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Insulin and Oral Diabetes Drugs Are Similarly Effective for Gestational Diabetes
NATIONAL HARBOR, MARYLAND — A combination of oral antihyperglycemics was as effective as insulin for managing gestational diabetes, based on data from more than 800 individuals.
After diet control, both insulin and oral agents such as metformin and glibenclamide are used as a first-line treatment for gestational diabetes mellitus, Doortje Rademaker, MD, of Amsterdam University Medical Center, the Netherlands, said in a presentation at the Pregnancy Meeting (abstract 28).
Oral antihyperglycemic agents (OAAs) are thought to be comparable to insulin in preventing large-for-gestational-age (LGA) infants at birth and potentially more convenient for patients, Dr. Rademaker said at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.
Metformin and glibenclamide monotherapy as first-line treatment for gestational diabetes (GDM) are often used as patient-friendly alternatives to insulin. However, side effects are a concern, and data on the use of sequential and combined metformin and glibenclamide compared with insulin are lacking, she said.
In the study known as the SUGAR-DIP trial, Dr. Rademaker and colleagues recruited 821 women older than 18 years with singleton pregnancies between 16 weeks’ and 34 weeks’ gestation who had insufficient glycemic control with diet alone.
The study was conducted between 2016 and 2022; 409 women were randomized to OAAs and 412 to insulin. The mean age of the participants was 33 years, and 58% were White.
The OAA group received metformin initially, with the addition of up to 15 mg/day of glibenclamide in cases of insufficient glycemic control. Those who still experienced insufficient glycemic control were given insulin. The insulin group received injections according to usual standard of care.
The primary outcome was neonatal LGA, defined as birth weight above the 90th percentile. Secondary outcomes included patient satisfaction based on the Diabetes Treatment Satisfaction Questionnaire.
The intent-to-treat population included 406 women in the OAA group and 398 in the insulin group.
Overall, LGA rates were 23.9% in the OAA group vs. 19.9% in the insulin group. The absolute risk difference was 4%, with P values of .09 for noninferiority and .17 for superiority, Dr. Rademaker said in her presentation.
Notably, the OAA treatment led to lower maternal weight gain, although side effects were similar between the groups, she said. Neonates in the OAA group were significantly more likely to need intravenous glucose therapy (6.4% vs. 3.2%, P = .04). However, gestational weight gain was significantly lower in the OAA group than the insulin group (mean of 9.3 kg vs. 10.4 kg, P = .03).
Rates of maternal hypoglycemia were higher in the OAA group (21% vs. 11%), and 20% of women in the OAA group needed insulin therapy.
Serious adverse events were similar between the groups, but more side effects overall were reported in the OAA group than in the insulin group (77.9% vs. 55.9%, P < .001). The most common patient-reported side effects in the OAA group were nausea and diarrhea (nearly 40% for each), while headache and fatigue were the most common side effects in the insulin group.
Participants in both groups reported high levels of treatment satisfaction, with median scores of 5 on a scale of 0-6, Dr. Rademaker said. However, the data supported the researchers’ hypothesis of greater satisfaction with oral therapy. Patients in the OAA group were more likely to recommend their treatment to others than were those in the insulin group, with ratings of 5 vs. 4 on a scale of 0-6, and significantly more women in the OAA group said they would be inclined to continue their current treatment (5 vs. 4, P < .001 for both).
Study limitations included the open-label design. However, the results support the use of oral treatments as a noninferior alternative to insulin for preventing LGA in women with gestational diabetes, Dr. Rademaker said.
Data Support Orals as Effective Gestational Diabetes Option
“Treatment of gestational diabetes is important for optimal pregnancy outcomes,” Catherine Spong, MD, a maternal-fetal medicine specialist at the University of Texas Southwestern Medical Center, Dallas, said in an interview.
Although the American College of Obstetrics and Gynecology recommends insulin as the first-line therapy for gestational diabetes, many individuals opt for OAAs for the ease of an oral medication compared with injections, she said.
The current study authors evaluated whether OAAs were noninferior to insulin alone. “The size of oral [antihyperglycemic] agents suggests they can cross the placenta and may result in hypoglycemia in the fetus,” she said.
Although the overall LGA rate in the current study seems high, the rate of LGA is increased in diabetes generally, she added.
A key takeaway was that although individuals who used oral agents were more likely to recommend their treatment and to continue their therapy, 20% of these patients needed insulin therapy, Dr. Spong said.
Additional research is needed to explore the effect of gestational diabetes treatments on the fetus, Dr. Spong said in an interview. Research questions include whether hypoglycemia is more common in women who received oral agents, whether the agents crossed the placenta, and long-term effects, she said.
The study was supported by a grant from the Dutch Organization for Health Research and Development. Dr. Rademaker had no financial conflicts to disclose. One of the study coauthors disclosed serving as a consultant for ObsEva and Merck, and travel support from Merck, as well as support from the National Health and Medical Research Council. Dr. Spong had no financial conflicts to disclose.
