Atopic dermatitis could be a risk factor for rheumatoid arthritis

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Key clinical point: Patients with atopic dermatitis (AD) were at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: Patients with AD had a significantly higher risk for incident RA than patients without AD (pooled odds ratio, 1.30; 95% confidence interval, 1.17-1.44).

Study details: Findings are from a meta-analysis of 4 cohorts and 9 case-control studies.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Rittiphairoj T et al. Dermatitis. 2021 Aug 16. doi: 10.1097/DER.0000000000000781.

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Key clinical point: Patients with atopic dermatitis (AD) were at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: Patients with AD had a significantly higher risk for incident RA than patients without AD (pooled odds ratio, 1.30; 95% confidence interval, 1.17-1.44).

Study details: Findings are from a meta-analysis of 4 cohorts and 9 case-control studies.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Rittiphairoj T et al. Dermatitis. 2021 Aug 16. doi: 10.1097/DER.0000000000000781.

Key clinical point: Patients with atopic dermatitis (AD) were at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: Patients with AD had a significantly higher risk for incident RA than patients without AD (pooled odds ratio, 1.30; 95% confidence interval, 1.17-1.44).

Study details: Findings are from a meta-analysis of 4 cohorts and 9 case-control studies.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Rittiphairoj T et al. Dermatitis. 2021 Aug 16. doi: 10.1097/DER.0000000000000781.

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Dupilumab is effective for pediatric atopic dermatitis across different anatomical regions

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Key clinical point: Dupilumab improved signs of atopic dermatitis (AD) rapidly and consistently across all anatomical regions in pediatric patients.

Major finding: In children, dupilumab improved Eczema Area and Severity Index (EASI) score as early as week 1 in head and neck, trunk, and upper extremities and as early as week 2 in lower extremities. In adolescents, dupilumab improved the EASI score in all anatomical regions as early as week 2. All improvements were sustained through week 16 (all P less than .05).

Study details: Findings are a post hoc analysis of 2 phase 3 dupilumab therapy trials, LIBERTY AD ADOL and LIBERTY AD PEDS, including 167 adolescents with moderate-to-severe AD and 304 children with severe AD inadequately controlled by topical medication.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared receiving grants, honoraria, and/or serving as a consultant, speaker, advisory board member, and investigator for various sources. Some of the authors declared being employees and/or holding stocks/stock of Regeneron Pharmaceuticals or Sanofi Genzyme.

Source: Simpson EL et al. Dermatol Ther (Heidelb). 2021 Aug 24. doi: 10.1007/s13555-021-00568-y.

 

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Key clinical point: Dupilumab improved signs of atopic dermatitis (AD) rapidly and consistently across all anatomical regions in pediatric patients.

Major finding: In children, dupilumab improved Eczema Area and Severity Index (EASI) score as early as week 1 in head and neck, trunk, and upper extremities and as early as week 2 in lower extremities. In adolescents, dupilumab improved the EASI score in all anatomical regions as early as week 2. All improvements were sustained through week 16 (all P less than .05).

Study details: Findings are a post hoc analysis of 2 phase 3 dupilumab therapy trials, LIBERTY AD ADOL and LIBERTY AD PEDS, including 167 adolescents with moderate-to-severe AD and 304 children with severe AD inadequately controlled by topical medication.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared receiving grants, honoraria, and/or serving as a consultant, speaker, advisory board member, and investigator for various sources. Some of the authors declared being employees and/or holding stocks/stock of Regeneron Pharmaceuticals or Sanofi Genzyme.

Source: Simpson EL et al. Dermatol Ther (Heidelb). 2021 Aug 24. doi: 10.1007/s13555-021-00568-y.

 

Key clinical point: Dupilumab improved signs of atopic dermatitis (AD) rapidly and consistently across all anatomical regions in pediatric patients.

Major finding: In children, dupilumab improved Eczema Area and Severity Index (EASI) score as early as week 1 in head and neck, trunk, and upper extremities and as early as week 2 in lower extremities. In adolescents, dupilumab improved the EASI score in all anatomical regions as early as week 2. All improvements were sustained through week 16 (all P less than .05).

