Federal Practitioner

TOPLINE:

Exposure to Agent Orange, the defoliant used by the US Air Force during the Vietnam War, was one of the factors associated with increased odds of acral melanoma (AM), a rare melanoma subtype affecting palms, soles, and nail units.

METHODOLOGY:

• Researchers conducted a nested case-control study in the Veterans Affairs healthcare system, and identified 1292 veterans (median age, 70.13 years; 94.0% men; 73.4% White, 14.6% Black) with AM through the Veterans Affairs Cancer Registry and a validated natural language processing pipeline from 2000 to 2024.
• Researchers matched each case of AM to 4 individuals with nonacral cutaneous melanoma (CM) and 4 control individuals without melanoma diagnoses, based on diagnosis year and outpatient visit frequency.
• Exposures included age, sex, race, ethnicity, rurality, region, military branch, comorbidities, smoking status, alcohol use, BMI, Agent Orange exposure, prior photosensitizing medications, nevi, and keratinocyte carcinoma.

TAKEAWAY:

• Veterans exposed to Agent Orange had higher odds of AM than individuals with CM (adjusted odds ratio [AOR], 1.31; 95% CI, 1.06-1.62) and control individuals without melanoma (AOR, 1.27; 95% CI, 1.04-1.56).
• Individuals with current smoking habit had lower odds of AM than those with CM (AOR, 0.65; 95% CI, 0.52-0.81) and control individuals without melanoma (AOR, 0.50; 95% CI, 0.40-0.62).
• Patients with prior keratinocyte carcinoma and actinic keratosis had higher odds of AM than control individuals without melanoma but lower odds than those with CM.
• History of nevus was associated with higher odds of acral melanoma compared with individuals without melanoma (AOR, 2.11; 95% CI, 1.49-2.98).

IN PRACTICE:

“Our results support the need for continued investigation of AM as a distinct entity from CM and may inform future evaluations of the associations between [Agent Orange exposure] in veteran populations, as well as those between other environmental exposures in different populations," the study authors wrote. Referring to the “continued search for a better understanding of a potential link” between Agent Orange and melanoma, as well as AM, and other possible etiologic factors for AM, this study “provides a strong impetus to further these research goals and contribute to the investigation of the legacy of the Vietnam War and honor a commitment to the veterans community,” Andrew F. Olshan, PhD, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, wrote in an accompanying editorial.

SOURCE:

The study was led by Jonathan C. Hwang, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, and was published online on February 4 in JAMA Dermatology.

LIMITATIONS:

The case-control design limits causal inference and the findings might not be generalized outside US veterans. Exposure misclassification could be present.

DISCLOSURES:

The study was supported by the Department of Defense and the Department of Veterans Affairs. Several authors reported receiving grants from CU Anschutz Medical Center, Department of Defense, CDMRP Melanoma Research Program, and Merck, Bayer, and Department of Veteran Affairs. They also reported receiving royalty from UpToDate, and being shareholder in many companies, including Apple. NVIDIA, Amazon, Gilead, AstraZeneca, BioNTech, and Moderna. Olshan declared being a member of the National Academies of Sciences, Engineering, and Medicine Veterans and Agent Orange review committee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Exposure to Agent Orange, the defoliant used by the US Air Force during the Vietnam War, was one of the factors associated with increased odds of acral melanoma (AM), a rare melanoma subtype affecting palms, soles, and nail units.

METHODOLOGY:

• Researchers conducted a nested case-control study in the Veterans Affairs healthcare system, and identified 1292 veterans (median age, 70.13 years; 94.0% men; 73.4% White, 14.6% Black) with AM through the Veterans Affairs Cancer Registry and a validated natural language processing pipeline from 2000 to 2024.
• Researchers matched each case of AM to 4 individuals with nonacral cutaneous melanoma (CM) and 4 control individuals without melanoma diagnoses, based on diagnosis year and outpatient visit frequency.
• Exposures included age, sex, race, ethnicity, rurality, region, military branch, comorbidities, smoking status, alcohol use, BMI, Agent Orange exposure, prior photosensitizing medications, nevi, and keratinocyte carcinoma.

TAKEAWAY:

• Veterans exposed to Agent Orange had higher odds of AM than individuals with CM (adjusted odds ratio [AOR], 1.31; 95% CI, 1.06-1.62) and control individuals without melanoma (AOR, 1.27; 95% CI, 1.04-1.56).
• Individuals with current smoking habit had lower odds of AM than those with CM (AOR, 0.65; 95% CI, 0.52-0.81) and control individuals without melanoma (AOR, 0.50; 95% CI, 0.40-0.62).
• Patients with prior keratinocyte carcinoma and actinic keratosis had higher odds of AM than control individuals without melanoma but lower odds than those with CM.
• History of nevus was associated with higher odds of acral melanoma compared with individuals without melanoma (AOR, 2.11; 95% CI, 1.49-2.98).

IN PRACTICE:

“Our results support the need for continued investigation of AM as a distinct entity from CM and may inform future evaluations of the associations between [Agent Orange exposure] in veteran populations, as well as those between other environmental exposures in different populations," the study authors wrote. Referring to the “continued search for a better understanding of a potential link” between Agent Orange and melanoma, as well as AM, and other possible etiologic factors for AM, this study “provides a strong impetus to further these research goals and contribute to the investigation of the legacy of the Vietnam War and honor a commitment to the veterans community,” Andrew F. Olshan, PhD, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, wrote in an accompanying editorial.

SOURCE:

The study was led by Jonathan C. Hwang, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, and was published online on February 4 in JAMA Dermatology.

LIMITATIONS:

The case-control design limits causal inference and the findings might not be generalized outside US veterans. Exposure misclassification could be present.

DISCLOSURES:

The study was supported by the Department of Defense and the Department of Veterans Affairs. Several authors reported receiving grants from CU Anschutz Medical Center, Department of Defense, CDMRP Melanoma Research Program, and Merck, Bayer, and Department of Veteran Affairs. They also reported receiving royalty from UpToDate, and being shareholder in many companies, including Apple. NVIDIA, Amazon, Gilead, AstraZeneca, BioNTech, and Moderna. Olshan declared being a member of the National Academies of Sciences, Engineering, and Medicine Veterans and Agent Orange review committee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Exposure to Agent Orange, the defoliant used by the US Air Force during the Vietnam War, was one of the factors associated with increased odds of acral melanoma (AM), a rare melanoma subtype affecting palms, soles, and nail units.

METHODOLOGY:

• Researchers conducted a nested case-control study in the Veterans Affairs healthcare system, and identified 1292 veterans (median age, 70.13 years; 94.0% men; 73.4% White, 14.6% Black) with AM through the Veterans Affairs Cancer Registry and a validated natural language processing pipeline from 2000 to 2024.
• Researchers matched each case of AM to 4 individuals with nonacral cutaneous melanoma (CM) and 4 control individuals without melanoma diagnoses, based on diagnosis year and outpatient visit frequency.
• Exposures included age, sex, race, ethnicity, rurality, region, military branch, comorbidities, smoking status, alcohol use, BMI, Agent Orange exposure, prior photosensitizing medications, nevi, and keratinocyte carcinoma.

TAKEAWAY:

• Veterans exposed to Agent Orange had higher odds of AM than individuals with CM (adjusted odds ratio [AOR], 1.31; 95% CI, 1.06-1.62) and control individuals without melanoma (AOR, 1.27; 95% CI, 1.04-1.56).
• Individuals with current smoking habit had lower odds of AM than those with CM (AOR, 0.65; 95% CI, 0.52-0.81) and control individuals without melanoma (AOR, 0.50; 95% CI, 0.40-0.62).
• Patients with prior keratinocyte carcinoma and actinic keratosis had higher odds of AM than control individuals without melanoma but lower odds than those with CM.
• History of nevus was associated with higher odds of acral melanoma compared with individuals without melanoma (AOR, 2.11; 95% CI, 1.49-2.98).

IN PRACTICE:

“Our results support the need for continued investigation of AM as a distinct entity from CM and may inform future evaluations of the associations between [Agent Orange exposure] in veteran populations, as well as those between other environmental exposures in different populations," the study authors wrote. Referring to the “continued search for a better understanding of a potential link” between Agent Orange and melanoma, as well as AM, and other possible etiologic factors for AM, this study “provides a strong impetus to further these research goals and contribute to the investigation of the legacy of the Vietnam War and honor a commitment to the veterans community,” Andrew F. Olshan, PhD, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, wrote in an accompanying editorial.

SOURCE:

The study was led by Jonathan C. Hwang, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, and was published online on February 4 in JAMA Dermatology.

LIMITATIONS:

The case-control design limits causal inference and the findings might not be generalized outside US veterans. Exposure misclassification could be present.

DISCLOSURES:

The study was supported by the Department of Defense and the Department of Veterans Affairs. Several authors reported receiving grants from CU Anschutz Medical Center, Department of Defense, CDMRP Melanoma Research Program, and Merck, Bayer, and Department of Veteran Affairs. They also reported receiving royalty from UpToDate, and being shareholder in many companies, including Apple. NVIDIA, Amazon, Gilead, AstraZeneca, BioNTech, and Moderna. Olshan declared being a member of the National Academies of Sciences, Engineering, and Medicine Veterans and Agent Orange review committee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Among pediatric beneficiaries in the Military Health System (MHS), racial and ethnic disparities in asthma care persisted, with Black children having the highest odds of an asthma diagnosis and emergency department (ED) visit among all racial and ethnic groups.

METHODOLOGY:

• This cross-sectional study examined racial and ethnic differences in asthma prevalence and related outcomes among pediatric beneficiaries in the MHS.
• They included 950,896 dependents aged 2-17 years (50.9% boys) who had ≥ 1 inpatient or outpatient encounter during fiscal year 2023.
• Race and ethnicity were self-reported by the beneficiary and derived from the sponsor’s demographic records.
• An asthma diagnosis required at least one inpatient claim or two outpatient claims with an asthma diagnostic code recorded in the primary or secondary diagnosis field.
• Asthma-related outcomes assessed were potentially avoidable hospitalizations, ED visits, specialist visits, and asthma-related prescriptions.

TAKEAWAY:

• Overall, 3.3% of children had an asthma diagnosis; the prevalence was higher among children aged 5-10 or 11-17 years, boys, and those with 1 or 2 siblings.
• The odds of an asthma diagnosis were significantly higher in all racial and ethnic groups than in White children, and were highest in Black children, who had 85% higher odds across all ages (P < .001).
• Similarly, Black children were 39% more likely than White children to have an asthma-related ED visit; Hispanic children were 36% more likely and Native Hawaiian or Pacific Islander children were 25% more likely (P < .05 for all comparisons).
• Black children also had slightly higher odds of an asthma-related specialist visit than White children, and both Black and Hispanic children were more likely to receive any asthma prescription.

IN PRACTICE:

These results highlighted how access to low-cost or no-cost care, consistent insurance coverage, and effective prescription practices within the MHS may have helped to improve asthma outcomes. Still, the persistence of racial and ethnic disparities pointed to the need for further action. Efforts to close these gaps should include expanding access to culturally responsive care, increasing availability of specialists, and continuing to assess and improve how care is delivered across the system,” the authors wrote.

