n = 56; sham, n = 57) constituted the modified intention-to-treat population.

Disclosures: The study was sponsored by electroCore, Inc. Some of the authors, including the lead author, reported serving as a consultant/advisor/speaker for and receiving research grants from various organizations, including electroCore. E Liebler is an employee and stockholder of electroCore.

Source: Najib U et al. Cephalalgia. 2022  (Jan 9). Doi: 10.1177/03331024211068813.

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Key clinical point: Noninvasive vagus nerve stimulation (nVNS) is an effective therapeutic option for preventing migraine.

Main finding: nVNS led to a greater mean reduction in monthly migraine days from baseline (3.12 days vs. 2.29 days; P = .2329) and a higher percentage of patients achieving 50% reduction in the number of migraine days (44.87% vs. 26.81%; P = .0481) compared to sham stimulation.

Study details: Findings are from the multicenter PREMIUM II trial wherein 231 adults with episodic or chronic migraine (with or without aura) were randomly assigned to receive nVNS (n = 114) or sham stimulation (n = 117) over 12 weeks. Of these, 113 (nVNS, n = 56; sham, n = 57) constituted the modified intention-to-treat population.

Disclosures: The study was sponsored by electroCore, Inc. Some of the authors, including the lead author, reported serving as a consultant/advisor/speaker for and receiving research grants from various organizations, including electroCore. E Liebler is an employee and stockholder of electroCore.

Source: Najib U et al. Cephalalgia. 2022  (Jan 9). Doi: 10.1177/03331024211068813.

Key clinical point: Noninvasive vagus nerve stimulation (nVNS) is an effective therapeutic option for preventing migraine.

Main finding: nVNS led to a greater mean reduction in monthly migraine days from baseline (3.12 days vs. 2.29 days; P = .2329) and a higher percentage of patients achieving 50% reduction in the number of migraine days (44.87% vs. 26.81%; P = .0481) compared to sham stimulation.

Study details: Findings are from the multicenter PREMIUM II trial wherein 231 adults with episodic or chronic migraine (with or without aura) were randomly assigned to receive nVNS (n = 114) or sham stimulation (n = 117) over 12 weeks. Of these, 113 (nVNS, n = 56; sham, n = 57) constituted the modified intention-to-treat population.

Disclosures: The study was sponsored by electroCore, Inc. Some of the authors, including the lead author, reported serving as a consultant/advisor/speaker for and receiving research grants from various organizations, including electroCore. E Liebler is an employee and stockholder of electroCore.

Source: Najib U et al. Cephalalgia. 2022  (Jan 9). Doi: 10.1177/03331024211068813.

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Erenumab is an effective therapeutic option for migraine with aura

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Key clinical point: Erenumab led to decreased migraine frequency in patients with migraine with a history of aura.

Main finding: Compared with placebo, the change in monthly migraine days at week 12 was greater with 70 mg and 140 mg of erenumab in patients with episodic (least-squares mean differences [LSM] 1.1; 95% CI –1.7 to –0.6 and 0.9; 95% CI –1.6 to –0.2; respectively) and chronic (LSM 2.1; 95% CI –3.8 to –0.5 and 3.1; 95% CI –4.8 to –1.4, respectively) migraine with aura.

Study details: This was a post hoc subgroup analysis of 4 double-blind randomized clinical trials involving 2,443 adults with chronic or episodic migraine who received either erenumab (70 or 140 mg; n = 1,400) or placebo (n = 1,043).

Disclosures: Amgen Inc. sponsored the study. M Ashina reported being a principal investigator for ongoing trials for various sources including Amgen and, along with some co-authors, receiving speaking/teaching honoraria, advisory/consultation fees, or research grants from; or being a board member of, various companies. A few authors served as employees and stockholders of Amgen during the study period. Amgen and Novartis have co-developed erenumab.

Source: Ashina M et al. JAMA Neurol. 2021 (Dec 20). Doi: 10.1001/jamaneurol.2021.4678.

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Key clinical point: Erenumab led to decreased migraine frequency in patients with migraine with a history of aura.

