Atopic Dermatitis

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

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

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

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

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

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

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w

Key clinical point: Adults with atopic dermatitis (AD) have a 1.28-fold increased risk for incident venous thromboembolism (VTE) compared with those without AD.

Major finding: Patients with AD vs control individuals without AD had an increased risk for incident VTE (hazard ratio [HR] 1.28; 95% CI 1.17-1.40), with the risk being elevated for both deep vein thrombosis (HR 1.26; 95% CI 1.14-1.40) and pulmonary embolism (HR 1.30; 95% CI 1.08-1.57).

Study details: The data come from a retrospective cohort study that included 142,429 patients age ≥ 20 years with AD and 142,429 matched control individuals without AD.

Disclosures: This study was funded by Hualien Tzu Chi Hospital, Taiwan. The authors declared no conflicts of interest.

Source: Chen TL et al. Risk of venous thromboembolism among adults with atopic dermatitis. JAMA Dermatol. 2023 (May 31). doi: 10.1001/jamadermatol.2023.1300.

Key clinical point: Adults with atopic dermatitis (AD) have a 1.28-fold increased risk for incident venous thromboembolism (VTE) compared with those without AD.

Major finding: Patients with AD vs control individuals without AD had an increased risk for incident VTE (hazard ratio [HR] 1.28; 95% CI 1.17-1.40), with the risk being elevated for both deep vein thrombosis (HR 1.26; 95% CI 1.14-1.40) and pulmonary embolism (HR 1.30; 95% CI 1.08-1.57).

Study details: The data come from a retrospective cohort study that included 142,429 patients age ≥ 20 years with AD and 142,429 matched control individuals without AD.

Disclosures: This study was funded by Hualien Tzu Chi Hospital, Taiwan. The authors declared no conflicts of interest.

Source: Chen TL et al. Risk of venous thromboembolism among adults with atopic dermatitis. JAMA Dermatol. 2023 (May 31). doi: 10.1001/jamadermatol.2023.1300.

Key clinical point: Adults with atopic dermatitis (AD) have a 1.28-fold increased risk for incident venous thromboembolism (VTE) compared with those without AD.

Major finding: Patients with AD vs control individuals without AD had an increased risk for incident VTE (hazard ratio [HR] 1.28; 95% CI 1.17-1.40), with the risk being elevated for both deep vein thrombosis (HR 1.26; 95% CI 1.14-1.40) and pulmonary embolism (HR 1.30; 95% CI 1.08-1.57).

Study details: The data come from a retrospective cohort study that included 142,429 patients age ≥ 20 years with AD and 142,429 matched control individuals without AD.

Disclosures: This study was funded by Hualien Tzu Chi Hospital, Taiwan. The authors declared no conflicts of interest.

Source: Chen TL et al. Risk of venous thromboembolism among adults with atopic dermatitis. JAMA Dermatol. 2023 (May 31). doi: 10.1001/jamadermatol.2023.1300.

Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.

Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.

Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.

Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or  stock options in AOBiome.

Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002

Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.

Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.

Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.

Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or  stock options in AOBiome.

Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002

Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.

Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.

Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.

Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or  stock options in AOBiome.

Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002

WASHINGTON – What does shared decision-making about atopic dermatitis (AD) treatment mean at a time of increasing treatment options and patient concerns about drug safety and the potentially lifelong need for systemic treatment?

The question was top of mind for experts who shared their advice during a “Tips and Tricks” session at the Revolutionizing Atopic Dermatitis meeting. Dupilumab dosing and dupilumab-associated facial redness and ocular disease, self-image issues, topical regimen adherence, and the quantification of disease were among the other topics raised by the experts.

Here are some of their practice pearls.
 

Treatment decisions, safety concerns

Deciding on a treatment is “kind of confusing ... particularly in the last year ... and it will only get more complicated,” said Raj J. Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago. “We’re all about some version of shared decision-making, but if all else is equal, sometimes it pays to explicitly ask the patient, what do you want to do?”

Questions about how long a systemic treatment should be tried, both initially and in the long run, are common. “I think that oftentimes we all get antsy about making changes when we’re not getting to the endpoint we want to. And at least in my real-world experience, late responders are a real thing. Sometimes 3-4 months ... isn’t enough,” he said.

Trial extension data show that patients who were nonresponders for various endpoints at 16 weeks are “captured continuously as you go further and further out,” Dr. Chovatiya said. Regarding the long term, “realistically, there’s no perfect time to call it quits.”

Addressing fears about Janus kinase inhibitors can be challenging, he said. “When you’ve identified the right patient and labs are done ... have them take the medication in front of you and hang out,” he advised. “It may sound ridiculous, but for the extremely anxious person it can be a big stress reducer for everyone involved.”

Regarding treatment fears more generally, “asking patients ‘what is the biggest risk of not treating your disease?’ sometimes gets people thinking,” Dr. Chovatiya said.

For parents of children with AD, said Robert Sidbury, MD, MPH, risks of not treating can become apparent once treatments are started and benefits are realized. “It’s so easy to focus on the risks of any treatment because they’re right there in black and white, and the risks of not treating are not always as apparent, even though – or maybe because – they live with them every day.”

When treatment is underway, “they see [how] everyone sleeps better, how school performance gets better, how concentration gets better,” said Dr. Sidbury, professor in the department of pediatrics at the University of Washington. Seattle, and chief of dermatology at Seattle Children’s Hospital.

