Key clinical point: Induction therapy with tofacitinib or prednisone significantly increased serum lipid levels in patients with inflammatory bowel disease (IBD), whereas no changes were observed with immunomodulators or biologics.

Major finding: At 10 weeks, the total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol levels increased significantly in patients who initiated tofacitinib (+20%, +25%, and +26%, respectively; all P < .05) or prednisone (+26%, +31%, and +12%, respectively; all P < .05) therapy. The changes in lipid levels were not significant with other biologics or immunomodulators.

Study details: This was a prospective study that included 198 patients with ulcerative colitis (n = 61), Crohn’s disease (n = 137), or unclassified IBD (n = 8) who initiated prednisone, thiopurine, methotrexate, an anti-tumor necrosis factor alpha agent, ustekinumab, vedolizumab, or tofacitinib.

Disclosures: This study did not receive any funding. AC de Vries and CJ van der Woude declared receiving research funding and serving as advisory board members for various sources.

Source: Sleutjes JAM et al. Lipid changes after induction therapy in patients with inflammatory bowel disease: Effect of different drug classes and inflammation. Inflamm Bowel Dis. 2022 (May 19). Doi: 10.1093/ibd/izac100

Key clinical point: Induction therapy with tofacitinib or prednisone significantly increased serum lipid levels in patients with inflammatory bowel disease (IBD), whereas no changes were observed with immunomodulators or biologics.

Major finding: At 10 weeks, the total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol levels increased significantly in patients who initiated tofacitinib (+20%, +25%, and +26%, respectively; all P < .05) or prednisone (+26%, +31%, and +12%, respectively; all P < .05) therapy. The changes in lipid levels were not significant with other biologics or immunomodulators.

Study details: This was a prospective study that included 198 patients with ulcerative colitis (n = 61), Crohn’s disease (n = 137), or unclassified IBD (n = 8) who initiated prednisone, thiopurine, methotrexate, an anti-tumor necrosis factor alpha agent, ustekinumab, vedolizumab, or tofacitinib.

Disclosures: This study did not receive any funding. AC de Vries and CJ van der Woude declared receiving research funding and serving as advisory board members for various sources.

Source: Sleutjes JAM et al. Lipid changes after induction therapy in patients with inflammatory bowel disease: Effect of different drug classes and inflammation. Inflamm Bowel Dis. 2022 (May 19). Doi: 10.1093/ibd/izac100

Key clinical point: Induction therapy with tofacitinib or prednisone significantly increased serum lipid levels in patients with inflammatory bowel disease (IBD), whereas no changes were observed with immunomodulators or biologics.

Major finding: At 10 weeks, the total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol levels increased significantly in patients who initiated tofacitinib (+20%, +25%, and +26%, respectively; all P < .05) or prednisone (+26%, +31%, and +12%, respectively; all P < .05) therapy. The changes in lipid levels were not significant with other biologics or immunomodulators.

Study details: This was a prospective study that included 198 patients with ulcerative colitis (n = 61), Crohn’s disease (n = 137), or unclassified IBD (n = 8) who initiated prednisone, thiopurine, methotrexate, an anti-tumor necrosis factor alpha agent, ustekinumab, vedolizumab, or tofacitinib.

Disclosures: This study did not receive any funding. AC de Vries and CJ van der Woude declared receiving research funding and serving as advisory board members for various sources.

Source: Sleutjes JAM et al. Lipid changes after induction therapy in patients with inflammatory bowel disease: Effect of different drug classes and inflammation. Inflamm Bowel Dis. 2022 (May 19). Doi: 10.1093/ibd/izac100

Key clinical point: Vedolizumab can be considered a safe and valid option for elderly patients with inflammatory bowel disease, with efficacy being unaffected by age in Crohn’s disease (CD), but slightly reduced in elderly vs. nonelderly patients with ulcerative colitis (UC).

Major finding: Nonelderly vs. elderly patients with UC showed significantly higher clinical remission at 24 months (47.3% vs. 34.3%; P < .05) and persistence (67.6% vs. 51.4%; P = .02), both of which were not significantly different between elderly and nonelderly patients with CD. Adverse events were comparable among elderly and nonelderly patients.

Study details: This was a retrospective-prospective study that included 198 elderly patients aged ≥ 65 years with UC (n = 108) or CD (n = 90) and 396 matched nonelderly patients with UC (n = 205) or CD (n = 191), all of whom received vedolizumab.

Disclosures: This study was funded by Takeda. Some authors reported receiving consulting, lecture, or speakers’ fees, or serving as advisory board members for various sources, including Takeda.

Source: Pugliese D et al. Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: The IG-IBD LIVE study. Aliment Pharmacol Ther. 2022;56(1):95-109 (May 12). Doi: 10.1111/apt.16923

Key clinical point: Vedolizumab can be considered a safe and valid option for elderly patients with inflammatory bowel disease, with efficacy being unaffected by age in Crohn’s disease (CD), but slightly reduced in elderly vs. nonelderly patients with ulcerative colitis (UC).

