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Pretreatment Lab Testing for Chronic Skin Diseases Diverges From Guidelines
in a national commercial insurance claims database.
Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.
“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.
“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.
In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.
The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.
A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.
The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.
Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.
The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.
However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.
“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.
“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”
“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.
Resist Routine Testing
The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.
The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.
However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.
Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.
The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.
Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.
Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.
Dr. Friedman had no relevant financial conflicts to disclose.
A version of this article appeared on Medscape.com.
in a national commercial insurance claims database.
Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.
“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.
“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.
In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.
The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.
A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.
The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.
Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.
The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.
However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.
“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.
“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”
“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.
Resist Routine Testing
The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.
The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.
However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.
Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.
The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.
Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.
Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.
Dr. Friedman had no relevant financial conflicts to disclose.
A version of this article appeared on Medscape.com.
in a national commercial insurance claims database.
Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.
“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.
“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.
In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.
The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.
A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.
The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.
Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.
The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.
However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.
“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.
“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”
“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.
Resist Routine Testing
The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.
The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.
However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.
Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.
The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.
Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.
Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.
Dr. Friedman had no relevant financial conflicts to disclose.
A version of this article appeared on Medscape.com.
FROM JAMA DERMATOLOGY
Prevalence of Risk Factors Impacting Oral Janus Kinase Inhibitor Treatment in Atopic Dermatitis
Key clinical point: Risk factors affecting oral Janus kinase inhibitor (JAKi) treatment were prevalent among adult patients with atopic dermatitis (AD), especially older individuals, thus necessitating careful risk assessment among patients before JAKi therapy initiation.
Major finding: Nearly half (49.5%) of the patients with AD at some point had at least one risk factor that could affect JAKi treatment and most (60.3%) patients age ≥ 65 years had at least three risk factors. The recorded non-modifiable risk factors included cancer (5.6%), smoking history (15.6%), age ≥ 65 years (12.4%), and major adverse cardiovascular events (2.6%).
Study details: This cross-sectional study included adult patients with AD from the Danish national registers (n = 18,618) and Danish Skin Cohort (n = 3573).
Disclosures: This study did not disclose the source of funding. Several authors declared receiving research support, lecture honoraria, or consulting honoraria from or serving as speakers or advisory board members for various organizations.
Source: Vittrup I, Thein D, Thomsen SF, Egeberg A, Thyssen JP. Risk factors that impact treatment with oral Janus kinase inhibitors among adult patients with atopic dermatitis: A nationwide registry study. Acta Derm Venereol. 2024 (Jan 22). doi: 10.2340/actadv.v104.18638 Source
Key clinical point: Risk factors affecting oral Janus kinase inhibitor (JAKi) treatment were prevalent among adult patients with atopic dermatitis (AD), especially older individuals, thus necessitating careful risk assessment among patients before JAKi therapy initiation.
Major finding: Nearly half (49.5%) of the patients with AD at some point had at least one risk factor that could affect JAKi treatment and most (60.3%) patients age ≥ 65 years had at least three risk factors. The recorded non-modifiable risk factors included cancer (5.6%), smoking history (15.6%), age ≥ 65 years (12.4%), and major adverse cardiovascular events (2.6%).
Study details: This cross-sectional study included adult patients with AD from the Danish national registers (n = 18,618) and Danish Skin Cohort (n = 3573).
Disclosures: This study did not disclose the source of funding. Several authors declared receiving research support, lecture honoraria, or consulting honoraria from or serving as speakers or advisory board members for various organizations.
Source: Vittrup I, Thein D, Thomsen SF, Egeberg A, Thyssen JP. Risk factors that impact treatment with oral Janus kinase inhibitors among adult patients with atopic dermatitis: A nationwide registry study. Acta Derm Venereol. 2024 (Jan 22). doi: 10.2340/actadv.v104.18638 Source
Key clinical point: Risk factors affecting oral Janus kinase inhibitor (JAKi) treatment were prevalent among adult patients with atopic dermatitis (AD), especially older individuals, thus necessitating careful risk assessment among patients before JAKi therapy initiation.
Major finding: Nearly half (49.5%) of the patients with AD at some point had at least one risk factor that could affect JAKi treatment and most (60.3%) patients age ≥ 65 years had at least three risk factors. The recorded non-modifiable risk factors included cancer (5.6%), smoking history (15.6%), age ≥ 65 years (12.4%), and major adverse cardiovascular events (2.6%).
