Key clinical point: Coadjuvant treatment with a specific probiotic preparation reduced disease severity in children and adolescents with atopic dermatitis (AD), as evidenced by a decrease in Scoring of Atopic Dermatitis (SCORAD) and Investigator’s Global Assessment (IGA) scores.

Major finding: At 12 weeks, patients receiving the probiotic preparation vs placebo had a significantly higher rate of achieving at least a 1-point improvement in IGA score (90.5% vs 56.7%; P < .002) and lower SCORAD score (13.52 vs 18.96; P = .041).

Study details: This study included 70 patients aged 4-17 years with AD who were randomly assigned to receive the probiotic preparation (containing Bifidobacterium lactis, Bifidobacterium longum, and Lactobacillus casei; n = 35) or placebo (n = 35) daily for 12 weeks.

Disclosures: This study was funded by Biopolis SL. The authors declared no conflicts of interest.

Source: Feíto-Rodríguez M et al. Randomised double blind placebo controlled clinical trial to evaluate the effect of a mixture of probiotic strains on symptom severity and the use of corticosteroids in children and adolescents with atopic dermatitis. Clin Exp Dermatol. 2023 (Jan 13). Doi: 10.1093/ced/llad007

Key clinical point: Coadjuvant treatment with a specific probiotic preparation reduced disease severity in children and adolescents with atopic dermatitis (AD), as evidenced by a decrease in Scoring of Atopic Dermatitis (SCORAD) and Investigator’s Global Assessment (IGA) scores.

Major finding: At 12 weeks, patients receiving the probiotic preparation vs placebo had a significantly higher rate of achieving at least a 1-point improvement in IGA score (90.5% vs 56.7%; P < .002) and lower SCORAD score (13.52 vs 18.96; P = .041).

Study details: This study included 70 patients aged 4-17 years with AD who were randomly assigned to receive the probiotic preparation (containing Bifidobacterium lactis, Bifidobacterium longum, and Lactobacillus casei; n = 35) or placebo (n = 35) daily for 12 weeks.

Disclosures: This study was funded by Biopolis SL. The authors declared no conflicts of interest.

Source: Feíto-Rodríguez M et al. Randomised double blind placebo controlled clinical trial to evaluate the effect of a mixture of probiotic strains on symptom severity and the use of corticosteroids in children and adolescents with atopic dermatitis. Clin Exp Dermatol. 2023 (Jan 13). Doi: 10.1093/ced/llad007

Key clinical point: Coadjuvant treatment with a specific probiotic preparation reduced disease severity in children and adolescents with atopic dermatitis (AD), as evidenced by a decrease in Scoring of Atopic Dermatitis (SCORAD) and Investigator’s Global Assessment (IGA) scores.

Major finding: At 12 weeks, patients receiving the probiotic preparation vs placebo had a significantly higher rate of achieving at least a 1-point improvement in IGA score (90.5% vs 56.7%; P < .002) and lower SCORAD score (13.52 vs 18.96; P = .041).

Study details: This study included 70 patients aged 4-17 years with AD who were randomly assigned to receive the probiotic preparation (containing Bifidobacterium lactis, Bifidobacterium longum, and Lactobacillus casei; n = 35) or placebo (n = 35) daily for 12 weeks.

Disclosures: This study was funded by Biopolis SL. The authors declared no conflicts of interest.

Source: Feíto-Rodríguez M et al. Randomised double blind placebo controlled clinical trial to evaluate the effect of a mixture of probiotic strains on symptom severity and the use of corticosteroids in children and adolescents with atopic dermatitis. Clin Exp Dermatol. 2023 (Jan 13). Doi: 10.1093/ced/llad007

Key clinical point: Upadacitinib can serve as an effective treatment option for atopic dermatitis (AD) and concomitant hand eczema (HE) in daily practice.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 17.2 (at baseline) to 4.8 (P < .001) and 50.0%, 40.6%, 59.3%, and 74.1% of patients achieved EASI-75, an Investigator’s Global Assessment score of (almost) clear, Hand Eczema Severity Index-75, and a score of (almost) clear on the photographic guide, respectively. Adverse events were generally mild in severity.

Study details: This multicenter prospective observational study included 38 patients with AD from the BioDay registry who received once-daily upadacitinib over 16 weeks, of which 32 patients had concomitant HE.

Disclosures: The BioDay registry is funded by Sanofi/Regeneron and others. Some authors declared serving as advisors, speakers, or consultants for or receiving consulting fees from various sources, including the registry funders.

Source: Kamphuis E, Loman L, et al. Experiences from daily practice of upadacitinib treatment on atopic dermatitis with a focus on hand eczema: Results from the BioDay registry. Contact Dermatitis. 2023 (Jan 9). Doi: 10.1111/cod.14276

Key clinical point: Upadacitinib can serve as an effective treatment option for atopic dermatitis (AD) and concomitant hand eczema (HE) in daily practice.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 17.2 (at baseline) to 4.8 (P < .001) and 50.0%, 40.6%, 59.3%, and 74.1% of patients achieved EASI-75, an Investigator’s Global Assessment score of (almost) clear, Hand Eczema Severity Index-75, and a score of (almost) clear on the photographic guide, respectively. Adverse events were generally mild in severity.

Study details: This multicenter prospective observational study included 38 patients with AD from the BioDay registry who received once-daily upadacitinib over 16 weeks, of which 32 patients had concomitant HE.

