Richard Mark Kirkner

It’s been 11 years since the American Academy of Dermatology updated its guidelines for using nonbiologic systemic therapies for psoriasis, and now new guidelines recommend oral apremilast monotherapy and suggest a framework for a number of off-label treatments.

The guidelines, issued jointly with the National Psoriasis Foundation (NPF), were published in the Journal of the American Academy of Dermatology.

“I think we are way behind,” Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, and cochair of the guideline writing committee, said in an interview. “Most other countries update their guidelines every 1 or 2 years; we were 10 years behind.” The guidelines for systemic nonbiologic drugs follow up psoriasis guidelines issued by the AAD and the NPF on pediatric patients issued earlier this year, and on phototherapy, biologic treatments, and management of comorbidities issued last year.

“A lot has happened in the last 10 years,” said cochair Craig Elmets, MD, professor of dermatology at the University of Alabama at Birmingham. “While much of the interest is on biologic agents, nonbiologics are still used quite frequently, and the guidelines for their appropriate use have changed. Use of the guidelines provides people in the health profession with the most up to date evidence-based information so they can give their patients the best care.”

The guidelines acknowledge that the medications it covers are still widely used, either by themselves or in combination with biologic agents; readily available; easy to use; and, in the case of older therapies, relatively cheap.

Methotrexate has been available since the 1970s. Given as an injection or taken orally, the guidelines recommend supplementation with folic acid to counteract methotrexate’s side effects, particularly GI upset. The guidelines note that folic acid is less expensive than folinic acid. Combination therapy with methotrexate and tumor necrosis factor (TNF) inhibitors is more effective than methotrexate monotherapy, with a similar side effect profile, the guidelines state.

Methotrexate is more widely used outside the United States, “but it is a very good, quick fix and it’s much safer in children and young people than it is in people with cardiovascular disease,” Dr. Menter noted. “It’s still the most commonly used drug worldwide because it’s cheap, and you do have to worry about the long-term toxicity which is related the liver issues.”

The guidelines say that subcutaneous administration of methotrexate “may be particularly useful” for patients on higher doses, which when taken orally, are associated with a higher risk of GI effects.

Dr. Menter referred to a 2017 study, which reported 41% of patients treated with subcutaneous methotrexate once a week achieved a Psoriasis Area and Severity Index 75 score of 41% after a year of treatment, compared with 10% of those on placebo (Lancet. 2017 Feb 4;389[10068]:528-37).

The guidelines rate strength of recommendation as class A for methotrexate for moderate to severe psoriasis in adults, recommend supplementation with folic or folinic acid to counteract GI complications and liver problems, and note that adalimumab and infliximab are more effective than methotrexate for cutaneous psoriasis. Class B recommendations for methotrexate and psoriasis include statements that patients should begin with a test dose, especially if they have impaired kidney function; methotrexate is effective for peripheral, but not axial, psoriatic arthritis (PsA); and TNF inhibitors are more effective than methotrexate for PsA.

Approved by the FDA in 2014 for psoriasis, apremilast, which inhibits phosphodiesterase-4, is the newest drug in the recommendations. The guidelines recommend its use for moderate to severe psoriasis in adults, with a class A recommendation. Patients should start on a low dose and then build up to the 30-mg, twice-daily dose over 6 days and should be counseled about the risk of depression before starting treatment. Routine laboratory testing can be considered on an individual basis.

The guidelines also lay out three recommendations (and strength of recommendation) for cyclosporine, a drug that’s been around since the 1990s: for severe, recalcitrant cases (class A); for erythrodermic, general pustular, and palmoplantar psoriasis (class B); and as short-term therapy for psoriasis flare in patients already on another drug (class C).

Acitretin is another longstanding therapy used mostly for palmar-plantar psoriasis, but it can also be used as monotherapy for plaque psoriasis as well as erythrodermic and pustular disease. It can also be used in combination with psoralens with UVA for psoriasis and combined with broadband UVB phototherapy for plaque psoriasis. The acitretin recommendations are class B.

The oral Janus kinase (JAK) inhibitor tofacitinib isn’t specifically approved for psoriasis, but it is approved for RA, PsA, and ulcerative colitis. The drug targets the JAK-STAT signaling pathway that causes inflammation. The guidelines state that tofacitinib can be considered for moderate to severe psoriasis, but lists no strength of recommendation. The recommended dose is either 5 or 10 mg orally twice a day, with a caveat that the higher dose carries a higher risk of adverse events. Patients should be evaluated for getting a zoster vaccine before they begin therapy.

“We thought that, because there was probably a small chance that it might get approved for psoriasis, that we would discuss it briefly,” Dr. Menter said of tofacitinib.

Another off-label use the guidelines address is for fumaric and acid esters, also known as fumarates, which are used to in Europe to treat moderate to severe psoriasis. Dimethyl fumarate is approved for relapsing forms of multiple sclerosis in the United States. The guidelines state that fumarates can be used for psoriasis, but offer no strength of recommendation. Side effects include gastrointestinal disturbance and flushing.

Other treatments that are also addressed in the guidelines include a host of systemic immunosuppressants and antimetabolites: azathioprine, hydroxyurea, leflunomide, mycophenolate mofetil, thioguanine, and tacrolimus, none of which are FDA approved for psoriasis. They’re rarely used for psoriasis, but may have value in selected cases, the guidelines state.

Dr. Menter said that apremilast is the only oral drug in the guidelines, but they are the wave of the future for treating psoriasis. “I think there’s a tremendous potential for new oral drugs – TK2 [thymidine kinase], the JAK inhibitors, and other drugs coming down the pipelines. The majority of patients, if you ask them their preference, would like to take an oral drug rather than an injectable drug. And it would be much easier for dermatologists, they wouldn’t have to train patients on how to do the injections.”

Dr. Menter and Dr. Elmets disclosed financial relationships with numerous pharmaceutical companies. Other authors/work group members also had disclosures related to pharmaceutical manufacturers, and several had no disclosures.

SOURCE: Menter A et al. J Am Acad Dermatol. 2020 Feb 28. doi: 10.1016/j.jaad.2020.02.044.

It’s been 11 years since the American Academy of Dermatology updated its guidelines for using nonbiologic systemic therapies for psoriasis, and now new guidelines recommend oral apremilast monotherapy and suggest a framework for a number of off-label treatments.

The guidelines, issued jointly with the National Psoriasis Foundation (NPF), were published in the Journal of the American Academy of Dermatology.

“I think we are way behind,” Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, and cochair of the guideline writing committee, said in an interview. “Most other countries update their guidelines every 1 or 2 years; we were 10 years behind.” The guidelines for systemic nonbiologic drugs follow up psoriasis guidelines issued by the AAD and the NPF on pediatric patients issued earlier this year, and on phototherapy, biologic treatments, and management of comorbidities issued last year.

“A lot has happened in the last 10 years,” said cochair Craig Elmets, MD, professor of dermatology at the University of Alabama at Birmingham. “While much of the interest is on biologic agents, nonbiologics are still used quite frequently, and the guidelines for their appropriate use have changed. Use of the guidelines provides people in the health profession with the most up to date evidence-based information so they can give their patients the best care.”

The guidelines acknowledge that the medications it covers are still widely used, either by themselves or in combination with biologic agents; readily available; easy to use; and, in the case of older therapies, relatively cheap.

Methotrexate has been available since the 1970s. Given as an injection or taken orally, the guidelines recommend supplementation with folic acid to counteract methotrexate’s side effects, particularly GI upset. The guidelines note that folic acid is less expensive than folinic acid. Combination therapy with methotrexate and tumor necrosis factor (TNF) inhibitors is more effective than methotrexate monotherapy, with a similar side effect profile, the guidelines state.

Methotrexate is more widely used outside the United States, “but it is a very good, quick fix and it’s much safer in children and young people than it is in people with cardiovascular disease,” Dr. Menter noted. “It’s still the most commonly used drug worldwide because it’s cheap, and you do have to worry about the long-term toxicity which is related the liver issues.”

The guidelines say that subcutaneous administration of methotrexate “may be particularly useful” for patients on higher doses, which when taken orally, are associated with a higher risk of GI effects.

Dr. Menter referred to a 2017 study, which reported 41% of patients treated with subcutaneous methotrexate once a week achieved a Psoriasis Area and Severity Index 75 score of 41% after a year of treatment, compared with 10% of those on placebo (Lancet. 2017 Feb 4;389[10068]:528-37).

The guidelines rate strength of recommendation as class A for methotrexate for moderate to severe psoriasis in adults, recommend supplementation with folic or folinic acid to counteract GI complications and liver problems, and note that adalimumab and infliximab are more effective than methotrexate for cutaneous psoriasis. Class B recommendations for methotrexate and psoriasis include statements that patients should begin with a test dose, especially if they have impaired kidney function; methotrexate is effective for peripheral, but not axial, psoriatic arthritis (PsA); and TNF inhibitors are more effective than methotrexate for PsA.

Approved by the FDA in 2014 for psoriasis, apremilast, which inhibits phosphodiesterase-4, is the newest drug in the recommendations. The guidelines recommend its use for moderate to severe psoriasis in adults, with a class A recommendation. Patients should start on a low dose and then build up to the 30-mg, twice-daily dose over 6 days and should be counseled about the risk of depression before starting treatment. Routine laboratory testing can be considered on an individual basis.

The guidelines also lay out three recommendations (and strength of recommendation) for cyclosporine, a drug that’s been around since the 1990s: for severe, recalcitrant cases (class A); for erythrodermic, general pustular, and palmoplantar psoriasis (class B); and as short-term therapy for psoriasis flare in patients already on another drug (class C).

Acitretin is another longstanding therapy used mostly for palmar-plantar psoriasis, but it can also be used as monotherapy for plaque psoriasis as well as erythrodermic and pustular disease. It can also be used in combination with psoralens with UVA for psoriasis and combined with broadband UVB phototherapy for plaque psoriasis. The acitretin recommendations are class B.

The oral Janus kinase (JAK) inhibitor tofacitinib isn’t specifically approved for psoriasis, but it is approved for RA, PsA, and ulcerative colitis. The drug targets the JAK-STAT signaling pathway that causes inflammation. The guidelines state that tofacitinib can be considered for moderate to severe psoriasis, but lists no strength of recommendation. The recommended dose is either 5 or 10 mg orally twice a day, with a caveat that the higher dose carries a higher risk of adverse events. Patients should be evaluated for getting a zoster vaccine before they begin therapy.

“We thought that, because there was probably a small chance that it might get approved for psoriasis, that we would discuss it briefly,” Dr. Menter said of tofacitinib.

Another off-label use the guidelines address is for fumaric and acid esters, also known as fumarates, which are used to in Europe to treat moderate to severe psoriasis. Dimethyl fumarate is approved for relapsing forms of multiple sclerosis in the United States. The guidelines state that fumarates can be used for psoriasis, but offer no strength of recommendation. Side effects include gastrointestinal disturbance and flushing.

