Atopic Dermatitis

Key clinical point: The first exposure of pediatric individuals to general anesthesia (GA) is not associated with an increased or decreased risk of developing atopic dermatitis (AD).

Major finding: Multivariate analysis revealed that individuals who were exposed vs not exposed to GA did not have an increased or decreased risk of developing AD (adjusted hazard ratio 1.03; P  =  .701).

Study details: This retrospective cohort study included pediatric individuals aged ≤18 years who were (n = 7,681) or were not (n = 38,405; control individuals) exposed to GA.

Disclosures: This study was funded by a 2020 Amorepacific (South Korea) grant. The authors declared no  conflicts of interest.

Source: Kim DC et al. No association between first exposure to general anaesthesia and atopic dermatitis in the paediatric population. Acta Derm Venereol. 2022;102:adv00813 (Nov 14). Doi: 10.2340/actadv.v102.2738

Key clinical point: The first exposure of pediatric individuals to general anesthesia (GA) is not associated with an increased or decreased risk of developing atopic dermatitis (AD).

Major finding: Multivariate analysis revealed that individuals who were exposed vs not exposed to GA did not have an increased or decreased risk of developing AD (adjusted hazard ratio 1.03; P  =  .701).

Study details: This retrospective cohort study included pediatric individuals aged ≤18 years who were (n = 7,681) or were not (n = 38,405; control individuals) exposed to GA.

Disclosures: This study was funded by a 2020 Amorepacific (South Korea) grant. The authors declared no  conflicts of interest.

Source: Kim DC et al. No association between first exposure to general anaesthesia and atopic dermatitis in the paediatric population. Acta Derm Venereol. 2022;102:adv00813 (Nov 14). Doi: 10.2340/actadv.v102.2738

Key clinical point: The first exposure of pediatric individuals to general anesthesia (GA) is not associated with an increased or decreased risk of developing atopic dermatitis (AD).

Major finding: Multivariate analysis revealed that individuals who were exposed vs not exposed to GA did not have an increased or decreased risk of developing AD (adjusted hazard ratio 1.03; P  =  .701).

Study details: This retrospective cohort study included pediatric individuals aged ≤18 years who were (n = 7,681) or were not (n = 38,405; control individuals) exposed to GA.

Disclosures: This study was funded by a 2020 Amorepacific (South Korea) grant. The authors declared no  conflicts of interest.

Source: Kim DC et al. No association between first exposure to general anaesthesia and atopic dermatitis in the paediatric population. Acta Derm Venereol. 2022;102:adv00813 (Nov 14). Doi: 10.2340/actadv.v102.2738

Key clinical point: Downtitrated baricitinib treatment was efficacious in most patients with moderate-to-severe atopic dermatitis (AD) through 16 weeks; clinically relevant efficacy was observed in most patients who were readministered the original dose due to downtitration or treatment withdrawal-related efficacy loss.

Major finding: In the 4-mg and 2-mg cohorts, 61% and 71% of patients maintained a validated Investigator’s Global Assessment for AD (vIGA-AD) score of 0/1/2 at downtitration week 16 and 80%/85%/88% and 90%/56%/86% of patients who switched to original dose in the continuous dosing/downtitration/treatment withdrawal group re-achieved vIGA-AD 0/1/2, respectively.

Study details: This BREEZE-AD3 trial substudy included 526 patients with moderate-to-severe AD treated with 4/2 mg baricitinib at trial entry who achieved vIGA-AD 0/1/2 at week 52, with each cohort being re-assigned to continuous dosing, downtitration, or treatment withdrawal.

Disclosures: This study was sponsored by Eli Lilly and Company under license from Incyte Corporation. Some authors reported ties with various sources, including Eli Lilly and Incyte. Three authors declared being current or former employees and shareholders of Eli Lilly.

Source: Reich K et al. Efficacy of downtitration or treatment withdrawal compared to continuous dosing after successful treatment with baricitinib in patients with moderate-to-severe atopic dermatitis in a randomised substudy from the long-term extension study, BREEZE-AD3. Br J Dermatol. 2022 (Nov 17). Doi: 10.1093/bjd/ljac057

Key clinical point: Downtitrated baricitinib treatment was efficacious in most patients with moderate-to-severe atopic dermatitis (AD) through 16 weeks; clinically relevant efficacy was observed in most patients who were readministered the original dose due to downtitration or treatment withdrawal-related efficacy loss.

Major finding: In the 4-mg and 2-mg cohorts, 61% and 71% of patients maintained a validated Investigator’s Global Assessment for AD (vIGA-AD) score of 0/1/2 at downtitration week 16 and 80%/85%/88% and 90%/56%/86% of patients who switched to original dose in the continuous dosing/downtitration/treatment withdrawal group re-achieved vIGA-AD 0/1/2, respectively.