SOURCE:

This study was led by Felicia Yeboah Denteh, DrPH, MHA, Center for Health Services Research, Uniformed Services University of the Health Sciences, Bethesda, Maryland. It was published online on January 26, 2026, in JAMA Network Open.

LIMITATIONS:

This study used the sponsor’s race and ethnicity as proxies for children’s race and ethnicity, which could have misclassified multiracial children, adopted children, and wards. It also relied on coding in secondary data and did not include factors such as BMI, pollution, and family history.

DISCLOSURES:

This study was funded by the Department of War, Defense Health Agency. The authors did not report any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Among pediatric beneficiaries in the Military Health System (MHS), racial and ethnic disparities in asthma care persisted, with Black children having the highest odds of an asthma diagnosis and emergency department (ED) visit among all racial and ethnic groups.

METHODOLOGY:

• This cross-sectional study examined racial and ethnic differences in asthma prevalence and related outcomes among pediatric beneficiaries in the MHS.
• They included 950,896 dependents aged 2-17 years (50.9% boys) who had ≥ 1 inpatient or outpatient encounter during fiscal year 2023.
• Race and ethnicity were self-reported by the beneficiary and derived from the sponsor’s demographic records.
• An asthma diagnosis required at least one inpatient claim or two outpatient claims with an asthma diagnostic code recorded in the primary or secondary diagnosis field.
• Asthma-related outcomes assessed were potentially avoidable hospitalizations, ED visits, specialist visits, and asthma-related prescriptions.

TAKEAWAY:

• Overall, 3.3% of children had an asthma diagnosis; the prevalence was higher among children aged 5-10 or 11-17 years, boys, and those with 1 or 2 siblings.
• The odds of an asthma diagnosis were significantly higher in all racial and ethnic groups than in White children, and were highest in Black children, who had 85% higher odds across all ages (P < .001).
• Similarly, Black children were 39% more likely than White children to have an asthma-related ED visit; Hispanic children were 36% more likely and Native Hawaiian or Pacific Islander children were 25% more likely (P < .05 for all comparisons).
• Black children also had slightly higher odds of an asthma-related specialist visit than White children, and both Black and Hispanic children were more likely to receive any asthma prescription.

IN PRACTICE:

These results highlighted how access to low-cost or no-cost care, consistent insurance coverage, and effective prescription practices within the MHS may have helped to improve asthma outcomes. Still, the persistence of racial and ethnic disparities pointed to the need for further action. Efforts to close these gaps should include expanding access to culturally responsive care, increasing availability of specialists, and continuing to assess and improve how care is delivered across the system,” the authors wrote.

SOURCE:

This study was led by Felicia Yeboah Denteh, DrPH, MHA, Center for Health Services Research, Uniformed Services University of the Health Sciences, Bethesda, Maryland. It was published online on January 26, 2026, in JAMA Network Open.

LIMITATIONS:

This study used the sponsor’s race and ethnicity as proxies for children’s race and ethnicity, which could have misclassified multiracial children, adopted children, and wards. It also relied on coding in secondary data and did not include factors such as BMI, pollution, and family history.

DISCLOSURES:

This study was funded by the Department of War, Defense Health Agency. The authors did not report any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Among pediatric beneficiaries in the Military Health System (MHS), racial and ethnic disparities in asthma care persisted, with Black children having the highest odds of an asthma diagnosis and emergency department (ED) visit among all racial and ethnic groups.

METHODOLOGY:

• This cross-sectional study examined racial and ethnic differences in asthma prevalence and related outcomes among pediatric beneficiaries in the MHS.
• They included 950,896 dependents aged 2-17 years (50.9% boys) who had ≥ 1 inpatient or outpatient encounter during fiscal year 2023.
• Race and ethnicity were self-reported by the beneficiary and derived from the sponsor’s demographic records.
• An asthma diagnosis required at least one inpatient claim or two outpatient claims with an asthma diagnostic code recorded in the primary or secondary diagnosis field.
• Asthma-related outcomes assessed were potentially avoidable hospitalizations, ED visits, specialist visits, and asthma-related prescriptions.

TAKEAWAY:

• Overall, 3.3% of children had an asthma diagnosis; the prevalence was higher among children aged 5-10 or 11-17 years, boys, and those with 1 or 2 siblings.
• The odds of an asthma diagnosis were significantly higher in all racial and ethnic groups than in White children, and were highest in Black children, who had 85% higher odds across all ages (P < .001).
• Similarly, Black children were 39% more likely than White children to have an asthma-related ED visit; Hispanic children were 36% more likely and Native Hawaiian or Pacific Islander children were 25% more likely (P < .05 for all comparisons).
• Black children also had slightly higher odds of an asthma-related specialist visit than White children, and both Black and Hispanic children were more likely to receive any asthma prescription.

IN PRACTICE:

These results highlighted how access to low-cost or no-cost care, consistent insurance coverage, and effective prescription practices within the MHS may have helped to improve asthma outcomes. Still, the persistence of racial and ethnic disparities pointed to the need for further action. Efforts to close these gaps should include expanding access to culturally responsive care, increasing availability of specialists, and continuing to assess and improve how care is delivered across the system,” the authors wrote.

SOURCE:

This study was led by Felicia Yeboah Denteh, DrPH, MHA, Center for Health Services Research, Uniformed Services University of the Health Sciences, Bethesda, Maryland. It was published online on January 26, 2026, in JAMA Network Open.

LIMITATIONS:

This study used the sponsor’s race and ethnicity as proxies for children’s race and ethnicity, which could have misclassified multiracial children, adopted children, and wards. It also relied on coding in secondary data and did not include factors such as BMI, pollution, and family history.

DISCLOSURES:

This study was funded by the Department of War, Defense Health Agency. The authors did not report any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

A history of tuberculosis (TB) and a history of chronic bronchitis were associated with an increased risk for lung cancer in individuals who had never smoked, whereas asthma had a positive, nonsignificant association overall and a significant association in women.

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis of clinical databases from inception to July 2025, to assess the association between asthma, TB, and/or chronic bronchitis and the risk for lung cancer among participants aged 18 years or older who had never smoked.
• They included data from 20 case-control studies involving 54,135 participants and five cohort studies involving 377,983 participants.
• The primary outcome was the risk for lung cancer among participants with a history of TB, asthma, or chronic bronchitis.
• Participants were labeled as “never smokers” if they were explicitly described in the manuscripts as having “never smoked” or reported smoking < 100 cigarettes in their lifetime.

TAKEAWAY:

• In case-control studies, TB (16 studies) and chronic bronchitis (9 studies) were significantly associated with an increased risk for lung cancer (odds ratio [OR], 1.76; P < .001 and OR, 1.36; P = .012, respectively).
• In four case-cohort studies, TB was associated with an increased but nonsignificant risk for lung cancer (hazard ratio, 1.64).
• Eleven case-control studies demonstrated a positive but nonsignificant association between asthma and the risk for lung cancer (OR, 1.34). However, a significant association emerged when analyses were limited to women (five studies; OR, 1.61; P < .01).

IN PRACTICE:

History of TB was especially associated with increased LC [lung cancer] risk, meriting particular attention for prospective CT screening studies,” the authors of the study wrote.

SOURCE:

This study was led by Nishwant Swami, MD, Hospital of the University of Pennsylvania, Philadelphia. It was published online on January 11, 2026, in Chest.

LIMITATIONS:

Most studies lacked uniform adjustment for key confounders, increasing the risk for residual confounding. The inclusion of few cohort studies in the analysis may have limited the assessment of temporality and precision. Additionally, differences in covariate adjustment, variable definitions, and language restrictions may have limited comparability and generalizability.

DISCLOSURES:

No specific funding was reported for this study. One author reported serving as a consultant or advisor for various companies, including AstraZeneca, Merck, and Pfizer. Another author reported receiving funding, in part, through the Prostate Cancer Foundation Young Investigator Award and through the Cancer Center Support Grant from the National Cancer Institute.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

A history of tuberculosis (TB) and a history of chronic bronchitis were associated with an increased risk for lung cancer in individuals who had never smoked, whereas asthma had a positive, nonsignificant association overall and a significant association in women.

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis of clinical databases from inception to July 2025, to assess the association between asthma, TB, and/or chronic bronchitis and the risk for lung cancer among participants aged 18 years or older who had never smoked.
• They included data from 20 case-control studies involving 54,135 participants and five cohort studies involving 377,983 participants.
• The primary outcome was the risk for lung cancer among participants with a history of TB, asthma, or chronic bronchitis.
• Participants were labeled as “never smokers” if they were explicitly described in the manuscripts as having “never smoked” or reported smoking < 100 cigarettes in their lifetime.

TAKEAWAY:

• In case-control studies, TB (16 studies) and chronic bronchitis (9 studies) were significantly associated with an increased risk for lung cancer (odds ratio [OR], 1.76; P < .001 and OR, 1.36; P = .012, respectively).
• In four case-cohort studies, TB was associated with an increased but nonsignificant risk for lung cancer (hazard ratio, 1.64).
• Eleven case-control studies demonstrated a positive but nonsignificant association between asthma and the risk for lung cancer (OR, 1.34). However, a significant association emerged when analyses were limited to women (five studies; OR, 1.61; P < .01).

IN PRACTICE:

History of TB was especially associated with increased LC [lung cancer] risk, meriting particular attention for prospective CT screening studies,” the authors of the study wrote.

SOURCE:

This study was led by Nishwant Swami, MD, Hospital of the University of Pennsylvania, Philadelphia. It was published online on January 11, 2026, in Chest.

LIMITATIONS:

Most studies lacked uniform adjustment for key confounders, increasing the risk for residual confounding. The inclusion of few cohort studies in the analysis may have limited the assessment of temporality and precision. Additionally, differences in covariate adjustment, variable definitions, and language restrictions may have limited comparability and generalizability.

DISCLOSURES:

No specific funding was reported for this study. One author reported serving as a consultant or advisor for various companies, including AstraZeneca, Merck, and Pfizer. Another author reported receiving funding, in part, through the Prostate Cancer Foundation Young Investigator Award and through the Cancer Center Support Grant from the National Cancer Institute.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

A history of tuberculosis (TB) and a history of chronic bronchitis were associated with an increased risk for lung cancer in individuals who had never smoked, whereas asthma had a positive, nonsignificant association overall and a significant association in women.

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis of clinical databases from inception to July 2025, to assess the association between asthma, TB, and/or chronic bronchitis and the risk for lung cancer among participants aged 18 years or older who had never smoked.
• They included data from 20 case-control studies involving 54,135 participants and five cohort studies involving 377,983 participants.
• The primary outcome was the risk for lung cancer among participants with a history of TB, asthma, or chronic bronchitis.
• Participants were labeled as “never smokers” if they were explicitly described in the manuscripts as having “never smoked” or reported smoking < 100 cigarettes in their lifetime.

