Atopic Dermatitis

Key clinical point: Treatment with an emollient plus balm significantly reduced corticosteroid use compared with routine treatment with commercial emollients in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: Until day 28, patients receiving emollient plus balm vs a commercial classical emollient used a significantly lower mean amount of corticosteroid (6.03 vs 9.16 g; P  =  .041), with corticosteroids being used on fewer days (37.5% vs 46.9% of days; P  =  .0256) and fewer times daily (0.55 vs 0.71 applications/day; P  =  .0203).

Study details: This single-center randomized controlled study included 119 patients age ≥3 years with mild-to-moderate AD who were randomly assigned to receive an emollient plus balm combination (n = 58) or a classical emollient (n = 61) for 28 days, both along with topical corticosteroids when necessary and as per prescription.

Disclosures: This study was supported by La Roche-Posay (LRP). A-L Demessant-Flavigny, S Salah, and D Kerob declared being employees of LRP. H Zelenkova reported no conflicts of interest.

Source: Zelenkova H et al. Impact of daily use of emollient ‘plus’ on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study. J Eur Acad Dermatol Venereol. 2023 (Apr 24). Doi: 10.1111/jdv.18947

Key clinical point: Treatment with an emollient plus balm significantly reduced corticosteroid use compared with routine treatment with commercial emollients in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: Until day 28, patients receiving emollient plus balm vs a commercial classical emollient used a significantly lower mean amount of corticosteroid (6.03 vs 9.16 g; P  =  .041), with corticosteroids being used on fewer days (37.5% vs 46.9% of days; P  =  .0256) and fewer times daily (0.55 vs 0.71 applications/day; P  =  .0203).

Study details: This single-center randomized controlled study included 119 patients age ≥3 years with mild-to-moderate AD who were randomly assigned to receive an emollient plus balm combination (n = 58) or a classical emollient (n = 61) for 28 days, both along with topical corticosteroids when necessary and as per prescription.

Disclosures: This study was supported by La Roche-Posay (LRP). A-L Demessant-Flavigny, S Salah, and D Kerob declared being employees of LRP. H Zelenkova reported no conflicts of interest.

Source: Zelenkova H et al. Impact of daily use of emollient ‘plus’ on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study. J Eur Acad Dermatol Venereol. 2023 (Apr 24). Doi: 10.1111/jdv.18947

Key clinical point: Treatment with an emollient plus balm significantly reduced corticosteroid use compared with routine treatment with commercial emollients in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: Until day 28, patients receiving emollient plus balm vs a commercial classical emollient used a significantly lower mean amount of corticosteroid (6.03 vs 9.16 g; P  =  .041), with corticosteroids being used on fewer days (37.5% vs 46.9% of days; P  =  .0256) and fewer times daily (0.55 vs 0.71 applications/day; P  =  .0203).

Study details: This single-center randomized controlled study included 119 patients age ≥3 years with mild-to-moderate AD who were randomly assigned to receive an emollient plus balm combination (n = 58) or a classical emollient (n = 61) for 28 days, both along with topical corticosteroids when necessary and as per prescription.

Disclosures: This study was supported by La Roche-Posay (LRP). A-L Demessant-Flavigny, S Salah, and D Kerob declared being employees of LRP. H Zelenkova reported no conflicts of interest.

Source: Zelenkova H et al. Impact of daily use of emollient ‘plus’ on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study. J Eur Acad Dermatol Venereol. 2023 (Apr 24). Doi: 10.1111/jdv.18947

Key clinical point: Tralokinumab demonstrated promising efficacy and an acceptable safety profile in a real-world cohort of patients with a long history of moderate-to-severe atopic dermatitis (AD) and multiple treatment failures.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI), SCORing AD, and peak pruritus numerical rating scale scores improved by 70.4%, 64.1%, and 57.1%, respectively (all P < .0001), and 57.6% of patients achieved a ≥75% improvement in EASI scores. The safety profile was acceptable.

Study details: Findings are from a multicenter retrospective study including 85 adult patients with moderate-to-severe AD who had unsuccessfully used prior therapy with systemics, biologics, or a Janus kinase inhibitor (n = 27) or were naive to advanced therapy (n = 58) and received tralokinumab.

Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, or consultants for or receiving lecture, speaking, or consulting fees from various sources.

Source: Pereyra-Rodriguez JJ et al. Treatment of severe atopic dermatitis with tralokinumab in real clinical practice. Short-term effectiveness and safety results. Clin Exp Dermatol. 2023 (Apr 25). Doi: 10.1093/ced/llad153

Key clinical point: Tralokinumab demonstrated promising efficacy and an acceptable safety profile in a real-world cohort of patients with a long history of moderate-to-severe atopic dermatitis (AD) and multiple treatment failures.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI), SCORing AD, and peak pruritus numerical rating scale scores improved by 70.4%, 64.1%, and 57.1%, respectively (all P < .0001), and 57.6% of patients achieved a ≥75% improvement in EASI scores. The safety profile was acceptable.

Study details: Findings are from a multicenter retrospective study including 85 adult patients with moderate-to-severe AD who had unsuccessfully used prior therapy with systemics, biologics, or a Janus kinase inhibitor (n = 27) or were naive to advanced therapy (n = 58) and received tralokinumab.

Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, or consultants for or receiving lecture, speaking, or consulting fees from various sources.

Source: Pereyra-Rodriguez JJ et al. Treatment of severe atopic dermatitis with tralokinumab in real clinical practice. Short-term effectiveness and safety results. Clin Exp Dermatol. 2023 (Apr 25). Doi: 10.1093/ced/llad153

Key clinical point: Tralokinumab demonstrated promising efficacy and an acceptable safety profile in a real-world cohort of patients with a long history of moderate-to-severe atopic dermatitis (AD) and multiple treatment failures.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI), SCORing AD, and peak pruritus numerical rating scale scores improved by 70.4%, 64.1%, and 57.1%, respectively (all P < .0001), and 57.6% of patients achieved a ≥75% improvement in EASI scores. The safety profile was acceptable.

Study details: Findings are from a multicenter retrospective study including 85 adult patients with moderate-to-severe AD who had unsuccessfully used prior therapy with systemics, biologics, or a Janus kinase inhibitor (n = 27) or were naive to advanced therapy (n = 58) and received tralokinumab.

Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, or consultants for or receiving lecture, speaking, or consulting fees from various sources.

Source: Pereyra-Rodriguez JJ et al. Treatment of severe atopic dermatitis with tralokinumab in real clinical practice. Short-term effectiveness and safety results. Clin Exp Dermatol. 2023 (Apr 25). Doi: 10.1093/ced/llad153

Key clinical point: Compared with the usual emollient and cleanser skincare routine, an emollient plus balm combination significantly improved pruritus in patients with moderate-to-severe atopic dermatitis (AD) receiving systemic treatment.