Major finding: Nonelderly vs. elderly patients with UC showed significantly higher clinical remission at 24 months (47.3% vs. 34.3%; P < .05) and persistence (67.6% vs. 51.4%; P = .02), both of which were not significantly different between elderly and nonelderly patients with CD. Adverse events were comparable among elderly and nonelderly patients.

Study details: This was a retrospective-prospective study that included 198 elderly patients aged ≥ 65 years with UC (n = 108) or CD (n = 90) and 396 matched nonelderly patients with UC (n = 205) or CD (n = 191), all of whom received vedolizumab.

Disclosures: This study was funded by Takeda. Some authors reported receiving consulting, lecture, or speakers’ fees, or serving as advisory board members for various sources, including Takeda.

Source: Pugliese D et al. Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: The IG-IBD LIVE study. Aliment Pharmacol Ther. 2022;56(1):95-109 (May 12). Doi: 10.1111/apt.16923

Key clinical point: Vedolizumab can be considered a safe and valid option for elderly patients with inflammatory bowel disease, with efficacy being unaffected by age in Crohn’s disease (CD), but slightly reduced in elderly vs. nonelderly patients with ulcerative colitis (UC).

Major finding: Nonelderly vs. elderly patients with UC showed significantly higher clinical remission at 24 months (47.3% vs. 34.3%; P < .05) and persistence (67.6% vs. 51.4%; P = .02), both of which were not significantly different between elderly and nonelderly patients with CD. Adverse events were comparable among elderly and nonelderly patients.

Study details: This was a retrospective-prospective study that included 198 elderly patients aged ≥ 65 years with UC (n = 108) or CD (n = 90) and 396 matched nonelderly patients with UC (n = 205) or CD (n = 191), all of whom received vedolizumab.

Disclosures: This study was funded by Takeda. Some authors reported receiving consulting, lecture, or speakers’ fees, or serving as advisory board members for various sources, including Takeda.

Source: Pugliese D et al. Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: The IG-IBD LIVE study. Aliment Pharmacol Ther. 2022;56(1):95-109 (May 12). Doi: 10.1111/apt.16923

Key clinical point: Early treatment with postoperative biological therapy decreased endoscopic recurrence rates and improved long-term outcomes in patients who underwent Crohn’s disease (CD)-related surgery.

Major finding: The rate of endoscopic recurrence was higher in patients not treated vs. treated with early postoperative biological therapy (80.8% vs. 45.2%; P < .000024), with the risk of experiencing hospitalization or surgery at 5 years being 23.3% higher (P = .02221) and the rate of medical therapy escalation being significantly higher (66.0% vs. 14.0%; P < .00001) in the no-treatment vs. treatment group.

Study details: Findings are from a retrospective cohort study including 141 patients with CD who underwent surgery and colonoscopy at 6-12 months postoperatively.

Disclosures: This study did not receive any funding. Some authors declared receiving consulting fees, lecture fees, speaker’s fees, grants, or serving as advisory board members for various sources.

Source: D'Amico F et al. Early biological therapy in operated Crohn’s disease patients is associated with a lower rate of endoscopic recurrence and improved long-term outcomes: A single-center experience. Inflamm Bowel Dis. 2022 (May 28). Doi: 10.1093/ibd/izac110

Key clinical point: Early treatment with postoperative biological therapy decreased endoscopic recurrence rates and improved long-term outcomes in patients who underwent Crohn’s disease (CD)-related surgery.

Major finding: The rate of endoscopic recurrence was higher in patients not treated vs. treated with early postoperative biological therapy (80.8% vs. 45.2%; P < .000024), with the risk of experiencing hospitalization or surgery at 5 years being 23.3% higher (P = .02221) and the rate of medical therapy escalation being significantly higher (66.0% vs. 14.0%; P < .00001) in the no-treatment vs. treatment group.

Study details: Findings are from a retrospective cohort study including 141 patients with CD who underwent surgery and colonoscopy at 6-12 months postoperatively.

Disclosures: This study did not receive any funding. Some authors declared receiving consulting fees, lecture fees, speaker’s fees, grants, or serving as advisory board members for various sources.

Source: D'Amico F et al. Early biological therapy in operated Crohn’s disease patients is associated with a lower rate of endoscopic recurrence and improved long-term outcomes: A single-center experience. Inflamm Bowel Dis. 2022 (May 28). Doi: 10.1093/ibd/izac110

Key clinical point: Early treatment with postoperative biological therapy decreased endoscopic recurrence rates and improved long-term outcomes in patients who underwent Crohn’s disease (CD)-related surgery.