TAKEAWAY:

• In case-control studies, TB (16 studies) and chronic bronchitis (9 studies) were significantly associated with an increased risk for lung cancer (odds ratio [OR], 1.76; P < .001 and OR, 1.36; P = .012, respectively).
• In four case-cohort studies, TB was associated with an increased but nonsignificant risk for lung cancer (hazard ratio, 1.64).
• Eleven case-control studies demonstrated a positive but nonsignificant association between asthma and the risk for lung cancer (OR, 1.34). However, a significant association emerged when analyses were limited to women (five studies; OR, 1.61; P < .01).

IN PRACTICE:

History of TB was especially associated with increased LC [lung cancer] risk, meriting particular attention for prospective CT screening studies,” the authors of the study wrote.

SOURCE:

This study was led by Nishwant Swami, MD, Hospital of the University of Pennsylvania, Philadelphia. It was published online on January 11, 2026, in Chest.

LIMITATIONS:

Most studies lacked uniform adjustment for key confounders, increasing the risk for residual confounding. The inclusion of few cohort studies in the analysis may have limited the assessment of temporality and precision. Additionally, differences in covariate adjustment, variable definitions, and language restrictions may have limited comparability and generalizability.

DISCLOSURES:

No specific funding was reported for this study. One author reported serving as a consultant or advisor for various companies, including AstraZeneca, Merck, and Pfizer. Another author reported receiving funding, in part, through the Prostate Cancer Foundation Young Investigator Award and through the Cancer Center Support Grant from the National Cancer Institute.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Healthy donor fecal microbiota transplantation (FMT) combined with immune checkpoint inhibitors (ICI) in metastatic renal cell carcinoma demonstrated safety with a 50% objective response rate and no grade 4-5 toxicities. Successful engraftment of diverse, anti-inflammatory microbiota correlated with improved clinical response and reduced immune-related adverse events.

METHODOLOGY:

• Many patients with metastatic renal cell carcinoma who take ICI experience immune-related adverse events that may require treatment interruption. Recent studies have provided proof of concept for microbiome modulation as a therapeutic adjunct in metastatic renal cell carcinoma, with FMT showing efficacy in resolving TKI-induced toxicities. However, the safety and clinical activity of healthy donor FMT in metastatic renal cell carcinoma remained unexplored, and its mechanism of action was unclear prior to this study.
• The new phase 1 trial enrolled 20 treatment-naive patients with metastatic renal cell carcinoma classified as intermediate-risk or poor-risk disease, who received encapsulated healthy donor FMT (LND101) combined with ipilimumab plus nivolumab (n = 16), pembrolizumab plus axitinib (n = 3), or pembrolizumab plus lenvatinib (n = 1).
• Participants underwent polyethylene glycol bowel preparation before receiving one full dose (36-40 capsules containing 80-100 g of stool) and two half-doses (20-25 capsules each containing 50-60 g of stool) of FMT from rigorously screened healthy donors.
• The primary endpoint was safety assessed through incidence and severity of immune-related adverse events, while secondary endpoints included objective response rate by response evaluation criteria in solid tumors version 1.1, gut microbiome changes, immune correlates, and quality of life.
• Analysis included longitudinal monitoring of stool and blood samples at five timepoints: baseline, week 1 post-FMT, week 4, week 7, and week 10, with a median follow-up of 21.9 months.

TAKEAWAY:

• The safety endpoint was met, with half (10 of 20) of patients experiencing grade 3 immune-related adverse events and no serious FMT-related toxicities or grade 4-5 immune-related adverse events. One patient (5%) reported experiencing an FMT-related grade 1 gastrointestinal event.
• Among evaluable patients (n = 18), the objective response rate was 50% (9 of 18), including two complete responses (11%; 2 of 18), while 67% (12 of 18) achieved clinical benefit defined as complete response, partial response, or stable disease for at least 6 months.
• Higher alpha diversity and greater functional engraftment of short-chain fatty acid-producing and anti-inflammatory taxa correlated with protection from severe immune-related adverse events (P = .041) and improved therapeutic response (P = .006).
• Expansion of Segatella copri above 10 counts per million at 10 weeks post-FMT predicted severe toxicity in patients receiving ipilimumab plus nivolumab, regardless of donor or recipient microbiota origin.

IN PRACTICE:

These findings demonstrate the safety and potential for functional microbiome engraftment to optimize response and minimize toxicity in ICI-treated [metastatic renal cell carcinoma]. Together, our results underscore the importance of functional donor screening and targeted modulation of the microbiome in optimizing the safety and efficacy of next-generation immune-based therapies,” wrote the authors of the study.

SOURCE:

The study was led by Ricardo Fernandes, Behnam Jabbarizadeh, and Adnan Rajeh, London Health Sciences Centre, London, Ontario, Canada. It was published online on January 28 in Nature Medicine.

LIMITATIONS:

According to the authors, the study’s primary limitation was its small sample size, which was not powered to define the ideal donor microbiome composition for enhancing immunotherapy efficacy without additional toxicities. The single-center design and highly selected patient population may limit external generalizability, requiring validation in larger, multicenter trials to refine donor selection criteria and clarify microbiome-immunity mechanisms.

DISCLOSURES:

The clinical trial was primarily funded through philanthropic donations to co-authors Saman Maleki Vareki and Fernandes through the London Health Sciences Foundation clinical trials program. Vareki and Michael Silverman, another co-author, reported having US Patent application no. 63/913,940 related to FMT donor screening. Vareki reported receiving grants from the Lotte and John Hecht Memorial Foundation, the Weston Family Foundation, and the Canadian Institutes of Health Research. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Healthy donor fecal microbiota transplantation (FMT) combined with immune checkpoint inhibitors (ICI) in metastatic renal cell carcinoma demonstrated safety with a 50% objective response rate and no grade 4-5 toxicities. Successful engraftment of diverse, anti-inflammatory microbiota correlated with improved clinical response and reduced immune-related adverse events.

METHODOLOGY:

• Many patients with metastatic renal cell carcinoma who take ICI experience immune-related adverse events that may require treatment interruption. Recent studies have provided proof of concept for microbiome modulation as a therapeutic adjunct in metastatic renal cell carcinoma, with FMT showing efficacy in resolving TKI-induced toxicities. However, the safety and clinical activity of healthy donor FMT in metastatic renal cell carcinoma remained unexplored, and its mechanism of action was unclear prior to this study.
• The new phase 1 trial enrolled 20 treatment-naive patients with metastatic renal cell carcinoma classified as intermediate-risk or poor-risk disease, who received encapsulated healthy donor FMT (LND101) combined with ipilimumab plus nivolumab (n = 16), pembrolizumab plus axitinib (n = 3), or pembrolizumab plus lenvatinib (n = 1).
• Participants underwent polyethylene glycol bowel preparation before receiving one full dose (36-40 capsules containing 80-100 g of stool) and two half-doses (20-25 capsules each containing 50-60 g of stool) of FMT from rigorously screened healthy donors.
• The primary endpoint was safety assessed through incidence and severity of immune-related adverse events, while secondary endpoints included objective response rate by response evaluation criteria in solid tumors version 1.1, gut microbiome changes, immune correlates, and quality of life.
• Analysis included longitudinal monitoring of stool and blood samples at five timepoints: baseline, week 1 post-FMT, week 4, week 7, and week 10, with a median follow-up of 21.9 months.

TAKEAWAY:

• The safety endpoint was met, with half (10 of 20) of patients experiencing grade 3 immune-related adverse events and no serious FMT-related toxicities or grade 4-5 immune-related adverse events. One patient (5%) reported experiencing an FMT-related grade 1 gastrointestinal event.
• Among evaluable patients (n = 18), the objective response rate was 50% (9 of 18), including two complete responses (11%; 2 of 18), while 67% (12 of 18) achieved clinical benefit defined as complete response, partial response, or stable disease for at least 6 months.
• Higher alpha diversity and greater functional engraftment of short-chain fatty acid-producing and anti-inflammatory taxa correlated with protection from severe immune-related adverse events (P = .041) and improved therapeutic response (P = .006).
• Expansion of Segatella copri above 10 counts per million at 10 weeks post-FMT predicted severe toxicity in patients receiving ipilimumab plus nivolumab, regardless of donor or recipient microbiota origin.

IN PRACTICE:

These findings demonstrate the safety and potential for functional microbiome engraftment to optimize response and minimize toxicity in ICI-treated [metastatic renal cell carcinoma]. Together, our results underscore the importance of functional donor screening and targeted modulation of the microbiome in optimizing the safety and efficacy of next-generation immune-based therapies,” wrote the authors of the study.

SOURCE:

The study was led by Ricardo Fernandes, Behnam Jabbarizadeh, and Adnan Rajeh, London Health Sciences Centre, London, Ontario, Canada. It was published online on January 28 in Nature Medicine.

LIMITATIONS:

According to the authors, the study’s primary limitation was its small sample size, which was not powered to define the ideal donor microbiome composition for enhancing immunotherapy efficacy without additional toxicities. The single-center design and highly selected patient population may limit external generalizability, requiring validation in larger, multicenter trials to refine donor selection criteria and clarify microbiome-immunity mechanisms.

DISCLOSURES:

The clinical trial was primarily funded through philanthropic donations to co-authors Saman Maleki Vareki and Fernandes through the London Health Sciences Foundation clinical trials program. Vareki and Michael Silverman, another co-author, reported having US Patent application no. 63/913,940 related to FMT donor screening. Vareki reported receiving grants from the Lotte and John Hecht Memorial Foundation, the Weston Family Foundation, and the Canadian Institutes of Health Research. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Healthy donor fecal microbiota transplantation (FMT) combined with immune checkpoint inhibitors (ICI) in metastatic renal cell carcinoma demonstrated safety with a 50% objective response rate and no grade 4-5 toxicities. Successful engraftment of diverse, anti-inflammatory microbiota correlated with improved clinical response and reduced immune-related adverse events.

METHODOLOGY:

• Many patients with metastatic renal cell carcinoma who take ICI experience immune-related adverse events that may require treatment interruption. Recent studies have provided proof of concept for microbiome modulation as a therapeutic adjunct in metastatic renal cell carcinoma, with FMT showing efficacy in resolving TKI-induced toxicities. However, the safety and clinical activity of healthy donor FMT in metastatic renal cell carcinoma remained unexplored, and its mechanism of action was unclear prior to this study.
• The new phase 1 trial enrolled 20 treatment-naive patients with metastatic renal cell carcinoma classified as intermediate-risk or poor-risk disease, who received encapsulated healthy donor FMT (LND101) combined with ipilimumab plus nivolumab (n = 16), pembrolizumab plus axitinib (n = 3), or pembrolizumab plus lenvatinib (n = 1).
• Participants underwent polyethylene glycol bowel preparation before receiving one full dose (36-40 capsules containing 80-100 g of stool) and two half-doses (20-25 capsules each containing 50-60 g of stool) of FMT from rigorously screened healthy donors.
• The primary endpoint was safety assessed through incidence and severity of immune-related adverse events, while secondary endpoints included objective response rate by response evaluation criteria in solid tumors version 1.1, gut microbiome changes, immune correlates, and quality of life.
• Analysis included longitudinal monitoring of stool and blood samples at five timepoints: baseline, week 1 post-FMT, week 4, week 7, and week 10, with a median follow-up of 21.9 months.