Study details: Findings are a post hoc analysis of 2 phase 3 dupilumab therapy trials, LIBERTY AD ADOL and LIBERTY AD PEDS, including 167 adolescents with moderate-to-severe AD and 304 children with severe AD inadequately controlled by topical medication.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared receiving grants, honoraria, and/or serving as a consultant, speaker, advisory board member, and investigator for various sources. Some of the authors declared being employees and/or holding stocks/stock of Regeneron Pharmaceuticals or Sanofi Genzyme.

Source: Simpson EL et al. Dermatol Ther (Heidelb). 2021 Aug 24. doi: 10.1007/s13555-021-00568-y.

 

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Atopic dermatitis: Continuous long-term use of crisaborole safe and effective

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Key clinical point: Continuous and long-term use of crisaborole is safe and effective for managing mild-to-moderate atopic dermatitis (AD).

Major finding: Following 1-4 crisaborole treatment cycles (TC), 77.6%, 76.3%, 59.4%, and 43.1% of patients achieved Investigator’s Static Global Assessment (ISGA) score of 0/1, respectively. After a 28-day off-TC, ISGA 0/1 was maintained in 49.5%, 37.8%, 44.4%, and 45.2% of patients from TC 1-4, respectively. Treatment-related adverse events were reported by less than 5% of patients across cohorts.

Study details: Findings are from CORE 3, a 48-week extension study including 418 patients aged 2 years or more with mild-to-moderate AD who completed CrisADe CORE 1 or CrisADe CORE 2 phase 3 trials without any drug-related safety issues and received crisaborole for 1-4 consecutive initial on-TC during the extension study.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving honoraria, serving as speaker and consultant, and/or being an employee and/or shareholders of various sources including Pfizer.

Source: Geng B et al. Dermatol Ther (Heidelb). 2021 Aug 11. doi: 10.1007/s13555-021-00584-y.

 

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Key clinical point: Continuous and long-term use of crisaborole is safe and effective for managing mild-to-moderate atopic dermatitis (AD).

Major finding: Following 1-4 crisaborole treatment cycles (TC), 77.6%, 76.3%, 59.4%, and 43.1% of patients achieved Investigator’s Static Global Assessment (ISGA) score of 0/1, respectively. After a 28-day off-TC, ISGA 0/1 was maintained in 49.5%, 37.8%, 44.4%, and 45.2% of patients from TC 1-4, respectively. Treatment-related adverse events were reported by less than 5% of patients across cohorts.

Study details: Findings are from CORE 3, a 48-week extension study including 418 patients aged 2 years or more with mild-to-moderate AD who completed CrisADe CORE 1 or CrisADe CORE 2 phase 3 trials without any drug-related safety issues and received crisaborole for 1-4 consecutive initial on-TC during the extension study.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving honoraria, serving as speaker and consultant, and/or being an employee and/or shareholders of various sources including Pfizer.

Source: Geng B et al. Dermatol Ther (Heidelb). 2021 Aug 11. doi: 10.1007/s13555-021-00584-y.

 

Key clinical point: Continuous and long-term use of crisaborole is safe and effective for managing mild-to-moderate atopic dermatitis (AD).

Major finding: Following 1-4 crisaborole treatment cycles (TC), 77.6%, 76.3%, 59.4%, and 43.1% of patients achieved Investigator’s Static Global Assessment (ISGA) score of 0/1, respectively. After a 28-day off-TC, ISGA 0/1 was maintained in 49.5%, 37.8%, 44.4%, and 45.2% of patients from TC 1-4, respectively. Treatment-related adverse events were reported by less than 5% of patients across cohorts.

Study details: Findings are from CORE 3, a 48-week extension study including 418 patients aged 2 years or more with mild-to-moderate AD who completed CrisADe CORE 1 or CrisADe CORE 2 phase 3 trials without any drug-related safety issues and received crisaborole for 1-4 consecutive initial on-TC during the extension study.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving honoraria, serving as speaker and consultant, and/or being an employee and/or shareholders of various sources including Pfizer.