Disclosures: The BioDay registry is funded by Sanofi/Regeneron and others. Some authors declared serving as advisors, speakers, or consultants for or receiving consulting fees from various sources, including the registry funders.

Source: Kamphuis E, Loman L, et al. Experiences from daily practice of upadacitinib treatment on atopic dermatitis with a focus on hand eczema: Results from the BioDay registry. Contact Dermatitis. 2023 (Jan 9). Doi: 10.1111/cod.14276

Key clinical point: Upadacitinib can serve as an effective treatment option for atopic dermatitis (AD) and concomitant hand eczema (HE) in daily practice.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 17.2 (at baseline) to 4.8 (P < .001) and 50.0%, 40.6%, 59.3%, and 74.1% of patients achieved EASI-75, an Investigator’s Global Assessment score of (almost) clear, Hand Eczema Severity Index-75, and a score of (almost) clear on the photographic guide, respectively. Adverse events were generally mild in severity.

Study details: This multicenter prospective observational study included 38 patients with AD from the BioDay registry who received once-daily upadacitinib over 16 weeks, of which 32 patients had concomitant HE.

Disclosures: The BioDay registry is funded by Sanofi/Regeneron and others. Some authors declared serving as advisors, speakers, or consultants for or receiving consulting fees from various sources, including the registry funders.

Source: Kamphuis E, Loman L, et al. Experiences from daily practice of upadacitinib treatment on atopic dermatitis with a focus on hand eczema: Results from the BioDay registry. Contact Dermatitis. 2023 (Jan 9). Doi: 10.1111/cod.14276

Key clinical point: Dupilumab provides rapid improvement in atopic dermatitis (AD) signs and symptoms and is well tolerated in patients with moderate-to-severe AD in a real-world setting.

Major finding: At week 12, the percentages of patients who achieved ≥75% improvement in the Eczema Area and Severity Index, an Investigator’s Global Assessment score of 0/1 with a ≥2-point reduction from baseline, and a ≥4-point decrease in itch-numerical rating scale score were 59.4%, 33.0%, and 57.0%, respectively. Adverse event rates were lower than those reported in previous phase 3 trials.

Study details: Findings are from a 12-week analysis of the multicenter prospective real-life study PROLEAD including 828 dupilumab-naive adult patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Some authors reported ties with various organizations, including Sanofi. Three authors declared being employees of or holding stock or stock options in Sanofi.

Source: Augustin M et al. Dupilumab demonstrates rapid onset of action in improving signs, symptoms and quality of life in adults with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 4). Doi: 10.1007/s13555-023-00894-3

Key clinical point: Dupilumab provides rapid improvement in atopic dermatitis (AD) signs and symptoms and is well tolerated in patients with moderate-to-severe AD in a real-world setting.

Major finding: At week 12, the percentages of patients who achieved ≥75% improvement in the Eczema Area and Severity Index, an Investigator’s Global Assessment score of 0/1 with a ≥2-point reduction from baseline, and a ≥4-point decrease in itch-numerical rating scale score were 59.4%, 33.0%, and 57.0%, respectively. Adverse event rates were lower than those reported in previous phase 3 trials.

Study details: Findings are from a 12-week analysis of the multicenter prospective real-life study PROLEAD including 828 dupilumab-naive adult patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Some authors reported ties with various organizations, including Sanofi. Three authors declared being employees of or holding stock or stock options in Sanofi.

Source: Augustin M et al. Dupilumab demonstrates rapid onset of action in improving signs, symptoms and quality of life in adults with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 4). Doi: 10.1007/s13555-023-00894-3

Key clinical point: Dupilumab provides rapid improvement in atopic dermatitis (AD) signs and symptoms and is well tolerated in patients with moderate-to-severe AD in a real-world setting.

Major finding: At week 12, the percentages of patients who achieved ≥75% improvement in the Eczema Area and Severity Index, an Investigator’s Global Assessment score of 0/1 with a ≥2-point reduction from baseline, and a ≥4-point decrease in itch-numerical rating scale score were 59.4%, 33.0%, and 57.0%, respectively. Adverse event rates were lower than those reported in previous phase 3 trials.

Study details: Findings are from a 12-week analysis of the multicenter prospective real-life study PROLEAD including 828 dupilumab-naive adult patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Some authors reported ties with various organizations, including Sanofi. Three authors declared being employees of or holding stock or stock options in Sanofi.

Source: Augustin M et al. Dupilumab demonstrates rapid onset of action in improving signs, symptoms and quality of life in adults with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 4). Doi: 10.1007/s13555-023-00894-3

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Children born by cesarean section or instrumental vaginal delivery are at a greater risk of developing atopic dermatitis (AD) compared with those born by uncomplicated vaginal delivery.

Major finding: Children aged <1 year born by instrumental vaginal delivery (adjusted hazard ratio [aHR] 1.10; 95% CI 1.07-1.13), emergency cesarean section (aHR 1.12; 95% CI 1.10-1.15), and elective caesarean section (aHR 1.13; 95% CI 1.10-1.16) were at a higher risk for AD compared with those born by uncomplicated vaginal delivery, with the risk being similar in children aged ≥1 year.

Study details: This prospective population-based study included 1,399,406 children aged ≤5 years with available information on the mode of delivery and mother's identity.

Disclosures: This study was supported by the Swedish Research Council, Swedish Heart-Lung Foundation, and Stiftelsen Frimurare Barnhuset i Stockholm. The authors declared no conflicts of interest.

