User login
Famotidine Injection Recalled in US
, according to a company announcement posted on the FDA website.
The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.
The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution.
Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death.
Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking.
Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.
Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug.
Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use.
For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at productcomplaint.USA@fresenius-kabi.com.
Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program.
A version of this article appeared on Medscape.com.
, according to a company announcement posted on the FDA website.
The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.
The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution.
Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death.
Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking.
Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.
Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug.
Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use.
For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at productcomplaint.USA@fresenius-kabi.com.
Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program.
A version of this article appeared on Medscape.com.
, according to a company announcement posted on the FDA website.
The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.
The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution.
Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death.
Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking.
Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.
Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug.
Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use.
For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at productcomplaint.USA@fresenius-kabi.com.
Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program.
A version of this article appeared on Medscape.com.
Duodenal Mucosal Resurfacing Curbs Weight Gain Post-GLP-1
, initial results of the open-label, multistage REMAIN-1 trial showed.
In addition, “the procedure was well tolerated, with only minor, transient TEAEs [treatment-emergent adverse events] consistent with routine upper endoscopy,” said Shailendra Singh, MD, of West Virginia University in Morgantown, West Virginia, who presented the findings at The Obesity Society’s Obesity Week 2025 meeting in Atlanta.
DMR uses hydrothermal ablation to treat the duodenal mucosa, which may be dysfunctional in both obesity and impaired glucose tolerance. A previous pooled clinical trial analysis of more than 100 patients with type 2 diabetes demonstrated that DMR helped patients maintain body weight loss up to 48 weeks post-procedure.
Metabolic therapeutics company Fractyl Health, Burlington, Massachusetts, developed the procedure, called Revita, and is sponsoring the current study. The trial’s aim is to determine the effect of DMR on weight-loss maintenance in patients with ≥ 15% total body weight loss using a GLP-1 RA in both an open-label arm and a prospective, randomized, double-blind, sham-controlled multicenter arm.
‘Encouraging Preliminary Findings’
The open-label arm included 15 DMR-treated participants (mean age, 49 years, 87% female ), all of whom had taken tirzepatide for a minimum of 5 months and a maximum of 3 years prior to DMR and had lost at least 15% of their total body weight.
Participants had a mean pre-GLP-1 RA weight of 104.8 kg and a mean weight prior to DMR of 79.4 kg, for a mean total body weight loss from the start of GLP-1 RA of 23.8%. Weight loss was heterogeneous and reflective of the real-world patient population taking GLP-1 medications, according to the poster presentation.
Participants discontinued their GLP-1 medication, underwent the DMR procedure, and were followed for 3 months. A total of 12 of 13 patients maintained or lost weight at that point, with 6 of 13 losing additional weight.
Specifically, participants experienced a median of 0.46% weight change (approximately 1 lb) compared with the 5%-6% weight regain (10-15 lb) observed after GLP-1 discontinuation in the literature.
The procedure was well tolerated, with most patients experiencing no TEAEs and none experiencing an event greater than grade 1. Grade 1 events occurred in three patients; 23% were transient in nature, lasting 2-5 days, and were similar to those typically seen with a routine upper endoscopy.
“These encouraging preliminary findings suggest that DMR may safely achieve durable weight maintenance for patients who wish to discontinue GLP-1 RA therapy,” the study authors stated.
Randomization is anticipated in early 2026, with 6-month topline data and a potential premarket approval filing expected in the second half of 2026.
A version of this article appeared on Medscape.com.
, initial results of the open-label, multistage REMAIN-1 trial showed.
In addition, “the procedure was well tolerated, with only minor, transient TEAEs [treatment-emergent adverse events] consistent with routine upper endoscopy,” said Shailendra Singh, MD, of West Virginia University in Morgantown, West Virginia, who presented the findings at The Obesity Society’s Obesity Week 2025 meeting in Atlanta.
DMR uses hydrothermal ablation to treat the duodenal mucosa, which may be dysfunctional in both obesity and impaired glucose tolerance. A previous pooled clinical trial analysis of more than 100 patients with type 2 diabetes demonstrated that DMR helped patients maintain body weight loss up to 48 weeks post-procedure.
Metabolic therapeutics company Fractyl Health, Burlington, Massachusetts, developed the procedure, called Revita, and is sponsoring the current study. The trial’s aim is to determine the effect of DMR on weight-loss maintenance in patients with ≥ 15% total body weight loss using a GLP-1 RA in both an open-label arm and a prospective, randomized, double-blind, sham-controlled multicenter arm.
‘Encouraging Preliminary Findings’
The open-label arm included 15 DMR-treated participants (mean age, 49 years, 87% female ), all of whom had taken tirzepatide for a minimum of 5 months and a maximum of 3 years prior to DMR and had lost at least 15% of their total body weight.
Participants had a mean pre-GLP-1 RA weight of 104.8 kg and a mean weight prior to DMR of 79.4 kg, for a mean total body weight loss from the start of GLP-1 RA of 23.8%. Weight loss was heterogeneous and reflective of the real-world patient population taking GLP-1 medications, according to the poster presentation.
Participants discontinued their GLP-1 medication, underwent the DMR procedure, and were followed for 3 months. A total of 12 of 13 patients maintained or lost weight at that point, with 6 of 13 losing additional weight.
Specifically, participants experienced a median of 0.46% weight change (approximately 1 lb) compared with the 5%-6% weight regain (10-15 lb) observed after GLP-1 discontinuation in the literature.
The procedure was well tolerated, with most patients experiencing no TEAEs and none experiencing an event greater than grade 1. Grade 1 events occurred in three patients; 23% were transient in nature, lasting 2-5 days, and were similar to those typically seen with a routine upper endoscopy.
“These encouraging preliminary findings suggest that DMR may safely achieve durable weight maintenance for patients who wish to discontinue GLP-1 RA therapy,” the study authors stated.
Randomization is anticipated in early 2026, with 6-month topline data and a potential premarket approval filing expected in the second half of 2026.
A version of this article appeared on Medscape.com.
, initial results of the open-label, multistage REMAIN-1 trial showed.
In addition, “the procedure was well tolerated, with only minor, transient TEAEs [treatment-emergent adverse events] consistent with routine upper endoscopy,” said Shailendra Singh, MD, of West Virginia University in Morgantown, West Virginia, who presented the findings at The Obesity Society’s Obesity Week 2025 meeting in Atlanta.
DMR uses hydrothermal ablation to treat the duodenal mucosa, which may be dysfunctional in both obesity and impaired glucose tolerance. A previous pooled clinical trial analysis of more than 100 patients with type 2 diabetes demonstrated that DMR helped patients maintain body weight loss up to 48 weeks post-procedure.
Metabolic therapeutics company Fractyl Health, Burlington, Massachusetts, developed the procedure, called Revita, and is sponsoring the current study. The trial’s aim is to determine the effect of DMR on weight-loss maintenance in patients with ≥ 15% total body weight loss using a GLP-1 RA in both an open-label arm and a prospective, randomized, double-blind, sham-controlled multicenter arm.
‘Encouraging Preliminary Findings’
The open-label arm included 15 DMR-treated participants (mean age, 49 years, 87% female ), all of whom had taken tirzepatide for a minimum of 5 months and a maximum of 3 years prior to DMR and had lost at least 15% of their total body weight.
