IBD & Intestinal Disorders

Key clinical point: Multiple bodily symptoms, female sex, and prior use of proton pump inhibitors (PPI) are the risk factors for irritable bowel syndrome (IBS) onset, with prior psychiatric disorder being the strongest risk factor.

Major finding: The presence of ≥2 prior psychiatric disorders was the strongest predictor of subsequent IBS (odds ratio [OR] 2.74; P  =  .006), with other risk factors in patients with prior psychiatric disorders being female sex (OR 1.87) and prior use of PPI (OR 1.73; both P < .001). Among patients without prior psychiatric disorder history, female sex (OR 4.24), fibromyalgia (OR 1.88), and prior PPI use (OR 1.73; all P < .001) most strongly predicted IBS onset.

Study details: Findings are from a prospective, population-based cohort study including 132,922 participants without prior IBS or IBS medication use at baseline who were followed-up twice during subsequent 3 years.

Disclosures: This study did not receive any funding. No conflicts of interest were declared.

Source: Creed F. Risk factors for self-reported irritable bowel syndrome with prior psychiatric disorder: The Lifelines cohort study. J Neurogastroenterol Motil. 2022;28(3):442-453 (Jul 30). Doi: 10.5056/jnm21041

Key clinical point: Multiple bodily symptoms, female sex, and prior use of proton pump inhibitors (PPI) are the risk factors for irritable bowel syndrome (IBS) onset, with prior psychiatric disorder being the strongest risk factor.

Major finding: The presence of ≥2 prior psychiatric disorders was the strongest predictor of subsequent IBS (odds ratio [OR] 2.74; P  =  .006), with other risk factors in patients with prior psychiatric disorders being female sex (OR 1.87) and prior use of PPI (OR 1.73; both P < .001). Among patients without prior psychiatric disorder history, female sex (OR 4.24), fibromyalgia (OR 1.88), and prior PPI use (OR 1.73; all P < .001) most strongly predicted IBS onset.

Study details: Findings are from a prospective, population-based cohort study including 132,922 participants without prior IBS or IBS medication use at baseline who were followed-up twice during subsequent 3 years.

Disclosures: This study did not receive any funding. No conflicts of interest were declared.

Source: Creed F. Risk factors for self-reported irritable bowel syndrome with prior psychiatric disorder: The Lifelines cohort study. J Neurogastroenterol Motil. 2022;28(3):442-453 (Jul 30). Doi: 10.5056/jnm21041

Key clinical point: Multiple bodily symptoms, female sex, and prior use of proton pump inhibitors (PPI) are the risk factors for irritable bowel syndrome (IBS) onset, with prior psychiatric disorder being the strongest risk factor.

Major finding: The presence of ≥2 prior psychiatric disorders was the strongest predictor of subsequent IBS (odds ratio [OR] 2.74; P  =  .006), with other risk factors in patients with prior psychiatric disorders being female sex (OR 1.87) and prior use of PPI (OR 1.73; both P < .001). Among patients without prior psychiatric disorder history, female sex (OR 4.24), fibromyalgia (OR 1.88), and prior PPI use (OR 1.73; all P < .001) most strongly predicted IBS onset.

Study details: Findings are from a prospective, population-based cohort study including 132,922 participants without prior IBS or IBS medication use at baseline who were followed-up twice during subsequent 3 years.

Disclosures: This study did not receive any funding. No conflicts of interest were declared.

Source: Creed F. Risk factors for self-reported irritable bowel syndrome with prior psychiatric disorder: The Lifelines cohort study. J Neurogastroenterol Motil. 2022;28(3):442-453 (Jul 30). Doi: 10.5056/jnm21041

COVID-19 can cause disorders of gut-brain interaction, including postinfection irritable bowel syndrome (IBS), researchers say.

Gastrointestinal symptoms are common with long COVID, also known as post-acute COVID-19 syndrome, according to Walter Chan, MD, MPH, and Madhusudan Grover, MBBS.

Dr. Chan, an assistant professor at Harvard Medical School, Boston, and Dr. Grover, an associate professor of medicine and physiology at Mayo Clinic, Rochester, Minn., conducted a review of the literature on COVID-19’s long-term gastrointestinal effects. Their review was published in Clinical Gastroenterology and Hepatology.

Estimates of the prevalence of gastrointestinal symptoms with COVID-19 have ranged as high as 60%, Dr. Chan and Dr. Grover report, and the symptoms may be present in patients with long COVID, a syndrome that continues 4 weeks or longer.

In one survey of 749 COVID-19 survivors, 29% reported at least one new chronic gastrointestinal symptom. The most common were heartburn, constipation, diarrhea, and abdominal pain. Of those with abdominal pain, 39% had symptoms that met Rome IV criteria for irritable bowel syndrome.

People who have gastrointestinal symptoms after their initial SARS-CoV-2 infection are more likely to have them with long COVID. Psychiatric diagnoses, hospitalization, and the loss of smell and taste are predictors of gastrointestinal symptoms.

Infectious gastroenteritis can increase the risk for disorders of gut-brain interaction, especially postinfection IBS, Dr. Chan and Dr. Grover write.

COVID-19 likely causes gastrointestinal symptoms through multiple mechanisms. It may suppress angiotensin-converting enzyme 2, which protects intestinal cells. It can alter the microbiome. It can cause or worsen weight gain and diabetes. It may disrupt the immune system and trigger an autoimmune reaction. It can cause depression and anxiety, and it can alter dietary habits.

No specific treatments for gastrointestinal symptoms associated with long COVID have emerged, so clinicians should make use of established therapies for disorders of gut-brain interaction, Dr. Chan and Dr. Grover recommend.

Beyond adequate sleep and exercise, these may include high-fiber, low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), gluten-free, low-carbohydrate, or elimination diets.

For diarrhea, they list loperamide, ondansetron, alosetron, eluxadoline, antispasmodics, rifaximin, and bile acid sequestrants.

For constipation, they mention fiber supplements, polyethylene glycol, linaclotide, plecanatide, lubiprostone, tenapanor, tegaserod, and prucalopride.

For modulating intestinal permeability, they recommend glutamine.

Neuromodulation may be achieved with tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, azaperones, and delta ligands, they write.

For psychological therapy, they recommend cognitive-behavioral therapy and gut-directed hypnotherapy.

A handful of studies have suggested benefits from Lactiplantibacillus plantarum and Pediococcus acidilactici as probiotic therapies. Additionally, one study showed positive results with a high-fiber formula, perhaps by nourishing short-chain fatty acid-producing bacteria, Dr. Chan and Dr. Grover write.

Dr. Chan reported financial relationships with Ironwood, Takeda, and Phathom Pharmaceuticals. Dr. Grover reported financial relationships with Takeda, Donga, Alexza Pharmaceuticals, and Alfasigma.

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

COVID-19 can cause disorders of gut-brain interaction, including postinfection irritable bowel syndrome (IBS), researchers say.

Gastrointestinal symptoms are common with long COVID, also known as post-acute COVID-19 syndrome, according to Walter Chan, MD, MPH, and Madhusudan Grover, MBBS.

Dr. Chan, an assistant professor at Harvard Medical School, Boston, and Dr. Grover, an associate professor of medicine and physiology at Mayo Clinic, Rochester, Minn., conducted a review of the literature on COVID-19’s long-term gastrointestinal effects. Their review was published in Clinical Gastroenterology and Hepatology.

Estimates of the prevalence of gastrointestinal symptoms with COVID-19 have ranged as high as 60%, Dr. Chan and Dr. Grover report, and the symptoms may be present in patients with long COVID, a syndrome that continues 4 weeks or longer.

In one survey of 749 COVID-19 survivors, 29% reported at least one new chronic gastrointestinal symptom. The most common were heartburn, constipation, diarrhea, and abdominal pain. Of those with abdominal pain, 39% had symptoms that met Rome IV criteria for irritable bowel syndrome.

People who have gastrointestinal symptoms after their initial SARS-CoV-2 infection are more likely to have them with long COVID. Psychiatric diagnoses, hospitalization, and the loss of smell and taste are predictors of gastrointestinal symptoms.

Infectious gastroenteritis can increase the risk for disorders of gut-brain interaction, especially postinfection IBS, Dr. Chan and Dr. Grover write.

COVID-19 likely causes gastrointestinal symptoms through multiple mechanisms. It may suppress angiotensin-converting enzyme 2, which protects intestinal cells. It can alter the microbiome. It can cause or worsen weight gain and diabetes. It may disrupt the immune system and trigger an autoimmune reaction. It can cause depression and anxiety, and it can alter dietary habits.

No specific treatments for gastrointestinal symptoms associated with long COVID have emerged, so clinicians should make use of established therapies for disorders of gut-brain interaction, Dr. Chan and Dr. Grover recommend.

Beyond adequate sleep and exercise, these may include high-fiber, low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), gluten-free, low-carbohydrate, or elimination diets.

For diarrhea, they list loperamide, ondansetron, alosetron, eluxadoline, antispasmodics, rifaximin, and bile acid sequestrants.

For constipation, they mention fiber supplements, polyethylene glycol, linaclotide, plecanatide, lubiprostone, tenapanor, tegaserod, and prucalopride.

For modulating intestinal permeability, they recommend glutamine.

Neuromodulation may be achieved with tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, azaperones, and delta ligands, they write.

For psychological therapy, they recommend cognitive-behavioral therapy and gut-directed hypnotherapy.

A handful of studies have suggested benefits from Lactiplantibacillus plantarum and Pediococcus acidilactici as probiotic therapies. Additionally, one study showed positive results with a high-fiber formula, perhaps by nourishing short-chain fatty acid-producing bacteria, Dr. Chan and Dr. Grover write.

Dr. Chan reported financial relationships with Ironwood, Takeda, and Phathom Pharmaceuticals. Dr. Grover reported financial relationships with Takeda, Donga, Alexza Pharmaceuticals, and Alfasigma.

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

COVID-19 can cause disorders of gut-brain interaction, including postinfection irritable bowel syndrome (IBS), researchers say.

Gastrointestinal symptoms are common with long COVID, also known as post-acute COVID-19 syndrome, according to Walter Chan, MD, MPH, and Madhusudan Grover, MBBS.

Dr. Chan, an assistant professor at Harvard Medical School, Boston, and Dr. Grover, an associate professor of medicine and physiology at Mayo Clinic, Rochester, Minn., conducted a review of the literature on COVID-19’s long-term gastrointestinal effects. Their review was published in Clinical Gastroenterology and Hepatology.

Estimates of the prevalence of gastrointestinal symptoms with COVID-19 have ranged as high as 60%, Dr. Chan and Dr. Grover report, and the symptoms may be present in patients with long COVID, a syndrome that continues 4 weeks or longer.

In one survey of 749 COVID-19 survivors, 29% reported at least one new chronic gastrointestinal symptom. The most common were heartburn, constipation, diarrhea, and abdominal pain. Of those with abdominal pain, 39% had symptoms that met Rome IV criteria for irritable bowel syndrome.

People who have gastrointestinal symptoms after their initial SARS-CoV-2 infection are more likely to have them with long COVID. Psychiatric diagnoses, hospitalization, and the loss of smell and taste are predictors of gastrointestinal symptoms.

Infectious gastroenteritis can increase the risk for disorders of gut-brain interaction, especially postinfection IBS, Dr. Chan and Dr. Grover write.

COVID-19 likely causes gastrointestinal symptoms through multiple mechanisms. It may suppress angiotensin-converting enzyme 2, which protects intestinal cells. It can alter the microbiome. It can cause or worsen weight gain and diabetes. It may disrupt the immune system and trigger an autoimmune reaction. It can cause depression and anxiety, and it can alter dietary habits.

No specific treatments for gastrointestinal symptoms associated with long COVID have emerged, so clinicians should make use of established therapies for disorders of gut-brain interaction, Dr. Chan and Dr. Grover recommend.

Beyond adequate sleep and exercise, these may include high-fiber, low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), gluten-free, low-carbohydrate, or elimination diets.

For diarrhea, they list loperamide, ondansetron, alosetron, eluxadoline, antispasmodics, rifaximin, and bile acid sequestrants.

For constipation, they mention fiber supplements, polyethylene glycol, linaclotide, plecanatide, lubiprostone, tenapanor, tegaserod, and prucalopride.

For modulating intestinal permeability, they recommend glutamine.

Neuromodulation may be achieved with tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, azaperones, and delta ligands, they write.

For psychological therapy, they recommend cognitive-behavioral therapy and gut-directed hypnotherapy.

A handful of studies have suggested benefits from Lactiplantibacillus plantarum and Pediococcus acidilactici as probiotic therapies. Additionally, one study showed positive results with a high-fiber formula, perhaps by nourishing short-chain fatty acid-producing bacteria, Dr. Chan and Dr. Grover write.