Source: Mubanga M et al. Mode of delivery and offspring atopic dermatitis in a Swedish nationwide study. Pediatr Allergy Immunol. 2023;34(1):e13904 (Jan 11). Doi: 10.1111/pai.13904

Key clinical point: Children born by cesarean section or instrumental vaginal delivery are at a greater risk of developing atopic dermatitis (AD) compared with those born by uncomplicated vaginal delivery.

Major finding: Children aged <1 year born by instrumental vaginal delivery (adjusted hazard ratio [aHR] 1.10; 95% CI 1.07-1.13), emergency cesarean section (aHR 1.12; 95% CI 1.10-1.15), and elective caesarean section (aHR 1.13; 95% CI 1.10-1.16) were at a higher risk for AD compared with those born by uncomplicated vaginal delivery, with the risk being similar in children aged ≥1 year.

Study details: This prospective population-based study included 1,399,406 children aged ≤5 years with available information on the mode of delivery and mother's identity.

Disclosures: This study was supported by the Swedish Research Council, Swedish Heart-Lung Foundation, and Stiftelsen Frimurare Barnhuset i Stockholm. The authors declared no conflicts of interest.

Source: Mubanga M et al. Mode of delivery and offspring atopic dermatitis in a Swedish nationwide study. Pediatr Allergy Immunol. 2023;34(1):e13904 (Jan 11). Doi: 10.1111/pai.13904

Key clinical point: Children born by cesarean section or instrumental vaginal delivery are at a greater risk of developing atopic dermatitis (AD) compared with those born by uncomplicated vaginal delivery.

Major finding: Children aged <1 year born by instrumental vaginal delivery (adjusted hazard ratio [aHR] 1.10; 95% CI 1.07-1.13), emergency cesarean section (aHR 1.12; 95% CI 1.10-1.15), and elective caesarean section (aHR 1.13; 95% CI 1.10-1.16) were at a higher risk for AD compared with those born by uncomplicated vaginal delivery, with the risk being similar in children aged ≥1 year.

Study details: This prospective population-based study included 1,399,406 children aged ≤5 years with available information on the mode of delivery and mother's identity.

Disclosures: This study was supported by the Swedish Research Council, Swedish Heart-Lung Foundation, and Stiftelsen Frimurare Barnhuset i Stockholm. The authors declared no conflicts of interest.

Source: Mubanga M et al. Mode of delivery and offspring atopic dermatitis in a Swedish nationwide study. Pediatr Allergy Immunol. 2023;34(1):e13904 (Jan 11). Doi: 10.1111/pai.13904

Key clinical point: Dupilumab with or without concomitant topical corticosteroids (TCS) was safe and provided rapid and sustained improvements in atopic dermatitis (AD) signs and symptoms in patients with erythrodermic AD.

Major finding: At week 16, dupilumab without and with concomitant TCS vs placebo provided significant improvements in the percentage of AD-affected body surface area (P = .02 and P < .001, respectively), Eczema Area and Severity Index score (P = .002 and P < .001, respectively), and Peak Pruritus Numerical Rating Scale score (P < .001 and P = .002, respectively), with improvements observed from week 1. Most treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of six multicenter randomized trials included 209 patients with erythrodermic AD who were randomly assigned to receive dupilumab or placebo (both with or without concomitant TCS).

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported ties with various organizations, including Sanofi/Regeneron. Four authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Paller AS et al. Efficacy and safety of dupilumab in patients with erythrodermic atopic dermatitis: A post hoc analysis of 6 randomized clinical trials. JAMA Dermatol. 2023 (Feb 1). Doi: 10.1001/jamadermatol.2022.6192

Key clinical point: Dupilumab with or without concomitant topical corticosteroids (TCS) was safe and provided rapid and sustained improvements in atopic dermatitis (AD) signs and symptoms in patients with erythrodermic AD.

Major finding: At week 16, dupilumab without and with concomitant TCS vs placebo provided significant improvements in the percentage of AD-affected body surface area (P = .02 and P < .001, respectively), Eczema Area and Severity Index score (P = .002 and P < .001, respectively), and Peak Pruritus Numerical Rating Scale score (P < .001 and P = .002, respectively), with improvements observed from week 1. Most treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of six multicenter randomized trials included 209 patients with erythrodermic AD who were randomly assigned to receive dupilumab or placebo (both with or without concomitant TCS).

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported ties with various organizations, including Sanofi/Regeneron. Four authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Paller AS et al. Efficacy and safety of dupilumab in patients with erythrodermic atopic dermatitis: A post hoc analysis of 6 randomized clinical trials. JAMA Dermatol. 2023 (Feb 1). Doi: 10.1001/jamadermatol.2022.6192

Key clinical point: Dupilumab with or without concomitant topical corticosteroids (TCS) was safe and provided rapid and sustained improvements in atopic dermatitis (AD) signs and symptoms in patients with erythrodermic AD.

Major finding: At week 16, dupilumab without and with concomitant TCS vs placebo provided significant improvements in the percentage of AD-affected body surface area (P = .02 and P < .001, respectively), Eczema Area and Severity Index score (P = .002 and P < .001, respectively), and Peak Pruritus Numerical Rating Scale score (P < .001 and P = .002, respectively), with improvements observed from week 1. Most treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of six multicenter randomized trials included 209 patients with erythrodermic AD who were randomly assigned to receive dupilumab or placebo (both with or without concomitant TCS).