Other treatments that are also addressed in the guidelines include a host of systemic immunosuppressants and antimetabolites: azathioprine, hydroxyurea, leflunomide, mycophenolate mofetil, thioguanine, and tacrolimus, none of which are FDA approved for psoriasis. They’re rarely used for psoriasis, but may have value in selected cases, the guidelines state.

Dr. Menter said that apremilast is the only oral drug in the guidelines, but they are the wave of the future for treating psoriasis. “I think there’s a tremendous potential for new oral drugs – TK2 [thymidine kinase], the JAK inhibitors, and other drugs coming down the pipelines. The majority of patients, if you ask them their preference, would like to take an oral drug rather than an injectable drug. And it would be much easier for dermatologists, they wouldn’t have to train patients on how to do the injections.”

Dr. Menter and Dr. Elmets disclosed financial relationships with numerous pharmaceutical companies. Other authors/work group members also had disclosures related to pharmaceutical manufacturers, and several had no disclosures.

SOURCE: Menter A et al. J Am Acad Dermatol. 2020 Feb 28. doi: 10.1016/j.jaad.2020.02.044.

It’s been 11 years since the American Academy of Dermatology updated its guidelines for using nonbiologic systemic therapies for psoriasis, and now new guidelines recommend oral apremilast monotherapy and suggest a framework for a number of off-label treatments.

The guidelines, issued jointly with the National Psoriasis Foundation (NPF), were published in the Journal of the American Academy of Dermatology.

“I think we are way behind,” Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, and cochair of the guideline writing committee, said in an interview. “Most other countries update their guidelines every 1 or 2 years; we were 10 years behind.” The guidelines for systemic nonbiologic drugs follow up psoriasis guidelines issued by the AAD and the NPF on pediatric patients issued earlier this year, and on phototherapy, biologic treatments, and management of comorbidities issued last year.

“A lot has happened in the last 10 years,” said cochair Craig Elmets, MD, professor of dermatology at the University of Alabama at Birmingham. “While much of the interest is on biologic agents, nonbiologics are still used quite frequently, and the guidelines for their appropriate use have changed. Use of the guidelines provides people in the health profession with the most up to date evidence-based information so they can give their patients the best care.”

The guidelines acknowledge that the medications it covers are still widely used, either by themselves or in combination with biologic agents; readily available; easy to use; and, in the case of older therapies, relatively cheap.

Methotrexate has been available since the 1970s. Given as an injection or taken orally, the guidelines recommend supplementation with folic acid to counteract methotrexate’s side effects, particularly GI upset. The guidelines note that folic acid is less expensive than folinic acid. Combination therapy with methotrexate and tumor necrosis factor (TNF) inhibitors is more effective than methotrexate monotherapy, with a similar side effect profile, the guidelines state.

Methotrexate is more widely used outside the United States, “but it is a very good, quick fix and it’s much safer in children and young people than it is in people with cardiovascular disease,” Dr. Menter noted. “It’s still the most commonly used drug worldwide because it’s cheap, and you do have to worry about the long-term toxicity which is related the liver issues.”

The guidelines say that subcutaneous administration of methotrexate “may be particularly useful” for patients on higher doses, which when taken orally, are associated with a higher risk of GI effects.

Dr. Menter referred to a 2017 study, which reported 41% of patients treated with subcutaneous methotrexate once a week achieved a Psoriasis Area and Severity Index 75 score of 41% after a year of treatment, compared with 10% of those on placebo (Lancet. 2017 Feb 4;389[10068]:528-37).

The guidelines rate strength of recommendation as class A for methotrexate for moderate to severe psoriasis in adults, recommend supplementation with folic or folinic acid to counteract GI complications and liver problems, and note that adalimumab and infliximab are more effective than methotrexate for cutaneous psoriasis. Class B recommendations for methotrexate and psoriasis include statements that patients should begin with a test dose, especially if they have impaired kidney function; methotrexate is effective for peripheral, but not axial, psoriatic arthritis (PsA); and TNF inhibitors are more effective than methotrexate for PsA.

Approved by the FDA in 2014 for psoriasis, apremilast, which inhibits phosphodiesterase-4, is the newest drug in the recommendations. The guidelines recommend its use for moderate to severe psoriasis in adults, with a class A recommendation. Patients should start on a low dose and then build up to the 30-mg, twice-daily dose over 6 days and should be counseled about the risk of depression before starting treatment. Routine laboratory testing can be considered on an individual basis.

The guidelines also lay out three recommendations (and strength of recommendation) for cyclosporine, a drug that’s been around since the 1990s: for severe, recalcitrant cases (class A); for erythrodermic, general pustular, and palmoplantar psoriasis (class B); and as short-term therapy for psoriasis flare in patients already on another drug (class C).

Acitretin is another longstanding therapy used mostly for palmar-plantar psoriasis, but it can also be used as monotherapy for plaque psoriasis as well as erythrodermic and pustular disease. It can also be used in combination with psoralens with UVA for psoriasis and combined with broadband UVB phototherapy for plaque psoriasis. The acitretin recommendations are class B.

The oral Janus kinase (JAK) inhibitor tofacitinib isn’t specifically approved for psoriasis, but it is approved for RA, PsA, and ulcerative colitis. The drug targets the JAK-STAT signaling pathway that causes inflammation. The guidelines state that tofacitinib can be considered for moderate to severe psoriasis, but lists no strength of recommendation. The recommended dose is either 5 or 10 mg orally twice a day, with a caveat that the higher dose carries a higher risk of adverse events. Patients should be evaluated for getting a zoster vaccine before they begin therapy.

“We thought that, because there was probably a small chance that it might get approved for psoriasis, that we would discuss it briefly,” Dr. Menter said of tofacitinib.

Another off-label use the guidelines address is for fumaric and acid esters, also known as fumarates, which are used to in Europe to treat moderate to severe psoriasis. Dimethyl fumarate is approved for relapsing forms of multiple sclerosis in the United States. The guidelines state that fumarates can be used for psoriasis, but offer no strength of recommendation. Side effects include gastrointestinal disturbance and flushing.

Other treatments that are also addressed in the guidelines include a host of systemic immunosuppressants and antimetabolites: azathioprine, hydroxyurea, leflunomide, mycophenolate mofetil, thioguanine, and tacrolimus, none of which are FDA approved for psoriasis. They’re rarely used for psoriasis, but may have value in selected cases, the guidelines state.

Dr. Menter said that apremilast is the only oral drug in the guidelines, but they are the wave of the future for treating psoriasis. “I think there’s a tremendous potential for new oral drugs – TK2 [thymidine kinase], the JAK inhibitors, and other drugs coming down the pipelines. The majority of patients, if you ask them their preference, would like to take an oral drug rather than an injectable drug. And it would be much easier for dermatologists, they wouldn’t have to train patients on how to do the injections.”

Dr. Menter and Dr. Elmets disclosed financial relationships with numerous pharmaceutical companies. Other authors/work group members also had disclosures related to pharmaceutical manufacturers, and several had no disclosures.

SOURCE: Menter A et al. J Am Acad Dermatol. 2020 Feb 28. doi: 10.1016/j.jaad.2020.02.044.

The risk for microvascular complications in adults with latent autoimmune diabetes increases the longer they have the disease, according a post hoc analysis of a large European database.

However, Ernesto Maddaloni, MD, of Sapienza University of Rome and University of Oxford (England), and colleagues noted that the risk is less than half that in patients with type 2 disease during the first several years after diagnosis but that, after 9 years, the risk curves cross over, and patients with latent autoimmune diabetes of adulthood (LADA) matriculate to a 25% greater risk microvascular complications than do their type 2 counterparts.

The results point to a need for tighter glycemic control in patients with latent autoimmune disease and “might have relevant implications for the understanding of the differential risk of complications between type 2 diabetes and autoimmune diabetes in general,” the researchers wrote online in The Lancet Diabetes & Endocrinology. They emphasized that the study represents the largest population of patients with latent autoimmune diabetes with the longest follow-up in a randomized controlled trial so far.

Diabetic microvascular complications are a major cause of end-stage renal disease and blindness in LADA, therefore, “implementing strict glycemic control from the time of diagnosis could reduce the later risk of microvascular complications in [these patients],” the authors wrote.

The researchers analyzed 30 years of data from the United Kingdom Prospective Diabetes Study, focusing on 564 patients with LADA and 4,464 adults with type 2 diabetes. The primary outcome was first occurrence of renal failure, death from renal disease, blindness in one eye, vitreous hemorrhage, or retinal laser treatment.

With a median follow-up of 17.3 years, 21% of all patients (1,041) developed microvascular complications, of which there were 65 renal events and 976 retinopathy events. Secondary outcomes were nephropathy and retinopathy.

The study measured incidence in 1,000 person-years and found that the incidence for the overall primary composite microvascular outcome was 5.3% for LADA and 10% for type 2 diabetes in the first 9 years after diagnosis (P = .0020), but 13.6% and 9.2%, respectively, after that (P less than .0001). That translated into adjusted hazard ratios of 0.45 for LADA, compared with type 2 diabetes, in the first 9 years (P less than .0001) and 1.25 beyond 9 years (P = .047). The incidence of retinopathy events was 5.3% for LADA and 9.6% for type 2 diabetes up to 9 years (P = .003), and 12.5% and 8.6% thereafter (P = .001). Nephropathy rates were similar in both groups at 1.3% or less.

“The lower risk of microvascular complications during the first years after the diagnosis of latent autoimmune diabetes needs further examination,” Dr. Maddaloni and colleagues wrote.

They cautioned that LADA is often misdiagnosed as a form of type 1 diabetes. “Therefore, latent autoimmune diabetes could be the right bench test for studying differences between autoimmune diabetes and type 2 diabetes, because of fewer disparities in age and disease duration than with the comparison of type 1 diabetes and type 2 diabetes,” they wrote.

In an accompanying editorial, Didac Mauricio, MD, of the Autonomous University of Barcelona, credited Dr. Maddaloni and colleagues with presenting evidence “of major relevance” in an adequately powered study that provided “a robust conclusion” about the risk of microvascular complications in latent autoimmune diabetes.

Dr. Mauricio noted that the study adds to the literature that different subgroups of type 2 diabetes patients exist and highlights the distinct characteristics of latent autoimmune diabetes. In addition, it builds on a previous study by Dr. Maddaloni and coauthors that found cardiovascular disease outcomes did not differ between latent autoimmune and type 2 diabetes (Diabetes Obes Metab. 2019;21:2115-22), he wrote. The research team’s most recent findings “emphasize the need for early identification of latent autoimmune disease,” he stated.