Participants had a mean pre-GLP-1 RA weight of 104.8 kg and a mean weight prior to DMR of 79.4 kg, for a mean total body weight loss from the start of GLP-1 RA of 23.8%. Weight loss was heterogeneous and reflective of the real-world patient population taking GLP-1 medications, according to the poster presentation.
Participants discontinued their GLP-1 medication, underwent the DMR procedure, and were followed for 3 months. A total of 12 of 13 patients maintained or lost weight at that point, with 6 of 13 losing additional weight.
Specifically, participants experienced a median of 0.46% weight change (approximately 1 lb) compared with the 5%-6% weight regain (10-15 lb) observed after GLP-1 discontinuation in the literature.
The procedure was well tolerated, with most patients experiencing no TEAEs and none experiencing an event greater than grade 1. Grade 1 events occurred in three patients; 23% were transient in nature, lasting 2-5 days, and were similar to those typically seen with a routine upper endoscopy.
“These encouraging preliminary findings suggest that DMR may safely achieve durable weight maintenance for patients who wish to discontinue GLP-1 RA therapy,” the study authors stated.
Randomization is anticipated in early 2026, with 6-month topline data and a potential premarket approval filing expected in the second half of 2026.
A version of this article appeared on Medscape.com.
Seladelpar Reduces Pruritus Measures in Primary Biliary Cholangitis
PHOENIX — , supporting the drug’s benefits for the large percentage of patients who may fail to improve with or become intolerant of standard PBC therapy.
“This pooled analysis demonstrated that seladelpar treatment for up to 6 months reduced pruritus to a greater extent vs placebo in patients with PBC who had moderate-to-severe pruritus at baseline,” said senior author Marlyn J. Mayo, MD, AGAF, of the Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, in presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
In PBC, a rare, chronic liver disease that can progressively destroy the intrahepatic bile ducts, ursodeoxycholic acid (UDCA) has remained a highly effective standard of care; however, up to 40% of patients either fail to achieve a biochemical response or develop intolerances to the therapy.
Seladelpar, in addition to improving measures of PBC disease including liver function tests and markers of cholestasis, has been shown in clinical trials to reduce the symptoms of pruritus and related sleep disturbances.
The drug is approved by the FDA for the treatment of PBC in combination with UDCA when patients fail to have an adequate response to UDCA alone, or as monotherapy when patients are intolerant to UDCA.
With pruritus, or itching, representing a key detrimental symptom of PBC and affecting as many as 70% of patients, Mayo and her colleagues conducted a pooled analysis of two phase 3, placebo-controlled trials, the ENHANCE and RESPONSE trials, in order to delve deeper into the specifics of how seladelpar improves itching.
The studies both involved patients with PBC and moderate-to-severe pruritus at baseline who had an inadequate response to UDCA and received seladelpar as add-on therapy to the drug, if tolerant of UDCA.
In the ENHANCE trial, patients were randomized 1:1:1 to daily oral seladelpar 5 mg, 10 mg, or placebo for 52 weeks, and in the RESPONSE trial, they were randomized 2:1 to daily oral seladelpar 10 mg or placebo for 52 weeks.
The ENHANCE trial was terminated early with key endpoints amended to 3 months.
In total, the analysis included 126 patients with a pruritus numerical rating scale (NRS) score of at least 4 at baseline (indicative of moderate-to-severe itch), with 76 patients receiving seladelpar 10 mg and 50 receiving placebo.
Patients in the two groups had a mean age of 53 years; 96% were female; their mean age at PBC diagnosis was 47 years; and itch scores — including the NRS, PBC-40 itch domain, and 5-D itch scale scores — were similar across the treatment and placebo groups at baseline.
After 6 months, patients treated with seladelpar reported greater improvements than those receiving placebo across all measures.
For changes in pruritus NRS through month 6, greater decreases were observed with seladelpar 10 mg at months 1, 3, and 6, with a 6-month decrease from baseline of 3.33 in the seladelpar group vs 1.77 with placebo (P < .01).
For PBC-40 itch domain scores, the mean reduction from baseline at 6 months was 2.41 vs 0.98, although significance was lost at month 6 due to a reduction in numbers.
For the 5-D itch total scores, the mean reduction from baseline to 6 months was 5.09 vs 1.70 (P < .0001).
And for the 5-D itch degree, the domain scores were also improved with seladelpar (mean reduction from baseline to 6 months of 1.08 vs 0.47; P = .01).
Patients treated with seladelpar also showed greater improvement in the sleep disturbances that can accompany pruritus, including on the 5-D itch Sleep Item scale (P < .01 at 6 months) and the PBC-40 Sleep Disturbance Item (P < .0001 at 1 month vs placebo; not significant at 6 months).
There were no significant differences between the groups in safety or tolerability profiles overall, with any adverse events occurring in 57 of the 76 (75%) patients receiving seladelpar and 40 of 50 (80%) receiving placebo.
Grade 3 or higher adverse events occurred in 8% of seladelpar and 12% of placebo patients, and pruritus-specific adverse events occurred in 8% and 14%, respectively.
“We found that improvement versus placebo was evident at month 1 of treatment and was sustained through month 6 using three different measures of pruritus,” Mayo said.
“And improvements in sleep disturbance were also seen in patients receiving seladelpar vs placebo through month 6 using two different measures of (5-D itch and PBC-40).”
Mayo noted that seladelpar is currently the only FDA-approved second-line therapy for people who have not had an adequate biochemical response or cannot tolerate UDCA.
While the drug is not likely at a point where it could be positioned as a first-line itch therapy, Mayo suggested that, for those who have had a poor response to UDCA, “I think it makes sense to start with something like this and then see how patients’ itching is affected by the drug.”
“It’s possible it could help avoid having to add yet another drug to treat the itch, and the hope is that this will help reduce the issue of polypharmacy.”
Commenting on the study, Luis F. Lara, MD, Division Chief of Digestive Diseases at the University of Cincinnati in Cincinnati, who co-moderated the session, underscored the need for treatment among patients who fail to respond to standard therapy.
“I think this is very important research,” he told GI & Hepatology News. “First, the fact that so many patients suffer their pruritus without any therapy is actually disturbing.”
“And the fact that this medication seems to be extremely effective in treating this, likely tremendously affecting patients’ quality of life, is something to really highlight.”
Lara noted that the findings raise the question of “whether this should be considered earlier in the disease process, rather than waiting to use it as a second-line therapy, when pruritus has already become significant.”
Akwi W. Asombang, MD, interventional enterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School in Boston, who was also a co-moderator, agreed that “having a disease process that results in itching all the time can represent profound discomfort and a significant quality of life issue.”
“So, to have a drug that could minimize or alleviate that process could be huge,” Asombang told GI & Hepatology News.
The ENHANCE and RESPONSE trials were funded by Gilead Sciences. Mayo’s disclosures included consulting and/or other relationships with CymaBay Therapeutics, GSK, Intra-Sana, Ipsen, Mirum Pharma, and Target PharmaSolutions. Lara disclosed having a relationship with AbbVie. Asombang reported having no disclosures.