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported ties with various organizations, including Sanofi/Regeneron. Four authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Paller AS et al. Efficacy and safety of dupilumab in patients with erythrodermic atopic dermatitis: A post hoc analysis of 6 randomized clinical trials. JAMA Dermatol. 2023 (Feb 1). Doi: 10.1001/jamadermatol.2022.6192

People at high risk for nonalcoholic fatty liver disease (NAFLD), such as those with type 2 diabetes or medically complicated obesity, should be screened for advanced fibrosis, says new guidance from the American Association for the Study of Liver Diseases.

The guidance, published online in Hepatology, also reflects recent advances in the diagnosis and management of NAFLD, particularly noninvasive testing, lead author Mary E. Rinella, MD, University of Chicago, told this news organization.

The “biggest change” from the previous guidance, published 5 years ago, is “that we are explicitly recommending that people in high-risk categories get screened in primary care,” she said.

NAFLD is “a silent disease ... you could easily have somebody develop cirrhosis,” Dr. Rinella said. By identifying patients earlier, physicians would be able to “prevent or reduce the number of people turning up decompensated or at an advanced stage,” she added.

The other message that Dr. Rinella wants clinicians to take away from the guidance is that “something can be done” for patients with NAFLD. “It’s very common, and the often-cited reason why patients aren’t referred to specialty care is that there’s ‘nothing that can be done.’ ”

Although there is no U.S. Food and Drug Administration–approved drug for NAFLD, clinicians can still support their patients and suggest lifestyle changes, she added.

The guidelines also are designed to prepare the groundwork for novel drugs in the pipeline, as well as discuss those that are already available for conditions such as obesity and diabetes and that benefit people with liver disease, Dr. Rinella said.
 

Screening and evaluation

The guidance covers all aspects of NAFLD, including the latest developments in understanding of the epidemiology and natural history of the disease, and its molecular and cellular pathogenesis.

The guidance continues to recommend against population-based screening for NAFLD. In addition to the aforementioned screening for advanced fibrosis in high-risk individuals, it calls for a primary risk assessment with FIB-4 to be performed every 1-2 years in patients with pre-diabetes, type 2 diabetes, two or more metabolic risk factors, or imaging evidence of hepatic steatosis.

Patients with nonalcoholic steatohepatitis (NASH) cirrhosis require routine monitoring, as they are at the highest risk for liver-related outcomes, the guidance adds. Those with suspected NASH should be referred for evaluation by a specialist.

In assessments of liver fibrosis in patients, findings such as highly elevated liver stiffness, FIB-4, and enhanced liver fibrosis scores can predict an increased risk for hepatic decompensation and mortality, the authors write.
 

Intervention guidance

Patients with NAFLD who are overweight or obese should be prescribed a reduced calorie diet in a multidisciplinary setting because weight loss “improves hepatic steatosis, NASH, and hepatic fibrosis in a dose-dependent manner,” the guidance states.

Bariatric surgery should be considered in appropriate patients because of its effectiveness in resolving NAFLD and NASH in most patients without cirrhosis, the guidance says. However, in patients with well-compensated NASH cirrhosis, the type, safety, and efficacy of bariatric surgery is not established, so a “careful benefit-risk assessment by a multidisciplinary team of experts that includes a hepatologist” is needed, the authors note.

The guidance discusses alcohol consumption’s role in the progression of fatty liver disease and recommends that intake be assessed on a regular basis in patients with NAFLD. Patients with clinically significant hepatic fibrosis should abstain completely, it adds. Abstinence, particularly for patients with moderate to heavy alcohol intake, may lower the risk of fibrosis progression and hepatic and extrahepatic malignancies, the authors note.

Additionally, drinking at least three cups of coffee, caffeinated or not, per day is “associated with less-advanced liver disease,” they write.

The guidance also sets out key considerations for people with comorbid conditions. It states that patients with NAFLD should be screened for type 2 diabetes and that statins can be safely used for cardiovascular risk reduction “across the disease spectrum, including compensated cirrhosis.”

While noting the lack of approved medications for NAFLD, the guidance states that some drugs prescribed for comorbidities also benefit patients with NASH. These are glucagon-like peptide 1 agonist semaglutide, pioglitazone, and vitamin E supplementation in select patients.

Available data on these same drugs, however, do not show an antifibrotic benefit and haven’t been studied in patients with cirrhosis, the guidance states.

Additionally, metformin, ursodeoxycholic acid, dipeptidyl peptidase-4 inhibitors, silymarin, and statins do not offer meaningful histologic benefit and shouldn’t be used as a treatment for NASH.
 

Help against an ‘evolving epidemic’

The guidance is “timely and long awaited,” Jamile Wakim-Fleming, MD, director of the fatty liver disease program at the Cleveland Clinic, said in an interview. NAFLD is an “evolving epidemic,” she added.

Numerous recent studies have “led to new modalities for diagnosis and therapy, and a better understanding” of the epidemiology and pathophysiology of NAFLD, she said. “More specifically, advancements in noninvasive testing, risk stratifications, and therapeutic modalities are now available and worth disseminating.”

NAFLD’s complexity and the lack of an FDA-approved therapy specifically targeting the liver means that managing the disease “requires expertise in multiple disciplines and knowledge of the latest developments,” Dr. Wakim-Fleming noted.

“This guidance describes preventive and treatment strategies for the metabolic conditions associated with NAFLD and is very useful for physicians in different specialties who treat individuals with these conditions,” she said.