Study details: This BREEZE-AD3 trial substudy included 526 patients with moderate-to-severe AD treated with 4/2 mg baricitinib at trial entry who achieved vIGA-AD 0/1/2 at week 52, with each cohort being re-assigned to continuous dosing, downtitration, or treatment withdrawal.

Disclosures: This study was sponsored by Eli Lilly and Company under license from Incyte Corporation. Some authors reported ties with various sources, including Eli Lilly and Incyte. Three authors declared being current or former employees and shareholders of Eli Lilly.

Source: Reich K et al. Efficacy of downtitration or treatment withdrawal compared to continuous dosing after successful treatment with baricitinib in patients with moderate-to-severe atopic dermatitis in a randomised substudy from the long-term extension study, BREEZE-AD3. Br J Dermatol. 2022 (Nov 17). Doi: 10.1093/bjd/ljac057

Key clinical point: Downtitrated baricitinib treatment was efficacious in most patients with moderate-to-severe atopic dermatitis (AD) through 16 weeks; clinically relevant efficacy was observed in most patients who were readministered the original dose due to downtitration or treatment withdrawal-related efficacy loss.

Major finding: In the 4-mg and 2-mg cohorts, 61% and 71% of patients maintained a validated Investigator’s Global Assessment for AD (vIGA-AD) score of 0/1/2 at downtitration week 16 and 80%/85%/88% and 90%/56%/86% of patients who switched to original dose in the continuous dosing/downtitration/treatment withdrawal group re-achieved vIGA-AD 0/1/2, respectively.

Study details: This BREEZE-AD3 trial substudy included 526 patients with moderate-to-severe AD treated with 4/2 mg baricitinib at trial entry who achieved vIGA-AD 0/1/2 at week 52, with each cohort being re-assigned to continuous dosing, downtitration, or treatment withdrawal.

Disclosures: This study was sponsored by Eli Lilly and Company under license from Incyte Corporation. Some authors reported ties with various sources, including Eli Lilly and Incyte. Three authors declared being current or former employees and shareholders of Eli Lilly.

Source: Reich K et al. Efficacy of downtitration or treatment withdrawal compared to continuous dosing after successful treatment with baricitinib in patients with moderate-to-severe atopic dermatitis in a randomised substudy from the long-term extension study, BREEZE-AD3. Br J Dermatol. 2022 (Nov 17). Doi: 10.1093/bjd/ljac057

Key clinical point: Dupilumab decreases disease severity, disease-associated symptoms, and severity-associated serum biomarker levels in pediatric patients with atopic dermatitis (AD) in daily practice.

Major finding: At week 28, 49.2% of patients achieved Eczema Area and Severity Index-75; 84.7%, 45.3%, and 77.4% achieved a ≥4-point improvement in the Patient-Oriented Eczema Measure, Numeric Rating Scale (NRS)-pruritus, and NRS-pain scores, respectively; 36.1% scored clear or almost clear on the Investigator’s Global Assessment. The levels of severity-associated markers soluble IL-2-receptor alpha (P < .05), periostin (P < .05), thymus- and activation-regulated chemokine (P < .005), and pulmonary- and activation-regulated chemokine (P < .005) were significantly reduced at week 4. Conjunctivitis (16.4%) and headache (6.6%) were the most common side effects.

Study details: This multicenter prospective observational study included 61 patients (children ≥6 to <12 years; adolescents ≥12 to <18 years) from the BioDay registry with moderate-to-severe AD who received dupilumab for 28 weeks.

Disclosures: The BioDay registry is sponsored by Sanofi/Regeneron and others. Some authors reported ties with various sources, including Sanofi.

Source: Kamphuis E, Boesjes CM et al. Dupilumab in daily practice for the treatment of pediatric atopic dermatitis: 28-week clinical and biomarker results from the BioDay registry. Pediatr Allergy Immunol. 2022;13(12):e13887 (Dec 5). Doi: 10.1111/pai.13887

Key clinical point: Dupilumab decreases disease severity, disease-associated symptoms, and severity-associated serum biomarker levels in pediatric patients with atopic dermatitis (AD) in daily practice.

Major finding: At week 28, 49.2% of patients achieved Eczema Area and Severity Index-75; 84.7%, 45.3%, and 77.4% achieved a ≥4-point improvement in the Patient-Oriented Eczema Measure, Numeric Rating Scale (NRS)-pruritus, and NRS-pain scores, respectively; 36.1% scored clear or almost clear on the Investigator’s Global Assessment. The levels of severity-associated markers soluble IL-2-receptor alpha (P < .05), periostin (P < .05), thymus- and activation-regulated chemokine (P < .005), and pulmonary- and activation-regulated chemokine (P < .005) were significantly reduced at week 4. Conjunctivitis (16.4%) and headache (6.6%) were the most common side effects.