“Always contextualize,” he advised. “As dermatologists, we’re savvy with navigating boxed warnings.”

David Rosmarin, MD, chair of dermatology, at Indiana University, Indianapolis, and formerly vice chair for research and education at Tufts Medical Center, Boston, said he addresses questions about the length of systemic treatment by advising patients: “Why don’t we start taking [the medication] for 3 months and then we’ll take it from there.”

In some pediatric cases, Dr. Rosmarin said, having the child express “what their AD means to them – how it affects them,” and then acknowledging and validating what the child says, is helpful to parents who are concerned about systemic treatments.
 

Dupilumab in the real world

Some patients on dupilumab do not have a complete response with dosing every 2 weeks and may benefit from more frequent dosing, said Dr. Rosmarin.

“We know from the SOLO-1 and SOLO-2 studies that dupilumab weekly dosing was evaluated. It was only the every-other-week dosing that was approved, and we can see why – in terms of the changes in EASI [Eczema Area and Severity Index] score they’re close to overlapping,” he said.

In real life, however, “some patients benefit from different dosing. It’s important to realize that. I think we all have some patients who may dose more frequently and some who may dose less frequently,” Dr. Rosmarin said.

For a patient who “gets absolutely no response from dupilumab after 3-4 months, I’d switch them to something else. But for those who are partial responders, particularly those who tell me they’re getting itchy before their next dose, they’re the ones who benefit most from doubling the dose to dupilumab weekly,” he said.

For patients who experience dupilumab-associated head and neck dermatitis, itraconazole may help, Dr. Rosmarin added. “We’re using 200 mg daily for 2 weeks and weekly thereafter, and it helps some of our patients.” The average self-reported improvement was 52% for patients with dupilumab-associated facial redness treated with itraconazole in a retrospective medical record review that he and his colleagues published in 2022.

Dr. Rosmarin pointed to a multicenter prospective cohort study also published in 2022 showing that baseline/pretreatment levels of Malassezia-specific IgE were associated with the development of dupilumab-associated head and neck dermatitis. The median levels of Malassezia-specific IgE were 32 kUL^–1 versus 2.3 kUL^–1 in patients who experienced dupilumab-associated facial redness, compared with those who did not.

He said that, while there “may be multiple reasons” for dupilumab-associated head and neck dermatitis and that “plenty of patients” who don’t have Malassezia-specific IgE develop head and neck dermatitis, “this could be one cause.”

Itraconazole has been shown in his practice to be superior to fluconazole, likely because it has greater anti-inflammatory effects and provides better coverage of Malassezia because it is more lipophilic, said Dr. Rosmarin, who does not test for Malassezia-specific IgE before trying itraconazole.

Topical adherence with diffuse xerosis and mild-moderate AD

For patients with diffuse xerosis and mild-moderate AD, especially those who are older and having difficulty with topical regimens, Anna De Benedetto, MD, said she tries to enhance adherence by simplifying the regimen. She asks patients to buy a pound jar of base cream (ceramide base) – “whatever emollient they like” – and mixes into it a high-potency steroid solution. They’re instructed to apply the combined cream once daily for 1-2 weeks, and then three times a week alternating with a nonmedicated cream.

“This way they’re using one [cream] to target the immune system and the skin barrier,” said Dr. De Benedetto, associate professor of dermatology and director of the dermatology clinical trial unit at the University of Rochester (N.Y.) Medical Center.
 

‘Wet wrap’ pajamas; self-image for children, teens

Dermatologist Melinda Gooderham, MSc, MD, assistant professor at Queen’s University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology, said that, for widespread and troublesome AD, she advises patients or parents to wet a thin cotton pajama top and bottom and spin it in the dryer “so it’s almost dry but still moist.” Dry, looser pajamas or a light track suit can then be worn over the damp pajamas. “I usually tell [patients] to buy one size up,” she said.

Bruce Jancin/Frontline Medical News

Body dysmorphia is common with skin disease, and its incidence is six times higher in people with eczema than those without the disease, said Dr. Siegfried. “I’ve found that, for patients subjected to AD for a long time,” this is still an issue, “even when you clear their skin.”

For children, teens and their families, the nonprofit organization Made a Masterpiece can be valuable, Dr. Siegfried said. It offers resources from parents, children, psychologists, dermatologists, and others to help manage the emotional, social and spiritual aspects of living with a skin condition.
 

To use or not to use BSA; environmental counseling

“I think [assessing] body surface area [BSA] is very important in pediatrics and for adolescents [especially in those with moderate to severe disease] because it quantifies the disease for the family,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego.

University of California, San Diego

“Families live with the disease, but quantification really matters” for understanding the extent and impact of the disease and for motivating families to treat, said Dr. Eichenfield.

(When the disease is markedly diminished in follow-up, knowing the BSA then “helps families to register the improvement and gives positive reinforcement,” Dr. Eichenfeld said after the meeting.)

Young patients can participate, he noted at the meeting. “When I do telemedicine visits, kids can tell me how many hands of eczema they have.”

Dr. Eichenfield also said that he now routinely counsels on the environmental impacts on eczema. For example, “I explain to people that we’re probably going to have a bad wildfire season in California, and it’s the kind of environmental perturbation that may impact some eczema patients,” he said, noting the 2021 study documenting an association of wildfire air pollution from the 2018 California Camp fire with an increase in dermatology clinic visits for AD and itch in San Francisco.

