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PHOENIX — Duvakitug, a novel anti-TL1a monoclonal antibody, demonstrated statistically significant differences in endoscopic response rates compared to placebo in adults with moderately to severely active Crohn’s disease, according to results from the phase 2b RELIEVE UCCD study.

“Additional clinical and endoscopic endpoints supported the primary endpoint of endoscopic response observed with duvakitug,” study author Vipul Jairath, MB ChB, DPhil, MRCP, professor of medicine at the Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada, reported.

These findings “support further development of duvakitug as a treatment option” for these patients, said Jairath, who presented the data at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

In the 14-week randomized controlled induction study, 138 adults aged 18-75 years with moderately to severely active Crohn’s disease were randomized to receive a 2250-mg loading dose of duvakitug or placebo subcutaneously, followed by either duvakitug 450 mg, 900 mg, or placebo every 2 weeks. Each arm of the study contained 46 patients, with a mean age of about 40 years, and a mean duration of disease of 9-11 years. The mean Simple Endoscopic Score for Crohn’s Disease (SES-CD) score at baseline was 12.

Half to two thirds of the patients had taken advanced therapies, either approved or investigational. The trial participants were allowed to take concomitant corticosteroids, 5-aminosalicylic acid drugs, and immunosuppressants (including 6-mercaptopurine, azathioprine, and methotrexate).

Notably, the primary endpoint of endoscopic response — defined as ≥ 50% reduction from baseline in SES-CD score — was achieved in almost half of the patients taking the 900-mg higher dose (22 of 46 patients). The endoscopic response was achieved in 13 of 27 patients who had previous experience with advanced therapies, including approved biologics (anti-TNF, anti-integrins, anti-interleukin [IL]-12/23, or anti-IL-23), and JAK inhibitors.

In the high-dose arm, 26% of participants achieved endoscopic remission, and 54% achieved clinical remission.

Just 13% of patients in the duvakitug arms had a treatment-related adverse event, with serious adverse events slightly higher in the 450 mg arm than in the 900 mg arm (13% vs 2%). The most common side effects were anemia, headache, and nasopharyngitis. One patient in the 900 mg group and four in the lower-dose group discontinued due to an adverse event.

When asked to comment by GI & Hepatology News, Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at the NYU Langone Health, New York City, said the “results demonstrate that duvakitug is a promising therapy for patients with Crohn’s disease, with 14-week induction placebo-adjusted endoscopic response rates rivaling or exceeding our currently FDA-approved advanced, effective therapies.”

The efficacy in patients with prior exposure to advanced therapies is especially noteworthy, as it is “a population in which most existing and investigational agents show limited clinical benefit,” said Axelrad, who is also an associate professor of medicine at the NYU Grossman School of Medicine, New York City.

Axelrad said there were no concerning safety signals, “which strengthens its appeal for clinical use.”

He said he sees promise in the anti-TL1a inhibitor class, noting that TL1A “is a key cytokine that spans innate and adaptive mucosal inflammation and also directly influences fibroblast and epithelial biology, contributing to intestinal fibrosis and barrier dysfunction.”

Because therapies in the class simultaneously target inflammatory and fibrotic pathways, “TL1A inhibition offers the potential for more durable disease control than conventional cytokine-directed therapies,” he said.

But, noted Axelrad, it is early in duvakitug’s development. “We certainly need a larger cohort in a phase 3 study with maintenance data,” he said.

Jairath disclosed having financial relationships with AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris Pharmaceuticals, AstraZeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Endpoint Health, Enthera, Ferring Pharmaceuticals, Flagship Pioneering, Fresenius Kabi, Galapagos NV, Genentech, Gilde Healthcare, GlaxoSmithKline, Innomar, JAMP, Johnson & Johnson, Merck, Metacrine, Mylan, Pandion Therapeutics, Pendopharm, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist Therapeutics, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Shire, Sorriso Pharmaceuticals, Syndegen, Takeda, TD Securities, Teva, Topivert, Ventyx Biosciences, and Vividion Therapeutics. Axelrad reported receiving research grants from BioFire Diagnostics, Genentech, Janssen, and Takeda; consultant, advisory board fees or honorarium from Abbvie, Abviax, Adiso, BioFire Diagnostics, Biomerieux, Bristol-Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Pfizer, Sanofi, Takeda, and Vedanta.

A version of this article appeared on Medscape.com . 

PHOENIX — Duvakitug, a novel anti-TL1a monoclonal antibody, demonstrated statistically significant differences in endoscopic response rates compared to placebo in adults with moderately to severely active Crohn’s disease, according to results from the phase 2b RELIEVE UCCD study.

“Additional clinical and endoscopic endpoints supported the primary endpoint of endoscopic response observed with duvakitug,” study author Vipul Jairath, MB ChB, DPhil, MRCP, professor of medicine at the Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada, reported.

These findings “support further development of duvakitug as a treatment option” for these patients, said Jairath, who presented the data at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

In the 14-week randomized controlled induction study, 138 adults aged 18-75 years with moderately to severely active Crohn’s disease were randomized to receive a 2250-mg loading dose of duvakitug or placebo subcutaneously, followed by either duvakitug 450 mg, 900 mg, or placebo every 2 weeks. Each arm of the study contained 46 patients, with a mean age of about 40 years, and a mean duration of disease of 9-11 years. The mean Simple Endoscopic Score for Crohn’s Disease (SES-CD) score at baseline was 12.

Half to two thirds of the patients had taken advanced therapies, either approved or investigational. The trial participants were allowed to take concomitant corticosteroids, 5-aminosalicylic acid drugs, and immunosuppressants (including 6-mercaptopurine, azathioprine, and methotrexate).

Notably, the primary endpoint of endoscopic response — defined as ≥ 50% reduction from baseline in SES-CD score — was achieved in almost half of the patients taking the 900-mg higher dose (22 of 46 patients). The endoscopic response was achieved in 13 of 27 patients who had previous experience with advanced therapies, including approved biologics (anti-TNF, anti-integrins, anti-interleukin [IL]-12/23, or anti-IL-23), and JAK inhibitors.

In the high-dose arm, 26% of participants achieved endoscopic remission, and 54% achieved clinical remission.

Just 13% of patients in the duvakitug arms had a treatment-related adverse event, with serious adverse events slightly higher in the 450 mg arm than in the 900 mg arm (13% vs 2%). The most common side effects were anemia, headache, and nasopharyngitis. One patient in the 900 mg group and four in the lower-dose group discontinued due to an adverse event.

When asked to comment by GI & Hepatology News, Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at the NYU Langone Health, New York City, said the “results demonstrate that duvakitug is a promising therapy for patients with Crohn’s disease, with 14-week induction placebo-adjusted endoscopic response rates rivaling or exceeding our currently FDA-approved advanced, effective therapies.”

The efficacy in patients with prior exposure to advanced therapies is especially noteworthy, as it is “a population in which most existing and investigational agents show limited clinical benefit,” said Axelrad, who is also an associate professor of medicine at the NYU Grossman School of Medicine, New York City.

Axelrad said there were no concerning safety signals, “which strengthens its appeal for clinical use.”

He said he sees promise in the anti-TL1a inhibitor class, noting that TL1A “is a key cytokine that spans innate and adaptive mucosal inflammation and also directly influences fibroblast and epithelial biology, contributing to intestinal fibrosis and barrier dysfunction.”

Because therapies in the class simultaneously target inflammatory and fibrotic pathways, “TL1A inhibition offers the potential for more durable disease control than conventional cytokine-directed therapies,” he said.

