Key clinical point: Upadacitinib treatment rapidly and sustainably improved multiple patient-reported outcomes, including itch, in adults and adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 1, more than 10% and 15% of patients receiving 15 and 30 mg upadacitinib, respectively, experienced improvements in itch; thereafter, response rates increased steadily and sustainably through week 52. Similar improvements were observed for pain and other skin symptoms.

Study details: This pooled analysis included 1609 adults and adolescents with moderate to severe AD from the phase 3 Measure Up 1 and Measure Up 2 studies who had received upadacitinib (15 mg n = 557; 30 mg n = 567) or placebo (followed by upadacitinib 15 or 30 mg after 16 weeks; n = 485).

Disclosures: This study was funded by AbbVie, Inc. Eight authors declared being employees of or holding stock or stock options in AbbVie. The other authors declared serving as speakers for, receiving consulting fees, or having other ties with various sources, including AbbVie.

Source: Silverberg JI, Gooderham MJ, Paller AS, et al. Early and sustained improvements in symptoms and quality of life with upadacitinib in adults and adolescents with moderate-to-severe atopic dermatitis: 52-week results from two phase III randomized clinical trials (Measure Up 1 and Measure Up 2). Am J Clin Dermatol. 2024 (Mar 25). doi: 10.1007/s40257-024-00853-4 Source

Key clinical point: Upadacitinib treatment rapidly and sustainably improved multiple patient-reported outcomes, including itch, in adults and adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 1, more than 10% and 15% of patients receiving 15 and 30 mg upadacitinib, respectively, experienced improvements in itch; thereafter, response rates increased steadily and sustainably through week 52. Similar improvements were observed for pain and other skin symptoms.

Study details: This pooled analysis included 1609 adults and adolescents with moderate to severe AD from the phase 3 Measure Up 1 and Measure Up 2 studies who had received upadacitinib (15 mg n = 557; 30 mg n = 567) or placebo (followed by upadacitinib 15 or 30 mg after 16 weeks; n = 485).

Disclosures: This study was funded by AbbVie, Inc. Eight authors declared being employees of or holding stock or stock options in AbbVie. The other authors declared serving as speakers for, receiving consulting fees, or having other ties with various sources, including AbbVie.

Source: Silverberg JI, Gooderham MJ, Paller AS, et al. Early and sustained improvements in symptoms and quality of life with upadacitinib in adults and adolescents with moderate-to-severe atopic dermatitis: 52-week results from two phase III randomized clinical trials (Measure Up 1 and Measure Up 2). Am J Clin Dermatol. 2024 (Mar 25). doi: 10.1007/s40257-024-00853-4 Source

Key clinical point: Upadacitinib treatment rapidly and sustainably improved multiple patient-reported outcomes, including itch, in adults and adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 1, more than 10% and 15% of patients receiving 15 and 30 mg upadacitinib, respectively, experienced improvements in itch; thereafter, response rates increased steadily and sustainably through week 52. Similar improvements were observed for pain and other skin symptoms.

Study details: This pooled analysis included 1609 adults and adolescents with moderate to severe AD from the phase 3 Measure Up 1 and Measure Up 2 studies who had received upadacitinib (15 mg n = 557; 30 mg n = 567) or placebo (followed by upadacitinib 15 or 30 mg after 16 weeks; n = 485).

Disclosures: This study was funded by AbbVie, Inc. Eight authors declared being employees of or holding stock or stock options in AbbVie. The other authors declared serving as speakers for, receiving consulting fees, or having other ties with various sources, including AbbVie.

Source: Silverberg JI, Gooderham MJ, Paller AS, et al. Early and sustained improvements in symptoms and quality of life with upadacitinib in adults and adolescents with moderate-to-severe atopic dermatitis: 52-week results from two phase III randomized clinical trials (Measure Up 1 and Measure Up 2). Am J Clin Dermatol. 2024 (Mar 25). doi: 10.1007/s40257-024-00853-4 Source

Key clinical point: Patients with atopic dermatitis (AD) treated with dupilumab have an increased risk for cutaneous T-cell lymphoma (CTCL) compared with those not treated with dupilumab.

Major finding: Patients with AD who did vs did not receive dupilumab had a significantly higher risk of developing CTCL (odds ratio [OR] 4.1003; 95% CI 2.055-8.192). The risk for CTCL persisted in those with no prior exposure to disease-modifying antirheumatic drugs (OR 3.202; 95% CI 1.573-6.514).

Study details: This retrospective cohort study included patients with AD who did (n = 22,888) or did not (n = 22,871) receive dupilumab treatment and did not have a preexisting diagnosis for CTCL, Hodgkin lymphoma, non-Hodgkin lymphoma, nonfollicular lymphoma, leukemia, malignant melanoma, squamous cell carcinoma, or basal cell carcinoma.

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

Source: Hasan I, Parsons L, Duran S, Zinn Z. Dupilumab therapy for atopic dermatitis is associated with increased risk of cutaneous T cell lymphoma: A retrospective cohort study. J Am Acad Dermatol. 2024 (Apr 6). doi: 10.1016/j.jaad.2024.03.039 Source

Key clinical point: Patients with atopic dermatitis (AD) treated with dupilumab have an increased risk for cutaneous T-cell lymphoma (CTCL) compared with those not treated with dupilumab.

Major finding: Patients with AD who did vs did not receive dupilumab had a significantly higher risk of developing CTCL (odds ratio [OR] 4.1003; 95% CI 2.055-8.192). The risk for CTCL persisted in those with no prior exposure to disease-modifying antirheumatic drugs (OR 3.202; 95% CI 1.573-6.514).

Study details: This retrospective cohort study included patients with AD who did (n = 22,888) or did not (n = 22,871) receive dupilumab treatment and did not have a preexisting diagnosis for CTCL, Hodgkin lymphoma, non-Hodgkin lymphoma, nonfollicular lymphoma, leukemia, malignant melanoma, squamous cell carcinoma, or basal cell carcinoma.

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

Source: Hasan I, Parsons L, Duran S, Zinn Z. Dupilumab therapy for atopic dermatitis is associated with increased risk of cutaneous T cell lymphoma: A retrospective cohort study. J Am Acad Dermatol. 2024 (Apr 6). doi: 10.1016/j.jaad.2024.03.039 Source

Key clinical point: Patients with atopic dermatitis (AD) treated with dupilumab have an increased risk for cutaneous T-cell lymphoma (CTCL) compared with those not treated with dupilumab.