Study details: This multicenter prospective observational study included 61 patients (children ≥6 to <12 years; adolescents ≥12 to <18 years) from the BioDay registry with moderate-to-severe AD who received dupilumab for 28 weeks.

Disclosures: The BioDay registry is sponsored by Sanofi/Regeneron and others. Some authors reported ties with various sources, including Sanofi.

Source: Kamphuis E, Boesjes CM et al. Dupilumab in daily practice for the treatment of pediatric atopic dermatitis: 28-week clinical and biomarker results from the BioDay registry. Pediatr Allergy Immunol. 2022;13(12):e13887 (Dec 5). Doi: 10.1111/pai.13887

Key clinical point: Dupilumab decreases disease severity, disease-associated symptoms, and severity-associated serum biomarker levels in pediatric patients with atopic dermatitis (AD) in daily practice.

Major finding: At week 28, 49.2% of patients achieved Eczema Area and Severity Index-75; 84.7%, 45.3%, and 77.4% achieved a ≥4-point improvement in the Patient-Oriented Eczema Measure, Numeric Rating Scale (NRS)-pruritus, and NRS-pain scores, respectively; 36.1% scored clear or almost clear on the Investigator’s Global Assessment. The levels of severity-associated markers soluble IL-2-receptor alpha (P < .05), periostin (P < .05), thymus- and activation-regulated chemokine (P < .005), and pulmonary- and activation-regulated chemokine (P < .005) were significantly reduced at week 4. Conjunctivitis (16.4%) and headache (6.6%) were the most common side effects.

Study details: This multicenter prospective observational study included 61 patients (children ≥6 to <12 years; adolescents ≥12 to <18 years) from the BioDay registry with moderate-to-severe AD who received dupilumab for 28 weeks.

Disclosures: The BioDay registry is sponsored by Sanofi/Regeneron and others. Some authors reported ties with various sources, including Sanofi.

Source: Kamphuis E, Boesjes CM et al. Dupilumab in daily practice for the treatment of pediatric atopic dermatitis: 28-week clinical and biomarker results from the BioDay registry. Pediatr Allergy Immunol. 2022;13(12):e13887 (Dec 5). Doi: 10.1111/pai.13887

Key clinical point: Early application of emollients can effectively prevent atopic dermatitis (AD) in infants, with emollient emulsion seeming an optimal treatment option in infancy compared with creams or mixed emollients.

Major finding: The incidence of AD was significantly lower in high-risk infants receiving early emollients vs standard care (risk ratio 0.64; 95% CI 0.47-0.88), with surface under the cumulative ranking curve analysis revealing emollient emulsion (82.6%) as the optimal treatment for AD prevention in infants, followed by mixed emollient (77.4%) and emollient cream (21.9%).

Study details: This was a systematic review and network meta-analysis of 11 randomized controlled trials including 3483 infants without AD who received either prophylactic emollients (cream, emulsion, or mixed types) or standard care.

Disclosures: This study was supported by the Key Research and Development Project of Xinjiang Uygur Autonomous Region, China. The authors declared no  conflicts of interest.

Source: Liang J, Hu F et al. Systematic review and network meta‐analysis of different types of emollient for the prevention of atopic dermatitis in infants. J Eur Acad Dermatol Venereol. 2022 (Nov 23). Doi: 10.1111/jdv.18688

Key clinical point: Early application of emollients can effectively prevent atopic dermatitis (AD) in infants, with emollient emulsion seeming an optimal treatment option in infancy compared with creams or mixed emollients.

Major finding: The incidence of AD was significantly lower in high-risk infants receiving early emollients vs standard care (risk ratio 0.64; 95% CI 0.47-0.88), with surface under the cumulative ranking curve analysis revealing emollient emulsion (82.6%) as the optimal treatment for AD prevention in infants, followed by mixed emollient (77.4%) and emollient cream (21.9%).

Study details: This was a systematic review and network meta-analysis of 11 randomized controlled trials including 3483 infants without AD who received either prophylactic emollients (cream, emulsion, or mixed types) or standard care.

Disclosures: This study was supported by the Key Research and Development Project of Xinjiang Uygur Autonomous Region, China. The authors declared no  conflicts of interest.

Source: Liang J, Hu F et al. Systematic review and network meta‐analysis of different types of emollient for the prevention of atopic dermatitis in infants. J Eur Acad Dermatol Venereol. 2022 (Nov 23). Doi: 10.1111/jdv.18688

Key clinical point: Early application of emollients can effectively prevent atopic dermatitis (AD) in infants, with emollient emulsion seeming an optimal treatment option in infancy compared with creams or mixed emollients.