“It helps to keep an eye out for that, and also to be aware of some of the environmental changes,” he said.

Dr. Chovatiya reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others. Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, and Lilly, among others. Dr. Rosmarin reported ties with AbbVie, Incyte, Lilly, Pfizer, Regeneron, and Sanofi, among others. Dr. Siegfried reported ties with Regeneron, Sanofi Genzyme, AbbVie, Incyte, Leo, and Pfizer, among others. Dr. De Benedetto reported ties with Incyte, Pfizer, AbbVie, and Sanofi Advent, among others. Dr. Gooderham reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, among others. Dr. Eichenfield disclosed ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others.

WASHINGTON – What does shared decision-making about atopic dermatitis (AD) treatment mean at a time of increasing treatment options and patient concerns about drug safety and the potentially lifelong need for systemic treatment?

The question was top of mind for experts who shared their advice during a “Tips and Tricks” session at the Revolutionizing Atopic Dermatitis meeting. Dupilumab dosing and dupilumab-associated facial redness and ocular disease, self-image issues, topical regimen adherence, and the quantification of disease were among the other topics raised by the experts.

Here are some of their practice pearls.
 

Treatment decisions, safety concerns

Deciding on a treatment is “kind of confusing ... particularly in the last year ... and it will only get more complicated,” said Raj J. Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago. “We’re all about some version of shared decision-making, but if all else is equal, sometimes it pays to explicitly ask the patient, what do you want to do?”

Questions about how long a systemic treatment should be tried, both initially and in the long run, are common. “I think that oftentimes we all get antsy about making changes when we’re not getting to the endpoint we want to. And at least in my real-world experience, late responders are a real thing. Sometimes 3-4 months ... isn’t enough,” he said.

Trial extension data show that patients who were nonresponders for various endpoints at 16 weeks are “captured continuously as you go further and further out,” Dr. Chovatiya said. Regarding the long term, “realistically, there’s no perfect time to call it quits.”

Addressing fears about Janus kinase inhibitors can be challenging, he said. “When you’ve identified the right patient and labs are done ... have them take the medication in front of you and hang out,” he advised. “It may sound ridiculous, but for the extremely anxious person it can be a big stress reducer for everyone involved.”

Regarding treatment fears more generally, “asking patients ‘what is the biggest risk of not treating your disease?’ sometimes gets people thinking,” Dr. Chovatiya said.

For parents of children with AD, said Robert Sidbury, MD, MPH, risks of not treating can become apparent once treatments are started and benefits are realized. “It’s so easy to focus on the risks of any treatment because they’re right there in black and white, and the risks of not treating are not always as apparent, even though – or maybe because – they live with them every day.”

When treatment is underway, “they see [how] everyone sleeps better, how school performance gets better, how concentration gets better,” said Dr. Sidbury, professor in the department of pediatrics at the University of Washington. Seattle, and chief of dermatology at Seattle Children’s Hospital.

“Always contextualize,” he advised. “As dermatologists, we’re savvy with navigating boxed warnings.”

David Rosmarin, MD, chair of dermatology, at Indiana University, Indianapolis, and formerly vice chair for research and education at Tufts Medical Center, Boston, said he addresses questions about the length of systemic treatment by advising patients: “Why don’t we start taking [the medication] for 3 months and then we’ll take it from there.”

In some pediatric cases, Dr. Rosmarin said, having the child express “what their AD means to them – how it affects them,” and then acknowledging and validating what the child says, is helpful to parents who are concerned about systemic treatments.
 

Dupilumab in the real world

Some patients on dupilumab do not have a complete response with dosing every 2 weeks and may benefit from more frequent dosing, said Dr. Rosmarin.

“We know from the SOLO-1 and SOLO-2 studies that dupilumab weekly dosing was evaluated. It was only the every-other-week dosing that was approved, and we can see why – in terms of the changes in EASI [Eczema Area and Severity Index] score they’re close to overlapping,” he said.

In real life, however, “some patients benefit from different dosing. It’s important to realize that. I think we all have some patients who may dose more frequently and some who may dose less frequently,” Dr. Rosmarin said.

For a patient who “gets absolutely no response from dupilumab after 3-4 months, I’d switch them to something else. But for those who are partial responders, particularly those who tell me they’re getting itchy before their next dose, they’re the ones who benefit most from doubling the dose to dupilumab weekly,” he said.

For patients who experience dupilumab-associated head and neck dermatitis, itraconazole may help, Dr. Rosmarin added. “We’re using 200 mg daily for 2 weeks and weekly thereafter, and it helps some of our patients.” The average self-reported improvement was 52% for patients with dupilumab-associated facial redness treated with itraconazole in a retrospective medical record review that he and his colleagues published in 2022.

Dr. Rosmarin pointed to a multicenter prospective cohort study also published in 2022 showing that baseline/pretreatment levels of Malassezia-specific IgE were associated with the development of dupilumab-associated head and neck dermatitis. The median levels of Malassezia-specific IgE were 32 kUL^–1 versus 2.3 kUL^–1 in patients who experienced dupilumab-associated facial redness, compared with those who did not.

He said that, while there “may be multiple reasons” for dupilumab-associated head and neck dermatitis and that “plenty of patients” who don’t have Malassezia-specific IgE develop head and neck dermatitis, “this could be one cause.”