The findings also raise important questions about screening all patients for antibodies upon diagnosis of diabetes, he said. “I firmly believe that it is time to take action,” first, because antibody testing is likely cost-effective and cost-saving because it facilitates better-informed, more timely decisions early in the disease trajectory, and second, it has already been well documented that patients with latent autoimmune diabetes have a higher glycemic burden.

An alternative to early universal screening for antibodies would be to raise awareness, especially among general practitioners, about the importance of timely diagnosis of LADA, Dr. Mauricio added.

The study received funding from the European Foundation for the Study of Diabetes Mentorship Program, supported by AstraZeneca. Dr. Maddaloni disclosed financial relationships with Sanofi, Eli Lilly, Abbott, and AstraZeneca. Another author disclosed financial relationships with Boehringer Ingelheim, Merck, Bayer, AstraZeneca, Novartis, and Novo Nordisk. All the other authors had no relevant financial relationships to disclose. Dr. Mauricio disclosed financial relationships with AstraZeneca, Eli Lilly, Merck Sharp & Dohme, NovoNordisk, Sanofi, Almirall, Boehringer Ingelheim, Eli Lilly, Ferrer, Janssen, Menarini, and URGO.
 

SOURCE: Maddaloni E et al. Lancet Diabetes Endocrinol. 2020 Feb 4. doi: 0.1016/S2213-8587(20)30003-6.

The risk for microvascular complications in adults with latent autoimmune diabetes increases the longer they have the disease, according a post hoc analysis of a large European database.

However, Ernesto Maddaloni, MD, of Sapienza University of Rome and University of Oxford (England), and colleagues noted that the risk is less than half that in patients with type 2 disease during the first several years after diagnosis but that, after 9 years, the risk curves cross over, and patients with latent autoimmune diabetes of adulthood (LADA) matriculate to a 25% greater risk microvascular complications than do their type 2 counterparts.

The results point to a need for tighter glycemic control in patients with latent autoimmune disease and “might have relevant implications for the understanding of the differential risk of complications between type 2 diabetes and autoimmune diabetes in general,” the researchers wrote online in The Lancet Diabetes & Endocrinology. They emphasized that the study represents the largest population of patients with latent autoimmune diabetes with the longest follow-up in a randomized controlled trial so far.

Diabetic microvascular complications are a major cause of end-stage renal disease and blindness in LADA, therefore, “implementing strict glycemic control from the time of diagnosis could reduce the later risk of microvascular complications in [these patients],” the authors wrote.

The researchers analyzed 30 years of data from the United Kingdom Prospective Diabetes Study, focusing on 564 patients with LADA and 4,464 adults with type 2 diabetes. The primary outcome was first occurrence of renal failure, death from renal disease, blindness in one eye, vitreous hemorrhage, or retinal laser treatment.

With a median follow-up of 17.3 years, 21% of all patients (1,041) developed microvascular complications, of which there were 65 renal events and 976 retinopathy events. Secondary outcomes were nephropathy and retinopathy.

The study measured incidence in 1,000 person-years and found that the incidence for the overall primary composite microvascular outcome was 5.3% for LADA and 10% for type 2 diabetes in the first 9 years after diagnosis (P = .0020), but 13.6% and 9.2%, respectively, after that (P less than .0001). That translated into adjusted hazard ratios of 0.45 for LADA, compared with type 2 diabetes, in the first 9 years (P less than .0001) and 1.25 beyond 9 years (P = .047). The incidence of retinopathy events was 5.3% for LADA and 9.6% for type 2 diabetes up to 9 years (P = .003), and 12.5% and 8.6% thereafter (P = .001). Nephropathy rates were similar in both groups at 1.3% or less.

“The lower risk of microvascular complications during the first years after the diagnosis of latent autoimmune diabetes needs further examination,” Dr. Maddaloni and colleagues wrote.

They cautioned that LADA is often misdiagnosed as a form of type 1 diabetes. “Therefore, latent autoimmune diabetes could be the right bench test for studying differences between autoimmune diabetes and type 2 diabetes, because of fewer disparities in age and disease duration than with the comparison of type 1 diabetes and type 2 diabetes,” they wrote.

In an accompanying editorial, Didac Mauricio, MD, of the Autonomous University of Barcelona, credited Dr. Maddaloni and colleagues with presenting evidence “of major relevance” in an adequately powered study that provided “a robust conclusion” about the risk of microvascular complications in latent autoimmune diabetes.

Dr. Mauricio noted that the study adds to the literature that different subgroups of type 2 diabetes patients exist and highlights the distinct characteristics of latent autoimmune diabetes. In addition, it builds on a previous study by Dr. Maddaloni and coauthors that found cardiovascular disease outcomes did not differ between latent autoimmune and type 2 diabetes (Diabetes Obes Metab. 2019;21:2115-22), he wrote. The research team’s most recent findings “emphasize the need for early identification of latent autoimmune disease,” he stated.

The findings also raise important questions about screening all patients for antibodies upon diagnosis of diabetes, he said. “I firmly believe that it is time to take action,” first, because antibody testing is likely cost-effective and cost-saving because it facilitates better-informed, more timely decisions early in the disease trajectory, and second, it has already been well documented that patients with latent autoimmune diabetes have a higher glycemic burden.

An alternative to early universal screening for antibodies would be to raise awareness, especially among general practitioners, about the importance of timely diagnosis of LADA, Dr. Mauricio added.

The study received funding from the European Foundation for the Study of Diabetes Mentorship Program, supported by AstraZeneca. Dr. Maddaloni disclosed financial relationships with Sanofi, Eli Lilly, Abbott, and AstraZeneca. Another author disclosed financial relationships with Boehringer Ingelheim, Merck, Bayer, AstraZeneca, Novartis, and Novo Nordisk. All the other authors had no relevant financial relationships to disclose. Dr. Mauricio disclosed financial relationships with AstraZeneca, Eli Lilly, Merck Sharp & Dohme, NovoNordisk, Sanofi, Almirall, Boehringer Ingelheim, Eli Lilly, Ferrer, Janssen, Menarini, and URGO.
 

SOURCE: Maddaloni E et al. Lancet Diabetes Endocrinol. 2020 Feb 4. doi: 0.1016/S2213-8587(20)30003-6.

The risk for microvascular complications in adults with latent autoimmune diabetes increases the longer they have the disease, according a post hoc analysis of a large European database.

However, Ernesto Maddaloni, MD, of Sapienza University of Rome and University of Oxford (England), and colleagues noted that the risk is less than half that in patients with type 2 disease during the first several years after diagnosis but that, after 9 years, the risk curves cross over, and patients with latent autoimmune diabetes of adulthood (LADA) matriculate to a 25% greater risk microvascular complications than do their type 2 counterparts.

The results point to a need for tighter glycemic control in patients with latent autoimmune disease and “might have relevant implications for the understanding of the differential risk of complications between type 2 diabetes and autoimmune diabetes in general,” the researchers wrote online in The Lancet Diabetes & Endocrinology. They emphasized that the study represents the largest population of patients with latent autoimmune diabetes with the longest follow-up in a randomized controlled trial so far.

Diabetic microvascular complications are a major cause of end-stage renal disease and blindness in LADA, therefore, “implementing strict glycemic control from the time of diagnosis could reduce the later risk of microvascular complications in [these patients],” the authors wrote.

The researchers analyzed 30 years of data from the United Kingdom Prospective Diabetes Study, focusing on 564 patients with LADA and 4,464 adults with type 2 diabetes. The primary outcome was first occurrence of renal failure, death from renal disease, blindness in one eye, vitreous hemorrhage, or retinal laser treatment.

With a median follow-up of 17.3 years, 21% of all patients (1,041) developed microvascular complications, of which there were 65 renal events and 976 retinopathy events. Secondary outcomes were nephropathy and retinopathy.

The study measured incidence in 1,000 person-years and found that the incidence for the overall primary composite microvascular outcome was 5.3% for LADA and 10% for type 2 diabetes in the first 9 years after diagnosis (P = .0020), but 13.6% and 9.2%, respectively, after that (P less than .0001). That translated into adjusted hazard ratios of 0.45 for LADA, compared with type 2 diabetes, in the first 9 years (P less than .0001) and 1.25 beyond 9 years (P = .047). The incidence of retinopathy events was 5.3% for LADA and 9.6% for type 2 diabetes up to 9 years (P = .003), and 12.5% and 8.6% thereafter (P = .001). Nephropathy rates were similar in both groups at 1.3% or less.

“The lower risk of microvascular complications during the first years after the diagnosis of latent autoimmune diabetes needs further examination,” Dr. Maddaloni and colleagues wrote.

They cautioned that LADA is often misdiagnosed as a form of type 1 diabetes. “Therefore, latent autoimmune diabetes could be the right bench test for studying differences between autoimmune diabetes and type 2 diabetes, because of fewer disparities in age and disease duration than with the comparison of type 1 diabetes and type 2 diabetes,” they wrote.

In an accompanying editorial, Didac Mauricio, MD, of the Autonomous University of Barcelona, credited Dr. Maddaloni and colleagues with presenting evidence “of major relevance” in an adequately powered study that provided “a robust conclusion” about the risk of microvascular complications in latent autoimmune diabetes.

Dr. Mauricio noted that the study adds to the literature that different subgroups of type 2 diabetes patients exist and highlights the distinct characteristics of latent autoimmune diabetes. In addition, it builds on a previous study by Dr. Maddaloni and coauthors that found cardiovascular disease outcomes did not differ between latent autoimmune and type 2 diabetes (Diabetes Obes Metab. 2019;21:2115-22), he wrote. The research team’s most recent findings “emphasize the need for early identification of latent autoimmune disease,” he stated.

The findings also raise important questions about screening all patients for antibodies upon diagnosis of diabetes, he said. “I firmly believe that it is time to take action,” first, because antibody testing is likely cost-effective and cost-saving because it facilitates better-informed, more timely decisions early in the disease trajectory, and second, it has already been well documented that patients with latent autoimmune diabetes have a higher glycemic burden.

An alternative to early universal screening for antibodies would be to raise awareness, especially among general practitioners, about the importance of timely diagnosis of LADA, Dr. Mauricio added.

The study received funding from the European Foundation for the Study of Diabetes Mentorship Program, supported by AstraZeneca. Dr. Maddaloni disclosed financial relationships with Sanofi, Eli Lilly, Abbott, and AstraZeneca. Another author disclosed financial relationships with Boehringer Ingelheim, Merck, Bayer, AstraZeneca, Novartis, and Novo Nordisk. All the other authors had no relevant financial relationships to disclose. Dr. Mauricio disclosed financial relationships with AstraZeneca, Eli Lilly, Merck Sharp & Dohme, NovoNordisk, Sanofi, Almirall, Boehringer Ingelheim, Eli Lilly, Ferrer, Janssen, Menarini, and URGO.
 

