Key clinical point: Abrocitinib treatment over 12 weeks significantly decreased the cutaneous expression of selected genes involved in inflammation, epidermal hyperplasia, and T-helper (Th) 2 and Th22 immune responses in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with placebo, 12-week abrocitinib treatment led to a dose-dependent reduction in the cutaneous expression of genes involved in inflammation (MMP-12), epidermal hyperplasia (KRT16), Th2 (CCL17 and CCL18), and Th22 (S100A8, S100A9, and S100A12) responses (all P < .05).

Study details: Findings are from the phase 2a JADE MOA trial including patients with moderate-to-severe AD who were randomly assigned to receive 100 mg (n = 16) or 200 mg (n = 14) abrocitinib monotherapy or placebo (n = 16) daily for 12 weeks.

Disclosures: This study was sponsored by Pfizer Inc. Several authors declared being on the advisory board of; serving as consultants, advisors, or speakers for; or receiving honoraria or grants from Pfizer or others. Seven authors declared being current or former employees and shareholders of Pfizer.

Source: Guttman-Yassky E et al. Effect of abrocitinib on skin biomarkers in patients with moderate-to-severe atopic dermatitis. Allergy. 2023 (Dec 18). doi: 10.1111/all.15969

Key clinical point: Abrocitinib treatment over 12 weeks significantly decreased the cutaneous expression of selected genes involved in inflammation, epidermal hyperplasia, and T-helper (Th) 2 and Th22 immune responses in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with placebo, 12-week abrocitinib treatment led to a dose-dependent reduction in the cutaneous expression of genes involved in inflammation (MMP-12), epidermal hyperplasia (KRT16), Th2 (CCL17 and CCL18), and Th22 (S100A8, S100A9, and S100A12) responses (all P < .05).

Study details: Findings are from the phase 2a JADE MOA trial including patients with moderate-to-severe AD who were randomly assigned to receive 100 mg (n = 16) or 200 mg (n = 14) abrocitinib monotherapy or placebo (n = 16) daily for 12 weeks.

Disclosures: This study was sponsored by Pfizer Inc. Several authors declared being on the advisory board of; serving as consultants, advisors, or speakers for; or receiving honoraria or grants from Pfizer or others. Seven authors declared being current or former employees and shareholders of Pfizer.

Source: Guttman-Yassky E et al. Effect of abrocitinib on skin biomarkers in patients with moderate-to-severe atopic dermatitis. Allergy. 2023 (Dec 18). doi: 10.1111/all.15969

Key clinical point: Abrocitinib treatment over 12 weeks significantly decreased the cutaneous expression of selected genes involved in inflammation, epidermal hyperplasia, and T-helper (Th) 2 and Th22 immune responses in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with placebo, 12-week abrocitinib treatment led to a dose-dependent reduction in the cutaneous expression of genes involved in inflammation (MMP-12), epidermal hyperplasia (KRT16), Th2 (CCL17 and CCL18), and Th22 (S100A8, S100A9, and S100A12) responses (all P < .05).

Study details: Findings are from the phase 2a JADE MOA trial including patients with moderate-to-severe AD who were randomly assigned to receive 100 mg (n = 16) or 200 mg (n = 14) abrocitinib monotherapy or placebo (n = 16) daily for 12 weeks.

Disclosures: This study was sponsored by Pfizer Inc. Several authors declared being on the advisory board of; serving as consultants, advisors, or speakers for; or receiving honoraria or grants from Pfizer or others. Seven authors declared being current or former employees and shareholders of Pfizer.

Source: Guttman-Yassky E et al. Effect of abrocitinib on skin biomarkers in patients with moderate-to-severe atopic dermatitis. Allergy. 2023 (Dec 18). doi: 10.1111/all.15969

Key clinical point: Abrocitinib as monotherapy or in combination with topical therapy improves skin pain in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Abrocitinib vs placebo led to a significantly greater dose-dependent least squares mean change in Pruritus and Symptoms Assessment for AD (PSAAD) skin pain score from baseline to as early as week 1 that were sustained through week 12 or 16 (nominal P < .05). A greater proportion of patients achieved a stringent threshold of skin pain improvement (PSAAD skin pain score < 2) with abrocitinib vs placebo (nominal P < .05).