Major finding: Patients with AD who did vs did not receive dupilumab had a significantly higher risk of developing CTCL (odds ratio [OR] 4.1003; 95% CI 2.055-8.192). The risk for CTCL persisted in those with no prior exposure to disease-modifying antirheumatic drugs (OR 3.202; 95% CI 1.573-6.514).

Study details: This retrospective cohort study included patients with AD who did (n = 22,888) or did not (n = 22,871) receive dupilumab treatment and did not have a preexisting diagnosis for CTCL, Hodgkin lymphoma, non-Hodgkin lymphoma, nonfollicular lymphoma, leukemia, malignant melanoma, squamous cell carcinoma, or basal cell carcinoma.

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

Source: Hasan I, Parsons L, Duran S, Zinn Z. Dupilumab therapy for atopic dermatitis is associated with increased risk of cutaneous T cell lymphoma: A retrospective cohort study. J Am Acad Dermatol. 2024 (Apr 6). doi: 10.1016/j.jaad.2024.03.039 Source

Key clinical point: Established and new atopic dermatitis (AD)-associated filaggrin loss-of-function variants are associated with increased risks for clinical AD outcomes and disruption of skin barrier integrity in lesional and nonlesional skin of children with AD.

Major finding: Twenty variants were identified, including one novel variant. The presence of one or more variants was associated with a higher risk for moderate or severe AD vs mild AD (odds ratio 2.00; corrected P = .0394), a higher Scoring AD score (corrected P = .0394), and transepidermal water loss in both lesional (P = .018) and nonlesional (P = .015) skin.

Study details: This study included 438 children with AD (age ≤ 2 years; gestation period ≥ 36 weeks) from the early-life Mechanisms of Progression of Atopic Dermatitis to Asthma in Children cohort without a comorbid lung condition or dependence on immunosuppression or oral steroids for a condition except asthma.

Disclosures: This study was funded by the US National Institutes of Health. Matthew S. Hestand declared being an employee and shareholder of Pacific Biosciences. The other authors declared no conflicts of interest.

Source: Virolainen SJ, Satish L, Biagini JM, et al. Filaggrin loss-of-function variants are associated with atopic dermatitis phenotypes in a diverse, early life prospective cohort. JCI Insight. 2024 (Apr 2). doi: 10.1172/jci.insight.178258 Source

Key clinical point: Established and new atopic dermatitis (AD)-associated filaggrin loss-of-function variants are associated with increased risks for clinical AD outcomes and disruption of skin barrier integrity in lesional and nonlesional skin of children with AD.

Major finding: Twenty variants were identified, including one novel variant. The presence of one or more variants was associated with a higher risk for moderate or severe AD vs mild AD (odds ratio 2.00; corrected P = .0394), a higher Scoring AD score (corrected P = .0394), and transepidermal water loss in both lesional (P = .018) and nonlesional (P = .015) skin.

Study details: This study included 438 children with AD (age ≤ 2 years; gestation period ≥ 36 weeks) from the early-life Mechanisms of Progression of Atopic Dermatitis to Asthma in Children cohort without a comorbid lung condition or dependence on immunosuppression or oral steroids for a condition except asthma.

Disclosures: This study was funded by the US National Institutes of Health. Matthew S. Hestand declared being an employee and shareholder of Pacific Biosciences. The other authors declared no conflicts of interest.

Source: Virolainen SJ, Satish L, Biagini JM, et al. Filaggrin loss-of-function variants are associated with atopic dermatitis phenotypes in a diverse, early life prospective cohort. JCI Insight. 2024 (Apr 2). doi: 10.1172/jci.insight.178258 Source

Key clinical point: Established and new atopic dermatitis (AD)-associated filaggrin loss-of-function variants are associated with increased risks for clinical AD outcomes and disruption of skin barrier integrity in lesional and nonlesional skin of children with AD.

Major finding: Twenty variants were identified, including one novel variant. The presence of one or more variants was associated with a higher risk for moderate or severe AD vs mild AD (odds ratio 2.00; corrected P = .0394), a higher Scoring AD score (corrected P = .0394), and transepidermal water loss in both lesional (P = .018) and nonlesional (P = .015) skin.

Study details: This study included 438 children with AD (age ≤ 2 years; gestation period ≥ 36 weeks) from the early-life Mechanisms of Progression of Atopic Dermatitis to Asthma in Children cohort without a comorbid lung condition or dependence on immunosuppression or oral steroids for a condition except asthma.

Disclosures: This study was funded by the US National Institutes of Health. Matthew S. Hestand declared being an employee and shareholder of Pacific Biosciences. The other authors declared no conflicts of interest.

Source: Virolainen SJ, Satish L, Biagini JM, et al. Filaggrin loss-of-function variants are associated with atopic dermatitis phenotypes in a diverse, early life prospective cohort. JCI Insight. 2024 (Apr 2). doi: 10.1172/jci.insight.178258 Source

Key clinical point: Baricitinib treatment was effective and well-tolerated in patients with moderate to severe atopic dermatitis (AD) who were followed-up for 3 months in real-world settings.

Major finding: Baricitinib led to a significant reduction in the Eczema Area Severity Index (21.5 ± 13.2 vs 9.3 ± 9.0) and objective Scoring AD (45.9 ± 12.3 vs 28.2 ± 15.5) scores at 3 months vs start visit (both P < .001). The treatment discontinuation rate was 16.7%, with two patients discontinuing baricitinib due to adverse events.

Study details: This was an interim analysis of the TREATgermany registry that included 81 adult patients with moderate to severe AD who received baricitinib and concomitant topical treatment, of whom 49 had initiated baricitinib at a registry visit; 26 of these did not switch from a previous systemic drug and had their first follow-up visit at 3 months.

Disclosures: TREATgermany is supported by AbbVie Deutschland GmbH & Co. KG, Galderma S.A., and others. Six authors declared serving as consultants, lecturers, etc., for or having other ties with various organizations, including the sponsors of TREATgermany. The other authors declared no conflicts of interest.

