Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.

Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD  (OR 20.4; P < .001) vs those with mild AD.

Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).

Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.

Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source

Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.

Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD  (OR 20.4; P < .001) vs those with mild AD.

Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).

Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.

Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source

Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.

Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD  (OR 20.4; P < .001) vs those with mild AD.

Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).

Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.

Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.

Major finding: At week 16, patients with BMI ≥ 25 kg/m² vs those with BMI < 25 kg/m² showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.

Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m² or ≥ 25 kg/m² who received dupilumab.

Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.

Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source

Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.

Major finding: At week 16, patients with BMI ≥ 25 kg/m² vs those with BMI < 25 kg/m² showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.

Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m² or ≥ 25 kg/m² who received dupilumab.

Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.

Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source

Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.

Major finding: At week 16, patients with BMI ≥ 25 kg/m² vs those with BMI < 25 kg/m² showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.

Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m² or ≥ 25 kg/m² who received dupilumab.

Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.

Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source

TOPLINE:

A small pool of major surgeries accounts for a large portion of opioids prescribed to children and teens, according to a new study.

METHODOLOGY:

• The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
• More than 200,000 procedures were included in the study.
• For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).

TAKEAWAY:

• In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
• In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
• Refill rates for children were all 1% or less.
• Refill rates for adolescents ranged from 2.3% to 9.6%.

IN PRACTICE:

“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.

SOURCE:

The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics

LIMITATIONS:

The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.

DISCLOSURES:

Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.

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

TOPLINE:

A small pool of major surgeries accounts for a large portion of opioids prescribed to children and teens, according to a new study.

METHODOLOGY:

• The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
• More than 200,000 procedures were included in the study.
• For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).

TAKEAWAY:

• In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
• In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
• Refill rates for children were all 1% or less.
• Refill rates for adolescents ranged from 2.3% to 9.6%.

IN PRACTICE:

“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.

SOURCE:

The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics

LIMITATIONS:

The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.

DISCLOSURES:

Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.

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

TOPLINE:

A small pool of major surgeries accounts for a large portion of opioids prescribed to children and teens, according to a new study.

METHODOLOGY:

• The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
• More than 200,000 procedures were included in the study.
• For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).

TAKEAWAY:

• In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
• In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
• Refill rates for children were all 1% or less.
• Refill rates for adolescents ranged from 2.3% to 9.6%.

IN PRACTICE:

“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.

SOURCE:

The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics

LIMITATIONS:

The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.

DISCLOSURES:

Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.

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

Key clinical point: Lebrikizumab monotherapy significantly improved skin symptoms and itch in adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 16, a higher proportion of patients treated with lebrikizumab vs placebo in ADvocate 1 and 2 achieved an Investigator’s Global Assessment score of 0 or 1 with at least a two-point improvement from baseline (46.6% vs 14.3%) and at least a 75% improvement in the Eczema Area and Severity Index score (62.0% vs 17.3%), with improvements observed as early as week 4 (all P < .05). Consistent corresponding results were observed for ADhere.

Study details: This post hoc analysis of the ADvocate 1 and 2 trials and ADhere trial included 148 adolescents with moderate to severe AD who were randomly assigned to receive subcutaneous lebrikizumab or placebo alone in ADvocate 1 and 2 or combined with topical corticosteroids in ADhere.

Disclosures: The three trials were funded by Dermira, Inc., a subsidiary wholly owned by Eli Lilly and Company. Four authors declared being employees of Eli Lilly and Company. Several authors declared being consultants or speakers for or having other ties with various sources, including Eli Lilly and Company.

Source: Hebert AA, Flohr C, Hong HC, et al. Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials. J Dermatolog Treat. 2024;35:2324833. doi: 10.1080/09546634.2024.2324833 Source

Key clinical point: Lebrikizumab monotherapy significantly improved skin symptoms and itch in adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 16, a higher proportion of patients treated with lebrikizumab vs placebo in ADvocate 1 and 2 achieved an Investigator’s Global Assessment score of 0 or 1 with at least a two-point improvement from baseline (46.6% vs 14.3%) and at least a 75% improvement in the Eczema Area and Severity Index score (62.0% vs 17.3%), with improvements observed as early as week 4 (all P < .05). Consistent corresponding results were observed for ADhere.