Dr. Chan reported financial relationships with Ironwood, Takeda, and Phathom Pharmaceuticals. Dr. Grover reported financial relationships with Takeda, Donga, Alexza Pharmaceuticals, and Alfasigma.

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

Switching from intravenous to subcutaneous vedolizumab for maintenance treatment of inflammatory bowel diseases appears to be effective, according to a study providing real-world data.

Subcutaneous treatment could reduce direct health care costs because no infusion equipment is necessary, as well as societal costs because patients don’t need to take time off work or travel to infusion locations, wrote the researchers, led by Adriaan Volkers, MD, a doctoral candidate in gastroenterology and hepatology at the Amsterdam Gastroenterology Endocrinology Metabolism Research Institute at the University of Amsterdam in The Netherlands.

“The option of a SC formulation of VDZ [vedolizumab] offers patients a choice regarding the route of administration,” they wrote. The study was published in Alimentary Pharmacology and Therapeutics.

Dr. Volkers and colleagues assessed the effectiveness, safety, drug discontinuation, and pharmacokinetics of a switch from intravenous to subcutaneous maintenance vedolizumab in a prospective real-world cohort of patients from two separate studies in The Netherlands between July 2020 and November 2021.

The cohort comprised 135 adults who had greater than 4 months of IV vedolizumab: 82 patients with Crohn’s disease and 53 with ulcerative colitis. Prospective follow-up took place during scheduled outpatient clinic visits at weeks 12 and 24 after switching administration. Patients received 108 mg of subcutaneous vedolizumab once every 2 weeks.

Overall, 16 patients (11.9%) discontinued subcutaneous administration, including 11 patients (13.4%) with Crohn’s disease who stopped after a median of 18 weeks, as well as 5 patients (9.4%) with ulcerative colitis who stopped after a median of 6 weeks. Four patients, who all had Crohn’s disease, discontinued vedolizumab and switched to a different treatment because of loss of response. Nine patients switched back to IV administration because of adverse events, and three switched back because of fear of needles.

In total, there were 59 adverse events and 13 infections that were possibly or probably related to subcutaneous injection among 42 patients. The most common adverse events that were probably related were injection site reactions such as pain or swelling, reported among 15 patients, and headaches, reported among 6 patients.

At the initiation of therapy, 57 of 81 Crohn’s disease patients (70.4%) were in corticosteroid-free clinical remission and 53 of 80 (66.3%) were in biochemical remission, which was defined as C-reactive protein levels of 5 mg/L or less and fecal calprotectin levels of 250 mcg/g or less. For ulcerative colitis patients, 35 of 49 (71.4%) were in corticosteroid-free clinical remission and 41 of 51 (80.4%) were in biochemical remission. Median clinical and biochemical disease levels remained stable after the switch to subcutaneous treatment and weren’t significantly different, compared with baseline measurements.

Median vedolizumab serum concentrations increased from 19 mcg/mL at the time of the switch to 31 mcg/mL at 12 weeks after the switch and 37 mcg/mL at 24 weeks. Serum concentrations of less than 25 mcg/mL were associated with lower rates of corticosteroid-free clinical remission, and serum concentrations of greater than 40 mcg/mL were associated with higher biochemical remission rates.

Importantly, there was no association between vedolizumab serum concentrations and the risk of adverse events that were deemed probably related to subcutaneous injection or infections.

“The most important point to understand here is that SC VDZ can be used to maintain clinical remission after IV VDZ induction in a real-world setting,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at Washington University, St. Louis.

Dr. DeBosch, who wasn’t involved with this study, noted that previous data have indicated that switching from intravenous to subcutaneous treatment after a 6-week induction is superior to placebo in maintaining clinical and biochemical remission. However, studies haven’t quantified the optimal timing and therapeutic efficacy of switching.

“This is critical to quantify because SC VDZ has slower and lower peak bioavailability when compared with IV administration,” he said. “These data indicate that IV induction overcomes the known pharmacokinetic limitations of SC VDZ during the induction phase.”

However, there are still some limitations and areas for future research around switching administration, Dr. DeBosch noted.

“A key comparison lacking in the study is the mean and trough serum VDZ, and proportion of patients with relapsing disease in patients on continued IV VDZ,” he said. “Yet, these data nevertheless indicate that tandem IV-SC drug administration can maximize the induction and maintenance of remission in IBD, while also mitigating some of the barriers associated with long-term, continued IV VDZ administration.”

The study authors reported advisory fees and speaker fees from several pharmaceutical companies, and some authors have received funding or served on advisory boards for Takeda Pharmaceuticals, which manufactures vedolizumab. Dr. DeBosch reported no relevant disclosures.

Switching from intravenous to subcutaneous vedolizumab for maintenance treatment of inflammatory bowel diseases appears to be effective, according to a study providing real-world data.

Subcutaneous treatment could reduce direct health care costs because no infusion equipment is necessary, as well as societal costs because patients don’t need to take time off work or travel to infusion locations, wrote the researchers, led by Adriaan Volkers, MD, a doctoral candidate in gastroenterology and hepatology at the Amsterdam Gastroenterology Endocrinology Metabolism Research Institute at the University of Amsterdam in The Netherlands.

“The option of a SC formulation of VDZ [vedolizumab] offers patients a choice regarding the route of administration,” they wrote. The study was published in Alimentary Pharmacology and Therapeutics.

Dr. Volkers and colleagues assessed the effectiveness, safety, drug discontinuation, and pharmacokinetics of a switch from intravenous to subcutaneous maintenance vedolizumab in a prospective real-world cohort of patients from two separate studies in The Netherlands between July 2020 and November 2021.

The cohort comprised 135 adults who had greater than 4 months of IV vedolizumab: 82 patients with Crohn’s disease and 53 with ulcerative colitis. Prospective follow-up took place during scheduled outpatient clinic visits at weeks 12 and 24 after switching administration. Patients received 108 mg of subcutaneous vedolizumab once every 2 weeks.

Overall, 16 patients (11.9%) discontinued subcutaneous administration, including 11 patients (13.4%) with Crohn’s disease who stopped after a median of 18 weeks, as well as 5 patients (9.4%) with ulcerative colitis who stopped after a median of 6 weeks. Four patients, who all had Crohn’s disease, discontinued vedolizumab and switched to a different treatment because of loss of response. Nine patients switched back to IV administration because of adverse events, and three switched back because of fear of needles.

In total, there were 59 adverse events and 13 infections that were possibly or probably related to subcutaneous injection among 42 patients. The most common adverse events that were probably related were injection site reactions such as pain or swelling, reported among 15 patients, and headaches, reported among 6 patients.

At the initiation of therapy, 57 of 81 Crohn’s disease patients (70.4%) were in corticosteroid-free clinical remission and 53 of 80 (66.3%) were in biochemical remission, which was defined as C-reactive protein levels of 5 mg/L or less and fecal calprotectin levels of 250 mcg/g or less. For ulcerative colitis patients, 35 of 49 (71.4%) were in corticosteroid-free clinical remission and 41 of 51 (80.4%) were in biochemical remission. Median clinical and biochemical disease levels remained stable after the switch to subcutaneous treatment and weren’t significantly different, compared with baseline measurements.

Median vedolizumab serum concentrations increased from 19 mcg/mL at the time of the switch to 31 mcg/mL at 12 weeks after the switch and 37 mcg/mL at 24 weeks. Serum concentrations of less than 25 mcg/mL were associated with lower rates of corticosteroid-free clinical remission, and serum concentrations of greater than 40 mcg/mL were associated with higher biochemical remission rates.

Importantly, there was no association between vedolizumab serum concentrations and the risk of adverse events that were deemed probably related to subcutaneous injection or infections.

“The most important point to understand here is that SC VDZ can be used to maintain clinical remission after IV VDZ induction in a real-world setting,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at Washington University, St. Louis.

Dr. DeBosch, who wasn’t involved with this study, noted that previous data have indicated that switching from intravenous to subcutaneous treatment after a 6-week induction is superior to placebo in maintaining clinical and biochemical remission. However, studies haven’t quantified the optimal timing and therapeutic efficacy of switching.

“This is critical to quantify because SC VDZ has slower and lower peak bioavailability when compared with IV administration,” he said. “These data indicate that IV induction overcomes the known pharmacokinetic limitations of SC VDZ during the induction phase.”

However, there are still some limitations and areas for future research around switching administration, Dr. DeBosch noted.

“A key comparison lacking in the study is the mean and trough serum VDZ, and proportion of patients with relapsing disease in patients on continued IV VDZ,” he said. “Yet, these data nevertheless indicate that tandem IV-SC drug administration can maximize the induction and maintenance of remission in IBD, while also mitigating some of the barriers associated with long-term, continued IV VDZ administration.”

The study authors reported advisory fees and speaker fees from several pharmaceutical companies, and some authors have received funding or served on advisory boards for Takeda Pharmaceuticals, which manufactures vedolizumab. Dr. DeBosch reported no relevant disclosures.

Switching from intravenous to subcutaneous vedolizumab for maintenance treatment of inflammatory bowel diseases appears to be effective, according to a study providing real-world data.

Subcutaneous treatment could reduce direct health care costs because no infusion equipment is necessary, as well as societal costs because patients don’t need to take time off work or travel to infusion locations, wrote the researchers, led by Adriaan Volkers, MD, a doctoral candidate in gastroenterology and hepatology at the Amsterdam Gastroenterology Endocrinology Metabolism Research Institute at the University of Amsterdam in The Netherlands.

“The option of a SC formulation of VDZ [vedolizumab] offers patients a choice regarding the route of administration,” they wrote. The study was published in Alimentary Pharmacology and Therapeutics.

Dr. Volkers and colleagues assessed the effectiveness, safety, drug discontinuation, and pharmacokinetics of a switch from intravenous to subcutaneous maintenance vedolizumab in a prospective real-world cohort of patients from two separate studies in The Netherlands between July 2020 and November 2021.

The cohort comprised 135 adults who had greater than 4 months of IV vedolizumab: 82 patients with Crohn’s disease and 53 with ulcerative colitis. Prospective follow-up took place during scheduled outpatient clinic visits at weeks 12 and 24 after switching administration. Patients received 108 mg of subcutaneous vedolizumab once every 2 weeks.

Overall, 16 patients (11.9%) discontinued subcutaneous administration, including 11 patients (13.4%) with Crohn’s disease who stopped after a median of 18 weeks, as well as 5 patients (9.4%) with ulcerative colitis who stopped after a median of 6 weeks. Four patients, who all had Crohn’s disease, discontinued vedolizumab and switched to a different treatment because of loss of response. Nine patients switched back to IV administration because of adverse events, and three switched back because of fear of needles.

In total, there were 59 adverse events and 13 infections that were possibly or probably related to subcutaneous injection among 42 patients. The most common adverse events that were probably related were injection site reactions such as pain or swelling, reported among 15 patients, and headaches, reported among 6 patients.

At the initiation of therapy, 57 of 81 Crohn’s disease patients (70.4%) were in corticosteroid-free clinical remission and 53 of 80 (66.3%) were in biochemical remission, which was defined as C-reactive protein levels of 5 mg/L or less and fecal calprotectin levels of 250 mcg/g or less. For ulcerative colitis patients, 35 of 49 (71.4%) were in corticosteroid-free clinical remission and 41 of 51 (80.4%) were in biochemical remission. Median clinical and biochemical disease levels remained stable after the switch to subcutaneous treatment and weren’t significantly different, compared with baseline measurements.

Median vedolizumab serum concentrations increased from 19 mcg/mL at the time of the switch to 31 mcg/mL at 12 weeks after the switch and 37 mcg/mL at 24 weeks. Serum concentrations of less than 25 mcg/mL were associated with lower rates of corticosteroid-free clinical remission, and serum concentrations of greater than 40 mcg/mL were associated with higher biochemical remission rates.

Importantly, there was no association between vedolizumab serum concentrations and the risk of adverse events that were deemed probably related to subcutaneous injection or infections.

“The most important point to understand here is that SC VDZ can be used to maintain clinical remission after IV VDZ induction in a real-world setting,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at Washington University, St. Louis.

Dr. DeBosch, who wasn’t involved with this study, noted that previous data have indicated that switching from intravenous to subcutaneous treatment after a 6-week induction is superior to placebo in maintaining clinical and biochemical remission. However, studies haven’t quantified the optimal timing and therapeutic efficacy of switching.

“This is critical to quantify because SC VDZ has slower and lower peak bioavailability when compared with IV administration,” he said. “These data indicate that IV induction overcomes the known pharmacokinetic limitations of SC VDZ during the induction phase.”

However, there are still some limitations and areas for future research around switching administration, Dr. DeBosch noted.