SOURCE: Maddaloni E et al. Lancet Diabetes Endocrinol. 2020 Feb 4. doi: 0.1016/S2213-8587(20)30003-6.

Researchers have found three potential gut mechanisms linked to secondary bile acid (SBA) deficiencies implicated in intestinal inflammation in ulcerative colitis (UC), and reported that supplementation may aid in restoring bile acid levels and potentially treating intestinal inflammation, according to a study published in Cell Host & Microbe.

The study identified lower levels of the following gut components in SBA deficiency in colectomy patients with UC, compared with those with familial adenomatous polyposis (FAP): deoxycholic and lithocholic acids (DCA and LCA), the most abundant gut secondary bile acids (SBAs); expression of the genes needed to convert primary bile acids (PBAs) into SBAs; and the number of Ruminococcaceae, one of the few taxa that include bacteria that generate SBAs.

“Our findings confirm that significant changes in bacterial diversity and composition occur in UC versus FAP pouches,” wrote Sidhartha R. Sinha, MD, of Stanford (Calif.) University, and coauthors. “Notably, our finding of decreased Ruminococcaceae in UC, compared to FAP pouch stool, requires further exploration.” They added that this is the first study to identify Ruminococcaceae as a key contributor to the production of LCA or DCA from PBAs.

The study found average DCA counts of 60,957 in FAP versus 1,593 in UC (P = .002), and average LCA counts of 30,644 and 282.9, respectively (P = .001). The study profiled stools from ileal pouches in colectomy patients who had UC (17) or FAP (7), a noninflammatory disease. “Remarkably, our data identify LCA and DCA to be almost undetectable in UC pouch patients,” Dr. Sinha and coauthors wrote. “This striking finding in patients who underwent colectomy suggests that SBAs may play a role in dysregulated metabolism-induced intestinal inflammation.”

The study found that UC pouches demonstrated less bacterial diversity, or alpha-diversity, than FAP pouches, which is in line with previously reported findings (J Inflamm Res. 2017;10:63-73), and had significantly lower expression of bile-acid inducible genes that encode enzymes that transform PBA to SBA.

The researchers also demonstrated that LCA and DCA supplementation reduced intestinal inflammation in mice with UC.

“Our results show that LCA and DCA treatments caused a remarkable and significant decrease in multiple chemokines and cytokines associated with inflammation, including those often increased in intestinal inflammation,” Dr. Sinha and coauthors wrote. However, they found that LCA had no protective effect on dextran sodium sulfate–induced colitis in mice with TGR5-deficient immune cells. The TGR5 bile acid receptor influences the anti-inflammatory effect in SBA supplementation, the study reported.

The researchers have initiated a clinical study (NCT03724175) to investigate the role of SBAs in patients with pouchitis that doesn’t respond to antibiotic therapy. “Insights from this study will further inform our understanding of the role of SBAs in intestinal inflammation and hold promise to provide an effective treatment,” Dr. Sinha and coauthors wrote.

Christian Jobin, PhD, of the University of Florida, Gainesville, said in an interview these findings are consistent with a recent paper that found a correlation between production of SBAs such as DCA and disease remission (ISME J. 2020;14:702-13). Dr. Jobin coauthored a 2018 study that similarly found SBAs have a role in intestinal inflammation (Gastroenterology. 2018;154:1751-63).

“For a long time, secondary bile acid, especially DCA was linked to cell injury, toxicity and even cancer,” he said. “It’s time to rehabilitate this important signaling molecule and recognize its important role in regulating host homeostasis.” The 2018 paper he coauthored showed that injection of DCA into germ-free mice did not promote intestinal pathology. “Actually, DCA was critical in preventing Campylobacter jejune–induced colitis,” he added.

Dr. Sinha received funding from the Crohn’s & Colitis Foundation, Stanford Clinical and Translational Science Award, and Kenneth Rainin Foundation Synergy Award. Coauthors received funding from the National Institutes of Health, the Ann and Bill Swindells Charitable Trust, Leslie and Douglas Ballinger, and the Kenneth Rainin Foundation.

SOURCE: Sinha SR et al. Cell Host Microbe. 2020 Feb 25. doi: 10.1016/j.chom.2020.01.021.

Researchers have found three potential gut mechanisms linked to secondary bile acid (SBA) deficiencies implicated in intestinal inflammation in ulcerative colitis (UC), and reported that supplementation may aid in restoring bile acid levels and potentially treating intestinal inflammation, according to a study published in Cell Host & Microbe.

The study identified lower levels of the following gut components in SBA deficiency in colectomy patients with UC, compared with those with familial adenomatous polyposis (FAP): deoxycholic and lithocholic acids (DCA and LCA), the most abundant gut secondary bile acids (SBAs); expression of the genes needed to convert primary bile acids (PBAs) into SBAs; and the number of Ruminococcaceae, one of the few taxa that include bacteria that generate SBAs.

“Our findings confirm that significant changes in bacterial diversity and composition occur in UC versus FAP pouches,” wrote Sidhartha R. Sinha, MD, of Stanford (Calif.) University, and coauthors. “Notably, our finding of decreased Ruminococcaceae in UC, compared to FAP pouch stool, requires further exploration.” They added that this is the first study to identify Ruminococcaceae as a key contributor to the production of LCA or DCA from PBAs.

The study found average DCA counts of 60,957 in FAP versus 1,593 in UC (P = .002), and average LCA counts of 30,644 and 282.9, respectively (P = .001). The study profiled stools from ileal pouches in colectomy patients who had UC (17) or FAP (7), a noninflammatory disease. “Remarkably, our data identify LCA and DCA to be almost undetectable in UC pouch patients,” Dr. Sinha and coauthors wrote. “This striking finding in patients who underwent colectomy suggests that SBAs may play a role in dysregulated metabolism-induced intestinal inflammation.”

The study found that UC pouches demonstrated less bacterial diversity, or alpha-diversity, than FAP pouches, which is in line with previously reported findings (J Inflamm Res. 2017;10:63-73), and had significantly lower expression of bile-acid inducible genes that encode enzymes that transform PBA to SBA.

The researchers also demonstrated that LCA and DCA supplementation reduced intestinal inflammation in mice with UC.

“Our results show that LCA and DCA treatments caused a remarkable and significant decrease in multiple chemokines and cytokines associated with inflammation, including those often increased in intestinal inflammation,” Dr. Sinha and coauthors wrote. However, they found that LCA had no protective effect on dextran sodium sulfate–induced colitis in mice with TGR5-deficient immune cells. The TGR5 bile acid receptor influences the anti-inflammatory effect in SBA supplementation, the study reported.

The researchers have initiated a clinical study (NCT03724175) to investigate the role of SBAs in patients with pouchitis that doesn’t respond to antibiotic therapy. “Insights from this study will further inform our understanding of the role of SBAs in intestinal inflammation and hold promise to provide an effective treatment,” Dr. Sinha and coauthors wrote.

Christian Jobin, PhD, of the University of Florida, Gainesville, said in an interview these findings are consistent with a recent paper that found a correlation between production of SBAs such as DCA and disease remission (ISME J. 2020;14:702-13). Dr. Jobin coauthored a 2018 study that similarly found SBAs have a role in intestinal inflammation (Gastroenterology. 2018;154:1751-63).

“For a long time, secondary bile acid, especially DCA was linked to cell injury, toxicity and even cancer,” he said. “It’s time to rehabilitate this important signaling molecule and recognize its important role in regulating host homeostasis.” The 2018 paper he coauthored showed that injection of DCA into germ-free mice did not promote intestinal pathology. “Actually, DCA was critical in preventing Campylobacter jejune–induced colitis,” he added.

Dr. Sinha received funding from the Crohn’s & Colitis Foundation, Stanford Clinical and Translational Science Award, and Kenneth Rainin Foundation Synergy Award. Coauthors received funding from the National Institutes of Health, the Ann and Bill Swindells Charitable Trust, Leslie and Douglas Ballinger, and the Kenneth Rainin Foundation.

SOURCE: Sinha SR et al. Cell Host Microbe. 2020 Feb 25. doi: 10.1016/j.chom.2020.01.021.

Researchers have found three potential gut mechanisms linked to secondary bile acid (SBA) deficiencies implicated in intestinal inflammation in ulcerative colitis (UC), and reported that supplementation may aid in restoring bile acid levels and potentially treating intestinal inflammation, according to a study published in Cell Host & Microbe.

The study identified lower levels of the following gut components in SBA deficiency in colectomy patients with UC, compared with those with familial adenomatous polyposis (FAP): deoxycholic and lithocholic acids (DCA and LCA), the most abundant gut secondary bile acids (SBAs); expression of the genes needed to convert primary bile acids (PBAs) into SBAs; and the number of Ruminococcaceae, one of the few taxa that include bacteria that generate SBAs.

“Our findings confirm that significant changes in bacterial diversity and composition occur in UC versus FAP pouches,” wrote Sidhartha R. Sinha, MD, of Stanford (Calif.) University, and coauthors. “Notably, our finding of decreased Ruminococcaceae in UC, compared to FAP pouch stool, requires further exploration.” They added that this is the first study to identify Ruminococcaceae as a key contributor to the production of LCA or DCA from PBAs.

The study found average DCA counts of 60,957 in FAP versus 1,593 in UC (P = .002), and average LCA counts of 30,644 and 282.9, respectively (P = .001). The study profiled stools from ileal pouches in colectomy patients who had UC (17) or FAP (7), a noninflammatory disease. “Remarkably, our data identify LCA and DCA to be almost undetectable in UC pouch patients,” Dr. Sinha and coauthors wrote. “This striking finding in patients who underwent colectomy suggests that SBAs may play a role in dysregulated metabolism-induced intestinal inflammation.”

The study found that UC pouches demonstrated less bacterial diversity, or alpha-diversity, than FAP pouches, which is in line with previously reported findings (J Inflamm Res. 2017;10:63-73), and had significantly lower expression of bile-acid inducible genes that encode enzymes that transform PBA to SBA.

The researchers also demonstrated that LCA and DCA supplementation reduced intestinal inflammation in mice with UC.

“Our results show that LCA and DCA treatments caused a remarkable and significant decrease in multiple chemokines and cytokines associated with inflammation, including those often increased in intestinal inflammation,” Dr. Sinha and coauthors wrote. However, they found that LCA had no protective effect on dextran sodium sulfate–induced colitis in mice with TGR5-deficient immune cells. The TGR5 bile acid receptor influences the anti-inflammatory effect in SBA supplementation, the study reported.

The researchers have initiated a clinical study (NCT03724175) to investigate the role of SBAs in patients with pouchitis that doesn’t respond to antibiotic therapy. “Insights from this study will further inform our understanding of the role of SBAs in intestinal inflammation and hold promise to provide an effective treatment,” Dr. Sinha and coauthors wrote.