But, noted Axelrad, it is early in duvakitug’s development. “We certainly need a larger cohort in a phase 3 study with maintenance data,” he said.

Jairath disclosed having financial relationships with AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris Pharmaceuticals, AstraZeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Endpoint Health, Enthera, Ferring Pharmaceuticals, Flagship Pioneering, Fresenius Kabi, Galapagos NV, Genentech, Gilde Healthcare, GlaxoSmithKline, Innomar, JAMP, Johnson & Johnson, Merck, Metacrine, Mylan, Pandion Therapeutics, Pendopharm, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist Therapeutics, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Shire, Sorriso Pharmaceuticals, Syndegen, Takeda, TD Securities, Teva, Topivert, Ventyx Biosciences, and Vividion Therapeutics. Axelrad reported receiving research grants from BioFire Diagnostics, Genentech, Janssen, and Takeda; consultant, advisory board fees or honorarium from Abbvie, Abviax, Adiso, BioFire Diagnostics, Biomerieux, Bristol-Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Pfizer, Sanofi, Takeda, and Vedanta.

A version of this article appeared on Medscape.com . 

PHOENIX — Duvakitug, a novel anti-TL1a monoclonal antibody, demonstrated statistically significant differences in endoscopic response rates compared to placebo in adults with moderately to severely active Crohn’s disease, according to results from the phase 2b RELIEVE UCCD study.

“Additional clinical and endoscopic endpoints supported the primary endpoint of endoscopic response observed with duvakitug,” study author Vipul Jairath, MB ChB, DPhil, MRCP, professor of medicine at the Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada, reported.

These findings “support further development of duvakitug as a treatment option” for these patients, said Jairath, who presented the data at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

In the 14-week randomized controlled induction study, 138 adults aged 18-75 years with moderately to severely active Crohn’s disease were randomized to receive a 2250-mg loading dose of duvakitug or placebo subcutaneously, followed by either duvakitug 450 mg, 900 mg, or placebo every 2 weeks. Each arm of the study contained 46 patients, with a mean age of about 40 years, and a mean duration of disease of 9-11 years. The mean Simple Endoscopic Score for Crohn’s Disease (SES-CD) score at baseline was 12.

Half to two thirds of the patients had taken advanced therapies, either approved or investigational. The trial participants were allowed to take concomitant corticosteroids, 5-aminosalicylic acid drugs, and immunosuppressants (including 6-mercaptopurine, azathioprine, and methotrexate).

Notably, the primary endpoint of endoscopic response — defined as ≥ 50% reduction from baseline in SES-CD score — was achieved in almost half of the patients taking the 900-mg higher dose (22 of 46 patients). The endoscopic response was achieved in 13 of 27 patients who had previous experience with advanced therapies, including approved biologics (anti-TNF, anti-integrins, anti-interleukin [IL]-12/23, or anti-IL-23), and JAK inhibitors.

In the high-dose arm, 26% of participants achieved endoscopic remission, and 54% achieved clinical remission.

Just 13% of patients in the duvakitug arms had a treatment-related adverse event, with serious adverse events slightly higher in the 450 mg arm than in the 900 mg arm (13% vs 2%). The most common side effects were anemia, headache, and nasopharyngitis. One patient in the 900 mg group and four in the lower-dose group discontinued due to an adverse event.

When asked to comment by GI & Hepatology News, Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at the NYU Langone Health, New York City, said the “results demonstrate that duvakitug is a promising therapy for patients with Crohn’s disease, with 14-week induction placebo-adjusted endoscopic response rates rivaling or exceeding our currently FDA-approved advanced, effective therapies.”

The efficacy in patients with prior exposure to advanced therapies is especially noteworthy, as it is “a population in which most existing and investigational agents show limited clinical benefit,” said Axelrad, who is also an associate professor of medicine at the NYU Grossman School of Medicine, New York City.

Axelrad said there were no concerning safety signals, “which strengthens its appeal for clinical use.”

He said he sees promise in the anti-TL1a inhibitor class, noting that TL1A “is a key cytokine that spans innate and adaptive mucosal inflammation and also directly influences fibroblast and epithelial biology, contributing to intestinal fibrosis and barrier dysfunction.”

Because therapies in the class simultaneously target inflammatory and fibrotic pathways, “TL1A inhibition offers the potential for more durable disease control than conventional cytokine-directed therapies,” he said.

But, noted Axelrad, it is early in duvakitug’s development. “We certainly need a larger cohort in a phase 3 study with maintenance data,” he said.

Jairath disclosed having financial relationships with AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris Pharmaceuticals, AstraZeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Endpoint Health, Enthera, Ferring Pharmaceuticals, Flagship Pioneering, Fresenius Kabi, Galapagos NV, Genentech, Gilde Healthcare, GlaxoSmithKline, Innomar, JAMP, Johnson & Johnson, Merck, Metacrine, Mylan, Pandion Therapeutics, Pendopharm, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist Therapeutics, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Shire, Sorriso Pharmaceuticals, Syndegen, Takeda, TD Securities, Teva, Topivert, Ventyx Biosciences, and Vividion Therapeutics. Axelrad reported receiving research grants from BioFire Diagnostics, Genentech, Janssen, and Takeda; consultant, advisory board fees or honorarium from Abbvie, Abviax, Adiso, BioFire Diagnostics, Biomerieux, Bristol-Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Pfizer, Sanofi, Takeda, and Vedanta.

A version of this article appeared on Medscape.com . 

TOPLINE: The Veterans Health Administration implemented 18 regional Clinical Resource Hubs (CRHs), where remote clinicians deliver virtual mental health care, addressing staffing gaps amid increasing demand and workforce shortages. Early implementation showed promise in improving access, with program benefits extending beyond temporary staffing solutions.

METHODOLOGY:

• Semistructured interviews were conducted with 36 CRH mental health leaders across all 18 regions.

• A rapid qualitative approach was used, incorporating templated summaries and matrix analysis.

• Participants included leads responsible for implementation and coordination, as well as Chief Mental Health Officers overseeing facility-based services.

• Regional leaders collaborated through executive meetings to ensure appropriate mental health practitioner assignments and effective service delivery to facilities in need.

TAKEAWAY:

• The CRH program demonstrated 3 key values: enhanced integration compared with community care, expanded specialty mental health services in rural areas, and improved provider recruitment and satisfaction.

• Leaders argued that the program could prevent unnecessary delays for veterans who might experience longer wait times for mental health services in the community.

• Mental health practitioners can work virtually across multiple health care systems, with hybrid schedules combining on-site and virtual care delivery.

• The program attracted numerous qualified applicants for virtual care.

IN PRACTICE: “Mental health leaders’ perspectives on CRH value suggest the program is more than a contingency staffing solution for mental health care access challenges, but also potentially offers additional benefits that could be leveraged to improve mental health care services more generally," wrote the authors of the study.

SOURCE: The study was led by the Center for the Study of Healthcare Innovation in Los Angeles. It was published online in Administration and Policy in Mental Health and Mental Health Services Research.

LIMITATIONS: The researchers identified lower productivity among CRH staff compared with facility staff, indicating unused capacity. The program's rapid national implementation may have contributed to challenges, as hubs were established quickly, potentially before fully determining regional demand. Some facilities requiring services may have lacked the necessary infrastructure for timely implementation.