No funding was declared. Dr. Rinella and Dr. Wakim-Fleming have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.


The AGA’s Clinical Practice Update on the Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Lean Individuals is available online.

People at high risk for nonalcoholic fatty liver disease (NAFLD), such as those with type 2 diabetes or medically complicated obesity, should be screened for advanced fibrosis, says new guidance from the American Association for the Study of Liver Diseases.

The guidance, published online in Hepatology, also reflects recent advances in the diagnosis and management of NAFLD, particularly noninvasive testing, lead author Mary E. Rinella, MD, University of Chicago, told this news organization.

The “biggest change” from the previous guidance, published 5 years ago, is “that we are explicitly recommending that people in high-risk categories get screened in primary care,” she said.

NAFLD is “a silent disease ... you could easily have somebody develop cirrhosis,” Dr. Rinella said. By identifying patients earlier, physicians would be able to “prevent or reduce the number of people turning up decompensated or at an advanced stage,” she added.

The other message that Dr. Rinella wants clinicians to take away from the guidance is that “something can be done” for patients with NAFLD. “It’s very common, and the often-cited reason why patients aren’t referred to specialty care is that there’s ‘nothing that can be done.’ ”

Although there is no U.S. Food and Drug Administration–approved drug for NAFLD, clinicians can still support their patients and suggest lifestyle changes, she added.

The guidelines also are designed to prepare the groundwork for novel drugs in the pipeline, as well as discuss those that are already available for conditions such as obesity and diabetes and that benefit people with liver disease, Dr. Rinella said.
 

Screening and evaluation

The guidance covers all aspects of NAFLD, including the latest developments in understanding of the epidemiology and natural history of the disease, and its molecular and cellular pathogenesis.

The guidance continues to recommend against population-based screening for NAFLD. In addition to the aforementioned screening for advanced fibrosis in high-risk individuals, it calls for a primary risk assessment with FIB-4 to be performed every 1-2 years in patients with pre-diabetes, type 2 diabetes, two or more metabolic risk factors, or imaging evidence of hepatic steatosis.

Patients with nonalcoholic steatohepatitis (NASH) cirrhosis require routine monitoring, as they are at the highest risk for liver-related outcomes, the guidance adds. Those with suspected NASH should be referred for evaluation by a specialist.

In assessments of liver fibrosis in patients, findings such as highly elevated liver stiffness, FIB-4, and enhanced liver fibrosis scores can predict an increased risk for hepatic decompensation and mortality, the authors write.
 

Intervention guidance

Patients with NAFLD who are overweight or obese should be prescribed a reduced calorie diet in a multidisciplinary setting because weight loss “improves hepatic steatosis, NASH, and hepatic fibrosis in a dose-dependent manner,” the guidance states.

Bariatric surgery should be considered in appropriate patients because of its effectiveness in resolving NAFLD and NASH in most patients without cirrhosis, the guidance says. However, in patients with well-compensated NASH cirrhosis, the type, safety, and efficacy of bariatric surgery is not established, so a “careful benefit-risk assessment by a multidisciplinary team of experts that includes a hepatologist” is needed, the authors note.

The guidance discusses alcohol consumption’s role in the progression of fatty liver disease and recommends that intake be assessed on a regular basis in patients with NAFLD. Patients with clinically significant hepatic fibrosis should abstain completely, it adds. Abstinence, particularly for patients with moderate to heavy alcohol intake, may lower the risk of fibrosis progression and hepatic and extrahepatic malignancies, the authors note.

Additionally, drinking at least three cups of coffee, caffeinated or not, per day is “associated with less-advanced liver disease,” they write.

The guidance also sets out key considerations for people with comorbid conditions. It states that patients with NAFLD should be screened for type 2 diabetes and that statins can be safely used for cardiovascular risk reduction “across the disease spectrum, including compensated cirrhosis.”

While noting the lack of approved medications for NAFLD, the guidance states that some drugs prescribed for comorbidities also benefit patients with NASH. These are glucagon-like peptide 1 agonist semaglutide, pioglitazone, and vitamin E supplementation in select patients.

Available data on these same drugs, however, do not show an antifibrotic benefit and haven’t been studied in patients with cirrhosis, the guidance states.

Additionally, metformin, ursodeoxycholic acid, dipeptidyl peptidase-4 inhibitors, silymarin, and statins do not offer meaningful histologic benefit and shouldn’t be used as a treatment for NASH.
 

Help against an ‘evolving epidemic’

The guidance is “timely and long awaited,” Jamile Wakim-Fleming, MD, director of the fatty liver disease program at the Cleveland Clinic, said in an interview. NAFLD is an “evolving epidemic,” she added.

Numerous recent studies have “led to new modalities for diagnosis and therapy, and a better understanding” of the epidemiology and pathophysiology of NAFLD, she said. “More specifically, advancements in noninvasive testing, risk stratifications, and therapeutic modalities are now available and worth disseminating.”

NAFLD’s complexity and the lack of an FDA-approved therapy specifically targeting the liver means that managing the disease “requires expertise in multiple disciplines and knowledge of the latest developments,” Dr. Wakim-Fleming noted.

“This guidance describes preventive and treatment strategies for the metabolic conditions associated with NAFLD and is very useful for physicians in different specialties who treat individuals with these conditions,” she said.

No funding was declared. Dr. Rinella and Dr. Wakim-Fleming have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.