Major finding: The rate of endoscopic recurrence was higher in patients not treated vs. treated with early postoperative biological therapy (80.8% vs. 45.2%; P < .000024), with the risk of experiencing hospitalization or surgery at 5 years being 23.3% higher (P = .02221) and the rate of medical therapy escalation being significantly higher (66.0% vs. 14.0%; P < .00001) in the no-treatment vs. treatment group.

Study details: Findings are from a retrospective cohort study including 141 patients with CD who underwent surgery and colonoscopy at 6-12 months postoperatively.

Disclosures: This study did not receive any funding. Some authors declared receiving consulting fees, lecture fees, speaker’s fees, grants, or serving as advisory board members for various sources.

Source: D'Amico F et al. Early biological therapy in operated Crohn’s disease patients is associated with a lower rate of endoscopic recurrence and improved long-term outcomes: A single-center experience. Inflamm Bowel Dis. 2022 (May 28). Doi: 10.1093/ibd/izac110

LONDON – A low-carbohydrate, high-fat (LCHF) diet reduced the progression of nonalcoholic fatty liver disease (NAFLD), and despite no calorie restriction, participants with both NAFLD and type 2 diabetes lost 5.8% of their body weight, according to a randomized controlled study.

“Based on these results, the LCHF diet may be recommended to people with NAFLD and type 2 diabetes,” said Camilla Dalby Hansen, MD, department of gastroenterology and hepatology, Odense University Hospital, Denmark, who presented the data at the International Liver Congress (ILC) 2022.  

“Basically, if you have fat in your liver, you will benefit from eating fat,” she said.

The LCHF diet was compared with a low-fat, high-carbohydrate diet more typically followed for these conditions. The low-fat diet was also found to reduce the progression of NAFLD, but to a lesser extent than the LCHF diet.

Dr. Dalby Hansen called their study one of the most extensive investigations of the LCHF diet in patients with type 2 diabetes and fatty liver disease.

“Combining this [reduction in NAFLD score] with the huge weight loss, the lower HbA1c [blood sugar], the lowering of blood pressure in women, the rise in HDL levels, and reduction in triglycerides – all in all, this diet is very promising,” she said.

Stephen Harrison, MD, visiting professor, University of Oxford, United Kingdom, medical director of Pinnacle Clinical Research and president of Summit Clinical Research, San Antonio, commended Dr. Dalby Hansen on her methodology, which included before-and-after liver biopsies. “It’s a heinous effort to do paired liver biopsies in a lifestyle modification trial. That’s huge.”

“This study tells me that the way we manage patients doesn’t change – it is still lifestyle modification,” said Dr. Harrison, who was not involved with the study. “It’s eat less [rather] than more. It’s exercise and try to lose weight. In the long term, we give patients benefit, and we show that the disease has improved, and we offer something that means they can maintain a healthy life.”

He added that the relatively small and short trial was informative.

“They improved the NAFLD activity score [NAS],” he said. “I don’t know by how much. There was no change in fibrosis, but we wouldn’t expect this at 6 months.”

“It’s provocative work, and it gives us healthy information about how we can help manage our patients from a lifestyle perspective,” he concluded.
 

‘Do not lose weight. Eat until you are full’

In the study, 110 participants with type 2 diabetes and NAFLD, aged 18-78 years, were allocated to the LCHF diet, and 55 were allocated to the low-fat diet for 6 months.

The researchers performed liver biopsies at baseline and 6 months, which were blinded for scoring.  

Participants had ongoing dietitian consultations, with follow-up visits at 3 and 6 months. Compliance was reported continuously through an online food diary platform.

The primary endpoint was change in glycemic control as measured by A1c level over 6 months. The secondary endpoints comprised the proportion of participants with changes in the NAS of at least 2 points over 6 months. Both these measures were compared between the two dietary groups.

The two groups were matched at baseline, with a mean age of 55-57 years, 58% were women, 89% with metabolic syndrome, and a mean BMI 34 kg/m².

In baseline liver disease, F1 level fibrosis was the most common (58%), followed by hepatic steatosis (S1, 47%; S2, 32%), with a median NAS of 3, and 19% had nonalcoholic steatohepatitis.

The special thing about these diets was that participants were told to “not lose weight, but eat until you are full,” remarked Dr. Dalby Hansen.

Those on the LCHF diet consumed an average of 61% energy from fat, 13% from carbohydrates, and 23% from protein, compared with the low-fat diet, which comprised an average of 29% energy from fat, 46% from carbohydrates, and 21% from protein.

“It’s a lot of fat and corresponds to a quarter of a liter of olive oil per day,” said Dr. Dalby Hansen. “They really had to change their mindset a lot, because it was difficult for them to start eating all these fats, especially since we’ve all been told for decades that it isn’t good. But we supported them, and they got into it.”