NATIONAL HARBOR, MARYLAND — A combination of oral antihyperglycemics was as effective as insulin for managing gestational diabetes, based on data from more than 800 individuals.
After diet control, both insulin and oral agents such as metformin and glibenclamide are used as a first-line treatment for gestational diabetes mellitus, Doortje Rademaker, MD, of Amsterdam University Medical Center, the Netherlands, said in a presentation at the Pregnancy Meeting (abstract 28).
Oral antihyperglycemic agents (OAAs) are thought to be comparable to insulin in preventing large-for-gestational-age (LGA) infants at birth and potentially more convenient for patients, Dr. Rademaker said at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.
Metformin and glibenclamide monotherapy as first-line treatment for gestational diabetes (GDM) are often used as patient-friendly alternatives to insulin. However, side effects are a concern, and data on the use of sequential and combined metformin and glibenclamide compared with insulin are lacking, she said.
In the study known as the SUGAR-DIP trial, Dr. Rademaker and colleagues recruited 821 women older than 18 years with singleton pregnancies between 16 weeks’ and 34 weeks’ gestation who had insufficient glycemic control with diet alone.
The study was conducted between 2016 and 2022; 409 women were randomized to OAAs and 412 to insulin. The mean age of the participants was 33 years, and 58% were White.
The OAA group received metformin initially, with the addition of up to 15 mg/day of glibenclamide in cases of insufficient glycemic control. Those who still experienced insufficient glycemic control were given insulin. The insulin group received injections according to usual standard of care.
The primary outcome was neonatal LGA, defined as birth weight above the 90th percentile. Secondary outcomes included patient satisfaction based on the Diabetes Treatment Satisfaction Questionnaire.
The intent-to-treat population included 406 women in the OAA group and 398 in the insulin group.
Overall, LGA rates were 23.9% in the OAA group vs. 19.9% in the insulin group. The absolute risk difference was 4%, with P values of .09 for noninferiority and .17 for superiority, Dr. Rademaker said in her presentation.
Notably, the OAA treatment led to lower maternal weight gain, although side effects were similar between the groups, she said. Neonates in the OAA group were significantly more likely to need intravenous glucose therapy (6.4% vs. 3.2%, P = .04). However, gestational weight gain was significantly lower in the OAA group than the insulin group (mean of 9.3 kg vs. 10.4 kg, P = .03).
Rates of maternal hypoglycemia were higher in the OAA group (21% vs. 11%), and 20% of women in the OAA group needed insulin therapy.
Serious adverse events were similar between the groups, but more side effects overall were reported in the OAA group than in the insulin group (77.9% vs. 55.9%, P < .001). The most common patient-reported side effects in the OAA group were nausea and diarrhea (nearly 40% for each), while headache and fatigue were the most common side effects in the insulin group.
Participants in both groups reported high levels of treatment satisfaction, with median scores of 5 on a scale of 0-6, Dr. Rademaker said. However, the data supported the researchers’ hypothesis of greater satisfaction with oral therapy. Patients in the OAA group were more likely to recommend their treatment to others than were those in the insulin group, with ratings of 5 vs. 4 on a scale of 0-6, and significantly more women in the OAA group said they would be inclined to continue their current treatment (5 vs. 4, P < .001 for both).
Study limitations included the open-label design. However, the results support the use of oral treatments as a noninferior alternative to insulin for preventing LGA in women with gestational diabetes, Dr. Rademaker said.
Data Support Orals as Effective Gestational Diabetes Option
“Treatment of gestational diabetes is important for optimal pregnancy outcomes,” Catherine Spong, MD, a maternal-fetal medicine specialist at the University of Texas Southwestern Medical Center, Dallas, said in an interview.
Although the American College of Obstetrics and Gynecology recommends insulin as the first-line therapy for gestational diabetes, many individuals opt for OAAs for the ease of an oral medication compared with injections, she said.
The current study authors evaluated whether OAAs were noninferior to insulin alone. “The size of oral [antihyperglycemic] agents suggests they can cross the placenta and may result in hypoglycemia in the fetus,” she said.
Although the overall LGA rate in the current study seems high, the rate of LGA is increased in diabetes generally, she added.
A key takeaway was that although individuals who used oral agents were more likely to recommend their treatment and to continue their therapy, 20% of these patients needed insulin therapy, Dr. Spong said.
Additional research is needed to explore the effect of gestational diabetes treatments on the fetus, Dr. Spong said in an interview. Research questions include whether hypoglycemia is more common in women who received oral agents, whether the agents crossed the placenta, and long-term effects, she said.
The study was supported by a grant from the Dutch Organization for Health Research and Development. Dr. Rademaker had no financial conflicts to disclose. One of the study coauthors disclosed serving as a consultant for ObsEva and Merck, and travel support from Merck, as well as support from the National Health and Medical Research Council. Dr. Spong had no financial conflicts to disclose.