The AGA’s Clinical Practice Update on the Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Lean Individuals is available online.

People at high risk for nonalcoholic fatty liver disease (NAFLD), such as those with type 2 diabetes or medically complicated obesity, should be screened for advanced fibrosis, says new guidance from the American Association for the Study of Liver Diseases.

The guidance, published online in Hepatology, also reflects recent advances in the diagnosis and management of NAFLD, particularly noninvasive testing, lead author Mary E. Rinella, MD, University of Chicago, told this news organization.

The “biggest change” from the previous guidance, published 5 years ago, is “that we are explicitly recommending that people in high-risk categories get screened in primary care,” she said.

NAFLD is “a silent disease ... you could easily have somebody develop cirrhosis,” Dr. Rinella said. By identifying patients earlier, physicians would be able to “prevent or reduce the number of people turning up decompensated or at an advanced stage,” she added.

The other message that Dr. Rinella wants clinicians to take away from the guidance is that “something can be done” for patients with NAFLD. “It’s very common, and the often-cited reason why patients aren’t referred to specialty care is that there’s ‘nothing that can be done.’ ”

Although there is no U.S. Food and Drug Administration–approved drug for NAFLD, clinicians can still support their patients and suggest lifestyle changes, she added.

The guidelines also are designed to prepare the groundwork for novel drugs in the pipeline, as well as discuss those that are already available for conditions such as obesity and diabetes and that benefit people with liver disease, Dr. Rinella said.
 

Screening and evaluation

The guidance covers all aspects of NAFLD, including the latest developments in understanding of the epidemiology and natural history of the disease, and its molecular and cellular pathogenesis.

The guidance continues to recommend against population-based screening for NAFLD. In addition to the aforementioned screening for advanced fibrosis in high-risk individuals, it calls for a primary risk assessment with FIB-4 to be performed every 1-2 years in patients with pre-diabetes, type 2 diabetes, two or more metabolic risk factors, or imaging evidence of hepatic steatosis.

Patients with nonalcoholic steatohepatitis (NASH) cirrhosis require routine monitoring, as they are at the highest risk for liver-related outcomes, the guidance adds. Those with suspected NASH should be referred for evaluation by a specialist.

In assessments of liver fibrosis in patients, findings such as highly elevated liver stiffness, FIB-4, and enhanced liver fibrosis scores can predict an increased risk for hepatic decompensation and mortality, the authors write.
 

Intervention guidance

Patients with NAFLD who are overweight or obese should be prescribed a reduced calorie diet in a multidisciplinary setting because weight loss “improves hepatic steatosis, NASH, and hepatic fibrosis in a dose-dependent manner,” the guidance states.

Bariatric surgery should be considered in appropriate patients because of its effectiveness in resolving NAFLD and NASH in most patients without cirrhosis, the guidance says. However, in patients with well-compensated NASH cirrhosis, the type, safety, and efficacy of bariatric surgery is not established, so a “careful benefit-risk assessment by a multidisciplinary team of experts that includes a hepatologist” is needed, the authors note.

The guidance discusses alcohol consumption’s role in the progression of fatty liver disease and recommends that intake be assessed on a regular basis in patients with NAFLD. Patients with clinically significant hepatic fibrosis should abstain completely, it adds. Abstinence, particularly for patients with moderate to heavy alcohol intake, may lower the risk of fibrosis progression and hepatic and extrahepatic malignancies, the authors note.

Additionally, drinking at least three cups of coffee, caffeinated or not, per day is “associated with less-advanced liver disease,” they write.

The guidance also sets out key considerations for people with comorbid conditions. It states that patients with NAFLD should be screened for type 2 diabetes and that statins can be safely used for cardiovascular risk reduction “across the disease spectrum, including compensated cirrhosis.”

While noting the lack of approved medications for NAFLD, the guidance states that some drugs prescribed for comorbidities also benefit patients with NASH. These are glucagon-like peptide 1 agonist semaglutide, pioglitazone, and vitamin E supplementation in select patients.

Available data on these same drugs, however, do not show an antifibrotic benefit and haven’t been studied in patients with cirrhosis, the guidance states.

Additionally, metformin, ursodeoxycholic acid, dipeptidyl peptidase-4 inhibitors, silymarin, and statins do not offer meaningful histologic benefit and shouldn’t be used as a treatment for NASH.
 

Help against an ‘evolving epidemic’

The guidance is “timely and long awaited,” Jamile Wakim-Fleming, MD, director of the fatty liver disease program at the Cleveland Clinic, said in an interview. NAFLD is an “evolving epidemic,” she added.

Numerous recent studies have “led to new modalities for diagnosis and therapy, and a better understanding” of the epidemiology and pathophysiology of NAFLD, she said. “More specifically, advancements in noninvasive testing, risk stratifications, and therapeutic modalities are now available and worth disseminating.”

NAFLD’s complexity and the lack of an FDA-approved therapy specifically targeting the liver means that managing the disease “requires expertise in multiple disciplines and knowledge of the latest developments,” Dr. Wakim-Fleming noted.

“This guidance describes preventive and treatment strategies for the metabolic conditions associated with NAFLD and is very useful for physicians in different specialties who treat individuals with these conditions,” she said.

No funding was declared. Dr. Rinella and Dr. Wakim-Fleming have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.


The AGA’s Clinical Practice Update on the Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Lean Individuals is available online.

Intermittent catheterization every 6 hours in postpartum women with urinary retention may be a better strategy than extended catheterization over 24 hours, a new prospective, randomized, controlled study suggests.