Study details: This post hoc analysis of five phase 2/3 trials included 1822 patients with moderate-to-severe AD (age ≥ 12 years) treated with 100 mg or 200 mg abrocitinib as monotherapy or in combination with topical therapy or placebo for 12 or 16 weeks.

Disclosures: This study was funded by Pfizer Inc., USA. Six authors declared being employees and stockholders of Pfizer. The other authors declared receiving research or travel grants or having other ties with various sources, including Pfizer.

Source: Thyssen JP et al. Abrocitinib provides rapid and sustained improvement in skin pain and is associated with improved quality of life outcomes in adult and adolescent patients with moderate-to-severe atopic dermatitis. Dermatology. 2023 (Dec 11). doi: 10.1159/000535285

Key clinical point: Abrocitinib as monotherapy or in combination with topical therapy improves skin pain in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Abrocitinib vs placebo led to a significantly greater dose-dependent least squares mean change in Pruritus and Symptoms Assessment for AD (PSAAD) skin pain score from baseline to as early as week 1 that were sustained through week 12 or 16 (nominal P < .05). A greater proportion of patients achieved a stringent threshold of skin pain improvement (PSAAD skin pain score < 2) with abrocitinib vs placebo (nominal P < .05).

Study details: This post hoc analysis of five phase 2/3 trials included 1822 patients with moderate-to-severe AD (age ≥ 12 years) treated with 100 mg or 200 mg abrocitinib as monotherapy or in combination with topical therapy or placebo for 12 or 16 weeks.

Disclosures: This study was funded by Pfizer Inc., USA. Six authors declared being employees and stockholders of Pfizer. The other authors declared receiving research or travel grants or having other ties with various sources, including Pfizer.

Source: Thyssen JP et al. Abrocitinib provides rapid and sustained improvement in skin pain and is associated with improved quality of life outcomes in adult and adolescent patients with moderate-to-severe atopic dermatitis. Dermatology. 2023 (Dec 11). doi: 10.1159/000535285

Key clinical point: Abrocitinib as monotherapy or in combination with topical therapy improves skin pain in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Abrocitinib vs placebo led to a significantly greater dose-dependent least squares mean change in Pruritus and Symptoms Assessment for AD (PSAAD) skin pain score from baseline to as early as week 1 that were sustained through week 12 or 16 (nominal P < .05). A greater proportion of patients achieved a stringent threshold of skin pain improvement (PSAAD skin pain score < 2) with abrocitinib vs placebo (nominal P < .05).

Study details: This post hoc analysis of five phase 2/3 trials included 1822 patients with moderate-to-severe AD (age ≥ 12 years) treated with 100 mg or 200 mg abrocitinib as monotherapy or in combination with topical therapy or placebo for 12 or 16 weeks.

Disclosures: This study was funded by Pfizer Inc., USA. Six authors declared being employees and stockholders of Pfizer. The other authors declared receiving research or travel grants or having other ties with various sources, including Pfizer.

Source: Thyssen JP et al. Abrocitinib provides rapid and sustained improvement in skin pain and is associated with improved quality of life outcomes in adult and adolescent patients with moderate-to-severe atopic dermatitis. Dermatology. 2023 (Dec 11). doi: 10.1159/000535285

Key clinical point: Allergic contact dermatitis (ACD) is an important comorbidity in patients with atopic dermatitis (AD) and leads to the maintenance and aggravation of their dermatosis, with a high frequency of ACD observed to textile dyes, isothiazolinones, and fragrances.

Major finding: Contact sensitization was significantly associated with facial involvement (P = .04) and a longer duration of AD (P = .005). The most frequent allergen was textile dye mix (24.70%) followed by nickel (20.21%), cobalt (12.70%), and methylchlorisothiazolinone+methylisothiazolinone (8.50%). The avoidance of relevant allergens led to a significant reduction in the Scoring of Atopic Dermatitis (SCORAD) scores at 6 months (P < .001).

Study details: This longitudinal prospective study included 93 patients with AD (age > 2 years) who were patch-tested with the 2019 European baseline series and the corticosteroid series, 60.2% of whom had positive patch test results.

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

Source: Trimeche K et al. Contact allergy in atopic dermatitis: A prospective study on prevalence, incriminated allergens and clinical insights. Contact Dermatitis. 2023 (Dec 27). doi: 10.1111/cod.14494

Key clinical point: Allergic contact dermatitis (ACD) is an important comorbidity in patients with atopic dermatitis (AD) and leads to the maintenance and aggravation of their dermatosis, with a high frequency of ACD observed to textile dyes, isothiazolinones, and fragrances.