Source: Geng B et al. Dermatol Ther (Heidelb). 2021 Aug 11. doi: 10.1007/s13555-021-00584-y.

 

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Abrocitinib safe for long-term management of moderate-to-severe atopic dermatitis

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Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.

Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.

Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.

Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.

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Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.

Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.

Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.

Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.

Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.

Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.

Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.

Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.

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Atopic dermatitis: Abrocitinib effective as flexible dose in phase 3

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Key clinical point: Most patients with moderate-to-severe atopic dermatitis (AD) who initially respond to abrocitinib maintained response with reduced dosing. Moreover, rescue treatment with abrocitinib and topical therapy recaptured response in patients who flared.

Major finding: At the end of the maintenance period, flare probability was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Overall, 351 patients entered the rescue period, and Investigator’s Global Assessment of 0/1 response was recaptured in 36.6%, 58.8%, and 81.6% of patients in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo maintenance arms, respectively.

Study details: JADE REGIMEN, a phase 3 trial included 1,233 patients with moderate-to-severe AD. Patients (n=798) who responded to 12 weeks of abrocitinib 200 mg were randomly assigned to abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 40 weeks.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as advisor, investigator, advisory board member, speaker, lecturer, and/or consultant and/or receiving grants and personal fees from various sources including Pfizer and being present/past employees and shareholders of Pfizer.

Source: Blauvelt A et al. J Am Acad Dermatol. 2021 Aug 16. doi: 10.1016/j.jaad.2021.05.075.

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Key clinical point: Most patients with moderate-to-severe atopic dermatitis (AD) who initially respond to abrocitinib maintained response with reduced dosing. Moreover, rescue treatment with abrocitinib and topical therapy recaptured response in patients who flared.

Major finding: At the end of the maintenance period, flare probability was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Overall, 351 patients entered the rescue period, and Investigator’s Global Assessment of 0/1 response was recaptured in 36.6%, 58.8%, and 81.6% of patients in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo maintenance arms, respectively.

Study details: JADE REGIMEN, a phase 3 trial included 1,233 patients with moderate-to-severe AD. Patients (n=798) who responded to 12 weeks of abrocitinib 200 mg were randomly assigned to abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 40 weeks.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as advisor, investigator, advisory board member, speaker, lecturer, and/or consultant and/or receiving grants and personal fees from various sources including Pfizer and being present/past employees and shareholders of Pfizer.

Source: Blauvelt A et al. J Am Acad Dermatol. 2021 Aug 16. doi: 10.1016/j.jaad.2021.05.075.

Key clinical point: Most patients with moderate-to-severe atopic dermatitis (AD) who initially respond to abrocitinib maintained response with reduced dosing. Moreover, rescue treatment with abrocitinib and topical therapy recaptured response in patients who flared.

Major finding: At the end of the maintenance period, flare probability was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Overall, 351 patients entered the rescue period, and Investigator’s Global Assessment of 0/1 response was recaptured in 36.6%, 58.8%, and 81.6% of patients in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo maintenance arms, respectively.

Study details: JADE REGIMEN, a phase 3 trial included 1,233 patients with moderate-to-severe AD. Patients (n=798) who responded to 12 weeks of abrocitinib 200 mg were randomly assigned to abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 40 weeks.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as advisor, investigator, advisory board member, speaker, lecturer, and/or consultant and/or receiving grants and personal fees from various sources including Pfizer and being present/past employees and shareholders of Pfizer.

Source: Blauvelt A et al. J Am Acad Dermatol. 2021 Aug 16. doi: 10.1016/j.jaad.2021.05.075.