A version of this article appeared on Medscape.com .
PHOENIX — , supporting the drug’s benefits for the large percentage of patients who may fail to improve with or become intolerant of standard PBC therapy.
“This pooled analysis demonstrated that seladelpar treatment for up to 6 months reduced pruritus to a greater extent vs placebo in patients with PBC who had moderate-to-severe pruritus at baseline,” said senior author Marlyn J. Mayo, MD, AGAF, of the Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, in presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
In PBC, a rare, chronic liver disease that can progressively destroy the intrahepatic bile ducts, ursodeoxycholic acid (UDCA) has remained a highly effective standard of care; however, up to 40% of patients either fail to achieve a biochemical response or develop intolerances to the therapy.
Seladelpar, in addition to improving measures of PBC disease including liver function tests and markers of cholestasis, has been shown in clinical trials to reduce the symptoms of pruritus and related sleep disturbances.
The drug is approved by the FDA for the treatment of PBC in combination with UDCA when patients fail to have an adequate response to UDCA alone, or as monotherapy when patients are intolerant to UDCA.
With pruritus, or itching, representing a key detrimental symptom of PBC and affecting as many as 70% of patients, Mayo and her colleagues conducted a pooled analysis of two phase 3, placebo-controlled trials, the ENHANCE and RESPONSE trials, in order to delve deeper into the specifics of how seladelpar improves itching.
The studies both involved patients with PBC and moderate-to-severe pruritus at baseline who had an inadequate response to UDCA and received seladelpar as add-on therapy to the drug, if tolerant of UDCA.
In the ENHANCE trial, patients were randomized 1:1:1 to daily oral seladelpar 5 mg, 10 mg, or placebo for 52 weeks, and in the RESPONSE trial, they were randomized 2:1 to daily oral seladelpar 10 mg or placebo for 52 weeks.
The ENHANCE trial was terminated early with key endpoints amended to 3 months.
In total, the analysis included 126 patients with a pruritus numerical rating scale (NRS) score of at least 4 at baseline (indicative of moderate-to-severe itch), with 76 patients receiving seladelpar 10 mg and 50 receiving placebo.
Patients in the two groups had a mean age of 53 years; 96% were female; their mean age at PBC diagnosis was 47 years; and itch scores — including the NRS, PBC-40 itch domain, and 5-D itch scale scores — were similar across the treatment and placebo groups at baseline.
After 6 months, patients treated with seladelpar reported greater improvements than those receiving placebo across all measures.
For changes in pruritus NRS through month 6, greater decreases were observed with seladelpar 10 mg at months 1, 3, and 6, with a 6-month decrease from baseline of 3.33 in the seladelpar group vs 1.77 with placebo (P < .01).
For PBC-40 itch domain scores, the mean reduction from baseline at 6 months was 2.41 vs 0.98, although significance was lost at month 6 due to a reduction in numbers.
For the 5-D itch total scores, the mean reduction from baseline to 6 months was 5.09 vs 1.70 (P < .0001).
And for the 5-D itch degree, the domain scores were also improved with seladelpar (mean reduction from baseline to 6 months of 1.08 vs 0.47; P = .01).
Patients treated with seladelpar also showed greater improvement in the sleep disturbances that can accompany pruritus, including on the 5-D itch Sleep Item scale (P < .01 at 6 months) and the PBC-40 Sleep Disturbance Item (P < .0001 at 1 month vs placebo; not significant at 6 months).
There were no significant differences between the groups in safety or tolerability profiles overall, with any adverse events occurring in 57 of the 76 (75%) patients receiving seladelpar and 40 of 50 (80%) receiving placebo.
Grade 3 or higher adverse events occurred in 8% of seladelpar and 12% of placebo patients, and pruritus-specific adverse events occurred in 8% and 14%, respectively.
“We found that improvement versus placebo was evident at month 1 of treatment and was sustained through month 6 using three different measures of pruritus,” Mayo said.
“And improvements in sleep disturbance were also seen in patients receiving seladelpar vs placebo through month 6 using two different measures of (5-D itch and PBC-40).”
Mayo noted that seladelpar is currently the only FDA-approved second-line therapy for people who have not had an adequate biochemical response or cannot tolerate UDCA.
While the drug is not likely at a point where it could be positioned as a first-line itch therapy, Mayo suggested that, for those who have had a poor response to UDCA, “I think it makes sense to start with something like this and then see how patients’ itching is affected by the drug.”
“It’s possible it could help avoid having to add yet another drug to treat the itch, and the hope is that this will help reduce the issue of polypharmacy.”
Commenting on the study, Luis F. Lara, MD, Division Chief of Digestive Diseases at the University of Cincinnati in Cincinnati, who co-moderated the session, underscored the need for treatment among patients who fail to respond to standard therapy.
“I think this is very important research,” he told GI & Hepatology News. “First, the fact that so many patients suffer their pruritus without any therapy is actually disturbing.”
“And the fact that this medication seems to be extremely effective in treating this, likely tremendously affecting patients’ quality of life, is something to really highlight.”
Lara noted that the findings raise the question of “whether this should be considered earlier in the disease process, rather than waiting to use it as a second-line therapy, when pruritus has already become significant.”
Akwi W. Asombang, MD, interventional enterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School in Boston, who was also a co-moderator, agreed that “having a disease process that results in itching all the time can represent profound discomfort and a significant quality of life issue.”
“So, to have a drug that could minimize or alleviate that process could be huge,” Asombang told GI & Hepatology News.
The ENHANCE and RESPONSE trials were funded by Gilead Sciences. Mayo’s disclosures included consulting and/or other relationships with CymaBay Therapeutics, GSK, Intra-Sana, Ipsen, Mirum Pharma, and Target PharmaSolutions. Lara disclosed having a relationship with AbbVie. Asombang reported having no disclosures.
A version of this article appeared on Medscape.com .
PHOENIX — , supporting the drug’s benefits for the large percentage of patients who may fail to improve with or become intolerant of standard PBC therapy.
“This pooled analysis demonstrated that seladelpar treatment for up to 6 months reduced pruritus to a greater extent vs placebo in patients with PBC who had moderate-to-severe pruritus at baseline,” said senior author Marlyn J. Mayo, MD, AGAF, of the Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, in presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
In PBC, a rare, chronic liver disease that can progressively destroy the intrahepatic bile ducts, ursodeoxycholic acid (UDCA) has remained a highly effective standard of care; however, up to 40% of patients either fail to achieve a biochemical response or develop intolerances to the therapy.
Seladelpar, in addition to improving measures of PBC disease including liver function tests and markers of cholestasis, has been shown in clinical trials to reduce the symptoms of pruritus and related sleep disturbances.
The drug is approved by the FDA for the treatment of PBC in combination with UDCA when patients fail to have an adequate response to UDCA alone, or as monotherapy when patients are intolerant to UDCA.
With pruritus, or itching, representing a key detrimental symptom of PBC and affecting as many as 70% of patients, Mayo and her colleagues conducted a pooled analysis of two phase 3, placebo-controlled trials, the ENHANCE and RESPONSE trials, in order to delve deeper into the specifics of how seladelpar improves itching.