Major finding: Patients treated with an emollient plus balm combination after pre-cleaning with a syndet (emollient “plus” group) vs the usual emollient and cleanser skincare routine (control group) had a significantly greater mean decrease in current pruritus after 70 days (P  =  .0277) and worse pruritus over the last 24 hours after 42 days (P  =  .025) of treatment.

Study details: This randomized controlled multicenter study included 57 adult patients with moderate-to-severe AD using systemic treatment who were randomly assigned 1:1 to the emollient “plus” group or the control group.

Disclosures: This study was funded by La Roche-Posay (LRP). Two authors declared being employees of LRP, and some authors declared serving on advisory boards or as speakers, consultants, or investigators in the presented trial or other clinical trials sponsored by various sources, including LRP.

Source: Magnolo N et al. Comparison of different skin care regimens in patients with moderate to severe atopic dermatitis receiving systemic treatment: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 (Apr 24). Doi: 10.1111/jdv.18949

Key clinical point: Compared with the usual emollient and cleanser skincare routine, an emollient plus balm combination significantly improved pruritus in patients with moderate-to-severe atopic dermatitis (AD) receiving systemic treatment.

Major finding: Patients treated with an emollient plus balm combination after pre-cleaning with a syndet (emollient “plus” group) vs the usual emollient and cleanser skincare routine (control group) had a significantly greater mean decrease in current pruritus after 70 days (P  =  .0277) and worse pruritus over the last 24 hours after 42 days (P  =  .025) of treatment.

Study details: This randomized controlled multicenter study included 57 adult patients with moderate-to-severe AD using systemic treatment who were randomly assigned 1:1 to the emollient “plus” group or the control group.

Disclosures: This study was funded by La Roche-Posay (LRP). Two authors declared being employees of LRP, and some authors declared serving on advisory boards or as speakers, consultants, or investigators in the presented trial or other clinical trials sponsored by various sources, including LRP.

Source: Magnolo N et al. Comparison of different skin care regimens in patients with moderate to severe atopic dermatitis receiving systemic treatment: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 (Apr 24). Doi: 10.1111/jdv.18949

Key clinical point: Compared with the usual emollient and cleanser skincare routine, an emollient plus balm combination significantly improved pruritus in patients with moderate-to-severe atopic dermatitis (AD) receiving systemic treatment.

Major finding: Patients treated with an emollient plus balm combination after pre-cleaning with a syndet (emollient “plus” group) vs the usual emollient and cleanser skincare routine (control group) had a significantly greater mean decrease in current pruritus after 70 days (P  =  .0277) and worse pruritus over the last 24 hours after 42 days (P  =  .025) of treatment.

Study details: This randomized controlled multicenter study included 57 adult patients with moderate-to-severe AD using systemic treatment who were randomly assigned 1:1 to the emollient “plus” group or the control group.

Disclosures: This study was funded by La Roche-Posay (LRP). Two authors declared being employees of LRP, and some authors declared serving on advisory boards or as speakers, consultants, or investigators in the presented trial or other clinical trials sponsored by various sources, including LRP.

Source: Magnolo N et al. Comparison of different skin care regimens in patients with moderate to severe atopic dermatitis receiving systemic treatment: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 (Apr 24). Doi: 10.1111/jdv.18949

Key clinical point: Dupilumab is efficacious and safe in pediatric patients with uncontrolled atopic dermatitis (AD), including those aged 2 to <6 years.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 29.0 to 5.1 (P < .0001) and 73.3% and 53.3% of patients achieved ≥75% improvement in EASI and Scoring Atopic Dermatitis scores, respectively. The change in clinical scores was similar among the 2 to <6-year, 6 to <12-year, and 12 to <18-year subgroups. No serious treatment-emergent adverse events were observed.

Study details: This single-center real-world retrospective study included 39 patients aged 2 to <18 years with uncontrolled AD who received dupilumab therapy.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang Y et al. Dupilumab improves clinical scores in pediatric patients aged 2 to <18 years with uncontrolled atopic dermatitis: A single-center, real-world study. Dermatol Ther. 2023;5626410 (Apr 17). Doi: 10.1155/2023/5626410

Key clinical point: Dupilumab is efficacious and safe in pediatric patients with uncontrolled atopic dermatitis (AD), including those aged 2 to <6 years.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 29.0 to 5.1 (P < .0001) and 73.3% and 53.3% of patients achieved ≥75% improvement in EASI and Scoring Atopic Dermatitis scores, respectively. The change in clinical scores was similar among the 2 to <6-year, 6 to <12-year, and 12 to <18-year subgroups. No serious treatment-emergent adverse events were observed.

Study details: This single-center real-world retrospective study included 39 patients aged 2 to <18 years with uncontrolled AD who received dupilumab therapy.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang Y et al. Dupilumab improves clinical scores in pediatric patients aged 2 to <18 years with uncontrolled atopic dermatitis: A single-center, real-world study. Dermatol Ther. 2023;5626410 (Apr 17). Doi: 10.1155/2023/5626410

Key clinical point: Dupilumab is efficacious and safe in pediatric patients with uncontrolled atopic dermatitis (AD), including those aged 2 to <6 years.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 29.0 to 5.1 (P < .0001) and 73.3% and 53.3% of patients achieved ≥75% improvement in EASI and Scoring Atopic Dermatitis scores, respectively. The change in clinical scores was similar among the 2 to <6-year, 6 to <12-year, and 12 to <18-year subgroups. No serious treatment-emergent adverse events were observed.

Study details: This single-center real-world retrospective study included 39 patients aged 2 to <18 years with uncontrolled AD who received dupilumab therapy.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang Y et al. Dupilumab improves clinical scores in pediatric patients aged 2 to <18 years with uncontrolled atopic dermatitis: A single-center, real-world study. Dermatol Ther. 2023;5626410 (Apr 17). Doi: 10.1155/2023/5626410

Key Clinical Point: Crisaborole induces proteomic changes and modulates the lesional skin phenotype toward normal skin in mild-to-moderate atopic dermatitis (AD).

Major finding: At days 8 and 15, a markedly greater number of biomarkers were down-regulated with crisaborole vs vehicle (123 vs 9 and 162 vs 22, respectively), with a significantly higher rate of improvement in the overall lesional (45.9% vs 12.6% and 57.0% vs 28.3%, respectively; both P < .001) and nonlesional (53.0% vs 15.5% and 62.6% vs 36.8%, respectively; both P < .001) proteomes relative to a normal skin proteome.

Study details: This phase 2a study conducted a proteomic analysis in 20 control individuals and 40 adult patients with mild-to-moderate AD after double-blind, 1:1 random assignment of two target lesions in each patient with AD to crisaborole (2% ointment) or vehicle twice daily for 14 days.

Disclosures: This study was funded by Pfizer, New York. Some authors reported ties with various organizations, including Pfizer. One author declared being an employee of and holding shares in Pfizer.

Source: Kim M et al. Crisaborole reverses dysregulation of the mild to moderate atopic dermatitis proteome towards nonlesional and normal skin. J Am Acad Dermatol. 2023 (Apr 10). Doi: 10.1016/j.jaad.2023.02.064

Key Clinical Point: Crisaborole induces proteomic changes and modulates the lesional skin phenotype toward normal skin in mild-to-moderate atopic dermatitis (AD).