NATIONAL HARBOR, MARYLAND — A combination of oral antihyperglycemics was as effective as insulin for managing gestational diabetes, based on data from more than 800 individuals.
After diet control, both insulin and oral agents such as metformin and glibenclamide are used as a first-line treatment for gestational diabetes mellitus, Doortje Rademaker, MD, of Amsterdam University Medical Center, the Netherlands, said in a presentation at the Pregnancy Meeting (abstract 28).
Oral antihyperglycemic agents (OAAs) are thought to be comparable to insulin in preventing large-for-gestational-age (LGA) infants at birth and potentially more convenient for patients, Dr. Rademaker said at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.
Metformin and glibenclamide monotherapy as first-line treatment for gestational diabetes (GDM) are often used as patient-friendly alternatives to insulin. However, side effects are a concern, and data on the use of sequential and combined metformin and glibenclamide compared with insulin are lacking, she said.
In the study known as the SUGAR-DIP trial, Dr. Rademaker and colleagues recruited 821 women older than 18 years with singleton pregnancies between 16 weeks’ and 34 weeks’ gestation who had insufficient glycemic control with diet alone.
The study was conducted between 2016 and 2022; 409 women were randomized to OAAs and 412 to insulin. The mean age of the participants was 33 years, and 58% were White.
The OAA group received metformin initially, with the addition of up to 15 mg/day of glibenclamide in cases of insufficient glycemic control. Those who still experienced insufficient glycemic control were given insulin. The insulin group received injections according to usual standard of care.
The primary outcome was neonatal LGA, defined as birth weight above the 90th percentile. Secondary outcomes included patient satisfaction based on the Diabetes Treatment Satisfaction Questionnaire.
The intent-to-treat population included 406 women in the OAA group and 398 in the insulin group.
Overall, LGA rates were 23.9% in the OAA group vs. 19.9% in the insulin group. The absolute risk difference was 4%, with P values of .09 for noninferiority and .17 for superiority, Dr. Rademaker said in her presentation.
Notably, the OAA treatment led to lower maternal weight gain, although side effects were similar between the groups, she said. Neonates in the OAA group were significantly more likely to need intravenous glucose therapy (6.4% vs. 3.2%, P = .04). However, gestational weight gain was significantly lower in the OAA group than the insulin group (mean of 9.3 kg vs. 10.4 kg, P = .03).
Rates of maternal hypoglycemia were higher in the OAA group (21% vs. 11%), and 20% of women in the OAA group needed insulin therapy.
Serious adverse events were similar between the groups, but more side effects overall were reported in the OAA group than in the insulin group (77.9% vs. 55.9%, P < .001). The most common patient-reported side effects in the OAA group were nausea and diarrhea (nearly 40% for each), while headache and fatigue were the most common side effects in the insulin group.
Participants in both groups reported high levels of treatment satisfaction, with median scores of 5 on a scale of 0-6, Dr. Rademaker said. However, the data supported the researchers’ hypothesis of greater satisfaction with oral therapy. Patients in the OAA group were more likely to recommend their treatment to others than were those in the insulin group, with ratings of 5 vs. 4 on a scale of 0-6, and significantly more women in the OAA group said they would be inclined to continue their current treatment (5 vs. 4, P < .001 for both).
Study limitations included the open-label design. However, the results support the use of oral treatments as a noninferior alternative to insulin for preventing LGA in women with gestational diabetes, Dr. Rademaker said.
Data Support Orals as Effective Gestational Diabetes Option
“Treatment of gestational diabetes is important for optimal pregnancy outcomes,” Catherine Spong, MD, a maternal-fetal medicine specialist at the University of Texas Southwestern Medical Center, Dallas, said in an interview.
Although the American College of Obstetrics and Gynecology recommends insulin as the first-line therapy for gestational diabetes, many individuals opt for OAAs for the ease of an oral medication compared with injections, she said.
The current study authors evaluated whether OAAs were noninferior to insulin alone. “The size of oral [antihyperglycemic] agents suggests they can cross the placenta and may result in hypoglycemia in the fetus,” she said.
Although the overall LGA rate in the current study seems high, the rate of LGA is increased in diabetes generally, she added.
A key takeaway was that although individuals who used oral agents were more likely to recommend their treatment and to continue their therapy, 20% of these patients needed insulin therapy, Dr. Spong said.
Additional research is needed to explore the effect of gestational diabetes treatments on the fetus, Dr. Spong said in an interview. Research questions include whether hypoglycemia is more common in women who received oral agents, whether the agents crossed the placenta, and long-term effects, she said.
The study was supported by a grant from the Dutch Organization for Health Research and Development. Dr. Rademaker had no financial conflicts to disclose. One of the study coauthors disclosed serving as a consultant for ObsEva and Merck, and travel support from Merck, as well as support from the National Health and Medical Research Council. Dr. Spong had no financial conflicts to disclose.
FROM THE PREGNANCY MEETING
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