“A key comparison lacking in the study is the mean and trough serum VDZ, and proportion of patients with relapsing disease in patients on continued IV VDZ,” he said. “Yet, these data nevertheless indicate that tandem IV-SC drug administration can maximize the induction and maintenance of remission in IBD, while also mitigating some of the barriers associated with long-term, continued IV VDZ administration.”

The study authors reported advisory fees and speaker fees from several pharmaceutical companies, and some authors have received funding or served on advisory boards for Takeda Pharmaceuticals, which manufactures vedolizumab. Dr. DeBosch reported no relevant disclosures.

For patients who experience endoscopic remission of ulcerative colitis (UC), signs of active disease on histology did not affect their risk of clinical relapse, according to a large prospective study that reinforces a low endoscopy score as the treatment target.

In the study of more than 250 patients in endoscopic remission from UC, 19% experienced a clinical relapse within 1 year. The researchers found that a lower baseline endoscopy score was linked to a lower risk of relapse.

While histologic activity, as reflected in the Geboes Score, was not associated with clinical relapse, the presence of basal plasmacytosis independently doubled the risk of relapse.

“Our findings do not support the use of histology as a target for treatment in patients with ulcerative colitis who already achieved clinical and endoscopic remission,” say Talat Bessissow, MD, McGill University Health Center, Montreal, and colleagues.

They add that the results “support the use of the Mayo endoscopic subscore of zero as the optimal target for endoscopic remission.”

Further prospective data are needed to “define the role of histology activity and basal plasmacytosis in the management of ulcerative colitis,” the authors write.

The study was published online in The American Journal of Gastroenterology.
 

Uncertain role of histology

Dr. Bessissow told this news organization that “some studies have shown that histologic healing is associated with better long-term outcomes and less relapse, but this topic remains controversial because other studies have shown the opposite.”

“Our study does not support histology as a treatment target,” he continued, adding that therapy should not be changed solely on the basis of histology.

Dr. Bessissow clarified that although histology was not associated with less relapse over 1 year of follow-up, the role of histology on other, longer-term outcomes, such as surgery and colorectal cancer, still needs to be studied.

The natural history of UC is characterized by frequent relapse, the authors write, but “treating symptoms alone is not sufficient to prevent long-term complications.”

This led to a shift toward using endoscopic healing as a therapeutic goal, a move that was aided by the advent of novel medical therapies, including biologic agents. Crucially, endoscopic healing is associated with improved long-term outcomes, as well as improved quality of life.

The authors continue, however, that a “significant proportion” of patients experience relapse despite achieving endoscopic healing, which “could be explained in part by the fact that up to 40% of patients in endoscopic healing will have ongoing active histologic disease.”

However, in studies in which histologic activity was an endpoint, results have conflicted, and questions remain as to which parameters to include when assessing histologic activity.
 

Measuring the predictive values of endoscopy and histology

To investigate further, the researchers conducted a prospective observational study of consecutive adult patients with confirmed UC who presented to an endoscopy unit for colonoscopy for disease assessment or surveillance.

To qualify for the study, the patients’ conditions had to have been in clinical remission for at least 3 months prior to the colonoscopy. They were excluded if they had undergone prior surgical resection, had experienced disease remission for a period of over 10 years, or had used oral or rectal steroids within 90 days, among other criteria.

During an initial colonoscopy, two biopsies were performed, with specimens taken from the rectosigmoid and, when possible, from the right and left colon. Blood and stool samples were taken, and demographic and clinical data were collected.

The study enrolled 253 patients. Almost half (47.4%) were younger than 50 years, and 46.3% were women. They were followed for 12 months, during which 19% developed clinical relapse, defined as a partial Mayo endoscopic score (MES) of greater than 2.

When compared with patients with an MES of 0, the team found that patients with an MES of 1 or greater than or equal to 2 were at higher risk of relapse, with an adjusted hazard ratio of 2.65 and 2.57, respectively.

Interestingly, a lower baseline MES also was associated with a lower risk of relapse, and patients with proctitis were more likely to experience relapse than those with pancolitis.
 

No impact of histology on relapse risk

Further analysis revealed that there was no association between clinical relapse and age, sex, disease extent, and C-reactive protein, hemoglobin, and albumin levels. However, there was a significant association between relapse and the occurrence of at least one relapse in the 2 years prior to enrollment.

While the mean baseline fecal calprotectin (FC) level was numerically higher in patients who experienced relapse, compared with those who did not (306.9 mcg/g vs. 213.7 mcg/g), the difference was not significant.

FC of greater than 100 mcg/g was, however, significantly associated with relapse, at an odds ratio of 2.26, although the association was no longer significant when using the False Discovery Rate test.

Active histology was no more common among those who experienced relapse than among those who did not. But with regard to histologic factors, the team found that the presence of basal plasmacytosis was associated with clinical relapse, at an adjusted odds ratio of 2.07.

On the other hand, a Geboes Score of greater than or equal to 3.1, indicating the presence of epithelial neutrophils with or without crypt destruction or erosions, was not significantly associated with the risk of relapse, nor with the time to clinical relapse.
 

Clinical implications

Approached for comment, Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic, said that this is “the largest prospective study assessing histologic activity or remission to predict future disease relapse in ulcerative colitis.”

He told this news organization that what the findings mean for clinical practice is that “patients who achieve an endoscopic and clinical remission are at a low likelihood of clinical relapse,” and added that “these should be the ‘treat-to-target’ endpoints.”

“Patients who have biopsy evidence, [such as] histologic activity based on the Geboes Score, do not require an escalation of therapy or a change in inflammatory bowel disease therapy,” Dr. Regueiro said.

He noted, however, that one primary question remains: Aside from surveillance of dysplasia, is there a role for biopsy in cases of UC in which the Mayo score is 0?

“In my practice, I still take biopsies from a previously involved colitis segment, even if Mayo 0,” he said.

“If there is histologic activity, I would not increase or optimize the current medications, but I also would not deescalate,” Dr. Regueiro added. “I would keep the patient on a regular surveillance colonoscopy regimen, too.”

No funding for the study has been reported. Dr. Bessissow has relationships with AbbVie, Alimentiv (formerly Robarts), Amgen, Bristol-Myers-Squibb, Ferring, Gilead, Janssen, Merck, Pentax, Pfizer, Roche, Sandoz, Takeda, and Viatris. Other authors have disclosed numerous financial relationships. Dr. Regueiro has disclosed no such relationships.

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

For patients who experience endoscopic remission of ulcerative colitis (UC), signs of active disease on histology did not affect their risk of clinical relapse, according to a large prospective study that reinforces a low endoscopy score as the treatment target.

In the study of more than 250 patients in endoscopic remission from UC, 19% experienced a clinical relapse within 1 year. The researchers found that a lower baseline endoscopy score was linked to a lower risk of relapse.

While histologic activity, as reflected in the Geboes Score, was not associated with clinical relapse, the presence of basal plasmacytosis independently doubled the risk of relapse.

“Our findings do not support the use of histology as a target for treatment in patients with ulcerative colitis who already achieved clinical and endoscopic remission,” say Talat Bessissow, MD, McGill University Health Center, Montreal, and colleagues.

They add that the results “support the use of the Mayo endoscopic subscore of zero as the optimal target for endoscopic remission.”

Further prospective data are needed to “define the role of histology activity and basal plasmacytosis in the management of ulcerative colitis,” the authors write.

The study was published online in The American Journal of Gastroenterology.
 

Uncertain role of histology

Dr. Bessissow told this news organization that “some studies have shown that histologic healing is associated with better long-term outcomes and less relapse, but this topic remains controversial because other studies have shown the opposite.”

“Our study does not support histology as a treatment target,” he continued, adding that therapy should not be changed solely on the basis of histology.

Dr. Bessissow clarified that although histology was not associated with less relapse over 1 year of follow-up, the role of histology on other, longer-term outcomes, such as surgery and colorectal cancer, still needs to be studied.

The natural history of UC is characterized by frequent relapse, the authors write, but “treating symptoms alone is not sufficient to prevent long-term complications.”

This led to a shift toward using endoscopic healing as a therapeutic goal, a move that was aided by the advent of novel medical therapies, including biologic agents. Crucially, endoscopic healing is associated with improved long-term outcomes, as well as improved quality of life.

The authors continue, however, that a “significant proportion” of patients experience relapse despite achieving endoscopic healing, which “could be explained in part by the fact that up to 40% of patients in endoscopic healing will have ongoing active histologic disease.”

However, in studies in which histologic activity was an endpoint, results have conflicted, and questions remain as to which parameters to include when assessing histologic activity.
 

Measuring the predictive values of endoscopy and histology

To investigate further, the researchers conducted a prospective observational study of consecutive adult patients with confirmed UC who presented to an endoscopy unit for colonoscopy for disease assessment or surveillance.

To qualify for the study, the patients’ conditions had to have been in clinical remission for at least 3 months prior to the colonoscopy. They were excluded if they had undergone prior surgical resection, had experienced disease remission for a period of over 10 years, or had used oral or rectal steroids within 90 days, among other criteria.

During an initial colonoscopy, two biopsies were performed, with specimens taken from the rectosigmoid and, when possible, from the right and left colon. Blood and stool samples were taken, and demographic and clinical data were collected.

The study enrolled 253 patients. Almost half (47.4%) were younger than 50 years, and 46.3% were women. They were followed for 12 months, during which 19% developed clinical relapse, defined as a partial Mayo endoscopic score (MES) of greater than 2.

When compared with patients with an MES of 0, the team found that patients with an MES of 1 or greater than or equal to 2 were at higher risk of relapse, with an adjusted hazard ratio of 2.65 and 2.57, respectively.

Interestingly, a lower baseline MES also was associated with a lower risk of relapse, and patients with proctitis were more likely to experience relapse than those with pancolitis.
 

No impact of histology on relapse risk

Further analysis revealed that there was no association between clinical relapse and age, sex, disease extent, and C-reactive protein, hemoglobin, and albumin levels. However, there was a significant association between relapse and the occurrence of at least one relapse in the 2 years prior to enrollment.

While the mean baseline fecal calprotectin (FC) level was numerically higher in patients who experienced relapse, compared with those who did not (306.9 mcg/g vs. 213.7 mcg/g), the difference was not significant.

FC of greater than 100 mcg/g was, however, significantly associated with relapse, at an odds ratio of 2.26, although the association was no longer significant when using the False Discovery Rate test.

Active histology was no more common among those who experienced relapse than among those who did not. But with regard to histologic factors, the team found that the presence of basal plasmacytosis was associated with clinical relapse, at an adjusted odds ratio of 2.07.

On the other hand, a Geboes Score of greater than or equal to 3.1, indicating the presence of epithelial neutrophils with or without crypt destruction or erosions, was not significantly associated with the risk of relapse, nor with the time to clinical relapse.
 

Clinical implications

Approached for comment, Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic, said that this is “the largest prospective study assessing histologic activity or remission to predict future disease relapse in ulcerative colitis.”

He told this news organization that what the findings mean for clinical practice is that “patients who achieve an endoscopic and clinical remission are at a low likelihood of clinical relapse,” and added that “these should be the ‘treat-to-target’ endpoints.”

“Patients who have biopsy evidence, [such as] histologic activity based on the Geboes Score, do not require an escalation of therapy or a change in inflammatory bowel disease therapy,” Dr. Regueiro said.

He noted, however, that one primary question remains: Aside from surveillance of dysplasia, is there a role for biopsy in cases of UC in which the Mayo score is 0?

“In my practice, I still take biopsies from a previously involved colitis segment, even if Mayo 0,” he said.

“If there is histologic activity, I would not increase or optimize the current medications, but I also would not deescalate,” Dr. Regueiro added. “I would keep the patient on a regular surveillance colonoscopy regimen, too.”

No funding for the study has been reported. Dr. Bessissow has relationships with AbbVie, Alimentiv (formerly Robarts), Amgen, Bristol-Myers-Squibb, Ferring, Gilead, Janssen, Merck, Pentax, Pfizer, Roche, Sandoz, Takeda, and Viatris. Other authors have disclosed numerous financial relationships. Dr. Regueiro has disclosed no such relationships.

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

For patients who experience endoscopic remission of ulcerative colitis (UC), signs of active disease on histology did not affect their risk of clinical relapse, according to a large prospective study that reinforces a low endoscopy score as the treatment target.

In the study of more than 250 patients in endoscopic remission from UC, 19% experienced a clinical relapse within 1 year. The researchers found that a lower baseline endoscopy score was linked to a lower risk of relapse.

While histologic activity, as reflected in the Geboes Score, was not associated with clinical relapse, the presence of basal plasmacytosis independently doubled the risk of relapse.