Study details: This cross-sectional study included adult patients with AD from the Danish national registers (n = 18,618) and Danish Skin Cohort (n = 3573).
Disclosures: This study did not disclose the source of funding. Several authors declared receiving research support, lecture honoraria, or consulting honoraria from or serving as speakers or advisory board members for various organizations.
Source: Vittrup I, Thein D, Thomsen SF, Egeberg A, Thyssen JP. Risk factors that impact treatment with oral Janus kinase inhibitors among adult patients with atopic dermatitis: A nationwide registry study. Acta Derm Venereol. 2024 (Jan 22). doi: 10.2340/actadv.v104.18638 Source
Dupilumab Efficacy in Atopic Dermatitis Is Not Influenced by Pathogenic Filaggrin Variants
Key clinical point: Pathogenic filaggrin (FLG) variants do not affect the effectiveness of dupilumab treatment in patients with atopic dermatitis (AD).
Major finding: No clinically relevant differences were observed in the Eczema Area and Severity Index, Investigator Global Assessment, Numeric Rating Scale for pruritus, and total Patient Oriented Eczema Measure (POEM) scores between patients with and without pathogenic FLG variants at week 16 or 52. However, patients with bi-allelic pathogenic variants vs wild-type alleles had significantly higher POEM dryness scores at week 16 (P = .002) and week 52 (P = .016).
Study details: This prospective observational study included 285 adult patients with AD from the Dutch BioDay Registry who had received dupilumab for 16 weeks or more and underwent genomic variant analysis for FLG.
Disclosures: This study did not receive any funding. Some authors declared being consultants, advisory board members, or speakers for or having other ties with various organizations.
Source: Clabbers J, Boesjes C, Spekhorst L, et al. Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis. J Allergy Clin Immunol. 2024 (Jan 22). doi: 10.1016/j.jaci.2023.12.027 Source
Key clinical point: Pathogenic filaggrin (FLG) variants do not affect the effectiveness of dupilumab treatment in patients with atopic dermatitis (AD).
Major finding: No clinically relevant differences were observed in the Eczema Area and Severity Index, Investigator Global Assessment, Numeric Rating Scale for pruritus, and total Patient Oriented Eczema Measure (POEM) scores between patients with and without pathogenic FLG variants at week 16 or 52. However, patients with bi-allelic pathogenic variants vs wild-type alleles had significantly higher POEM dryness scores at week 16 (P = .002) and week 52 (P = .016).
Study details: This prospective observational study included 285 adult patients with AD from the Dutch BioDay Registry who had received dupilumab for 16 weeks or more and underwent genomic variant analysis for FLG.
Disclosures: This study did not receive any funding. Some authors declared being consultants, advisory board members, or speakers for or having other ties with various organizations.
Source: Clabbers J, Boesjes C, Spekhorst L, et al. Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis. J Allergy Clin Immunol. 2024 (Jan 22). doi: 10.1016/j.jaci.2023.12.027 Source
Key clinical point: Pathogenic filaggrin (FLG) variants do not affect the effectiveness of dupilumab treatment in patients with atopic dermatitis (AD).
Major finding: No clinically relevant differences were observed in the Eczema Area and Severity Index, Investigator Global Assessment, Numeric Rating Scale for pruritus, and total Patient Oriented Eczema Measure (POEM) scores between patients with and without pathogenic FLG variants at week 16 or 52. However, patients with bi-allelic pathogenic variants vs wild-type alleles had significantly higher POEM dryness scores at week 16 (P = .002) and week 52 (P = .016).
Study details: This prospective observational study included 285 adult patients with AD from the Dutch BioDay Registry who had received dupilumab for 16 weeks or more and underwent genomic variant analysis for FLG.
Disclosures: This study did not receive any funding. Some authors declared being consultants, advisory board members, or speakers for or having other ties with various organizations.
Source: Clabbers J, Boesjes C, Spekhorst L, et al. Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis. J Allergy Clin Immunol. 2024 (Jan 22). doi: 10.1016/j.jaci.2023.12.027 Source
Upadacitinib Shows Good Drug Survival in Moderate to Severe Atopic Dermatitis
Key clinical point: Upadacitinib resulted in a good survival rate and was effective in patients with moderate to severe atopic dermatitis (AD) after over a year of continuous treatment, with no single characteristic of the study population being significantly associated with drug discontinuation.