TAKEAWAY:

• The safety endpoint was met, with half (10 of 20) of patients experiencing grade 3 immune-related adverse events and no serious FMT-related toxicities or grade 4-5 immune-related adverse events. One patient (5%) reported experiencing an FMT-related grade 1 gastrointestinal event.
• Among evaluable patients (n = 18), the objective response rate was 50% (9 of 18), including two complete responses (11%; 2 of 18), while 67% (12 of 18) achieved clinical benefit defined as complete response, partial response, or stable disease for at least 6 months.
• Higher alpha diversity and greater functional engraftment of short-chain fatty acid-producing and anti-inflammatory taxa correlated with protection from severe immune-related adverse events (P = .041) and improved therapeutic response (P = .006).
• Expansion of Segatella copri above 10 counts per million at 10 weeks post-FMT predicted severe toxicity in patients receiving ipilimumab plus nivolumab, regardless of donor or recipient microbiota origin.

IN PRACTICE:

These findings demonstrate the safety and potential for functional microbiome engraftment to optimize response and minimize toxicity in ICI-treated [metastatic renal cell carcinoma]. Together, our results underscore the importance of functional donor screening and targeted modulation of the microbiome in optimizing the safety and efficacy of next-generation immune-based therapies,” wrote the authors of the study.

SOURCE:

The study was led by Ricardo Fernandes, Behnam Jabbarizadeh, and Adnan Rajeh, London Health Sciences Centre, London, Ontario, Canada. It was published online on January 28 in Nature Medicine.

LIMITATIONS:

According to the authors, the study’s primary limitation was its small sample size, which was not powered to define the ideal donor microbiome composition for enhancing immunotherapy efficacy without additional toxicities. The single-center design and highly selected patient population may limit external generalizability, requiring validation in larger, multicenter trials to refine donor selection criteria and clarify microbiome-immunity mechanisms.

DISCLOSURES:

The clinical trial was primarily funded through philanthropic donations to co-authors Saman Maleki Vareki and Fernandes through the London Health Sciences Foundation clinical trials program. Vareki and Michael Silverman, another co-author, reported having US Patent application no. 63/913,940 related to FMT donor screening. Vareki reported receiving grants from the Lotte and John Hecht Memorial Foundation, the Weston Family Foundation, and the Canadian Institutes of Health Research. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disorder characterized by painful nodules, abscesses, and tunnels predominantly affecting intertriginous areas of the body.^1,2 The condition poses significant challenges in terms of diagnosis, treatment, and quality of life for affected individuals. Various systemic therapies have been explored to manage this debilitating condition, with the emergence of biologic agents offering hope for improved outcomes. In 2015, adalimumab (ADA) was the first biologic approved by the US Food and Drug Administration (FDA) for the treatment of HS, followed by secukinumab in 2023 and bimekizumab in 2024. However, the off-label use of other biologics and/or tumor necrosis factor inhibitors such as infliximab (IFX) has become common practice.³

Although these therapies have demonstrated promising results in the treatment of HS, their widespread use may be hindered by accessibility and cost barriers. Orenstein et al analyzed data from the IBM Explorys platform from 2015 to 2020 and found that only 1.8% of patients diagnosed with HS had been prescribed ADA or IFX.⁴ More recently, Garg et al examined IBM MarketScan and IBM US Medicaid data from 2015 to 2018 to evaluate trends in clinical care and treatment. The prevalence of ADA and IFX prescriptions among patients with HS ranged from 2.3% to 8.0% (ADA) and 0.7% to 0.9% (IFX) for patients with commercial insurance, and 1.4% to 4.8% (ADA) and 0.5% to 0.7% (IFX) for patients with Medicaid.⁵ Biologics are often expensive, and the high cost associated with these therapies has been identified as a significant barrier to access for patients with HS, particularly those who lack adequate insurance coverage or face financial constraints.⁶

Furthermore, these barriers, particularly the financial barriers, are potentially compounded by the demographics of patients most notably affected by HS. In the US, a disproportionate incidence of HS has been noted in specific groups and age ranges, including women, individuals aged 18 to 29 years, and Black individuals.⁴ Orenstein et al found a statistically significant difference in use of ADA and IFX biologics based on age, sex, and race.⁴

The aim of this study was to examine the use of 2 biologics (ADA and IFX) in the Veterans Health Administration (VHA), a unique population in which financial barriers are reduced due to the single-payer government health care system structure. This design allowed for improved isolation and evaluation of variation in ADA and/or IFX prescription rates by demographics and health-related factors among patients with HS. To our knowledge, no studies have analyzed these metrics within the VHA.

Methods

This retrospective, cross-sectional analysis of VHA patients used data from the US Department of Veterans Affairs (VA) Corporate Data Warehouse, a data repository that provides access to longitudinal national electronic health record data for all veterans receiving care through VHA facilities. This study received ethical approval from institutional review boards at the Minneapolis Veterans Affairs Health Care System and VA Salt Lake City Healthcare System. Patient information was deidentified, and patient consent was not required.

Patients with HS were identified using ≥ 1 International Classification of Diseases (ICD) diagnostic code: (ICD-9 [705.83] or ICD-10 [L73.2]) between January 1, 2011, and December 31, 2021. The study included patients aged ≥ 18 years as of January 1, 2011, with ≥ 2 patient encounters during the postdiagnosis follow-up period, and with ≥ 1 encounter 6 months postindex. Patients with a biologic prescription prior to HS diagnosis were excluded. For this study, the term biologics refers to ADA and/or IFX prescriptions, unless otherwise specified. Only ADA and IFX were included in this analysis because ADA, a tumor necrosis factor (TNF)-á inhibitor, was the only FDA-approved medication at the time of the search, and IFX is another common TNF-α inhibitor used for the treatment of HS.

Statistical Analysis

We calculated logistic regression using SAS 9.4 (SAS Institute, Cary, NC). For each variable, the univariate relationship with biologic prescriptions was examined first, followed by the multivariate relationship controlling for all other variables. The following variables were controlled for in the multivariate models and were chosen a priori: sex, age, race, ethnicity, US region, hospital setting, current or previous tobacco use, obesity (defined as body mass index [BMI] ≥ 30), and Charlson Comorbidity Index (CCI).⁷

Results

Using ICD codes, we identified 29,483 individuals with ≥ 1 HS diagnosis (Figure 1). Of those identified, 1537 patients (5.21%) had been prescribed ≥ 1 biologic. The cohort was predominantly White (60.56%), male (75.27%), obese (59.34%), and had a history of current or previous tobacco use (73.47%) (Table 1). There were significant adjusted differences in prescription rates among veterans with HS based on age, race, and BMI. Notably, there was an age-dependent reduction in the odds of being prescribed a biologic in patients with HS. Compared with patients aged 18 to 44 years, patients aged 45 to 64 years (adjusted odds ratio [aOR], 0.63; 95% CI, 0.54–0.74; P < .001) and patients aged ≥ 65 years (aOR, 0.36; 95% CI, 0.27–0.48; P < .001) had significantly lower odds of receiving a biologic prescription (Table 2). Compared with White patients with HS, Native Hawaiian (NH) or Pacific Islander (PI) patients were less likely to be prescribed a biologic (aOR, 0.23; 95% CI, 0.06–0.92; P = .04). Patients with obesity had significantly higher odds of receiving a biologic prescription compared with patients without obesity (aOR, 1.47; 95% CI, 1.27– 1.71; P < .001).

After adjusting for the variables listed in Table 1, there were no significant differences in biologic prescription rates for men compared with women (aOR, 0.97; 95% CI, 0.83-1.12; P = .68). We observed slight variations in biologic prescriptions between US regions (Midwest 5.0%, East 4.2%, South 5.8%, West 4.6%), none of which were significantly different in the fully adjusted model. No statistically significant differences were found in biologic prescriptions between urban and rural VA settings (5.4% vs 4.8%; aOR, 1.06; 95% CI, 0.90–1.24; P = .47). Tobacco use was not associated with the rate of biologic prescription receipt (aOR, 1.14; 95% CI, 0.97–1.34; P = .11). After adjusting for other variables (as outlined in Table 2), no significant differences were found between CCI of 0 and 1 (aOR, 0.97; 95% CI, 0.82–1.16; P = .77) or between CCI of 0 and 2 (aOR, 0.89; 95% CI, 0.74–1.07; P = .22).⁷

Discussion

The aim of the study was to ascertain potential discrepancies in biologic prescription patterns among patients with HS in the VHA by demographic and lifestyle behavior modifiers. Veteran cohorts are unique in composition, consisting predominantly of older White men within a single-payer health care system. The prevalence of biologic prescriptions in this population was low (5.2%), consistent with prior studies (1.8%–8.9%).^4,5

We found a significant difference in ADA/IFX prescription patterns between White patients and NH/PI patients (aOR, 0.23; 95% CI, 0.06-0.92; P = .04). Further replication of this result is needed due to the small number of NH/PI patients included in the study (n = 241). Notably, we did not find a significant difference in the odds of Black patients being prescribed a biologic compared with White patients (aOR, 1.07; 95% CI, 0.92–1.25; P = .38), consistent with prior studies.⁴

In line with prior studies, age was associated with the likelihood of receiving a biologic prescription.⁴ Using the multivariate model adjusting for variables listed in Table 1, including CCI, patients aged 45 to 64 years and > 64 years were less likely to be prescribed a biologic than patients aged 18 to 44 years. HS disease activity could be a potential confounding variable, as HS severity may subside in some people with increasing age or menopause.⁸

Because different regions in the US have different sociopolitical ideologies and governing legislation, we hypothesized that there may be dissimilarities in the prevalence rates of biologic prescribing across various US regions. However, no significant differences were found in prescription patterns among US regions or between rural and urban settings. Previous research has demonstrated discernible disparities in both dermatologic care and clinical outcomes based on hospital setting (ie, urban vs rural).^9-11

Tobacco use has been demonstrated to be associated with the development of HS.¹² In a large retrospective analysis, Garg et al reported increased odds of receiving a new HS diagnosis in known tobacco users (aOR, 1.9; 95% CI, 1.8–2.0).¹³ The extent to which tobacco use affects HS severity is less understood. While some studies have found an association between smoking and HS severity, other analyses have failed to find this association.^14,15 The effects of smoking cessation on the disease course of HS are unknown.¹⁶ This analysis, found no significant difference in prescriptions for biologics among patients with HS comparing current or previous tobacco users with nonusers.