Major finding: At days 8 and 15, a markedly greater number of biomarkers were down-regulated with crisaborole vs vehicle (123 vs 9 and 162 vs 22, respectively), with a significantly higher rate of improvement in the overall lesional (45.9% vs 12.6% and 57.0% vs 28.3%, respectively; both P < .001) and nonlesional (53.0% vs 15.5% and 62.6% vs 36.8%, respectively; both P < .001) proteomes relative to a normal skin proteome.

Study details: This phase 2a study conducted a proteomic analysis in 20 control individuals and 40 adult patients with mild-to-moderate AD after double-blind, 1:1 random assignment of two target lesions in each patient with AD to crisaborole (2% ointment) or vehicle twice daily for 14 days.

Disclosures: This study was funded by Pfizer, New York. Some authors reported ties with various organizations, including Pfizer. One author declared being an employee of and holding shares in Pfizer.

Source: Kim M et al. Crisaborole reverses dysregulation of the mild to moderate atopic dermatitis proteome towards nonlesional and normal skin. J Am Acad Dermatol. 2023 (Apr 10). Doi: 10.1016/j.jaad.2023.02.064

Key Clinical Point: Crisaborole induces proteomic changes and modulates the lesional skin phenotype toward normal skin in mild-to-moderate atopic dermatitis (AD).

Major finding: At days 8 and 15, a markedly greater number of biomarkers were down-regulated with crisaborole vs vehicle (123 vs 9 and 162 vs 22, respectively), with a significantly higher rate of improvement in the overall lesional (45.9% vs 12.6% and 57.0% vs 28.3%, respectively; both P < .001) and nonlesional (53.0% vs 15.5% and 62.6% vs 36.8%, respectively; both P < .001) proteomes relative to a normal skin proteome.

Study details: This phase 2a study conducted a proteomic analysis in 20 control individuals and 40 adult patients with mild-to-moderate AD after double-blind, 1:1 random assignment of two target lesions in each patient with AD to crisaborole (2% ointment) or vehicle twice daily for 14 days.

Disclosures: This study was funded by Pfizer, New York. Some authors reported ties with various organizations, including Pfizer. One author declared being an employee of and holding shares in Pfizer.

Source: Kim M et al. Crisaborole reverses dysregulation of the mild to moderate atopic dermatitis proteome towards nonlesional and normal skin. J Am Acad Dermatol. 2023 (Apr 10). Doi: 10.1016/j.jaad.2023.02.064

Key clinical point: Tralokinumab-mediated specific targeting of interleukin-13 is effective and safe in treating adolescents with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving 150 mg or 300 mg tralokinumab vs placebo achieved an Investigator’s Global Assessment score of 0 or 1 (21.4% and 17.5% vs 4.3%; P < .001 and P  =  .002, respectively) and ≥75% improvement in the Eczema Area and Severity Index score (28.6% and 27.8% vs 6.4%, respectively; both P < .001) without rescue medication. Most adverse events were mild or moderate in severity.

Study details: Findings are from the phase 3 ECZTRA 6 trial including 289 adolescents (12-17 years) with moderate-to-severe AD who were randomly assigned to receive 150 mg tralokinumab (n = 98), 300 mg tralokinumab (n = 97), or placebo (n = 94).

Disclosures: This study was funded by LEO Pharma. Some authors reported ties with various organizations including LEO Pharma. Five authors declared being employees of or holding shares in LEO Pharma.

Source: Paller AS et al. Efficacy and safety of tralokinumab in adolescents with moderate to severe atopic dermatitis: The phase 3 ECZTRA 6 randomized clinical trial. JAMA Dermatol. 2023 (Apr 19). Doi: 10.1001/jamadermatol.2023.0627

Key clinical point: Tralokinumab-mediated specific targeting of interleukin-13 is effective and safe in treating adolescents with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving 150 mg or 300 mg tralokinumab vs placebo achieved an Investigator’s Global Assessment score of 0 or 1 (21.4% and 17.5% vs 4.3%; P < .001 and P  =  .002, respectively) and ≥75% improvement in the Eczema Area and Severity Index score (28.6% and 27.8% vs 6.4%, respectively; both P < .001) without rescue medication. Most adverse events were mild or moderate in severity.

Study details: Findings are from the phase 3 ECZTRA 6 trial including 289 adolescents (12-17 years) with moderate-to-severe AD who were randomly assigned to receive 150 mg tralokinumab (n = 98), 300 mg tralokinumab (n = 97), or placebo (n = 94).

Disclosures: This study was funded by LEO Pharma. Some authors reported ties with various organizations including LEO Pharma. Five authors declared being employees of or holding shares in LEO Pharma.

Source: Paller AS et al. Efficacy and safety of tralokinumab in adolescents with moderate to severe atopic dermatitis: The phase 3 ECZTRA 6 randomized clinical trial. JAMA Dermatol. 2023 (Apr 19). Doi: 10.1001/jamadermatol.2023.0627

Key clinical point: Tralokinumab-mediated specific targeting of interleukin-13 is effective and safe in treating adolescents with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving 150 mg or 300 mg tralokinumab vs placebo achieved an Investigator’s Global Assessment score of 0 or 1 (21.4% and 17.5% vs 4.3%; P < .001 and P  =  .002, respectively) and ≥75% improvement in the Eczema Area and Severity Index score (28.6% and 27.8% vs 6.4%, respectively; both P < .001) without rescue medication. Most adverse events were mild or moderate in severity.

Study details: Findings are from the phase 3 ECZTRA 6 trial including 289 adolescents (12-17 years) with moderate-to-severe AD who were randomly assigned to receive 150 mg tralokinumab (n = 98), 300 mg tralokinumab (n = 97), or placebo (n = 94).

Disclosures: This study was funded by LEO Pharma. Some authors reported ties with various organizations including LEO Pharma. Five authors declared being employees of or holding shares in LEO Pharma.

Source: Paller AS et al. Efficacy and safety of tralokinumab in adolescents with moderate to severe atopic dermatitis: The phase 3 ECZTRA 6 randomized clinical trial. JAMA Dermatol. 2023 (Apr 19). Doi: 10.1001/jamadermatol.2023.0627

Key clinical point: Upadacitinib is as effective and safe in adolescents with moderate-to-severe atopic dermatitis (AD) as in adults with AD.

Major finding: At week 16, in Measure Up 1 and 2 and AD Up, a significantly higher proportion of patients receiving 15/30 mg upadacitinib vs placebo achieved Eczema Area and Severity Index-75 (73%/78%, 69%/73%, and 63%/84% vs 12%, 13%, and 30%, respectively; all P < .001) and Investigator’s Global Assessment score of 0/1 (45%/64%, 45%/59%, and 38%/67% vs 7%, 5%, and 11%, respectively; all P < .001). The safety profile was consistent in adolescents and adults.