The studies both involved patients with PBC and moderate-to-severe pruritus at baseline who had an inadequate response to UDCA and received seladelpar as add-on therapy to the drug, if tolerant of UDCA.
In the ENHANCE trial, patients were randomized 1:1:1 to daily oral seladelpar 5 mg, 10 mg, or placebo for 52 weeks, and in the RESPONSE trial, they were randomized 2:1 to daily oral seladelpar 10 mg or placebo for 52 weeks.
The ENHANCE trial was terminated early with key endpoints amended to 3 months.
In total, the analysis included 126 patients with a pruritus numerical rating scale (NRS) score of at least 4 at baseline (indicative of moderate-to-severe itch), with 76 patients receiving seladelpar 10 mg and 50 receiving placebo.
Patients in the two groups had a mean age of 53 years; 96% were female; their mean age at PBC diagnosis was 47 years; and itch scores — including the NRS, PBC-40 itch domain, and 5-D itch scale scores — were similar across the treatment and placebo groups at baseline.
After 6 months, patients treated with seladelpar reported greater improvements than those receiving placebo across all measures.
For changes in pruritus NRS through month 6, greater decreases were observed with seladelpar 10 mg at months 1, 3, and 6, with a 6-month decrease from baseline of 3.33 in the seladelpar group vs 1.77 with placebo (P < .01).
For PBC-40 itch domain scores, the mean reduction from baseline at 6 months was 2.41 vs 0.98, although significance was lost at month 6 due to a reduction in numbers.
For the 5-D itch total scores, the mean reduction from baseline to 6 months was 5.09 vs 1.70 (P < .0001).
And for the 5-D itch degree, the domain scores were also improved with seladelpar (mean reduction from baseline to 6 months of 1.08 vs 0.47; P = .01).
Patients treated with seladelpar also showed greater improvement in the sleep disturbances that can accompany pruritus, including on the 5-D itch Sleep Item scale (P < .01 at 6 months) and the PBC-40 Sleep Disturbance Item (P < .0001 at 1 month vs placebo; not significant at 6 months).
There were no significant differences between the groups in safety or tolerability profiles overall, with any adverse events occurring in 57 of the 76 (75%) patients receiving seladelpar and 40 of 50 (80%) receiving placebo.
Grade 3 or higher adverse events occurred in 8% of seladelpar and 12% of placebo patients, and pruritus-specific adverse events occurred in 8% and 14%, respectively.
“We found that improvement versus placebo was evident at month 1 of treatment and was sustained through month 6 using three different measures of pruritus,” Mayo said.
“And improvements in sleep disturbance were also seen in patients receiving seladelpar vs placebo through month 6 using two different measures of (5-D itch and PBC-40).”
Mayo noted that seladelpar is currently the only FDA-approved second-line therapy for people who have not had an adequate biochemical response or cannot tolerate UDCA.
While the drug is not likely at a point where it could be positioned as a first-line itch therapy, Mayo suggested that, for those who have had a poor response to UDCA, “I think it makes sense to start with something like this and then see how patients’ itching is affected by the drug.”
“It’s possible it could help avoid having to add yet another drug to treat the itch, and the hope is that this will help reduce the issue of polypharmacy.”
Commenting on the study, Luis F. Lara, MD, Division Chief of Digestive Diseases at the University of Cincinnati in Cincinnati, who co-moderated the session, underscored the need for treatment among patients who fail to respond to standard therapy.
“I think this is very important research,” he told GI & Hepatology News. “First, the fact that so many patients suffer their pruritus without any therapy is actually disturbing.”
“And the fact that this medication seems to be extremely effective in treating this, likely tremendously affecting patients’ quality of life, is something to really highlight.”
Lara noted that the findings raise the question of “whether this should be considered earlier in the disease process, rather than waiting to use it as a second-line therapy, when pruritus has already become significant.”
Akwi W. Asombang, MD, interventional enterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School in Boston, who was also a co-moderator, agreed that “having a disease process that results in itching all the time can represent profound discomfort and a significant quality of life issue.”
“So, to have a drug that could minimize or alleviate that process could be huge,” Asombang told GI & Hepatology News.
The ENHANCE and RESPONSE trials were funded by Gilead Sciences. Mayo’s disclosures included consulting and/or other relationships with CymaBay Therapeutics, GSK, Intra-Sana, Ipsen, Mirum Pharma, and Target PharmaSolutions. Lara disclosed having a relationship with AbbVie. Asombang reported having no disclosures.
A version of this article appeared on Medscape.com .
FROM ACG 2025
Novel Anti-TL1a Antibody Shows Potential for Crohn’s Disease
PHOENIX — , 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 — , 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 — , 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 .
FROM ACG 2025
Developing the Next Generation of GI Leaders
In this episode of Private Practice Perspectives, Dr. Naresh Gunaratnam, current president and board chair of Digestive Health Physician Association, speaks with Dr. Larry Kim, current president of AGA, about .
In this episode of Private Practice Perspectives, Dr. Naresh Gunaratnam, current president and board chair of Digestive Health Physician Association, speaks with Dr. Larry Kim, current president of AGA, about .
In this episode of Private Practice Perspectives, Dr. Naresh Gunaratnam, current president and board chair of Digestive Health Physician Association, speaks with Dr. Larry Kim, current president of AGA, about .
Can Clinical Resource Hubs Address Mental Health Staffing Gaps?
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.
Socioeconomic Status Linked to Psychiatric Disorders in Older Women Veterans
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.
Nine VA Facilities to Open Research Trials for Psychedelics
Nine VA Facilities to Open Research Trials for Psychedelics
On Nov. 22, 2014, 8 years after he came back from Iraq with “crippling” posttraumatic stress disorder (PTSD), Jonathan Lubecky took his first dose of the psychedelic compound methylenedioxymethamphetamine (MDMA). Lubecky, a Marine, Army, and National Guard veteran, described his path to MDMA therapy in in the New Horizons in Health podcast.
After 5 suicide attempts and “the hundreds of times I thought about it or stood on a bridge or had a plan,” he felt he had run out of options. Then, in a counseling session, a psychiatric intern slid a piece of paper across the table to him. It read “Google MDMA PTSD.”
Luckily for Lubecky, a space in a clinical trial opened up, in which he had 8 hours of talk therapy with specially trained therapists, combined with MDMA. “MDMA is a tool that opens up the mind, body and spirit,” he said, “so you can heal and process all those memories and traumas that are causing yourissues. It puts you in a middle place where you can talk about trauma without having panic attacks, without your body betraying you, and look at it from a different perspective.” said he added, “It’s like doing therapy while being hugged by everyone who loves you in a bathtub full of puppies licking your face.” In 2023, 9 years after that first dose, Lubecky said, “I’ve been PTSD free longer than I had it.”
And now, in 2025, the research into psychedelic therapy for veterans like Lubecky is taking another step forward according to a report by Military.com. Nine VA facilities, in the Bronx, Los Angeles, Omaha, Palo Alto, Portland (Oregon), San Diego, San Francisco, West Haven, and White River Junction, are participating in long-term studies to test the safety and clinical impact of psychedelic compounds for PTSD, treatment-resistant depression, and anxiety disorders.