“Our findings do not support the use of histology as a target for treatment in patients with ulcerative colitis who already achieved clinical and endoscopic remission,” say Talat Bessissow, MD, McGill University Health Center, Montreal, and colleagues.

They add that the results “support the use of the Mayo endoscopic subscore of zero as the optimal target for endoscopic remission.”

Further prospective data are needed to “define the role of histology activity and basal plasmacytosis in the management of ulcerative colitis,” the authors write.

The study was published online in The American Journal of Gastroenterology.
 

Uncertain role of histology

Dr. Bessissow told this news organization that “some studies have shown that histologic healing is associated with better long-term outcomes and less relapse, but this topic remains controversial because other studies have shown the opposite.”

“Our study does not support histology as a treatment target,” he continued, adding that therapy should not be changed solely on the basis of histology.

Dr. Bessissow clarified that although histology was not associated with less relapse over 1 year of follow-up, the role of histology on other, longer-term outcomes, such as surgery and colorectal cancer, still needs to be studied.

The natural history of UC is characterized by frequent relapse, the authors write, but “treating symptoms alone is not sufficient to prevent long-term complications.”

This led to a shift toward using endoscopic healing as a therapeutic goal, a move that was aided by the advent of novel medical therapies, including biologic agents. Crucially, endoscopic healing is associated with improved long-term outcomes, as well as improved quality of life.

The authors continue, however, that a “significant proportion” of patients experience relapse despite achieving endoscopic healing, which “could be explained in part by the fact that up to 40% of patients in endoscopic healing will have ongoing active histologic disease.”

However, in studies in which histologic activity was an endpoint, results have conflicted, and questions remain as to which parameters to include when assessing histologic activity.
 

Measuring the predictive values of endoscopy and histology

To investigate further, the researchers conducted a prospective observational study of consecutive adult patients with confirmed UC who presented to an endoscopy unit for colonoscopy for disease assessment or surveillance.

To qualify for the study, the patients’ conditions had to have been in clinical remission for at least 3 months prior to the colonoscopy. They were excluded if they had undergone prior surgical resection, had experienced disease remission for a period of over 10 years, or had used oral or rectal steroids within 90 days, among other criteria.

During an initial colonoscopy, two biopsies were performed, with specimens taken from the rectosigmoid and, when possible, from the right and left colon. Blood and stool samples were taken, and demographic and clinical data were collected.

The study enrolled 253 patients. Almost half (47.4%) were younger than 50 years, and 46.3% were women. They were followed for 12 months, during which 19% developed clinical relapse, defined as a partial Mayo endoscopic score (MES) of greater than 2.

When compared with patients with an MES of 0, the team found that patients with an MES of 1 or greater than or equal to 2 were at higher risk of relapse, with an adjusted hazard ratio of 2.65 and 2.57, respectively.

Interestingly, a lower baseline MES also was associated with a lower risk of relapse, and patients with proctitis were more likely to experience relapse than those with pancolitis.
 

No impact of histology on relapse risk

Further analysis revealed that there was no association between clinical relapse and age, sex, disease extent, and C-reactive protein, hemoglobin, and albumin levels. However, there was a significant association between relapse and the occurrence of at least one relapse in the 2 years prior to enrollment.

While the mean baseline fecal calprotectin (FC) level was numerically higher in patients who experienced relapse, compared with those who did not (306.9 mcg/g vs. 213.7 mcg/g), the difference was not significant.

FC of greater than 100 mcg/g was, however, significantly associated with relapse, at an odds ratio of 2.26, although the association was no longer significant when using the False Discovery Rate test.

Active histology was no more common among those who experienced relapse than among those who did not. But with regard to histologic factors, the team found that the presence of basal plasmacytosis was associated with clinical relapse, at an adjusted odds ratio of 2.07.

On the other hand, a Geboes Score of greater than or equal to 3.1, indicating the presence of epithelial neutrophils with or without crypt destruction or erosions, was not significantly associated with the risk of relapse, nor with the time to clinical relapse.
 

Clinical implications

Approached for comment, Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic, said that this is “the largest prospective study assessing histologic activity or remission to predict future disease relapse in ulcerative colitis.”

He told this news organization that what the findings mean for clinical practice is that “patients who achieve an endoscopic and clinical remission are at a low likelihood of clinical relapse,” and added that “these should be the ‘treat-to-target’ endpoints.”

“Patients who have biopsy evidence, [such as] histologic activity based on the Geboes Score, do not require an escalation of therapy or a change in inflammatory bowel disease therapy,” Dr. Regueiro said.

He noted, however, that one primary question remains: Aside from surveillance of dysplasia, is there a role for biopsy in cases of UC in which the Mayo score is 0?

“In my practice, I still take biopsies from a previously involved colitis segment, even if Mayo 0,” he said.

“If there is histologic activity, I would not increase or optimize the current medications, but I also would not deescalate,” Dr. Regueiro added. “I would keep the patient on a regular surveillance colonoscopy regimen, too.”

No funding for the study has been reported. Dr. Bessissow has relationships with AbbVie, Alimentiv (formerly Robarts), Amgen, Bristol-Myers-Squibb, Ferring, Gilead, Janssen, Merck, Pentax, Pfizer, Roche, Sandoz, Takeda, and Viatris. Other authors have disclosed numerous financial relationships. Dr. Regueiro has disclosed no such relationships.

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

Among biologic agents, vedolizumab (Entyvio) and ustekinumab (Stelara) are associated with lower rates of infection-related hospitalizations than anti-tumor necrosis factor (TNF) agents in older patients with inflammatory bowel disease (IBD), but only if older patients also have comorbidities, U.S. researchers have found.

The researchers examined U.S. health insurance claims for three cohorts – patients with IBD who were treated with anti-TNF agents, vedolizumab, and ustekinumab – and found no overall difference in infection rates or infection-related hospitalizations between the groups.

But in patients with a greater burden of comorbidity, the monoclonal antibodies vedolizumab and ustekinumab were associated with lower rates of infection-related hospitalizations, compared with anti-TNF agents, with 22% less for vedolizumab and 34% less for ustekinumab.

In the “first pharmacoepidemiologic study comparing all approved classes of biologic agents to treat IBD focused on older adults,” the authors say they “demonstrate that comorbidity is a mediator of infections requiring hospitalizations.”

“These data can help counsel older adults who are about to initiate a biologic agent in clinical practice,” they write.

The research was published online in The American Journal of Gastroenterology.

Co-lead author Bharati Kochar, MD, MS, a gastroenterologist at Massachusetts General Hospital, Boston, said that the real question, when we’re seeing an older patient, is which medications are safer.

“Not surprisingly, we found that there was no overall difference in the three classes of medications,” she said, adding that “if you take your healthy older adults without any serious comorbidities, anti-TNF agents are not different in terms of a safety profile.”

With the more selective biologics like vedolizumab and ustekinumab seeming to confer a lower risk for serious infections in patients with comorbidities, Dr. Kochar said the hope is that their study will help doctors feel more confident in prescribing and encourage thinking about the patient in a broader manner beyond chronological age.
 

Real-world study on older adults with IBD

The authors note that the number of older adults with IBD is rising rapidly. It is estimated that almost 1 million individuals aged 60 years and older in the United States are living with the disease.

They add that there has been a rapid proliferation of treatment options for both Crohn’s disease and ulcerative colitis, but the likelihood of achieving remission may vary by mechanism of immunosuppression.

Older adults have a higher baseline risk for infections than younger adults, regardless of treatment type, the authors underline; yet, older adults with IBD are disproportionately under-represented in clinical trials of IBD therapies.

Recognizing the need for real-world studies focused on older adults, Dr. Kochar and her colleagues gathered claims data from a commercial U.S. health insurance plan totaling nearly 86 million individuals between 2008 and 2019.

They identified patients with IBD aged 60 years or older (average age, 67 years) who had at least one claim for vedolizumab, ustekinumab, or anti-TNF agents, including adalimumab, infliximab, golimumab, or certolizumab pegol.

The cohorts included 2,369 patients treated with anti-TNF agents, 972 who were started on vedolizumab and 352 who were given ustekinumab.

Patients were excluded if they received vedolizumab or ustekinumab during the first 6 months of treatment and were then switched to anti-TNF therapy.

The on-treatment period was defined as starting with the index treatment date and ending with the date of treatment discontinuation. Treatment was required to last more than 90 days.

The overall incidence rates for any infection were similar across the three treatment groups, at 3,606 per 1,000 person-years in the anti-TNF group, 3,748 per 1,000 person-years in patients given vedolizumab, and 3,139 per 1,000 person-years in those treated with ustekinumab.

There were also no significant differences in the rate of infection-related hospitalizations, at a hazard ratio for vedolizumab versus anti-TNF agents of 0.94, and for ustekinumab, again versus anti-TNF agents, of 0.92.

However, the authors found that there was a “significant interaction” between comorbidities and treatment in terms of infection-related hospitalizations.

Among IBD patients older than 60 with a Charlson Comorbidity Index (CCI) score of greater than 1, treatment with vedolizumab and ustekinumab was associated with a significantly lower rate of infection-related hospitalizations versus anti-TNF agents, at hazard ratios of 0.78 and 0.66, respectively.

In contrast, the rates of hospitalization were similar between the treatment groups among patients without significant comorbidity.

Interestingly, patients with ulcerative colitis treated with vedolizumab also had a lower rate of infection versus those given anti-TNF agents, at a hazard ratio of 0.96, while no such difference was seen in patients with Crohn’s disease.
 

Results will help refine clinical practice

Approached for comment, Dana J. Lukin, MD, PhD, clinical director of translational research at the Jill Roberts Center for Inflammatory Bowel Disease, New York, said the study is limited by the lack of granular data on disease activity.

Moreover, he told this news organization that since it is not a randomized controlled trial, the selection of medications in the claims database may have factored in some of the intangible contraindications to anti-TNF agents.

“It makes sense that comorbidity confers the biggest risk for hospitalization from infections,” Dr. Lukin said, adding that “what is interesting is that there is no difference overall in infection rates between any of the medication classes.”

He said the study therefore “rebuffs the traditional thinking” that, among older adults, anti-TNF agents will be associated with a higher risk of infections per se, “because really it’s specifically among those patients who have more comorbidities.”

Most importantly, Dr. Lukin said that the findings will help to refine clinical practice, as clinicians are specifically tasked with treating the inflammatory bowel disease but are not necessarily focused on comorbidities, which patients accrue more and more as they age.

Dr. Lukin continued that, for patients with comorbid conditions, “we should carefully consider using a non–anti-TNF agent.”

“We should also not be afraid to continue to use anti-TNF agents” in those without comorbidities, he added, as they are “very effective in patients who might need them for their disease-related characteristics.”

The study was supported in part by grants from the National Institutes of Health, the Crohn’s and Colitis Foundation, and the Chleck Family Foundation.

Dr. Lukin declares relationships with Takeda, Abbvie, and Janssen. No other relevant financial relationships were declared.

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

Among biologic agents, vedolizumab (Entyvio) and ustekinumab (Stelara) are associated with lower rates of infection-related hospitalizations than anti-tumor necrosis factor (TNF) agents in older patients with inflammatory bowel disease (IBD), but only if older patients also have comorbidities, U.S. researchers have found.

The researchers examined U.S. health insurance claims for three cohorts – patients with IBD who were treated with anti-TNF agents, vedolizumab, and ustekinumab – and found no overall difference in infection rates or infection-related hospitalizations between the groups.

But in patients with a greater burden of comorbidity, the monoclonal antibodies vedolizumab and ustekinumab were associated with lower rates of infection-related hospitalizations, compared with anti-TNF agents, with 22% less for vedolizumab and 34% less for ustekinumab.

In the “first pharmacoepidemiologic study comparing all approved classes of biologic agents to treat IBD focused on older adults,” the authors say they “demonstrate that comorbidity is a mediator of infections requiring hospitalizations.”

“These data can help counsel older adults who are about to initiate a biologic agent in clinical practice,” they write.

The research was published online in The American Journal of Gastroenterology.

Co-lead author Bharati Kochar, MD, MS, a gastroenterologist at Massachusetts General Hospital, Boston, said that the real question, when we’re seeing an older patient, is which medications are safer.

“Not surprisingly, we found that there was no overall difference in the three classes of medications,” she said, adding that “if you take your healthy older adults without any serious comorbidities, anti-TNF agents are not different in terms of a safety profile.”

With the more selective biologics like vedolizumab and ustekinumab seeming to confer a lower risk for serious infections in patients with comorbidities, Dr. Kochar said the hope is that their study will help doctors feel more confident in prescribing and encourage thinking about the patient in a broader manner beyond chronological age.
 

Real-world study on older adults with IBD

The authors note that the number of older adults with IBD is rising rapidly. It is estimated that almost 1 million individuals aged 60 years and older in the United States are living with the disease.

