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Atopic dermatitis shortens biologic-free survival in inflammatory bowel disease
Key clinical point: Presence of concurrent atopic dermatitis (AD) significantly affects the biologic-free survival in patients with inflammatory bowel disease (IBD).
Major finding: Presence of concurrent AD was associated with a significantly shorter biologic-free survival in patients with IBD (adjusted hazard ratio [aHR] 1.743; P = .032), with the association being stronger in patients with ulcerative colitis (aHR 4.769; P = .004).
Study details: Findings are from a retrospective study including 61 adult patients with IBD and concurrent AD and 122 matched control individuals with IBD alone.
Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.
Source: Kim KW, et al, and Seoul National University Inflammatory Bowel Disease Research Network (SIRN) and Inflammatory Bowel Disease Research Group of Korean Association for the Study of Intestinal Disease (KASID). Atopic dermatitis is associated with the clinical course of inflammatory bowel disease. Scand J Gastroenterol. 2023;1-7 (May 11). doi: 10.1080/00365521.2023.2209688
Key clinical point: Presence of concurrent atopic dermatitis (AD) significantly affects the biologic-free survival in patients with inflammatory bowel disease (IBD).
Major finding: Presence of concurrent AD was associated with a significantly shorter biologic-free survival in patients with IBD (adjusted hazard ratio [aHR] 1.743; P = .032), with the association being stronger in patients with ulcerative colitis (aHR 4.769; P = .004).
Study details: Findings are from a retrospective study including 61 adult patients with IBD and concurrent AD and 122 matched control individuals with IBD alone.
Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.
Source: Kim KW, et al, and Seoul National University Inflammatory Bowel Disease Research Network (SIRN) and Inflammatory Bowel Disease Research Group of Korean Association for the Study of Intestinal Disease (KASID). Atopic dermatitis is associated with the clinical course of inflammatory bowel disease. Scand J Gastroenterol. 2023;1-7 (May 11). doi: 10.1080/00365521.2023.2209688
Key clinical point: Presence of concurrent atopic dermatitis (AD) significantly affects the biologic-free survival in patients with inflammatory bowel disease (IBD).
Major finding: Presence of concurrent AD was associated with a significantly shorter biologic-free survival in patients with IBD (adjusted hazard ratio [aHR] 1.743; P = .032), with the association being stronger in patients with ulcerative colitis (aHR 4.769; P = .004).
Study details: Findings are from a retrospective study including 61 adult patients with IBD and concurrent AD and 122 matched control individuals with IBD alone.
Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.
Source: Kim KW, et al, and Seoul National University Inflammatory Bowel Disease Research Network (SIRN) and Inflammatory Bowel Disease Research Group of Korean Association for the Study of Intestinal Disease (KASID). Atopic dermatitis is associated with the clinical course of inflammatory bowel disease. Scand J Gastroenterol. 2023;1-7 (May 11). doi: 10.1080/00365521.2023.2209688
Dupilumab ameliorates disease signs and symptoms in children with severe atopic dermatitis
Key clinical point: Dupilumab significantly improves disease signs and symptoms in children with severe atopic dermatitis (AD), including those not achieving a clear or almost clear skin by week 16.
Major finding: At week 16, a significantly higher proportion of children in the dupilumab 200 mg+topical corticosteroid (TCS) and dupilumab 300 mg+TCS vs placebo+TCS groups achieved a ≥50% improvement in the Eczema Area and Severity Index score (both P < .0001), with patients in both treatment groups with an Investigator’s Global Assessment score of >1 also showing significant improvements (P = .0002 and P < .0001, respectively). No new safety signals were reported.
Study details: This post hoc analysis of LIBERTY AD PEDS trial included 304 children age 6-11 years with severe AD who were randomly assigned to receive dupilumab 200 mg+TCS, dupilumab 300 mg+TCS, or placebo+TCS.
Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Some authors reported ties with Sanofi-Regeneron and others. Six authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.
Source: Siegfried EC et al. Dupilumab provides clinically meaningful responses in children aged 6–11 years with severe atopic dermatitis: Post hoc analysis results from a phase III trial. Am J Clin Dermatol. 2023 (Jun 10). doi: 10.1007/s40257-023-00791-7
Key clinical point: Dupilumab significantly improves disease signs and symptoms in children with severe atopic dermatitis (AD), including those not achieving a clear or almost clear skin by week 16.
Major finding: At week 16, a significantly higher proportion of children in the dupilumab 200 mg+topical corticosteroid (TCS) and dupilumab 300 mg+TCS vs placebo+TCS groups achieved a ≥50% improvement in the Eczema Area and Severity Index score (both P < .0001), with patients in both treatment groups with an Investigator’s Global Assessment score of >1 also showing significant improvements (P = .0002 and P < .0001, respectively). No new safety signals were reported.
Study details: This post hoc analysis of LIBERTY AD PEDS trial included 304 children age 6-11 years with severe AD who were randomly assigned to receive dupilumab 200 mg+TCS, dupilumab 300 mg+TCS, or placebo+TCS.
Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Some authors reported ties with Sanofi-Regeneron and others. Six authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.