Early trials from Johns Hopkins University, the Multidisciplinary Association for Psychedelic Studies (MAPS), and others found significant symptom reductions for some participants with chronic PTSD. MAPP2, the multisite phase 3 study that extended the findings of MAPP1, found that MDMA-assisted therapy significantly improved PTSD symptoms and functional impairment, compared with placebo-assisted therapy. Notably, of the 52 participants (including 16 veterans) 45 (86%) achieved a clinically meaningful benefit, and 37 (71%) no longer met criteria for PTSD by study end. Despite the promising findings, a US Food and Drug Administration (FDA) advisory panel recommended against approving the treatment.
In 2024 the VA issued a request for applications for proposals from its network of VA researchers and academic institutions to gather “definitive scientific evidence” on the potential efficacy and safety of psychedelic compounds, such as MDMA and psilocybin, when used in conjunction with psychotherapy. It would be the first time since the 1960s that the VA had funded research on such compounds.
Funding proposals for such research have cycled in and out of Congress for years, but have gathered more steam in the last few years. The 2024 National Defense Authorization Act directed the US Department of Defense to establish a process for funding clinical research into the use of certain psychedelic substances to treat PTSD and traumatic brain injury. In April 2024, Representatives Lou Correa (D-CA) and Jack Bergman (R-MI), cochairs of the Psychedelics Advancing Therapies (PATH) caucus, introduced the Innovative Therapies Centers of Excellence Act of 2025, bipartisan legislation that would increase federally funded research on innovative therapies to treat veterans with PTSD, substance use disorder, and depression. It would also, if enacted, direct the VA to create ≥ 5 dedicated centers of excellence to study the therapeutic uses of psychedelic substances. The bill has also been endorsed by the American Legion, Veterans of Foreign Wars, Iraq and Afghanistan Veterans of America, Disabled American Veterans, and the Wounded Warrior Project.
The current administration has two strong high-level supporters of psychedelics research: VA Secretary Doug Collins and US Department of Health and Human Service Secretary Robert F. Kennedy Jr. Sec. Kennedy has castigated the FDA for what he calls “aggressive suppression” of alternative and complementary treatments, including psychedelics. This, although the FDA granted breakthrough therapy status for MDMA for treating PTSD and psilocybin for treating depression in 2018 and 2019, respectively, as well a pivotal draft guidance in 2023 for the development of psychedelic drugs for psychiatric disorders, substance use disorders, and various medical conditions.
Collins, citing an “eye-opening” discussion with Kennedy, enthusiastically backs the research into psychedelics. In a May 2025 hearing that was mainly a series of testy exchanges about his proposed budget slashing, he emphasized the importance of keeping and expanding VA programs and studies on psychedelic treatments, something he has been advocating for since the beginning of his appointment. “We want to make sure we’re not closing off any outlet for a veteran who could be helped by these programs,” he said.
Taking the intern’s advice to look into MDMA, Jonathan Lubecky said, was one of the best decisions he’d ever made. But “it’s not the MDMA that fixes you,” he said. “It’s the therapy. It’s the therapist working with you and you doing the hard work.”
On Nov. 22, 2014, 8 years after he came back from Iraq with “crippling” posttraumatic stress disorder (PTSD), Jonathan Lubecky took his first dose of the psychedelic compound methylenedioxymethamphetamine (MDMA). Lubecky, a Marine, Army, and National Guard veteran, described his path to MDMA therapy in in the New Horizons in Health podcast.
After 5 suicide attempts and “the hundreds of times I thought about it or stood on a bridge or had a plan,” he felt he had run out of options. Then, in a counseling session, a psychiatric intern slid a piece of paper across the table to him. It read “Google MDMA PTSD.”
Luckily for Lubecky, a space in a clinical trial opened up, in which he had 8 hours of talk therapy with specially trained therapists, combined with MDMA. “MDMA is a tool that opens up the mind, body and spirit,” he said, “so you can heal and process all those memories and traumas that are causing yourissues. It puts you in a middle place where you can talk about trauma without having panic attacks, without your body betraying you, and look at it from a different perspective.” said he added, “It’s like doing therapy while being hugged by everyone who loves you in a bathtub full of puppies licking your face.” In 2023, 9 years after that first dose, Lubecky said, “I’ve been PTSD free longer than I had it.”
And now, in 2025, the research into psychedelic therapy for veterans like Lubecky is taking another step forward according to a report by Military.com. Nine VA facilities, in the Bronx, Los Angeles, Omaha, Palo Alto, Portland (Oregon), San Diego, San Francisco, West Haven, and White River Junction, are participating in long-term studies to test the safety and clinical impact of psychedelic compounds for PTSD, treatment-resistant depression, and anxiety disorders.
Early trials from Johns Hopkins University, the Multidisciplinary Association for Psychedelic Studies (MAPS), and others found significant symptom reductions for some participants with chronic PTSD. MAPP2, the multisite phase 3 study that extended the findings of MAPP1, found that MDMA-assisted therapy significantly improved PTSD symptoms and functional impairment, compared with placebo-assisted therapy. Notably, of the 52 participants (including 16 veterans) 45 (86%) achieved a clinically meaningful benefit, and 37 (71%) no longer met criteria for PTSD by study end. Despite the promising findings, a US Food and Drug Administration (FDA) advisory panel recommended against approving the treatment.
In 2024 the VA issued a request for applications for proposals from its network of VA researchers and academic institutions to gather “definitive scientific evidence” on the potential efficacy and safety of psychedelic compounds, such as MDMA and psilocybin, when used in conjunction with psychotherapy. It would be the first time since the 1960s that the VA had funded research on such compounds.
Funding proposals for such research have cycled in and out of Congress for years, but have gathered more steam in the last few years. The 2024 National Defense Authorization Act directed the US Department of Defense to establish a process for funding clinical research into the use of certain psychedelic substances to treat PTSD and traumatic brain injury. In April 2024, Representatives Lou Correa (D-CA) and Jack Bergman (R-MI), cochairs of the Psychedelics Advancing Therapies (PATH) caucus, introduced the Innovative Therapies Centers of Excellence Act of 2025, bipartisan legislation that would increase federally funded research on innovative therapies to treat veterans with PTSD, substance use disorder, and depression. It would also, if enacted, direct the VA to create ≥ 5 dedicated centers of excellence to study the therapeutic uses of psychedelic substances. The bill has also been endorsed by the American Legion, Veterans of Foreign Wars, Iraq and Afghanistan Veterans of America, Disabled American Veterans, and the Wounded Warrior Project.
The current administration has two strong high-level supporters of psychedelics research: VA Secretary Doug Collins and US Department of Health and Human Service Secretary Robert F. Kennedy Jr. Sec. Kennedy has castigated the FDA for what he calls “aggressive suppression” of alternative and complementary treatments, including psychedelics. This, although the FDA granted breakthrough therapy status for MDMA for treating PTSD and psilocybin for treating depression in 2018 and 2019, respectively, as well a pivotal draft guidance in 2023 for the development of psychedelic drugs for psychiatric disorders, substance use disorders, and various medical conditions.