 DISCLOSURES: This work received support from the Veterans Health Administration Primary Care Analytics Team, funded by the Veterans Health Administration Office of Primary Care. The views expressed do not necessarily reflect the position or policy of the Department of Veterans Affairs or the U.S. Government.

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

TOPLINE: The Veterans Health Administration implemented 18 regional Clinical Resource Hubs (CRHs), where remote clinicians deliver virtual mental health care, addressing staffing gaps amid increasing demand and workforce shortages. Early implementation showed promise in improving access, with program benefits extending beyond temporary staffing solutions.

METHODOLOGY:

• Semistructured interviews were conducted with 36 CRH mental health leaders across all 18 regions.

• A rapid qualitative approach was used, incorporating templated summaries and matrix analysis.

• Participants included leads responsible for implementation and coordination, as well as Chief Mental Health Officers overseeing facility-based services.

• Regional leaders collaborated through executive meetings to ensure appropriate mental health practitioner assignments and effective service delivery to facilities in need.

TAKEAWAY:

• The CRH program demonstrated 3 key values: enhanced integration compared with community care, expanded specialty mental health services in rural areas, and improved provider recruitment and satisfaction.

• Leaders argued that the program could prevent unnecessary delays for veterans who might experience longer wait times for mental health services in the community.

• Mental health practitioners can work virtually across multiple health care systems, with hybrid schedules combining on-site and virtual care delivery.

• The program attracted numerous qualified applicants for virtual care.

IN PRACTICE: “Mental health leaders’ perspectives on CRH value suggest the program is more than a contingency staffing solution for mental health care access challenges, but also potentially offers additional benefits that could be leveraged to improve mental health care services more generally," wrote the authors of the study.

SOURCE: The study was led by the Center for the Study of Healthcare Innovation in Los Angeles. It was published online in Administration and Policy in Mental Health and Mental Health Services Research.

LIMITATIONS: The researchers identified lower productivity among CRH staff compared with facility staff, indicating unused capacity. The program's rapid national implementation may have contributed to challenges, as hubs were established quickly, potentially before fully determining regional demand. Some facilities requiring services may have lacked the necessary infrastructure for timely implementation.

 DISCLOSURES: This work received support from the Veterans Health Administration Primary Care Analytics Team, funded by the Veterans Health Administration Office of Primary Care. The views expressed do not necessarily reflect the position or policy of the Department of Veterans Affairs or the U.S. Government.

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

TOPLINE: The Veterans Health Administration implemented 18 regional Clinical Resource Hubs (CRHs), where remote clinicians deliver virtual mental health care, addressing staffing gaps amid increasing demand and workforce shortages. Early implementation showed promise in improving access, with program benefits extending beyond temporary staffing solutions.

METHODOLOGY:

• Semistructured interviews were conducted with 36 CRH mental health leaders across all 18 regions.

• A rapid qualitative approach was used, incorporating templated summaries and matrix analysis.

• Participants included leads responsible for implementation and coordination, as well as Chief Mental Health Officers overseeing facility-based services.

• Regional leaders collaborated through executive meetings to ensure appropriate mental health practitioner assignments and effective service delivery to facilities in need.

TAKEAWAY:

• The CRH program demonstrated 3 key values: enhanced integration compared with community care, expanded specialty mental health services in rural areas, and improved provider recruitment and satisfaction.

• Leaders argued that the program could prevent unnecessary delays for veterans who might experience longer wait times for mental health services in the community.

• Mental health practitioners can work virtually across multiple health care systems, with hybrid schedules combining on-site and virtual care delivery.

• The program attracted numerous qualified applicants for virtual care.

IN PRACTICE: “Mental health leaders’ perspectives on CRH value suggest the program is more than a contingency staffing solution for mental health care access challenges, but also potentially offers additional benefits that could be leveraged to improve mental health care services more generally," wrote the authors of the study.

SOURCE: The study was led by the Center for the Study of Healthcare Innovation in Los Angeles. It was published online in Administration and Policy in Mental Health and Mental Health Services Research.

LIMITATIONS: The researchers identified lower productivity among CRH staff compared with facility staff, indicating unused capacity. The program's rapid national implementation may have contributed to challenges, as hubs were established quickly, potentially before fully determining regional demand. Some facilities requiring services may have lacked the necessary infrastructure for timely implementation.

 DISCLOSURES: This work received support from the Veterans Health Administration Primary Care Analytics Team, funded by the Veterans Health Administration Office of Primary Care. The views expressed do not necessarily reflect the position or policy of the Department of Veterans Affairs or the U.S. Government.

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

TOPLINE: Psychiatric disorders affect 37.8% of veteran vs 37.3% of nonveteran in a study of > 42,000 women aged ≥ 65 years. Most differences between veterans and nonveterans were statistically insignificant after removing confounders.

METHODOLOGY: 

• Researchers analyzed 42,031 Women's Health Initiative (WHI) participants aged > 65 years at enrollment (1993-1998), including 1,512 veterans and 40,519 non-veterans, through linked WHI-Medicare databases with approximately 15 years of follow-up.

• Analysis included multivariable logistic and Cox regression models to evaluate characteristics associated with prevalent and incident psychiatric disorders, respectively.

• Participants were followed from WHI enrollment until first psychiatric diagnosis, with censoring at death, end of follow-up, or December 31, 2013.

• Investigators examined relationships between individual-level and neighborhood-level socioeconomic status indicators with psychiatric disorders before and after stratification by veteran status.

TAKEAWAY:

• The overall prevalence of psychiatric disorders was 37.3%, with an incidence rate of 25.5 per 1,000 person-years, showing no significant differences between veterans and non-veterans (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.85-0.06).

• There was a higher prevalence of psychiatric disorders for women veterans with technical, sales, or administrative occupations (adjusted OR [aOR], 1.72; 95 % CI, 1.02, 2.89) and those with “other” occupations (aOR, 2.09; 95 % CI, 1.13, 3.88) when compared with women veterans with managerial or professional occupations.

• Mood and anxiety disorders emerged as the leading types of psychiatric conditions among both veteran and nonveteran women.

IN PRACTICE: "Although interaction effects by veteran status were nonsignificant,” the authors of the study explained, “lower education, household income, and neighborhood socioeconomic status were associated with higher frequencies of psychiatric disorders only among women non-veterans.”

SOURCE: The study was led by Jack Tsai and the US Department of Veterans Affairs National Center on Homelessness Among Veterans in Washington, DC. It was published online in Journal of Affective Disorders.

LIMITATIONS: The study faced several limitations including potential selection and survival biases, as findings correspond only to Women's Health Initiative participants who survived until age 65 or later. Information bias likely occurred due to self-reported measures and sole reliance on International Classification of Disease, 9th revision, Clinical Modification diagnostic codes from Medicare claims. Additionally, socioeconomic status indicators assessed at enrollment may not reflect early life or midlife exposures that could influence psychiatric diagnoses.

 DISCLOSURES: The Women’s Health Initiative program received funding from the National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services through grants 75N92021D00001, 75N92021D00002, 75N92021D00003, 75N92021D00004, and 75N92021D00005.

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

TOPLINE: Psychiatric disorders affect 37.8% of veteran vs 37.3% of nonveteran in a study of > 42,000 women aged ≥ 65 years. Most differences between veterans and nonveterans were statistically insignificant after removing confounders.

METHODOLOGY: 

• Researchers analyzed 42,031 Women's Health Initiative (WHI) participants aged > 65 years at enrollment (1993-1998), including 1,512 veterans and 40,519 non-veterans, through linked WHI-Medicare databases with approximately 15 years of follow-up.