Study details: This post hoc analysis of the ADvocate 1 and 2 trials and ADhere trial included 148 adolescents with moderate to severe AD who were randomly assigned to receive subcutaneous lebrikizumab or placebo alone in ADvocate 1 and 2 or combined with topical corticosteroids in ADhere.

Disclosures: The three trials were funded by Dermira, Inc., a subsidiary wholly owned by Eli Lilly and Company. Four authors declared being employees of Eli Lilly and Company. Several authors declared being consultants or speakers for or having other ties with various sources, including Eli Lilly and Company.

Source: Hebert AA, Flohr C, Hong HC, et al. Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials. J Dermatolog Treat. 2024;35:2324833. doi: 10.1080/09546634.2024.2324833 Source

Key clinical point: Lebrikizumab monotherapy significantly improved skin symptoms and itch in adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 16, a higher proportion of patients treated with lebrikizumab vs placebo in ADvocate 1 and 2 achieved an Investigator’s Global Assessment score of 0 or 1 with at least a two-point improvement from baseline (46.6% vs 14.3%) and at least a 75% improvement in the Eczema Area and Severity Index score (62.0% vs 17.3%), with improvements observed as early as week 4 (all P < .05). Consistent corresponding results were observed for ADhere.

Study details: This post hoc analysis of the ADvocate 1 and 2 trials and ADhere trial included 148 adolescents with moderate to severe AD who were randomly assigned to receive subcutaneous lebrikizumab or placebo alone in ADvocate 1 and 2 or combined with topical corticosteroids in ADhere.

Disclosures: The three trials were funded by Dermira, Inc., a subsidiary wholly owned by Eli Lilly and Company. Four authors declared being employees of Eli Lilly and Company. Several authors declared being consultants or speakers for or having other ties with various sources, including Eli Lilly and Company.

Source: Hebert AA, Flohr C, Hong HC, et al. Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials. J Dermatolog Treat. 2024;35:2324833. doi: 10.1080/09546634.2024.2324833 Source

Key clinical point: Dupilumab demonstrated sustained clinical benefits and an acceptable long-term safety profile in children age 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis (AD).

Major finding: At week 52, 36.2% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 96.6%, 79.3%, and 58.6% of patients achieved at least a 50%, 75%, and 90% improvement in the Eczema Area and Severity Index score, respectively. Overall, 78.2% of patients reported one or more treatment-emergent adverse events, most of mild or moderate severity.

Study details: Findings are from the phase 3 LIBERTY AD PED-OLE study that included 142 children with moderate to severe AD who had previously participated in the LIBERTY AD PRESCHOOL part B study and received a weight-tiered dose of 200 mg or 300 mg of subcutaneous dupilumab every 4 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Five authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared having ties with various sources, including Sanofi and Regeneron.

Source: Paller AS, Siegfried EC, Simpson EL, et al. Dupilumab safety and efficacy up to 1 year in children aged 6 months to 5 years with atopic dermatitis: Results from a phase 3 open-label extension study. Am J Clin Dermatol. 2024 (May 14). doi: 10.1007/s40257-024-00859-y Source

Key clinical point: Dupilumab demonstrated sustained clinical benefits and an acceptable long-term safety profile in children age 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis (AD).

Major finding: At week 52, 36.2% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 96.6%, 79.3%, and 58.6% of patients achieved at least a 50%, 75%, and 90% improvement in the Eczema Area and Severity Index score, respectively. Overall, 78.2% of patients reported one or more treatment-emergent adverse events, most of mild or moderate severity.

Study details: Findings are from the phase 3 LIBERTY AD PED-OLE study that included 142 children with moderate to severe AD who had previously participated in the LIBERTY AD PRESCHOOL part B study and received a weight-tiered dose of 200 mg or 300 mg of subcutaneous dupilumab every 4 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Five authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared having ties with various sources, including Sanofi and Regeneron.

Source: Paller AS, Siegfried EC, Simpson EL, et al. Dupilumab safety and efficacy up to 1 year in children aged 6 months to 5 years with atopic dermatitis: Results from a phase 3 open-label extension study. Am J Clin Dermatol. 2024 (May 14). doi: 10.1007/s40257-024-00859-y Source

Key clinical point: Dupilumab demonstrated sustained clinical benefits and an acceptable long-term safety profile in children age 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis (AD).