Major finding: The incidence of AD was significantly lower in high-risk infants receiving early emollients vs standard care (risk ratio 0.64; 95% CI 0.47-0.88), with surface under the cumulative ranking curve analysis revealing emollient emulsion (82.6%) as the optimal treatment for AD prevention in infants, followed by mixed emollient (77.4%) and emollient cream (21.9%).

Study details: This was a systematic review and network meta-analysis of 11 randomized controlled trials including 3483 infants without AD who received either prophylactic emollients (cream, emulsion, or mixed types) or standard care.

Disclosures: This study was supported by the Key Research and Development Project of Xinjiang Uygur Autonomous Region, China. The authors declared no  conflicts of interest.

Source: Liang J, Hu F et al. Systematic review and network meta‐analysis of different types of emollient for the prevention of atopic dermatitis in infants. J Eur Acad Dermatol Venereol. 2022 (Nov 23). Doi: 10.1111/jdv.18688

Key clinical point: Ruxolitinib cream demonstrated effective disease control and was well tolerated in patients with atopic dermatitis (AD) during 44 weeks of as-needed treatment.

Major finding: At week 52, 74.1%-77.8% of patients had an Investigator’s Global Assessment score of 0/1, with the mean affected body surface area being 1.4%-1.8%. Treatment-related adverse events were reported in 8.7%/7.4% of patients on 0.75%/1.5% ruxolitinib and in 2.0%/6.1% of those who switched from vehicle to 0.75%/1.5% ruxolitinib, respectively.

Study details: This study analyzed pooled data from two phase 3 studies, TRuE-AD1 and TRuE-AD2, including 1249 patients aged ≥12 years with AD who were randomly assigned to receive 0.75% or 1.5% ruxolitinib cream or vehicle for 8 weeks; thereafter, the vehicle group patients were re-assigned to receive either strength ruxolitinib cream for 44 weeks.

Disclosures: This study was funded by Incyte Corporation, U.S. Some authors reported ties with various sources, including Incyte. Four authors declared being current or former employees and shareholders of Incyte.

Source: Papp K et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. J Am Acad Dermatol. 2022 (Nov 25). Doi: 10.1016/j.jaad.2022.09.060

Key clinical point: Ruxolitinib cream demonstrated effective disease control and was well tolerated in patients with atopic dermatitis (AD) during 44 weeks of as-needed treatment.

Major finding: At week 52, 74.1%-77.8% of patients had an Investigator’s Global Assessment score of 0/1, with the mean affected body surface area being 1.4%-1.8%. Treatment-related adverse events were reported in 8.7%/7.4% of patients on 0.75%/1.5% ruxolitinib and in 2.0%/6.1% of those who switched from vehicle to 0.75%/1.5% ruxolitinib, respectively.

Study details: This study analyzed pooled data from two phase 3 studies, TRuE-AD1 and TRuE-AD2, including 1249 patients aged ≥12 years with AD who were randomly assigned to receive 0.75% or 1.5% ruxolitinib cream or vehicle for 8 weeks; thereafter, the vehicle group patients were re-assigned to receive either strength ruxolitinib cream for 44 weeks.

Disclosures: This study was funded by Incyte Corporation, U.S. Some authors reported ties with various sources, including Incyte. Four authors declared being current or former employees and shareholders of Incyte.

Source: Papp K et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. J Am Acad Dermatol. 2022 (Nov 25). Doi: 10.1016/j.jaad.2022.09.060

Key clinical point: Ruxolitinib cream demonstrated effective disease control and was well tolerated in patients with atopic dermatitis (AD) during 44 weeks of as-needed treatment.

Major finding: At week 52, 74.1%-77.8% of patients had an Investigator’s Global Assessment score of 0/1, with the mean affected body surface area being 1.4%-1.8%. Treatment-related adverse events were reported in 8.7%/7.4% of patients on 0.75%/1.5% ruxolitinib and in 2.0%/6.1% of those who switched from vehicle to 0.75%/1.5% ruxolitinib, respectively.

Study details: This study analyzed pooled data from two phase 3 studies, TRuE-AD1 and TRuE-AD2, including 1249 patients aged ≥12 years with AD who were randomly assigned to receive 0.75% or 1.5% ruxolitinib cream or vehicle for 8 weeks; thereafter, the vehicle group patients were re-assigned to receive either strength ruxolitinib cream for 44 weeks.

Disclosures: This study was funded by Incyte Corporation, U.S. Some authors reported ties with various sources, including Incyte. Four authors declared being current or former employees and shareholders of Incyte.

Source: Papp K et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. J Am Acad Dermatol. 2022 (Nov 25). Doi: 10.1016/j.jaad.2022.09.060

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: An exposure to topical calcineurin inhibitors did not increase the risk for cancer in patients with atopic dermatitis (AD), with findings being similar among infants, children, and adults.