The LCHF diet was primarily comprised of unsaturated fats – for example, avocado, oil, nuts, and seeds – but also included saturated fats, such as cheese, cream, and high-fat dairy products. Participants were free to eat unsaturated and saturated fats, but Dr. Dalby Hansen and her team advised participants that “good” unsaturated fats were preferable.

“Also, this diet contained vegetables but no bread, no potatoes, no rice, and no pasta. It was low in carbohydrates, below 20%,” she added.
 

Improved glycemic control, reduced liver fat

“We found that the LCHF diet improved diabetes control, it reduced the fat in the liver, and, even though they’re eating as many calories as they were used to until they were full, they lost 5.8% of body weight,” said Dr. Dalby Hansen in reporting the results. Participants in the low-fat group lost only 1.8% of body weight.

However, mean calorie intake dropped in both groups, by –2.2% in the LCHF group and –8.7% in the low-fat group. 

“The LCHF diet improved the primary outcome of A1c by 9.5 mmol/mol, which is similar to some anti-diabetic medications, such as DPP-4 inhibitors and SGLT2 inhibitors,” she said.

The low-fat group reduced A1c by 3.4 mmol/mol, resulting in a between-group difference of 6.1 mmol/mol.

“Upon follow-up of 3 months, after stopping the diets, on average the participants in both groups returned their HbA1c levels to nearly baseline values,” she said. Results were adjusted for weight loss and baseline values.

Both diets also improved the NAS. The proportion of participants who improved their NAS score by 2 or more points was 22% in the LCHF group versus 17% in the low-fat group (P = 0.58). Additionally, in the LCHF group, 70% of participants improved their score by 1 or more points, compared with 49% in the low-fat group and fewer in the LCHF group experienced a worsening of their score (1% vs. 23%, respectively).

One participant on LCHF had high triglycerides of 12 mmol/L after 3 months. Overall, the low-density lipoprotein increased marginally by 0.2 mmol per liter in the high-fat group, said Dr. Dalby Hansen.

Dr. Dalby Hansen noted some limitations. The findings might not be applicable in more severe NAFLD, dietary assessment relied on self-reporting, no food was provided, and participants had to cook themselves. It was also an open-label study because of the nature of the intervention.
 

Some hope for more sustainable dieting

Many diets are difficult to adhere to, remarked Dr. Dalby Hansen. “We thought this [diet] might be easier to comply with in the longer term, and we hope that these results might provide patients with more options.”

She added that most people who started the diet adapted and complied with it. “However, it might not be for everyone, but I think we can say that if people try, and it fits into their lives, then they go for it.”

However, “it is not about going out and eating whatever fat and how much of it you want. It’s important that you cut the carbohydrates too,” she said. “With this approach, we really saw amazing results.”

Dr. Dalby Hansen added that having various diets available, including the LCHF one, meant that as clinicians they could empower patients to take control of their metabolic health.

“We can ask them directly, ‘What would fit into their life?’” she said. “We know that one size does not fit at all, and I believe that if we could engage patients more, then they can take control of their own situation.”

Asked whether these findings were enough to change guidelines, Zobair Younossi, MD, professor and chairman, department of medicine, Inova Fairfax Medical Campus, Falls Church, Va., remarked that it was the sugar at work here.

“Dietary fat – it’s not the same as fat in the liver, and this diet has more to do with the sugar levels,” he said.

“I’m always reluctant to take results from a short-term study without long-term follow-up,” Dr. Younossi said. “I want to know will patients live longer, and long-term data are needed for this. Until I have that strong evidence that outcomes are going to change, or at least some sign that the outcome is going to change, it is too early to change any guidelines.”

Dr. Dalby Hansen reports no relevant financial relationships. Dr. Harrison reported financial relationships with numerous pharmaceutical companies. Dr. Younossi reports the following financial relationships: research funds and/or consultant to Abbott, Allergan, Bristol Myers Squibb, Echosens, Genfit, Gilead Sciences, Intercept, Madrigal, Merck, and Novo Nordisk.

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

LONDON – A low-carbohydrate, high-fat (LCHF) diet reduced the progression of nonalcoholic fatty liver disease (NAFLD), and despite no calorie restriction, participants with both NAFLD and type 2 diabetes lost 5.8% of their body weight, according to a randomized controlled study.

“Based on these results, the LCHF diet may be recommended to people with NAFLD and type 2 diabetes,” said Camilla Dalby Hansen, MD, department of gastroenterology and hepatology, Odense University Hospital, Denmark, who presented the data at the International Liver Congress (ILC) 2022.  

“Basically, if you have fat in your liver, you will benefit from eating fat,” she said.

The LCHF diet was compared with a low-fat, high-carbohydrate diet more typically followed for these conditions. The low-fat diet was also found to reduce the progression of NAFLD, but to a lesser extent than the LCHF diet.

Dr. Dalby Hansen called their study one of the most extensive investigations of the LCHF diet in patients with type 2 diabetes and fatty liver disease.