Patients who were catheterized every 6 hours took significantly less time to reach full relief than those who were catheterized for at least 24 hours (mean 10.2 ± 11.8 hours vs. 26.5 ± 9.0 hours, P < .001, respectively), Israeli researchers found. Their research was released at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There was no difference in hospital stay or in the rate of positive urine culture after catheter removal,” said ob.gyn. Dana Vitner, MD, of Rambam Health Care Campus in Haifa, Israel, in a presentation at the conference. “Our conclusion is that intermittent catheterization for postpartum urinary retention results in shorter time to resolution with a higher satisfaction rate and no additional complications.”

The true incidence of postpartum urinary retention is unclear, and estimates vary widely, said ob.gyn. and surgeon Lisa Hickman, MD, of the Ohio State University, Columbus, in an interview. “This is likely because many cases of covert urinary retention – when postpartum women are able to urinate but have incomplete emptying – go undiagnosed unless you are screening for it.”

According to Dr. Hickman, risk factors for postpartum urinary retention include operative vaginal births, having an epidural, obstetric anal sphincter injury, episiotomy, large newborns, first-time births, and prolonged induction of labor. Most cases resolve within 72 hours, she said, but they can lead to rare complications such as bladder injury.

For the new study, researchers defined urinary retention at the bladder holding least 150 mL more than 6 hours after vaginal delivery or removal of an in-dwelling catheter after cesarean delivery. “The treatment is catheterization,” Dr. Vitner said. “However, there is no standard protocol.”

From 2020 to 2022, researchers randomly assigned 73 women to the intermittent catheterization group and 74 to continuous catheterization. The average ages in the groups were 27.7 and 29.1 years, respectively (P = .11) and other characteristics such as body mass index, parity, infant birth weight, and mode of delivery were similar.

Most women in the intermittent catheterization group needed just one catheterization to reach resolution (75.3%); 93.2% had resolution after two, and 95.9% reached it after three. All resolved their urinary retention by 48 hours.

In the continuous catheterization group, 90.5% reached resolution at 24 hours, 97.3% at 48 hours, and 100% at 72 hours. Birth satisfaction scores were higher in the intermittent catheterization group (P < .001).

Dr. Hickman, who did not take part in the study, said the findings are helpful. Randomized, controlled trials are “important to get a better understanding of the natural history of this condition and ways to improve how we manage it clinically,” she said. Should intermittent catheterization become routine? “You need to have the staffing and the resources in order to do that, such as a bladder scanner and intermittent catheterization supplies,” Dr. Hickman said. “It can be time-intensive to continue to follow the patients to make sure they are voiding normally. And there may be many hospitals in the country that just don’t have the resources to do this, especially with all the current workforce issues.”

She added that some patients may not want the intermittent approach: “It can be uncomfortable for patients. They’ve just delivered a baby, they are likely experiencing discomfort from their delivery, and their anatomy can be distorted,” she said. “Some patients may say, ‘I would prefer you not insert a catheter into my bladder every few hours.’ They may just want to rest after having a baby.”

The best approach is to let patients make an informed choice, Dr. Hickman said. She recommended that clinicians say something like, “Because of your delivery, you are not able to empty your bladder all the way. This is typically a self-limited problem, meaning that it will likely resolve within a few days. But in the meantime, we need to let your bladder rest so that it can have time to start functioning on its own.” And then, she said, explain the catheterization options.

Dr. Vitner and Dr. Hickman have no disclosures.
 

Intermittent catheterization every 6 hours in postpartum women with urinary retention may be a better strategy than extended catheterization over 24 hours, a new prospective, randomized, controlled study suggests.

Patients who were catheterized every 6 hours took significantly less time to reach full relief than those who were catheterized for at least 24 hours (mean 10.2 ± 11.8 hours vs. 26.5 ± 9.0 hours, P < .001, respectively), Israeli researchers found. Their research was released at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There was no difference in hospital stay or in the rate of positive urine culture after catheter removal,” said ob.gyn. Dana Vitner, MD, of Rambam Health Care Campus in Haifa, Israel, in a presentation at the conference. “Our conclusion is that intermittent catheterization for postpartum urinary retention results in shorter time to resolution with a higher satisfaction rate and no additional complications.”

The true incidence of postpartum urinary retention is unclear, and estimates vary widely, said ob.gyn. and surgeon Lisa Hickman, MD, of the Ohio State University, Columbus, in an interview. “This is likely because many cases of covert urinary retention – when postpartum women are able to urinate but have incomplete emptying – go undiagnosed unless you are screening for it.”

According to Dr. Hickman, risk factors for postpartum urinary retention include operative vaginal births, having an epidural, obstetric anal sphincter injury, episiotomy, large newborns, first-time births, and prolonged induction of labor. Most cases resolve within 72 hours, she said, but they can lead to rare complications such as bladder injury.

For the new study, researchers defined urinary retention at the bladder holding least 150 mL more than 6 hours after vaginal delivery or removal of an in-dwelling catheter after cesarean delivery. “The treatment is catheterization,” Dr. Vitner said. “However, there is no standard protocol.”

From 2020 to 2022, researchers randomly assigned 73 women to the intermittent catheterization group and 74 to continuous catheterization. The average ages in the groups were 27.7 and 29.1 years, respectively (P = .11) and other characteristics such as body mass index, parity, infant birth weight, and mode of delivery were similar.