Major finding: Compared with no exposure, topical calcineurin inhibitor exposure was not associated with an increased risk for cancer (odds ratio [OR] 1.03; 95% credible interval [CrI] 0.94-1.11), with neither pimecrolimus (OR 1.05; 95% CrI 0.94-1.15) nor tacrolimus (OR 0.99; 95% CrI 0.89-1.09) use revealing any association with increased cancer risk, across all age groups.

Study details: This was a systematic review and meta-analysis of 110 unique studies (52 randomized controlled trials and 69 nonrandomized studies) including 3.4 million patients with AD followed-up for a mean of 11 months.

Disclosures: This study was funded by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology. L Schneider declared receiving consulting fees and payments to her institutions from, serving on data safety monitoring and advisory boards for, and holding stock or stock options in various sources.

Source: Devasenapathy N et al for the AAAAI/ACAAI Joint Task Force on Practice Parameters for Atopic Dermatitis Guideline Development Group. Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: A systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 (Nov 9). Doi: 10.1016/S2352-4642(22)00283-8

Key clinical point: An exposure to topical calcineurin inhibitors did not increase the risk for cancer in patients with atopic dermatitis (AD), with findings being similar among infants, children, and adults.

Major finding: Compared with no exposure, topical calcineurin inhibitor exposure was not associated with an increased risk for cancer (odds ratio [OR] 1.03; 95% credible interval [CrI] 0.94-1.11), with neither pimecrolimus (OR 1.05; 95% CrI 0.94-1.15) nor tacrolimus (OR 0.99; 95% CrI 0.89-1.09) use revealing any association with increased cancer risk, across all age groups.

Study details: This was a systematic review and meta-analysis of 110 unique studies (52 randomized controlled trials and 69 nonrandomized studies) including 3.4 million patients with AD followed-up for a mean of 11 months.

Disclosures: This study was funded by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology. L Schneider declared receiving consulting fees and payments to her institutions from, serving on data safety monitoring and advisory boards for, and holding stock or stock options in various sources.

Source: Devasenapathy N et al for the AAAAI/ACAAI Joint Task Force on Practice Parameters for Atopic Dermatitis Guideline Development Group. Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: A systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 (Nov 9). Doi: 10.1016/S2352-4642(22)00283-8

Key clinical point: An exposure to topical calcineurin inhibitors did not increase the risk for cancer in patients with atopic dermatitis (AD), with findings being similar among infants, children, and adults.

Major finding: Compared with no exposure, topical calcineurin inhibitor exposure was not associated with an increased risk for cancer (odds ratio [OR] 1.03; 95% credible interval [CrI] 0.94-1.11), with neither pimecrolimus (OR 1.05; 95% CrI 0.94-1.15) nor tacrolimus (OR 0.99; 95% CrI 0.89-1.09) use revealing any association with increased cancer risk, across all age groups.

Study details: This was a systematic review and meta-analysis of 110 unique studies (52 randomized controlled trials and 69 nonrandomized studies) including 3.4 million patients with AD followed-up for a mean of 11 months.

Disclosures: This study was funded by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology. L Schneider declared receiving consulting fees and payments to her institutions from, serving on data safety monitoring and advisory boards for, and holding stock or stock options in various sources.

Source: Devasenapathy N et al for the AAAAI/ACAAI Joint Task Force on Practice Parameters for Atopic Dermatitis Guideline Development Group. Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: A systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 (Nov 9). Doi: 10.1016/S2352-4642(22)00283-8

Key clinical point: Treatment with rocatinlimab, a novel monoclonal antibody, significantly improved disease severity at all dosing regimens in patients with moderate-to-severe atopic dermatitis (AD) inadequately controlled with topical therapy, which was maintained in most patients even after treatment discontinuation.

Major finding: The least-squares mean percent reductions in the Eczema Area and Severity Index at week 16 were significantly greater with 150 mg rocatinlimab every 4 weeks vs placebo (−48.3% vs −15.0%; P  =  .0003), with all other active rocatinlimab dose regimens vs placebo showing improvement (all P < .05) and most patients showing sustained response during off-drug follow-up.

Study details: The data come from a multicenter phase 2b study including 274 patients with moderate-to-severe AD and inadequate response or intolerance to topical medications and who were randomly assigned to receive rocatinlimab or placebo.

Disclosures: This study was funded by Kyowa Kirin. Some authors reported ties with various sources, including Kyowa Kirin. E Esfandiari declared being an employee of Kyowa Kirin.

Source: Guttman-Yassky E et al. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: A multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2022 (Dec 9). Doi: 10.1016/S0140-6736(22)02037-2

Key clinical point: Treatment with rocatinlimab, a novel monoclonal antibody, significantly improved disease severity at all dosing regimens in patients with moderate-to-severe atopic dermatitis (AD) inadequately controlled with topical therapy, which was maintained in most patients even after treatment discontinuation.