Major finding: Contact sensitization was significantly associated with facial involvement (P = .04) and a longer duration of AD (P = .005). The most frequent allergen was textile dye mix (24.70%) followed by nickel (20.21%), cobalt (12.70%), and methylchlorisothiazolinone+methylisothiazolinone (8.50%). The avoidance of relevant allergens led to a significant reduction in the Scoring of Atopic Dermatitis (SCORAD) scores at 6 months (P < .001).

Study details: This longitudinal prospective study included 93 patients with AD (age > 2 years) who were patch-tested with the 2019 European baseline series and the corticosteroid series, 60.2% of whom had positive patch test results.

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

Source: Trimeche K et al. Contact allergy in atopic dermatitis: A prospective study on prevalence, incriminated allergens and clinical insights. Contact Dermatitis. 2023 (Dec 27). doi: 10.1111/cod.14494

Key clinical point: Allergic contact dermatitis (ACD) is an important comorbidity in patients with atopic dermatitis (AD) and leads to the maintenance and aggravation of their dermatosis, with a high frequency of ACD observed to textile dyes, isothiazolinones, and fragrances.

Major finding: Contact sensitization was significantly associated with facial involvement (P = .04) and a longer duration of AD (P = .005). The most frequent allergen was textile dye mix (24.70%) followed by nickel (20.21%), cobalt (12.70%), and methylchlorisothiazolinone+methylisothiazolinone (8.50%). The avoidance of relevant allergens led to a significant reduction in the Scoring of Atopic Dermatitis (SCORAD) scores at 6 months (P < .001).

Study details: This longitudinal prospective study included 93 patients with AD (age > 2 years) who were patch-tested with the 2019 European baseline series and the corticosteroid series, 60.2% of whom had positive patch test results.

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

Source: Trimeche K et al. Contact allergy in atopic dermatitis: A prospective study on prevalence, incriminated allergens and clinical insights. Contact Dermatitis. 2023 (Dec 27). doi: 10.1111/cod.14494

Key clinical point: The overall improvement in skin clearance and itch reduction suggested a preference for 30 mg upadacitinib over dupilumab and that for 15 mg or 30 mg upadacitinib over placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 24, the aggregate response benefit for skin clearance and itch, respectively, was 32.5% and 25.8% higher with 30 mg upadacitinib vs dupilumab. The benefit favored upadacitinib over dupilumab as early as week 4. Moreover, 15 and 30 mg upadacitinib showed similar benefits over placebo.

Study details: This post hoc analysis of the data from phase 3 studies (Heads Up, Measure Up 1, and Measure Up 2) included 2356 patients with moderate-to-severe AD who received upadacitinib, dupilumab, or placebo.

Disclosures: This study was sponsored by AbbVie. Five authors declared being employees of or owning stock or stock options in AbbVie. Several authors declared being consultants, speakers, or advisors of or having other ties with various sources, including AbbVie.

Source: Silverberg JI et al. Aggregate response benefit in skin clearance and itch reduction with upadacitinib or dupilumab in patients with moderate-to-severe atopic dermatitis. Dermatitis. 2023 (Dec 18). doi: 10.1089/derm.2023.0153

Key clinical point: The overall improvement in skin clearance and itch reduction suggested a preference for 30 mg upadacitinib over dupilumab and that for 15 mg or 30 mg upadacitinib over placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 24, the aggregate response benefit for skin clearance and itch, respectively, was 32.5% and 25.8% higher with 30 mg upadacitinib vs dupilumab. The benefit favored upadacitinib over dupilumab as early as week 4. Moreover, 15 and 30 mg upadacitinib showed similar benefits over placebo.

Study details: This post hoc analysis of the data from phase 3 studies (Heads Up, Measure Up 1, and Measure Up 2) included 2356 patients with moderate-to-severe AD who received upadacitinib, dupilumab, or placebo.

Disclosures: This study was sponsored by AbbVie. Five authors declared being employees of or owning stock or stock options in AbbVie. Several authors declared being consultants, speakers, or advisors of or having other ties with various sources, including AbbVie.