Study details: This interim analysis of 3 phase 3 trials included 552 adolescents (12-17 years) with moderate-to-severe AD who were randomly assigned to receive 15 mg upadacitinib, 30 mg upadacitinib, or placebo alone (Measure Up 1 and Measure Up 2) or with topical corticosteroids (AD Up).

Disclosures: This study was funded by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Nine authors declared being employees of or holding stock or stock options in AbbVie.

Source: Paller AS et al. Efficacy and safety of upadacitinib treatment in adolescents with moderate-to-severe atopic dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up randomized clinical trials. JAMA Dermatol. 2023 (Apr 12). Doi: 10.1001/jamadermatol.2023.0391

Key clinical point: Upadacitinib is as effective and safe in adolescents with moderate-to-severe atopic dermatitis (AD) as in adults with AD.

Major finding: At week 16, in Measure Up 1 and 2 and AD Up, a significantly higher proportion of patients receiving 15/30 mg upadacitinib vs placebo achieved Eczema Area and Severity Index-75 (73%/78%, 69%/73%, and 63%/84% vs 12%, 13%, and 30%, respectively; all P < .001) and Investigator’s Global Assessment score of 0/1 (45%/64%, 45%/59%, and 38%/67% vs 7%, 5%, and 11%, respectively; all P < .001). The safety profile was consistent in adolescents and adults.

Study details: This interim analysis of 3 phase 3 trials included 552 adolescents (12-17 years) with moderate-to-severe AD who were randomly assigned to receive 15 mg upadacitinib, 30 mg upadacitinib, or placebo alone (Measure Up 1 and Measure Up 2) or with topical corticosteroids (AD Up).

Disclosures: This study was funded by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Nine authors declared being employees of or holding stock or stock options in AbbVie.

Source: Paller AS et al. Efficacy and safety of upadacitinib treatment in adolescents with moderate-to-severe atopic dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up randomized clinical trials. JAMA Dermatol. 2023 (Apr 12). Doi: 10.1001/jamadermatol.2023.0391

Key clinical point: Upadacitinib is as effective and safe in adolescents with moderate-to-severe atopic dermatitis (AD) as in adults with AD.

Major finding: At week 16, in Measure Up 1 and 2 and AD Up, a significantly higher proportion of patients receiving 15/30 mg upadacitinib vs placebo achieved Eczema Area and Severity Index-75 (73%/78%, 69%/73%, and 63%/84% vs 12%, 13%, and 30%, respectively; all P < .001) and Investigator’s Global Assessment score of 0/1 (45%/64%, 45%/59%, and 38%/67% vs 7%, 5%, and 11%, respectively; all P < .001). The safety profile was consistent in adolescents and adults.

Study details: This interim analysis of 3 phase 3 trials included 552 adolescents (12-17 years) with moderate-to-severe AD who were randomly assigned to receive 15 mg upadacitinib, 30 mg upadacitinib, or placebo alone (Measure Up 1 and Measure Up 2) or with topical corticosteroids (AD Up).

Disclosures: This study was funded by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Nine authors declared being employees of or holding stock or stock options in AbbVie.

Source: Paller AS et al. Efficacy and safety of upadacitinib treatment in adolescents with moderate-to-severe atopic dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up randomized clinical trials. JAMA Dermatol. 2023 (Apr 12). Doi: 10.1001/jamadermatol.2023.0391

Last month, I described a 28-year-old patient with a history of injection drug use who presented with pain in his left forearm. His history showed that, within the past 2 years, he’d been seen for cutaneous infections multiple times as an outpatient and in the emergency department. His records indicated that he was diagnosed with a penicillin allergy as a child when he developed a rash after receiving amoxicillin. I believed the next course of action should be to test for a penicillin allergy with an oral amoxicillin challenge.
 

Thank you for your excellent questions regarding this case. Great to hear the enthusiasm for testing for penicillin allergy!

One question focused on the course of action in the case of a mild or moderate IgE-mediated reaction after a single dose test with amoxicillin. Treatment for these reactions should include an antihistamine. I would reserve intravenous antihistamines for more severe cases, which also require treatment with a course of corticosteroids. However, the risk for a moderate to severe reaction to amoxicillin on retesting is quite low.

Clinicians need to exercise caution in the use of systemic corticosteroids. These drugs can be lifesaving, but even short courses of corticosteroids are associated with potentially serious adverse events. In a review of adverse events associated with short-course systemic corticosteroids among children, the rate of vomiting was 5.4%; behavioral change, 4.7%; and sleep disturbance, 4.3%. One child died after contracting herpes zoster, more than one-third of children developed elevated blood pressure, and 81.1% had evidence of suppression of the hypothalamic-pituitary-adrenal axis.

Among adults, short courses of systemic corticosteroids are associated with acute increases in the risks for gastrointestinal bleeding and hypertension. Cumulative exposure to short courses of corticosteroids over time results in higher risks for obesity, type 2 diabetes, and osteoporosis.

Another question prompted by this young man’s case focused on the durability of IgE reactions against penicillin. The IgE response to penicillin does indeed wane over time; 80% of patients with a previous true penicillin allergy can tolerate the antibiotic after 10 years. Thus, about 95% of patients with a remote history of penicillin allergy are tolerant of penicillin, and testing can be performed using the algorithm described.

Clinicians should avoid applying current guidelines for the evaluation of patients with penicillin allergy to other common drug allergies. The overall prevalence of sulfonamide allergy is 3%-8%, and the vast majority of these reactions follow treatment with trimethoprim-sulfamethoxazole. Sulfa allergy is even more common among persons living with HIV infection. The natural history of sulfa allergy is not as well established as penicillin allergy. Allergy testing is encouraged in these cases. Graded oral challenge testing is best reserved for patients who are unlikely to have a true sulfa allergy based on their history.

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

Last month, I described a 28-year-old patient with a history of injection drug use who presented with pain in his left forearm. His history showed that, within the past 2 years, he’d been seen for cutaneous infections multiple times as an outpatient and in the emergency department. His records indicated that he was diagnosed with a penicillin allergy as a child when he developed a rash after receiving amoxicillin. I believed the next course of action should be to test for a penicillin allergy with an oral amoxicillin challenge.
 

Thank you for your excellent questions regarding this case. Great to hear the enthusiasm for testing for penicillin allergy!

One question focused on the course of action in the case of a mild or moderate IgE-mediated reaction after a single dose test with amoxicillin. Treatment for these reactions should include an antihistamine. I would reserve intravenous antihistamines for more severe cases, which also require treatment with a course of corticosteroids. However, the risk for a moderate to severe reaction to amoxicillin on retesting is quite low.

Clinicians need to exercise caution in the use of systemic corticosteroids. These drugs can be lifesaving, but even short courses of corticosteroids are associated with potentially serious adverse events. In a review of adverse events associated with short-course systemic corticosteroids among children, the rate of vomiting was 5.4%; behavioral change, 4.7%; and sleep disturbance, 4.3%. One child died after contracting herpes zoster, more than one-third of children developed elevated blood pressure, and 81.1% had evidence of suppression of the hypothalamic-pituitary-adrenal axis.