“Combining this [reduction in NAFLD score] with the huge weight loss, the lower HbA1c [blood sugar], the lowering of blood pressure in women, the rise in HDL levels, and reduction in triglycerides – all in all, this diet is very promising,” she said.

Stephen Harrison, MD, visiting professor, University of Oxford, United Kingdom, medical director of Pinnacle Clinical Research and president of Summit Clinical Research, San Antonio, commended Dr. Dalby Hansen on her methodology, which included before-and-after liver biopsies. “It’s a heinous effort to do paired liver biopsies in a lifestyle modification trial. That’s huge.”

“This study tells me that the way we manage patients doesn’t change – it is still lifestyle modification,” said Dr. Harrison, who was not involved with the study. “It’s eat less [rather] than more. It’s exercise and try to lose weight. In the long term, we give patients benefit, and we show that the disease has improved, and we offer something that means they can maintain a healthy life.”

He added that the relatively small and short trial was informative.

“They improved the NAFLD activity score [NAS],” he said. “I don’t know by how much. There was no change in fibrosis, but we wouldn’t expect this at 6 months.”

“It’s provocative work, and it gives us healthy information about how we can help manage our patients from a lifestyle perspective,” he concluded.
 

‘Do not lose weight. Eat until you are full’

In the study, 110 participants with type 2 diabetes and NAFLD, aged 18-78 years, were allocated to the LCHF diet, and 55 were allocated to the low-fat diet for 6 months.

The researchers performed liver biopsies at baseline and 6 months, which were blinded for scoring.  

Participants had ongoing dietitian consultations, with follow-up visits at 3 and 6 months. Compliance was reported continuously through an online food diary platform.

The primary endpoint was change in glycemic control as measured by A1c level over 6 months. The secondary endpoints comprised the proportion of participants with changes in the NAS of at least 2 points over 6 months. Both these measures were compared between the two dietary groups.

The two groups were matched at baseline, with a mean age of 55-57 years, 58% were women, 89% with metabolic syndrome, and a mean BMI 34 kg/m².

In baseline liver disease, F1 level fibrosis was the most common (58%), followed by hepatic steatosis (S1, 47%; S2, 32%), with a median NAS of 3, and 19% had nonalcoholic steatohepatitis.

The special thing about these diets was that participants were told to “not lose weight, but eat until you are full,” remarked Dr. Dalby Hansen.

Those on the LCHF diet consumed an average of 61% energy from fat, 13% from carbohydrates, and 23% from protein, compared with the low-fat diet, which comprised an average of 29% energy from fat, 46% from carbohydrates, and 21% from protein.

“It’s a lot of fat and corresponds to a quarter of a liter of olive oil per day,” said Dr. Dalby Hansen. “They really had to change their mindset a lot, because it was difficult for them to start eating all these fats, especially since we’ve all been told for decades that it isn’t good. But we supported them, and they got into it.”

The LCHF diet was primarily comprised of unsaturated fats – for example, avocado, oil, nuts, and seeds – but also included saturated fats, such as cheese, cream, and high-fat dairy products. Participants were free to eat unsaturated and saturated fats, but Dr. Dalby Hansen and her team advised participants that “good” unsaturated fats were preferable.

“Also, this diet contained vegetables but no bread, no potatoes, no rice, and no pasta. It was low in carbohydrates, below 20%,” she added.
 

Improved glycemic control, reduced liver fat

“We found that the LCHF diet improved diabetes control, it reduced the fat in the liver, and, even though they’re eating as many calories as they were used to until they were full, they lost 5.8% of body weight,” said Dr. Dalby Hansen in reporting the results. Participants in the low-fat group lost only 1.8% of body weight.

However, mean calorie intake dropped in both groups, by –2.2% in the LCHF group and –8.7% in the low-fat group. 

“The LCHF diet improved the primary outcome of A1c by 9.5 mmol/mol, which is similar to some anti-diabetic medications, such as DPP-4 inhibitors and SGLT2 inhibitors,” she said.

The low-fat group reduced A1c by 3.4 mmol/mol, resulting in a between-group difference of 6.1 mmol/mol.

“Upon follow-up of 3 months, after stopping the diets, on average the participants in both groups returned their HbA1c levels to nearly baseline values,” she said. Results were adjusted for weight loss and baseline values.

Both diets also improved the NAS. The proportion of participants who improved their NAS score by 2 or more points was 22% in the LCHF group versus 17% in the low-fat group (P = 0.58). Additionally, in the LCHF group, 70% of participants improved their score by 1 or more points, compared with 49% in the low-fat group and fewer in the LCHF group experienced a worsening of their score (1% vs. 23%, respectively).

One participant on LCHF had high triglycerides of 12 mmol/L after 3 months. Overall, the low-density lipoprotein increased marginally by 0.2 mmol per liter in the high-fat group, said Dr. Dalby Hansen.

