Atopic Dermatitis

Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.

Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.

Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.

Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 Source

Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.

Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.

Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.

Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 Source

Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.

Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.

Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.

Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 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: 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

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

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

Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”

In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.

Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”

In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.

Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”

In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.