Main finding: Compared with placebo, the change in monthly migraine days at week 12 was greater with 70 mg and 140 mg of erenumab in patients with episodic (least-squares mean differences [LSM] 1.1; 95% CI –1.7 to –0.6 and 0.9; 95% CI –1.6 to –0.2; respectively) and chronic (LSM 2.1; 95% CI –3.8 to –0.5 and 3.1; 95% CI –4.8 to –1.4, respectively) migraine with aura.

Study details: This was a post hoc subgroup analysis of 4 double-blind randomized clinical trials involving 2,443 adults with chronic or episodic migraine who received either erenumab (70 or 140 mg; n = 1,400) or placebo (n = 1,043).

Disclosures: Amgen Inc. sponsored the study. M Ashina reported being a principal investigator for ongoing trials for various sources including Amgen and, along with some co-authors, receiving speaking/teaching honoraria, advisory/consultation fees, or research grants from; or being a board member of, various companies. A few authors served as employees and stockholders of Amgen during the study period. Amgen and Novartis have co-developed erenumab.

Source: Ashina M et al. JAMA Neurol. 2021 (Dec 20). Doi: 10.1001/jamaneurol.2021.4678.

Key clinical point: Erenumab led to decreased migraine frequency in patients with migraine with a history of aura.

Main finding: Compared with placebo, the change in monthly migraine days at week 12 was greater with 70 mg and 140 mg of erenumab in patients with episodic (least-squares mean differences [LSM] 1.1; 95% CI –1.7 to –0.6 and 0.9; 95% CI –1.6 to –0.2; respectively) and chronic (LSM 2.1; 95% CI –3.8 to –0.5 and 3.1; 95% CI –4.8 to –1.4, respectively) migraine with aura.

Study details: This was a post hoc subgroup analysis of 4 double-blind randomized clinical trials involving 2,443 adults with chronic or episodic migraine who received either erenumab (70 or 140 mg; n = 1,400) or placebo (n = 1,043).

Disclosures: Amgen Inc. sponsored the study. M Ashina reported being a principal investigator for ongoing trials for various sources including Amgen and, along with some co-authors, receiving speaking/teaching honoraria, advisory/consultation fees, or research grants from; or being a board member of, various companies. A few authors served as employees and stockholders of Amgen during the study period. Amgen and Novartis have co-developed erenumab.

Source: Ashina M et al. JAMA Neurol. 2021 (Dec 20). Doi: 10.1001/jamaneurol.2021.4678.

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Skin pain increases disease burden and decreases QoL in children with atopic dermatitis

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Key clinical point: In children with atopic dermatitis (AD), skin pain is a burdensome symptom with heterogeneous presentation and is associated with decreased quality of life (QoL).

Major finding: Skin pain intensity was associated with conditions such as bleeding (adjusted β 1.47; 95% CI 0.61-2.33), weeping/oozing (adjusted β 1.18; 95% CI 0.47-1.90), and cracking of skin (adjusted β 1.00; 95% CI 0.27-1.73). Parent-reported pain intensity was associated with impaired QoL in infants aged 1-4 years (adjusted β 1.16; 95% CI 0.18-2.14) and children aged 5-17 years (adjusted β 1.68; 95% CI 1.00-2.36).

Study details: Findings are from a cross-sectional national survey of 240 children with AD and their parents, of which 60 and 180 were aged 1-4 years and 5-17 years, respectively, and 200 had moderate-to-very severe disease.

Disclosures: This study was funded by the Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Cheng BT et al. J Allergy Clin Immunol Pract. 2021 (Dec 23). Doi: 10.1016/j.jaip.2021.12.012.

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Key clinical point: In children with atopic dermatitis (AD), skin pain is a burdensome symptom with heterogeneous presentation and is associated with decreased quality of life (QoL).

Major finding: Skin pain intensity was associated with conditions such as bleeding (adjusted β 1.47; 95% CI 0.61-2.33), weeping/oozing (adjusted β 1.18; 95% CI 0.47-1.90), and cracking of skin (adjusted β 1.00; 95% CI 0.27-1.73). Parent-reported pain intensity was associated with impaired QoL in infants aged 1-4 years (adjusted β 1.16; 95% CI 0.18-2.14) and children aged 5-17 years (adjusted β 1.68; 95% CI 1.00-2.36).