Among adults, short courses of systemic corticosteroids are associated with acute increases in the risks for gastrointestinal bleeding and hypertension. Cumulative exposure to short courses of corticosteroids over time results in higher risks for obesity, type 2 diabetes, and osteoporosis.

Another question prompted by this young man’s case focused on the durability of IgE reactions against penicillin. The IgE response to penicillin does indeed wane over time; 80% of patients with a previous true penicillin allergy can tolerate the antibiotic after 10 years. Thus, about 95% of patients with a remote history of penicillin allergy are tolerant of penicillin, and testing can be performed using the algorithm described.

Clinicians should avoid applying current guidelines for the evaluation of patients with penicillin allergy to other common drug allergies. The overall prevalence of sulfonamide allergy is 3%-8%, and the vast majority of these reactions follow treatment with trimethoprim-sulfamethoxazole. Sulfa allergy is even more common among persons living with HIV infection. The natural history of sulfa allergy is not as well established as penicillin allergy. Allergy testing is encouraged in these cases. Graded oral challenge testing is best reserved for patients who are unlikely to have a true sulfa allergy based on their history.

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

Last month, I described a 28-year-old patient with a history of injection drug use who presented with pain in his left forearm. His history showed that, within the past 2 years, he’d been seen for cutaneous infections multiple times as an outpatient and in the emergency department. His records indicated that he was diagnosed with a penicillin allergy as a child when he developed a rash after receiving amoxicillin. I believed the next course of action should be to test for a penicillin allergy with an oral amoxicillin challenge.
 

Thank you for your excellent questions regarding this case. Great to hear the enthusiasm for testing for penicillin allergy!

One question focused on the course of action in the case of a mild or moderate IgE-mediated reaction after a single dose test with amoxicillin. Treatment for these reactions should include an antihistamine. I would reserve intravenous antihistamines for more severe cases, which also require treatment with a course of corticosteroids. However, the risk for a moderate to severe reaction to amoxicillin on retesting is quite low.

Clinicians need to exercise caution in the use of systemic corticosteroids. These drugs can be lifesaving, but even short courses of corticosteroids are associated with potentially serious adverse events. In a review of adverse events associated with short-course systemic corticosteroids among children, the rate of vomiting was 5.4%; behavioral change, 4.7%; and sleep disturbance, 4.3%. One child died after contracting herpes zoster, more than one-third of children developed elevated blood pressure, and 81.1% had evidence of suppression of the hypothalamic-pituitary-adrenal axis.

Among adults, short courses of systemic corticosteroids are associated with acute increases in the risks for gastrointestinal bleeding and hypertension. Cumulative exposure to short courses of corticosteroids over time results in higher risks for obesity, type 2 diabetes, and osteoporosis.

Another question prompted by this young man’s case focused on the durability of IgE reactions against penicillin. The IgE response to penicillin does indeed wane over time; 80% of patients with a previous true penicillin allergy can tolerate the antibiotic after 10 years. Thus, about 95% of patients with a remote history of penicillin allergy are tolerant of penicillin, and testing can be performed using the algorithm described.

Clinicians should avoid applying current guidelines for the evaluation of patients with penicillin allergy to other common drug allergies. The overall prevalence of sulfonamide allergy is 3%-8%, and the vast majority of these reactions follow treatment with trimethoprim-sulfamethoxazole. Sulfa allergy is even more common among persons living with HIV infection. The natural history of sulfa allergy is not as well established as penicillin allergy. Allergy testing is encouraged in these cases. Graded oral challenge testing is best reserved for patients who are unlikely to have a true sulfa allergy based on their history.

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

Lebrikizumab, an interleukin (IL)–13 inhibitor under investigation for adult and adolescents with moderate to severe atopic dermatitis (AD), was efficacious in improving facial and hand dermatitis in a secondary analysis of randomized, double-blind, placebo-controlled phase 3 trials of the drug, Jenny E. Murase, MD, reported at the annual Revolutionizing Atopic Dermatitis conference.

At week 16 in the ADvocate 1, ADvocate 2, and ADhere trials, with and without concomitant topical corticosteroid (TCS) use, at least 58% of treated patients experienced improvement in facial dermatitis, and 62% or more experienced improvement in hand dermatitis – statistically significant differences over placebo.

Injenerker/Getty Images

“Lebrikizumab was efficacious in clearing and improving facial and hand dermatitis, burdensome and difficult-to-treat areas, in most patients with moderate to severe AD,” said Dr. Murase, of the department of dermatology at the University of California, San Francisco, and director of medical dermatology consultative services and patch testing for the Palo Alto (Calf.) Foundation Medical Group.

In another late-breaking abstract presented at the RAD conference, the injectable biologic dupilumab – now in its 6th year on the market – was reported by Jonathan I. Silverberg, MD, PhD, MPH, to “rapidly and significantly” improve the signs, symptoms, and quality of life in some adults and adolescents with moderate to severe hand and foot AD in a recently completed phase 3 trial of dupilumab.
 

Lebrikizumab results for facial, hand dermatitis

The ADvocate 1 and ADvocate 2 trials evaluated lebrikizumab monotherapy and randomized patients to receive 250 mg subcutaneously every 2 weeks (after a 500-mg loading dose at baseline and week 2) or placebo. (Patients who received any corticosteroid as a rescue medication were considered nonresponders.) The ADhere trial compared low to mid–potency TCS plus lebrikizumab, using the same dosing of lebrikizumab as in the ADvocate studies, versus TCS plus placebo.

In all three trials, with a total of more than 1,000 participants, clinicians assessed for the presence or absence of facial or hand dermatitis at baseline. At week 16, they then assessed the change from baseline based on a 4-point scale of cleared, improved, no change, and worsened. “Improvement” was defined as cleared or improved.

Both facial and hand dermatitis were identified in a majority of patients at baseline. For instance, in ADvocate 1, facial dermatitis was identified in 71.4% of patients in the lebrikizumab group and 80.9% of those in the placebo group. Hand dermatitis was identified in 72% and 73% of the treatment and placebo groups, respectively.

Across the trials, at 16 weeks, 58%-69% of adult and adolescent patients receiving lebrikizumab had improvement in facial dermatitis, compared with 22%-46% on placebo. For hand dermatitis, 62%-73% experienced improvement, compared with 19%-43% on placebo, respectively. Proportions of improved patients in both the lebrikizumab and placebo groups were highest in the ADhere trial, Dr. Murase reported.

In the ADvocate trials, 16 weeks marked the end of the induction phase and the start of a 36-week maintenance period. The ADhere trial was a 16-week study. Overall results from ADhere were published in January in JAMA Dermatology, and results from the 16-week induction period of the ADvocate trials were published in March in the New England Journal of Medicine.