Major finding: At week 52, 36.2% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 96.6%, 79.3%, and 58.6% of patients achieved at least a 50%, 75%, and 90% improvement in the Eczema Area and Severity Index score, respectively. Overall, 78.2% of patients reported one or more treatment-emergent adverse events, most of mild or moderate severity.

Study details: Findings are from the phase 3 LIBERTY AD PED-OLE study that included 142 children with moderate to severe AD who had previously participated in the LIBERTY AD PRESCHOOL part B study and received a weight-tiered dose of 200 mg or 300 mg of subcutaneous dupilumab every 4 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Five authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared having ties with various sources, including Sanofi and Regeneron.

Source: Paller AS, Siegfried EC, Simpson EL, et al. Dupilumab safety and efficacy up to 1 year in children aged 6 months to 5 years with atopic dermatitis: Results from a phase 3 open-label extension study. Am J Clin Dermatol. 2024 (May 14). doi: 10.1007/s40257-024-00859-y Source

The MUC-1 vaccine tecemotide plus standard neoadjuvant systemic therapy was shown to notably improve distant relapse-free survival and overall survival rates in breast cancer patients, in a new study.

“This is the first successful study of a breast cancer vaccine to date,” Christian F. Singer, MD, said during an interview. Dr. Singer, the lead author of the new study, presented the results during a poster session at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO).

Previously known as both liposomal BLP25 and Stimuvax, tecemotide is an antigen-specific immunotherapy that targets the cancer therapy–resistant MUC-1 glycoprotein, which is overexpressed in over 90% of breast cancers. Tecemotide also has been shown to moderately improve overall survival rates in non–small cell lung cancer.

“We are not at all surprised by the results of this study in breast cancer,” Gregory T. Wurz, PhD, senior researcher at RCU Labs in Lincoln, California, said in an interview.

Dr. Wurz is coauthor of several studies on peptide vaccines, including a mouse model study of human MUC-1–expressing mammary tumors showing that tecemotide combined with letrozole had additive antitumor activity. Another paper he coauthored showed that ospemifene enhanced the immune response to tecemotide in both tumor-bearing and non–tumor-bearing mice. These findings, combined with other research, led to the creation of a patented method of combining therapies to enhance the efficacy of immunotherapy in the treatment of cancer and infectious diseases. Dr. Wurz was not involved in the new research that Dr. Singer presented at ASCO.
 

Study Methods and Results

Dr. Singer, head of obstetrics and gynecology at the Medical University of Vienna, Vienna, Austria, and coauthors randomized 400 patients with HER2-negative early breast cancer in a prospective, multicenter, two-arm, phase 2 ABCSG 34 trial to receive preoperative standard of care (SOC) neoadjuvant treatment with or without tecemotide.

Postmenopausal women with luminal A tumors were given 6 months of letrozole as SOC. Postmenopausal patients with triple-negative breast cancer, luminal B tumors, in whom chemotherapy was SOC, as well as all premenopausal study participants, were given four cycles of both epirubicin cyclophosphamide and docetaxel every 3 weeks.

The study’s primary endpoint was the residual cancer burden at the time of surgery.

Long-term outcomes were measured as part of a translational project, while distant relapse-free survival (DRFS) and overall survival (OS) were analyzed with Cox regression models. Long-term outcome data were available for 291 women, of whom 236 had received chemotherapy as SOC.

While tecemotide plus neoadjuvant SOC was not associated with a significant increase in residual cancer burden (RCB) at the time of surgery (36.4% vs 31.5%; P = .42; 40.5% vs 34.8%; P = .37 for the chemotherapy-only cohort), follow-up at 7 years showed 80.8% of patients who had received SOC plus tecemotide were still alive and free from metastasis.

In patients who had received SOC alone, the OS rate at 7 years with no metastasis was 64.7% (hazard ratio [HR] for DRFS, 0.53; 95% CI, 0.34-0.83; P = .005). The OS rate for the study group was 83.0% vs 68.2% in the non-tecemotide cohort (HR for OS, 0.53; 95% CI, 0.33-0.85; P = .008).

The lack of RCB signal at the endpoints, “tells us that pathologic complete response and residual cancer burden simply are not adequate endpoints for cancer vaccination studies and we need to find other predictive/prognostic markers, said Dr. Singer. “We are currently looking into this in exploratory studies.”