Collins, citing an “eye-opening” discussion with Kennedy, enthusiastically backs the research into psychedelics. In a May 2025 hearing that was mainly a series of testy exchanges about his proposed budget slashing, he emphasized the importance of keeping and expanding VA programs and studies on psychedelic treatments, something he has been advocating for since the beginning of his appointment. “We want to make sure we’re not closing off any outlet for a veteran who could be helped by these programs,” he said.
Taking the intern’s advice to look into MDMA, Jonathan Lubecky said, was one of the best decisions he’d ever made. But “it’s not the MDMA that fixes you,” he said. “It’s the therapy. It’s the therapist working with you and you doing the hard work.”
On Nov. 22, 2014, 8 years after he came back from Iraq with “crippling” posttraumatic stress disorder (PTSD), Jonathan Lubecky took his first dose of the psychedelic compound methylenedioxymethamphetamine (MDMA). Lubecky, a Marine, Army, and National Guard veteran, described his path to MDMA therapy in in the New Horizons in Health podcast.
After 5 suicide attempts and “the hundreds of times I thought about it or stood on a bridge or had a plan,” he felt he had run out of options. Then, in a counseling session, a psychiatric intern slid a piece of paper across the table to him. It read “Google MDMA PTSD.”
Luckily for Lubecky, a space in a clinical trial opened up, in which he had 8 hours of talk therapy with specially trained therapists, combined with MDMA. “MDMA is a tool that opens up the mind, body and spirit,” he said, “so you can heal and process all those memories and traumas that are causing yourissues. It puts you in a middle place where you can talk about trauma without having panic attacks, without your body betraying you, and look at it from a different perspective.” said he added, “It’s like doing therapy while being hugged by everyone who loves you in a bathtub full of puppies licking your face.” In 2023, 9 years after that first dose, Lubecky said, “I’ve been PTSD free longer than I had it.”
And now, in 2025, the research into psychedelic therapy for veterans like Lubecky is taking another step forward according to a report by Military.com. Nine VA facilities, in the Bronx, Los Angeles, Omaha, Palo Alto, Portland (Oregon), San Diego, San Francisco, West Haven, and White River Junction, are participating in long-term studies to test the safety and clinical impact of psychedelic compounds for PTSD, treatment-resistant depression, and anxiety disorders.
Early trials from Johns Hopkins University, the Multidisciplinary Association for Psychedelic Studies (MAPS), and others found significant symptom reductions for some participants with chronic PTSD. MAPP2, the multisite phase 3 study that extended the findings of MAPP1, found that MDMA-assisted therapy significantly improved PTSD symptoms and functional impairment, compared with placebo-assisted therapy. Notably, of the 52 participants (including 16 veterans) 45 (86%) achieved a clinically meaningful benefit, and 37 (71%) no longer met criteria for PTSD by study end. Despite the promising findings, a US Food and Drug Administration (FDA) advisory panel recommended against approving the treatment.
In 2024 the VA issued a request for applications for proposals from its network of VA researchers and academic institutions to gather “definitive scientific evidence” on the potential efficacy and safety of psychedelic compounds, such as MDMA and psilocybin, when used in conjunction with psychotherapy. It would be the first time since the 1960s that the VA had funded research on such compounds.
Funding proposals for such research have cycled in and out of Congress for years, but have gathered more steam in the last few years. The 2024 National Defense Authorization Act directed the US Department of Defense to establish a process for funding clinical research into the use of certain psychedelic substances to treat PTSD and traumatic brain injury. In April 2024, Representatives Lou Correa (D-CA) and Jack Bergman (R-MI), cochairs of the Psychedelics Advancing Therapies (PATH) caucus, introduced the Innovative Therapies Centers of Excellence Act of 2025, bipartisan legislation that would increase federally funded research on innovative therapies to treat veterans with PTSD, substance use disorder, and depression. It would also, if enacted, direct the VA to create ≥ 5 dedicated centers of excellence to study the therapeutic uses of psychedelic substances. The bill has also been endorsed by the American Legion, Veterans of Foreign Wars, Iraq and Afghanistan Veterans of America, Disabled American Veterans, and the Wounded Warrior Project.
The current administration has two strong high-level supporters of psychedelics research: VA Secretary Doug Collins and US Department of Health and Human Service Secretary Robert F. Kennedy Jr. Sec. Kennedy has castigated the FDA for what he calls “aggressive suppression” of alternative and complementary treatments, including psychedelics. This, although the FDA granted breakthrough therapy status for MDMA for treating PTSD and psilocybin for treating depression in 2018 and 2019, respectively, as well a pivotal draft guidance in 2023 for the development of psychedelic drugs for psychiatric disorders, substance use disorders, and various medical conditions.
Collins, citing an “eye-opening” discussion with Kennedy, enthusiastically backs the research into psychedelics. In a May 2025 hearing that was mainly a series of testy exchanges about his proposed budget slashing, he emphasized the importance of keeping and expanding VA programs and studies on psychedelic treatments, something he has been advocating for since the beginning of his appointment. “We want to make sure we’re not closing off any outlet for a veteran who could be helped by these programs,” he said.
Taking the intern’s advice to look into MDMA, Jonathan Lubecky said, was one of the best decisions he’d ever made. But “it’s not the MDMA that fixes you,” he said. “It’s the therapy. It’s the therapist working with you and you doing the hard work.”
Nine VA Facilities to Open Research Trials for Psychedelics
Nine VA Facilities to Open Research Trials for Psychedelics
Pediatric Wilson’s Disease Carries Higher Risk of Worse Outcomes
, according to data from a large single-center study in India.
These findings underscore the importance of early recognition and genetic evaluation in pediatric patients, and timely consideration of liver transplantation in severe presentations, reported lead author Anand V. Kulkarni, MD, of AIG Hospitals, Hyderabad, India, and colleagues.
“There is a lack of large cohort studies evaluating the clinical presentation of WD, along with a limited understanding of genotype–phenotype correlations in patients with WD presenting with liver disease and the absence of comprehensive comparisons between pediatric and adult outcomes,” the investigators wrote in Gastro Hep Advances (2025 Jun. doi: 10.1016/j.gastha.2025.100717). “Additionally, data on living donor liver transplantation (LDLT) outcomes in WD remain scarce.”
To address these gaps, Kulkarni and colleagues performed a single-center retrospective study of all patients with WD diagnosed and managed at AIG Hospitals between June 2020 and April 2024.
Diagnosis followed Leipzig criteria, incorporating clinical features, slit-lamp examination for Kayser–Fleischer rings, serum ceruloplasmin, 24-hour urinary copper, hepatic copper when available, and genetic testing when available.
Patients were stratified by age into pediatric and adult groups. The investigators compared clinical presentation, laboratory parameters, and outcomes across age groups.
Management reflected standard practice at the center: chelation with D-penicillamine or trientine, zinc therapy as monotherapy or adjunctive therapy, plasma exchange for acute liver failure or acute-on-chronic liver failure, and evaluation for living-donor liver transplantation when indicated. Genetic analysis was performed in approximately 70% of the cohort.
The final dataset included 156 patients, with a median age of 19 years (range, 2–57), and an approximately equal split between adult and pediatric groups.