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Atopic dermatitis: Upadacitinib and topical corticosteroids combo shows long-term efficacy and safety in phase 3

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

Major finding: Among patients receiving upadacitinib 15 mg or 30 mg each in combination with TCS, 50.8% (95% confidence interval [CI], 45.1%-56.5%) and 69.0% (95% CI, 63.7%-74.3%) achieved 75% or more improvement in Eczema Area and Severity Index, whereas 33.5% (95% CI, 28.1%-38.9%) and 45.2% (95% CI, 39.5%-50.9%) achieved validated Investigator’s Global Assessment for AD 0/1, respectively, at week 52. Both doses of upadacitinib+TCS were well tolerated with no new safety risks or deaths.

Study details: Findings are 52-week results from AD Up, an ongoing phase 3 trial including 901 patients with chronic AD randomly assigned to upadacitinib 15 mg, upadacitinib 30 mg, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, advisor, and investigator and/or receiving consulting fees, honoraria, and grants from various sources including AbbVie. Five authors declared being employees and/or shareholders of AbbVie.

Source: Silverberg JI et al. J Allergy Clin Immunol. 2021 Aug 14. doi: 10.1016/j.jaci.2021.07.036.

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

Major finding: Among patients receiving upadacitinib 15 mg or 30 mg each in combination with TCS, 50.8% (95% confidence interval [CI], 45.1%-56.5%) and 69.0% (95% CI, 63.7%-74.3%) achieved 75% or more improvement in Eczema Area and Severity Index, whereas 33.5% (95% CI, 28.1%-38.9%) and 45.2% (95% CI, 39.5%-50.9%) achieved validated Investigator’s Global Assessment for AD 0/1, respectively, at week 52. Both doses of upadacitinib+TCS were well tolerated with no new safety risks or deaths.

Study details: Findings are 52-week results from AD Up, an ongoing phase 3 trial including 901 patients with chronic AD randomly assigned to upadacitinib 15 mg, upadacitinib 30 mg, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, advisor, and investigator and/or receiving consulting fees, honoraria, and grants from various sources including AbbVie. Five authors declared being employees and/or shareholders of AbbVie.

Source: Silverberg JI et al. J Allergy Clin Immunol. 2021 Aug 14. doi: 10.1016/j.jaci.2021.07.036.

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

Major finding: Among patients receiving upadacitinib 15 mg or 30 mg each in combination with TCS, 50.8% (95% confidence interval [CI], 45.1%-56.5%) and 69.0% (95% CI, 63.7%-74.3%) achieved 75% or more improvement in Eczema Area and Severity Index, whereas 33.5% (95% CI, 28.1%-38.9%) and 45.2% (95% CI, 39.5%-50.9%) achieved validated Investigator’s Global Assessment for AD 0/1, respectively, at week 52. Both doses of upadacitinib+TCS were well tolerated with no new safety risks or deaths.

Study details: Findings are 52-week results from AD Up, an ongoing phase 3 trial including 901 patients with chronic AD randomly assigned to upadacitinib 15 mg, upadacitinib 30 mg, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, advisor, and investigator and/or receiving consulting fees, honoraria, and grants from various sources including AbbVie. Five authors declared being employees and/or shareholders of AbbVie.

Source: Silverberg JI et al. J Allergy Clin Immunol. 2021 Aug 14. doi: 10.1016/j.jaci.2021.07.036.

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Atopic dermatitis tied to symptoms of depression and internalizing behavior in early childhood

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Key clinical point: Severe atopic dermatitis (AD) is associated with an almost 2-fold higher risk for depression and internalizing behavior in early childhood.

Major finding: Children with vs. without severe AD were more prone to experience depressive (adjusted odds ratio [aOR], 2.38; 95% confidence interval [CI], 1.21-4.72) and internalizing (aOR, 1.90; 95% CI, 1.14-3.16) symptoms.

Study details: Findings are from a longitudinal, population-based birth cohort study including 11,181 children who were followed up from birth for a mean duration of 10 years.

Disclosures: This study was funded by Wellcome Trust, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Advancing Translational Sciences, and National Institutes of Health. Dr. Wan and Dr. Abuabara declared receiving research funding from Pfizer.