There is a known positive correlation between increasing BMI and HS prevalence and severity that may be explained by the downstream effects of adipose tissue secretion of proinflammatory mediators and insulin resistance in the setting of chronic inflammation.¹² This analysis found that patients with HS and obesity were 1.47 times more likely to be prescribed a biologic than patients with HS without obesity, which may be confounded by increased HS severity among patients with obesity. The initial concern when analyzing tobacco use and obesity was that clinician bias may result in a decrease in the prevalence of biologic use in these demographics, which was not supported in this study.

Although we identified few disparities, the results demonstrated a substantial underutilization of biologic therapies (5.2%), similar to the other US civilian studies (1.8-8.9%).^4,5 While there is no current universal, standardized severity scoring system to evaluate HS (it is difficult to objectively define moderate to severe HS), estimates have shown that 40.3% to 65.8% of patients with HS have Hurley stage II or III.^17-19 Therefore, only a small percentage of patients with moderate to severe disease were prescribed the only FDA-approved medication during this time period. The persistence of this underutilization within a medical system that reduces financial barriers suggests that nonfinancial barriers have a notable role in the underutilization of biologics.

For instance, risk of adverse events, particularly lymphoma and infection, has been cited by patients as a reason to avoid biologics. Additionally, treatment fatigue reduced some patients’ willingness to try new treatments, as did lack of knowledge about treatment options.^6,20 Other reported barriers included the frequency of injections and fear of needles.⁶ Additionally, within the VA, ADA may require prior authorization at the local facility level.²¹ An established relationship with a dermatologist has been shown to significantly increase the odds of being prescribed a biologic medication in the face of these barriers.⁴ Future system-wide quality improvement initiatives could be implemented to identify patients with HS not followed by dermatology, with the goal of establishing care with a dermatologist.

Limitations

Limitations to this study include an inability to categorize HS disease severity and assess the degree to which disease severity confounded study findings, particularly in relation to tobacco use and obesity. The generalizability of this study is also limited because of the demographic characteristics of the veteran patient population, which is predominantly older, White, and male, whereas HS disproportionately affects younger, Black, and female individuals in the US.²² Despite these limitations, this study contributes valuable insights into the use of biologic therapies for veteran populations with HS using a national dataset.

Conclusions

This study was performed within a single-payer government medical system, likely reducing or removing the financial barriers that some patient populations may face when pursuing biologics for HS treatment. However, the prevalence of biologic use in this population was low overall (5.2%), suggesting that other factors play a role in the underutilization of biologics in HS. Consistent with previous studies, younger individuals were more likely to be prescribed a biologic, and no difference in prescription rates between Black and White patients was observed. Unlike previous studies, no significant difference in prescription rates between men and women was observed.

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disorder characterized by painful nodules, abscesses, and tunnels predominantly affecting intertriginous areas of the body.^1,2 The condition poses significant challenges in terms of diagnosis, treatment, and quality of life for affected individuals. Various systemic therapies have been explored to manage this debilitating condition, with the emergence of biologic agents offering hope for improved outcomes. In 2015, adalimumab (ADA) was the first biologic approved by the US Food and Drug Administration (FDA) for the treatment of HS, followed by secukinumab in 2023 and bimekizumab in 2024. However, the off-label use of other biologics and/or tumor necrosis factor inhibitors such as infliximab (IFX) has become common practice.³

Although these therapies have demonstrated promising results in the treatment of HS, their widespread use may be hindered by accessibility and cost barriers. Orenstein et al analyzed data from the IBM Explorys platform from 2015 to 2020 and found that only 1.8% of patients diagnosed with HS had been prescribed ADA or IFX.⁴ More recently, Garg et al examined IBM MarketScan and IBM US Medicaid data from 2015 to 2018 to evaluate trends in clinical care and treatment. The prevalence of ADA and IFX prescriptions among patients with HS ranged from 2.3% to 8.0% (ADA) and 0.7% to 0.9% (IFX) for patients with commercial insurance, and 1.4% to 4.8% (ADA) and 0.5% to 0.7% (IFX) for patients with Medicaid.⁵ Biologics are often expensive, and the high cost associated with these therapies has been identified as a significant barrier to access for patients with HS, particularly those who lack adequate insurance coverage or face financial constraints.⁶

Furthermore, these barriers, particularly the financial barriers, are potentially compounded by the demographics of patients most notably affected by HS. In the US, a disproportionate incidence of HS has been noted in specific groups and age ranges, including women, individuals aged 18 to 29 years, and Black individuals.⁴ Orenstein et al found a statistically significant difference in use of ADA and IFX biologics based on age, sex, and race.⁴

The aim of this study was to examine the use of 2 biologics (ADA and IFX) in the Veterans Health Administration (VHA), a unique population in which financial barriers are reduced due to the single-payer government health care system structure. This design allowed for improved isolation and evaluation of variation in ADA and/or IFX prescription rates by demographics and health-related factors among patients with HS. To our knowledge, no studies have analyzed these metrics within the VHA.

Methods

This retrospective, cross-sectional analysis of VHA patients used data from the US Department of Veterans Affairs (VA) Corporate Data Warehouse, a data repository that provides access to longitudinal national electronic health record data for all veterans receiving care through VHA facilities. This study received ethical approval from institutional review boards at the Minneapolis Veterans Affairs Health Care System and VA Salt Lake City Healthcare System. Patient information was deidentified, and patient consent was not required.

Patients with HS were identified using ≥ 1 International Classification of Diseases (ICD) diagnostic code: (ICD-9 [705.83] or ICD-10 [L73.2]) between January 1, 2011, and December 31, 2021. The study included patients aged ≥ 18 years as of January 1, 2011, with ≥ 2 patient encounters during the postdiagnosis follow-up period, and with ≥ 1 encounter 6 months postindex. Patients with a biologic prescription prior to HS diagnosis were excluded. For this study, the term biologics refers to ADA and/or IFX prescriptions, unless otherwise specified. Only ADA and IFX were included in this analysis because ADA, a tumor necrosis factor (TNF)-á inhibitor, was the only FDA-approved medication at the time of the search, and IFX is another common TNF-α inhibitor used for the treatment of HS.

Statistical Analysis

We calculated logistic regression using SAS 9.4 (SAS Institute, Cary, NC). For each variable, the univariate relationship with biologic prescriptions was examined first, followed by the multivariate relationship controlling for all other variables. The following variables were controlled for in the multivariate models and were chosen a priori: sex, age, race, ethnicity, US region, hospital setting, current or previous tobacco use, obesity (defined as body mass index [BMI] ≥ 30), and Charlson Comorbidity Index (CCI).⁷

Results

Using ICD codes, we identified 29,483 individuals with ≥ 1 HS diagnosis (Figure 1). Of those identified, 1537 patients (5.21%) had been prescribed ≥ 1 biologic. The cohort was predominantly White (60.56%), male (75.27%), obese (59.34%), and had a history of current or previous tobacco use (73.47%) (Table 1). There were significant adjusted differences in prescription rates among veterans with HS based on age, race, and BMI. Notably, there was an age-dependent reduction in the odds of being prescribed a biologic in patients with HS. Compared with patients aged 18 to 44 years, patients aged 45 to 64 years (adjusted odds ratio [aOR], 0.63; 95% CI, 0.54–0.74; P < .001) and patients aged ≥ 65 years (aOR, 0.36; 95% CI, 0.27–0.48; P < .001) had significantly lower odds of receiving a biologic prescription (Table 2). Compared with White patients with HS, Native Hawaiian (NH) or Pacific Islander (PI) patients were less likely to be prescribed a biologic (aOR, 0.23; 95% CI, 0.06–0.92; P = .04). Patients with obesity had significantly higher odds of receiving a biologic prescription compared with patients without obesity (aOR, 1.47; 95% CI, 1.27– 1.71; P < .001).

After adjusting for the variables listed in Table 1, there were no significant differences in biologic prescription rates for men compared with women (aOR, 0.97; 95% CI, 0.83-1.12; P = .68). We observed slight variations in biologic prescriptions between US regions (Midwest 5.0%, East 4.2%, South 5.8%, West 4.6%), none of which were significantly different in the fully adjusted model. No statistically significant differences were found in biologic prescriptions between urban and rural VA settings (5.4% vs 4.8%; aOR, 1.06; 95% CI, 0.90–1.24; P = .47). Tobacco use was not associated with the rate of biologic prescription receipt (aOR, 1.14; 95% CI, 0.97–1.34; P = .11). After adjusting for other variables (as outlined in Table 2), no significant differences were found between CCI of 0 and 1 (aOR, 0.97; 95% CI, 0.82–1.16; P = .77) or between CCI of 0 and 2 (aOR, 0.89; 95% CI, 0.74–1.07; P = .22).⁷

Discussion

The aim of the study was to ascertain potential discrepancies in biologic prescription patterns among patients with HS in the VHA by demographic and lifestyle behavior modifiers. Veteran cohorts are unique in composition, consisting predominantly of older White men within a single-payer health care system. The prevalence of biologic prescriptions in this population was low (5.2%), consistent with prior studies (1.8%–8.9%).^4,5

We found a significant difference in ADA/IFX prescription patterns between White patients and NH/PI patients (aOR, 0.23; 95% CI, 0.06-0.92; P = .04). Further replication of this result is needed due to the small number of NH/PI patients included in the study (n = 241). Notably, we did not find a significant difference in the odds of Black patients being prescribed a biologic compared with White patients (aOR, 1.07; 95% CI, 0.92–1.25; P = .38), consistent with prior studies.⁴

In line with prior studies, age was associated with the likelihood of receiving a biologic prescription.⁴ Using the multivariate model adjusting for variables listed in Table 1, including CCI, patients aged 45 to 64 years and > 64 years were less likely to be prescribed a biologic than patients aged 18 to 44 years. HS disease activity could be a potential confounding variable, as HS severity may subside in some people with increasing age or menopause.⁸

Because different regions in the US have different sociopolitical ideologies and governing legislation, we hypothesized that there may be dissimilarities in the prevalence rates of biologic prescribing across various US regions. However, no significant differences were found in prescription patterns among US regions or between rural and urban settings. Previous research has demonstrated discernible disparities in both dermatologic care and clinical outcomes based on hospital setting (ie, urban vs rural).^9-11

Tobacco use has been demonstrated to be associated with the development of HS.¹² In a large retrospective analysis, Garg et al reported increased odds of receiving a new HS diagnosis in known tobacco users (aOR, 1.9; 95% CI, 1.8–2.0).¹³ The extent to which tobacco use affects HS severity is less understood. While some studies have found an association between smoking and HS severity, other analyses have failed to find this association.^14,15 The effects of smoking cessation on the disease course of HS are unknown.¹⁶ This analysis, found no significant difference in prescriptions for biologics among patients with HS comparing current or previous tobacco users with nonusers.

There is a known positive correlation between increasing BMI and HS prevalence and severity that may be explained by the downstream effects of adipose tissue secretion of proinflammatory mediators and insulin resistance in the setting of chronic inflammation.¹² This analysis found that patients with HS and obesity were 1.47 times more likely to be prescribed a biologic than patients with HS without obesity, which may be confounded by increased HS severity among patients with obesity. The initial concern when analyzing tobacco use and obesity was that clinician bias may result in a decrease in the prevalence of biologic use in these demographics, which was not supported in this study.