Source: Traidl S, Heinrich L, Siegels D, et al, and the TREATgermany study group. Treatment of moderate-to-severe atopic dermatitis with baricitinib: Results from an interim analysis of the TREATgermany registry. J Eur Acad Dermatol Venereol. 2024 (Mar 28). doi: 10.1111/jdv.19979 Source

Key clinical point: Baricitinib treatment was effective and well-tolerated in patients with moderate to severe atopic dermatitis (AD) who were followed-up for 3 months in real-world settings.

Major finding: Baricitinib led to a significant reduction in the Eczema Area Severity Index (21.5 ± 13.2 vs 9.3 ± 9.0) and objective Scoring AD (45.9 ± 12.3 vs 28.2 ± 15.5) scores at 3 months vs start visit (both P < .001). The treatment discontinuation rate was 16.7%, with two patients discontinuing baricitinib due to adverse events.

Study details: This was an interim analysis of the TREATgermany registry that included 81 adult patients with moderate to severe AD who received baricitinib and concomitant topical treatment, of whom 49 had initiated baricitinib at a registry visit; 26 of these did not switch from a previous systemic drug and had their first follow-up visit at 3 months.

Disclosures: TREATgermany is supported by AbbVie Deutschland GmbH & Co. KG, Galderma S.A., and others. Six authors declared serving as consultants, lecturers, etc., for or having other ties with various organizations, including the sponsors of TREATgermany. The other authors declared no conflicts of interest.

Source: Traidl S, Heinrich L, Siegels D, et al, and the TREATgermany study group. Treatment of moderate-to-severe atopic dermatitis with baricitinib: Results from an interim analysis of the TREATgermany registry. J Eur Acad Dermatol Venereol. 2024 (Mar 28). doi: 10.1111/jdv.19979 Source

Key clinical point: Baricitinib treatment was effective and well-tolerated in patients with moderate to severe atopic dermatitis (AD) who were followed-up for 3 months in real-world settings.

Major finding: Baricitinib led to a significant reduction in the Eczema Area Severity Index (21.5 ± 13.2 vs 9.3 ± 9.0) and objective Scoring AD (45.9 ± 12.3 vs 28.2 ± 15.5) scores at 3 months vs start visit (both P < .001). The treatment discontinuation rate was 16.7%, with two patients discontinuing baricitinib due to adverse events.

Study details: This was an interim analysis of the TREATgermany registry that included 81 adult patients with moderate to severe AD who received baricitinib and concomitant topical treatment, of whom 49 had initiated baricitinib at a registry visit; 26 of these did not switch from a previous systemic drug and had their first follow-up visit at 3 months.

Disclosures: TREATgermany is supported by AbbVie Deutschland GmbH & Co. KG, Galderma S.A., and others. Six authors declared serving as consultants, lecturers, etc., for or having other ties with various organizations, including the sponsors of TREATgermany. The other authors declared no conflicts of interest.

Source: Traidl S, Heinrich L, Siegels D, et al, and the TREATgermany study group. Treatment of moderate-to-severe atopic dermatitis with baricitinib: Results from an interim analysis of the TREATgermany registry. J Eur Acad Dermatol Venereol. 2024 (Mar 28). doi: 10.1111/jdv.19979 Source

Key clinical point: Patients with atopic dermatitis (AD) have a significantly increased risk of developing lymphoma.

Major finding: Patients with AD vs control individuals showed a significantly increased likelihood of developing noncutaneous T-cell lymphoma (odds ratio [OR] 2.52; 95% CI 1.37-4.62), with similar outcomes for the peripheral T-cell lymphoma subtype (OR 4.00; 95% CI 1.50-10.66).

Study details: Findings are from a nested case-control study including 6425 adult patients with AD and 25,700 matched control individuals without AD from electronic health records.

Disclosures: This study did not receive any funding. Benjamin Ungar reported being an employee of Mount Sinai and receiving research funds from and serving as a consultant for various organizations.

Source: Powers CM, Piontkowski AJ, Orloff J, et al. Risk of lymphoma in patients with atopic dermatitis: A case-control study in the All of Us database. J Am Acad Dermatol. 2024 (Apr 4). doi: 10.1016/j.jaad.2024.03.038 Source

Key clinical point: Patients with atopic dermatitis (AD) have a significantly increased risk of developing lymphoma.

Major finding: Patients with AD vs control individuals showed a significantly increased likelihood of developing noncutaneous T-cell lymphoma (odds ratio [OR] 2.52; 95% CI 1.37-4.62), with similar outcomes for the peripheral T-cell lymphoma subtype (OR 4.00; 95% CI 1.50-10.66).

Study details: Findings are from a nested case-control study including 6425 adult patients with AD and 25,700 matched control individuals without AD from electronic health records.

Disclosures: This study did not receive any funding. Benjamin Ungar reported being an employee of Mount Sinai and receiving research funds from and serving as a consultant for various organizations.

Source: Powers CM, Piontkowski AJ, Orloff J, et al. Risk of lymphoma in patients with atopic dermatitis: A case-control study in the All of Us database. J Am Acad Dermatol. 2024 (Apr 4). doi: 10.1016/j.jaad.2024.03.038 Source

Key clinical point: Patients with atopic dermatitis (AD) have a significantly increased risk of developing lymphoma.

Major finding: Patients with AD vs control individuals showed a significantly increased likelihood of developing noncutaneous T-cell lymphoma (odds ratio [OR] 2.52; 95% CI 1.37-4.62), with similar outcomes for the peripheral T-cell lymphoma subtype (OR 4.00; 95% CI 1.50-10.66).

Study details: Findings are from a nested case-control study including 6425 adult patients with AD and 25,700 matched control individuals without AD from electronic health records.

Disclosures: This study did not receive any funding. Benjamin Ungar reported being an employee of Mount Sinai and receiving research funds from and serving as a consultant for various organizations.

Source: Powers CM, Piontkowski AJ, Orloff J, et al. Risk of lymphoma in patients with atopic dermatitis: A case-control study in the All of Us database. J Am Acad Dermatol. 2024 (Apr 4). doi: 10.1016/j.jaad.2024.03.038 Source

Key clinical point: Passive smoking during pregnancy is associated with an increased risk for atopic dermatitis (AD) in offspring; however, the association between active smoking during pregnancy and AD in offspring remains unestablished.