Source: Silverberg JI et al. Aggregate response benefit in skin clearance and itch reduction with upadacitinib or dupilumab in patients with moderate-to-severe atopic dermatitis. Dermatitis. 2023 (Dec 18). doi: 10.1089/derm.2023.0153

Key clinical point: The overall improvement in skin clearance and itch reduction suggested a preference for 30 mg upadacitinib over dupilumab and that for 15 mg or 30 mg upadacitinib over placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 24, the aggregate response benefit for skin clearance and itch, respectively, was 32.5% and 25.8% higher with 30 mg upadacitinib vs dupilumab. The benefit favored upadacitinib over dupilumab as early as week 4. Moreover, 15 and 30 mg upadacitinib showed similar benefits over placebo.

Study details: This post hoc analysis of the data from phase 3 studies (Heads Up, Measure Up 1, and Measure Up 2) included 2356 patients with moderate-to-severe AD who received upadacitinib, dupilumab, or placebo.

Disclosures: This study was sponsored by AbbVie. Five authors declared being employees of or owning stock or stock options in AbbVie. Several authors declared being consultants, speakers, or advisors of or having other ties with various sources, including AbbVie.

Source: Silverberg JI et al. Aggregate response benefit in skin clearance and itch reduction with upadacitinib or dupilumab in patients with moderate-to-severe atopic dermatitis. Dermatitis. 2023 (Dec 18). doi: 10.1089/derm.2023.0153

Key clinical point: Rademikibart administered at 2-week (Q2W) and 4-week (Q4W) intervals was well-tolerated and effective in improving the overall symptoms in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the least squares mean percent reductions in the Eczema Area Severity Index scores with 300 mg Q2W (−63.0%; P = .0007), 150 mg Q2W (−57.6%; P = .0067), and 300 mg Q4W (−63.5%; P = .0004) rademikibart were significantly higher than that with placebo (−39.7%). Treatment-emergent adverse event rates were similar with rademikibart (48.2%) and placebo (53.6%).

Study details: This phase 2 trial included 226 anti-interleukin (IL)-4Ra/IL-13 treatment-naive adults with moderate-to-severe AD who were randomly assigned (1:1:1:1) to receive rademikibart (300 mg Q2W, 150 mg Q2W, or 300 mg Q4W) or placebo for 16 weeks following a 600 mg loading dose of rademikibart or placebo, respectively, on day 1.

Disclosures: This study was funded by Connect Biopharma. Ten authors declared being employees or shareholders of Connect Biopharma. The other authors declared being consultants of or having other ties with various sources, including Connect Biopharma.

Source: Silverberg JI et al. Efficacy and safety of rademikibart (CBP-201), a next-generation monoclonal antibody targeting IL-4Rα, in adults with moderate-to-severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2023 (Dec 27). doi: 10.1016/j.jaci.2023.11.924

Key clinical point: Rademikibart administered at 2-week (Q2W) and 4-week (Q4W) intervals was well-tolerated and effective in improving the overall symptoms in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the least squares mean percent reductions in the Eczema Area Severity Index scores with 300 mg Q2W (−63.0%; P = .0007), 150 mg Q2W (−57.6%; P = .0067), and 300 mg Q4W (−63.5%; P = .0004) rademikibart were significantly higher than that with placebo (−39.7%). Treatment-emergent adverse event rates were similar with rademikibart (48.2%) and placebo (53.6%).

Study details: This phase 2 trial included 226 anti-interleukin (IL)-4Ra/IL-13 treatment-naive adults with moderate-to-severe AD who were randomly assigned (1:1:1:1) to receive rademikibart (300 mg Q2W, 150 mg Q2W, or 300 mg Q4W) or placebo for 16 weeks following a 600 mg loading dose of rademikibart or placebo, respectively, on day 1.

Disclosures: This study was funded by Connect Biopharma. Ten authors declared being employees or shareholders of Connect Biopharma. The other authors declared being consultants of or having other ties with various sources, including Connect Biopharma.

Source: Silverberg JI et al. Efficacy and safety of rademikibart (CBP-201), a next-generation monoclonal antibody targeting IL-4Rα, in adults with moderate-to-severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2023 (Dec 27). doi: 10.1016/j.jaci.2023.11.924

Key clinical point: Rademikibart administered at 2-week (Q2W) and 4-week (Q4W) intervals was well-tolerated and effective in improving the overall symptoms in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the least squares mean percent reductions in the Eczema Area Severity Index scores with 300 mg Q2W (−63.0%; P = .0007), 150 mg Q2W (−57.6%; P = .0067), and 300 mg Q4W (−63.5%; P = .0004) rademikibart were significantly higher than that with placebo (−39.7%). Treatment-emergent adverse event rates were similar with rademikibart (48.2%) and placebo (53.6%).