They add that there has been a rapid proliferation of treatment options for both Crohn’s disease and ulcerative colitis, but the likelihood of achieving remission may vary by mechanism of immunosuppression.

Older adults have a higher baseline risk for infections than younger adults, regardless of treatment type, the authors underline; yet, older adults with IBD are disproportionately under-represented in clinical trials of IBD therapies.

Recognizing the need for real-world studies focused on older adults, Dr. Kochar and her colleagues gathered claims data from a commercial U.S. health insurance plan totaling nearly 86 million individuals between 2008 and 2019.

They identified patients with IBD aged 60 years or older (average age, 67 years) who had at least one claim for vedolizumab, ustekinumab, or anti-TNF agents, including adalimumab, infliximab, golimumab, or certolizumab pegol.

The cohorts included 2,369 patients treated with anti-TNF agents, 972 who were started on vedolizumab and 352 who were given ustekinumab.

Patients were excluded if they received vedolizumab or ustekinumab during the first 6 months of treatment and were then switched to anti-TNF therapy.

The on-treatment period was defined as starting with the index treatment date and ending with the date of treatment discontinuation. Treatment was required to last more than 90 days.

The overall incidence rates for any infection were similar across the three treatment groups, at 3,606 per 1,000 person-years in the anti-TNF group, 3,748 per 1,000 person-years in patients given vedolizumab, and 3,139 per 1,000 person-years in those treated with ustekinumab.

There were also no significant differences in the rate of infection-related hospitalizations, at a hazard ratio for vedolizumab versus anti-TNF agents of 0.94, and for ustekinumab, again versus anti-TNF agents, of 0.92.

However, the authors found that there was a “significant interaction” between comorbidities and treatment in terms of infection-related hospitalizations.

Among IBD patients older than 60 with a Charlson Comorbidity Index (CCI) score of greater than 1, treatment with vedolizumab and ustekinumab was associated with a significantly lower rate of infection-related hospitalizations versus anti-TNF agents, at hazard ratios of 0.78 and 0.66, respectively.

In contrast, the rates of hospitalization were similar between the treatment groups among patients without significant comorbidity.

Interestingly, patients with ulcerative colitis treated with vedolizumab also had a lower rate of infection versus those given anti-TNF agents, at a hazard ratio of 0.96, while no such difference was seen in patients with Crohn’s disease.
 

Results will help refine clinical practice

Approached for comment, Dana J. Lukin, MD, PhD, clinical director of translational research at the Jill Roberts Center for Inflammatory Bowel Disease, New York, said the study is limited by the lack of granular data on disease activity.

Moreover, he told this news organization that since it is not a randomized controlled trial, the selection of medications in the claims database may have factored in some of the intangible contraindications to anti-TNF agents.

“It makes sense that comorbidity confers the biggest risk for hospitalization from infections,” Dr. Lukin said, adding that “what is interesting is that there is no difference overall in infection rates between any of the medication classes.”

He said the study therefore “rebuffs the traditional thinking” that, among older adults, anti-TNF agents will be associated with a higher risk of infections per se, “because really it’s specifically among those patients who have more comorbidities.”

Most importantly, Dr. Lukin said that the findings will help to refine clinical practice, as clinicians are specifically tasked with treating the inflammatory bowel disease but are not necessarily focused on comorbidities, which patients accrue more and more as they age.

Dr. Lukin continued that, for patients with comorbid conditions, “we should carefully consider using a non–anti-TNF agent.”

“We should also not be afraid to continue to use anti-TNF agents” in those without comorbidities, he added, as they are “very effective in patients who might need them for their disease-related characteristics.”

The study was supported in part by grants from the National Institutes of Health, the Crohn’s and Colitis Foundation, and the Chleck Family Foundation.

Dr. Lukin declares relationships with Takeda, Abbvie, and Janssen. No other relevant financial relationships were declared.

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

Among biologic agents, vedolizumab (Entyvio) and ustekinumab (Stelara) are associated with lower rates of infection-related hospitalizations than anti-tumor necrosis factor (TNF) agents in older patients with inflammatory bowel disease (IBD), but only if older patients also have comorbidities, U.S. researchers have found.

The researchers examined U.S. health insurance claims for three cohorts – patients with IBD who were treated with anti-TNF agents, vedolizumab, and ustekinumab – and found no overall difference in infection rates or infection-related hospitalizations between the groups.

But in patients with a greater burden of comorbidity, the monoclonal antibodies vedolizumab and ustekinumab were associated with lower rates of infection-related hospitalizations, compared with anti-TNF agents, with 22% less for vedolizumab and 34% less for ustekinumab.

In the “first pharmacoepidemiologic study comparing all approved classes of biologic agents to treat IBD focused on older adults,” the authors say they “demonstrate that comorbidity is a mediator of infections requiring hospitalizations.”

“These data can help counsel older adults who are about to initiate a biologic agent in clinical practice,” they write.

The research was published online in The American Journal of Gastroenterology.

Co-lead author Bharati Kochar, MD, MS, a gastroenterologist at Massachusetts General Hospital, Boston, said that the real question, when we’re seeing an older patient, is which medications are safer.

“Not surprisingly, we found that there was no overall difference in the three classes of medications,” she said, adding that “if you take your healthy older adults without any serious comorbidities, anti-TNF agents are not different in terms of a safety profile.”

With the more selective biologics like vedolizumab and ustekinumab seeming to confer a lower risk for serious infections in patients with comorbidities, Dr. Kochar said the hope is that their study will help doctors feel more confident in prescribing and encourage thinking about the patient in a broader manner beyond chronological age.
 

Real-world study on older adults with IBD

The authors note that the number of older adults with IBD is rising rapidly. It is estimated that almost 1 million individuals aged 60 years and older in the United States are living with the disease.

They add that there has been a rapid proliferation of treatment options for both Crohn’s disease and ulcerative colitis, but the likelihood of achieving remission may vary by mechanism of immunosuppression.

Older adults have a higher baseline risk for infections than younger adults, regardless of treatment type, the authors underline; yet, older adults with IBD are disproportionately under-represented in clinical trials of IBD therapies.

Recognizing the need for real-world studies focused on older adults, Dr. Kochar and her colleagues gathered claims data from a commercial U.S. health insurance plan totaling nearly 86 million individuals between 2008 and 2019.

They identified patients with IBD aged 60 years or older (average age, 67 years) who had at least one claim for vedolizumab, ustekinumab, or anti-TNF agents, including adalimumab, infliximab, golimumab, or certolizumab pegol.

The cohorts included 2,369 patients treated with anti-TNF agents, 972 who were started on vedolizumab and 352 who were given ustekinumab.

Patients were excluded if they received vedolizumab or ustekinumab during the first 6 months of treatment and were then switched to anti-TNF therapy.

The on-treatment period was defined as starting with the index treatment date and ending with the date of treatment discontinuation. Treatment was required to last more than 90 days.

The overall incidence rates for any infection were similar across the three treatment groups, at 3,606 per 1,000 person-years in the anti-TNF group, 3,748 per 1,000 person-years in patients given vedolizumab, and 3,139 per 1,000 person-years in those treated with ustekinumab.

There were also no significant differences in the rate of infection-related hospitalizations, at a hazard ratio for vedolizumab versus anti-TNF agents of 0.94, and for ustekinumab, again versus anti-TNF agents, of 0.92.

However, the authors found that there was a “significant interaction” between comorbidities and treatment in terms of infection-related hospitalizations.

Among IBD patients older than 60 with a Charlson Comorbidity Index (CCI) score of greater than 1, treatment with vedolizumab and ustekinumab was associated with a significantly lower rate of infection-related hospitalizations versus anti-TNF agents, at hazard ratios of 0.78 and 0.66, respectively.

In contrast, the rates of hospitalization were similar between the treatment groups among patients without significant comorbidity.

Interestingly, patients with ulcerative colitis treated with vedolizumab also had a lower rate of infection versus those given anti-TNF agents, at a hazard ratio of 0.96, while no such difference was seen in patients with Crohn’s disease.
 

Results will help refine clinical practice

Approached for comment, Dana J. Lukin, MD, PhD, clinical director of translational research at the Jill Roberts Center for Inflammatory Bowel Disease, New York, said the study is limited by the lack of granular data on disease activity.

Moreover, he told this news organization that since it is not a randomized controlled trial, the selection of medications in the claims database may have factored in some of the intangible contraindications to anti-TNF agents.

“It makes sense that comorbidity confers the biggest risk for hospitalization from infections,” Dr. Lukin said, adding that “what is interesting is that there is no difference overall in infection rates between any of the medication classes.”

He said the study therefore “rebuffs the traditional thinking” that, among older adults, anti-TNF agents will be associated with a higher risk of infections per se, “because really it’s specifically among those patients who have more comorbidities.”

Most importantly, Dr. Lukin said that the findings will help to refine clinical practice, as clinicians are specifically tasked with treating the inflammatory bowel disease but are not necessarily focused on comorbidities, which patients accrue more and more as they age.

Dr. Lukin continued that, for patients with comorbid conditions, “we should carefully consider using a non–anti-TNF agent.”

“We should also not be afraid to continue to use anti-TNF agents” in those without comorbidities, he added, as they are “very effective in patients who might need them for their disease-related characteristics.”

The study was supported in part by grants from the National Institutes of Health, the Crohn’s and Colitis Foundation, and the Chleck Family Foundation.

Dr. Lukin declares relationships with Takeda, Abbvie, and Janssen. No other relevant financial relationships were declared.

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

A newly developed artificial intelligence (AI) model accurately evaluated endoscopic images from patients with ulcerative colitis (UC), according to new research. The AI could even distinguish between all four Mayo endoscopic subscore (MES) levels of disease activity, which is a first among similar AI models, the researchers noted.

Although management of UC involves disease activity monitoring and prompt response with appropriate therapy, endoscopic assessment has shown significant intra- and interobserver variation, thereby reducing the reliability of individual evaluations. Techniques that use AI may eliminate observer variation and aid in distinguishing between all levels of endoscopic activity with good accuracy.

“However, up until now, only a few computer-assisted diagnostic tools have been available for UC, and none are capable of distinguishing between all levels of endoscopic activity with sufficient accuracy,” wrote study authors Bobby Lo, MD, of the Copenhagen University Hospital Hvidovre, and colleagues, who published their findings in The American Journal of Gastroenterology. The researchers believe their new AI could optimize and standardize the assessment of UC severity measured by MES, regardless of the operator’s level of expertise.

The researchers extracted 1,484 unique endoscopic images from 467 patients with UC (median age, 45 years; 45.3% male) who had undergone a colonoscopy or sigmoidoscopy. Images of healthy colon mucosa were also extracted from a colorectal cancer surveillance program “to adequately reflect the distribution in the clinic,” the researchers wrote.

Two experts blinded for clinical details or other identifying information separately scored all images according to the MES. A third expert, blinded to results from the initial two experts, also scored the images in case of disagreement between the first sets of scores. Nearly half of the images (47.3%) were classified as normal, while 26.0% were deemed MES 1 (mild activity), 20.2% were classified as MES 2 (moderate activity), and 6.5% were classified as MES 3 (severe activity).

All endoscopic images were randomly split into a training dataset (85%) and a testing dataset (15%) with stratified sampling. Several convolutional neural networks architectures were considered for automatically classifying the severity of UC. The investigators used a fivefold cross-validation of the training data to develop and select the optimal final model. Subsequently, the investigators then used unseen test datasets to evaluate the model.

The final chosen model was the EfficientNetB2, given the superiority of its mean accuracy during cross-validation. This model, according to the researchers, is able to “process images significantly faster and requires less computing power than InceptionNetV3,” which was the other model evaluated in the study.

The test accuracy of the final model in distinguishing between all categories of MES was 0.84. The investigators evaluated the model on binary tasks of distinguishing MES 0 versus MES 1-3 and MES 0-1 versus 2-3. They found the model achieved accuracies of 0.94 and 0.93 and areas under the receiver operating characteristic curves of 0.997 and 0.998, respectively.

According to the researchers, they used 10-fold fewer images in this study than have been used in similar studies but noted that the developed model demonstrated an accuracy of around 0.74 “even when using images from another cohort” that had lower image quality. The investigators added that the model could have achieved better results if more data were available, citing this as a limitation of the study.

“In conclusion, we have developed a deep learning model that exceeded previously reported results in classifying endoscopic images from UC patients. This may automate and optimize the evaluation of disease severity in both clinical and academic settings and ideally in clinical trials,” they wrote.“Finally, this study serves as a stepping stone for future projects, including the use of video material and the assessment of long-term outcomes.”

The authors reported no relevant conflicts of interest.