Major finding: Passive smoking during pregnancy led to a higher risk for AD in offspring (odds ratio [OR] 1.52; 95% CI 1.36-1.70); however, active smoking during pregnancy did not increase the risk for AD in offspring (OR 0.96; 95% CI 0.86-1.07).

Study details: This meta-analysis of 15 observational studies included children or mother-child pairs who underwent either questionnaire-based or physician assessment for AD diagnosis and questionnaire-based assessment or cotinine level measurement for evaluating exposure to active or passive smoking.

Disclosures: This study was supported by the Key Scientific and Technological Research Projects of Henan Province and the Key Scientific Research Projects in Universities of Henan Province, China. The authors declared no conflicts of interest.

Source: Chao L, Liang W, Zhao X, et al. Maternal tobacco exposure during pregnancy and atopic dermatitis in offspring: A systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2024 (Ma 14). doi: 10.1111/jdv.19958 Source

Key clinical point: Passive smoking during pregnancy is associated with an increased risk for atopic dermatitis (AD) in offspring; however, the association between active smoking during pregnancy and AD in offspring remains unestablished.

Major finding: Passive smoking during pregnancy led to a higher risk for AD in offspring (odds ratio [OR] 1.52; 95% CI 1.36-1.70); however, active smoking during pregnancy did not increase the risk for AD in offspring (OR 0.96; 95% CI 0.86-1.07).

Study details: This meta-analysis of 15 observational studies included children or mother-child pairs who underwent either questionnaire-based or physician assessment for AD diagnosis and questionnaire-based assessment or cotinine level measurement for evaluating exposure to active or passive smoking.

Disclosures: This study was supported by the Key Scientific and Technological Research Projects of Henan Province and the Key Scientific Research Projects in Universities of Henan Province, China. The authors declared no conflicts of interest.

Source: Chao L, Liang W, Zhao X, et al. Maternal tobacco exposure during pregnancy and atopic dermatitis in offspring: A systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2024 (Ma 14). doi: 10.1111/jdv.19958 Source

Key clinical point: Passive smoking during pregnancy is associated with an increased risk for atopic dermatitis (AD) in offspring; however, the association between active smoking during pregnancy and AD in offspring remains unestablished.

Major finding: Passive smoking during pregnancy led to a higher risk for AD in offspring (odds ratio [OR] 1.52; 95% CI 1.36-1.70); however, active smoking during pregnancy did not increase the risk for AD in offspring (OR 0.96; 95% CI 0.86-1.07).

Study details: This meta-analysis of 15 observational studies included children or mother-child pairs who underwent either questionnaire-based or physician assessment for AD diagnosis and questionnaire-based assessment or cotinine level measurement for evaluating exposure to active or passive smoking.

Disclosures: This study was supported by the Key Scientific and Technological Research Projects of Henan Province and the Key Scientific Research Projects in Universities of Henan Province, China. The authors declared no conflicts of interest.

Source: Chao L, Liang W, Zhao X, et al. Maternal tobacco exposure during pregnancy and atopic dermatitis in offspring: A systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2024 (Ma 14). doi: 10.1111/jdv.19958 Source

Key clinical point: In children with atopic dermatitis (AD), weekly vitamin D3 (VD3) supplementation vs placebo for 6 weeks failed to decrease the clinical severity of AD or alter type 2 immunity biomarkers.

Major finding: At 6 weeks, the change in the Severity Scoring of AD (SCORAD) index was similar in the VD3 (−5.3 ± 11.6) and placebo (−5.5 ± 9.9; P = .91) groups. No significant between-group differences were observed for change in type 2 immunity blood biomarkers, such as eosinophil counts, total immunoglobulin E (IgE), and specific IgE against staphylococcal enterotoxin A and B (all P > .05).

Study details: This randomized controlled trial included 101 children with AD (age 2-17 years) who were randomly assigned to receive weekly oral VD3 (8000, 12,000, and 16,000 IU for ages 2-5.9, 6-11.9, and 12-17.9 years, respectively; n = 53) or placebo (n = 48) for 6 weeks.

Disclosures: This study was funded by Fondo de Desarrollo Científico y Tecnológico, Chile. The authors declared no conflicts of interest.

Source: Borzutzky A, Iturriaga C, Pérez-Mateluna G, et al. Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2024 (Mar 14). doi: 10.1111/jdv.19959 Source

Key clinical point: In children with atopic dermatitis (AD), weekly vitamin D3 (VD3) supplementation vs placebo for 6 weeks failed to decrease the clinical severity of AD or alter type 2 immunity biomarkers.

Major finding: At 6 weeks, the change in the Severity Scoring of AD (SCORAD) index was similar in the VD3 (−5.3 ± 11.6) and placebo (−5.5 ± 9.9; P = .91) groups. No significant between-group differences were observed for change in type 2 immunity blood biomarkers, such as eosinophil counts, total immunoglobulin E (IgE), and specific IgE against staphylococcal enterotoxin A and B (all P > .05).

Study details: This randomized controlled trial included 101 children with AD (age 2-17 years) who were randomly assigned to receive weekly oral VD3 (8000, 12,000, and 16,000 IU for ages 2-5.9, 6-11.9, and 12-17.9 years, respectively; n = 53) or placebo (n = 48) for 6 weeks.

Disclosures: This study was funded by Fondo de Desarrollo Científico y Tecnológico, Chile. The authors declared no conflicts of interest.

Source: Borzutzky A, Iturriaga C, Pérez-Mateluna G, et al. Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2024 (Mar 14). doi: 10.1111/jdv.19959 Source

Key clinical point: In children with atopic dermatitis (AD), weekly vitamin D3 (VD3) supplementation vs placebo for 6 weeks failed to decrease the clinical severity of AD or alter type 2 immunity biomarkers.

Major finding: At 6 weeks, the change in the Severity Scoring of AD (SCORAD) index was similar in the VD3 (−5.3 ± 11.6) and placebo (−5.5 ± 9.9; P = .91) groups. No significant between-group differences were observed for change in type 2 immunity blood biomarkers, such as eosinophil counts, total immunoglobulin E (IgE), and specific IgE against staphylococcal enterotoxin A and B (all P > .05).

Study details: This randomized controlled trial included 101 children with AD (age 2-17 years) who were randomly assigned to receive weekly oral VD3 (8000, 12,000, and 16,000 IU for ages 2-5.9, 6-11.9, and 12-17.9 years, respectively; n = 53) or placebo (n = 48) for 6 weeks.