Source: Kern C et al. JAMA Dermatol. 2021 Sep 1. doi: 10.1001/jamadermatol.2021.2657.

 

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Key clinical point: Severe atopic dermatitis (AD) is associated with an almost 2-fold higher risk for depression and internalizing behavior in early childhood.

Major finding: Children with vs. without severe AD were more prone to experience depressive (adjusted odds ratio [aOR], 2.38; 95% confidence interval [CI], 1.21-4.72) and internalizing (aOR, 1.90; 95% CI, 1.14-3.16) symptoms.

Study details: Findings are from a longitudinal, population-based birth cohort study including 11,181 children who were followed up from birth for a mean duration of 10 years.

Disclosures: This study was funded by Wellcome Trust, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Advancing Translational Sciences, and National Institutes of Health. Dr. Wan and Dr. Abuabara declared receiving research funding from Pfizer.

Source: Kern C et al. JAMA Dermatol. 2021 Sep 1. doi: 10.1001/jamadermatol.2021.2657.

 

Key clinical point: Severe atopic dermatitis (AD) is associated with an almost 2-fold higher risk for depression and internalizing behavior in early childhood.

Major finding: Children with vs. without severe AD were more prone to experience depressive (adjusted odds ratio [aOR], 2.38; 95% confidence interval [CI], 1.21-4.72) and internalizing (aOR, 1.90; 95% CI, 1.14-3.16) symptoms.

Study details: Findings are from a longitudinal, population-based birth cohort study including 11,181 children who were followed up from birth for a mean duration of 10 years.

Disclosures: This study was funded by Wellcome Trust, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Advancing Translational Sciences, and National Institutes of Health. Dr. Wan and Dr. Abuabara declared receiving research funding from Pfizer.

Source: Kern C et al. JAMA Dermatol. 2021 Sep 1. doi: 10.1001/jamadermatol.2021.2657.

 

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Oral abrocitinib plus topical therapy effective in adolescents with atopic dermatitis

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Key clinical point: The combination of oral abrocitinib and topical therapy was effective and well tolerated in adolescents with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 12, a significantly higher proportion of patients treated with abrocitinib 200 mg or 100 mg vs placebo achieved an Investigator’s Global Assessment response of 0/1 (46.2% and 41.6% vs 24.5%) and 75% or more improvement in Eczema Area and Severity Index (72.0% and 68.5% vs 41.5%; P < .05 for all). Serious adverse events were reported by less than 3% of patients.

Study details: Findings are from JADE TEEN, a phase 3 trial including 285 adolescents with moderate-to-severe AD and an inadequate response to topical medication or in need for systemic therapy, who were randomly assigned to receive once-daily oral abrocitinib, 200 mg or 100 mg, or placebo for 12 weeks in combination with topical therapy.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving nonfinancial support, grants, and personal fees from several sources including Pfizer. Four authors reported being employees and/or shareholders of Pfizer.

Source: Eichenfield LF et al. JAMA Dermatol. 2021 Aug 18. doi: 10.1001/jamadermatol.2021.2830.

 

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Key clinical point: The combination of oral abrocitinib and topical therapy was effective and well tolerated in adolescents with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 12, a significantly higher proportion of patients treated with abrocitinib 200 mg or 100 mg vs placebo achieved an Investigator’s Global Assessment response of 0/1 (46.2% and 41.6% vs 24.5%) and 75% or more improvement in Eczema Area and Severity Index (72.0% and 68.5% vs 41.5%; P < .05 for all). Serious adverse events were reported by less than 3% of patients.

Study details: Findings are from JADE TEEN, a phase 3 trial including 285 adolescents with moderate-to-severe AD and an inadequate response to topical medication or in need for systemic therapy, who were randomly assigned to receive once-daily oral abrocitinib, 200 mg or 100 mg, or placebo for 12 weeks in combination with topical therapy.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving nonfinancial support, grants, and personal fees from several sources including Pfizer. Four authors reported being employees and/or shareholders of Pfizer.