Study details: This phase 2 trial included 226 anti-interleukin (IL)-4Ra/IL-13 treatment-naive adults with moderate-to-severe AD who were randomly assigned (1:1:1:1) to receive rademikibart (300 mg Q2W, 150 mg Q2W, or 300 mg Q4W) or placebo for 16 weeks following a 600 mg loading dose of rademikibart or placebo, respectively, on day 1.

Disclosures: This study was funded by Connect Biopharma. Ten authors declared being employees or shareholders of Connect Biopharma. The other authors declared being consultants of or having other ties with various sources, including Connect Biopharma.

Source: Silverberg JI et al. Efficacy and safety of rademikibart (CBP-201), a next-generation monoclonal antibody targeting IL-4Rα, in adults with moderate-to-severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2023 (Dec 27). doi: 10.1016/j.jaci.2023.11.924

Key clinical point: Dupilumab led to a rapid improvement in disease control that was sustained through 2 years and showed an acceptable safety profile in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab led to an improvement in the mean Eczema Area and Severity Index score at 3 months (5.5) and 24 months (2.6) compared with baseline (16.1), with a mean absolute change from baseline to 24 months being −14.0. No new safety signals were observed.

Study details: Findings are from a 2-year interim analysis of real-world data from the PROSE registry study including 764 patients with moderate-to-severe AD (age ≥ 12 years) who initiated dupilumab.

Disclosures: The PROSE registry is sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors declared being employees of or holding stock or stock options in Sanofi or Regeneron. The other authors declared serving as consultants, investigators, or advisory board members for or receiving speaker or investigator fees from Sanofi, Regeneron, and others.

Source: Simpson EL et al. Real-world effectiveness of dupilumab in adult and adolescent patients with atopic dermatitis: 2-year Interim data from the PROSE registry. Dermatol Ther (Heidelb). 2024 (Jan 4). doi: 10.1007/s13555-023-01061-4

Key clinical point: Dupilumab led to a rapid improvement in disease control that was sustained through 2 years and showed an acceptable safety profile in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab led to an improvement in the mean Eczema Area and Severity Index score at 3 months (5.5) and 24 months (2.6) compared with baseline (16.1), with a mean absolute change from baseline to 24 months being −14.0. No new safety signals were observed.

Study details: Findings are from a 2-year interim analysis of real-world data from the PROSE registry study including 764 patients with moderate-to-severe AD (age ≥ 12 years) who initiated dupilumab.

Disclosures: The PROSE registry is sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors declared being employees of or holding stock or stock options in Sanofi or Regeneron. The other authors declared serving as consultants, investigators, or advisory board members for or receiving speaker or investigator fees from Sanofi, Regeneron, and others.

Source: Simpson EL et al. Real-world effectiveness of dupilumab in adult and adolescent patients with atopic dermatitis: 2-year Interim data from the PROSE registry. Dermatol Ther (Heidelb). 2024 (Jan 4). doi: 10.1007/s13555-023-01061-4

Key clinical point: Dupilumab led to a rapid improvement in disease control that was sustained through 2 years and showed an acceptable safety profile in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab led to an improvement in the mean Eczema Area and Severity Index score at 3 months (5.5) and 24 months (2.6) compared with baseline (16.1), with a mean absolute change from baseline to 24 months being −14.0. No new safety signals were observed.

Study details: Findings are from a 2-year interim analysis of real-world data from the PROSE registry study including 764 patients with moderate-to-severe AD (age ≥ 12 years) who initiated dupilumab.

Disclosures: The PROSE registry is sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors declared being employees of or holding stock or stock options in Sanofi or Regeneron. The other authors declared serving as consultants, investigators, or advisory board members for or receiving speaker or investigator fees from Sanofi, Regeneron, and others.