Christian Jobin, PhD, of the University of Florida, Gainesville, said in an interview these findings are consistent with a recent paper that found a correlation between production of SBAs such as DCA and disease remission (ISME J. 2020;14:702-13). Dr. Jobin coauthored a 2018 study that similarly found SBAs have a role in intestinal inflammation (Gastroenterology. 2018;154:1751-63).

“For a long time, secondary bile acid, especially DCA was linked to cell injury, toxicity and even cancer,” he said. “It’s time to rehabilitate this important signaling molecule and recognize its important role in regulating host homeostasis.” The 2018 paper he coauthored showed that injection of DCA into germ-free mice did not promote intestinal pathology. “Actually, DCA was critical in preventing Campylobacter jejune–induced colitis,” he added.

Dr. Sinha received funding from the Crohn’s & Colitis Foundation, Stanford Clinical and Translational Science Award, and Kenneth Rainin Foundation Synergy Award. Coauthors received funding from the National Institutes of Health, the Ann and Bill Swindells Charitable Trust, Leslie and Douglas Ballinger, and the Kenneth Rainin Foundation.

SOURCE: Sinha SR et al. Cell Host Microbe. 2020 Feb 25. doi: 10.1016/j.chom.2020.01.021.

A unique collection of bacteria in the gut may have a strong association with pulmonary arterial hypertension and could be highly predictive of the disease in undiagnosed patients, according to a study published in the journal Hypertension.

This is the first study to show that people with PAH have a common specific gut microbiota profile, wrote lead study author Mohan Raizada, PhD, distinguished professor in the department of physiology and functional genomics at the University of Florida, Gainesville.

The findings have the potential to change how cardiologists diagnose and treat PAH, he added. “While current PAH treatments focus on the lungs, looking at the lung/gut axis could open the door to new therapies centered in the digestive system,” Dr. Raizada said.

The researchers developed a model that found the specific microbiota profile was 83% accurate in predicting the presence or absence of PAH. If a larger study can validate the findings, the researchers wrote, this could lead to a new test for diagnosing PAH that’s less invasive than cardiac catheterization. It could also lead to new treatments that target the gut microbiome.

Study investigators collected stool samples from 18 PAH patients and 12 people without a history of cardiopulmonary disease. The microbiota DNA from the stool samples were isolated and sequenced. The analysis revealed that PAH patients had reduced richness and evenness of the gut bacteria, known as alpha diversity. They had increased levels of bacteria associated with atherosclerosis, and healthy patients had increased levels of bacteria that produced short-chain fatty acids.

Although recent studies have begun to show potential associations between the gut microbiome and cardiovascular diseases, this research is in its infancy, Mariell Jessup, MD, commented. “Even though the study by Dr. Raizada and colleagues predicted pulmonary arterial hypertension based on an individual’s microbiome with some accuracy, it is an observational study, so it does not prove cause and effect. Many other factors, especially diet, affect the gut microbiome,” added Dr. Jessup, Chief Science and Medical Officer for the American Heart Association.

SOURCE: Raizada MK et al. Hypertension. 2020. doi: 10.1161/HYPERTENSIONAHA.119.14294.

A unique collection of bacteria in the gut may have a strong association with pulmonary arterial hypertension and could be highly predictive of the disease in undiagnosed patients, according to a study published in the journal Hypertension.

This is the first study to show that people with PAH have a common specific gut microbiota profile, wrote lead study author Mohan Raizada, PhD, distinguished professor in the department of physiology and functional genomics at the University of Florida, Gainesville.

The findings have the potential to change how cardiologists diagnose and treat PAH, he added. “While current PAH treatments focus on the lungs, looking at the lung/gut axis could open the door to new therapies centered in the digestive system,” Dr. Raizada said.

The researchers developed a model that found the specific microbiota profile was 83% accurate in predicting the presence or absence of PAH. If a larger study can validate the findings, the researchers wrote, this could lead to a new test for diagnosing PAH that’s less invasive than cardiac catheterization. It could also lead to new treatments that target the gut microbiome.

Study investigators collected stool samples from 18 PAH patients and 12 people without a history of cardiopulmonary disease. The microbiota DNA from the stool samples were isolated and sequenced. The analysis revealed that PAH patients had reduced richness and evenness of the gut bacteria, known as alpha diversity. They had increased levels of bacteria associated with atherosclerosis, and healthy patients had increased levels of bacteria that produced short-chain fatty acids.

Although recent studies have begun to show potential associations between the gut microbiome and cardiovascular diseases, this research is in its infancy, Mariell Jessup, MD, commented. “Even though the study by Dr. Raizada and colleagues predicted pulmonary arterial hypertension based on an individual’s microbiome with some accuracy, it is an observational study, so it does not prove cause and effect. Many other factors, especially diet, affect the gut microbiome,” added Dr. Jessup, Chief Science and Medical Officer for the American Heart Association.

SOURCE: Raizada MK et al. Hypertension. 2020. doi: 10.1161/HYPERTENSIONAHA.119.14294.

A unique collection of bacteria in the gut may have a strong association with pulmonary arterial hypertension and could be highly predictive of the disease in undiagnosed patients, according to a study published in the journal Hypertension.

This is the first study to show that people with PAH have a common specific gut microbiota profile, wrote lead study author Mohan Raizada, PhD, distinguished professor in the department of physiology and functional genomics at the University of Florida, Gainesville.

The findings have the potential to change how cardiologists diagnose and treat PAH, he added. “While current PAH treatments focus on the lungs, looking at the lung/gut axis could open the door to new therapies centered in the digestive system,” Dr. Raizada said.

The researchers developed a model that found the specific microbiota profile was 83% accurate in predicting the presence or absence of PAH. If a larger study can validate the findings, the researchers wrote, this could lead to a new test for diagnosing PAH that’s less invasive than cardiac catheterization. It could also lead to new treatments that target the gut microbiome.

Study investigators collected stool samples from 18 PAH patients and 12 people without a history of cardiopulmonary disease. The microbiota DNA from the stool samples were isolated and sequenced. The analysis revealed that PAH patients had reduced richness and evenness of the gut bacteria, known as alpha diversity. They had increased levels of bacteria associated with atherosclerosis, and healthy patients had increased levels of bacteria that produced short-chain fatty acids.

Although recent studies have begun to show potential associations between the gut microbiome and cardiovascular diseases, this research is in its infancy, Mariell Jessup, MD, commented. “Even though the study by Dr. Raizada and colleagues predicted pulmonary arterial hypertension based on an individual’s microbiome with some accuracy, it is an observational study, so it does not prove cause and effect. Many other factors, especially diet, affect the gut microbiome,” added Dr. Jessup, Chief Science and Medical Officer for the American Heart Association.

SOURCE: Raizada MK et al. Hypertension. 2020. doi: 10.1161/HYPERTENSIONAHA.119.14294.

AUSTIN, TEX. – A program of frequent monitoring in Crohn’s disease and ulcerative colitis that includes fecal calprotectin (FC) and C-reactive protein (CRP) testing may be cost effective to significantly reduce disease recurrence and hospitalization rates, according to a review of published studies presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Some data show that calprotectin levels rise months before the onset of symptoms, so it’s my practice that every 3-4 months patients should undergo CRP and calprotectin testing, if they’re willing to do so, while they’re on biologic therapy,” Frank I. Scott, MD, MSCE, of the University of Colorado in Aurora, Denver, said in an interview after the presentation.

Regular monitoring of the two levels makes sense as the practice of tight control of IBD symptoms and treating to target has emerged over the past decade, Dr. Scott said. He noted the 2015 Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) guidelines called for using CRP and FC as adjunctive targets only in symptom assessment (Am J Gastroenterol. 2015:110[9]:1324-58). “I argue that we’ve had a growing body of literature that we should be using these tests regularly as well,” he said.

STRIDE calls for endoscopic assessment 6-9 months after therapy change and consideration of cross-sectional imaging if the small bowel is involved, with assessment every 3 months until symptoms improve and then every 6-12 months thereafter.

However, Dr. Scott noted potential drawbacks to these follow-up steps. “They currently focus on clinical symptoms in the short-term follow-up, and we know from looking at our disease activity indices, such as the CDAI [Crohn’s disease activity index] or Harvey-Bradshaw index, that they don’t always perfectly correlate with actual mucosal healing or resolution of inflammation in Crohn’s or [ulcerative colitis],” he said, pointing to a 2014 study that found CDAI had an area under the curve of 0.57, “which is pretty poor correlation” (Gut. 2014;63[1]:88-95).

Whereas a study of 2,499 patients that showed CRP had an area under the curve of 0.72 and FC of 0.89 (Am J Gastroentrol. 2015;110[6]:802-19). “CRP is a really attractive potential noninvasive marker of inflammation,” he said. “It’s relatively inexpensive, it’s widely available, and the cutoff ranges are well defined.”

He noted four potential drawbacks of CRP: the false-positive rate is relatively high; as a marker of systemic inflammation it’s not specific to the GI tract; false negatives have been well described, with up to 15% of patients not registering a response; and levels can depend on disease location. “Those with isolated ileal disease, for instance, may have relatively low CRP elevations when their disease is active,” Dr. Scott said.

Stool-based FC “represents a potentially more attractive option,” Dr. Scott said. Along with an area under the curve superior to CRP, FC has a documented sensitivity and specificity of 88% and 73%, respectively, versus 49% and 92% for CRP. Drawbacks of fecal calprotectin are that it’s specific to the GI tract but not inflammatory bowel disease, it costs more, and insurance coverage is not as universal as it is for CRP, although more carriers are covering the test, he said.

“However, we do know that through clinical trial data that the use of CRP and FC, in addition to clinical symptom monitoring, does appear to improve care,” Dr. Scott said, noting that the CALM trial of tight disease control through the frequent use of biochemical markers of inflammation with anti–tumor necrosis therapy bore this out (Lancet. 2018;390[10114]:2779-89). “This trial was able to demonstrate at 48 weeks that mucosal healing rates were improved in those receiving CRP and FC monitoring, compared to symptom monitoring alone, with higher rates of steroid-free remission at each visit, which persisted over the follow-up time.”

Dr. Scott also cited a post hoc analysis of CALM trial data that validated CRP and FC monitoring to improve steroid-free remission rates and other outcomes (Gut. 2019 Jul 8. doi: 10.1136/gutjnl-2019-318256). That trial reported steroid-free remission rates of 39.3% with clinical management and 59.8% with tight control, a 34% overall difference (P less than .001). “And it was cost effective to incorporate this monitoring at a cost of about $24,300 per quality-adjusted life-year, well below the typically used $50,000 willingness-to-pay threshold when considering new tests,” Dr. Scott said.