Itraconazole has been shown in his practice to be superior to fluconazole, likely because it has greater anti-inflammatory effects and provides better coverage of Malassezia because it is more lipophilic, said Dr. Rosmarin, who does not test for Malassezia-specific IgE before trying itraconazole.

Topical adherence with diffuse xerosis and mild-moderate AD

For patients with diffuse xerosis and mild-moderate AD, especially those who are older and having difficulty with topical regimens, Anna De Benedetto, MD, said she tries to enhance adherence by simplifying the regimen. She asks patients to buy a pound jar of base cream (ceramide base) – “whatever emollient they like” – and mixes into it a high-potency steroid solution. They’re instructed to apply the combined cream once daily for 1-2 weeks, and then three times a week alternating with a nonmedicated cream.

“This way they’re using one [cream] to target the immune system and the skin barrier,” said Dr. De Benedetto, associate professor of dermatology and director of the dermatology clinical trial unit at the University of Rochester (N.Y.) Medical Center.
 

‘Wet wrap’ pajamas; self-image for children, teens

Dermatologist Melinda Gooderham, MSc, MD, assistant professor at Queen’s University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology, said that, for widespread and troublesome AD, she advises patients or parents to wet a thin cotton pajama top and bottom and spin it in the dryer “so it’s almost dry but still moist.” Dry, looser pajamas or a light track suit can then be worn over the damp pajamas. “I usually tell [patients] to buy one size up,” she said.

Bruce Jancin/Frontline Medical News

Body dysmorphia is common with skin disease, and its incidence is six times higher in people with eczema than those without the disease, said Dr. Siegfried. “I’ve found that, for patients subjected to AD for a long time,” this is still an issue, “even when you clear their skin.”

For children, teens and their families, the nonprofit organization Made a Masterpiece can be valuable, Dr. Siegfried said. It offers resources from parents, children, psychologists, dermatologists, and others to help manage the emotional, social and spiritual aspects of living with a skin condition.
 

To use or not to use BSA; environmental counseling

“I think [assessing] body surface area [BSA] is very important in pediatrics and for adolescents [especially in those with moderate to severe disease] because it quantifies the disease for the family,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego.

University of California, San Diego

“Families live with the disease, but quantification really matters” for understanding the extent and impact of the disease and for motivating families to treat, said Dr. Eichenfield.

(When the disease is markedly diminished in follow-up, knowing the BSA then “helps families to register the improvement and gives positive reinforcement,” Dr. Eichenfeld said after the meeting.)

Young patients can participate, he noted at the meeting. “When I do telemedicine visits, kids can tell me how many hands of eczema they have.”

Dr. Eichenfield also said that he now routinely counsels on the environmental impacts on eczema. For example, “I explain to people that we’re probably going to have a bad wildfire season in California, and it’s the kind of environmental perturbation that may impact some eczema patients,” he said, noting the 2021 study documenting an association of wildfire air pollution from the 2018 California Camp fire with an increase in dermatology clinic visits for AD and itch in San Francisco.

“It helps to keep an eye out for that, and also to be aware of some of the environmental changes,” he said.

Dr. Chovatiya reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others. Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, and Lilly, among others. Dr. Rosmarin reported ties with AbbVie, Incyte, Lilly, Pfizer, Regeneron, and Sanofi, among others. Dr. Siegfried reported ties with Regeneron, Sanofi Genzyme, AbbVie, Incyte, Leo, and Pfizer, among others. Dr. De Benedetto reported ties with Incyte, Pfizer, AbbVie, and Sanofi Advent, among others. Dr. Gooderham reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, among others. Dr. Eichenfield disclosed ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others.

WASHINGTON – What does shared decision-making about atopic dermatitis (AD) treatment mean at a time of increasing treatment options and patient concerns about drug safety and the potentially lifelong need for systemic treatment?

The question was top of mind for experts who shared their advice during a “Tips and Tricks” session at the Revolutionizing Atopic Dermatitis meeting. Dupilumab dosing and dupilumab-associated facial redness and ocular disease, self-image issues, topical regimen adherence, and the quantification of disease were among the other topics raised by the experts.

Here are some of their practice pearls.
 

Treatment decisions, safety concerns

Deciding on a treatment is “kind of confusing ... particularly in the last year ... and it will only get more complicated,” said Raj J. Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago. “We’re all about some version of shared decision-making, but if all else is equal, sometimes it pays to explicitly ask the patient, what do you want to do?”

Questions about how long a systemic treatment should be tried, both initially and in the long run, are common. “I think that oftentimes we all get antsy about making changes when we’re not getting to the endpoint we want to. And at least in my real-world experience, late responders are a real thing. Sometimes 3-4 months ... isn’t enough,” he said.

Trial extension data show that patients who were nonresponders for various endpoints at 16 weeks are “captured continuously as you go further and further out,” Dr. Chovatiya said. Regarding the long term, “realistically, there’s no perfect time to call it quits.”

Addressing fears about Janus kinase inhibitors can be challenging, he said. “When you’ve identified the right patient and labs are done ... have them take the medication in front of you and hang out,” he advised. “It may sound ridiculous, but for the extremely anxious person it can be a big stress reducer for everyone involved.”

Regarding treatment fears more generally, “asking patients ‘what is the biggest risk of not treating your disease?’ sometimes gets people thinking,” Dr. Chovatiya said.

For parents of children with AD, said Robert Sidbury, MD, MPH, risks of not treating can become apparent once treatments are started and benefits are realized. “It’s so easy to focus on the risks of any treatment because they’re right there in black and white, and the risks of not treating are not always as apparent, even though – or maybe because – they live with them every day.”