Disclosures: This study was funded by Fondo de Desarrollo Científico y Tecnológico, Chile. The authors declared no conflicts of interest.

Source: Borzutzky A, Iturriaga C, Pérez-Mateluna G, et al. Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2024 (Mar 14). doi: 10.1111/jdv.19959 Source

Key clinical point: Tralokinumab-mediated inhibition of interleukin (IL)-13 improved epidermal pathology and reduced the expression of key atopic dermatitis (AD) biomarkers in the serum of patients with moderate to severe AD.

Major finding: At week 16, tralokinumab vs placebo led to a significantly greater decrease from baseline in serum levels of type 2 biomarkers (CCL17/TARC, periostin, immunoglobulin E, and IL-22; all P < .05), a greater mean percentage change in the Eczema Area Severity Index score (−55.6 vs −36.7), and improved expression of genes dysregulated in AD (46.6% vs 16.4%; P < .001).

Study details: This study involved the collection of blood samples from 802 patients with moderate to severe AD randomized in the ECZTRA 1 and ECZTEND trials, followed by the selection of a subset of 299 patients with relevant samples available who had received tralokinumab (n = 223) or placebo (n = 76).

Disclosures: LEO Pharma A/S funded both ECZTRA 1 and the ongoing ECZTEND trial. Six authors declared being employees or shareholders of LEO Pharma. Several authors declared receiving research grants from or having other ties with various sources, including LEO Pharma.

Source: Guttman-Yassky E, Kabashima K, Staumont-Salle D, et al. Targeting IL-13 with tralokinumab normalizes type 2 inflammation in atopic dermatitis both early and at 2 years. Allergy. 2024 (Apr 2). doi: 10.1111/all.16108 Source

Key clinical point: Tralokinumab-mediated inhibition of interleukin (IL)-13 improved epidermal pathology and reduced the expression of key atopic dermatitis (AD) biomarkers in the serum of patients with moderate to severe AD.

Major finding: At week 16, tralokinumab vs placebo led to a significantly greater decrease from baseline in serum levels of type 2 biomarkers (CCL17/TARC, periostin, immunoglobulin E, and IL-22; all P < .05), a greater mean percentage change in the Eczema Area Severity Index score (−55.6 vs −36.7), and improved expression of genes dysregulated in AD (46.6% vs 16.4%; P < .001).

Study details: This study involved the collection of blood samples from 802 patients with moderate to severe AD randomized in the ECZTRA 1 and ECZTEND trials, followed by the selection of a subset of 299 patients with relevant samples available who had received tralokinumab (n = 223) or placebo (n = 76).

Disclosures: LEO Pharma A/S funded both ECZTRA 1 and the ongoing ECZTEND trial. Six authors declared being employees or shareholders of LEO Pharma. Several authors declared receiving research grants from or having other ties with various sources, including LEO Pharma.

Source: Guttman-Yassky E, Kabashima K, Staumont-Salle D, et al. Targeting IL-13 with tralokinumab normalizes type 2 inflammation in atopic dermatitis both early and at 2 years. Allergy. 2024 (Apr 2). doi: 10.1111/all.16108 Source

Key clinical point: Tralokinumab-mediated inhibition of interleukin (IL)-13 improved epidermal pathology and reduced the expression of key atopic dermatitis (AD) biomarkers in the serum of patients with moderate to severe AD.

Major finding: At week 16, tralokinumab vs placebo led to a significantly greater decrease from baseline in serum levels of type 2 biomarkers (CCL17/TARC, periostin, immunoglobulin E, and IL-22; all P < .05), a greater mean percentage change in the Eczema Area Severity Index score (−55.6 vs −36.7), and improved expression of genes dysregulated in AD (46.6% vs 16.4%; P < .001).

Study details: This study involved the collection of blood samples from 802 patients with moderate to severe AD randomized in the ECZTRA 1 and ECZTEND trials, followed by the selection of a subset of 299 patients with relevant samples available who had received tralokinumab (n = 223) or placebo (n = 76).

Disclosures: LEO Pharma A/S funded both ECZTRA 1 and the ongoing ECZTEND trial. Six authors declared being employees or shareholders of LEO Pharma. Several authors declared receiving research grants from or having other ties with various sources, including LEO Pharma.

Source: Guttman-Yassky E, Kabashima K, Staumont-Salle D, et al. Targeting IL-13 with tralokinumab normalizes type 2 inflammation in atopic dermatitis both early and at 2 years. Allergy. 2024 (Apr 2). doi: 10.1111/all.16108 Source

Key clinical point: Children with atopic dermatitis (AD) at age 3 years showed an increased subsequent risk of developing inflammatory bowel disease (IBD), Crohn's disease (CD), and ulcerative colitis (UC); however, atopic manifestations were not associated with IBD.

Major finding: The presence of AD at age 3 years significantly increased the risk for IBD (pooled adjusted hazard ratio [aHR] 1.46; 95% CI 1.13-1.88), CD (pooled aHR 1.53; 95% CI 1.04-2.26), and UC (pooled aHR 1.78; 95% CI 1.15-2.75) later in life. Any atopic manifestation by age 3 years was not associated with IBD (pooled aHR 1.20; 95% CI 0.95-1.52).

Study details: This study included 83,311 children from the All Babies in Southeast Sweden (1997-1999) and the Norwegian Mother, Father, and Child (1999-2008) birth cohorts with questionnaire-based prospectively collected parent-reported information on asthma, AD, etc., developed by 3 years of age who were followed up from birth until 2021 or a diagnosis of IBD.

Disclosure: This study was supported by The Swedish Research Council and others. The authors declared no conflicts of interest.

Source: Lerchova T, Størdal K, Andersson B, Ludvigsson J, Mårild K. Atopic dermatitis in early childhood and risk of inflammatory bowel disease: A Scandinavian birth cohort study. J Pediatr. 2024;270:14027 (Mar21). doi: 10.1016/j.jpeds.2024.114027. Source

Key clinical point: Children with atopic dermatitis (AD) at age 3 years showed an increased subsequent risk of developing inflammatory bowel disease (IBD), Crohn's disease (CD), and ulcerative colitis (UC); however, atopic manifestations were not associated with IBD.