Major finding: The least-squares mean percent reductions in the Eczema Area and Severity Index at week 16 were significantly greater with 150 mg rocatinlimab every 4 weeks vs placebo (−48.3% vs −15.0%; P  =  .0003), with all other active rocatinlimab dose regimens vs placebo showing improvement (all P < .05) and most patients showing sustained response during off-drug follow-up.

Study details: The data come from a multicenter phase 2b study including 274 patients with moderate-to-severe AD and inadequate response or intolerance to topical medications and who were randomly assigned to receive rocatinlimab or placebo.

Disclosures: This study was funded by Kyowa Kirin. Some authors reported ties with various sources, including Kyowa Kirin. E Esfandiari declared being an employee of Kyowa Kirin.

Source: Guttman-Yassky E et al. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: A multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2022 (Dec 9). Doi: 10.1016/S0140-6736(22)02037-2

Key clinical point: Treatment with rocatinlimab, a novel monoclonal antibody, significantly improved disease severity at all dosing regimens in patients with moderate-to-severe atopic dermatitis (AD) inadequately controlled with topical therapy, which was maintained in most patients even after treatment discontinuation.

Major finding: The least-squares mean percent reductions in the Eczema Area and Severity Index at week 16 were significantly greater with 150 mg rocatinlimab every 4 weeks vs placebo (−48.3% vs −15.0%; P  =  .0003), with all other active rocatinlimab dose regimens vs placebo showing improvement (all P < .05) and most patients showing sustained response during off-drug follow-up.

Study details: The data come from a multicenter phase 2b study including 274 patients with moderate-to-severe AD and inadequate response or intolerance to topical medications and who were randomly assigned to receive rocatinlimab or placebo.

Disclosures: This study was funded by Kyowa Kirin. Some authors reported ties with various sources, including Kyowa Kirin. E Esfandiari declared being an employee of Kyowa Kirin.

Source: Guttman-Yassky E et al. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: A multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2022 (Dec 9). Doi: 10.1016/S0140-6736(22)02037-2

A registry-based study provides further evidence that treatment with dupilumab significantly reduces severity and symptoms of atopic dermatitis (AD) in clinical practice.

Dupilumab also decreased severity-associated biomarkers in pediatric patients with moderate to severe AD, researchers in the Netherlands reported.

Obtaining serum biomarkers is not the current standard in everyday practice, but studying them may improve understanding of who might respond best to dupilumab, said Jessica Hui, MD, a pediatric allergist and immunologist at National Jewish Health in Denver, in an email comment to this news organization.

“AD is heterogeneous, as each patient may have different presentations and underlying biology,” said Dr. Hui, who wasn’t involved in the research. “Studying biomarkers can eventually assist us in providing targeted therapy to each individual patient.”

Dr. Hui added, “As blood biomarkers can inform us of severity and treatment response, we can be hopeful that this will assist us in the management of AD patients in the future.”
 

Examining effect on disease severity

Dupilumab, a monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is approved in Europe and the United States to treat moderate to severe AD in patients 6 months of age or older, and to treat certain other inflammatory conditions.

Phase 3 studies show that dupilumab is effective for improving AD symptoms and quality of life in pediatric patients, but few clinical practice studies have researched the effect of the therapy on severity- and disease-related biomarkers in this population, the study authors write.

The study was published online in Pediatric Allergy Immunology.

In a new study, a team led by Esmé Kamphuis, MD, of the University of Groningen, the Netherlands, and colleagues evaluated the efficacy and safety of a 28-week dupilumab treatment course in 61 pediatric patients with moderate to severe AD. Additionally, the investigators examined the effect of this treatment regimen on serum biomarkers associated with disease severity.

Patients in the study were registered in the multicenter BioDay registry, which includes patients with moderate to severe AD receiving biologics or small-molecule agents. The AD cohort included children between 6 and 12 years of age (n = 16) and adolescents between 12 and less than 18 years of age (n = 45), all of whom received dupilumab on a dosing regimen indicated by age and body weight.

Over one-third (36.1%) of dupilumab-treated patients achieved an Investigator Global Assessment score of “almost clear” by 28 weeks of treatment. Approximately 75.4% of patients reached an Eczema Area and Severity Index (EASI) of 50, 49.2% reached EASI-75, and 24.6% reached EASI-90 at the 7-month follow-up.

Among patient-reported outcomes, 84.7% experienced improvements of 4 or more points on the Patient-Oriented Eczema Measure after the 28-week dupilumab treatment. In addition, improvements of 4 or more points on the Numeric Rating Scale for pruritus and pain were achieved by 45.3% and 77.4% of patients, respectively.

The most frequently reported side effects included conjunctivitis (n = 10) and headache (n = 4).