Most women in the intermittent catheterization group needed just one catheterization to reach resolution (75.3%); 93.2% had resolution after two, and 95.9% reached it after three. All resolved their urinary retention by 48 hours.

In the continuous catheterization group, 90.5% reached resolution at 24 hours, 97.3% at 48 hours, and 100% at 72 hours. Birth satisfaction scores were higher in the intermittent catheterization group (P < .001).

Dr. Hickman, who did not take part in the study, said the findings are helpful. Randomized, controlled trials are “important to get a better understanding of the natural history of this condition and ways to improve how we manage it clinically,” she said. Should intermittent catheterization become routine? “You need to have the staffing and the resources in order to do that, such as a bladder scanner and intermittent catheterization supplies,” Dr. Hickman said. “It can be time-intensive to continue to follow the patients to make sure they are voiding normally. And there may be many hospitals in the country that just don’t have the resources to do this, especially with all the current workforce issues.”

She added that some patients may not want the intermittent approach: “It can be uncomfortable for patients. They’ve just delivered a baby, they are likely experiencing discomfort from their delivery, and their anatomy can be distorted,” she said. “Some patients may say, ‘I would prefer you not insert a catheter into my bladder every few hours.’ They may just want to rest after having a baby.”

The best approach is to let patients make an informed choice, Dr. Hickman said. She recommended that clinicians say something like, “Because of your delivery, you are not able to empty your bladder all the way. This is typically a self-limited problem, meaning that it will likely resolve within a few days. But in the meantime, we need to let your bladder rest so that it can have time to start functioning on its own.” And then, she said, explain the catheterization options.

Dr. Vitner and Dr. Hickman have no disclosures.
 

Intermittent catheterization every 6 hours in postpartum women with urinary retention may be a better strategy than extended catheterization over 24 hours, a new prospective, randomized, controlled study suggests.

Patients who were catheterized every 6 hours took significantly less time to reach full relief than those who were catheterized for at least 24 hours (mean 10.2 ± 11.8 hours vs. 26.5 ± 9.0 hours, P < .001, respectively), Israeli researchers found. Their research was released at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There was no difference in hospital stay or in the rate of positive urine culture after catheter removal,” said ob.gyn. Dana Vitner, MD, of Rambam Health Care Campus in Haifa, Israel, in a presentation at the conference. “Our conclusion is that intermittent catheterization for postpartum urinary retention results in shorter time to resolution with a higher satisfaction rate and no additional complications.”

The true incidence of postpartum urinary retention is unclear, and estimates vary widely, said ob.gyn. and surgeon Lisa Hickman, MD, of the Ohio State University, Columbus, in an interview. “This is likely because many cases of covert urinary retention – when postpartum women are able to urinate but have incomplete emptying – go undiagnosed unless you are screening for it.”

According to Dr. Hickman, risk factors for postpartum urinary retention include operative vaginal births, having an epidural, obstetric anal sphincter injury, episiotomy, large newborns, first-time births, and prolonged induction of labor. Most cases resolve within 72 hours, she said, but they can lead to rare complications such as bladder injury.

For the new study, researchers defined urinary retention at the bladder holding least 150 mL more than 6 hours after vaginal delivery or removal of an in-dwelling catheter after cesarean delivery. “The treatment is catheterization,” Dr. Vitner said. “However, there is no standard protocol.”

From 2020 to 2022, researchers randomly assigned 73 women to the intermittent catheterization group and 74 to continuous catheterization. The average ages in the groups were 27.7 and 29.1 years, respectively (P = .11) and other characteristics such as body mass index, parity, infant birth weight, and mode of delivery were similar.

Most women in the intermittent catheterization group needed just one catheterization to reach resolution (75.3%); 93.2% had resolution after two, and 95.9% reached it after three. All resolved their urinary retention by 48 hours.

In the continuous catheterization group, 90.5% reached resolution at 24 hours, 97.3% at 48 hours, and 100% at 72 hours. Birth satisfaction scores were higher in the intermittent catheterization group (P < .001).

Dr. Hickman, who did not take part in the study, said the findings are helpful. Randomized, controlled trials are “important to get a better understanding of the natural history of this condition and ways to improve how we manage it clinically,” she said. Should intermittent catheterization become routine? “You need to have the staffing and the resources in order to do that, such as a bladder scanner and intermittent catheterization supplies,” Dr. Hickman said. “It can be time-intensive to continue to follow the patients to make sure they are voiding normally. And there may be many hospitals in the country that just don’t have the resources to do this, especially with all the current workforce issues.”

She added that some patients may not want the intermittent approach: “It can be uncomfortable for patients. They’ve just delivered a baby, they are likely experiencing discomfort from their delivery, and their anatomy can be distorted,” she said. “Some patients may say, ‘I would prefer you not insert a catheter into my bladder every few hours.’ They may just want to rest after having a baby.”

The best approach is to let patients make an informed choice, Dr. Hickman said. She recommended that clinicians say something like, “Because of your delivery, you are not able to empty your bladder all the way. This is typically a self-limited problem, meaning that it will likely resolve within a few days. But in the meantime, we need to let your bladder rest so that it can have time to start functioning on its own.” And then, she said, explain the catheterization options.

Dr. Vitner and Dr. Hickman have no disclosures.
 

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

A version of this article first appeared on Medscape.com.

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

A version of this article first appeared on Medscape.com.

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

A version of this article first appeared on Medscape.com.