Major finding: The presence of AD at age 3 years significantly increased the risk for IBD (pooled adjusted hazard ratio [aHR] 1.46; 95% CI 1.13-1.88), CD (pooled aHR 1.53; 95% CI 1.04-2.26), and UC (pooled aHR 1.78; 95% CI 1.15-2.75) later in life. Any atopic manifestation by age 3 years was not associated with IBD (pooled aHR 1.20; 95% CI 0.95-1.52).

Study details: This study included 83,311 children from the All Babies in Southeast Sweden (1997-1999) and the Norwegian Mother, Father, and Child (1999-2008) birth cohorts with questionnaire-based prospectively collected parent-reported information on asthma, AD, etc., developed by 3 years of age who were followed up from birth until 2021 or a diagnosis of IBD.

Disclosure: This study was supported by The Swedish Research Council and others. The authors declared no conflicts of interest.

Source: Lerchova T, Størdal K, Andersson B, Ludvigsson J, Mårild K. Atopic dermatitis in early childhood and risk of inflammatory bowel disease: A Scandinavian birth cohort study. J Pediatr. 2024;270:14027 (Mar21). doi: 10.1016/j.jpeds.2024.114027. Source

Key clinical point: Children with atopic dermatitis (AD) at age 3 years showed an increased subsequent risk of developing inflammatory bowel disease (IBD), Crohn's disease (CD), and ulcerative colitis (UC); however, atopic manifestations were not associated with IBD.

Major finding: The presence of AD at age 3 years significantly increased the risk for IBD (pooled adjusted hazard ratio [aHR] 1.46; 95% CI 1.13-1.88), CD (pooled aHR 1.53; 95% CI 1.04-2.26), and UC (pooled aHR 1.78; 95% CI 1.15-2.75) later in life. Any atopic manifestation by age 3 years was not associated with IBD (pooled aHR 1.20; 95% CI 0.95-1.52).

Study details: This study included 83,311 children from the All Babies in Southeast Sweden (1997-1999) and the Norwegian Mother, Father, and Child (1999-2008) birth cohorts with questionnaire-based prospectively collected parent-reported information on asthma, AD, etc., developed by 3 years of age who were followed up from birth until 2021 or a diagnosis of IBD.

Disclosure: This study was supported by The Swedish Research Council and others. The authors declared no conflicts of interest.

Source: Lerchova T, Størdal K, Andersson B, Ludvigsson J, Mårild K. Atopic dermatitis in early childhood and risk of inflammatory bowel disease: A Scandinavian birth cohort study. J Pediatr. 2024;270:14027 (Mar21). doi: 10.1016/j.jpeds.2024.114027. Source

DENVER — Treatment with AXS-05, a combination of dextromethorphan and bupropion, demonstrated rapid, sustained, and clinically meaningful improvement in agitation related to Alzheimer’s disease and was generally well tolerated in the phase 3 ACCORD trial. 

More than half of participants in the open-label extension period of the randomized clinical trial responded to the medication, which was associated with a 3.6-fold lower risk for relapse compared with placebo. 

“The positive efficacy and favorable safety results with AXS-05 support its potential to fulfill a high unmet need for the treatment of Alzheimer’s disease agitation,” said Anton P. Porsteinsson, MD, director of the Alzheimer’s Disease Care, Research and Education Program, University of Rochester, New York. 

The findings were presented at the 2024 annual meeting of the American Academy of Neurology. 
 

Common and Disruptive

Agitation is reported in up to 70% of patients with Alzheimer’s disease and is characterized by emotional distress, aggressive behaviors, disruptive irritability, and disinhibition. Alzheimer’s disease-related agitation has been associated with increased caregiver burden, decreased functioning, accelerated cognitive decline, earlier nursing home placement, and increased mortality.

A previous phase 2/3 study of AXS-05 showed that the investigative agent led to rapid and significantly improvement in Alzheimer’s disease agitation, as measured by the Cohen-Mansfield Agitation Inventory (CMAI) total score, compared with placebo. 

ACCORD was a phase 3, randomized, double-blind, placebo-controlled withdrawal trial evaluating the efficacy and safety of AXS-05 in patients with Alzheimer’s disease agitation. 

In the open-label period, 178 adults with probable Alzheimer’s disease and clinically significant agitation received AXS-05 (titrated to 45 mg dextromethorphan/105 mg bupropion twice daily) for up to 9 weeks.

A total of 108 (61%) patients had a sustained response, with 30% or more improvement from baseline in the CMAI total score and improvement on the Patient Global Impression of Change that were both maintained for 4 or more consecutive weeks. These patients entered the double-blind phase and were randomly allocated to receive twice-daily AXS-05 or placebo for up to 26 weeks.

In the double-blind period, AXS-05 “substantially and statistically” increased the time to relapse of agitation symptoms compared with placebo (hazard ratio [HR], 0.275; P = .014).

“The risk of relapse was 3.6-fold lower with AXS-05 compared with placebo,” Dr. Porsteinsson reported. 

AXS-05 was also associated with a significantly lower relapse rate compared with placebo (7.5% vs 25.9%; P = .018).

Rates of discontinuation in the double-blind period owing to adverse events (AEs) were low (0% for AXS-05 and 1.9% for placebo). Three serious AEs were reported: one in the AXS-05 group (fecaloma), which was not related to study medication, and two in the placebo group (cardiac arrest, femur fracture).

Falls were reported in four participants in the AXS-05 group, none of which were related to study medication or associated with serious AEs, and in two participants in the placebo group, one of which was associated with femur fracture.

One death was reported in the placebo group. There was no evidence of cognitive decline with AXS-05, and treatment was not associated with sedation. 
 

Promising Agent 

Commenting on this research, Glen R. Finney, MD, director of the Geisinger Memory and Cognition Clinic in Wilkes-Barre, Pennsylvania, said the data “look promising as a safe way to help address acute agitation and reduce agitation reoccurrence.

“Agitation is a common, distressing, and sometimes safety issue for people fighting Alzheimer’s disease, and there’s very little evidence for efficacy and significant side effect issues for current medical management of agitation in Alzheimer’s disease,” said Dr. Finney, who was not part of the study.

He noted that first-line strategies for addressing agitation involve behavioral and environmental interventions. 