Dr. Scott acknowledged that FC testing may pose some inconvenience to patients when collecting their stool samples, but accuracy has improved. “Laboratories are becoming more reliable in terms of what the values are, and the cutoffs are becoming more defined as far as what’s positive and what’s negative, so it’s good way to monitor whether or not patients are at increased risk of a future flare,” he said.

Dr. Scott reported financial relationships with Takeda, Janssen, Merck and PRIME.

SOURCE: Scott FI et al. Crohn’s & Colitis Congress 2020, Session Sp125.

AUSTIN, TEX. – A program of frequent monitoring in Crohn’s disease and ulcerative colitis that includes fecal calprotectin (FC) and C-reactive protein (CRP) testing may be cost effective to significantly reduce disease recurrence and hospitalization rates, according to a review of published studies presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Some data show that calprotectin levels rise months before the onset of symptoms, so it’s my practice that every 3-4 months patients should undergo CRP and calprotectin testing, if they’re willing to do so, while they’re on biologic therapy,” Frank I. Scott, MD, MSCE, of the University of Colorado in Aurora, Denver, said in an interview after the presentation.

Regular monitoring of the two levels makes sense as the practice of tight control of IBD symptoms and treating to target has emerged over the past decade, Dr. Scott said. He noted the 2015 Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) guidelines called for using CRP and FC as adjunctive targets only in symptom assessment (Am J Gastroenterol. 2015:110[9]:1324-58). “I argue that we’ve had a growing body of literature that we should be using these tests regularly as well,” he said.

STRIDE calls for endoscopic assessment 6-9 months after therapy change and consideration of cross-sectional imaging if the small bowel is involved, with assessment every 3 months until symptoms improve and then every 6-12 months thereafter.

However, Dr. Scott noted potential drawbacks to these follow-up steps. “They currently focus on clinical symptoms in the short-term follow-up, and we know from looking at our disease activity indices, such as the CDAI [Crohn’s disease activity index] or Harvey-Bradshaw index, that they don’t always perfectly correlate with actual mucosal healing or resolution of inflammation in Crohn’s or [ulcerative colitis],” he said, pointing to a 2014 study that found CDAI had an area under the curve of 0.57, “which is pretty poor correlation” (Gut. 2014;63[1]:88-95).

Whereas a study of 2,499 patients that showed CRP had an area under the curve of 0.72 and FC of 0.89 (Am J Gastroentrol. 2015;110[6]:802-19). “CRP is a really attractive potential noninvasive marker of inflammation,” he said. “It’s relatively inexpensive, it’s widely available, and the cutoff ranges are well defined.”

He noted four potential drawbacks of CRP: the false-positive rate is relatively high; as a marker of systemic inflammation it’s not specific to the GI tract; false negatives have been well described, with up to 15% of patients not registering a response; and levels can depend on disease location. “Those with isolated ileal disease, for instance, may have relatively low CRP elevations when their disease is active,” Dr. Scott said.

Stool-based FC “represents a potentially more attractive option,” Dr. Scott said. Along with an area under the curve superior to CRP, FC has a documented sensitivity and specificity of 88% and 73%, respectively, versus 49% and 92% for CRP. Drawbacks of fecal calprotectin are that it’s specific to the GI tract but not inflammatory bowel disease, it costs more, and insurance coverage is not as universal as it is for CRP, although more carriers are covering the test, he said.

“However, we do know that through clinical trial data that the use of CRP and FC, in addition to clinical symptom monitoring, does appear to improve care,” Dr. Scott said, noting that the CALM trial of tight disease control through the frequent use of biochemical markers of inflammation with anti–tumor necrosis therapy bore this out (Lancet. 2018;390[10114]:2779-89). “This trial was able to demonstrate at 48 weeks that mucosal healing rates were improved in those receiving CRP and FC monitoring, compared to symptom monitoring alone, with higher rates of steroid-free remission at each visit, which persisted over the follow-up time.”

Dr. Scott also cited a post hoc analysis of CALM trial data that validated CRP and FC monitoring to improve steroid-free remission rates and other outcomes (Gut. 2019 Jul 8. doi: 10.1136/gutjnl-2019-318256). That trial reported steroid-free remission rates of 39.3% with clinical management and 59.8% with tight control, a 34% overall difference (P less than .001). “And it was cost effective to incorporate this monitoring at a cost of about $24,300 per quality-adjusted life-year, well below the typically used $50,000 willingness-to-pay threshold when considering new tests,” Dr. Scott said.

Dr. Scott acknowledged that FC testing may pose some inconvenience to patients when collecting their stool samples, but accuracy has improved. “Laboratories are becoming more reliable in terms of what the values are, and the cutoffs are becoming more defined as far as what’s positive and what’s negative, so it’s good way to monitor whether or not patients are at increased risk of a future flare,” he said.

Dr. Scott reported financial relationships with Takeda, Janssen, Merck and PRIME.

SOURCE: Scott FI et al. Crohn’s & Colitis Congress 2020, Session Sp125.

AUSTIN, TEX. – A program of frequent monitoring in Crohn’s disease and ulcerative colitis that includes fecal calprotectin (FC) and C-reactive protein (CRP) testing may be cost effective to significantly reduce disease recurrence and hospitalization rates, according to a review of published studies presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Some data show that calprotectin levels rise months before the onset of symptoms, so it’s my practice that every 3-4 months patients should undergo CRP and calprotectin testing, if they’re willing to do so, while they’re on biologic therapy,” Frank I. Scott, MD, MSCE, of the University of Colorado in Aurora, Denver, said in an interview after the presentation.

Regular monitoring of the two levels makes sense as the practice of tight control of IBD symptoms and treating to target has emerged over the past decade, Dr. Scott said. He noted the 2015 Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) guidelines called for using CRP and FC as adjunctive targets only in symptom assessment (Am J Gastroenterol. 2015:110[9]:1324-58). “I argue that we’ve had a growing body of literature that we should be using these tests regularly as well,” he said.

STRIDE calls for endoscopic assessment 6-9 months after therapy change and consideration of cross-sectional imaging if the small bowel is involved, with assessment every 3 months until symptoms improve and then every 6-12 months thereafter.

However, Dr. Scott noted potential drawbacks to these follow-up steps. “They currently focus on clinical symptoms in the short-term follow-up, and we know from looking at our disease activity indices, such as the CDAI [Crohn’s disease activity index] or Harvey-Bradshaw index, that they don’t always perfectly correlate with actual mucosal healing or resolution of inflammation in Crohn’s or [ulcerative colitis],” he said, pointing to a 2014 study that found CDAI had an area under the curve of 0.57, “which is pretty poor correlation” (Gut. 2014;63[1]:88-95).

Whereas a study of 2,499 patients that showed CRP had an area under the curve of 0.72 and FC of 0.89 (Am J Gastroentrol. 2015;110[6]:802-19). “CRP is a really attractive potential noninvasive marker of inflammation,” he said. “It’s relatively inexpensive, it’s widely available, and the cutoff ranges are well defined.”

He noted four potential drawbacks of CRP: the false-positive rate is relatively high; as a marker of systemic inflammation it’s not specific to the GI tract; false negatives have been well described, with up to 15% of patients not registering a response; and levels can depend on disease location. “Those with isolated ileal disease, for instance, may have relatively low CRP elevations when their disease is active,” Dr. Scott said.

Stool-based FC “represents a potentially more attractive option,” Dr. Scott said. Along with an area under the curve superior to CRP, FC has a documented sensitivity and specificity of 88% and 73%, respectively, versus 49% and 92% for CRP. Drawbacks of fecal calprotectin are that it’s specific to the GI tract but not inflammatory bowel disease, it costs more, and insurance coverage is not as universal as it is for CRP, although more carriers are covering the test, he said.

“However, we do know that through clinical trial data that the use of CRP and FC, in addition to clinical symptom monitoring, does appear to improve care,” Dr. Scott said, noting that the CALM trial of tight disease control through the frequent use of biochemical markers of inflammation with anti–tumor necrosis therapy bore this out (Lancet. 2018;390[10114]:2779-89). “This trial was able to demonstrate at 48 weeks that mucosal healing rates were improved in those receiving CRP and FC monitoring, compared to symptom monitoring alone, with higher rates of steroid-free remission at each visit, which persisted over the follow-up time.”

Dr. Scott also cited a post hoc analysis of CALM trial data that validated CRP and FC monitoring to improve steroid-free remission rates and other outcomes (Gut. 2019 Jul 8. doi: 10.1136/gutjnl-2019-318256). That trial reported steroid-free remission rates of 39.3% with clinical management and 59.8% with tight control, a 34% overall difference (P less than .001). “And it was cost effective to incorporate this monitoring at a cost of about $24,300 per quality-adjusted life-year, well below the typically used $50,000 willingness-to-pay threshold when considering new tests,” Dr. Scott said.

Dr. Scott acknowledged that FC testing may pose some inconvenience to patients when collecting their stool samples, but accuracy has improved. “Laboratories are becoming more reliable in terms of what the values are, and the cutoffs are becoming more defined as far as what’s positive and what’s negative, so it’s good way to monitor whether or not patients are at increased risk of a future flare,” he said.

Dr. Scott reported financial relationships with Takeda, Janssen, Merck and PRIME.

SOURCE: Scott FI et al. Crohn’s & Colitis Congress 2020, Session Sp125.

AUSTIN, TEX. – As more states legalize recreational and medical marijuana and cannabinoid products, and as evidence shows that up to 40% of patients with inflammatory bowel disease may be users, their gastroenterologists and other medical providers may be failing to even ask if they’re using, let alone talk to them about how it could impact their disease, according to a study of a hospital population in Washington, where recreational marijuana is legal.

The single-center, chart-review study at George Washington University found that providers noted they inquired about marijuana/CBD use in fewer than half of encounters with IBD patients – 47.8% to be precise – and that 4.9% of charts actually noted patients were users, according to a poster at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“This study acknowledges the growth of recreational and medical marijuana use as well as CBD products,” said poster presenter Scott Baumgartner, PA, a fourth-year medical student. “Understanding that because there’s increased legalization of both medical and recreational marijuana, our patients may be using them at increased rates. But are we asking them?”

According to the Drug Policy Alliance, recreational marijuana is legal in 11 states as well as Washington, which legalized recreational pot in 2014, and medical marijuana is legal in 33 states. The prevalence of cannabis use in patients with IBD has been reported at 15%-40% (Gastroenterol Hepatol [NY]. 2016;12:668-79).

The study consisted of a retrospective review of 381 charts of patients with IBD. Of the 19 charts that noted marijuana/CBD use, only 2 noted a prescription for medical purposes, although 4 noted IBD symptoms as the reason for use. Three charts noted recreational use and 12 gave no reason.