Source: Eichenfield LF et al. JAMA Dermatol. 2021 Aug 18. doi: 10.1001/jamadermatol.2021.2830.

 

Key clinical point: The combination of oral abrocitinib and topical therapy was effective and well tolerated in adolescents with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 12, a significantly higher proportion of patients treated with abrocitinib 200 mg or 100 mg vs placebo achieved an Investigator’s Global Assessment response of 0/1 (46.2% and 41.6% vs 24.5%) and 75% or more improvement in Eczema Area and Severity Index (72.0% and 68.5% vs 41.5%; P < .05 for all). Serious adverse events were reported by less than 3% of patients.

Study details: Findings are from JADE TEEN, a phase 3 trial including 285 adolescents with moderate-to-severe AD and an inadequate response to topical medication or in need for systemic therapy, who were randomly assigned to receive once-daily oral abrocitinib, 200 mg or 100 mg, or placebo for 12 weeks in combination with topical therapy.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving nonfinancial support, grants, and personal fees from several sources including Pfizer. Four authors reported being employees and/or shareholders of Pfizer.

Source: Eichenfield LF et al. JAMA Dermatol. 2021 Aug 18. doi: 10.1001/jamadermatol.2021.2830.

 

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Positive cytokeratin 19 expression promotes poor outcomes in HCC

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Thu, 09/30/2021 - 11:35

Key clinical point: Among hepatitis B virus-positive HCC patients, the 2-year recurrence-free survival rate was higher in those with negative expression of cytokeratin 19 compared to those who were CK19-positive. 

Major finding: In a multivariate analysis, CK19 expression was significantly associated with poor recurrence-free survival (hazard ratio 1.586, P = 0.042); other independent predictors were postoperative platelet > 300/L (HR 2.82), satellite nodule (HR = 1.71), 95 microvascular invasion (HR = 1.61), and tumor without capsule (HR 1.87).

Study details: The data come from a retrospective study of 674 adults with hepatitis B virus (HBV) positive hepatocellular carcinoma who underwent resection between January 2010 and May 2020. Researchers used a multivariate analysis to create a nomogram of 2-year recurrence-free survival.

Disclosures: The study was supported by the Gansu Science and Technology Department. The researchers had no financial conflicts to disclose.

Source: Shuyao W et al. J Gastrointest Surg. 2021 Sep 10. doi: 10.1007/s11605-021-05107-w.

 

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Key clinical point: Among hepatitis B virus-positive HCC patients, the 2-year recurrence-free survival rate was higher in those with negative expression of cytokeratin 19 compared to those who were CK19-positive. 

Major finding: In a multivariate analysis, CK19 expression was significantly associated with poor recurrence-free survival (hazard ratio 1.586, P = 0.042); other independent predictors were postoperative platelet > 300/L (HR 2.82), satellite nodule (HR = 1.71), 95 microvascular invasion (HR = 1.61), and tumor without capsule (HR 1.87).

Study details: The data come from a retrospective study of 674 adults with hepatitis B virus (HBV) positive hepatocellular carcinoma who underwent resection between January 2010 and May 2020. Researchers used a multivariate analysis to create a nomogram of 2-year recurrence-free survival.

Disclosures: The study was supported by the Gansu Science and Technology Department. The researchers had no financial conflicts to disclose.

Source: Shuyao W et al. J Gastrointest Surg. 2021 Sep 10. doi: 10.1007/s11605-021-05107-w.

 

Key clinical point: Among hepatitis B virus-positive HCC patients, the 2-year recurrence-free survival rate was higher in those with negative expression of cytokeratin 19 compared to those who were CK19-positive. 

Major finding: In a multivariate analysis, CK19 expression was significantly associated with poor recurrence-free survival (hazard ratio 1.586, P = 0.042); other independent predictors were postoperative platelet > 300/L (HR 2.82), satellite nodule (HR = 1.71), 95 microvascular invasion (HR = 1.61), and tumor without capsule (HR 1.87).