A newly developed artificial intelligence (AI) model accurately evaluated endoscopic images from patients with ulcerative colitis (UC), according to new research. The AI could even distinguish between all four Mayo endoscopic subscore (MES) levels of disease activity, which is a first among similar AI models, the researchers noted.

Although management of UC involves disease activity monitoring and prompt response with appropriate therapy, endoscopic assessment has shown significant intra- and interobserver variation, thereby reducing the reliability of individual evaluations. Techniques that use AI may eliminate observer variation and aid in distinguishing between all levels of endoscopic activity with good accuracy.

“However, up until now, only a few computer-assisted diagnostic tools have been available for UC, and none are capable of distinguishing between all levels of endoscopic activity with sufficient accuracy,” wrote study authors Bobby Lo, MD, of the Copenhagen University Hospital Hvidovre, and colleagues, who published their findings in The American Journal of Gastroenterology. The researchers believe their new AI could optimize and standardize the assessment of UC severity measured by MES, regardless of the operator’s level of expertise.

The researchers extracted 1,484 unique endoscopic images from 467 patients with UC (median age, 45 years; 45.3% male) who had undergone a colonoscopy or sigmoidoscopy. Images of healthy colon mucosa were also extracted from a colorectal cancer surveillance program “to adequately reflect the distribution in the clinic,” the researchers wrote.

Two experts blinded for clinical details or other identifying information separately scored all images according to the MES. A third expert, blinded to results from the initial two experts, also scored the images in case of disagreement between the first sets of scores. Nearly half of the images (47.3%) were classified as normal, while 26.0% were deemed MES 1 (mild activity), 20.2% were classified as MES 2 (moderate activity), and 6.5% were classified as MES 3 (severe activity).

All endoscopic images were randomly split into a training dataset (85%) and a testing dataset (15%) with stratified sampling. Several convolutional neural networks architectures were considered for automatically classifying the severity of UC. The investigators used a fivefold cross-validation of the training data to develop and select the optimal final model. Subsequently, the investigators then used unseen test datasets to evaluate the model.

The final chosen model was the EfficientNetB2, given the superiority of its mean accuracy during cross-validation. This model, according to the researchers, is able to “process images significantly faster and requires less computing power than InceptionNetV3,” which was the other model evaluated in the study.

The test accuracy of the final model in distinguishing between all categories of MES was 0.84. The investigators evaluated the model on binary tasks of distinguishing MES 0 versus MES 1-3 and MES 0-1 versus 2-3. They found the model achieved accuracies of 0.94 and 0.93 and areas under the receiver operating characteristic curves of 0.997 and 0.998, respectively.

According to the researchers, they used 10-fold fewer images in this study than have been used in similar studies but noted that the developed model demonstrated an accuracy of around 0.74 “even when using images from another cohort” that had lower image quality. The investigators added that the model could have achieved better results if more data were available, citing this as a limitation of the study.

“In conclusion, we have developed a deep learning model that exceeded previously reported results in classifying endoscopic images from UC patients. This may automate and optimize the evaluation of disease severity in both clinical and academic settings and ideally in clinical trials,” they wrote.“Finally, this study serves as a stepping stone for future projects, including the use of video material and the assessment of long-term outcomes.”

The authors reported no relevant conflicts of interest.

A newly developed artificial intelligence (AI) model accurately evaluated endoscopic images from patients with ulcerative colitis (UC), according to new research. The AI could even distinguish between all four Mayo endoscopic subscore (MES) levels of disease activity, which is a first among similar AI models, the researchers noted.

Although management of UC involves disease activity monitoring and prompt response with appropriate therapy, endoscopic assessment has shown significant intra- and interobserver variation, thereby reducing the reliability of individual evaluations. Techniques that use AI may eliminate observer variation and aid in distinguishing between all levels of endoscopic activity with good accuracy.

“However, up until now, only a few computer-assisted diagnostic tools have been available for UC, and none are capable of distinguishing between all levels of endoscopic activity with sufficient accuracy,” wrote study authors Bobby Lo, MD, of the Copenhagen University Hospital Hvidovre, and colleagues, who published their findings in The American Journal of Gastroenterology. The researchers believe their new AI could optimize and standardize the assessment of UC severity measured by MES, regardless of the operator’s level of expertise.

The researchers extracted 1,484 unique endoscopic images from 467 patients with UC (median age, 45 years; 45.3% male) who had undergone a colonoscopy or sigmoidoscopy. Images of healthy colon mucosa were also extracted from a colorectal cancer surveillance program “to adequately reflect the distribution in the clinic,” the researchers wrote.

Two experts blinded for clinical details or other identifying information separately scored all images according to the MES. A third expert, blinded to results from the initial two experts, also scored the images in case of disagreement between the first sets of scores. Nearly half of the images (47.3%) were classified as normal, while 26.0% were deemed MES 1 (mild activity), 20.2% were classified as MES 2 (moderate activity), and 6.5% were classified as MES 3 (severe activity).

All endoscopic images were randomly split into a training dataset (85%) and a testing dataset (15%) with stratified sampling. Several convolutional neural networks architectures were considered for automatically classifying the severity of UC. The investigators used a fivefold cross-validation of the training data to develop and select the optimal final model. Subsequently, the investigators then used unseen test datasets to evaluate the model.

The final chosen model was the EfficientNetB2, given the superiority of its mean accuracy during cross-validation. This model, according to the researchers, is able to “process images significantly faster and requires less computing power than InceptionNetV3,” which was the other model evaluated in the study.

The test accuracy of the final model in distinguishing between all categories of MES was 0.84. The investigators evaluated the model on binary tasks of distinguishing MES 0 versus MES 1-3 and MES 0-1 versus 2-3. They found the model achieved accuracies of 0.94 and 0.93 and areas under the receiver operating characteristic curves of 0.997 and 0.998, respectively.

According to the researchers, they used 10-fold fewer images in this study than have been used in similar studies but noted that the developed model demonstrated an accuracy of around 0.74 “even when using images from another cohort” that had lower image quality. The investigators added that the model could have achieved better results if more data were available, citing this as a limitation of the study.

“In conclusion, we have developed a deep learning model that exceeded previously reported results in classifying endoscopic images from UC patients. This may automate and optimize the evaluation of disease severity in both clinical and academic settings and ideally in clinical trials,” they wrote.“Finally, this study serves as a stepping stone for future projects, including the use of video material and the assessment of long-term outcomes.”

The authors reported no relevant conflicts of interest.

Donor microbiota stability and species evenness, along with presence of certain microbial species, may predict donor efficacy in fecal microbiota transplantation (FMT) for the treatment of patients with ulcerative colitis (UC), a new study suggests.

The authors noted that these markers of donor efficacy could be used to optimize selection of donors to treat patients with UC and improve outcomes.

The investigators hypothesized that “there are features beyond microbial richness, individual bacterial species, and specific metabolites that may aid in successful identification of effective donors.” They published these findings in Gut.

The LOTUS clinical trial explored the efficacy of lyophilized FMT in patients with UC, but was cut short because of the COVID-19 pandemic. The study investigators analyzed fecal samples from the two donors enrolled in the trial to identify functional and taxonomic differences within the donors’ microbiota that have clinical relevance to their efficacy in active UC. Donor 1’s samples showed 100% efficacy among patients with UC, while donor 2’s samples showed 36% efficacy.

In donor 1, the researchers observed “robust stability in species richness” during the sampling periods, whereas donor 2 exhibited larger fluctuations. Although the species richness was significantly greater in the donor 2, the researchers reported that donor 1 exhibited significantly greater diversity at the higher taxonomic level of phylum. According to the investigators, this was reflected by the detection of Euryarchaeota, Synergistetes, and Verrucomicrobia in donor 1 but not in the second donor.

Despite a higher species richness in donor 2, the researchers found that a higher rate of uniquely classified metagenome-assembled genomes was produced per sample in the donor 1, which indicates greater species evenness, the second marker of efficacy according to investigators.

Blautia wexlerae was a highly prevalent metagenome-assembled genome that was enriched in donor 1 compared with donor 2, and the researchers reported that “a taxon with high similarity (OTU215) showed evidence of engraftment in patients receiving donor 1.” In addition, B. wexlerae demonstrated a trend toward enrichment in donor 2 samples that were associated with positive outcomes in patients and demonstrated evidence of engraftment in patients who received donor 2.

Ninety bacterial species as well as one archaeon were differentially abundant between donors, including 44 donor samples which were greater than 0.1% in relative abundance. According to the researchers, 17 out of the 44 species were enriched in the effective donor, with 11 (64.7%) assembled into high-quality genomes highly prevalent in that donor and 6 that demonstrated evidence of engraftment in patients.

Lastly, the investigators sought to validate the observed associations between certain microbial taxa and donor clinical efficacy in an independent cohort. In this analysis, the investigators evaluated shotgun metagenomics data of donors used to treat patients with UC and examined relative abundances against patient outcomes. Species associated with treatment success included Ruminococcus bromii, B. wexlerae, Eubacterium hallii, Coprococcus catus, Fusicatenibacter saccharivorans, and Parabacteroides merdae.

“We identified microbiota stability and species evenness as markers of donor efficacy, as well as specific microbial species that could be employed to improve donor selection and build artificial microbial consortia to treat UC,” the investigators concluded.

Given that the study enrolled only two donors, the generalizability of the findings may be limited. The researchers wrote that another limitation of the data analysis was “the bias towards more relatively abundant taxa due to the inability to assemble genomes from low-abundance species.” The lack of prospective validation studies on the novel metrics is another limitation of the study.

Some investigators disclosed relationships with biomedical companies, such as Takeda and Janssen.

Donor microbiota stability and species evenness, along with presence of certain microbial species, may predict donor efficacy in fecal microbiota transplantation (FMT) for the treatment of patients with ulcerative colitis (UC), a new study suggests.

The authors noted that these markers of donor efficacy could be used to optimize selection of donors to treat patients with UC and improve outcomes.

The investigators hypothesized that “there are features beyond microbial richness, individual bacterial species, and specific metabolites that may aid in successful identification of effective donors.” They published these findings in Gut.

The LOTUS clinical trial explored the efficacy of lyophilized FMT in patients with UC, but was cut short because of the COVID-19 pandemic. The study investigators analyzed fecal samples from the two donors enrolled in the trial to identify functional and taxonomic differences within the donors’ microbiota that have clinical relevance to their efficacy in active UC. Donor 1’s samples showed 100% efficacy among patients with UC, while donor 2’s samples showed 36% efficacy.

In donor 1, the researchers observed “robust stability in species richness” during the sampling periods, whereas donor 2 exhibited larger fluctuations. Although the species richness was significantly greater in the donor 2, the researchers reported that donor 1 exhibited significantly greater diversity at the higher taxonomic level of phylum. According to the investigators, this was reflected by the detection of Euryarchaeota, Synergistetes, and Verrucomicrobia in donor 1 but not in the second donor.

Despite a higher species richness in donor 2, the researchers found that a higher rate of uniquely classified metagenome-assembled genomes was produced per sample in the donor 1, which indicates greater species evenness, the second marker of efficacy according to investigators.

Blautia wexlerae was a highly prevalent metagenome-assembled genome that was enriched in donor 1 compared with donor 2, and the researchers reported that “a taxon with high similarity (OTU215) showed evidence of engraftment in patients receiving donor 1.” In addition, B. wexlerae demonstrated a trend toward enrichment in donor 2 samples that were associated with positive outcomes in patients and demonstrated evidence of engraftment in patients who received donor 2.

Ninety bacterial species as well as one archaeon were differentially abundant between donors, including 44 donor samples which were greater than 0.1% in relative abundance. According to the researchers, 17 out of the 44 species were enriched in the effective donor, with 11 (64.7%) assembled into high-quality genomes highly prevalent in that donor and 6 that demonstrated evidence of engraftment in patients.

Lastly, the investigators sought to validate the observed associations between certain microbial taxa and donor clinical efficacy in an independent cohort. In this analysis, the investigators evaluated shotgun metagenomics data of donors used to treat patients with UC and examined relative abundances against patient outcomes. Species associated with treatment success included Ruminococcus bromii, B. wexlerae, Eubacterium hallii, Coprococcus catus, Fusicatenibacter saccharivorans, and Parabacteroides merdae.

“We identified microbiota stability and species evenness as markers of donor efficacy, as well as specific microbial species that could be employed to improve donor selection and build artificial microbial consortia to treat UC,” the investigators concluded.

Given that the study enrolled only two donors, the generalizability of the findings may be limited. The researchers wrote that another limitation of the data analysis was “the bias towards more relatively abundant taxa due to the inability to assemble genomes from low-abundance species.” The lack of prospective validation studies on the novel metrics is another limitation of the study.

Some investigators disclosed relationships with biomedical companies, such as Takeda and Janssen.