Source: Simpson EL et al. Real-world effectiveness of dupilumab in adult and adolescent patients with atopic dermatitis: 2-year Interim data from the PROSE registry. Dermatol Ther (Heidelb). 2024 (Jan 4). doi: 10.1007/s13555-023-01061-4

Key clinical point: Atopic dermatitis (AD) is associated with a lower risk for venous thromboembolism (VTE) than several rheumatologic and gastrointestinal immune-mediated inflammatory diseases (IMID).

Major finding: Patients with AD vs AD-matched control individuals did not have a higher risk for VTE (adjusted hazard ratio [aHR] 0.96; 95% CI 0.90-1.02). Compared with patients having AD, those with Crohn’s disease (aHR 1.71; 95% CI 1.47-1.99), rheumatoid arthritis (aHR 1.57; 95% CI 1.43-1.72), ulcerative colitis (aHR 1.84; 95% CI 1.63-2.09), and ankylosing spondylitis (aHR 1.45; 95% CI 1.03-2.03) had higher risks for VTE.

Study details: This retrospective observational cohort study analyzed 2,061,222 adult patients with IMID, including 1,098,633 patients with AD who were matched with 1,098,633 control individuals without IMID.

Disclosures: This study was funded by AbbVie Inc. JF Merola declared being a consultant or investigator for AbbVie and others. The other authors declared being current or former employees of or owning stocks or stock options in AbbVie.

Source: Merola JF et al. Venous thromboembolism risk is lower in patients with atopic dermatitis than other immune-mediated inflammatory diseases: A retrospective, observational, comparative cohort study using US claims data. J Am Acad Dermatol. 2023 (Dec 23). doi: 10.1016/j.jaad.2023.12.027

Key clinical point: Atopic dermatitis (AD) is associated with a lower risk for venous thromboembolism (VTE) than several rheumatologic and gastrointestinal immune-mediated inflammatory diseases (IMID).

Major finding: Patients with AD vs AD-matched control individuals did not have a higher risk for VTE (adjusted hazard ratio [aHR] 0.96; 95% CI 0.90-1.02). Compared with patients having AD, those with Crohn’s disease (aHR 1.71; 95% CI 1.47-1.99), rheumatoid arthritis (aHR 1.57; 95% CI 1.43-1.72), ulcerative colitis (aHR 1.84; 95% CI 1.63-2.09), and ankylosing spondylitis (aHR 1.45; 95% CI 1.03-2.03) had higher risks for VTE.

Study details: This retrospective observational cohort study analyzed 2,061,222 adult patients with IMID, including 1,098,633 patients with AD who were matched with 1,098,633 control individuals without IMID.

Disclosures: This study was funded by AbbVie Inc. JF Merola declared being a consultant or investigator for AbbVie and others. The other authors declared being current or former employees of or owning stocks or stock options in AbbVie.

Source: Merola JF et al. Venous thromboembolism risk is lower in patients with atopic dermatitis than other immune-mediated inflammatory diseases: A retrospective, observational, comparative cohort study using US claims data. J Am Acad Dermatol. 2023 (Dec 23). doi: 10.1016/j.jaad.2023.12.027

Key clinical point: Atopic dermatitis (AD) is associated with a lower risk for venous thromboembolism (VTE) than several rheumatologic and gastrointestinal immune-mediated inflammatory diseases (IMID).

Major finding: Patients with AD vs AD-matched control individuals did not have a higher risk for VTE (adjusted hazard ratio [aHR] 0.96; 95% CI 0.90-1.02). Compared with patients having AD, those with Crohn’s disease (aHR 1.71; 95% CI 1.47-1.99), rheumatoid arthritis (aHR 1.57; 95% CI 1.43-1.72), ulcerative colitis (aHR 1.84; 95% CI 1.63-2.09), and ankylosing spondylitis (aHR 1.45; 95% CI 1.03-2.03) had higher risks for VTE.

Study details: This retrospective observational cohort study analyzed 2,061,222 adult patients with IMID, including 1,098,633 patients with AD who were matched with 1,098,633 control individuals without IMID.

Disclosures: This study was funded by AbbVie Inc. JF Merola declared being a consultant or investigator for AbbVie and others. The other authors declared being current or former employees of or owning stocks or stock options in AbbVie.

Source: Merola JF et al. Venous thromboembolism risk is lower in patients with atopic dermatitis than other immune-mediated inflammatory diseases: A retrospective, observational, comparative cohort study using US claims data. J Am Acad Dermatol. 2023 (Dec 23). doi: 10.1016/j.jaad.2023.12.027

Key clinical point: Atopic dermatitis (AD) is associated with a lower risk for venous thromboembolism (VTE) than several rheumatologic and gastrointestinal immune-mediated inflammatory diseases (IMID).