• Analysis included multivariable logistic and Cox regression models to evaluate characteristics associated with prevalent and incident psychiatric disorders, respectively.

• Participants were followed from WHI enrollment until first psychiatric diagnosis, with censoring at death, end of follow-up, or December 31, 2013.

• Investigators examined relationships between individual-level and neighborhood-level socioeconomic status indicators with psychiatric disorders before and after stratification by veteran status.

TAKEAWAY:

• The overall prevalence of psychiatric disorders was 37.3%, with an incidence rate of 25.5 per 1,000 person-years, showing no significant differences between veterans and non-veterans (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.85-0.06).

• There was a higher prevalence of psychiatric disorders for women veterans with technical, sales, or administrative occupations (adjusted OR [aOR], 1.72; 95 % CI, 1.02, 2.89) and those with “other” occupations (aOR, 2.09; 95 % CI, 1.13, 3.88) when compared with women veterans with managerial or professional occupations.

• Mood and anxiety disorders emerged as the leading types of psychiatric conditions among both veteran and nonveteran women.

IN PRACTICE: "Although interaction effects by veteran status were nonsignificant,” the authors of the study explained, “lower education, household income, and neighborhood socioeconomic status were associated with higher frequencies of psychiatric disorders only among women non-veterans.”

SOURCE: The study was led by Jack Tsai and the US Department of Veterans Affairs National Center on Homelessness Among Veterans in Washington, DC. It was published online in Journal of Affective Disorders.

LIMITATIONS: The study faced several limitations including potential selection and survival biases, as findings correspond only to Women's Health Initiative participants who survived until age 65 or later. Information bias likely occurred due to self-reported measures and sole reliance on International Classification of Disease, 9th revision, Clinical Modification diagnostic codes from Medicare claims. Additionally, socioeconomic status indicators assessed at enrollment may not reflect early life or midlife exposures that could influence psychiatric diagnoses.

 DISCLOSURES: The Women’s Health Initiative program received funding from the National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services through grants 75N92021D00001, 75N92021D00002, 75N92021D00003, 75N92021D00004, and 75N92021D00005.

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

TOPLINE: Psychiatric disorders affect 37.8% of veteran vs 37.3% of nonveteran in a study of > 42,000 women aged ≥ 65 years. Most differences between veterans and nonveterans were statistically insignificant after removing confounders.

METHODOLOGY: 

• Researchers analyzed 42,031 Women's Health Initiative (WHI) participants aged > 65 years at enrollment (1993-1998), including 1,512 veterans and 40,519 non-veterans, through linked WHI-Medicare databases with approximately 15 years of follow-up.

• Analysis included multivariable logistic and Cox regression models to evaluate characteristics associated with prevalent and incident psychiatric disorders, respectively.

• Participants were followed from WHI enrollment until first psychiatric diagnosis, with censoring at death, end of follow-up, or December 31, 2013.

• Investigators examined relationships between individual-level and neighborhood-level socioeconomic status indicators with psychiatric disorders before and after stratification by veteran status.

TAKEAWAY:

• The overall prevalence of psychiatric disorders was 37.3%, with an incidence rate of 25.5 per 1,000 person-years, showing no significant differences between veterans and non-veterans (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.85-0.06).

• There was a higher prevalence of psychiatric disorders for women veterans with technical, sales, or administrative occupations (adjusted OR [aOR], 1.72; 95 % CI, 1.02, 2.89) and those with “other” occupations (aOR, 2.09; 95 % CI, 1.13, 3.88) when compared with women veterans with managerial or professional occupations.

• Mood and anxiety disorders emerged as the leading types of psychiatric conditions among both veteran and nonveteran women.

IN PRACTICE: "Although interaction effects by veteran status were nonsignificant,” the authors of the study explained, “lower education, household income, and neighborhood socioeconomic status were associated with higher frequencies of psychiatric disorders only among women non-veterans.”

SOURCE: The study was led by Jack Tsai and the US Department of Veterans Affairs National Center on Homelessness Among Veterans in Washington, DC. It was published online in Journal of Affective Disorders.

LIMITATIONS: The study faced several limitations including potential selection and survival biases, as findings correspond only to Women's Health Initiative participants who survived until age 65 or later. Information bias likely occurred due to self-reported measures and sole reliance on International Classification of Disease, 9th revision, Clinical Modification diagnostic codes from Medicare claims. Additionally, socioeconomic status indicators assessed at enrollment may not reflect early life or midlife exposures that could influence psychiatric diagnoses.

 DISCLOSURES: The Women’s Health Initiative program received funding from the National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services through grants 75N92021D00001, 75N92021D00002, 75N92021D00003, 75N92021D00004, and 75N92021D00005.

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

TOPLINE: Agent Orange exposure was associated with a 26% to 71% increased risk for multiple lymphoid cancers in veterans enrolled in the US Department of Veterans Affairs (VA) Million Veterans Program (MVP), while genetic predisposition independently raised risk by 12% to 81% across different lymphoma subtypes. A case-controlled analysis of 255,155 veterans found no significant interaction between genetic risk scores and Agent Orange exposure.

METHODOLOGY:

• A case-control study included 255,155 non-Hispanic White veterans (median age 67 years, 92.5% male) enrolled in the VA MVP with genotype and Agent Orange exposure data.

• Researchers analyzed five lymphoid malignant neoplasm subtypes: chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and multiple myeloma diagnosed from January 1965 through June 2024.

• Agent Orange exposure was determined through self-reported survey responses, while polygenic risk scores were derived from genome-wide association studies of lymphoid malignant neoplasms.

• Analysis included adjustments for age at enrollment, sex, and the first 10 genetic principal components in logistic regression models evaluating Agent Orange exposure, polygenic risk scores, and their potential interaction.

TAKEAWAY:

• Agent Orange exposure significantly increased risk for chronic lymphocytic leukemia (odds ratio [OR], 1.61; 95% CI, 1.40-1.84), diffuse large B-cell lymphoma (OR, 1.26; 95% CI, 1.03-1.53), follicular lymphoma (OR, 1.71; 95% CI, 1.39-2.11), and multiple myeloma (OR, 1.58; 95% CI, 1.35-1.86).

• Polygenic risk scores were independently associated with all lymphoma subtypes, with strongest associations for chronic lymphocytic leukemia (OR, 1.81; 95% CI, 1.70-1.93) and multiple myeloma (OR, 1.41; 95% CI, 1.31-1.52).

• Analysis in African American participants showed similar associations for multiple myeloma with both Agent Orange exposure (OR, 1.56; 95% CI, 1.18-2.07) and polygenic risk scores (OR, 1.31; 95% CI, 1.15-1.49).

• According to the researchers, no significant polygenic risk score and Agent Orange exposure interactions were observed for any lymphoma subtype.

IN PRACTICE: "Our study addressed the public health concerns surrounding Agent Orange exposure and lymphoid malignant neoplasms, finding that both Agent Orange exposure and polygenic risk are independently associated with disease, suggesting potentially distinct and additive pathways that merit further investigation," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, Irvine and the Tibor Rubin Veterans Affairs Medical Center, Long Beach, Californiaand was published online on August 13 in JAMA Network Open.

LIMITATIONS: According to the authors, while this represents the largest case-control study of Agent Orange exposure and lymphoid malignant neoplasm risk, the power to detect interaction associations in specific subtypes might be limited. Self-reported Agent Orange exposure data may have introduced survival bias, particularly in aggressive subtypes, as patients with aggressive tumors may have died before joining the MVP. Additionally, about half of the patients were diagnosed with lymphoid malignant neoplasms before self-reporting Agent Orange exposure, potentially introducing recall bias.