Donor microbiota stability and species evenness, along with presence of certain microbial species, may predict donor efficacy in fecal microbiota transplantation (FMT) for the treatment of patients with ulcerative colitis (UC), a new study suggests.

The authors noted that these markers of donor efficacy could be used to optimize selection of donors to treat patients with UC and improve outcomes.

The investigators hypothesized that “there are features beyond microbial richness, individual bacterial species, and specific metabolites that may aid in successful identification of effective donors.” They published these findings in Gut.

The LOTUS clinical trial explored the efficacy of lyophilized FMT in patients with UC, but was cut short because of the COVID-19 pandemic. The study investigators analyzed fecal samples from the two donors enrolled in the trial to identify functional and taxonomic differences within the donors’ microbiota that have clinical relevance to their efficacy in active UC. Donor 1’s samples showed 100% efficacy among patients with UC, while donor 2’s samples showed 36% efficacy.

In donor 1, the researchers observed “robust stability in species richness” during the sampling periods, whereas donor 2 exhibited larger fluctuations. Although the species richness was significantly greater in the donor 2, the researchers reported that donor 1 exhibited significantly greater diversity at the higher taxonomic level of phylum. According to the investigators, this was reflected by the detection of Euryarchaeota, Synergistetes, and Verrucomicrobia in donor 1 but not in the second donor.

Despite a higher species richness in donor 2, the researchers found that a higher rate of uniquely classified metagenome-assembled genomes was produced per sample in the donor 1, which indicates greater species evenness, the second marker of efficacy according to investigators.

Blautia wexlerae was a highly prevalent metagenome-assembled genome that was enriched in donor 1 compared with donor 2, and the researchers reported that “a taxon with high similarity (OTU215) showed evidence of engraftment in patients receiving donor 1.” In addition, B. wexlerae demonstrated a trend toward enrichment in donor 2 samples that were associated with positive outcomes in patients and demonstrated evidence of engraftment in patients who received donor 2.

Ninety bacterial species as well as one archaeon were differentially abundant between donors, including 44 donor samples which were greater than 0.1% in relative abundance. According to the researchers, 17 out of the 44 species were enriched in the effective donor, with 11 (64.7%) assembled into high-quality genomes highly prevalent in that donor and 6 that demonstrated evidence of engraftment in patients.

Lastly, the investigators sought to validate the observed associations between certain microbial taxa and donor clinical efficacy in an independent cohort. In this analysis, the investigators evaluated shotgun metagenomics data of donors used to treat patients with UC and examined relative abundances against patient outcomes. Species associated with treatment success included Ruminococcus bromii, B. wexlerae, Eubacterium hallii, Coprococcus catus, Fusicatenibacter saccharivorans, and Parabacteroides merdae.

“We identified microbiota stability and species evenness as markers of donor efficacy, as well as specific microbial species that could be employed to improve donor selection and build artificial microbial consortia to treat UC,” the investigators concluded.

Given that the study enrolled only two donors, the generalizability of the findings may be limited. The researchers wrote that another limitation of the data analysis was “the bias towards more relatively abundant taxa due to the inability to assemble genomes from low-abundance species.” The lack of prospective validation studies on the novel metrics is another limitation of the study.

Some investigators disclosed relationships with biomedical companies, such as Takeda and Janssen.

Assessing how race and other characteristics may impact the presentation and outcomes of patients with inflammatory bowel disease (IBD) is a powerful method for understanding the basic underpinnings of IBD (microbiome, environmental, immune, and genetic). Yet, exclusively viewing race with this biologic lens leaves out another critical explanation for potential differences in IBD presentation and outcomes, which is health disparities.

Health disparities are a specific type of health difference, linked with economic, social, or environmental disadvantages and in groups traditionally subjected to discrimination, exclusion, or disadvantages. These social determinants of health can, many times, have an even greater effect on disease presentation and outcomes than biological determinants. In the field of IBD, racial disparities are an underrecognized and understudied area. Yet what we do know is enough to demonstrate that critical disparities in IBD exist and that additional study and action are needed.

For example, surgery is more common in African Americans and Hispanics compared to Whites with IBD.¹ Despite these findings, African Americans and Hispanics tend to have low use of biologics early in the disease course. Surgical outcomes are also worse in African Americans and Hispanics, who experience increased morbidity, mortality, and readmission after surgery.²

While the above outcomes may be attributable to inherent biologic differences, disparities quite likely have an important role. African Americans for example are less likely to see a GI or IBD specialist, more likely use the emergency room for their IBD care, and more likely to delay health visits because of transportation and financial issues. Non-Whites are more often seen in low–IBD volume hospitals, which can affect surgical outcomes. African Americans and Hispanics more often have reduced health literacy, which could affect their confidence and understanding in starting biologic therapy.

Fortunately, understanding and eliminating disparities in IBD is increasingly recognized as a priority area for research and action by the AGA and funding societies. We can do our part in many ways. We can immediately impact what is in our control right now (asking patients what economic and social barriers they may have to accessing care). We can advocate where we may not have direct control (policies that improve health access and social determinants of health). Finally, we can better understand and study social determinants of health in our research to get a more complete picture of how health disparities affect IBD presentation and outcomes.

Dr. Velayos is chief of gastroenterology at San Francisco Medical Center of the Permanente Medical Group, regional lead for inflammatory bowel disease for Northern California Kaiser Permanente, and chair of the immunology, microbiology, and inflammatory bowel disease section for the American Gastroenterological Association. He has no relevant conflicts to declare. Dr. Velayos made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.

References

1. Shi HY et al. Clin Gastroenterol Hepatol. 2018 Feb;16(2):190-7.

2. Booth A et al. Inflamm Bowel Dis. 2021 Sep 23. doi: 10.1093/ibd/izab237.

Assessing how race and other characteristics may impact the presentation and outcomes of patients with inflammatory bowel disease (IBD) is a powerful method for understanding the basic underpinnings of IBD (microbiome, environmental, immune, and genetic). Yet, exclusively viewing race with this biologic lens leaves out another critical explanation for potential differences in IBD presentation and outcomes, which is health disparities.

Health disparities are a specific type of health difference, linked with economic, social, or environmental disadvantages and in groups traditionally subjected to discrimination, exclusion, or disadvantages. These social determinants of health can, many times, have an even greater effect on disease presentation and outcomes than biological determinants. In the field of IBD, racial disparities are an underrecognized and understudied area. Yet what we do know is enough to demonstrate that critical disparities in IBD exist and that additional study and action are needed.

For example, surgery is more common in African Americans and Hispanics compared to Whites with IBD.¹ Despite these findings, African Americans and Hispanics tend to have low use of biologics early in the disease course. Surgical outcomes are also worse in African Americans and Hispanics, who experience increased morbidity, mortality, and readmission after surgery.²

While the above outcomes may be attributable to inherent biologic differences, disparities quite likely have an important role. African Americans for example are less likely to see a GI or IBD specialist, more likely use the emergency room for their IBD care, and more likely to delay health visits because of transportation and financial issues. Non-Whites are more often seen in low–IBD volume hospitals, which can affect surgical outcomes. African Americans and Hispanics more often have reduced health literacy, which could affect their confidence and understanding in starting biologic therapy.

Fortunately, understanding and eliminating disparities in IBD is increasingly recognized as a priority area for research and action by the AGA and funding societies. We can do our part in many ways. We can immediately impact what is in our control right now (asking patients what economic and social barriers they may have to accessing care). We can advocate where we may not have direct control (policies that improve health access and social determinants of health). Finally, we can better understand and study social determinants of health in our research to get a more complete picture of how health disparities affect IBD presentation and outcomes.

Dr. Velayos is chief of gastroenterology at San Francisco Medical Center of the Permanente Medical Group, regional lead for inflammatory bowel disease for Northern California Kaiser Permanente, and chair of the immunology, microbiology, and inflammatory bowel disease section for the American Gastroenterological Association. He has no relevant conflicts to declare. Dr. Velayos made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.

References

1. Shi HY et al. Clin Gastroenterol Hepatol. 2018 Feb;16(2):190-7.

2. Booth A et al. Inflamm Bowel Dis. 2021 Sep 23. doi: 10.1093/ibd/izab237.

Assessing how race and other characteristics may impact the presentation and outcomes of patients with inflammatory bowel disease (IBD) is a powerful method for understanding the basic underpinnings of IBD (microbiome, environmental, immune, and genetic). Yet, exclusively viewing race with this biologic lens leaves out another critical explanation for potential differences in IBD presentation and outcomes, which is health disparities.

Health disparities are a specific type of health difference, linked with economic, social, or environmental disadvantages and in groups traditionally subjected to discrimination, exclusion, or disadvantages. These social determinants of health can, many times, have an even greater effect on disease presentation and outcomes than biological determinants. In the field of IBD, racial disparities are an underrecognized and understudied area. Yet what we do know is enough to demonstrate that critical disparities in IBD exist and that additional study and action are needed.

For example, surgery is more common in African Americans and Hispanics compared to Whites with IBD.¹ Despite these findings, African Americans and Hispanics tend to have low use of biologics early in the disease course. Surgical outcomes are also worse in African Americans and Hispanics, who experience increased morbidity, mortality, and readmission after surgery.²

While the above outcomes may be attributable to inherent biologic differences, disparities quite likely have an important role. African Americans for example are less likely to see a GI or IBD specialist, more likely use the emergency room for their IBD care, and more likely to delay health visits because of transportation and financial issues. Non-Whites are more often seen in low–IBD volume hospitals, which can affect surgical outcomes. African Americans and Hispanics more often have reduced health literacy, which could affect their confidence and understanding in starting biologic therapy.

Fortunately, understanding and eliminating disparities in IBD is increasingly recognized as a priority area for research and action by the AGA and funding societies. We can do our part in many ways. We can immediately impact what is in our control right now (asking patients what economic and social barriers they may have to accessing care). We can advocate where we may not have direct control (policies that improve health access and social determinants of health). Finally, we can better understand and study social determinants of health in our research to get a more complete picture of how health disparities affect IBD presentation and outcomes.

Dr. Velayos is chief of gastroenterology at San Francisco Medical Center of the Permanente Medical Group, regional lead for inflammatory bowel disease for Northern California Kaiser Permanente, and chair of the immunology, microbiology, and inflammatory bowel disease section for the American Gastroenterological Association. He has no relevant conflicts to declare. Dr. Velayos made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.

References

1. Shi HY et al. Clin Gastroenterol Hepatol. 2018 Feb;16(2):190-7.

2. Booth A et al. Inflamm Bowel Dis. 2021 Sep 23. doi: 10.1093/ibd/izab237.

In the 15 years between 2007 and 2022, demographics, treatment options, management and monitoring strategies and even outcomes have dramatically changed in inflammatory bowel diseases (IBD) creating a whole new landscape for the disease.

In 2007, IBD seemed to be primarily a disease of Caucasian and Jewish ancestry. While prevalence of IBD is still highest in the Western world, there is now increasing incidence, even accounting for detection bias, in people of all other ancestries globally. Incidence of IBD in children under the age of 18 years is also rising. Patients with IBD are living longer and, despite the notion that IBD is a disease primarily of younger adults, nearly one-third of Americans with IBD are 60 years and older.

“Adalimumab aids in Crohn’s disease” read the front page of the inaugural issue of GI & Hepatology News in January 2007. The article highlighted the GAIN study, which demonstrated that patients who lost response to infliximab responded to adalimumab, the second anti-tumor necrosis factor (TNF) agent approved for the treatment of Crohn’s disease and subsequently ulcerative colitis. Over the subsequent 15 years, the armamentarium of treatment options for Crohn’s disease and ulcerative colitis have rapidly proliferated: there are now four anti–tumor necrosis factor (TNF) agents, two anti-integrin agents, two anti-interleukin agents, two Janus kinase inhibitors and a sphingosine-1 receptor modulator approved for the treatment of IBD. Many more promising treatment options are in trials. Other mechanisms are under investigation as well, including antimicrobial therapies for ulcerative colitis and stem cell therapeutics for the treatment of refractory perianal fistulizing Crohn’s disease. Perhaps even more novel – dietary therapies are more rigorously under investigation.

“Ulcerative colitis guidelines endorse combined therapy” reads another headline from the inaugural GI & Hepatology News issue. The article discusses the European Crohn’s and Colitis Organisation’s consensus guideline that topical and systemic agents used together are superior to either used alone, referring specifically to mesalamine, both systemic and topical as well as the additional of topical corticosteroid to systemic mesalamine. Combination therapy has a completely new meaning in modern times. With the publication of the SONIC trial in 2010, combination therapy referred to an anti-TNF in combination with an immunomodulator for the ensuing decade. However, in this new era of IBD treatment, combination therapy could also mean a biologic with a small molecule or even combination biologics, for which there is an ongoing randomized controlled trial. On the topic of treatment strategies, one of the biggest shifts in the IBD treatment paradigm is the bottom-up versus top-down approach of treatment, with increasing evidence to suggest that early biologic initiation is more effective, especially in patients with Crohn’s disease. Therapeutic drug monitoring is mainstream. Treat-to-target strategies to achieve more stringent outcomes, such as biomarker, endoscopic and histologic normalization, especially in ulcerative colitis, have evolved to become the norm in 2022.