Presentation differed markedly by age. Among pediatric patients, the most common presentations were acute liver failure (26.7%) and acute-on-chronic liver failure (20%). Adults most frequently presented with decompensated cirrhosis (30.9%). Kayser–Fleischer rings were more prevalent in the pediatric group, consistent with underlying disease despite acute presentation.
Outcomes also varied by age and presentation. On Kaplan–Meier analysis, transplant-free survival was 72% in children and 87.7% in adults after a median follow-up of 1.33 years (P = .01). Overall cohort transplant-free survival at 1.33 years was 80.1%. Thirteen percent of patients underwent LDLT, with 90% 1-year post-transplant survival. Among those who received plasma exchange for acute presentations, transplant-free survival was 40.5%.
Among the patients with genetic data, 54.1% were homozygous or compound heterozygous for combinations of pathogenic variants and variants of uncertain significance in ATP7B. The most frequently observed pathogenic variants were p.Gly977Glu, p.Cys271Ter, and p.Asn1186Ser. Several additional variants, including novel changes, were identified across the cohort.
No consistent genotype–phenotype correlation was observed. The investigators noted that the center’s focus on liver disease likely enriched the cohort for hepatic presentations, and that some patients were included based on Leipzig scores of 2-3 with supportive clinical response to therapy.
“Further research should focus on identifying structural variants, variants in other genes, and epigenetic modulators of genetic expression,” Kulkarni and colleagues concluded.
The genetic tests were performed with intramural funding support from the Asian Healthcare Foundation, provided to AIG Hospitals Hyderabad. The investigators disclosed no conflicts of interest.
Wilson’s disease (WD), initially described in 1912 by Dr. Kinnier Wilson, continues to pose a significant challenge to clinicians over a century later. This autosomal recessive disorder is characterized by mutations in ATP7B gene, which impair the body’s capacity to transport and eliminate copper effectively. Although classified as rare, WD has a notable clinical impact. It is estimated to affect approximately 1 in every 30,000 individuals globally. Given the disease’s highly variable presentation, many individuals likely remain undiagnosed or misdiagnosed, and the consequences of delayed treatment are substantial.
The presented study by Kulkarni and colleagues offers a valuable contribution to the understanding of WD, particularly emphasizing the major clinical differences between pediatric and adult patients, and the implications of these differences for management and survival. As the authors note, transplant-free survival was significantly lower in children (72%) compared with adults (87.7%), reflecting the more aggressive natural history at younger ages. This reinforces the need for earlier detection and prompt initiation of chelation therapy when WD is suspected. Another observation is poor transplant-free survival among patients with acute liver failure with plasma exchange (40.5%), which highlights its role may be as a bridge to liver transplant. The genetic analysis is particularly interesting. Although over half of patients carried homozygous or compound heterozygous ATP7B variants, there was no clear genotype–phenotype correlation. This aligns with prior WD literature.
The investigators acknowledge limitations like the center’s focus on liver disease likely selected for hepatically severe WD, and the retrospective design limits completeness of data. Nevertheless, its strengths lie in the relatively large single-center cohort, use of standardized diagnostic criteria, and detailed genetic analysis in 70% of cases. The study reinforces several practical takeaways. Children require heightened vigilance, as their disease often presents suddenly, and timely referral for transplant evaluation is critical in ALF presentations. Long-term survival hinges on early detection and consistent chelation therapy.
Hrishikesh Samant, MD, is medical director, hepatology, at Ochsner Medical Center, Baton Rouge, Louisiana, and associate professor of gastroenterology, LSU Health and Xavier Ochsner College of Medicine, New Orleans. He declared no conflicts of interest.
Wilson’s disease (WD), initially described in 1912 by Dr. Kinnier Wilson, continues to pose a significant challenge to clinicians over a century later. This autosomal recessive disorder is characterized by mutations in ATP7B gene, which impair the body’s capacity to transport and eliminate copper effectively. Although classified as rare, WD has a notable clinical impact. It is estimated to affect approximately 1 in every 30,000 individuals globally. Given the disease’s highly variable presentation, many individuals likely remain undiagnosed or misdiagnosed, and the consequences of delayed treatment are substantial.
The presented study by Kulkarni and colleagues offers a valuable contribution to the understanding of WD, particularly emphasizing the major clinical differences between pediatric and adult patients, and the implications of these differences for management and survival. As the authors note, transplant-free survival was significantly lower in children (72%) compared with adults (87.7%), reflecting the more aggressive natural history at younger ages. This reinforces the need for earlier detection and prompt initiation of chelation therapy when WD is suspected. Another observation is poor transplant-free survival among patients with acute liver failure with plasma exchange (40.5%), which highlights its role may be as a bridge to liver transplant. The genetic analysis is particularly interesting. Although over half of patients carried homozygous or compound heterozygous ATP7B variants, there was no clear genotype–phenotype correlation. This aligns with prior WD literature.
The investigators acknowledge limitations like the center’s focus on liver disease likely selected for hepatically severe WD, and the retrospective design limits completeness of data. Nevertheless, its strengths lie in the relatively large single-center cohort, use of standardized diagnostic criteria, and detailed genetic analysis in 70% of cases. The study reinforces several practical takeaways. Children require heightened vigilance, as their disease often presents suddenly, and timely referral for transplant evaluation is critical in ALF presentations. Long-term survival hinges on early detection and consistent chelation therapy.
Hrishikesh Samant, MD, is medical director, hepatology, at Ochsner Medical Center, Baton Rouge, Louisiana, and associate professor of gastroenterology, LSU Health and Xavier Ochsner College of Medicine, New Orleans. He declared no conflicts of interest.
Wilson’s disease (WD), initially described in 1912 by Dr. Kinnier Wilson, continues to pose a significant challenge to clinicians over a century later. This autosomal recessive disorder is characterized by mutations in ATP7B gene, which impair the body’s capacity to transport and eliminate copper effectively. Although classified as rare, WD has a notable clinical impact. It is estimated to affect approximately 1 in every 30,000 individuals globally. Given the disease’s highly variable presentation, many individuals likely remain undiagnosed or misdiagnosed, and the consequences of delayed treatment are substantial.
The presented study by Kulkarni and colleagues offers a valuable contribution to the understanding of WD, particularly emphasizing the major clinical differences between pediatric and adult patients, and the implications of these differences for management and survival. As the authors note, transplant-free survival was significantly lower in children (72%) compared with adults (87.7%), reflecting the more aggressive natural history at younger ages. This reinforces the need for earlier detection and prompt initiation of chelation therapy when WD is suspected. Another observation is poor transplant-free survival among patients with acute liver failure with plasma exchange (40.5%), which highlights its role may be as a bridge to liver transplant. The genetic analysis is particularly interesting. Although over half of patients carried homozygous or compound heterozygous ATP7B variants, there was no clear genotype–phenotype correlation. This aligns with prior WD literature.