Although we identified few disparities, the results demonstrated a substantial underutilization of biologic therapies (5.2%), similar to the other US civilian studies (1.8-8.9%).^4,5 While there is no current universal, standardized severity scoring system to evaluate HS (it is difficult to objectively define moderate to severe HS), estimates have shown that 40.3% to 65.8% of patients with HS have Hurley stage II or III.^17-19 Therefore, only a small percentage of patients with moderate to severe disease were prescribed the only FDA-approved medication during this time period. The persistence of this underutilization within a medical system that reduces financial barriers suggests that nonfinancial barriers have a notable role in the underutilization of biologics.

For instance, risk of adverse events, particularly lymphoma and infection, has been cited by patients as a reason to avoid biologics. Additionally, treatment fatigue reduced some patients’ willingness to try new treatments, as did lack of knowledge about treatment options.^6,20 Other reported barriers included the frequency of injections and fear of needles.⁶ Additionally, within the VA, ADA may require prior authorization at the local facility level.²¹ An established relationship with a dermatologist has been shown to significantly increase the odds of being prescribed a biologic medication in the face of these barriers.⁴ Future system-wide quality improvement initiatives could be implemented to identify patients with HS not followed by dermatology, with the goal of establishing care with a dermatologist.

Limitations

Limitations to this study include an inability to categorize HS disease severity and assess the degree to which disease severity confounded study findings, particularly in relation to tobacco use and obesity. The generalizability of this study is also limited because of the demographic characteristics of the veteran patient population, which is predominantly older, White, and male, whereas HS disproportionately affects younger, Black, and female individuals in the US.²² Despite these limitations, this study contributes valuable insights into the use of biologic therapies for veteran populations with HS using a national dataset.

Conclusions

This study was performed within a single-payer government medical system, likely reducing or removing the financial barriers that some patient populations may face when pursuing biologics for HS treatment. However, the prevalence of biologic use in this population was low overall (5.2%), suggesting that other factors play a role in the underutilization of biologics in HS. Consistent with previous studies, younger individuals were more likely to be prescribed a biologic, and no difference in prescription rates between Black and White patients was observed. Unlike previous studies, no significant difference in prescription rates between men and women was observed.

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disorder characterized by painful nodules, abscesses, and tunnels predominantly affecting intertriginous areas of the body.^1,2 The condition poses significant challenges in terms of diagnosis, treatment, and quality of life for affected individuals. Various systemic therapies have been explored to manage this debilitating condition, with the emergence of biologic agents offering hope for improved outcomes. In 2015, adalimumab (ADA) was the first biologic approved by the US Food and Drug Administration (FDA) for the treatment of HS, followed by secukinumab in 2023 and bimekizumab in 2024. However, the off-label use of other biologics and/or tumor necrosis factor inhibitors such as infliximab (IFX) has become common practice.³

Although these therapies have demonstrated promising results in the treatment of HS, their widespread use may be hindered by accessibility and cost barriers. Orenstein et al analyzed data from the IBM Explorys platform from 2015 to 2020 and found that only 1.8% of patients diagnosed with HS had been prescribed ADA or IFX.⁴ More recently, Garg et al examined IBM MarketScan and IBM US Medicaid data from 2015 to 2018 to evaluate trends in clinical care and treatment. The prevalence of ADA and IFX prescriptions among patients with HS ranged from 2.3% to 8.0% (ADA) and 0.7% to 0.9% (IFX) for patients with commercial insurance, and 1.4% to 4.8% (ADA) and 0.5% to 0.7% (IFX) for patients with Medicaid.⁵ Biologics are often expensive, and the high cost associated with these therapies has been identified as a significant barrier to access for patients with HS, particularly those who lack adequate insurance coverage or face financial constraints.⁶

Furthermore, these barriers, particularly the financial barriers, are potentially compounded by the demographics of patients most notably affected by HS. In the US, a disproportionate incidence of HS has been noted in specific groups and age ranges, including women, individuals aged 18 to 29 years, and Black individuals.⁴ Orenstein et al found a statistically significant difference in use of ADA and IFX biologics based on age, sex, and race.⁴

The aim of this study was to examine the use of 2 biologics (ADA and IFX) in the Veterans Health Administration (VHA), a unique population in which financial barriers are reduced due to the single-payer government health care system structure. This design allowed for improved isolation and evaluation of variation in ADA and/or IFX prescription rates by demographics and health-related factors among patients with HS. To our knowledge, no studies have analyzed these metrics within the VHA.

Methods

This retrospective, cross-sectional analysis of VHA patients used data from the US Department of Veterans Affairs (VA) Corporate Data Warehouse, a data repository that provides access to longitudinal national electronic health record data for all veterans receiving care through VHA facilities. This study received ethical approval from institutional review boards at the Minneapolis Veterans Affairs Health Care System and VA Salt Lake City Healthcare System. Patient information was deidentified, and patient consent was not required.

Patients with HS were identified using ≥ 1 International Classification of Diseases (ICD) diagnostic code: (ICD-9 [705.83] or ICD-10 [L73.2]) between January 1, 2011, and December 31, 2021. The study included patients aged ≥ 18 years as of January 1, 2011, with ≥ 2 patient encounters during the postdiagnosis follow-up period, and with ≥ 1 encounter 6 months postindex. Patients with a biologic prescription prior to HS diagnosis were excluded. For this study, the term biologics refers to ADA and/or IFX prescriptions, unless otherwise specified. Only ADA and IFX were included in this analysis because ADA, a tumor necrosis factor (TNF)-á inhibitor, was the only FDA-approved medication at the time of the search, and IFX is another common TNF-α inhibitor used for the treatment of HS.

Statistical Analysis

We calculated logistic regression using SAS 9.4 (SAS Institute, Cary, NC). For each variable, the univariate relationship with biologic prescriptions was examined first, followed by the multivariate relationship controlling for all other variables. The following variables were controlled for in the multivariate models and were chosen a priori: sex, age, race, ethnicity, US region, hospital setting, current or previous tobacco use, obesity (defined as body mass index [BMI] ≥ 30), and Charlson Comorbidity Index (CCI).⁷

Results

Using ICD codes, we identified 29,483 individuals with ≥ 1 HS diagnosis (Figure 1). Of those identified, 1537 patients (5.21%) had been prescribed ≥ 1 biologic. The cohort was predominantly White (60.56%), male (75.27%), obese (59.34%), and had a history of current or previous tobacco use (73.47%) (Table 1). There were significant adjusted differences in prescription rates among veterans with HS based on age, race, and BMI. Notably, there was an age-dependent reduction in the odds of being prescribed a biologic in patients with HS. Compared with patients aged 18 to 44 years, patients aged 45 to 64 years (adjusted odds ratio [aOR], 0.63; 95% CI, 0.54–0.74; P < .001) and patients aged ≥ 65 years (aOR, 0.36; 95% CI, 0.27–0.48; P < .001) had significantly lower odds of receiving a biologic prescription (Table 2). Compared with White patients with HS, Native Hawaiian (NH) or Pacific Islander (PI) patients were less likely to be prescribed a biologic (aOR, 0.23; 95% CI, 0.06–0.92; P = .04). Patients with obesity had significantly higher odds of receiving a biologic prescription compared with patients without obesity (aOR, 1.47; 95% CI, 1.27– 1.71; P < .001).

After adjusting for the variables listed in Table 1, there were no significant differences in biologic prescription rates for men compared with women (aOR, 0.97; 95% CI, 0.83-1.12; P = .68). We observed slight variations in biologic prescriptions between US regions (Midwest 5.0%, East 4.2%, South 5.8%, West 4.6%), none of which were significantly different in the fully adjusted model. No statistically significant differences were found in biologic prescriptions between urban and rural VA settings (5.4% vs 4.8%; aOR, 1.06; 95% CI, 0.90–1.24; P = .47). Tobacco use was not associated with the rate of biologic prescription receipt (aOR, 1.14; 95% CI, 0.97–1.34; P = .11). After adjusting for other variables (as outlined in Table 2), no significant differences were found between CCI of 0 and 1 (aOR, 0.97; 95% CI, 0.82–1.16; P = .77) or between CCI of 0 and 2 (aOR, 0.89; 95% CI, 0.74–1.07; P = .22).⁷

Discussion

The aim of the study was to ascertain potential discrepancies in biologic prescription patterns among patients with HS in the VHA by demographic and lifestyle behavior modifiers. Veteran cohorts are unique in composition, consisting predominantly of older White men within a single-payer health care system. The prevalence of biologic prescriptions in this population was low (5.2%), consistent with prior studies (1.8%–8.9%).^4,5

We found a significant difference in ADA/IFX prescription patterns between White patients and NH/PI patients (aOR, 0.23; 95% CI, 0.06-0.92; P = .04). Further replication of this result is needed due to the small number of NH/PI patients included in the study (n = 241). Notably, we did not find a significant difference in the odds of Black patients being prescribed a biologic compared with White patients (aOR, 1.07; 95% CI, 0.92–1.25; P = .38), consistent with prior studies.⁴

In line with prior studies, age was associated with the likelihood of receiving a biologic prescription.⁴ Using the multivariate model adjusting for variables listed in Table 1, including CCI, patients aged 45 to 64 years and > 64 years were less likely to be prescribed a biologic than patients aged 18 to 44 years. HS disease activity could be a potential confounding variable, as HS severity may subside in some people with increasing age or menopause.⁸

Because different regions in the US have different sociopolitical ideologies and governing legislation, we hypothesized that there may be dissimilarities in the prevalence rates of biologic prescribing across various US regions. However, no significant differences were found in prescription patterns among US regions or between rural and urban settings. Previous research has demonstrated discernible disparities in both dermatologic care and clinical outcomes based on hospital setting (ie, urban vs rural).^9-11

Tobacco use has been demonstrated to be associated with the development of HS.¹² In a large retrospective analysis, Garg et al reported increased odds of receiving a new HS diagnosis in known tobacco users (aOR, 1.9; 95% CI, 1.8–2.0).¹³ The extent to which tobacco use affects HS severity is less understood. While some studies have found an association between smoking and HS severity, other analyses have failed to find this association.^14,15 The effects of smoking cessation on the disease course of HS are unknown.¹⁶ This analysis, found no significant difference in prescriptions for biologics among patients with HS comparing current or previous tobacco users with nonusers.

There is a known positive correlation between increasing BMI and HS prevalence and severity that may be explained by the downstream effects of adipose tissue secretion of proinflammatory mediators and insulin resistance in the setting of chronic inflammation.¹² This analysis found that patients with HS and obesity were 1.47 times more likely to be prescribed a biologic than patients with HS without obesity, which may be confounded by increased HS severity among patients with obesity. The initial concern when analyzing tobacco use and obesity was that clinician bias may result in a decrease in the prevalence of biologic use in these demographics, which was not supported in this study.