The chemotherapy plus tecemotide cohort had a notable outcome with a DRFS of 81.9% vs 65.0% in the SOC group (HR, 0.50; 95% CI, 0.31-0.83; P = .007), and an OS rate of 83.6% vs 67.8% (HR, 0.51; 95% CI, 0.30-0.88; P = .016).

Dr. Singer characterized the HRs as intriguing, saying that they “pave the way for new trials.”
 

Ideas for Further Study of Tecemotide

“What we would like to see next for tecemotide are clinical studies that explore whether immunomodulatory agents can further enhance the response to tecemotide in lung, breast, and potentially other MUC-1–expressing cancers,” Dr. Wurz said.

Future phase 3 studies of MUC-1 cancer vaccines, possibly those using mRNA technology, are yet to come, according to Dr. Singer. “We also need to find out why the vaccine works sometimes and sometimes not.”

Dr. Singer disclosed financial ties to AstraZeneca/MedImmune, Daiichi Sankyo Europe, Novartis, Gilead Sciences, Sanofi/Aventis, Amgen, Myriad Genetics, and Roche. Dr. Wurz had no disclosures, but his research partner and founder of RCU Labs, Michael De Gregorio, is the sole inventor of the patent referenced in the story. That patent has been assigned to the Regents of the University of California.

The MUC-1 vaccine tecemotide plus standard neoadjuvant systemic therapy was shown to notably improve distant relapse-free survival and overall survival rates in breast cancer patients, in a new study.

“This is the first successful study of a breast cancer vaccine to date,” Christian F. Singer, MD, said during an interview. Dr. Singer, the lead author of the new study, presented the results during a poster session at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO).

Previously known as both liposomal BLP25 and Stimuvax, tecemotide is an antigen-specific immunotherapy that targets the cancer therapy–resistant MUC-1 glycoprotein, which is overexpressed in over 90% of breast cancers. Tecemotide also has been shown to moderately improve overall survival rates in non–small cell lung cancer.

“We are not at all surprised by the results of this study in breast cancer,” Gregory T. Wurz, PhD, senior researcher at RCU Labs in Lincoln, California, said in an interview.

Dr. Wurz is coauthor of several studies on peptide vaccines, including a mouse model study of human MUC-1–expressing mammary tumors showing that tecemotide combined with letrozole had additive antitumor activity. Another paper he coauthored showed that ospemifene enhanced the immune response to tecemotide in both tumor-bearing and non–tumor-bearing mice. These findings, combined with other research, led to the creation of a patented method of combining therapies to enhance the efficacy of immunotherapy in the treatment of cancer and infectious diseases. Dr. Wurz was not involved in the new research that Dr. Singer presented at ASCO.
 

Study Methods and Results

Dr. Singer, head of obstetrics and gynecology at the Medical University of Vienna, Vienna, Austria, and coauthors randomized 400 patients with HER2-negative early breast cancer in a prospective, multicenter, two-arm, phase 2 ABCSG 34 trial to receive preoperative standard of care (SOC) neoadjuvant treatment with or without tecemotide.

Postmenopausal women with luminal A tumors were given 6 months of letrozole as SOC. Postmenopausal patients with triple-negative breast cancer, luminal B tumors, in whom chemotherapy was SOC, as well as all premenopausal study participants, were given four cycles of both epirubicin cyclophosphamide and docetaxel every 3 weeks.

The study’s primary endpoint was the residual cancer burden at the time of surgery.

Long-term outcomes were measured as part of a translational project, while distant relapse-free survival (DRFS) and overall survival (OS) were analyzed with Cox regression models. Long-term outcome data were available for 291 women, of whom 236 had received chemotherapy as SOC.

While tecemotide plus neoadjuvant SOC was not associated with a significant increase in residual cancer burden (RCB) at the time of surgery (36.4% vs 31.5%; P = .42; 40.5% vs 34.8%; P = .37 for the chemotherapy-only cohort), follow-up at 7 years showed 80.8% of patients who had received SOC plus tecemotide were still alive and free from metastasis.

In patients who had received SOC alone, the OS rate at 7 years with no metastasis was 64.7% (hazard ratio [HR] for DRFS, 0.53; 95% CI, 0.34-0.83; P = .005). The OS rate for the study group was 83.0% vs 68.2% in the non-tecemotide cohort (HR for OS, 0.53; 95% CI, 0.33-0.85; P = .008).