DISCLOSURES: The research was supported by a Veterans Affairs Career Development Award Xueyi Teng, PhD, received grants from the George E. Hewitt Foundation for Medical Research Postdoc Fellowship during the study.

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

TOPLINE: Agent Orange exposure was associated with a 26% to 71% increased risk for multiple lymphoid cancers in veterans enrolled in the US Department of Veterans Affairs (VA) Million Veterans Program (MVP), while genetic predisposition independently raised risk by 12% to 81% across different lymphoma subtypes. A case-controlled analysis of 255,155 veterans found no significant interaction between genetic risk scores and Agent Orange exposure.

METHODOLOGY:

• A case-control study included 255,155 non-Hispanic White veterans (median age 67 years, 92.5% male) enrolled in the VA MVP with genotype and Agent Orange exposure data.

• Researchers analyzed five lymphoid malignant neoplasm subtypes: chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and multiple myeloma diagnosed from January 1965 through June 2024.

• Agent Orange exposure was determined through self-reported survey responses, while polygenic risk scores were derived from genome-wide association studies of lymphoid malignant neoplasms.

• Analysis included adjustments for age at enrollment, sex, and the first 10 genetic principal components in logistic regression models evaluating Agent Orange exposure, polygenic risk scores, and their potential interaction.

TAKEAWAY:

• Agent Orange exposure significantly increased risk for chronic lymphocytic leukemia (odds ratio [OR], 1.61; 95% CI, 1.40-1.84), diffuse large B-cell lymphoma (OR, 1.26; 95% CI, 1.03-1.53), follicular lymphoma (OR, 1.71; 95% CI, 1.39-2.11), and multiple myeloma (OR, 1.58; 95% CI, 1.35-1.86).

• Polygenic risk scores were independently associated with all lymphoma subtypes, with strongest associations for chronic lymphocytic leukemia (OR, 1.81; 95% CI, 1.70-1.93) and multiple myeloma (OR, 1.41; 95% CI, 1.31-1.52).

• Analysis in African American participants showed similar associations for multiple myeloma with both Agent Orange exposure (OR, 1.56; 95% CI, 1.18-2.07) and polygenic risk scores (OR, 1.31; 95% CI, 1.15-1.49).

• According to the researchers, no significant polygenic risk score and Agent Orange exposure interactions were observed for any lymphoma subtype.

IN PRACTICE: "Our study addressed the public health concerns surrounding Agent Orange exposure and lymphoid malignant neoplasms, finding that both Agent Orange exposure and polygenic risk are independently associated with disease, suggesting potentially distinct and additive pathways that merit further investigation," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, Irvine and the Tibor Rubin Veterans Affairs Medical Center, Long Beach, Californiaand was published online on August 13 in JAMA Network Open.

LIMITATIONS: According to the authors, while this represents the largest case-control study of Agent Orange exposure and lymphoid malignant neoplasm risk, the power to detect interaction associations in specific subtypes might be limited. Self-reported Agent Orange exposure data may have introduced survival bias, particularly in aggressive subtypes, as patients with aggressive tumors may have died before joining the MVP. Additionally, about half of the patients were diagnosed with lymphoid malignant neoplasms before self-reporting Agent Orange exposure, potentially introducing recall bias.

DISCLOSURES: The research was supported by a Veterans Affairs Career Development Award Xueyi Teng, PhD, received grants from the George E. Hewitt Foundation for Medical Research Postdoc Fellowship during the study.

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

TOPLINE: Agent Orange exposure was associated with a 26% to 71% increased risk for multiple lymphoid cancers in veterans enrolled in the US Department of Veterans Affairs (VA) Million Veterans Program (MVP), while genetic predisposition independently raised risk by 12% to 81% across different lymphoma subtypes. A case-controlled analysis of 255,155 veterans found no significant interaction between genetic risk scores and Agent Orange exposure.

METHODOLOGY:

• A case-control study included 255,155 non-Hispanic White veterans (median age 67 years, 92.5% male) enrolled in the VA MVP with genotype and Agent Orange exposure data.

• Researchers analyzed five lymphoid malignant neoplasm subtypes: chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and multiple myeloma diagnosed from January 1965 through June 2024.

• Agent Orange exposure was determined through self-reported survey responses, while polygenic risk scores were derived from genome-wide association studies of lymphoid malignant neoplasms.

• Analysis included adjustments for age at enrollment, sex, and the first 10 genetic principal components in logistic regression models evaluating Agent Orange exposure, polygenic risk scores, and their potential interaction.

TAKEAWAY:

• Agent Orange exposure significantly increased risk for chronic lymphocytic leukemia (odds ratio [OR], 1.61; 95% CI, 1.40-1.84), diffuse large B-cell lymphoma (OR, 1.26; 95% CI, 1.03-1.53), follicular lymphoma (OR, 1.71; 95% CI, 1.39-2.11), and multiple myeloma (OR, 1.58; 95% CI, 1.35-1.86).

• Polygenic risk scores were independently associated with all lymphoma subtypes, with strongest associations for chronic lymphocytic leukemia (OR, 1.81; 95% CI, 1.70-1.93) and multiple myeloma (OR, 1.41; 95% CI, 1.31-1.52).

• Analysis in African American participants showed similar associations for multiple myeloma with both Agent Orange exposure (OR, 1.56; 95% CI, 1.18-2.07) and polygenic risk scores (OR, 1.31; 95% CI, 1.15-1.49).

• According to the researchers, no significant polygenic risk score and Agent Orange exposure interactions were observed for any lymphoma subtype.

IN PRACTICE: "Our study addressed the public health concerns surrounding Agent Orange exposure and lymphoid malignant neoplasms, finding that both Agent Orange exposure and polygenic risk are independently associated with disease, suggesting potentially distinct and additive pathways that merit further investigation," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, Irvine and the Tibor Rubin Veterans Affairs Medical Center, Long Beach, Californiaand was published online on August 13 in JAMA Network Open.

LIMITATIONS: According to the authors, while this represents the largest case-control study of Agent Orange exposure and lymphoid malignant neoplasm risk, the power to detect interaction associations in specific subtypes might be limited. Self-reported Agent Orange exposure data may have introduced survival bias, particularly in aggressive subtypes, as patients with aggressive tumors may have died before joining the MVP. Additionally, about half of the patients were diagnosed with lymphoid malignant neoplasms before self-reporting Agent Orange exposure, potentially introducing recall bias.

DISCLOSURES: The research was supported by a Veterans Affairs Career Development Award Xueyi Teng, PhD, received grants from the George E. Hewitt Foundation for Medical Research Postdoc Fellowship during the study.

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

Abiraterone and enzalutamide showed identical survival outcomes when used as first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC), according to a new study using US Department of Veterans Affairs (VA) data. The report represents the first head-to-head clinical analysis of these commonly used androgen receptor inhibitors.

Among 1258 veterans treated with abiraterone and 311 treated with enzalutamide, median overall survival was 36.2 months for both drugs. Patients were followed for a mean of 28.7 months (abiraterone) and 30.8 months (enzalutamide), reported by Martin W. Schoen, MD, MPH, from Saint Louis University School of Medicine and the St. Louis VA Medical Center, in JAMA Network Open. 

Notably, there was no significant difference in outcomes among Black veterans, who often have poorer outcomes in prostate cancer, and in patients with cardiovascular disease.