Source: Siegfried EC et al. Dupilumab provides clinically meaningful responses in children aged 6–11 years with severe atopic dermatitis: Post hoc analysis results from a phase III trial. Am J Clin Dermatol. 2023 (Jun 10). doi: 10.1007/s40257-023-00791-7
Key clinical point: Dupilumab significantly improves disease signs and symptoms in children with severe atopic dermatitis (AD), including those not achieving a clear or almost clear skin by week 16.
Major finding: At week 16, a significantly higher proportion of children in the dupilumab 200 mg+topical corticosteroid (TCS) and dupilumab 300 mg+TCS vs placebo+TCS groups achieved a ≥50% improvement in the Eczema Area and Severity Index score (both P < .0001), with patients in both treatment groups with an Investigator’s Global Assessment score of >1 also showing significant improvements (P = .0002 and P < .0001, respectively). No new safety signals were reported.
Study details: This post hoc analysis of LIBERTY AD PEDS trial included 304 children age 6-11 years with severe AD who were randomly assigned to receive dupilumab 200 mg+TCS, dupilumab 300 mg+TCS, or placebo+TCS.
Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Some authors reported ties with Sanofi-Regeneron and others. Six authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.
Source: Siegfried EC et al. Dupilumab provides clinically meaningful responses in children aged 6–11 years with severe atopic dermatitis: Post hoc analysis results from a phase III trial. Am J Clin Dermatol. 2023 (Jun 10). doi: 10.1007/s40257-023-00791-7
Meta-analysis reveals that abrocitinib and upadacitinib top dupilumab in moderate-to-severe atopic dermatitis
Key clinical point: Abrocitinib and upadacitinib demonstrated acceptable safety profiles and provided greater improvements in disease signs and symptoms compared with dupilumab as early as week 2 in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: A significantly higher proportion of patients in the abrocitinib/upadacitinib vs dupilumab group achieved a ≥75% improvement in Eczema Area and Severity Index scores and ≥4-point improvement in Peak Pruritus Numerical Rating Scale scores at 2 weeks (relative risk [RR] 1.92 and RR 1.87, respectively; both P < .001) and the end of therapy (RR 1.12; P = .002 and RR 1.20; P < .001, respectively). Although the severe adverse event rate was higher in the abrocitinib/upadacitinib vs dupilumab group (P = .043), the treatment-emergent adverse event rate leading to treatment discontinuation was similar.
Study details: This meta-analysis of three randomized controlled trials included 2256 patients with moderate-to-severe AD who received abrocitinib, upadacitinib, or dupilumab.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Gao Q et al. Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. Heliyon. 2023;9:E16704 (Jun 2). doi: 10.1016/j.heliyon.2023.e16704/p>
Key clinical point: Abrocitinib and upadacitinib demonstrated acceptable safety profiles and provided greater improvements in disease signs and symptoms compared with dupilumab as early as week 2 in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: A significantly higher proportion of patients in the abrocitinib/upadacitinib vs dupilumab group achieved a ≥75% improvement in Eczema Area and Severity Index scores and ≥4-point improvement in Peak Pruritus Numerical Rating Scale scores at 2 weeks (relative risk [RR] 1.92 and RR 1.87, respectively; both P < .001) and the end of therapy (RR 1.12; P = .002 and RR 1.20; P < .001, respectively). Although the severe adverse event rate was higher in the abrocitinib/upadacitinib vs dupilumab group (P = .043), the treatment-emergent adverse event rate leading to treatment discontinuation was similar.
Study details: This meta-analysis of three randomized controlled trials included 2256 patients with moderate-to-severe AD who received abrocitinib, upadacitinib, or dupilumab.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Gao Q et al. Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. Heliyon. 2023;9:E16704 (Jun 2). doi: 10.1016/j.heliyon.2023.e16704/p>
Key clinical point: Abrocitinib and upadacitinib demonstrated acceptable safety profiles and provided greater improvements in disease signs and symptoms compared with dupilumab as early as week 2 in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: A significantly higher proportion of patients in the abrocitinib/upadacitinib vs dupilumab group achieved a ≥75% improvement in Eczema Area and Severity Index scores and ≥4-point improvement in Peak Pruritus Numerical Rating Scale scores at 2 weeks (relative risk [RR] 1.92 and RR 1.87, respectively; both P < .001) and the end of therapy (RR 1.12; P = .002 and RR 1.20; P < .001, respectively). Although the severe adverse event rate was higher in the abrocitinib/upadacitinib vs dupilumab group (P = .043), the treatment-emergent adverse event rate leading to treatment discontinuation was similar.
Study details: This meta-analysis of three randomized controlled trials included 2256 patients with moderate-to-severe AD who received abrocitinib, upadacitinib, or dupilumab.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Gao Q et al. Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. Heliyon. 2023;9:E16704 (Jun 2). doi: 10.1016/j.heliyon.2023.e16704/p>
Early emollient use does not lower the odds of atopic dermatitis in high-risk infants
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
Abrocitinib improves outcomes in severe or difficult-to-treat atopic dermatitis
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
Successful dupilumab dose tapering in controlled atopic dermatitis
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
Switching to upadacitinib from dupilumab improves atopic dermatitis
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
Crisaborole once daily an effective long-term maintenance therapy for atopic dermatitis
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
Atopic dermatitis positively linked with the risk for incident venous thromboembolism
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.
A live topical biotherapeutic spray improves pruritus in atopic dermatitis
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