Lebrikizumab received fast-track designation for AD by the Food and Drug Administration in 2019. Regulatory decisions in the United States and the European Union are expected later this year, according to a press release from Eli Lilly, the drug’s developer.

Asked to comment on the study results, Zelma Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, called the post-hoc results promising. “While newer, more targeted treatments for AD offer the possibility of overall improvement and long-term disease control, we do not have sufficient data to help guide us when it comes to selecting treatment based on which area of the body is affected,” she explained. Most published findings have used “overall scores and not scores stratified by body region.”

The new findings, “help expand our current understanding of how the drug works for different areas of the body,” which can help inform treatment discussions with patients, she added.

AD can be especially challenging to treat when it involves “what are considered to be more sensitive areas such as the face or hands,” said Dr. Chiesa Fuxench. Challenges may include poor tolerance to topical medications, concerns for safety with long-term use, and the need for constant reapplication.

“Those of us who treat a large number of AD patients suspect that the impact and/or burden of AD may be different depending on what areas of the body are affected,” but more data are needed, she added. Limitations of the study, she noted, include “that the study may not have been adequately powered and that the sample size was small.”
 

Dupilumab result for hand, foot dermatitis

The phase 3 LIBERTY-AD-HAFT trial randomized 133 patients with moderate to severe atopic hand and/or foot dermatitis to a 16-week course of dupilumab (Dupixent) monotherapy, 300 mg every 2 weeks in adults and 200 or 300 mg every 2 weeks in adolescents, or placebo. Patients were then followed during a 12-week safety follow-up period.

Significantly more patients in the dupilumab group achieved the primary endpoint of a hand and foot Investigator Global Assessment (IGA) score of 0/1 at 16 weeks: 40.3% vs. 16.7% in the placebo group (P = .003). Statistical significance was reached at week 8, reported Dr. Silverberg, professor of dermatology and director of clinical research at George Washington University, Washington. Dupilumab, a human monoclonal IgG4 antibody that inhibits IL-4 and IL-13 signaling, is FDA approved for treating moderate to severe AD in patients age 6 months and older, among other indications.

In addition, the proportion of patients achieving a 4-point or greater improvement in the weekly average of daily hand and foot Peak Pruritus Numerical Rating Scale (PPNRS), the key secondary endpoint, was about fourfold greater with dupilumab: 52.2%, compared with 13.6% on placebo (P < .0001). This reduction in itch reached statistical significance by week 1. Dupilumab-treated patients also experienced significant improvement in other lesion measures and in Quality of Life in Hand Eczema Questionnaire scores, Dr. Silverberg noted.

The patients had a mean age in their 30s and a mean duration of atopic hand and/or foot dermatitis of 15-16 years. For more than one-quarter of patients, morphology was hyperkeratotic, which “has to be one of the toughest subsets to affect positive change in,” he said.

About 40% of patients had lesions on the hands only, and more than half had lesions on both hands and feet. “This is pretty realistic – we generally don’t see much isolated foot dermatitis in the AD population,” Dr. Silverberg said.

About 70%-75% had concomitant AD outside of the hands and feet, mostly of moderate severity. Patients with positive patch tests or whose hand and foot eczema was believed to be driven by irritants were excluded from the trial, as were patients who had used TCS or other topical treatments within 2 weeks of the baseline visit.

Rescue medication use was low (3% with dupilumab vs. 21% with placebo), and adverse events were “pretty consistent with everything we’ve seen with dupilumab,” said Dr. Silverberg.

Commenting on this study, Dr. Chiesa Fuxench said she was “excited to see [the findings], as hand and foot AD can often be quite challenging to treat in clinic.” The improvements in overall disease scores, itch, and quality of life scores – with fairly good tolerance – are “reassuring and what we would expect based on our current experience with dupilumab,” she said.

The lebrikizumab study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. The dupilumab study was sponsored by Sanofi and Regeneron Pharmaceuticals. Some of the data were also reported by lead investigator Eric Simpson, MD, of Oregon Health and Science University at the annual meeting of the American Academy of Dermatology in March 2023.

Dr. Murase reported consulting/advising for Eli Lilly, Leo Pharma, UCB, Sanofi-Genzyme, and non-CME speaking/honoraria for UCB and Regeneron. Dr. Silverberg reported consulting fees and fees for non-CME services from Sanofi Genzyme, Regeneron, Pfizer, and other companies. Dr. Chiesa Fuxench, who was a speaker at the RAD meeting but was not involved in the studies, disclosed receiving honoraria for CME work in AD sponsored by education grants from Regeneron/Sanofi, and grant/research support from Lilly, Regeneron, and Sanofi, among other disclosures.

Lebrikizumab, an interleukin (IL)–13 inhibitor under investigation for adult and adolescents with moderate to severe atopic dermatitis (AD), was efficacious in improving facial and hand dermatitis in a secondary analysis of randomized, double-blind, placebo-controlled phase 3 trials of the drug, Jenny E. Murase, MD, reported at the annual Revolutionizing Atopic Dermatitis conference.

At week 16 in the ADvocate 1, ADvocate 2, and ADhere trials, with and without concomitant topical corticosteroid (TCS) use, at least 58% of treated patients experienced improvement in facial dermatitis, and 62% or more experienced improvement in hand dermatitis – statistically significant differences over placebo.

Injenerker/Getty Images

“Lebrikizumab was efficacious in clearing and improving facial and hand dermatitis, burdensome and difficult-to-treat areas, in most patients with moderate to severe AD,” said Dr. Murase, of the department of dermatology at the University of California, San Francisco, and director of medical dermatology consultative services and patch testing for the Palo Alto (Calf.) Foundation Medical Group.

In another late-breaking abstract presented at the RAD conference, the injectable biologic dupilumab – now in its 6th year on the market – was reported by Jonathan I. Silverberg, MD, PhD, MPH, to “rapidly and significantly” improve the signs, symptoms, and quality of life in some adults and adolescents with moderate to severe hand and foot AD in a recently completed phase 3 trial of dupilumab.
 

Lebrikizumab results for facial, hand dermatitis

The ADvocate 1 and ADvocate 2 trials evaluated lebrikizumab monotherapy and randomized patients to receive 250 mg subcutaneously every 2 weeks (after a 500-mg loading dose at baseline and week 2) or placebo. (Patients who received any corticosteroid as a rescue medication were considered nonresponders.) The ADhere trial compared low to mid–potency TCS plus lebrikizumab, using the same dosing of lebrikizumab as in the ADvocate studies, versus TCS plus placebo.

In all three trials, with a total of more than 1,000 participants, clinicians assessed for the presence or absence of facial or hand dermatitis at baseline. At week 16, they then assessed the change from baseline based on a 4-point scale of cleared, improved, no change, and worsened. “Improvement” was defined as cleared or improved.

Both facial and hand dermatitis were identified in a majority of patients at baseline. For instance, in ADvocate 1, facial dermatitis was identified in 71.4% of patients in the lebrikizumab group and 80.9% of those in the placebo group. Hand dermatitis was identified in 72% and 73% of the treatment and placebo groups, respectively.