Study details: Findings are from a cross-sectional national survey of 240 children with AD and their parents, of which 60 and 180 were aged 1-4 years and 5-17 years, respectively, and 200 had moderate-to-very severe disease.

Disclosures: This study was funded by the Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Cheng BT et al. J Allergy Clin Immunol Pract. 2021 (Dec 23). Doi: 10.1016/j.jaip.2021.12.012.

Key clinical point: In children with atopic dermatitis (AD), skin pain is a burdensome symptom with heterogeneous presentation and is associated with decreased quality of life (QoL).

Major finding: Skin pain intensity was associated with conditions such as bleeding (adjusted β 1.47; 95% CI 0.61-2.33), weeping/oozing (adjusted β 1.18; 95% CI 0.47-1.90), and cracking of skin (adjusted β 1.00; 95% CI 0.27-1.73). Parent-reported pain intensity was associated with impaired QoL in infants aged 1-4 years (adjusted β 1.16; 95% CI 0.18-2.14) and children aged 5-17 years (adjusted β 1.68; 95% CI 1.00-2.36).

Study details: Findings are from a cross-sectional national survey of 240 children with AD and their parents, of which 60 and 180 were aged 1-4 years and 5-17 years, respectively, and 200 had moderate-to-very severe disease.

Disclosures: This study was funded by the Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Cheng BT et al. J Allergy Clin Immunol Pract. 2021 (Dec 23). Doi: 10.1016/j.jaip.2021.12.012.

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Antibiotic use in infancy may increase the risk of developing atopic dermatitis

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Key clinical point: Antibiotic use in infants younger than 12 months is associated with an increased risk of developing atopic dermatitis (AD) if shared familial and environmental factors are disregarded.

Major finding: A higher proportion of infants exposed (13.7%) vs. not exposed (13.4%) to antibiotics developed AD after 12 months of age. The risk of developing AD was higher in infants exposed to antibiotics in the first 12 months after birth (adjusted hazard ratio 1.12; 95% CI 1.04-1.21); however, this association disappeared when the data were matched with those obtained from their siblings.

Study details: Findings are from a retrospective, large-scale study including 85,954 infants, of which 10.1% were exposed to antibiotics at <12 months of age.

Disclosures: This study was funded by the Japan Society for the Promotion of Science and Grants-in-Aid for Scientific Research and the Project Promoting Clinical Trials for Development of New Drugs in Japan Agency for Medical Research and Development. Dr. Kawakami declared holding stock options and receiving research funds, consulting fees, and executive compensation from several sources.

Source: Tsuchida T et al. Acta Paediatr. 2021 (Dec 17). Doi: 10.1111/apa.16221.

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Key clinical point: Antibiotic use in infants younger than 12 months is associated with an increased risk of developing atopic dermatitis (AD) if shared familial and environmental factors are disregarded.

Major finding: A higher proportion of infants exposed (13.7%) vs. not exposed (13.4%) to antibiotics developed AD after 12 months of age. The risk of developing AD was higher in infants exposed to antibiotics in the first 12 months after birth (adjusted hazard ratio 1.12; 95% CI 1.04-1.21); however, this association disappeared when the data were matched with those obtained from their siblings.

Study details: Findings are from a retrospective, large-scale study including 85,954 infants, of which 10.1% were exposed to antibiotics at <12 months of age.

Disclosures: This study was funded by the Japan Society for the Promotion of Science and Grants-in-Aid for Scientific Research and the Project Promoting Clinical Trials for Development of New Drugs in Japan Agency for Medical Research and Development. Dr. Kawakami declared holding stock options and receiving research funds, consulting fees, and executive compensation from several sources.

Source: Tsuchida T et al. Acta Paediatr. 2021 (Dec 17). Doi: 10.1111/apa.16221.

Key clinical point: Antibiotic use in infants younger than 12 months is associated with an increased risk of developing atopic dermatitis (AD) if shared familial and environmental factors are disregarded.