Major finding: Patients with AD vs AD-matched control individuals did not have a higher risk for VTE (adjusted hazard ratio [aHR] 0.96; 95% CI 0.90-1.02). Compared with patients having AD, those with Crohn’s disease (aHR 1.71; 95% CI 1.47-1.99), rheumatoid arthritis (aHR 1.57; 95% CI 1.43-1.72), ulcerative colitis (aHR 1.84; 95% CI 1.63-2.09), and ankylosing spondylitis (aHR 1.45; 95% CI 1.03-2.03) had higher risks for VTE.

Study details: This retrospective observational cohort study analyzed 2,061,222 adult patients with IMID, including 1,098,633 patients with AD who were matched with 1,098,633 control individuals without IMID.

Disclosures: This study was funded by AbbVie Inc. JF Merola declared being a consultant or investigator for AbbVie and others. The other authors declared being current or former employees of or owning stocks or stock options in AbbVie.

Source: Merola JF et al. Venous thromboembolism risk is lower in patients with atopic dermatitis than other immune-mediated inflammatory diseases: A retrospective, observational, comparative cohort study using US claims data. J Am Acad Dermatol. 2023 (Dec 23). doi: 10.1016/j.jaad.2023.12.027

Key clinical point: Atopic dermatitis (AD) is associated with a lower risk for venous thromboembolism (VTE) than several rheumatologic and gastrointestinal immune-mediated inflammatory diseases (IMID).

Major finding: Patients with AD vs AD-matched control individuals did not have a higher risk for VTE (adjusted hazard ratio [aHR] 0.96; 95% CI 0.90-1.02). Compared with patients having AD, those with Crohn’s disease (aHR 1.71; 95% CI 1.47-1.99), rheumatoid arthritis (aHR 1.57; 95% CI 1.43-1.72), ulcerative colitis (aHR 1.84; 95% CI 1.63-2.09), and ankylosing spondylitis (aHR 1.45; 95% CI 1.03-2.03) had higher risks for VTE.

Study details: This retrospective observational cohort study analyzed 2,061,222 adult patients with IMID, including 1,098,633 patients with AD who were matched with 1,098,633 control individuals without IMID.

Disclosures: This study was funded by AbbVie Inc. JF Merola declared being a consultant or investigator for AbbVie and others. The other authors declared being current or former employees of or owning stocks or stock options in AbbVie.

Source: Merola JF et al. Venous thromboembolism risk is lower in patients with atopic dermatitis than other immune-mediated inflammatory diseases: A retrospective, observational, comparative cohort study using US claims data. J Am Acad Dermatol. 2023 (Dec 23). doi: 10.1016/j.jaad.2023.12.027

Key clinical point: Atopic dermatitis (AD) is associated with a lower risk for venous thromboembolism (VTE) than several rheumatologic and gastrointestinal immune-mediated inflammatory diseases (IMID).

Major finding: Patients with AD vs AD-matched control individuals did not have a higher risk for VTE (adjusted hazard ratio [aHR] 0.96; 95% CI 0.90-1.02). Compared with patients having AD, those with Crohn’s disease (aHR 1.71; 95% CI 1.47-1.99), rheumatoid arthritis (aHR 1.57; 95% CI 1.43-1.72), ulcerative colitis (aHR 1.84; 95% CI 1.63-2.09), and ankylosing spondylitis (aHR 1.45; 95% CI 1.03-2.03) had higher risks for VTE.

Study details: This retrospective observational cohort study analyzed 2,061,222 adult patients with IMID, including 1,098,633 patients with AD who were matched with 1,098,633 control individuals without IMID.

Disclosures: This study was funded by AbbVie Inc. JF Merola declared being a consultant or investigator for AbbVie and others. The other authors declared being current or former employees of or owning stocks or stock options in AbbVie.

Source: Merola JF et al. Venous thromboembolism risk is lower in patients with atopic dermatitis than other immune-mediated inflammatory diseases: A retrospective, observational, comparative cohort study using US claims data. J Am Acad Dermatol. 2023 (Dec 23). doi: 10.1016/j.jaad.2023.12.027

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.