Of the 19 severity-associated serum biomarkers measured at baseline, week 4, and week 16, markers related to AD severity and treatment response significantly decreased during treatment (thymus- and activation-regulated chemokine, pulmonary and activation-regulated chemokine, periostin, soluble IL-2 receptor alpha).

A predicted EASI, calculated from selected biomarkers, demonstrated a significant association with disease severity in the cohort.
 

Implications for practice

When asked to comment on the study findings, Raegan Hunt, MD, the division chief of pediatric dermatology at Texas Children’s Hospital in Houston, said it is important to validate the changes in AD serum biomarkers in pediatric patients on dupilumab therapy, given that this treatment has historically been better studied in adults.

“This study adds to daily practice outcomes data, which in many cases is more relevant to the everyday care of patients than structured clinical trial data,” said Dr. Hunt, an associate professor at the Baylor College of Medicine, Houston.

Dr. Hunt, who didn’t participate in the study, noted that more research is needed on the adverse effects of dupilumab in the pediatric AD population.

Dr. Hui added that there is a lack of clear understanding of the exact underlying mechanisms for certain side effects, such as conjunctivitis, warranting further study.

The study’s BioDay registry is funded by Sanofi/Regeneron, AbbVie, Leo Pharma, Pfizer, and Eli Lilly. Several study coauthors report relationships with several pharmaceutical companies. Dr. Hunt and Dr. Hui report no relevant financial relationships.

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

A registry-based study provides further evidence that treatment with dupilumab significantly reduces severity and symptoms of atopic dermatitis (AD) in clinical practice.

Dupilumab also decreased severity-associated biomarkers in pediatric patients with moderate to severe AD, researchers in the Netherlands reported.

Obtaining serum biomarkers is not the current standard in everyday practice, but studying them may improve understanding of who might respond best to dupilumab, said Jessica Hui, MD, a pediatric allergist and immunologist at National Jewish Health in Denver, in an email comment to this news organization.

“AD is heterogeneous, as each patient may have different presentations and underlying biology,” said Dr. Hui, who wasn’t involved in the research. “Studying biomarkers can eventually assist us in providing targeted therapy to each individual patient.”

Dr. Hui added, “As blood biomarkers can inform us of severity and treatment response, we can be hopeful that this will assist us in the management of AD patients in the future.”
 

Examining effect on disease severity

Dupilumab, a monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is approved in Europe and the United States to treat moderate to severe AD in patients 6 months of age or older, and to treat certain other inflammatory conditions.

Phase 3 studies show that dupilumab is effective for improving AD symptoms and quality of life in pediatric patients, but few clinical practice studies have researched the effect of the therapy on severity- and disease-related biomarkers in this population, the study authors write.

The study was published online in Pediatric Allergy Immunology.

In a new study, a team led by Esmé Kamphuis, MD, of the University of Groningen, the Netherlands, and colleagues evaluated the efficacy and safety of a 28-week dupilumab treatment course in 61 pediatric patients with moderate to severe AD. Additionally, the investigators examined the effect of this treatment regimen on serum biomarkers associated with disease severity.

Patients in the study were registered in the multicenter BioDay registry, which includes patients with moderate to severe AD receiving biologics or small-molecule agents. The AD cohort included children between 6 and 12 years of age (n = 16) and adolescents between 12 and less than 18 years of age (n = 45), all of whom received dupilumab on a dosing regimen indicated by age and body weight.

Over one-third (36.1%) of dupilumab-treated patients achieved an Investigator Global Assessment score of “almost clear” by 28 weeks of treatment. Approximately 75.4% of patients reached an Eczema Area and Severity Index (EASI) of 50, 49.2% reached EASI-75, and 24.6% reached EASI-90 at the 7-month follow-up.

Among patient-reported outcomes, 84.7% experienced improvements of 4 or more points on the Patient-Oriented Eczema Measure after the 28-week dupilumab treatment. In addition, improvements of 4 or more points on the Numeric Rating Scale for pruritus and pain were achieved by 45.3% and 77.4% of patients, respectively.

The most frequently reported side effects included conjunctivitis (n = 10) and headache (n = 4).

Of the 19 severity-associated serum biomarkers measured at baseline, week 4, and week 16, markers related to AD severity and treatment response significantly decreased during treatment (thymus- and activation-regulated chemokine, pulmonary and activation-regulated chemokine, periostin, soluble IL-2 receptor alpha).

A predicted EASI, calculated from selected biomarkers, demonstrated a significant association with disease severity in the cohort.
 

Implications for practice

When asked to comment on the study findings, Raegan Hunt, MD, the division chief of pediatric dermatology at Texas Children’s Hospital in Houston, said it is important to validate the changes in AD serum biomarkers in pediatric patients on dupilumab therapy, given that this treatment has historically been better studied in adults.