Mr. Baumgartner noted that it’s important gastroenterologists and other providers ask about marijuana/CBD use in their patients because of the inconclusive evidence about how it affects the disease (Dig Dis Sci. 2019;64:2696-8). “If you’re using marijuana for an IBD such as Crohn’s or ulcerative colitis because you think it’s relieving your symptoms, does it actually work in your long-term course?” he asked. “Does it relieve some symptoms but make other disease manifestations worse. We need more research in that area.”

The takeaway of the study: “We need to do a better job of asking whether or not patients are using recreational drugs,” Mr. Baumgartner said. “And if they are using recreational drugs, what recreational drugs they are using, because it could have a big impact on the outcome of their disease.”

The next steps for this research, Mr. Baumgartner said, is to focus on the specific questions providers are asking about their patients’ marijuana and recreational drug use and how they’re documenting those responses. “Once we see that, we could consider looking at a cohort of patients who are using and see if they are reporting symptom relief, or if we are seeing disease remission, or not,” Mr. Baumgartner said.

Mr. Baumgartner has no financial relationships to disclose.

SOURCE: Baumgartner S et al. Crohn’s & Colitis Congress 2020. 2020 Jan 23. Poster 011.

AUSTIN, TEX. – As more states legalize recreational and medical marijuana and cannabinoid products, and as evidence shows that up to 40% of patients with inflammatory bowel disease may be users, their gastroenterologists and other medical providers may be failing to even ask if they’re using, let alone talk to them about how it could impact their disease, according to a study of a hospital population in Washington, where recreational marijuana is legal.

The single-center, chart-review study at George Washington University found that providers noted they inquired about marijuana/CBD use in fewer than half of encounters with IBD patients – 47.8% to be precise – and that 4.9% of charts actually noted patients were users, according to a poster at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“This study acknowledges the growth of recreational and medical marijuana use as well as CBD products,” said poster presenter Scott Baumgartner, PA, a fourth-year medical student. “Understanding that because there’s increased legalization of both medical and recreational marijuana, our patients may be using them at increased rates. But are we asking them?”

According to the Drug Policy Alliance, recreational marijuana is legal in 11 states as well as Washington, which legalized recreational pot in 2014, and medical marijuana is legal in 33 states. The prevalence of cannabis use in patients with IBD has been reported at 15%-40% (Gastroenterol Hepatol [NY]. 2016;12:668-79).

The study consisted of a retrospective review of 381 charts of patients with IBD. Of the 19 charts that noted marijuana/CBD use, only 2 noted a prescription for medical purposes, although 4 noted IBD symptoms as the reason for use. Three charts noted recreational use and 12 gave no reason.

Mr. Baumgartner noted that it’s important gastroenterologists and other providers ask about marijuana/CBD use in their patients because of the inconclusive evidence about how it affects the disease (Dig Dis Sci. 2019;64:2696-8). “If you’re using marijuana for an IBD such as Crohn’s or ulcerative colitis because you think it’s relieving your symptoms, does it actually work in your long-term course?” he asked. “Does it relieve some symptoms but make other disease manifestations worse. We need more research in that area.”

The takeaway of the study: “We need to do a better job of asking whether or not patients are using recreational drugs,” Mr. Baumgartner said. “And if they are using recreational drugs, what recreational drugs they are using, because it could have a big impact on the outcome of their disease.”

The next steps for this research, Mr. Baumgartner said, is to focus on the specific questions providers are asking about their patients’ marijuana and recreational drug use and how they’re documenting those responses. “Once we see that, we could consider looking at a cohort of patients who are using and see if they are reporting symptom relief, or if we are seeing disease remission, or not,” Mr. Baumgartner said.

Mr. Baumgartner has no financial relationships to disclose.

SOURCE: Baumgartner S et al. Crohn’s & Colitis Congress 2020. 2020 Jan 23. Poster 011.

AUSTIN, TEX. – As more states legalize recreational and medical marijuana and cannabinoid products, and as evidence shows that up to 40% of patients with inflammatory bowel disease may be users, their gastroenterologists and other medical providers may be failing to even ask if they’re using, let alone talk to them about how it could impact their disease, according to a study of a hospital population in Washington, where recreational marijuana is legal.

The single-center, chart-review study at George Washington University found that providers noted they inquired about marijuana/CBD use in fewer than half of encounters with IBD patients – 47.8% to be precise – and that 4.9% of charts actually noted patients were users, according to a poster at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“This study acknowledges the growth of recreational and medical marijuana use as well as CBD products,” said poster presenter Scott Baumgartner, PA, a fourth-year medical student. “Understanding that because there’s increased legalization of both medical and recreational marijuana, our patients may be using them at increased rates. But are we asking them?”

According to the Drug Policy Alliance, recreational marijuana is legal in 11 states as well as Washington, which legalized recreational pot in 2014, and medical marijuana is legal in 33 states. The prevalence of cannabis use in patients with IBD has been reported at 15%-40% (Gastroenterol Hepatol [NY]. 2016;12:668-79).

The study consisted of a retrospective review of 381 charts of patients with IBD. Of the 19 charts that noted marijuana/CBD use, only 2 noted a prescription for medical purposes, although 4 noted IBD symptoms as the reason for use. Three charts noted recreational use and 12 gave no reason.

Mr. Baumgartner noted that it’s important gastroenterologists and other providers ask about marijuana/CBD use in their patients because of the inconclusive evidence about how it affects the disease (Dig Dis Sci. 2019;64:2696-8). “If you’re using marijuana for an IBD such as Crohn’s or ulcerative colitis because you think it’s relieving your symptoms, does it actually work in your long-term course?” he asked. “Does it relieve some symptoms but make other disease manifestations worse. We need more research in that area.”

The takeaway of the study: “We need to do a better job of asking whether or not patients are using recreational drugs,” Mr. Baumgartner said. “And if they are using recreational drugs, what recreational drugs they are using, because it could have a big impact on the outcome of their disease.”

The next steps for this research, Mr. Baumgartner said, is to focus on the specific questions providers are asking about their patients’ marijuana and recreational drug use and how they’re documenting those responses. “Once we see that, we could consider looking at a cohort of patients who are using and see if they are reporting symptom relief, or if we are seeing disease remission, or not,” Mr. Baumgartner said.

Mr. Baumgartner has no financial relationships to disclose.

SOURCE: Baumgartner S et al. Crohn’s & Colitis Congress 2020. 2020 Jan 23. Poster 011.

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

The AGA IBD Parenthood Project can help guide your patients with IBD throughout their pregnancy, from trying to conceive through postpartum care. Learn more at IBDParenthoodProject.org.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

The AGA IBD Parenthood Project can help guide your patients with IBD throughout their pregnancy, from trying to conceive through postpartum care. Learn more at IBDParenthoodProject.org.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

The AGA IBD Parenthood Project can help guide your patients with IBD throughout their pregnancy, from trying to conceive through postpartum care. Learn more at IBDParenthoodProject.org.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.

AUSTIN, TEX. – A quality improvement initiative aimed at patients with inflammatory bowel disease (IBD) has reduced emergency department visits and hospitalizations by 20% or more and slashed opioid use by half, according to study results presented at the Crohn’s & Colitis Congress^®, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association.

After 15 months, the quality improvement program saw emergency department visit rates decline from 18% to 14%, a 22% relative decrease, Gil Y. Melmed, MD, of Cedars-Sinai Medical Center, Los Angeles, said. Additionally, the study documented a similar decrease in the rate of hospitalization, declining from 14% to 11%, while opioid utilization rates declined from 8% to 4%. “We also found decreases in special-cause variation in other measures of interest, including CT scan utilization as well as corticosteroid use, which was reduced 29% during the course of the program,” he said.

The quality initiative was conducted through the Crohn’s & Colitis Foundation as an outgrowth of its IBD Qorus quality improvement program. The 15-month study involved 20,392 patient visits at 15 academic and 11 private/community practices from January 2018 to April 2019. “This specific project within Qorus is focused specifically around the concept of improving access during times of urgent care need,” Dr. Melmed told this news organization. The goal was to identify practice changes that can drive improvement.

The intervention consisted of 19 different strategies, called a “Change Package,” and participating sites could choose to test and implement one or more of them, Dr. Melmed said. Some examples included designating urgent care slots in the clinic schedule, installing a nurse hotline, a weekly “huddle” to review high-risk patients, and patient education on using urgent care.

One of the drivers of the program was to provide immediate care improvement to patients, Dr. Melmed said in the interview. “As opposed to investments into the cure of IBD that we need, but which can take years to develop, this research has immediate, practical applicability for patients today,” he said.

“The fact that we were able to demonstrate reduction in emergency room utilization and hospitalization, steroid use, and narcotic use has really energized the work that we were doing. We can now show that very-low-cost process changes at a site level lead to robust improvement in patient outcomes. These changes are potentially implementable in any practice setting,” Dr. Melmed said in the interview.

After Dr. Melmed’s presentation, Maria T. Abreu, MD, director of the Crohn’s and Colitis Center at the University of Miami, asked about the cost of the interventions. Dr. Melmed said the costs were nominal, such as paying for a new phone line for a patient hotline. “But overall the cost really involved in the program was the time that it took to review the high-risk list on a weekly basis with the team, and that is essentially a 15-minute huddle,” he said.

Later, Dr. Abreu said in an interview that the program was “a terrific example of how measuring outcomes and sharing ideas can make huge impacts in the lives of patients.” She added, “An enormous amount of money is spent on clinical trials of expensive biologics which have revolutionized treatment, yet the humanistic aspects of our care have just as great of an impact. In this study, each center focused on ways they could lower ER visits and hospitalizations. One size did not fit all, yet they could learn from each other. The very platform they used to conduct the study is a model for all of us.”

Corey A. Siegel, MD, of the Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and Dr. Melmed's coprincipal investigator on Qorus, said the quality initiative now includes 49 GI practices across the country with plans to grow to 60 by the end of the year. "We have created this 'collaboratory' for providers from actross the country to work togetherr to learn how to best deliver high-qulaity care for patients with IBD," he said.

Another feature of the quality initiative allowed participating sites to see how they compared with others anonymously, Dr. Melmed said. “Using the data, we called out high-performing sites to teach the rest of us what they were doing that enabled them to improve, so that all of us could learn from their successes,” he said.

The researchers are aiming to evaluate costs and identify the most successful interventions, with the plan to present the latter at Digestive Disease Week^® 2020 and use them to develop a toolkit practices can use. “Ultimately,” said Dr. Melmed, “this is scalable.”

Dr. Melmed disclosed financial relationships with AbbVie, Boehringer-Ingelheim, Celgene, Jannsen, GSK, Medtronic, Pfizer, Samsung Bioepis, Takeda, and Techlab; IBD Qorus receives support from Abbvie, AMAG, Helmsley Charitable Trust, Janssen, Nephoroceuticals, Pfizer, Takeda, and UCB.