“This is the first direct comparison of abiraterone and enzalutamide for mHSPC in a clinical practice setting,” Schoen told Federal Practitioner. “At the population level, there are no differences based on initial treatment choice.”

Abiraterone Is Preferred in the VA Due to Cost

According to Schoen, abiraterone and enzalutamide are the most commonly used androgen receptor inhibitors to treat mHSPC within the VA. A 2025 study by Schoen and colleagues found that 53.7% of veterans with mHSPC in 2022 received androgen receptor inhibitor therapy, up from 16.9% in 2017. 

“In the VA, the preference for most patients is abiraterone since it is the least expensive agent,” he said. A generic version has been available for several years.

Additionally, abiraterone “has been on the market for the longest, and therefore clinicians are familiar with its use,” Schoen said. However, “clinicians have little idea of the comparative efficacy between these 2 agents,” he added.

The authors suggest that the cost and toxicities of the medications should guide clinician decisions, Schoen said. “There is data that abiraterone may worsen diabetes, since it is given with prednisone and could increase the risk of cardiovascular events,” he said.

He added that 2 newer drugs, apalutamide and darolutamide, are also “viable options.” Chemotherapies and certain targeted drugs are also available, “but they are only used in a select group of patients.”

Outside Specialist: Diverse Study Population Is a Plus

Hematologist-oncologist Natalie Reizine, MD, of the University of Illinois College of Medicine, Chicago, who was not involved in the study, told Federal Practitioner that the real-world data are valuable given the limitations of clinical trial populations.

“It’s difficult to compare clinical trials because they enroll different groups of patients,” she said. And, she said, they often exclude patients with significant comorbidities. “If they have bad cardiovascular disease, for instance, or poorly controlled diabetes, they're excluded from the clinical trial. But in real life, many of our patients have other medical problems that we have to manage.”

Reizine also emphasized the significance of the study’s diverse patient population. “Black men are very underrepresented in clinical trials. Many clinical trials that lead to drug approval will have only few or no Black men at all, yet these drugs go on to be widely prescribed to all men with prostate cancer.”

Results Are ‘Reassuring’

Reizine described the overall study findings as “reassuring,” especially in light of “studies that show that abiraterone and prednisone may be associated with worse cardiovascular outcomes. This study showed that in this VA population, even for patients who had cardiovascular disease, there was not a difference in how they did.”

As for choosing between agents, she recommended considering comorbidities and potential drug-drug interactions. “One of the big reasons that you may not be able to safely prescribe enzalutamide, for instance, is if a patient is on an anticoagulant, which is incredibly common in cancer patients. Enzalutamide has more drug-drug interactions than abiraterone and prednisone.” 

Study Demographics and Findings

The study included all patients with mHSPC who initiated abiraterone or enzalutamide between July 2017 and April 2023.

Median ages were 73 (abiraterone) and 74 years (enzalutamide, P = .29). Racial distribution was similar between groups: abiraterone (68.1% White, 25.0% Black, 6.9% other/unknown) and enzalutamide (66.6% White, 27.0% Black, 6.4% other/unknown; P = .74). Ethnicity was 89.2% non-Hispanic, 4.4% Hispanic, and 6.4% unknown in the abiraterone group vs 88.4% non-Hispanic, 3.5% Hispanic, and 8.0% unknown in the enzalutamide group (P = .50).

The groups had similar rates of the most common comorbidities: diabetes (40.5% vs 46.3%, respectively, P = .07), peripheral vascular disease (40.2% vs 37.6%, respectively, P = .44), and chronic pulmonary disease (37.0% vs 40.5%, P = .29).

In an inverse probability weighting analysis with abiraterone as reference, weighted median overall survival was comparable across the entire cohort (36.2 months, P = .32), Black veterans (39.7 months, P = .90), and those with cardiovascular disease (31.5 months, P = .30).

The authors noted limitations such as the observational cohort design and data constraints. 

The study was supported by the American Society of Clinical Oncology Conquer Cancer Foundation, the Prostate Cancer Foundation, and the Blavatnik Family Foundation.

Schoen discloses relationships with the Prostate Cancer Foundation, Astellas, and US Department of Defense. Other authors disclose relationships with the American Society of Clinical Oncology, Pfizer, Exelixis, Eli Lilly, Sanofi, Merck, Seagen, Bellicum, and BMS.

Outside the submitted work. Reizine discloses relationships with the US Department of Defense, Sanofi, Exelexis, Janssen, AstraZeneca, EMD Serono, Janssen, Merck, and Tempus.

Abiraterone and enzalutamide showed identical survival outcomes when used as first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC), according to a new study using US Department of Veterans Affairs (VA) data. The report represents the first head-to-head clinical analysis of these commonly used androgen receptor inhibitors.

Among 1258 veterans treated with abiraterone and 311 treated with enzalutamide, median overall survival was 36.2 months for both drugs. Patients were followed for a mean of 28.7 months (abiraterone) and 30.8 months (enzalutamide), reported by Martin W. Schoen, MD, MPH, from Saint Louis University School of Medicine and the St. Louis VA Medical Center, in JAMA Network Open. 

Notably, there was no significant difference in outcomes among Black veterans, who often have poorer outcomes in prostate cancer, and in patients with cardiovascular disease.

“This is the first direct comparison of abiraterone and enzalutamide for mHSPC in a clinical practice setting,” Schoen told Federal Practitioner. “At the population level, there are no differences based on initial treatment choice.”

Abiraterone Is Preferred in the VA Due to Cost

According to Schoen, abiraterone and enzalutamide are the most commonly used androgen receptor inhibitors to treat mHSPC within the VA. A 2025 study by Schoen and colleagues found that 53.7% of veterans with mHSPC in 2022 received androgen receptor inhibitor therapy, up from 16.9% in 2017. 

“In the VA, the preference for most patients is abiraterone since it is the least expensive agent,” he said. A generic version has been available for several years.

Additionally, abiraterone “has been on the market for the longest, and therefore clinicians are familiar with its use,” Schoen said. However, “clinicians have little idea of the comparative efficacy between these 2 agents,” he added.

The authors suggest that the cost and toxicities of the medications should guide clinician decisions, Schoen said. “There is data that abiraterone may worsen diabetes, since it is given with prednisone and could increase the risk of cardiovascular events,” he said.

He added that 2 newer drugs, apalutamide and darolutamide, are also “viable options.” Chemotherapies and certain targeted drugs are also available, “but they are only used in a select group of patients.”

Outside Specialist: Diverse Study Population Is a Plus

Hematologist-oncologist Natalie Reizine, MD, of the University of Illinois College of Medicine, Chicago, who was not involved in the study, told Federal Practitioner that the real-world data are valuable given the limitations of clinical trial populations.

“It’s difficult to compare clinical trials because they enroll different groups of patients,” she said. And, she said, they often exclude patients with significant comorbidities. “If they have bad cardiovascular disease, for instance, or poorly controlled diabetes, they're excluded from the clinical trial. But in real life, many of our patients have other medical problems that we have to manage.”

Reizine also emphasized the significance of the study’s diverse patient population. “Black men are very underrepresented in clinical trials. Many clinical trials that lead to drug approval will have only few or no Black men at all, yet these drugs go on to be widely prescribed to all men with prostate cancer.”

Results Are ‘Reassuring’

Reizine described the overall study findings as “reassuring,” especially in light of “studies that show that abiraterone and prednisone may be associated with worse cardiovascular outcomes. This study showed that in this VA population, even for patients who had cardiovascular disease, there was not a difference in how they did.”