Dr. Dalby Hansen noted some limitations. The findings might not be applicable in more severe NAFLD, dietary assessment relied on self-reporting, no food was provided, and participants had to cook themselves. It was also an open-label study because of the nature of the intervention.
 

Some hope for more sustainable dieting

Many diets are difficult to adhere to, remarked Dr. Dalby Hansen. “We thought this [diet] might be easier to comply with in the longer term, and we hope that these results might provide patients with more options.”

She added that most people who started the diet adapted and complied with it. “However, it might not be for everyone, but I think we can say that if people try, and it fits into their lives, then they go for it.”

However, “it is not about going out and eating whatever fat and how much of it you want. It’s important that you cut the carbohydrates too,” she said. “With this approach, we really saw amazing results.”

Dr. Dalby Hansen added that having various diets available, including the LCHF one, meant that as clinicians they could empower patients to take control of their metabolic health.

“We can ask them directly, ‘What would fit into their life?’” she said. “We know that one size does not fit at all, and I believe that if we could engage patients more, then they can take control of their own situation.”

Asked whether these findings were enough to change guidelines, Zobair Younossi, MD, professor and chairman, department of medicine, Inova Fairfax Medical Campus, Falls Church, Va., remarked that it was the sugar at work here.

“Dietary fat – it’s not the same as fat in the liver, and this diet has more to do with the sugar levels,” he said.

“I’m always reluctant to take results from a short-term study without long-term follow-up,” Dr. Younossi said. “I want to know will patients live longer, and long-term data are needed for this. Until I have that strong evidence that outcomes are going to change, or at least some sign that the outcome is going to change, it is too early to change any guidelines.”

Dr. Dalby Hansen reports no relevant financial relationships. Dr. Harrison reported financial relationships with numerous pharmaceutical companies. Dr. Younossi reports the following financial relationships: research funds and/or consultant to Abbott, Allergan, Bristol Myers Squibb, Echosens, Genfit, Gilead Sciences, Intercept, Madrigal, Merck, and Novo Nordisk.

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

LONDON – A low-carbohydrate, high-fat (LCHF) diet reduced the progression of nonalcoholic fatty liver disease (NAFLD), and despite no calorie restriction, participants with both NAFLD and type 2 diabetes lost 5.8% of their body weight, according to a randomized controlled study.

“Based on these results, the LCHF diet may be recommended to people with NAFLD and type 2 diabetes,” said Camilla Dalby Hansen, MD, department of gastroenterology and hepatology, Odense University Hospital, Denmark, who presented the data at the International Liver Congress (ILC) 2022.  

“Basically, if you have fat in your liver, you will benefit from eating fat,” she said.

The LCHF diet was compared with a low-fat, high-carbohydrate diet more typically followed for these conditions. The low-fat diet was also found to reduce the progression of NAFLD, but to a lesser extent than the LCHF diet.

Dr. Dalby Hansen called their study one of the most extensive investigations of the LCHF diet in patients with type 2 diabetes and fatty liver disease.

“Combining this [reduction in NAFLD score] with the huge weight loss, the lower HbA1c [blood sugar], the lowering of blood pressure in women, the rise in HDL levels, and reduction in triglycerides – all in all, this diet is very promising,” she said.

Stephen Harrison, MD, visiting professor, University of Oxford, United Kingdom, medical director of Pinnacle Clinical Research and president of Summit Clinical Research, San Antonio, commended Dr. Dalby Hansen on her methodology, which included before-and-after liver biopsies. “It’s a heinous effort to do paired liver biopsies in a lifestyle modification trial. That’s huge.”

“This study tells me that the way we manage patients doesn’t change – it is still lifestyle modification,” said Dr. Harrison, who was not involved with the study. “It’s eat less [rather] than more. It’s exercise and try to lose weight. In the long term, we give patients benefit, and we show that the disease has improved, and we offer something that means they can maintain a healthy life.”

He added that the relatively small and short trial was informative.

“They improved the NAFLD activity score [NAS],” he said. “I don’t know by how much. There was no change in fibrosis, but we wouldn’t expect this at 6 months.”

“It’s provocative work, and it gives us healthy information about how we can help manage our patients from a lifestyle perspective,” he concluded.
 

‘Do not lose weight. Eat until you are full’

In the study, 110 participants with type 2 diabetes and NAFLD, aged 18-78 years, were allocated to the LCHF diet, and 55 were allocated to the low-fat diet for 6 months.

The researchers performed liver biopsies at baseline and 6 months, which were blinded for scoring.  

Participants had ongoing dietitian consultations, with follow-up visits at 3 and 6 months. Compliance was reported continuously through an online food diary platform.

The primary endpoint was change in glycemic control as measured by A1c level over 6 months. The secondary endpoints comprised the proportion of participants with changes in the NAS of at least 2 points over 6 months. Both these measures were compared between the two dietary groups.