Major finding: A higher proportion of infants exposed (13.7%) vs. not exposed (13.4%) to antibiotics developed AD after 12 months of age. The risk of developing AD was higher in infants exposed to antibiotics in the first 12 months after birth (adjusted hazard ratio 1.12; 95% CI 1.04-1.21); however, this association disappeared when the data were matched with those obtained from their siblings.

Study details: Findings are from a retrospective, large-scale study including 85,954 infants, of which 10.1% were exposed to antibiotics at <12 months of age.

Disclosures: This study was funded by the Japan Society for the Promotion of Science and Grants-in-Aid for Scientific Research and the Project Promoting Clinical Trials for Development of New Drugs in Japan Agency for Medical Research and Development. Dr. Kawakami declared holding stock options and receiving research funds, consulting fees, and executive compensation from several sources.

Source: Tsuchida T et al. Acta Paediatr. 2021 (Dec 17). Doi: 10.1111/apa.16221.

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More severe atopic dermatitis tied with poor sleep health and attention dysregulation

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Key clinical point: Children aged <5 years with atopic dermatitis (AD) show a disease severity-dependent increased risk for poor sleep health and attention dysregulation (AdR).

Major finding: AD-induced sleep disturbance on ≥5 nights/week was reported in 76% children with severe AD, 24% children with moderate AD, and none with mild AD (P = .01), and children with more severe AD had greater AdR (correlation coefficient 0.65; P < .01). Severity of AD was a significant predictor of poor sleep health (β 0.79; P < .01) and AdR (β 1.22; P < .01).

Study details: Findings are from a cross-sectional study including 60 children aged 1-4 years with mild-to-severe AD.

Disclosures: This study was supported by the Ann & Robert H. Lurie Children’s Hospital of Chicago and the Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Zhou NY et al. Pediatr Dermatol. 2021 (Dec 21). Doi: 10.1111/pde.14889.

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Key clinical point: Children aged <5 years with atopic dermatitis (AD) show a disease severity-dependent increased risk for poor sleep health and attention dysregulation (AdR).

Major finding: AD-induced sleep disturbance on ≥5 nights/week was reported in 76% children with severe AD, 24% children with moderate AD, and none with mild AD (P = .01), and children with more severe AD had greater AdR (correlation coefficient 0.65; P < .01). Severity of AD was a significant predictor of poor sleep health (β 0.79; P < .01) and AdR (β 1.22; P < .01).

Study details: Findings are from a cross-sectional study including 60 children aged 1-4 years with mild-to-severe AD.

Disclosures: This study was supported by the Ann & Robert H. Lurie Children’s Hospital of Chicago and the Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Zhou NY et al. Pediatr Dermatol. 2021 (Dec 21). Doi: 10.1111/pde.14889.

Key clinical point: Children aged <5 years with atopic dermatitis (AD) show a disease severity-dependent increased risk for poor sleep health and attention dysregulation (AdR).

Major finding: AD-induced sleep disturbance on ≥5 nights/week was reported in 76% children with severe AD, 24% children with moderate AD, and none with mild AD (P = .01), and children with more severe AD had greater AdR (correlation coefficient 0.65; P < .01). Severity of AD was a significant predictor of poor sleep health (β 0.79; P < .01) and AdR (β 1.22; P < .01).

Study details: Findings are from a cross-sectional study including 60 children aged 1-4 years with mild-to-severe AD.

Disclosures: This study was supported by the Ann & Robert H. Lurie Children’s Hospital of Chicago and the Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Zhou NY et al. Pediatr Dermatol. 2021 (Dec 21). Doi: 10.1111/pde.14889.

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Atopic dermatitis may precede the onset of delinquent behaviors in children and adolescents

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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.

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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.

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Patients with atopic dermatitis at higher risk for COVID-19 infection

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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.

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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.

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Atopic dermatitis: Patients showing suboptimal response to initial dupilumab may benefit from long-term treatment

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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.

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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.

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RINVOQ [ 5260 ]

Upadacitinib and topical corticosteroids combo safe in mild-to-moderate atopic dermatitis

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Wed, 03/23/2022 - 20:25

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.

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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.

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RINVOQ [ 5260 ]

GlcChol levels and GBA activity could serve as biomarkers of therapeutic response in atopic dermatitis

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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.

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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.

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RINVOQ [ 5260 ]