Although we identified few disparities, the results demonstrated a substantial underutilization of biologic therapies (5.2%), similar to the other US civilian studies (1.8-8.9%).^4,5 While there is no current universal, standardized severity scoring system to evaluate HS (it is difficult to objectively define moderate to severe HS), estimates have shown that 40.3% to 65.8% of patients with HS have Hurley stage II or III.^17-19 Therefore, only a small percentage of patients with moderate to severe disease were prescribed the only FDA-approved medication during this time period. The persistence of this underutilization within a medical system that reduces financial barriers suggests that nonfinancial barriers have a notable role in the underutilization of biologics.

For instance, risk of adverse events, particularly lymphoma and infection, has been cited by patients as a reason to avoid biologics. Additionally, treatment fatigue reduced some patients’ willingness to try new treatments, as did lack of knowledge about treatment options.^6,20 Other reported barriers included the frequency of injections and fear of needles.⁶ Additionally, within the VA, ADA may require prior authorization at the local facility level.²¹ An established relationship with a dermatologist has been shown to significantly increase the odds of being prescribed a biologic medication in the face of these barriers.⁴ Future system-wide quality improvement initiatives could be implemented to identify patients with HS not followed by dermatology, with the goal of establishing care with a dermatologist.

Limitations

Limitations to this study include an inability to categorize HS disease severity and assess the degree to which disease severity confounded study findings, particularly in relation to tobacco use and obesity. The generalizability of this study is also limited because of the demographic characteristics of the veteran patient population, which is predominantly older, White, and male, whereas HS disproportionately affects younger, Black, and female individuals in the US.²² Despite these limitations, this study contributes valuable insights into the use of biologic therapies for veteran populations with HS using a national dataset.

Conclusions

This study was performed within a single-payer government medical system, likely reducing or removing the financial barriers that some patient populations may face when pursuing biologics for HS treatment. However, the prevalence of biologic use in this population was low overall (5.2%), suggesting that other factors play a role in the underutilization of biologics in HS. Consistent with previous studies, younger individuals were more likely to be prescribed a biologic, and no difference in prescription rates between Black and White patients was observed. Unlike previous studies, no significant difference in prescription rates between men and women was observed.

TOPLINE:

An artificial intelligence (AI) model, developed using stool images, accurately assessed whether a patient’s bowel preparation was sufficient for colonoscopy. The best version of the model achieved an area under the receiver operating characteristic curve (AUC) of 0.95, accuracy of 0.90, sensitivity of 0.93, and specificity of 0.86.

METHODOLOGY:

• Patients often need help during bowel preparation for colonoscopy, which increases staff workload; up to 20%-25% of colonoscopies are reported to be inadequately prepared. Researchers developed and tested an AI tool (AI-PREPOO) using stool images to assess whether patients were ready for colonoscopy.
• They conducted a multicenter observational study in Japan between 2022 and 2023 that included 37 patients scheduled for colonoscopy (median age, 57 years; 45.9% women).
• After starting consumption of a 2-liter polyethylene glycol solution, patients used smartphones to take photos of their stool in the toilet after each bowel movement and uploaded the images to a secure web server.
• The images were divided into training and test sets. Images were classified as “ready” for colonoscopy when the stool was clear or light yellow and watery with no solid content.
• Four image-recognition models based on different deep learning architectures were developed using transfer learning to classify readiness for colonoscopy.

TAKEAWAY:

• Researchers collected 282 stool images, with 141 classified as ready and 141 as not ready. Of these, 224 images were used for training (the number augmented to 2240 images) and 58 for testing.
• All four AI-PREPOO models showed high performance, with AUCs ranging from 0.92 to 0.95; pairwise differences in AUCs were not significant.
• The AI-PREPOO 1 model, based on the MobileNetV3-Small architecture, showed the most balanced performance, with an AUC of 0.95, accuracy of 0.90, sensitivity of 0.93, and specificity of 0.86 on the test set.
• During colonoscopy, all patients had a Boston Bowel Preparation Scale score of 6 or higher, indicating that “ready” images corresponded to an adequately prepared bowel.

IN PRACTICE:

“If implemented as a mobile application, our model would allow patients to quickly and independently assess bowel preparation adequacy, reducing reliance on nurses and alleviating embarrassment associated with sharing stool images. This approach could also lessen nurses’ workload by minimizing unnecessary inquiries and preventing excessive or insufficient bowel preparation due to uncertainty,” the authors wrote.

SOURCE:

This study was led by Kosuke Kojima, Graduate School of Medical and Dental Sciences, Niigata University in Niigata, Japan. It was published online in the Journal of Gastroenterology and Hepatology.

LIMITATIONS:

The small dataset limited generalizability and increased the risk for overfitting. In real-world practice, stool images might vary in lighting, angle, focus, zoom, and background; thus, a larger and more diverse dataset was needed. The model lacked external validation in an independent or prospective cohort.

DISCLOSURES:

This study received support from the Japanese Foundation for Research and Promotion of Endoscopy. The authors reported having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

An artificial intelligence (AI) model, developed using stool images, accurately assessed whether a patient’s bowel preparation was sufficient for colonoscopy. The best version of the model achieved an area under the receiver operating characteristic curve (AUC) of 0.95, accuracy of 0.90, sensitivity of 0.93, and specificity of 0.86.

METHODOLOGY:

• Patients often need help during bowel preparation for colonoscopy, which increases staff workload; up to 20%-25% of colonoscopies are reported to be inadequately prepared. Researchers developed and tested an AI tool (AI-PREPOO) using stool images to assess whether patients were ready for colonoscopy.
• They conducted a multicenter observational study in Japan between 2022 and 2023 that included 37 patients scheduled for colonoscopy (median age, 57 years; 45.9% women).
• After starting consumption of a 2-liter polyethylene glycol solution, patients used smartphones to take photos of their stool in the toilet after each bowel movement and uploaded the images to a secure web server.
• The images were divided into training and test sets. Images were classified as “ready” for colonoscopy when the stool was clear or light yellow and watery with no solid content.
• Four image-recognition models based on different deep learning architectures were developed using transfer learning to classify readiness for colonoscopy.

TAKEAWAY:

• Researchers collected 282 stool images, with 141 classified as ready and 141 as not ready. Of these, 224 images were used for training (the number augmented to 2240 images) and 58 for testing.
• All four AI-PREPOO models showed high performance, with AUCs ranging from 0.92 to 0.95; pairwise differences in AUCs were not significant.
• The AI-PREPOO 1 model, based on the MobileNetV3-Small architecture, showed the most balanced performance, with an AUC of 0.95, accuracy of 0.90, sensitivity of 0.93, and specificity of 0.86 on the test set.
• During colonoscopy, all patients had a Boston Bowel Preparation Scale score of 6 or higher, indicating that “ready” images corresponded to an adequately prepared bowel.

IN PRACTICE:

“If implemented as a mobile application, our model would allow patients to quickly and independently assess bowel preparation adequacy, reducing reliance on nurses and alleviating embarrassment associated with sharing stool images. This approach could also lessen nurses’ workload by minimizing unnecessary inquiries and preventing excessive or insufficient bowel preparation due to uncertainty,” the authors wrote.

SOURCE:

This study was led by Kosuke Kojima, Graduate School of Medical and Dental Sciences, Niigata University in Niigata, Japan. It was published online in the Journal of Gastroenterology and Hepatology.

LIMITATIONS:

The small dataset limited generalizability and increased the risk for overfitting. In real-world practice, stool images might vary in lighting, angle, focus, zoom, and background; thus, a larger and more diverse dataset was needed. The model lacked external validation in an independent or prospective cohort.

DISCLOSURES:

This study received support from the Japanese Foundation for Research and Promotion of Endoscopy. The authors reported having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

An artificial intelligence (AI) model, developed using stool images, accurately assessed whether a patient’s bowel preparation was sufficient for colonoscopy. The best version of the model achieved an area under the receiver operating characteristic curve (AUC) of 0.95, accuracy of 0.90, sensitivity of 0.93, and specificity of 0.86.

METHODOLOGY:

• Patients often need help during bowel preparation for colonoscopy, which increases staff workload; up to 20%-25% of colonoscopies are reported to be inadequately prepared. Researchers developed and tested an AI tool (AI-PREPOO) using stool images to assess whether patients were ready for colonoscopy.
• They conducted a multicenter observational study in Japan between 2022 and 2023 that included 37 patients scheduled for colonoscopy (median age, 57 years; 45.9% women).
• After starting consumption of a 2-liter polyethylene glycol solution, patients used smartphones to take photos of their stool in the toilet after each bowel movement and uploaded the images to a secure web server.
• The images were divided into training and test sets. Images were classified as “ready” for colonoscopy when the stool was clear or light yellow and watery with no solid content.
• Four image-recognition models based on different deep learning architectures were developed using transfer learning to classify readiness for colonoscopy.

TAKEAWAY:

• Researchers collected 282 stool images, with 141 classified as ready and 141 as not ready. Of these, 224 images were used for training (the number augmented to 2240 images) and 58 for testing.
• All four AI-PREPOO models showed high performance, with AUCs ranging from 0.92 to 0.95; pairwise differences in AUCs were not significant.
• The AI-PREPOO 1 model, based on the MobileNetV3-Small architecture, showed the most balanced performance, with an AUC of 0.95, accuracy of 0.90, sensitivity of 0.93, and specificity of 0.86 on the test set.
• During colonoscopy, all patients had a Boston Bowel Preparation Scale score of 6 or higher, indicating that “ready” images corresponded to an adequately prepared bowel.

IN PRACTICE:

“If implemented as a mobile application, our model would allow patients to quickly and independently assess bowel preparation adequacy, reducing reliance on nurses and alleviating embarrassment associated with sharing stool images. This approach could also lessen nurses’ workload by minimizing unnecessary inquiries and preventing excessive or insufficient bowel preparation due to uncertainty,” the authors wrote.

SOURCE:

This study was led by Kosuke Kojima, Graduate School of Medical and Dental Sciences, Niigata University in Niigata, Japan. It was published online in the Journal of Gastroenterology and Hepatology.

LIMITATIONS:

The small dataset limited generalizability and increased the risk for overfitting. In real-world practice, stool images might vary in lighting, angle, focus, zoom, and background; thus, a larger and more diverse dataset was needed. The model lacked external validation in an independent or prospective cohort.

DISCLOSURES:

This study received support from the Japanese Foundation for Research and Promotion of Endoscopy. The authors reported having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

France has authorized Ricimed, the first antibody-based treatment specifically indicated for acute ricin intoxication, providing clinicians with a targeted option beyond supportive care for exposure to one of the most lethal naturally occurring toxins.

Fabentech is a French biopharmaceutical company specializing in medical countermeasures against biological threats and infectious diseases.

The polyclonal antibody technology used in the development of Ricimed has received marketing authorization in France as a treatment for ricin poisoning. Ricin is a highly toxic natural substance that can cause death within hours to a few days of exposure.

Supported by the Ministry of Armed Forces and Veterans Affairs (Directorate General of Armaments [DGA] and Armed Forces Health Service) in France, Ricimed is the first approved antidote for ricin poisoning, a condition for which treatment was previously limited to supportive measures alone.