When treatment is underway, “they see [how] everyone sleeps better, how school performance gets better, how concentration gets better,” said Dr. Sidbury, professor in the department of pediatrics at the University of Washington. Seattle, and chief of dermatology at Seattle Children’s Hospital.

“Always contextualize,” he advised. “As dermatologists, we’re savvy with navigating boxed warnings.”

David Rosmarin, MD, chair of dermatology, at Indiana University, Indianapolis, and formerly vice chair for research and education at Tufts Medical Center, Boston, said he addresses questions about the length of systemic treatment by advising patients: “Why don’t we start taking [the medication] for 3 months and then we’ll take it from there.”

In some pediatric cases, Dr. Rosmarin said, having the child express “what their AD means to them – how it affects them,” and then acknowledging and validating what the child says, is helpful to parents who are concerned about systemic treatments.
 

Dupilumab in the real world

Some patients on dupilumab do not have a complete response with dosing every 2 weeks and may benefit from more frequent dosing, said Dr. Rosmarin.

“We know from the SOLO-1 and SOLO-2 studies that dupilumab weekly dosing was evaluated. It was only the every-other-week dosing that was approved, and we can see why – in terms of the changes in EASI [Eczema Area and Severity Index] score they’re close to overlapping,” he said.

In real life, however, “some patients benefit from different dosing. It’s important to realize that. I think we all have some patients who may dose more frequently and some who may dose less frequently,” Dr. Rosmarin said.

For a patient who “gets absolutely no response from dupilumab after 3-4 months, I’d switch them to something else. But for those who are partial responders, particularly those who tell me they’re getting itchy before their next dose, they’re the ones who benefit most from doubling the dose to dupilumab weekly,” he said.

For patients who experience dupilumab-associated head and neck dermatitis, itraconazole may help, Dr. Rosmarin added. “We’re using 200 mg daily for 2 weeks and weekly thereafter, and it helps some of our patients.” The average self-reported improvement was 52% for patients with dupilumab-associated facial redness treated with itraconazole in a retrospective medical record review that he and his colleagues published in 2022.

Dr. Rosmarin pointed to a multicenter prospective cohort study also published in 2022 showing that baseline/pretreatment levels of Malassezia-specific IgE were associated with the development of dupilumab-associated head and neck dermatitis. The median levels of Malassezia-specific IgE were 32 kUL^–1 versus 2.3 kUL^–1 in patients who experienced dupilumab-associated facial redness, compared with those who did not.

He said that, while there “may be multiple reasons” for dupilumab-associated head and neck dermatitis and that “plenty of patients” who don’t have Malassezia-specific IgE develop head and neck dermatitis, “this could be one cause.”

Itraconazole has been shown in his practice to be superior to fluconazole, likely because it has greater anti-inflammatory effects and provides better coverage of Malassezia because it is more lipophilic, said Dr. Rosmarin, who does not test for Malassezia-specific IgE before trying itraconazole.

Topical adherence with diffuse xerosis and mild-moderate AD

For patients with diffuse xerosis and mild-moderate AD, especially those who are older and having difficulty with topical regimens, Anna De Benedetto, MD, said she tries to enhance adherence by simplifying the regimen. She asks patients to buy a pound jar of base cream (ceramide base) – “whatever emollient they like” – and mixes into it a high-potency steroid solution. They’re instructed to apply the combined cream once daily for 1-2 weeks, and then three times a week alternating with a nonmedicated cream.

“This way they’re using one [cream] to target the immune system and the skin barrier,” said Dr. De Benedetto, associate professor of dermatology and director of the dermatology clinical trial unit at the University of Rochester (N.Y.) Medical Center.
 

‘Wet wrap’ pajamas; self-image for children, teens

Dermatologist Melinda Gooderham, MSc, MD, assistant professor at Queen’s University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology, said that, for widespread and troublesome AD, she advises patients or parents to wet a thin cotton pajama top and bottom and spin it in the dryer “so it’s almost dry but still moist.” Dry, looser pajamas or a light track suit can then be worn over the damp pajamas. “I usually tell [patients] to buy one size up,” she said.

Bruce Jancin/Frontline Medical News

Body dysmorphia is common with skin disease, and its incidence is six times higher in people with eczema than those without the disease, said Dr. Siegfried. “I’ve found that, for patients subjected to AD for a long time,” this is still an issue, “even when you clear their skin.”

For children, teens and their families, the nonprofit organization Made a Masterpiece can be valuable, Dr. Siegfried said. It offers resources from parents, children, psychologists, dermatologists, and others to help manage the emotional, social and spiritual aspects of living with a skin condition.
 

To use or not to use BSA; environmental counseling

“I think [assessing] body surface area [BSA] is very important in pediatrics and for adolescents [especially in those with moderate to severe disease] because it quantifies the disease for the family,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego.

University of California, San Diego

“Families live with the disease, but quantification really matters” for understanding the extent and impact of the disease and for motivating families to treat, said Dr. Eichenfield.

(When the disease is markedly diminished in follow-up, knowing the BSA then “helps families to register the improvement and gives positive reinforcement,” Dr. Eichenfeld said after the meeting.)

Young patients can participate, he noted at the meeting. “When I do telemedicine visits, kids can tell me how many hands of eczema they have.”