Study details: The data come from a retrospective study of 674 adults with hepatitis B virus (HBV) positive hepatocellular carcinoma who underwent resection between January 2010 and May 2020. Researchers used a multivariate analysis to create a nomogram of 2-year recurrence-free survival.

Disclosures: The study was supported by the Gansu Science and Technology Department. The researchers had no financial conflicts to disclose.

Source: Shuyao W et al. J Gastrointest Surg. 2021 Sep 10. doi: 10.1007/s11605-021-05107-w.

 

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Treatment-related adverse events correlate with improved outcomes in HCC patients on immune checkpoint inhibitor therapy

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Key clinical point: The development of treatment-related adverse events was significantly correlated with improve overall and progression-free survival in HCC patients treated with ICI monotherapy in clinical trials.

Major finding: Treatment-related adverse events were reported in 56% of patients with unresectable or advanced HCC; the development of adverse events was associated with longer overall survival and progression-free survival rates compared to patients who did not develop treatment-related adverse events (16.7 months vs 11.2 months; 5.5 months vs 2.2 months, respectively).

Study details: The data come from a cohort of 406 adults with unresectable or advanced HCC who were receiving immune checkpoint inhibitor (ICI) therapy while enrolled in clinical trials submitted to the Food and Drug Administration.

Disclosures: The study received no outside funding. Lead author Dr. Pinato disclosed lecture fees from ViiV Healthcare, and Bayer Healthcare; travel expenses from BMS and Bayer Healthcare; consulting fees for Mina Therapeutics, EISAI, Roche, AstraZeneca; and research funding (to his institution) from MSD and BMS.

Source: Pinato DJ et al. Eur J Cancer. 2021 Sep 8. doi: 10.1016/j.ejca.2021.08.020. 

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Key clinical point: The development of treatment-related adverse events was significantly correlated with improve overall and progression-free survival in HCC patients treated with ICI monotherapy in clinical trials.

Major finding: Treatment-related adverse events were reported in 56% of patients with unresectable or advanced HCC; the development of adverse events was associated with longer overall survival and progression-free survival rates compared to patients who did not develop treatment-related adverse events (16.7 months vs 11.2 months; 5.5 months vs 2.2 months, respectively).

Study details: The data come from a cohort of 406 adults with unresectable or advanced HCC who were receiving immune checkpoint inhibitor (ICI) therapy while enrolled in clinical trials submitted to the Food and Drug Administration.

Disclosures: The study received no outside funding. Lead author Dr. Pinato disclosed lecture fees from ViiV Healthcare, and Bayer Healthcare; travel expenses from BMS and Bayer Healthcare; consulting fees for Mina Therapeutics, EISAI, Roche, AstraZeneca; and research funding (to his institution) from MSD and BMS.

Source: Pinato DJ et al. Eur J Cancer. 2021 Sep 8. doi: 10.1016/j.ejca.2021.08.020. 

Key clinical point: The development of treatment-related adverse events was significantly correlated with improve overall and progression-free survival in HCC patients treated with ICI monotherapy in clinical trials.

Major finding: Treatment-related adverse events were reported in 56% of patients with unresectable or advanced HCC; the development of adverse events was associated with longer overall survival and progression-free survival rates compared to patients who did not develop treatment-related adverse events (16.7 months vs 11.2 months; 5.5 months vs 2.2 months, respectively).

Study details: The data come from a cohort of 406 adults with unresectable or advanced HCC who were receiving immune checkpoint inhibitor (ICI) therapy while enrolled in clinical trials submitted to the Food and Drug Administration.

Disclosures: The study received no outside funding. Lead author Dr. Pinato disclosed lecture fees from ViiV Healthcare, and Bayer Healthcare; travel expenses from BMS and Bayer Healthcare; consulting fees for Mina Therapeutics, EISAI, Roche, AstraZeneca; and research funding (to his institution) from MSD and BMS.

Source: Pinato DJ et al. Eur J Cancer. 2021 Sep 8. doi: 10.1016/j.ejca.2021.08.020. 

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