The investigators acknowledge limitations like the center’s focus on liver disease likely selected for hepatically severe WD, and the retrospective design limits completeness of data. Nevertheless, its strengths lie in the relatively large single-center cohort, use of standardized diagnostic criteria, and detailed genetic analysis in 70% of cases. The study reinforces several practical takeaways. Children require heightened vigilance, as their disease often presents suddenly, and timely referral for transplant evaluation is critical in ALF presentations. Long-term survival hinges on early detection and consistent chelation therapy.
Hrishikesh Samant, MD, is medical director, hepatology, at Ochsner Medical Center, Baton Rouge, Louisiana, and associate professor of gastroenterology, LSU Health and Xavier Ochsner College of Medicine, New Orleans. He declared no conflicts of interest.
, according to data from a large single-center study in India.
These findings underscore the importance of early recognition and genetic evaluation in pediatric patients, and timely consideration of liver transplantation in severe presentations, reported lead author Anand V. Kulkarni, MD, of AIG Hospitals, Hyderabad, India, and colleagues.
“There is a lack of large cohort studies evaluating the clinical presentation of WD, along with a limited understanding of genotype–phenotype correlations in patients with WD presenting with liver disease and the absence of comprehensive comparisons between pediatric and adult outcomes,” the investigators wrote in Gastro Hep Advances (2025 Jun. doi: 10.1016/j.gastha.2025.100717). “Additionally, data on living donor liver transplantation (LDLT) outcomes in WD remain scarce.”
To address these gaps, Kulkarni and colleagues performed a single-center retrospective study of all patients with WD diagnosed and managed at AIG Hospitals between June 2020 and April 2024.
Diagnosis followed Leipzig criteria, incorporating clinical features, slit-lamp examination for Kayser–Fleischer rings, serum ceruloplasmin, 24-hour urinary copper, hepatic copper when available, and genetic testing when available.
Patients were stratified by age into pediatric and adult groups. The investigators compared clinical presentation, laboratory parameters, and outcomes across age groups.
Management reflected standard practice at the center: chelation with D-penicillamine or trientine, zinc therapy as monotherapy or adjunctive therapy, plasma exchange for acute liver failure or acute-on-chronic liver failure, and evaluation for living-donor liver transplantation when indicated. Genetic analysis was performed in approximately 70% of the cohort.
The final dataset included 156 patients, with a median age of 19 years (range, 2–57), and an approximately equal split between adult and pediatric groups.
Presentation differed markedly by age. Among pediatric patients, the most common presentations were acute liver failure (26.7%) and acute-on-chronic liver failure (20%). Adults most frequently presented with decompensated cirrhosis (30.9%). Kayser–Fleischer rings were more prevalent in the pediatric group, consistent with underlying disease despite acute presentation.
Outcomes also varied by age and presentation. On Kaplan–Meier analysis, transplant-free survival was 72% in children and 87.7% in adults after a median follow-up of 1.33 years (P = .01). Overall cohort transplant-free survival at 1.33 years was 80.1%. Thirteen percent of patients underwent LDLT, with 90% 1-year post-transplant survival. Among those who received plasma exchange for acute presentations, transplant-free survival was 40.5%.
Among the patients with genetic data, 54.1% were homozygous or compound heterozygous for combinations of pathogenic variants and variants of uncertain significance in ATP7B. The most frequently observed pathogenic variants were p.Gly977Glu, p.Cys271Ter, and p.Asn1186Ser. Several additional variants, including novel changes, were identified across the cohort.
No consistent genotype–phenotype correlation was observed. The investigators noted that the center’s focus on liver disease likely enriched the cohort for hepatic presentations, and that some patients were included based on Leipzig scores of 2-3 with supportive clinical response to therapy.
“Further research should focus on identifying structural variants, variants in other genes, and epigenetic modulators of genetic expression,” Kulkarni and colleagues concluded.
The genetic tests were performed with intramural funding support from the Asian Healthcare Foundation, provided to AIG Hospitals Hyderabad. The investigators disclosed no conflicts of interest.
, according to data from a large single-center study in India.
These findings underscore the importance of early recognition and genetic evaluation in pediatric patients, and timely consideration of liver transplantation in severe presentations, reported lead author Anand V. Kulkarni, MD, of AIG Hospitals, Hyderabad, India, and colleagues.
“There is a lack of large cohort studies evaluating the clinical presentation of WD, along with a limited understanding of genotype–phenotype correlations in patients with WD presenting with liver disease and the absence of comprehensive comparisons between pediatric and adult outcomes,” the investigators wrote in Gastro Hep Advances (2025 Jun. doi: 10.1016/j.gastha.2025.100717). “Additionally, data on living donor liver transplantation (LDLT) outcomes in WD remain scarce.”
To address these gaps, Kulkarni and colleagues performed a single-center retrospective study of all patients with WD diagnosed and managed at AIG Hospitals between June 2020 and April 2024.
Diagnosis followed Leipzig criteria, incorporating clinical features, slit-lamp examination for Kayser–Fleischer rings, serum ceruloplasmin, 24-hour urinary copper, hepatic copper when available, and genetic testing when available.
Patients were stratified by age into pediatric and adult groups. The investigators compared clinical presentation, laboratory parameters, and outcomes across age groups.
Management reflected standard practice at the center: chelation with D-penicillamine or trientine, zinc therapy as monotherapy or adjunctive therapy, plasma exchange for acute liver failure or acute-on-chronic liver failure, and evaluation for living-donor liver transplantation when indicated. Genetic analysis was performed in approximately 70% of the cohort.
The final dataset included 156 patients, with a median age of 19 years (range, 2–57), and an approximately equal split between adult and pediatric groups.
Presentation differed markedly by age. Among pediatric patients, the most common presentations were acute liver failure (26.7%) and acute-on-chronic liver failure (20%). Adults most frequently presented with decompensated cirrhosis (30.9%). Kayser–Fleischer rings were more prevalent in the pediatric group, consistent with underlying disease despite acute presentation.
Outcomes also varied by age and presentation. On Kaplan–Meier analysis, transplant-free survival was 72% in children and 87.7% in adults after a median follow-up of 1.33 years (P = .01). Overall cohort transplant-free survival at 1.33 years was 80.1%. Thirteen percent of patients underwent LDLT, with 90% 1-year post-transplant survival. Among those who received plasma exchange for acute presentations, transplant-free survival was 40.5%.
Among the patients with genetic data, 54.1% were homozygous or compound heterozygous for combinations of pathogenic variants and variants of uncertain significance in ATP7B. The most frequently observed pathogenic variants were p.Gly977Glu, p.Cys271Ter, and p.Asn1186Ser. Several additional variants, including novel changes, were identified across the cohort.
No consistent genotype–phenotype correlation was observed. The investigators noted that the center’s focus on liver disease likely enriched the cohort for hepatic presentations, and that some patients were included based on Leipzig scores of 2-3 with supportive clinical response to therapy.
“Further research should focus on identifying structural variants, variants in other genes, and epigenetic modulators of genetic expression,” Kulkarni and colleagues concluded.
The genetic tests were performed with intramural funding support from the Asian Healthcare Foundation, provided to AIG Hospitals Hyderabad. The investigators disclosed no conflicts of interest.
FROM GASTRO HEP ADVANCES
Agent Orange Exposure Increases Lymphoma Risk in Million Veteran Program Cohort
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.