Dr. Eichenfield also said that he now routinely counsels on the environmental impacts on eczema. For example, “I explain to people that we’re probably going to have a bad wildfire season in California, and it’s the kind of environmental perturbation that may impact some eczema patients,” he said, noting the 2021 study documenting an association of wildfire air pollution from the 2018 California Camp fire with an increase in dermatology clinic visits for AD and itch in San Francisco.

“It helps to keep an eye out for that, and also to be aware of some of the environmental changes,” he said.

Dr. Chovatiya reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others. Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, and Lilly, among others. Dr. Rosmarin reported ties with AbbVie, Incyte, Lilly, Pfizer, Regeneron, and Sanofi, among others. Dr. Siegfried reported ties with Regeneron, Sanofi Genzyme, AbbVie, Incyte, Leo, and Pfizer, among others. Dr. De Benedetto reported ties with Incyte, Pfizer, AbbVie, and Sanofi Advent, among others. Dr. Gooderham reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, among others. Dr. Eichenfield disclosed ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others.

WASHINGTON – A substantial proportion of adults with moderate to severe atopic dermatitis (AD) treated with oral abrocitinib 100 mg or 200 mg once daily for up to 96 weeks had sustained improvements in skin clearance, itch, and quality of life in a post hoc analysis of the JADE EXTEND phase 3 trial, Andrew F. Alexis, MD, MPH, reported in a late-breaker abstract session at the annual Revolutionizing Atopic Dermatitis conference.

The analysis stratified patients by age – 18-50 and over 50 years – and found that the sustained improvement with the JAK-1 selective inhibitor as monotherapy was seen regardless of age. “In practice, patients who are older tend to have had AD for a longer period of time and tend to be more difficult to treat so it’s reassuring to see that even in the over-50 age group, they show substantial responses, even with more stringent endpoints,” said Dr. Alexis, professor of clinical dermatology at Weill Cornell Medical College, New York.

At week 96, for instance, the proportion of patients who achieved at least a 75% improvement from baseline on the Eczema Area and Severity Index (EASI-75) was 73% with the 100-mg dose and 85% with the 200-mg dose in the younger age group, and 86% and 89%, respectively, in the older age group.

An EASI-90 response – one of the more stringent outcomes – was achieved by 45% and 58% in the 18-50 group and 58% and 73% in the over 50 group (for 100-mg and 200-mg doses, respectively), Dr. Alexis reported.

The interim analysis also showed dose-dependent efficacy overall up to 96 weeks in the younger age group but only up to 48 weeks in the older age group. Response to some outcome measures in patients over age 50 years was “less clearly dose dependent after week 48” than earlier, Dr. Alexis said.

The ongoing JADE EXTEND trial enrolled patients who had participated in the phase 3 JADE clinical trials. This analysis covered 1,309 patients who were enrolled by a September 2021 cutoff. The patient population leaned young: Eighty percent (1,046) were aged 18-50, and 20% (263) were over 50.

Patients who were randomly assigned to abrocitinib 200 mg or 100 mg in the parent trials continued to receive the same dose in JADE EXTEND with blinding maintained. Those who received placebo in the qualifying trial were randomly assigned to abrocitinib 200 mg or 100 mg. And patients from JADE DARE continued with their dosing of 200 mg. Grouping by age for the analysis was made based on the age recorded at the screening visit of the qualifying trial.
 

IGA, PP-NRS, and DLQI results

At week 96, the proportion of patients 18-50 years of age who achieved the Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline was 44% in the 100-mg group and 55% in the 200-mg group. Among patients over 50, these proportions were 51% and 58%, respectively.

The proportion of patients who achieved at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (PP-NRS) score was 54% and 66% (on 100 mg and 200 mg, respectively) among those aged 18-50, and 79% and 80%, respectively, among those over 50.

Looking at more stringent outcomes, 26% and 38% in the 18-50 group on 100 mg and 200 mg, respectively, achieved a PP-NRS of 0/1, as did 54% and 44% in the over-50 group.

Lastly, a score of less than 2 on the Dermatology Life Quality Index (DLQI 0/1) was achieved by 32% and 41% of patients aged 18-50 and by 51% and 48% of patients over 50, for the 100-mg and 200-mg doses, respectively.

The decline in dose-dependent efficacy in the older age group after 48 weeks may be due to the smaller sample of older patients and/or the fact that a higher proportion of older patients had moderate baseline disease per their IGA score, versus severe disease, compared with the younger patients, Dr. Alexis said. “We see a skewing toward a bit more severe [disease] in the younger age group compared to the older,” he noted.

Abrocitinib (Cibinqo) is approved for the treatment of moderate to severe AD in adolescents aged 12 and up and adults whose disease is not adequately controlled with other systemic treatments or those for whom the use of these drugs is not advised. It is available in a 50-mg dose for dose adjustments in special populations, but this dose was not studied in the clinical trials, Dr. Alexis noted. The interim analysis did not include safety data.

In a separate presentation in which he reviewed long-term data on AD medications, Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that most patients who meet defined endpoints at week 12 of treatment with abrocitinib maintain that response over time. “By and large, there’s a steep initial rise that flattens over the long run, which is what you want to see. People getting that response are generally staying there over the course of treatment,” he said, referring to the JADE EXTEND data up to week 48.

It’s important to also appreciate, however, that the proportion of patients meeting efficacy outcomes in the trials of abrocitinib has grown well beyond 12 weeks, Dr. Chovatiya said.