Major finding: The drug survival rates at 1 and 1.5 years were 91.5% and 80.2%, respectively. The main reasons for discontinuation, occurring in 7.7% of patients, were adverse effects and ineffectiveness. However, no specific patient characteristics, such as sex or age at AD onset, showed a significant association with drug discontinuation.
Study details: This real-world retrospective study included 325 adult patients with moderate to severe AD who were treated with upadacitinib for at least 4 weeks and up to 72 weeks.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Pezzolo E, Ortoncelli M, Ferrucci SM, et al. Drug survival of upadacitinib and predicting factors of discontinuation in adult patients affected by moderate-to-severe atopic dermatitis: An Italian multicenter analysis. J Clin Med. 2024;13:553 (Jan 18). doi: 10.3390/jcm13020553 Source
Key clinical point: Upadacitinib resulted in a good survival rate and was effective in patients with moderate to severe atopic dermatitis (AD) after over a year of continuous treatment, with no single characteristic of the study population being significantly associated with drug discontinuation.
Major finding: The drug survival rates at 1 and 1.5 years were 91.5% and 80.2%, respectively. The main reasons for discontinuation, occurring in 7.7% of patients, were adverse effects and ineffectiveness. However, no specific patient characteristics, such as sex or age at AD onset, showed a significant association with drug discontinuation.
Study details: This real-world retrospective study included 325 adult patients with moderate to severe AD who were treated with upadacitinib for at least 4 weeks and up to 72 weeks.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Pezzolo E, Ortoncelli M, Ferrucci SM, et al. Drug survival of upadacitinib and predicting factors of discontinuation in adult patients affected by moderate-to-severe atopic dermatitis: An Italian multicenter analysis. J Clin Med. 2024;13:553 (Jan 18). doi: 10.3390/jcm13020553 Source
Key clinical point: Upadacitinib resulted in a good survival rate and was effective in patients with moderate to severe atopic dermatitis (AD) after over a year of continuous treatment, with no single characteristic of the study population being significantly associated with drug discontinuation.
Major finding: The drug survival rates at 1 and 1.5 years were 91.5% and 80.2%, respectively. The main reasons for discontinuation, occurring in 7.7% of patients, were adverse effects and ineffectiveness. However, no specific patient characteristics, such as sex or age at AD onset, showed a significant association with drug discontinuation.
Study details: This real-world retrospective study included 325 adult patients with moderate to severe AD who were treated with upadacitinib for at least 4 weeks and up to 72 weeks.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Pezzolo E, Ortoncelli M, Ferrucci SM, et al. Drug survival of upadacitinib and predicting factors of discontinuation in adult patients affected by moderate-to-severe atopic dermatitis: An Italian multicenter analysis. J Clin Med. 2024;13:553 (Jan 18). doi: 10.3390/jcm13020553 Source
Does Dupilumab Treatment in Atopic Dermatitis Increase Infection Risk in Infants and Children?
Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.
Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).
Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.
Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source
Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.
Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).
Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.
Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source
Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.
Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).
Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.
Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source
Dupilumab Dose Reduction Achievable in Persistently Controlled Atopic Dermatitis
Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).
Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).
Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030 Source
Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).
Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).
Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030 Source
Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).
Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).
Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030 Source
Dupilumab Effective in Patients With Atopic Dermatitis and Comorbidities Including Malignancies
Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.
Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.
Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.
Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.
Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002 Source
Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.
Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.
Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.
Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.
Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002 Source
Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.
Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.
Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.
Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.
Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002 Source
Atopic Dermatitis Remission in Children Unaffected by Washing With Water or Cleanser During Summer
Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.
Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).
Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.
Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.
Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source
Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.
Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).
Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.
Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.
Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source
Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.
Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).
Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.
Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.
Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source
Air Quality Index Tied to the Incidence of Atopic Dermatitis
Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).
Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.
Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.
Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.
Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058 Source
Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).
Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.
Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.
Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.
Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058 Source
Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).
Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.
Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.
Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.
Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058 Source
Dupilumab Monotherapy Safe and Effective Against Hand and Foot Atopic Dermatitis
Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).
Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.
Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.
Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066 Source
Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).
Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.
Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.
Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066 Source
Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).
Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.
Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.
Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066 Source