As for choosing between agents, she recommended considering comorbidities and potential drug-drug interactions. “One of the big reasons that you may not be able to safely prescribe enzalutamide, for instance, is if a patient is on an anticoagulant, which is incredibly common in cancer patients. Enzalutamide has more drug-drug interactions than abiraterone and prednisone.” 

Study Demographics and Findings

The study included all patients with mHSPC who initiated abiraterone or enzalutamide between July 2017 and April 2023.

Median ages were 73 (abiraterone) and 74 years (enzalutamide, P = .29). Racial distribution was similar between groups: abiraterone (68.1% White, 25.0% Black, 6.9% other/unknown) and enzalutamide (66.6% White, 27.0% Black, 6.4% other/unknown; P = .74). Ethnicity was 89.2% non-Hispanic, 4.4% Hispanic, and 6.4% unknown in the abiraterone group vs 88.4% non-Hispanic, 3.5% Hispanic, and 8.0% unknown in the enzalutamide group (P = .50).

The groups had similar rates of the most common comorbidities: diabetes (40.5% vs 46.3%, respectively, P = .07), peripheral vascular disease (40.2% vs 37.6%, respectively, P = .44), and chronic pulmonary disease (37.0% vs 40.5%, P = .29).

In an inverse probability weighting analysis with abiraterone as reference, weighted median overall survival was comparable across the entire cohort (36.2 months, P = .32), Black veterans (39.7 months, P = .90), and those with cardiovascular disease (31.5 months, P = .30).

The authors noted limitations such as the observational cohort design and data constraints. 

The study was supported by the American Society of Clinical Oncology Conquer Cancer Foundation, the Prostate Cancer Foundation, and the Blavatnik Family Foundation.

Schoen discloses relationships with the Prostate Cancer Foundation, Astellas, and US Department of Defense. Other authors disclose relationships with the American Society of Clinical Oncology, Pfizer, Exelixis, Eli Lilly, Sanofi, Merck, Seagen, Bellicum, and BMS.

Outside the submitted work. Reizine discloses relationships with the US Department of Defense, Sanofi, Exelexis, Janssen, AstraZeneca, EMD Serono, Janssen, Merck, and Tempus.

Abiraterone and enzalutamide showed identical survival outcomes when used as first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC), according to a new study using US Department of Veterans Affairs (VA) data. The report represents the first head-to-head clinical analysis of these commonly used androgen receptor inhibitors.

Among 1258 veterans treated with abiraterone and 311 treated with enzalutamide, median overall survival was 36.2 months for both drugs. Patients were followed for a mean of 28.7 months (abiraterone) and 30.8 months (enzalutamide), reported by Martin W. Schoen, MD, MPH, from Saint Louis University School of Medicine and the St. Louis VA Medical Center, in JAMA Network Open. 

Notably, there was no significant difference in outcomes among Black veterans, who often have poorer outcomes in prostate cancer, and in patients with cardiovascular disease.

“This is the first direct comparison of abiraterone and enzalutamide for mHSPC in a clinical practice setting,” Schoen told Federal Practitioner. “At the population level, there are no differences based on initial treatment choice.”

Abiraterone Is Preferred in the VA Due to Cost

According to Schoen, abiraterone and enzalutamide are the most commonly used androgen receptor inhibitors to treat mHSPC within the VA. A 2025 study by Schoen and colleagues found that 53.7% of veterans with mHSPC in 2022 received androgen receptor inhibitor therapy, up from 16.9% in 2017. 

“In the VA, the preference for most patients is abiraterone since it is the least expensive agent,” he said. A generic version has been available for several years.

Additionally, abiraterone “has been on the market for the longest, and therefore clinicians are familiar with its use,” Schoen said. However, “clinicians have little idea of the comparative efficacy between these 2 agents,” he added.

The authors suggest that the cost and toxicities of the medications should guide clinician decisions, Schoen said. “There is data that abiraterone may worsen diabetes, since it is given with prednisone and could increase the risk of cardiovascular events,” he said.

He added that 2 newer drugs, apalutamide and darolutamide, are also “viable options.” Chemotherapies and certain targeted drugs are also available, “but they are only used in a select group of patients.”

Outside Specialist: Diverse Study Population Is a Plus

Hematologist-oncologist Natalie Reizine, MD, of the University of Illinois College of Medicine, Chicago, who was not involved in the study, told Federal Practitioner that the real-world data are valuable given the limitations of clinical trial populations.

“It’s difficult to compare clinical trials because they enroll different groups of patients,” she said. And, she said, they often exclude patients with significant comorbidities. “If they have bad cardiovascular disease, for instance, or poorly controlled diabetes, they're excluded from the clinical trial. But in real life, many of our patients have other medical problems that we have to manage.”

Reizine also emphasized the significance of the study’s diverse patient population. “Black men are very underrepresented in clinical trials. Many clinical trials that lead to drug approval will have only few or no Black men at all, yet these drugs go on to be widely prescribed to all men with prostate cancer.”

Results Are ‘Reassuring’

Reizine described the overall study findings as “reassuring,” especially in light of “studies that show that abiraterone and prednisone may be associated with worse cardiovascular outcomes. This study showed that in this VA population, even for patients who had cardiovascular disease, there was not a difference in how they did.”

As for choosing between agents, she recommended considering comorbidities and potential drug-drug interactions. “One of the big reasons that you may not be able to safely prescribe enzalutamide, for instance, is if a patient is on an anticoagulant, which is incredibly common in cancer patients. Enzalutamide has more drug-drug interactions than abiraterone and prednisone.” 

Study Demographics and Findings

The study included all patients with mHSPC who initiated abiraterone or enzalutamide between July 2017 and April 2023.

Median ages were 73 (abiraterone) and 74 years (enzalutamide, P = .29). Racial distribution was similar between groups: abiraterone (68.1% White, 25.0% Black, 6.9% other/unknown) and enzalutamide (66.6% White, 27.0% Black, 6.4% other/unknown; P = .74). Ethnicity was 89.2% non-Hispanic, 4.4% Hispanic, and 6.4% unknown in the abiraterone group vs 88.4% non-Hispanic, 3.5% Hispanic, and 8.0% unknown in the enzalutamide group (P = .50).

The groups had similar rates of the most common comorbidities: diabetes (40.5% vs 46.3%, respectively, P = .07), peripheral vascular disease (40.2% vs 37.6%, respectively, P = .44), and chronic pulmonary disease (37.0% vs 40.5%, P = .29).

In an inverse probability weighting analysis with abiraterone as reference, weighted median overall survival was comparable across the entire cohort (36.2 months, P = .32), Black veterans (39.7 months, P = .90), and those with cardiovascular disease (31.5 months, P = .30).

The authors noted limitations such as the observational cohort design and data constraints. 

The study was supported by the American Society of Clinical Oncology Conquer Cancer Foundation, the Prostate Cancer Foundation, and the Blavatnik Family Foundation.

Schoen discloses relationships with the Prostate Cancer Foundation, Astellas, and US Department of Defense. Other authors disclose relationships with the American Society of Clinical Oncology, Pfizer, Exelixis, Eli Lilly, Sanofi, Merck, Seagen, Bellicum, and BMS.

Outside the submitted work. Reizine discloses relationships with the US Department of Defense, Sanofi, Exelexis, Janssen, AstraZeneca, EMD Serono, Janssen, Merck, and Tempus.