The lack of RCB signal at the endpoints, “tells us that pathologic complete response and residual cancer burden simply are not adequate endpoints for cancer vaccination studies and we need to find other predictive/prognostic markers, said Dr. Singer. “We are currently looking into this in exploratory studies.”

The chemotherapy plus tecemotide cohort had a notable outcome with a DRFS of 81.9% vs 65.0% in the SOC group (HR, 0.50; 95% CI, 0.31-0.83; P = .007), and an OS rate of 83.6% vs 67.8% (HR, 0.51; 95% CI, 0.30-0.88; P = .016).

Dr. Singer characterized the HRs as intriguing, saying that they “pave the way for new trials.”
 

Ideas for Further Study of Tecemotide

“What we would like to see next for tecemotide are clinical studies that explore whether immunomodulatory agents can further enhance the response to tecemotide in lung, breast, and potentially other MUC-1–expressing cancers,” Dr. Wurz said.

Future phase 3 studies of MUC-1 cancer vaccines, possibly those using mRNA technology, are yet to come, according to Dr. Singer. “We also need to find out why the vaccine works sometimes and sometimes not.”

Dr. Singer disclosed financial ties to AstraZeneca/MedImmune, Daiichi Sankyo Europe, Novartis, Gilead Sciences, Sanofi/Aventis, Amgen, Myriad Genetics, and Roche. Dr. Wurz had no disclosures, but his research partner and founder of RCU Labs, Michael De Gregorio, is the sole inventor of the patent referenced in the story. That patent has been assigned to the Regents of the University of California.

The MUC-1 vaccine tecemotide plus standard neoadjuvant systemic therapy was shown to notably improve distant relapse-free survival and overall survival rates in breast cancer patients, in a new study.

“This is the first successful study of a breast cancer vaccine to date,” Christian F. Singer, MD, said during an interview. Dr. Singer, the lead author of the new study, presented the results during a poster session at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO).

Previously known as both liposomal BLP25 and Stimuvax, tecemotide is an antigen-specific immunotherapy that targets the cancer therapy–resistant MUC-1 glycoprotein, which is overexpressed in over 90% of breast cancers. Tecemotide also has been shown to moderately improve overall survival rates in non–small cell lung cancer.

“We are not at all surprised by the results of this study in breast cancer,” Gregory T. Wurz, PhD, senior researcher at RCU Labs in Lincoln, California, said in an interview.

Dr. Wurz is coauthor of several studies on peptide vaccines, including a mouse model study of human MUC-1–expressing mammary tumors showing that tecemotide combined with letrozole had additive antitumor activity. Another paper he coauthored showed that ospemifene enhanced the immune response to tecemotide in both tumor-bearing and non–tumor-bearing mice. These findings, combined with other research, led to the creation of a patented method of combining therapies to enhance the efficacy of immunotherapy in the treatment of cancer and infectious diseases. Dr. Wurz was not involved in the new research that Dr. Singer presented at ASCO.
 

Study Methods and Results

Dr. Singer, head of obstetrics and gynecology at the Medical University of Vienna, Vienna, Austria, and coauthors randomized 400 patients with HER2-negative early breast cancer in a prospective, multicenter, two-arm, phase 2 ABCSG 34 trial to receive preoperative standard of care (SOC) neoadjuvant treatment with or without tecemotide.

Postmenopausal women with luminal A tumors were given 6 months of letrozole as SOC. Postmenopausal patients with triple-negative breast cancer, luminal B tumors, in whom chemotherapy was SOC, as well as all premenopausal study participants, were given four cycles of both epirubicin cyclophosphamide and docetaxel every 3 weeks.

The study’s primary endpoint was the residual cancer burden at the time of surgery.

Long-term outcomes were measured as part of a translational project, while distant relapse-free survival (DRFS) and overall survival (OS) were analyzed with Cox regression models. Long-term outcome data were available for 291 women, of whom 236 had received chemotherapy as SOC.

While tecemotide plus neoadjuvant SOC was not associated with a significant increase in residual cancer burden (RCB) at the time of surgery (36.4% vs 31.5%; P = .42; 40.5% vs 34.8%; P = .37 for the chemotherapy-only cohort), follow-up at 7 years showed 80.8% of patients who had received SOC plus tecemotide were still alive and free from metastasis.