Across the trials, at 16 weeks, 58%-69% of adult and adolescent patients receiving lebrikizumab had improvement in facial dermatitis, compared with 22%-46% on placebo. For hand dermatitis, 62%-73% experienced improvement, compared with 19%-43% on placebo, respectively. Proportions of improved patients in both the lebrikizumab and placebo groups were highest in the ADhere trial, Dr. Murase reported.

In the ADvocate trials, 16 weeks marked the end of the induction phase and the start of a 36-week maintenance period. The ADhere trial was a 16-week study. Overall results from ADhere were published in January in JAMA Dermatology, and results from the 16-week induction period of the ADvocate trials were published in March in the New England Journal of Medicine.

Lebrikizumab received fast-track designation for AD by the Food and Drug Administration in 2019. Regulatory decisions in the United States and the European Union are expected later this year, according to a press release from Eli Lilly, the drug’s developer.

Asked to comment on the study results, Zelma Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, called the post-hoc results promising. “While newer, more targeted treatments for AD offer the possibility of overall improvement and long-term disease control, we do not have sufficient data to help guide us when it comes to selecting treatment based on which area of the body is affected,” she explained. Most published findings have used “overall scores and not scores stratified by body region.”

The new findings, “help expand our current understanding of how the drug works for different areas of the body,” which can help inform treatment discussions with patients, she added.

AD can be especially challenging to treat when it involves “what are considered to be more sensitive areas such as the face or hands,” said Dr. Chiesa Fuxench. Challenges may include poor tolerance to topical medications, concerns for safety with long-term use, and the need for constant reapplication.

“Those of us who treat a large number of AD patients suspect that the impact and/or burden of AD may be different depending on what areas of the body are affected,” but more data are needed, she added. Limitations of the study, she noted, include “that the study may not have been adequately powered and that the sample size was small.”
 

Dupilumab result for hand, foot dermatitis

The phase 3 LIBERTY-AD-HAFT trial randomized 133 patients with moderate to severe atopic hand and/or foot dermatitis to a 16-week course of dupilumab (Dupixent) monotherapy, 300 mg every 2 weeks in adults and 200 or 300 mg every 2 weeks in adolescents, or placebo. Patients were then followed during a 12-week safety follow-up period.

Significantly more patients in the dupilumab group achieved the primary endpoint of a hand and foot Investigator Global Assessment (IGA) score of 0/1 at 16 weeks: 40.3% vs. 16.7% in the placebo group (P = .003). Statistical significance was reached at week 8, reported Dr. Silverberg, professor of dermatology and director of clinical research at George Washington University, Washington. Dupilumab, a human monoclonal IgG4 antibody that inhibits IL-4 and IL-13 signaling, is FDA approved for treating moderate to severe AD in patients age 6 months and older, among other indications.

In addition, the proportion of patients achieving a 4-point or greater improvement in the weekly average of daily hand and foot Peak Pruritus Numerical Rating Scale (PPNRS), the key secondary endpoint, was about fourfold greater with dupilumab: 52.2%, compared with 13.6% on placebo (P < .0001). This reduction in itch reached statistical significance by week 1. Dupilumab-treated patients also experienced significant improvement in other lesion measures and in Quality of Life in Hand Eczema Questionnaire scores, Dr. Silverberg noted.

The patients had a mean age in their 30s and a mean duration of atopic hand and/or foot dermatitis of 15-16 years. For more than one-quarter of patients, morphology was hyperkeratotic, which “has to be one of the toughest subsets to affect positive change in,” he said.

About 40% of patients had lesions on the hands only, and more than half had lesions on both hands and feet. “This is pretty realistic – we generally don’t see much isolated foot dermatitis in the AD population,” Dr. Silverberg said.

About 70%-75% had concomitant AD outside of the hands and feet, mostly of moderate severity. Patients with positive patch tests or whose hand and foot eczema was believed to be driven by irritants were excluded from the trial, as were patients who had used TCS or other topical treatments within 2 weeks of the baseline visit.

Rescue medication use was low (3% with dupilumab vs. 21% with placebo), and adverse events were “pretty consistent with everything we’ve seen with dupilumab,” said Dr. Silverberg.

Commenting on this study, Dr. Chiesa Fuxench said she was “excited to see [the findings], as hand and foot AD can often be quite challenging to treat in clinic.” The improvements in overall disease scores, itch, and quality of life scores – with fairly good tolerance – are “reassuring and what we would expect based on our current experience with dupilumab,” she said.

The lebrikizumab study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. The dupilumab study was sponsored by Sanofi and Regeneron Pharmaceuticals. Some of the data were also reported by lead investigator Eric Simpson, MD, of Oregon Health and Science University at the annual meeting of the American Academy of Dermatology in March 2023.

Dr. Murase reported consulting/advising for Eli Lilly, Leo Pharma, UCB, Sanofi-Genzyme, and non-CME speaking/honoraria for UCB and Regeneron. Dr. Silverberg reported consulting fees and fees for non-CME services from Sanofi Genzyme, Regeneron, Pfizer, and other companies. Dr. Chiesa Fuxench, who was a speaker at the RAD meeting but was not involved in the studies, disclosed receiving honoraria for CME work in AD sponsored by education grants from Regeneron/Sanofi, and grant/research support from Lilly, Regeneron, and Sanofi, among other disclosures.

Lebrikizumab, an interleukin (IL)–13 inhibitor under investigation for adult and adolescents with moderate to severe atopic dermatitis (AD), was efficacious in improving facial and hand dermatitis in a secondary analysis of randomized, double-blind, placebo-controlled phase 3 trials of the drug, Jenny E. Murase, MD, reported at the annual Revolutionizing Atopic Dermatitis conference.

At week 16 in the ADvocate 1, ADvocate 2, and ADhere trials, with and without concomitant topical corticosteroid (TCS) use, at least 58% of treated patients experienced improvement in facial dermatitis, and 62% or more experienced improvement in hand dermatitis – statistically significant differences over placebo.

Injenerker/Getty Images

“Lebrikizumab was efficacious in clearing and improving facial and hand dermatitis, burdensome and difficult-to-treat areas, in most patients with moderate to severe AD,” said Dr. Murase, of the department of dermatology at the University of California, San Francisco, and director of medical dermatology consultative services and patch testing for the Palo Alto (Calf.) Foundation Medical Group.

In another late-breaking abstract presented at the RAD conference, the injectable biologic dupilumab – now in its 6th year on the market – was reported by Jonathan I. Silverberg, MD, PhD, MPH, to “rapidly and significantly” improve the signs, symptoms, and quality of life in some adults and adolescents with moderate to severe hand and foot AD in a recently completed phase 3 trial of dupilumab.
 

Lebrikizumab results for facial, hand dermatitis

The ADvocate 1 and ADvocate 2 trials evaluated lebrikizumab monotherapy and randomized patients to receive 250 mg subcutaneously every 2 weeks (after a 500-mg loading dose at baseline and week 2) or placebo. (Patients who received any corticosteroid as a rescue medication were considered nonresponders.) The ADhere trial compared low to mid–potency TCS plus lebrikizumab, using the same dosing of lebrikizumab as in the ADvocate studies, versus TCS plus placebo.