“See if there’s a reason for the agitation and address that. Look for triggers for agitation and avoid those. Find places, things, and interactions that help people with Alzheimer’s disease avoid agitation: familiar locations, music, simple engaging activities. Reassurance, redirection, and distraction can help de-escalate agitation. Provide a safe environment that reduces safety risks,” Dr. Finney explained. 

The next step, when medically appropriate, is trying acetylcholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, and then adding memantine, a weak N-methyl-D-aspartate receptor antagonist. 

“These medications can help reduce the risk of agitation,” Dr. Finney said. 

“Beyond that, the evidence becomes weaker for any specific treatments, and that is where treatments with emerging evidence of efficacy and safety like dextromethorphan-bupropion become important,” Dr. Finney added. 

Last May, the US Food and Drug Administration (FDA) approved the antipsychotic brexpiprazole (Rexulti) for Alzheimer’s disease-related agitation, making it the first FDA-approved drug for this indication. 

The drug includes a boxed warning for medications in this class that older patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk for death.

“There’s certainly a need to have multiple options for treating agitation in individuals with Alzheimer’s disease,” said Rebecca Edelmayer, PhD, senior director of scientific engagement for the Alzheimer’s Association. 

Dr. Edelmayer, who was not part of the study, noted that in the ACCORD study, AXS-05 “significantly delayed the relapse or prevented the relapse with Alzheimer’s disease agitation compared with the placebo group and it was generally well tolerated, but it will be important to make sure that there’s more thorough review of the data overall to be sure that it’s both safe and effective.”

The study was funded by Axsome Therapeutics, the manufacturer of AXS-05. Dr. Porsteinsson has disclosed no relevant conflicts of interest. Dr. Finney and Dr. Edelmayer have no relevant disclosures.

A version of this article appeared on Medscape.com.

DENVER — Treatment with AXS-05, a combination of dextromethorphan and bupropion, demonstrated rapid, sustained, and clinically meaningful improvement in agitation related to Alzheimer’s disease and was generally well tolerated in the phase 3 ACCORD trial. 

More than half of participants in the open-label extension period of the randomized clinical trial responded to the medication, which was associated with a 3.6-fold lower risk for relapse compared with placebo. 

“The positive efficacy and favorable safety results with AXS-05 support its potential to fulfill a high unmet need for the treatment of Alzheimer’s disease agitation,” said Anton P. Porsteinsson, MD, director of the Alzheimer’s Disease Care, Research and Education Program, University of Rochester, New York. 

The findings were presented at the 2024 annual meeting of the American Academy of Neurology. 
 

Common and Disruptive

Agitation is reported in up to 70% of patients with Alzheimer’s disease and is characterized by emotional distress, aggressive behaviors, disruptive irritability, and disinhibition. Alzheimer’s disease-related agitation has been associated with increased caregiver burden, decreased functioning, accelerated cognitive decline, earlier nursing home placement, and increased mortality.

A previous phase 2/3 study of AXS-05 showed that the investigative agent led to rapid and significantly improvement in Alzheimer’s disease agitation, as measured by the Cohen-Mansfield Agitation Inventory (CMAI) total score, compared with placebo. 

ACCORD was a phase 3, randomized, double-blind, placebo-controlled withdrawal trial evaluating the efficacy and safety of AXS-05 in patients with Alzheimer’s disease agitation. 

In the open-label period, 178 adults with probable Alzheimer’s disease and clinically significant agitation received AXS-05 (titrated to 45 mg dextromethorphan/105 mg bupropion twice daily) for up to 9 weeks.

A total of 108 (61%) patients had a sustained response, with 30% or more improvement from baseline in the CMAI total score and improvement on the Patient Global Impression of Change that were both maintained for 4 or more consecutive weeks. These patients entered the double-blind phase and were randomly allocated to receive twice-daily AXS-05 or placebo for up to 26 weeks.

In the double-blind period, AXS-05 “substantially and statistically” increased the time to relapse of agitation symptoms compared with placebo (hazard ratio [HR], 0.275; P = .014).

“The risk of relapse was 3.6-fold lower with AXS-05 compared with placebo,” Dr. Porsteinsson reported. 

AXS-05 was also associated with a significantly lower relapse rate compared with placebo (7.5% vs 25.9%; P = .018).

Rates of discontinuation in the double-blind period owing to adverse events (AEs) were low (0% for AXS-05 and 1.9% for placebo). Three serious AEs were reported: one in the AXS-05 group (fecaloma), which was not related to study medication, and two in the placebo group (cardiac arrest, femur fracture).

Falls were reported in four participants in the AXS-05 group, none of which were related to study medication or associated with serious AEs, and in two participants in the placebo group, one of which was associated with femur fracture.

One death was reported in the placebo group. There was no evidence of cognitive decline with AXS-05, and treatment was not associated with sedation. 
 

Promising Agent 

Commenting on this research, Glen R. Finney, MD, director of the Geisinger Memory and Cognition Clinic in Wilkes-Barre, Pennsylvania, said the data “look promising as a safe way to help address acute agitation and reduce agitation reoccurrence.

“Agitation is a common, distressing, and sometimes safety issue for people fighting Alzheimer’s disease, and there’s very little evidence for efficacy and significant side effect issues for current medical management of agitation in Alzheimer’s disease,” said Dr. Finney, who was not part of the study.

He noted that first-line strategies for addressing agitation involve behavioral and environmental interventions. 

“See if there’s a reason for the agitation and address that. Look for triggers for agitation and avoid those. Find places, things, and interactions that help people with Alzheimer’s disease avoid agitation: familiar locations, music, simple engaging activities. Reassurance, redirection, and distraction can help de-escalate agitation. Provide a safe environment that reduces safety risks,” Dr. Finney explained. 

The next step, when medically appropriate, is trying acetylcholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, and then adding memantine, a weak N-methyl-D-aspartate receptor antagonist. 

“These medications can help reduce the risk of agitation,” Dr. Finney said. 

“Beyond that, the evidence becomes weaker for any specific treatments, and that is where treatments with emerging evidence of efficacy and safety like dextromethorphan-bupropion become important,” Dr. Finney added. 

Last May, the US Food and Drug Administration (FDA) approved the antipsychotic brexpiprazole (Rexulti) for Alzheimer’s disease-related agitation, making it the first FDA-approved drug for this indication. 