TOPLINE: COVID-19 infection is associated with a 25% reduction in cancer risk over 3 years among veterans who survived the initial infection. This protective effect was observed across sexes and racial groups, with stronger benefits seen in older patients and those with mild disease.

METHODOLOGY: 

• Researchers conducted a retrospective cohort study comparing Veterans who tested positive for COVID-19 between March 15, 2020, and November 30, 2020, to those who tested negative.

• Analysis included 499,396 veterans, with 88,590 (17.2%) COVID-19 positive and 427,566 (82.8%) COVID-19 negative patients, with mean (SD) ages of 57.9 (16.4) and 59.5 (15.8) years, respectively.

• Investigators utilized Cox proportional hazard regression models to determine the hazard ratio of new cancer diagnosis within a three-year follow-up period.

• Patient characteristics included age, race, ethnicity, sex, BMI, smoking status, and various comorbidities as covariates in the analysis.

TAKEAWAY:

• For patients surviving ≥ 30 days after COVID-19 testing, infection was associated with a 25% reduction in cancer hazard (hazard ratio [HR], 0.75; 95% CI, 0.73-0.77).

• The reduction in cancer risk was similar across sexes and races, with the exception of Asians, and showed greater decreases with advancing age above 45 years.

• Patients with mild COVID-19 showed the strongest reduction in cancer risk (adjusted HR, 0.72; 95% CI, 0.70-0.74), while those with moderate COVID-19 showed an 11% reduction (adjusted HR, 0.89; 95% CI, 0.83-0.93), and severe COVID-19 showed no significant reduction in cancer risk.

IN PRACTICE: "Regarding age, the incidence of cancer appeared to decrease with each decade of life in the COVID-19 group com­pared to that in the non-exposed group,” the authors noted. “This is surprising, given that cancer diagnoses typically increase with age.” 

SOURCE: The study was led by researchers at the Miami Veterans Affairs (VA) Healthcare System Geriatric Research, Education, and Clinical Center and was published online on August 25 in PLoS One.

LIMITATIONS: The findings of this retrospective and observational study should be interpreted with caution. Results may not be generalizable beyond the predominantly male, older veteran population. The 3-year follow-up period may be insufficient to fully understand long-term cancer incidence patterns. Researchers could not capture all COVID-19 reinfection cases due to testing occurring outside the Veterans Affairs system, including at-home testing. The impact of vaccination status and reinfection on cancer risk could not be fully assessed, as the initial study cohort was grouped prior to vaccine availability.

DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.

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

TOPLINE: COVID-19 infection is associated with a 25% reduction in cancer risk over 3 years among veterans who survived the initial infection. This protective effect was observed across sexes and racial groups, with stronger benefits seen in older patients and those with mild disease.

METHODOLOGY: 

• Researchers conducted a retrospective cohort study comparing Veterans who tested positive for COVID-19 between March 15, 2020, and November 30, 2020, to those who tested negative.

• Analysis included 499,396 veterans, with 88,590 (17.2%) COVID-19 positive and 427,566 (82.8%) COVID-19 negative patients, with mean (SD) ages of 57.9 (16.4) and 59.5 (15.8) years, respectively.

• Investigators utilized Cox proportional hazard regression models to determine the hazard ratio of new cancer diagnosis within a three-year follow-up period.

• Patient characteristics included age, race, ethnicity, sex, BMI, smoking status, and various comorbidities as covariates in the analysis.

TAKEAWAY:

• For patients surviving ≥ 30 days after COVID-19 testing, infection was associated with a 25% reduction in cancer hazard (hazard ratio [HR], 0.75; 95% CI, 0.73-0.77).

• The reduction in cancer risk was similar across sexes and races, with the exception of Asians, and showed greater decreases with advancing age above 45 years.

• Patients with mild COVID-19 showed the strongest reduction in cancer risk (adjusted HR, 0.72; 95% CI, 0.70-0.74), while those with moderate COVID-19 showed an 11% reduction (adjusted HR, 0.89; 95% CI, 0.83-0.93), and severe COVID-19 showed no significant reduction in cancer risk.

IN PRACTICE: "Regarding age, the incidence of cancer appeared to decrease with each decade of life in the COVID-19 group com­pared to that in the non-exposed group,” the authors noted. “This is surprising, given that cancer diagnoses typically increase with age.” 

SOURCE: The study was led by researchers at the Miami Veterans Affairs (VA) Healthcare System Geriatric Research, Education, and Clinical Center and was published online on August 25 in PLoS One.

LIMITATIONS: The findings of this retrospective and observational study should be interpreted with caution. Results may not be generalizable beyond the predominantly male, older veteran population. The 3-year follow-up period may be insufficient to fully understand long-term cancer incidence patterns. Researchers could not capture all COVID-19 reinfection cases due to testing occurring outside the Veterans Affairs system, including at-home testing. The impact of vaccination status and reinfection on cancer risk could not be fully assessed, as the initial study cohort was grouped prior to vaccine availability.

DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.

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

TOPLINE: COVID-19 infection is associated with a 25% reduction in cancer risk over 3 years among veterans who survived the initial infection. This protective effect was observed across sexes and racial groups, with stronger benefits seen in older patients and those with mild disease.

METHODOLOGY: 

• Researchers conducted a retrospective cohort study comparing Veterans who tested positive for COVID-19 between March 15, 2020, and November 30, 2020, to those who tested negative.

• Analysis included 499,396 veterans, with 88,590 (17.2%) COVID-19 positive and 427,566 (82.8%) COVID-19 negative patients, with mean (SD) ages of 57.9 (16.4) and 59.5 (15.8) years, respectively.

• Investigators utilized Cox proportional hazard regression models to determine the hazard ratio of new cancer diagnosis within a three-year follow-up period.

• Patient characteristics included age, race, ethnicity, sex, BMI, smoking status, and various comorbidities as covariates in the analysis.

TAKEAWAY:

• For patients surviving ≥ 30 days after COVID-19 testing, infection was associated with a 25% reduction in cancer hazard (hazard ratio [HR], 0.75; 95% CI, 0.73-0.77).

• The reduction in cancer risk was similar across sexes and races, with the exception of Asians, and showed greater decreases with advancing age above 45 years.

• Patients with mild COVID-19 showed the strongest reduction in cancer risk (adjusted HR, 0.72; 95% CI, 0.70-0.74), while those with moderate COVID-19 showed an 11% reduction (adjusted HR, 0.89; 95% CI, 0.83-0.93), and severe COVID-19 showed no significant reduction in cancer risk.

IN PRACTICE: "Regarding age, the incidence of cancer appeared to decrease with each decade of life in the COVID-19 group com­pared to that in the non-exposed group,” the authors noted. “This is surprising, given that cancer diagnoses typically increase with age.” 

SOURCE: The study was led by researchers at the Miami Veterans Affairs (VA) Healthcare System Geriatric Research, Education, and Clinical Center and was published online on August 25 in PLoS One.

LIMITATIONS: The findings of this retrospective and observational study should be interpreted with caution. Results may not be generalizable beyond the predominantly male, older veteran population. The 3-year follow-up period may be insufficient to fully understand long-term cancer incidence patterns. Researchers could not capture all COVID-19 reinfection cases due to testing occurring outside the Veterans Affairs system, including at-home testing. The impact of vaccination status and reinfection on cancer risk could not be fully assessed, as the initial study cohort was grouped prior to vaccine availability.

DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.

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

Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study. 

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”

Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study. 

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”

Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study. 

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”