Pointing to data presented at a 2021 RAD meeting depicting the proportion of 12-week nonresponders achieving a response at weeks 24 and 48 on IGA 0/1, EASI-75, and PP-NRS, Dr. Chovatiya said the level of response grew at both time points. “You’re capturing a chunk of people well beyond the primary endpoint if you keep them on therapy continuously, suggesting that ... we may need to reframe how we’re thinking about oral JAK inhibitors,” he said. “Not only are they rapidly acting, but they are medications that can provide good control and changes in the long run.”

Dr. Alexis and Dr. Chovatiya disclosed ties with Pfizer, which funded the study.

WASHINGTON – A substantial proportion of adults with moderate to severe atopic dermatitis (AD) treated with oral abrocitinib 100 mg or 200 mg once daily for up to 96 weeks had sustained improvements in skin clearance, itch, and quality of life in a post hoc analysis of the JADE EXTEND phase 3 trial, Andrew F. Alexis, MD, MPH, reported in a late-breaker abstract session at the annual Revolutionizing Atopic Dermatitis conference.

The analysis stratified patients by age – 18-50 and over 50 years – and found that the sustained improvement with the JAK-1 selective inhibitor as monotherapy was seen regardless of age. “In practice, patients who are older tend to have had AD for a longer period of time and tend to be more difficult to treat so it’s reassuring to see that even in the over-50 age group, they show substantial responses, even with more stringent endpoints,” said Dr. Alexis, professor of clinical dermatology at Weill Cornell Medical College, New York.

At week 96, for instance, the proportion of patients who achieved at least a 75% improvement from baseline on the Eczema Area and Severity Index (EASI-75) was 73% with the 100-mg dose and 85% with the 200-mg dose in the younger age group, and 86% and 89%, respectively, in the older age group.

An EASI-90 response – one of the more stringent outcomes – was achieved by 45% and 58% in the 18-50 group and 58% and 73% in the over 50 group (for 100-mg and 200-mg doses, respectively), Dr. Alexis reported.

The interim analysis also showed dose-dependent efficacy overall up to 96 weeks in the younger age group but only up to 48 weeks in the older age group. Response to some outcome measures in patients over age 50 years was “less clearly dose dependent after week 48” than earlier, Dr. Alexis said.

The ongoing JADE EXTEND trial enrolled patients who had participated in the phase 3 JADE clinical trials. This analysis covered 1,309 patients who were enrolled by a September 2021 cutoff. The patient population leaned young: Eighty percent (1,046) were aged 18-50, and 20% (263) were over 50.

Patients who were randomly assigned to abrocitinib 200 mg or 100 mg in the parent trials continued to receive the same dose in JADE EXTEND with blinding maintained. Those who received placebo in the qualifying trial were randomly assigned to abrocitinib 200 mg or 100 mg. And patients from JADE DARE continued with their dosing of 200 mg. Grouping by age for the analysis was made based on the age recorded at the screening visit of the qualifying trial.
 

IGA, PP-NRS, and DLQI results

At week 96, the proportion of patients 18-50 years of age who achieved the Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline was 44% in the 100-mg group and 55% in the 200-mg group. Among patients over 50, these proportions were 51% and 58%, respectively.

The proportion of patients who achieved at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (PP-NRS) score was 54% and 66% (on 100 mg and 200 mg, respectively) among those aged 18-50, and 79% and 80%, respectively, among those over 50.

Looking at more stringent outcomes, 26% and 38% in the 18-50 group on 100 mg and 200 mg, respectively, achieved a PP-NRS of 0/1, as did 54% and 44% in the over-50 group.

Lastly, a score of less than 2 on the Dermatology Life Quality Index (DLQI 0/1) was achieved by 32% and 41% of patients aged 18-50 and by 51% and 48% of patients over 50, for the 100-mg and 200-mg doses, respectively.

The decline in dose-dependent efficacy in the older age group after 48 weeks may be due to the smaller sample of older patients and/or the fact that a higher proportion of older patients had moderate baseline disease per their IGA score, versus severe disease, compared with the younger patients, Dr. Alexis said. “We see a skewing toward a bit more severe [disease] in the younger age group compared to the older,” he noted.

Abrocitinib (Cibinqo) is approved for the treatment of moderate to severe AD in adolescents aged 12 and up and adults whose disease is not adequately controlled with other systemic treatments or those for whom the use of these drugs is not advised. It is available in a 50-mg dose for dose adjustments in special populations, but this dose was not studied in the clinical trials, Dr. Alexis noted. The interim analysis did not include safety data.

In a separate presentation in which he reviewed long-term data on AD medications, Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that most patients who meet defined endpoints at week 12 of treatment with abrocitinib maintain that response over time. “By and large, there’s a steep initial rise that flattens over the long run, which is what you want to see. People getting that response are generally staying there over the course of treatment,” he said, referring to the JADE EXTEND data up to week 48.

It’s important to also appreciate, however, that the proportion of patients meeting efficacy outcomes in the trials of abrocitinib has grown well beyond 12 weeks, Dr. Chovatiya said.

Pointing to data presented at a 2021 RAD meeting depicting the proportion of 12-week nonresponders achieving a response at weeks 24 and 48 on IGA 0/1, EASI-75, and PP-NRS, Dr. Chovatiya said the level of response grew at both time points. “You’re capturing a chunk of people well beyond the primary endpoint if you keep them on therapy continuously, suggesting that ... we may need to reframe how we’re thinking about oral JAK inhibitors,” he said. “Not only are they rapidly acting, but they are medications that can provide good control and changes in the long run.”