The drug includes a boxed warning for medications in this class that older patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk for death.

“There’s certainly a need to have multiple options for treating agitation in individuals with Alzheimer’s disease,” said Rebecca Edelmayer, PhD, senior director of scientific engagement for the Alzheimer’s Association. 

Dr. Edelmayer, who was not part of the study, noted that in the ACCORD study, AXS-05 “significantly delayed the relapse or prevented the relapse with Alzheimer’s disease agitation compared with the placebo group and it was generally well tolerated, but it will be important to make sure that there’s more thorough review of the data overall to be sure that it’s both safe and effective.”

The study was funded by Axsome Therapeutics, the manufacturer of AXS-05. Dr. Porsteinsson has disclosed no relevant conflicts of interest. Dr. Finney and Dr. Edelmayer have no relevant disclosures.

A version of this article appeared on Medscape.com.

DENVER — Treatment with AXS-05, a combination of dextromethorphan and bupropion, demonstrated rapid, sustained, and clinically meaningful improvement in agitation related to Alzheimer’s disease and was generally well tolerated in the phase 3 ACCORD trial. 

More than half of participants in the open-label extension period of the randomized clinical trial responded to the medication, which was associated with a 3.6-fold lower risk for relapse compared with placebo. 

“The positive efficacy and favorable safety results with AXS-05 support its potential to fulfill a high unmet need for the treatment of Alzheimer’s disease agitation,” said Anton P. Porsteinsson, MD, director of the Alzheimer’s Disease Care, Research and Education Program, University of Rochester, New York. 

The findings were presented at the 2024 annual meeting of the American Academy of Neurology. 
 

Common and Disruptive

Agitation is reported in up to 70% of patients with Alzheimer’s disease and is characterized by emotional distress, aggressive behaviors, disruptive irritability, and disinhibition. Alzheimer’s disease-related agitation has been associated with increased caregiver burden, decreased functioning, accelerated cognitive decline, earlier nursing home placement, and increased mortality.

A previous phase 2/3 study of AXS-05 showed that the investigative agent led to rapid and significantly improvement in Alzheimer’s disease agitation, as measured by the Cohen-Mansfield Agitation Inventory (CMAI) total score, compared with placebo. 

ACCORD was a phase 3, randomized, double-blind, placebo-controlled withdrawal trial evaluating the efficacy and safety of AXS-05 in patients with Alzheimer’s disease agitation. 

In the open-label period, 178 adults with probable Alzheimer’s disease and clinically significant agitation received AXS-05 (titrated to 45 mg dextromethorphan/105 mg bupropion twice daily) for up to 9 weeks.

A total of 108 (61%) patients had a sustained response, with 30% or more improvement from baseline in the CMAI total score and improvement on the Patient Global Impression of Change that were both maintained for 4 or more consecutive weeks. These patients entered the double-blind phase and were randomly allocated to receive twice-daily AXS-05 or placebo for up to 26 weeks.

In the double-blind period, AXS-05 “substantially and statistically” increased the time to relapse of agitation symptoms compared with placebo (hazard ratio [HR], 0.275; P = .014).

“The risk of relapse was 3.6-fold lower with AXS-05 compared with placebo,” Dr. Porsteinsson reported. 

AXS-05 was also associated with a significantly lower relapse rate compared with placebo (7.5% vs 25.9%; P = .018).

Rates of discontinuation in the double-blind period owing to adverse events (AEs) were low (0% for AXS-05 and 1.9% for placebo). Three serious AEs were reported: one in the AXS-05 group (fecaloma), which was not related to study medication, and two in the placebo group (cardiac arrest, femur fracture).

Falls were reported in four participants in the AXS-05 group, none of which were related to study medication or associated with serious AEs, and in two participants in the placebo group, one of which was associated with femur fracture.

One death was reported in the placebo group. There was no evidence of cognitive decline with AXS-05, and treatment was not associated with sedation. 
 

Promising Agent 

Commenting on this research, Glen R. Finney, MD, director of the Geisinger Memory and Cognition Clinic in Wilkes-Barre, Pennsylvania, said the data “look promising as a safe way to help address acute agitation and reduce agitation reoccurrence.

“Agitation is a common, distressing, and sometimes safety issue for people fighting Alzheimer’s disease, and there’s very little evidence for efficacy and significant side effect issues for current medical management of agitation in Alzheimer’s disease,” said Dr. Finney, who was not part of the study.

He noted that first-line strategies for addressing agitation involve behavioral and environmental interventions. 

“See if there’s a reason for the agitation and address that. Look for triggers for agitation and avoid those. Find places, things, and interactions that help people with Alzheimer’s disease avoid agitation: familiar locations, music, simple engaging activities. Reassurance, redirection, and distraction can help de-escalate agitation. Provide a safe environment that reduces safety risks,” Dr. Finney explained. 

The next step, when medically appropriate, is trying acetylcholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, and then adding memantine, a weak N-methyl-D-aspartate receptor antagonist. 

“These medications can help reduce the risk of agitation,” Dr. Finney said. 

“Beyond that, the evidence becomes weaker for any specific treatments, and that is where treatments with emerging evidence of efficacy and safety like dextromethorphan-bupropion become important,” Dr. Finney added. 

Last May, the US Food and Drug Administration (FDA) approved the antipsychotic brexpiprazole (Rexulti) for Alzheimer’s disease-related agitation, making it the first FDA-approved drug for this indication. 

The drug includes a boxed warning for medications in this class that older patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk for death.

“There’s certainly a need to have multiple options for treating agitation in individuals with Alzheimer’s disease,” said Rebecca Edelmayer, PhD, senior director of scientific engagement for the Alzheimer’s Association. 

Dr. Edelmayer, who was not part of the study, noted that in the ACCORD study, AXS-05 “significantly delayed the relapse or prevented the relapse with Alzheimer’s disease agitation compared with the placebo group and it was generally well tolerated, but it will be important to make sure that there’s more thorough review of the data overall to be sure that it’s both safe and effective.”

The study was funded by Axsome Therapeutics, the manufacturer of AXS-05. Dr. Porsteinsson has disclosed no relevant conflicts of interest. Dr. Finney and Dr. Edelmayer have no relevant disclosures.

A version of this article appeared on Medscape.com.