The two groups were matched at baseline, with a mean age of 55-57 years, 58% were women, 89% with metabolic syndrome, and a mean BMI 34 kg/m².

In baseline liver disease, F1 level fibrosis was the most common (58%), followed by hepatic steatosis (S1, 47%; S2, 32%), with a median NAS of 3, and 19% had nonalcoholic steatohepatitis.

The special thing about these diets was that participants were told to “not lose weight, but eat until you are full,” remarked Dr. Dalby Hansen.

Those on the LCHF diet consumed an average of 61% energy from fat, 13% from carbohydrates, and 23% from protein, compared with the low-fat diet, which comprised an average of 29% energy from fat, 46% from carbohydrates, and 21% from protein.

“It’s a lot of fat and corresponds to a quarter of a liter of olive oil per day,” said Dr. Dalby Hansen. “They really had to change their mindset a lot, because it was difficult for them to start eating all these fats, especially since we’ve all been told for decades that it isn’t good. But we supported them, and they got into it.”

The LCHF diet was primarily comprised of unsaturated fats – for example, avocado, oil, nuts, and seeds – but also included saturated fats, such as cheese, cream, and high-fat dairy products. Participants were free to eat unsaturated and saturated fats, but Dr. Dalby Hansen and her team advised participants that “good” unsaturated fats were preferable.

“Also, this diet contained vegetables but no bread, no potatoes, no rice, and no pasta. It was low in carbohydrates, below 20%,” she added.
 

Improved glycemic control, reduced liver fat

“We found that the LCHF diet improved diabetes control, it reduced the fat in the liver, and, even though they’re eating as many calories as they were used to until they were full, they lost 5.8% of body weight,” said Dr. Dalby Hansen in reporting the results. Participants in the low-fat group lost only 1.8% of body weight.

However, mean calorie intake dropped in both groups, by –2.2% in the LCHF group and –8.7% in the low-fat group. 

“The LCHF diet improved the primary outcome of A1c by 9.5 mmol/mol, which is similar to some anti-diabetic medications, such as DPP-4 inhibitors and SGLT2 inhibitors,” she said.

The low-fat group reduced A1c by 3.4 mmol/mol, resulting in a between-group difference of 6.1 mmol/mol.

“Upon follow-up of 3 months, after stopping the diets, on average the participants in both groups returned their HbA1c levels to nearly baseline values,” she said. Results were adjusted for weight loss and baseline values.

Both diets also improved the NAS. The proportion of participants who improved their NAS score by 2 or more points was 22% in the LCHF group versus 17% in the low-fat group (P = 0.58). Additionally, in the LCHF group, 70% of participants improved their score by 1 or more points, compared with 49% in the low-fat group and fewer in the LCHF group experienced a worsening of their score (1% vs. 23%, respectively).

One participant on LCHF had high triglycerides of 12 mmol/L after 3 months. Overall, the low-density lipoprotein increased marginally by 0.2 mmol per liter in the high-fat group, said Dr. Dalby Hansen.

Dr. Dalby Hansen noted some limitations. The findings might not be applicable in more severe NAFLD, dietary assessment relied on self-reporting, no food was provided, and participants had to cook themselves. It was also an open-label study because of the nature of the intervention.
 

Some hope for more sustainable dieting

Many diets are difficult to adhere to, remarked Dr. Dalby Hansen. “We thought this [diet] might be easier to comply with in the longer term, and we hope that these results might provide patients with more options.”

She added that most people who started the diet adapted and complied with it. “However, it might not be for everyone, but I think we can say that if people try, and it fits into their lives, then they go for it.”

However, “it is not about going out and eating whatever fat and how much of it you want. It’s important that you cut the carbohydrates too,” she said. “With this approach, we really saw amazing results.”

Dr. Dalby Hansen added that having various diets available, including the LCHF one, meant that as clinicians they could empower patients to take control of their metabolic health.

“We can ask them directly, ‘What would fit into their life?’” she said. “We know that one size does not fit at all, and I believe that if we could engage patients more, then they can take control of their own situation.”

Asked whether these findings were enough to change guidelines, Zobair Younossi, MD, professor and chairman, department of medicine, Inova Fairfax Medical Campus, Falls Church, Va., remarked that it was the sugar at work here.

“Dietary fat – it’s not the same as fat in the liver, and this diet has more to do with the sugar levels,” he said.

“I’m always reluctant to take results from a short-term study without long-term follow-up,” Dr. Younossi said. “I want to know will patients live longer, and long-term data are needed for this. Until I have that strong evidence that outcomes are going to change, or at least some sign that the outcome is going to change, it is too early to change any guidelines.”

Dr. Dalby Hansen reports no relevant financial relationships. Dr. Harrison reported financial relationships with numerous pharmaceutical companies. Dr. Younossi reports the following financial relationships: research funds and/or consultant to Abbott, Allergan, Bristol Myers Squibb, Echosens, Genfit, Gilead Sciences, Intercept, Madrigal, Merck, and Novo Nordisk.