“This study adds to daily practice outcomes data, which in many cases is more relevant to the everyday care of patients than structured clinical trial data,” said Dr. Hunt, an associate professor at the Baylor College of Medicine, Houston.

Dr. Hunt, who didn’t participate in the study, noted that more research is needed on the adverse effects of dupilumab in the pediatric AD population.

Dr. Hui added that there is a lack of clear understanding of the exact underlying mechanisms for certain side effects, such as conjunctivitis, warranting further study.

The study’s BioDay registry is funded by Sanofi/Regeneron, AbbVie, Leo Pharma, Pfizer, and Eli Lilly. Several study coauthors report relationships with several pharmaceutical companies. Dr. Hunt and Dr. Hui report no relevant financial relationships.

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

A registry-based study provides further evidence that treatment with dupilumab significantly reduces severity and symptoms of atopic dermatitis (AD) in clinical practice.

Dupilumab also decreased severity-associated biomarkers in pediatric patients with moderate to severe AD, researchers in the Netherlands reported.

Obtaining serum biomarkers is not the current standard in everyday practice, but studying them may improve understanding of who might respond best to dupilumab, said Jessica Hui, MD, a pediatric allergist and immunologist at National Jewish Health in Denver, in an email comment to this news organization.

“AD is heterogeneous, as each patient may have different presentations and underlying biology,” said Dr. Hui, who wasn’t involved in the research. “Studying biomarkers can eventually assist us in providing targeted therapy to each individual patient.”

Dr. Hui added, “As blood biomarkers can inform us of severity and treatment response, we can be hopeful that this will assist us in the management of AD patients in the future.”
 

Examining effect on disease severity

Dupilumab, a monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is approved in Europe and the United States to treat moderate to severe AD in patients 6 months of age or older, and to treat certain other inflammatory conditions.

Phase 3 studies show that dupilumab is effective for improving AD symptoms and quality of life in pediatric patients, but few clinical practice studies have researched the effect of the therapy on severity- and disease-related biomarkers in this population, the study authors write.

The study was published online in Pediatric Allergy Immunology.

In a new study, a team led by Esmé Kamphuis, MD, of the University of Groningen, the Netherlands, and colleagues evaluated the efficacy and safety of a 28-week dupilumab treatment course in 61 pediatric patients with moderate to severe AD. Additionally, the investigators examined the effect of this treatment regimen on serum biomarkers associated with disease severity.

Patients in the study were registered in the multicenter BioDay registry, which includes patients with moderate to severe AD receiving biologics or small-molecule agents. The AD cohort included children between 6 and 12 years of age (n = 16) and adolescents between 12 and less than 18 years of age (n = 45), all of whom received dupilumab on a dosing regimen indicated by age and body weight.

Over one-third (36.1%) of dupilumab-treated patients achieved an Investigator Global Assessment score of “almost clear” by 28 weeks of treatment. Approximately 75.4% of patients reached an Eczema Area and Severity Index (EASI) of 50, 49.2% reached EASI-75, and 24.6% reached EASI-90 at the 7-month follow-up.

Among patient-reported outcomes, 84.7% experienced improvements of 4 or more points on the Patient-Oriented Eczema Measure after the 28-week dupilumab treatment. In addition, improvements of 4 or more points on the Numeric Rating Scale for pruritus and pain were achieved by 45.3% and 77.4% of patients, respectively.

The most frequently reported side effects included conjunctivitis (n = 10) and headache (n = 4).

Of the 19 severity-associated serum biomarkers measured at baseline, week 4, and week 16, markers related to AD severity and treatment response significantly decreased during treatment (thymus- and activation-regulated chemokine, pulmonary and activation-regulated chemokine, periostin, soluble IL-2 receptor alpha).

A predicted EASI, calculated from selected biomarkers, demonstrated a significant association with disease severity in the cohort.
 

Implications for practice

When asked to comment on the study findings, Raegan Hunt, MD, the division chief of pediatric dermatology at Texas Children’s Hospital in Houston, said it is important to validate the changes in AD serum biomarkers in pediatric patients on dupilumab therapy, given that this treatment has historically been better studied in adults.

“This study adds to daily practice outcomes data, which in many cases is more relevant to the everyday care of patients than structured clinical trial data,” said Dr. Hunt, an associate professor at the Baylor College of Medicine, Houston.

Dr. Hunt, who didn’t participate in the study, noted that more research is needed on the adverse effects of dupilumab in the pediatric AD population.

Dr. Hui added that there is a lack of clear understanding of the exact underlying mechanisms for certain side effects, such as conjunctivitis, warranting further study.

The study’s BioDay registry is funded by Sanofi/Regeneron, AbbVie, Leo Pharma, Pfizer, and Eli Lilly. Several study coauthors report relationships with several pharmaceutical companies. Dr. Hunt and Dr. Hui report no relevant financial relationships.

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