Historical Incident

One incident, in particular, remains etched in espionage history. On September 7, 1978 in London during the Cold War, Bulgarian dissident writer Georgi Markov, living in exile, was struck by the umbrella of a passer-by while waiting at a bus stop. He felt a slight sting. Four days later, he died in the hospital due to a sudden and unexplained illness. An autopsy revealed that he had been poisoned by a tiny metal pellet implanted at the tip of an umbrella containing ricin, a lethal toxin. The legend of the “Bulgarian umbrella,” later invoked in other assassination attempts, was born.

Since then, although Markov remains the only known individual to have been killed by ricin poisoning, this theoretically extremely toxic substance, which can be manufactured relatively easily from castor beans, a widely available plant, has continued to fascinate authors of thrillers and spy novels.

Numerous works of fiction depict characters who succumb to ricin poisoning. The toxin is notably portrayed as a favored weapon of the main character in the hit television series Breaking Bad.

However, ricin is not confined to the realm of science fiction. For several years, authorities in various countries have feared that extremist groups could carry out attacks using ricin. The threat has been taken particularly seriously since 2018, when a clandestine ricin laboratory operated by members of the Islamic State was dismantled in Germany. Since then, several similar attack plots have been thwarted.

This context triggered a race among major powers to develop an effective antidote as quickly as possible. In this effort, Fabentech has risen to a challenge.

“Having demonstrated its ability to target and then neutralize ricin before it causes irreparable damage, Ricimed is a treatment that works based on polyclonal antibodies and compensates for the absence of a vaccine or specific treatment,” Fabentech said in a press release.

The polyclonal antibody technology used by Fabentech offers potential for the development of antidotes against bioterrorist attacks and for the treatment of many infectious diseases.

Ricimed contributed to the deployment of a European health shield against intentional biological threats in France.

Military Backing

Speaking to Le Figaro, France’s oldest national newspaper, Fabentech CEO Sébastien Iva explained that ricin disrupts the body by halting cell function, while noting several other drug candidates in development at the firm.

Typically, the lungs sustain fatal damage. Our treatment interrupts this toxic process. In animals administered the antidote, we observed pulmonary function recovery, allowing survival.

Given that the possibility of terrorist attacks using ricin is considered a national security issue, Fabentech benefited from the support by the Ministry of the Armed Forces and the DGA and lasted nearly a decade of research and development work.

The granting of marketing authorisation was also supported by the French Armed Forces and welcomed by the French Minister of the Armed Forces, Catherine Vautrin, who previously served as France’s Minister of Labour, Health, and Solidarity.

“Supporting the development of companies in France capable of manufacturing antidotes against certain biological agents helps guarantee the operational superiority of our armed forces. Developing and producing such drugs when they do not yet exist on the market is also serving the nation and the public interest,” she said.

Although the threat posed by ricin remains hypothetical, Fabentech reports a strong interest from potential clients, with many countries seeking protection against possible bioterrorist attacks.

The DGA had already placed an order for several doses of Ricimed for deployment in France. For optimal effectiveness, the antidote must be administered within 6 hours of poisoning. Iva confirmed that multiple countries had already expressed interest in acquiring the antidote.

This story was translated from JIM, part of the Medscape Professional Network.

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

France has authorized Ricimed, the first antibody-based treatment specifically indicated for acute ricin intoxication, providing clinicians with a targeted option beyond supportive care for exposure to one of the most lethal naturally occurring toxins.

Fabentech is a French biopharmaceutical company specializing in medical countermeasures against biological threats and infectious diseases.

The polyclonal antibody technology used in the development of Ricimed has received marketing authorization in France as a treatment for ricin poisoning. Ricin is a highly toxic natural substance that can cause death within hours to a few days of exposure.

Supported by the Ministry of Armed Forces and Veterans Affairs (Directorate General of Armaments [DGA] and Armed Forces Health Service) in France, Ricimed is the first approved antidote for ricin poisoning, a condition for which treatment was previously limited to supportive measures alone.

Historical Incident

One incident, in particular, remains etched in espionage history. On September 7, 1978 in London during the Cold War, Bulgarian dissident writer Georgi Markov, living in exile, was struck by the umbrella of a passer-by while waiting at a bus stop. He felt a slight sting. Four days later, he died in the hospital due to a sudden and unexplained illness. An autopsy revealed that he had been poisoned by a tiny metal pellet implanted at the tip of an umbrella containing ricin, a lethal toxin. The legend of the “Bulgarian umbrella,” later invoked in other assassination attempts, was born.

Since then, although Markov remains the only known individual to have been killed by ricin poisoning, this theoretically extremely toxic substance, which can be manufactured relatively easily from castor beans, a widely available plant, has continued to fascinate authors of thrillers and spy novels.

Numerous works of fiction depict characters who succumb to ricin poisoning. The toxin is notably portrayed as a favored weapon of the main character in the hit television series Breaking Bad.

However, ricin is not confined to the realm of science fiction. For several years, authorities in various countries have feared that extremist groups could carry out attacks using ricin. The threat has been taken particularly seriously since 2018, when a clandestine ricin laboratory operated by members of the Islamic State was dismantled in Germany. Since then, several similar attack plots have been thwarted.

This context triggered a race among major powers to develop an effective antidote as quickly as possible. In this effort, Fabentech has risen to a challenge.

“Having demonstrated its ability to target and then neutralize ricin before it causes irreparable damage, Ricimed is a treatment that works based on polyclonal antibodies and compensates for the absence of a vaccine or specific treatment,” Fabentech said in a press release.

The polyclonal antibody technology used by Fabentech offers potential for the development of antidotes against bioterrorist attacks and for the treatment of many infectious diseases.

Ricimed contributed to the deployment of a European health shield against intentional biological threats in France.

Military Backing

Speaking to Le Figaro, France’s oldest national newspaper, Fabentech CEO Sébastien Iva explained that ricin disrupts the body by halting cell function, while noting several other drug candidates in development at the firm.

Typically, the lungs sustain fatal damage. Our treatment interrupts this toxic process. In animals administered the antidote, we observed pulmonary function recovery, allowing survival.

Given that the possibility of terrorist attacks using ricin is considered a national security issue, Fabentech benefited from the support by the Ministry of the Armed Forces and the DGA and lasted nearly a decade of research and development work.

The granting of marketing authorisation was also supported by the French Armed Forces and welcomed by the French Minister of the Armed Forces, Catherine Vautrin, who previously served as France’s Minister of Labour, Health, and Solidarity.

“Supporting the development of companies in France capable of manufacturing antidotes against certain biological agents helps guarantee the operational superiority of our armed forces. Developing and producing such drugs when they do not yet exist on the market is also serving the nation and the public interest,” she said.

Although the threat posed by ricin remains hypothetical, Fabentech reports a strong interest from potential clients, with many countries seeking protection against possible bioterrorist attacks.

The DGA had already placed an order for several doses of Ricimed for deployment in France. For optimal effectiveness, the antidote must be administered within 6 hours of poisoning. Iva confirmed that multiple countries had already expressed interest in acquiring the antidote.

This story was translated from JIM, part of the Medscape Professional Network.

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

France has authorized Ricimed, the first antibody-based treatment specifically indicated for acute ricin intoxication, providing clinicians with a targeted option beyond supportive care for exposure to one of the most lethal naturally occurring toxins.

Fabentech is a French biopharmaceutical company specializing in medical countermeasures against biological threats and infectious diseases.

The polyclonal antibody technology used in the development of Ricimed has received marketing authorization in France as a treatment for ricin poisoning. Ricin is a highly toxic natural substance that can cause death within hours to a few days of exposure.

Supported by the Ministry of Armed Forces and Veterans Affairs (Directorate General of Armaments [DGA] and Armed Forces Health Service) in France, Ricimed is the first approved antidote for ricin poisoning, a condition for which treatment was previously limited to supportive measures alone.

Historical Incident

One incident, in particular, remains etched in espionage history. On September 7, 1978 in London during the Cold War, Bulgarian dissident writer Georgi Markov, living in exile, was struck by the umbrella of a passer-by while waiting at a bus stop. He felt a slight sting. Four days later, he died in the hospital due to a sudden and unexplained illness. An autopsy revealed that he had been poisoned by a tiny metal pellet implanted at the tip of an umbrella containing ricin, a lethal toxin. The legend of the “Bulgarian umbrella,” later invoked in other assassination attempts, was born.

Since then, although Markov remains the only known individual to have been killed by ricin poisoning, this theoretically extremely toxic substance, which can be manufactured relatively easily from castor beans, a widely available plant, has continued to fascinate authors of thrillers and spy novels.

Numerous works of fiction depict characters who succumb to ricin poisoning. The toxin is notably portrayed as a favored weapon of the main character in the hit television series Breaking Bad.

However, ricin is not confined to the realm of science fiction. For several years, authorities in various countries have feared that extremist groups could carry out attacks using ricin. The threat has been taken particularly seriously since 2018, when a clandestine ricin laboratory operated by members of the Islamic State was dismantled in Germany. Since then, several similar attack plots have been thwarted.

This context triggered a race among major powers to develop an effective antidote as quickly as possible. In this effort, Fabentech has risen to a challenge.

“Having demonstrated its ability to target and then neutralize ricin before it causes irreparable damage, Ricimed is a treatment that works based on polyclonal antibodies and compensates for the absence of a vaccine or specific treatment,” Fabentech said in a press release.

The polyclonal antibody technology used by Fabentech offers potential for the development of antidotes against bioterrorist attacks and for the treatment of many infectious diseases.

Ricimed contributed to the deployment of a European health shield against intentional biological threats in France.

Military Backing

Speaking to Le Figaro, France’s oldest national newspaper, Fabentech CEO Sébastien Iva explained that ricin disrupts the body by halting cell function, while noting several other drug candidates in development at the firm.

Typically, the lungs sustain fatal damage. Our treatment interrupts this toxic process. In animals administered the antidote, we observed pulmonary function recovery, allowing survival.

Given that the possibility of terrorist attacks using ricin is considered a national security issue, Fabentech benefited from the support by the Ministry of the Armed Forces and the DGA and lasted nearly a decade of research and development work.

The granting of marketing authorisation was also supported by the French Armed Forces and welcomed by the French Minister of the Armed Forces, Catherine Vautrin, who previously served as France’s Minister of Labour, Health, and Solidarity.

“Supporting the development of companies in France capable of manufacturing antidotes against certain biological agents helps guarantee the operational superiority of our armed forces. Developing and producing such drugs when they do not yet exist on the market is also serving the nation and the public interest,” she said.

Although the threat posed by ricin remains hypothetical, Fabentech reports a strong interest from potential clients, with many countries seeking protection against possible bioterrorist attacks.

The DGA had already placed an order for several doses of Ricimed for deployment in France. For optimal effectiveness, the antidote must be administered within 6 hours of poisoning. Iva confirmed that multiple countries had already expressed interest in acquiring the antidote.

This story was translated from JIM, part of the Medscape Professional Network.

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