In patients who had received SOC alone, the OS rate at 7 years with no metastasis was 64.7% (hazard ratio [HR] for DRFS, 0.53; 95% CI, 0.34-0.83; P = .005). The OS rate for the study group was 83.0% vs 68.2% in the non-tecemotide cohort (HR for OS, 0.53; 95% CI, 0.33-0.85; P = .008).

The lack of RCB signal at the endpoints, “tells us that pathologic complete response and residual cancer burden simply are not adequate endpoints for cancer vaccination studies and we need to find other predictive/prognostic markers, said Dr. Singer. “We are currently looking into this in exploratory studies.”

The chemotherapy plus tecemotide cohort had a notable outcome with a DRFS of 81.9% vs 65.0% in the SOC group (HR, 0.50; 95% CI, 0.31-0.83; P = .007), and an OS rate of 83.6% vs 67.8% (HR, 0.51; 95% CI, 0.30-0.88; P = .016).

Dr. Singer characterized the HRs as intriguing, saying that they “pave the way for new trials.”
 

Ideas for Further Study of Tecemotide

“What we would like to see next for tecemotide are clinical studies that explore whether immunomodulatory agents can further enhance the response to tecemotide in lung, breast, and potentially other MUC-1–expressing cancers,” Dr. Wurz said.

Future phase 3 studies of MUC-1 cancer vaccines, possibly those using mRNA technology, are yet to come, according to Dr. Singer. “We also need to find out why the vaccine works sometimes and sometimes not.”

Dr. Singer disclosed financial ties to AstraZeneca/MedImmune, Daiichi Sankyo Europe, Novartis, Gilead Sciences, Sanofi/Aventis, Amgen, Myriad Genetics, and Roche. Dr. Wurz had no disclosures, but his research partner and founder of RCU Labs, Michael De Gregorio, is the sole inventor of the patent referenced in the story. That patent has been assigned to the Regents of the University of California.

Key clinical point: Use of e-cigarettes by parents is associated with an increased risk for atopic dermatitis (AD) in children.

Major finding: The prevalence of parental e-cigarette use was 18.0% (95% CI 16.5%-19.0%) among children with AD and 14.4% (95% CI 13.9%-15.0%) among those without AD. The risk for AD was significantly higher in children whose parents used e-cigarettes (adjusted odds ratio 1.24; P = .002).

Study details: This retrospective, cross-sectional analysis of data from the US National Health Interview Survey (2014-2018) included 48,637,111 children (age < 18 years), of whom 6,354,515 had a history of AD.

Disclosures: This study did not receive specific funding from any sources. Albert S. Chiou declared receiving consultation fees from Corvus Therapeutics outside the submitted work.

Source: Youn GM, Sarin KY, Chiou AS, et al. Parental e-cigarette use and pediatric atopic dermatitis. JAMA Dermatol. 2024 (May 22). doi: 10.1001/jamadermatol.2024.1283 Source

Key clinical point: Use of e-cigarettes by parents is associated with an increased risk for atopic dermatitis (AD) in children.

Major finding: The prevalence of parental e-cigarette use was 18.0% (95% CI 16.5%-19.0%) among children with AD and 14.4% (95% CI 13.9%-15.0%) among those without AD. The risk for AD was significantly higher in children whose parents used e-cigarettes (adjusted odds ratio 1.24; P = .002).

Study details: This retrospective, cross-sectional analysis of data from the US National Health Interview Survey (2014-2018) included 48,637,111 children (age < 18 years), of whom 6,354,515 had a history of AD.

Disclosures: This study did not receive specific funding from any sources. Albert S. Chiou declared receiving consultation fees from Corvus Therapeutics outside the submitted work.

Source: Youn GM, Sarin KY, Chiou AS, et al. Parental e-cigarette use and pediatric atopic dermatitis. JAMA Dermatol. 2024 (May 22). doi: 10.1001/jamadermatol.2024.1283 Source

Key clinical point: Use of e-cigarettes by parents is associated with an increased risk for atopic dermatitis (AD) in children.