The combination of increased treatment options, decreased reliance on corticosteroids and stringent treatment strategies have resulted in improved outcomes: IBD-related hospitalizations, surgeries, and even mortality have declined since 2007. The growing recognition and focus on extra-intestinal manifestations, including fatigue, and the gut-brain axis are important steps to improving the overall quality of life of patients with IBD. Beyond treating the disease, we are now learning how to treat the patient. We will be developing personalized strategies to identify the right patient for the right treatment, including patient-level clinical and biologic markers. We need to identify those who are at risk for IBD to prevent the disease at a preclinical phase. Concomitantly, we must continue the quest to cure the disease!

Dr. Kochar is a gastroenterologist and inflammatory bowel disease specialist at Massachusetts General Hospital and a physician investigator in the clinical and translational epidemiology unit at The Mongan Institute, both in Boston. She has no relevant disclosures.

In the 15 years between 2007 and 2022, demographics, treatment options, management and monitoring strategies and even outcomes have dramatically changed in inflammatory bowel diseases (IBD) creating a whole new landscape for the disease.

In 2007, IBD seemed to be primarily a disease of Caucasian and Jewish ancestry. While prevalence of IBD is still highest in the Western world, there is now increasing incidence, even accounting for detection bias, in people of all other ancestries globally. Incidence of IBD in children under the age of 18 years is also rising. Patients with IBD are living longer and, despite the notion that IBD is a disease primarily of younger adults, nearly one-third of Americans with IBD are 60 years and older.

“Adalimumab aids in Crohn’s disease” read the front page of the inaugural issue of GI & Hepatology News in January 2007. The article highlighted the GAIN study, which demonstrated that patients who lost response to infliximab responded to adalimumab, the second anti-tumor necrosis factor (TNF) agent approved for the treatment of Crohn’s disease and subsequently ulcerative colitis. Over the subsequent 15 years, the armamentarium of treatment options for Crohn’s disease and ulcerative colitis have rapidly proliferated: there are now four anti–tumor necrosis factor (TNF) agents, two anti-integrin agents, two anti-interleukin agents, two Janus kinase inhibitors and a sphingosine-1 receptor modulator approved for the treatment of IBD. Many more promising treatment options are in trials. Other mechanisms are under investigation as well, including antimicrobial therapies for ulcerative colitis and stem cell therapeutics for the treatment of refractory perianal fistulizing Crohn’s disease. Perhaps even more novel – dietary therapies are more rigorously under investigation.

“Ulcerative colitis guidelines endorse combined therapy” reads another headline from the inaugural GI & Hepatology News issue. The article discusses the European Crohn’s and Colitis Organisation’s consensus guideline that topical and systemic agents used together are superior to either used alone, referring specifically to mesalamine, both systemic and topical as well as the additional of topical corticosteroid to systemic mesalamine. Combination therapy has a completely new meaning in modern times. With the publication of the SONIC trial in 2010, combination therapy referred to an anti-TNF in combination with an immunomodulator for the ensuing decade. However, in this new era of IBD treatment, combination therapy could also mean a biologic with a small molecule or even combination biologics, for which there is an ongoing randomized controlled trial. On the topic of treatment strategies, one of the biggest shifts in the IBD treatment paradigm is the bottom-up versus top-down approach of treatment, with increasing evidence to suggest that early biologic initiation is more effective, especially in patients with Crohn’s disease. Therapeutic drug monitoring is mainstream. Treat-to-target strategies to achieve more stringent outcomes, such as biomarker, endoscopic and histologic normalization, especially in ulcerative colitis, have evolved to become the norm in 2022.

The combination of increased treatment options, decreased reliance on corticosteroids and stringent treatment strategies have resulted in improved outcomes: IBD-related hospitalizations, surgeries, and even mortality have declined since 2007. The growing recognition and focus on extra-intestinal manifestations, including fatigue, and the gut-brain axis are important steps to improving the overall quality of life of patients with IBD. Beyond treating the disease, we are now learning how to treat the patient. We will be developing personalized strategies to identify the right patient for the right treatment, including patient-level clinical and biologic markers. We need to identify those who are at risk for IBD to prevent the disease at a preclinical phase. Concomitantly, we must continue the quest to cure the disease!

Dr. Kochar is a gastroenterologist and inflammatory bowel disease specialist at Massachusetts General Hospital and a physician investigator in the clinical and translational epidemiology unit at The Mongan Institute, both in Boston. She has no relevant disclosures.

In the 15 years between 2007 and 2022, demographics, treatment options, management and monitoring strategies and even outcomes have dramatically changed in inflammatory bowel diseases (IBD) creating a whole new landscape for the disease.

In 2007, IBD seemed to be primarily a disease of Caucasian and Jewish ancestry. While prevalence of IBD is still highest in the Western world, there is now increasing incidence, even accounting for detection bias, in people of all other ancestries globally. Incidence of IBD in children under the age of 18 years is also rising. Patients with IBD are living longer and, despite the notion that IBD is a disease primarily of younger adults, nearly one-third of Americans with IBD are 60 years and older.

“Adalimumab aids in Crohn’s disease” read the front page of the inaugural issue of GI & Hepatology News in January 2007. The article highlighted the GAIN study, which demonstrated that patients who lost response to infliximab responded to adalimumab, the second anti-tumor necrosis factor (TNF) agent approved for the treatment of Crohn’s disease and subsequently ulcerative colitis. Over the subsequent 15 years, the armamentarium of treatment options for Crohn’s disease and ulcerative colitis have rapidly proliferated: there are now four anti–tumor necrosis factor (TNF) agents, two anti-integrin agents, two anti-interleukin agents, two Janus kinase inhibitors and a sphingosine-1 receptor modulator approved for the treatment of IBD. Many more promising treatment options are in trials. Other mechanisms are under investigation as well, including antimicrobial therapies for ulcerative colitis and stem cell therapeutics for the treatment of refractory perianal fistulizing Crohn’s disease. Perhaps even more novel – dietary therapies are more rigorously under investigation.

“Ulcerative colitis guidelines endorse combined therapy” reads another headline from the inaugural GI & Hepatology News issue. The article discusses the European Crohn’s and Colitis Organisation’s consensus guideline that topical and systemic agents used together are superior to either used alone, referring specifically to mesalamine, both systemic and topical as well as the additional of topical corticosteroid to systemic mesalamine. Combination therapy has a completely new meaning in modern times. With the publication of the SONIC trial in 2010, combination therapy referred to an anti-TNF in combination with an immunomodulator for the ensuing decade. However, in this new era of IBD treatment, combination therapy could also mean a biologic with a small molecule or even combination biologics, for which there is an ongoing randomized controlled trial. On the topic of treatment strategies, one of the biggest shifts in the IBD treatment paradigm is the bottom-up versus top-down approach of treatment, with increasing evidence to suggest that early biologic initiation is more effective, especially in patients with Crohn’s disease. Therapeutic drug monitoring is mainstream. Treat-to-target strategies to achieve more stringent outcomes, such as biomarker, endoscopic and histologic normalization, especially in ulcerative colitis, have evolved to become the norm in 2022.

The combination of increased treatment options, decreased reliance on corticosteroids and stringent treatment strategies have resulted in improved outcomes: IBD-related hospitalizations, surgeries, and even mortality have declined since 2007. The growing recognition and focus on extra-intestinal manifestations, including fatigue, and the gut-brain axis are important steps to improving the overall quality of life of patients with IBD. Beyond treating the disease, we are now learning how to treat the patient. We will be developing personalized strategies to identify the right patient for the right treatment, including patient-level clinical and biologic markers. We need to identify those who are at risk for IBD to prevent the disease at a preclinical phase. Concomitantly, we must continue the quest to cure the disease!

Dr. Kochar is a gastroenterologist and inflammatory bowel disease specialist at Massachusetts General Hospital and a physician investigator in the clinical and translational epidemiology unit at The Mongan Institute, both in Boston. She has no relevant disclosures.

The study by Huang and colleagues investigates the long-term effects and potential mechanisms of action of transcutaneous electrical acustimulation (TEA) in patients with IBS with constipation (IBS-C) experiencing colonic transit issues and visceral hypersensitivity. Patients with IBS-C receiving TEA had increased frequency of spontaneous bowel movements and significant improvements in analog pain score compared with the placebo group. This supports the benefit of TEA for improving constipation and the concomitant symptoms by accelerating colonic transit and reducing rectal sensation. It can be inferred that the improvement of these symptoms will lead to enhanced quality of life in patients with IBS-C.

The study by Melchior and colleagues¹ emphasizes the effect that IBS can have on a patient's life. Patients with IBS report reduced disease-specific quality of life. The cumulative impact of the demographic factors and the severity of psychological symptoms, somatic symptoms, and gastrointestinal symptoms are associated with decreased quality of life. The severity of this impact is determined by the combination of these factors and the level of severity at which they occur. This decrease in quality of life can lead to increased anxiety related to gastrointestinal function. It is important for providers to acknowledge the effect that gastrointestinal function has on the patient's life in a broader sense. The appreciation and understanding of the patient experience enhances the therapeutic relationship and shared decision-making between the patient and the healthcare provider.

Additional References

1. Melchior C, Colomier E, Trindade IA, et al. Irritable bowel syndrome: Factors of importance for disease-specific quality of life. United European Gastroenterol J. 2022 Jul 13. Doi: 10.1002/ueg2.12277  

The study by Huang and colleagues investigates the long-term effects and potential mechanisms of action of transcutaneous electrical acustimulation (TEA) in patients with IBS with constipation (IBS-C) experiencing colonic transit issues and visceral hypersensitivity. Patients with IBS-C receiving TEA had increased frequency of spontaneous bowel movements and significant improvements in analog pain score compared with the placebo group. This supports the benefit of TEA for improving constipation and the concomitant symptoms by accelerating colonic transit and reducing rectal sensation. It can be inferred that the improvement of these symptoms will lead to enhanced quality of life in patients with IBS-C.

The study by Melchior and colleagues¹ emphasizes the effect that IBS can have on a patient's life. Patients with IBS report reduced disease-specific quality of life. The cumulative impact of the demographic factors and the severity of psychological symptoms, somatic symptoms, and gastrointestinal symptoms are associated with decreased quality of life. The severity of this impact is determined by the combination of these factors and the level of severity at which they occur. This decrease in quality of life can lead to increased anxiety related to gastrointestinal function. It is important for providers to acknowledge the effect that gastrointestinal function has on the patient's life in a broader sense. The appreciation and understanding of the patient experience enhances the therapeutic relationship and shared decision-making between the patient and the healthcare provider.

Additional References

1. Melchior C, Colomier E, Trindade IA, et al. Irritable bowel syndrome: Factors of importance for disease-specific quality of life. United European Gastroenterol J. 2022 Jul 13. Doi: 10.1002/ueg2.12277  

The study by Huang and colleagues investigates the long-term effects and potential mechanisms of action of transcutaneous electrical acustimulation (TEA) in patients with IBS with constipation (IBS-C) experiencing colonic transit issues and visceral hypersensitivity. Patients with IBS-C receiving TEA had increased frequency of spontaneous bowel movements and significant improvements in analog pain score compared with the placebo group. This supports the benefit of TEA for improving constipation and the concomitant symptoms by accelerating colonic transit and reducing rectal sensation. It can be inferred that the improvement of these symptoms will lead to enhanced quality of life in patients with IBS-C.

The study by Melchior and colleagues¹ emphasizes the effect that IBS can have on a patient's life. Patients with IBS report reduced disease-specific quality of life. The cumulative impact of the demographic factors and the severity of psychological symptoms, somatic symptoms, and gastrointestinal symptoms are associated with decreased quality of life. The severity of this impact is determined by the combination of these factors and the level of severity at which they occur. This decrease in quality of life can lead to increased anxiety related to gastrointestinal function. It is important for providers to acknowledge the effect that gastrointestinal function has on the patient's life in a broader sense. The appreciation and understanding of the patient experience enhances the therapeutic relationship and shared decision-making between the patient and the healthcare provider.

Additional References

1. Melchior C, Colomier E, Trindade IA, et al. Irritable bowel syndrome: Factors of importance for disease-specific quality of life. United European Gastroenterol J. 2022 Jul 13. Doi: 10.1002/ueg2.12277