Dr. Alexis and Dr. Chovatiya disclosed ties with Pfizer, which funded the study.

WASHINGTON – A substantial proportion of adults with moderate to severe atopic dermatitis (AD) treated with oral abrocitinib 100 mg or 200 mg once daily for up to 96 weeks had sustained improvements in skin clearance, itch, and quality of life in a post hoc analysis of the JADE EXTEND phase 3 trial, Andrew F. Alexis, MD, MPH, reported in a late-breaker abstract session at the annual Revolutionizing Atopic Dermatitis conference.

The analysis stratified patients by age – 18-50 and over 50 years – and found that the sustained improvement with the JAK-1 selective inhibitor as monotherapy was seen regardless of age. “In practice, patients who are older tend to have had AD for a longer period of time and tend to be more difficult to treat so it’s reassuring to see that even in the over-50 age group, they show substantial responses, even with more stringent endpoints,” said Dr. Alexis, professor of clinical dermatology at Weill Cornell Medical College, New York.

At week 96, for instance, the proportion of patients who achieved at least a 75% improvement from baseline on the Eczema Area and Severity Index (EASI-75) was 73% with the 100-mg dose and 85% with the 200-mg dose in the younger age group, and 86% and 89%, respectively, in the older age group.

An EASI-90 response – one of the more stringent outcomes – was achieved by 45% and 58% in the 18-50 group and 58% and 73% in the over 50 group (for 100-mg and 200-mg doses, respectively), Dr. Alexis reported.

The interim analysis also showed dose-dependent efficacy overall up to 96 weeks in the younger age group but only up to 48 weeks in the older age group. Response to some outcome measures in patients over age 50 years was “less clearly dose dependent after week 48” than earlier, Dr. Alexis said.

The ongoing JADE EXTEND trial enrolled patients who had participated in the phase 3 JADE clinical trials. This analysis covered 1,309 patients who were enrolled by a September 2021 cutoff. The patient population leaned young: Eighty percent (1,046) were aged 18-50, and 20% (263) were over 50.

Patients who were randomly assigned to abrocitinib 200 mg or 100 mg in the parent trials continued to receive the same dose in JADE EXTEND with blinding maintained. Those who received placebo in the qualifying trial were randomly assigned to abrocitinib 200 mg or 100 mg. And patients from JADE DARE continued with their dosing of 200 mg. Grouping by age for the analysis was made based on the age recorded at the screening visit of the qualifying trial.
 

IGA, PP-NRS, and DLQI results

At week 96, the proportion of patients 18-50 years of age who achieved the Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline was 44% in the 100-mg group and 55% in the 200-mg group. Among patients over 50, these proportions were 51% and 58%, respectively.

The proportion of patients who achieved at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (PP-NRS) score was 54% and 66% (on 100 mg and 200 mg, respectively) among those aged 18-50, and 79% and 80%, respectively, among those over 50.

Looking at more stringent outcomes, 26% and 38% in the 18-50 group on 100 mg and 200 mg, respectively, achieved a PP-NRS of 0/1, as did 54% and 44% in the over-50 group.

Lastly, a score of less than 2 on the Dermatology Life Quality Index (DLQI 0/1) was achieved by 32% and 41% of patients aged 18-50 and by 51% and 48% of patients over 50, for the 100-mg and 200-mg doses, respectively.

The decline in dose-dependent efficacy in the older age group after 48 weeks may be due to the smaller sample of older patients and/or the fact that a higher proportion of older patients had moderate baseline disease per their IGA score, versus severe disease, compared with the younger patients, Dr. Alexis said. “We see a skewing toward a bit more severe [disease] in the younger age group compared to the older,” he noted.

Abrocitinib (Cibinqo) is approved for the treatment of moderate to severe AD in adolescents aged 12 and up and adults whose disease is not adequately controlled with other systemic treatments or those for whom the use of these drugs is not advised. It is available in a 50-mg dose for dose adjustments in special populations, but this dose was not studied in the clinical trials, Dr. Alexis noted. The interim analysis did not include safety data.

In a separate presentation in which he reviewed long-term data on AD medications, Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that most patients who meet defined endpoints at week 12 of treatment with abrocitinib maintain that response over time. “By and large, there’s a steep initial rise that flattens over the long run, which is what you want to see. People getting that response are generally staying there over the course of treatment,” he said, referring to the JADE EXTEND data up to week 48.

It’s important to also appreciate, however, that the proportion of patients meeting efficacy outcomes in the trials of abrocitinib has grown well beyond 12 weeks, Dr. Chovatiya said.

Pointing to data presented at a 2021 RAD meeting depicting the proportion of 12-week nonresponders achieving a response at weeks 24 and 48 on IGA 0/1, EASI-75, and PP-NRS, Dr. Chovatiya said the level of response grew at both time points. “You’re capturing a chunk of people well beyond the primary endpoint if you keep them on therapy continuously, suggesting that ... we may need to reframe how we’re thinking about oral JAK inhibitors,” he said. “Not only are they rapidly acting, but they are medications that can provide good control and changes in the long run.”

Dr. Alexis and Dr. Chovatiya disclosed ties with Pfizer, which funded the study.

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.