Major finding: The prevalence of parental e-cigarette use was 18.0% (95% CI 16.5%-19.0%) among children with AD and 14.4% (95% CI 13.9%-15.0%) among those without AD. The risk for AD was significantly higher in children whose parents used e-cigarettes (adjusted odds ratio 1.24; P = .002).

Study details: This retrospective, cross-sectional analysis of data from the US National Health Interview Survey (2014-2018) included 48,637,111 children (age < 18 years), of whom 6,354,515 had a history of AD.

Disclosures: This study did not receive specific funding from any sources. Albert S. Chiou declared receiving consultation fees from Corvus Therapeutics outside the submitted work.

Source: Youn GM, Sarin KY, Chiou AS, et al. Parental e-cigarette use and pediatric atopic dermatitis. JAMA Dermatol. 2024 (May 22). doi: 10.1001/jamadermatol.2024.1283 Source

Key clinical point: High dietary intake of sodium, estimated according to 24-hour urinary sodium excretion, was associated with a greater likelihood of atopic dermatitis (AD) diagnosis, having active AD, and increasing severity of AD.

Major finding: A 1-g increase in estimated 24-hour urine sodium excretion was associated with an increased likelihood of AD (adjusted odds ratio [aOR] 1.11; 95% CI 1.07-1.14), active AD (aOR 1.16; 95% CI 1.05-1.28), and increasing AD severity (aOR 1.11; 95% CI 1.07-1.15).

Study details: This cross-sectional study evaluated the association between high levels of dietary sodium intake and AD prevalence, activity, and severity in 215,832 adults from the UK Biobank cohort, of whom 10,839 had AD.

Disclosures: This study was supported by grants from the Medical Student in Aging Research Program and US National Institute on Aging and by the National Eczema Association. One author declared receiving research funding to her institution and consulting fees from various sources.

Source: Chiang BM, Ye M, Chattopadhyay A, et al. Sodium intake and atopic dermatitis. JAMA Dermatol. 2024 (Jun 5). doi: 10.1001/jamadermatol.2024.1544 Source

Key clinical point: High dietary intake of sodium, estimated according to 24-hour urinary sodium excretion, was associated with a greater likelihood of atopic dermatitis (AD) diagnosis, having active AD, and increasing severity of AD.

Major finding: A 1-g increase in estimated 24-hour urine sodium excretion was associated with an increased likelihood of AD (adjusted odds ratio [aOR] 1.11; 95% CI 1.07-1.14), active AD (aOR 1.16; 95% CI 1.05-1.28), and increasing AD severity (aOR 1.11; 95% CI 1.07-1.15).

Study details: This cross-sectional study evaluated the association between high levels of dietary sodium intake and AD prevalence, activity, and severity in 215,832 adults from the UK Biobank cohort, of whom 10,839 had AD.

Disclosures: This study was supported by grants from the Medical Student in Aging Research Program and US National Institute on Aging and by the National Eczema Association. One author declared receiving research funding to her institution and consulting fees from various sources.

Source: Chiang BM, Ye M, Chattopadhyay A, et al. Sodium intake and atopic dermatitis. JAMA Dermatol. 2024 (Jun 5). doi: 10.1001/jamadermatol.2024.1544 Source

Key clinical point: High dietary intake of sodium, estimated according to 24-hour urinary sodium excretion, was associated with a greater likelihood of atopic dermatitis (AD) diagnosis, having active AD, and increasing severity of AD.

Major finding: A 1-g increase in estimated 24-hour urine sodium excretion was associated with an increased likelihood of AD (adjusted odds ratio [aOR] 1.11; 95% CI 1.07-1.14), active AD (aOR 1.16; 95% CI 1.05-1.28), and increasing AD severity (aOR 1.11; 95% CI 1.07-1.15).

Study details: This cross-sectional study evaluated the association between high levels of dietary sodium intake and AD prevalence, activity, and severity in 215,832 adults from the UK Biobank cohort, of whom 10,839 had AD.

Disclosures: This study was supported by grants from the Medical Student in Aging Research Program and US National Institute on Aging and by the National Eczema Association. One author declared receiving research funding to her institution and consulting fees from various sources.

Source: Chiang BM, Ye M, Chattopadhyay A, et al. Sodium intake and atopic dermatitis. JAMA Dermatol. 2024 (Jun 5). doi: 10.1001/jamadermatol.2024.1544 Source