In all three trials, with a total of more than 1,000 participants, clinicians assessed for the presence or absence of facial or hand dermatitis at baseline. At week 16, they then assessed the change from baseline based on a 4-point scale of cleared, improved, no change, and worsened. “Improvement” was defined as cleared or improved.

Both facial and hand dermatitis were identified in a majority of patients at baseline. For instance, in ADvocate 1, facial dermatitis was identified in 71.4% of patients in the lebrikizumab group and 80.9% of those in the placebo group. Hand dermatitis was identified in 72% and 73% of the treatment and placebo groups, respectively.

Across the trials, at 16 weeks, 58%-69% of adult and adolescent patients receiving lebrikizumab had improvement in facial dermatitis, compared with 22%-46% on placebo. For hand dermatitis, 62%-73% experienced improvement, compared with 19%-43% on placebo, respectively. Proportions of improved patients in both the lebrikizumab and placebo groups were highest in the ADhere trial, Dr. Murase reported.

In the ADvocate trials, 16 weeks marked the end of the induction phase and the start of a 36-week maintenance period. The ADhere trial was a 16-week study. Overall results from ADhere were published in January in JAMA Dermatology, and results from the 16-week induction period of the ADvocate trials were published in March in the New England Journal of Medicine.

Lebrikizumab received fast-track designation for AD by the Food and Drug Administration in 2019. Regulatory decisions in the United States and the European Union are expected later this year, according to a press release from Eli Lilly, the drug’s developer.

Asked to comment on the study results, Zelma Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, called the post-hoc results promising. “While newer, more targeted treatments for AD offer the possibility of overall improvement and long-term disease control, we do not have sufficient data to help guide us when it comes to selecting treatment based on which area of the body is affected,” she explained. Most published findings have used “overall scores and not scores stratified by body region.”

The new findings, “help expand our current understanding of how the drug works for different areas of the body,” which can help inform treatment discussions with patients, she added.

AD can be especially challenging to treat when it involves “what are considered to be more sensitive areas such as the face or hands,” said Dr. Chiesa Fuxench. Challenges may include poor tolerance to topical medications, concerns for safety with long-term use, and the need for constant reapplication.

“Those of us who treat a large number of AD patients suspect that the impact and/or burden of AD may be different depending on what areas of the body are affected,” but more data are needed, she added. Limitations of the study, she noted, include “that the study may not have been adequately powered and that the sample size was small.”
 

Dupilumab result for hand, foot dermatitis

The phase 3 LIBERTY-AD-HAFT trial randomized 133 patients with moderate to severe atopic hand and/or foot dermatitis to a 16-week course of dupilumab (Dupixent) monotherapy, 300 mg every 2 weeks in adults and 200 or 300 mg every 2 weeks in adolescents, or placebo. Patients were then followed during a 12-week safety follow-up period.

Significantly more patients in the dupilumab group achieved the primary endpoint of a hand and foot Investigator Global Assessment (IGA) score of 0/1 at 16 weeks: 40.3% vs. 16.7% in the placebo group (P = .003). Statistical significance was reached at week 8, reported Dr. Silverberg, professor of dermatology and director of clinical research at George Washington University, Washington. Dupilumab, a human monoclonal IgG4 antibody that inhibits IL-4 and IL-13 signaling, is FDA approved for treating moderate to severe AD in patients age 6 months and older, among other indications.

In addition, the proportion of patients achieving a 4-point or greater improvement in the weekly average of daily hand and foot Peak Pruritus Numerical Rating Scale (PPNRS), the key secondary endpoint, was about fourfold greater with dupilumab: 52.2%, compared with 13.6% on placebo (P < .0001). This reduction in itch reached statistical significance by week 1. Dupilumab-treated patients also experienced significant improvement in other lesion measures and in Quality of Life in Hand Eczema Questionnaire scores, Dr. Silverberg noted.

The patients had a mean age in their 30s and a mean duration of atopic hand and/or foot dermatitis of 15-16 years. For more than one-quarter of patients, morphology was hyperkeratotic, which “has to be one of the toughest subsets to affect positive change in,” he said.

About 40% of patients had lesions on the hands only, and more than half had lesions on both hands and feet. “This is pretty realistic – we generally don’t see much isolated foot dermatitis in the AD population,” Dr. Silverberg said.

About 70%-75% had concomitant AD outside of the hands and feet, mostly of moderate severity. Patients with positive patch tests or whose hand and foot eczema was believed to be driven by irritants were excluded from the trial, as were patients who had used TCS or other topical treatments within 2 weeks of the baseline visit.

Rescue medication use was low (3% with dupilumab vs. 21% with placebo), and adverse events were “pretty consistent with everything we’ve seen with dupilumab,” said Dr. Silverberg.

Commenting on this study, Dr. Chiesa Fuxench said she was “excited to see [the findings], as hand and foot AD can often be quite challenging to treat in clinic.” The improvements in overall disease scores, itch, and quality of life scores – with fairly good tolerance – are “reassuring and what we would expect based on our current experience with dupilumab,” she said.

The lebrikizumab study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. The dupilumab study was sponsored by Sanofi and Regeneron Pharmaceuticals. Some of the data were also reported by lead investigator Eric Simpson, MD, of Oregon Health and Science University at the annual meeting of the American Academy of Dermatology in March 2023.

Dr. Murase reported consulting/advising for Eli Lilly, Leo Pharma, UCB, Sanofi-Genzyme, and non-CME speaking/honoraria for UCB and Regeneron. Dr. Silverberg reported consulting fees and fees for non-CME services from Sanofi Genzyme, Regeneron, Pfizer, and other companies. Dr. Chiesa Fuxench, who was a speaker at the RAD meeting but was not involved in the studies, disclosed receiving honoraria for CME work in AD sponsored by education grants from Regeneron/Sanofi, and grant/research support from Lilly, Regeneron, and Sanofi, among other disclosures.

Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.

Researchers have developed a scorecard to help pediatricians identify and assess the severity of atopic dermatitis in infants of various skin tones and to then predict risk of allergies to peanuts. Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.

Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.

The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.

“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”

Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.

The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.

To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.

Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.

“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.

Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.

“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.

The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.

“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”

The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.

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

Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.

Researchers have developed a scorecard to help pediatricians identify and assess the severity of atopic dermatitis in infants of various skin tones and to then predict risk of allergies to peanuts. Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.

Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.

The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.

“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”

Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.

The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.

To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.

Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.

“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.

Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.

“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.

The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.

“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”

The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.

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

Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.

Researchers have developed a scorecard to help pediatricians identify and assess the severity of atopic dermatitis in infants of various skin tones and to then predict risk of allergies to peanuts. Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.

Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.

The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.

“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”

Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.

The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.

To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.

Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.

“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.

Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.

“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.

The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.

“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”

The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.

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