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

Key clinical point: Risk for overall cancer was 17% higher and cancer-specific mortality 26% higher in patients with inflammatory bowel disease (IBD) compared with non-IBD individuals.

Major finding: Risk for overall cancer (adjusted hazard ratio [aHR] 1.17; P < .001), particularly digestive cancer (aHR 1.33; P = .001), skin cancer (aHR 1.25; P < .001), and male genital cancer (aHR 1.29; P = .003), and cancer-specific mortality (aHR 1.26; P < .001) was significantly higher among patients with IBD vs. non-IBD individuals.

Study details: Findings are from a prospective study that included 5142 patients with ulcerative colitis (n = 3258), Crohn’s disease (n = 1449), or unclassified IBD (n = 435) and who were compared with 450,785 non-IBD reference individuals from the UK Biobank cohort.

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wu S et al. Inflammatory bowel disease and long-term risk of cancer: A prospective cohort study among half a million adults in UK Biobank. Inflamm Bowel Dis. 2022 (May 27). Doi:  10.1093/ibd/izac096

Key clinical point: Risk for overall cancer was 17% higher and cancer-specific mortality 26% higher in patients with inflammatory bowel disease (IBD) compared with non-IBD individuals.

Major finding: Risk for overall cancer (adjusted hazard ratio [aHR] 1.17; P < .001), particularly digestive cancer (aHR 1.33; P = .001), skin cancer (aHR 1.25; P < .001), and male genital cancer (aHR 1.29; P = .003), and cancer-specific mortality (aHR 1.26; P < .001) was significantly higher among patients with IBD vs. non-IBD individuals.

Study details: Findings are from a prospective study that included 5142 patients with ulcerative colitis (n = 3258), Crohn’s disease (n = 1449), or unclassified IBD (n = 435) and who were compared with 450,785 non-IBD reference individuals from the UK Biobank cohort.

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wu S et al. Inflammatory bowel disease and long-term risk of cancer: A prospective cohort study among half a million adults in UK Biobank. Inflamm Bowel Dis. 2022 (May 27). Doi:  10.1093/ibd/izac096

Key clinical point: Risk for overall cancer was 17% higher and cancer-specific mortality 26% higher in patients with inflammatory bowel disease (IBD) compared with non-IBD individuals.

Major finding: Risk for overall cancer (adjusted hazard ratio [aHR] 1.17; P < .001), particularly digestive cancer (aHR 1.33; P = .001), skin cancer (aHR 1.25; P < .001), and male genital cancer (aHR 1.29; P = .003), and cancer-specific mortality (aHR 1.26; P < .001) was significantly higher among patients with IBD vs. non-IBD individuals.

Study details: Findings are from a prospective study that included 5142 patients with ulcerative colitis (n = 3258), Crohn’s disease (n = 1449), or unclassified IBD (n = 435) and who were compared with 450,785 non-IBD reference individuals from the UK Biobank cohort.

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wu S et al. Inflammatory bowel disease and long-term risk of cancer: A prospective cohort study among half a million adults in UK Biobank. Inflamm Bowel Dis. 2022 (May 27). Doi:  10.1093/ibd/izac096

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6

Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.

Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.

Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.

Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”

Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week^® (DDW), held in person in San Diego and virtually.
 

Breakdown by physician specialty

“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.

Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.

Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P <  .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).

Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).

Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
 

Ongoing and future research

Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.

When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.

Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.

The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.

“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
 

Some unanswered questions

“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”

“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor, and president of the American Gastroenterological Association. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”

Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?

“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”

“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.

According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.

“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”

“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”

“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.

The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.

To help your patients understand their colorectal cancer screening options, send them to the AGA GI Patient Center.

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

Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.

Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.

Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.

Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”

Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week^® (DDW), held in person in San Diego and virtually.
 

Breakdown by physician specialty

“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.

Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.

Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P <  .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).

Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).

Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
 

Ongoing and future research

Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.

When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.

Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.

The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.

“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
 

Some unanswered questions

“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”

“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor, and president of the American Gastroenterological Association. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”

Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?

“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”

“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.

According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.

“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”

“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”

“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.

The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.

To help your patients understand their colorectal cancer screening options, send them to the AGA GI Patient Center.

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

Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.

Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.

Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.

Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”

Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week^® (DDW), held in person in San Diego and virtually.
 

Breakdown by physician specialty

“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.

Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.

Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P <  .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).

Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).

Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
 

Ongoing and future research

Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.

When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.

Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.

The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.

“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
 

Some unanswered questions

“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”

“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor, and president of the American Gastroenterological Association. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”

Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?

“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”

“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.

According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.

“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”

“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”

“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.

The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.

To help your patients understand their colorectal cancer screening options, send them to the AGA GI Patient Center.

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