SOURCE: Melmed GT et al. Crohn’s & Colitis Congress 2020, Session 28.

AUSTIN, TEX. – A quality improvement initiative aimed at patients with inflammatory bowel disease (IBD) has reduced emergency department visits and hospitalizations by 20% or more and slashed opioid use by half, according to study results presented at the Crohn’s & Colitis Congress^®, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association.

After 15 months, the quality improvement program saw emergency department visit rates decline from 18% to 14%, a 22% relative decrease, Gil Y. Melmed, MD, of Cedars-Sinai Medical Center, Los Angeles, said. Additionally, the study documented a similar decrease in the rate of hospitalization, declining from 14% to 11%, while opioid utilization rates declined from 8% to 4%. “We also found decreases in special-cause variation in other measures of interest, including CT scan utilization as well as corticosteroid use, which was reduced 29% during the course of the program,” he said.

The quality initiative was conducted through the Crohn’s & Colitis Foundation as an outgrowth of its IBD Qorus quality improvement program. The 15-month study involved 20,392 patient visits at 15 academic and 11 private/community practices from January 2018 to April 2019. “This specific project within Qorus is focused specifically around the concept of improving access during times of urgent care need,” Dr. Melmed told this news organization. The goal was to identify practice changes that can drive improvement.

The intervention consisted of 19 different strategies, called a “Change Package,” and participating sites could choose to test and implement one or more of them, Dr. Melmed said. Some examples included designating urgent care slots in the clinic schedule, installing a nurse hotline, a weekly “huddle” to review high-risk patients, and patient education on using urgent care.

One of the drivers of the program was to provide immediate care improvement to patients, Dr. Melmed said in the interview. “As opposed to investments into the cure of IBD that we need, but which can take years to develop, this research has immediate, practical applicability for patients today,” he said.

“The fact that we were able to demonstrate reduction in emergency room utilization and hospitalization, steroid use, and narcotic use has really energized the work that we were doing. We can now show that very-low-cost process changes at a site level lead to robust improvement in patient outcomes. These changes are potentially implementable in any practice setting,” Dr. Melmed said in the interview.

After Dr. Melmed’s presentation, Maria T. Abreu, MD, director of the Crohn’s and Colitis Center at the University of Miami, asked about the cost of the interventions. Dr. Melmed said the costs were nominal, such as paying for a new phone line for a patient hotline. “But overall the cost really involved in the program was the time that it took to review the high-risk list on a weekly basis with the team, and that is essentially a 15-minute huddle,” he said.

Later, Dr. Abreu said in an interview that the program was “a terrific example of how measuring outcomes and sharing ideas can make huge impacts in the lives of patients.” She added, “An enormous amount of money is spent on clinical trials of expensive biologics which have revolutionized treatment, yet the humanistic aspects of our care have just as great of an impact. In this study, each center focused on ways they could lower ER visits and hospitalizations. One size did not fit all, yet they could learn from each other. The very platform they used to conduct the study is a model for all of us.”

Corey A. Siegel, MD, of the Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and Dr. Melmed's coprincipal investigator on Qorus, said the quality initiative now includes 49 GI practices across the country with plans to grow to 60 by the end of the year. "We have created this 'collaboratory' for providers from actross the country to work togetherr to learn how to best deliver high-qulaity care for patients with IBD," he said.

Another feature of the quality initiative allowed participating sites to see how they compared with others anonymously, Dr. Melmed said. “Using the data, we called out high-performing sites to teach the rest of us what they were doing that enabled them to improve, so that all of us could learn from their successes,” he said.

The researchers are aiming to evaluate costs and identify the most successful interventions, with the plan to present the latter at Digestive Disease Week^® 2020 and use them to develop a toolkit practices can use. “Ultimately,” said Dr. Melmed, “this is scalable.”

Dr. Melmed disclosed financial relationships with AbbVie, Boehringer-Ingelheim, Celgene, Jannsen, GSK, Medtronic, Pfizer, Samsung Bioepis, Takeda, and Techlab; IBD Qorus receives support from Abbvie, AMAG, Helmsley Charitable Trust, Janssen, Nephoroceuticals, Pfizer, Takeda, and UCB.

SOURCE: Melmed GT et al. Crohn’s & Colitis Congress 2020, Session 28.

AUSTIN, TEX. – A quality improvement initiative aimed at patients with inflammatory bowel disease (IBD) has reduced emergency department visits and hospitalizations by 20% or more and slashed opioid use by half, according to study results presented at the Crohn’s & Colitis Congress^®, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association.

After 15 months, the quality improvement program saw emergency department visit rates decline from 18% to 14%, a 22% relative decrease, Gil Y. Melmed, MD, of Cedars-Sinai Medical Center, Los Angeles, said. Additionally, the study documented a similar decrease in the rate of hospitalization, declining from 14% to 11%, while opioid utilization rates declined from 8% to 4%. “We also found decreases in special-cause variation in other measures of interest, including CT scan utilization as well as corticosteroid use, which was reduced 29% during the course of the program,” he said.

The quality initiative was conducted through the Crohn’s & Colitis Foundation as an outgrowth of its IBD Qorus quality improvement program. The 15-month study involved 20,392 patient visits at 15 academic and 11 private/community practices from January 2018 to April 2019. “This specific project within Qorus is focused specifically around the concept of improving access during times of urgent care need,” Dr. Melmed told this news organization. The goal was to identify practice changes that can drive improvement.

The intervention consisted of 19 different strategies, called a “Change Package,” and participating sites could choose to test and implement one or more of them, Dr. Melmed said. Some examples included designating urgent care slots in the clinic schedule, installing a nurse hotline, a weekly “huddle” to review high-risk patients, and patient education on using urgent care.

One of the drivers of the program was to provide immediate care improvement to patients, Dr. Melmed said in the interview. “As opposed to investments into the cure of IBD that we need, but which can take years to develop, this research has immediate, practical applicability for patients today,” he said.

“The fact that we were able to demonstrate reduction in emergency room utilization and hospitalization, steroid use, and narcotic use has really energized the work that we were doing. We can now show that very-low-cost process changes at a site level lead to robust improvement in patient outcomes. These changes are potentially implementable in any practice setting,” Dr. Melmed said in the interview.

After Dr. Melmed’s presentation, Maria T. Abreu, MD, director of the Crohn’s and Colitis Center at the University of Miami, asked about the cost of the interventions. Dr. Melmed said the costs were nominal, such as paying for a new phone line for a patient hotline. “But overall the cost really involved in the program was the time that it took to review the high-risk list on a weekly basis with the team, and that is essentially a 15-minute huddle,” he said.

Later, Dr. Abreu said in an interview that the program was “a terrific example of how measuring outcomes and sharing ideas can make huge impacts in the lives of patients.” She added, “An enormous amount of money is spent on clinical trials of expensive biologics which have revolutionized treatment, yet the humanistic aspects of our care have just as great of an impact. In this study, each center focused on ways they could lower ER visits and hospitalizations. One size did not fit all, yet they could learn from each other. The very platform they used to conduct the study is a model for all of us.”

Corey A. Siegel, MD, of the Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and Dr. Melmed's coprincipal investigator on Qorus, said the quality initiative now includes 49 GI practices across the country with plans to grow to 60 by the end of the year. "We have created this 'collaboratory' for providers from actross the country to work togetherr to learn how to best deliver high-qulaity care for patients with IBD," he said.

Another feature of the quality initiative allowed participating sites to see how they compared with others anonymously, Dr. Melmed said. “Using the data, we called out high-performing sites to teach the rest of us what they were doing that enabled them to improve, so that all of us could learn from their successes,” he said.

The researchers are aiming to evaluate costs and identify the most successful interventions, with the plan to present the latter at Digestive Disease Week^® 2020 and use them to develop a toolkit practices can use. “Ultimately,” said Dr. Melmed, “this is scalable.”

Dr. Melmed disclosed financial relationships with AbbVie, Boehringer-Ingelheim, Celgene, Jannsen, GSK, Medtronic, Pfizer, Samsung Bioepis, Takeda, and Techlab; IBD Qorus receives support from Abbvie, AMAG, Helmsley Charitable Trust, Janssen, Nephoroceuticals, Pfizer, Takeda, and UCB.

SOURCE: Melmed GT et al. Crohn’s & Colitis Congress 2020, Session 28.

AUSTIN, TEX. – Enhanced recovery after surgery (ERAS) protocols have been around for decades, but typically excluded patients having surgery for inflammatory bowel disease (IBD). However, recent studies have shown strategies to optimize these patients, including presurgery carbohydrate loading and early postsurgery feeding, can improve outcomes, according to a review of evidence presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“It’s really important that we implement strategies to help mitigate the impact that malnutrition is going to have on our perioperative patients, and one of the ways we do that is by using an ERAS or enhanced recovery after surgery protocol,” said Kelly Issokson, MS, RD, of Cedars-Sinai Medical Center, Los Angeles. She noted that patients with IBD are five times more likely to be malnourished than non-IBD patients, and those with fistulizing Crohn’s disease and bowel resections are at greatest risk (Inflamm Bowel Dis. 2008;14:1139-46).

“I constantly see patients who are kept NPO [nothing by mouth] 12 or 24 hours before surgery, maybe even longer sometimes, unfortunately,” she said. “We should really be minimizing that NPO to help mitigate the catabolic effect that surgery has on our patients and help them recover more quickly.”

To screen surgery patients for nutrition risk, Ms. Issokson said that gastroenterologists can ask two questions from the malnutrition screening tool: Did the patient have recent unintentional weight loss, and is the patient eating less because of poor appetite? A yes to either question merits referral to a registered dietician. Malnutrition, weight loss of 5%-10% of total body weight, and sarcopenia are predictors of surgical complications for IBD patients, the latter an independent predictor in patients aged 40 years and older.

The ERAS protocol involves optimizing preoperative and postoperative nutrition, she said. It has been linked with improved outcomes in elective colorectal surgery (World J Surg. 2014;38:1531-41), although the evidence in IBD isn’t as robust. She cited a retrospective study reported at the 2019 annual Digestive Disease Week of patients with Crohn’s disease that found no difference in readmissions, complications, or reoperations between ERAS and standard-care patients.

Preoperative nutrition optimization in ERAS involves anemia and fluid management, oral nutrition supplementation, and – based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2017 guidelines – delaying the operation where possible if the patient is malnourished. “Patients who receive preoperative nutrition support have been shown to have better outcomes postoperatively,” Ms. Issokson said, citing a meta-analysis of 1,111 Crohn’s disease patients that reported the complication rate was 20% in patients on nutrition support versus 60% for those on standard care; in those on enteral nutrition, the disparity was more pronounced: 21% versus 73% (Eur J Gastro Hep. 2018;30:997-1002).

Gastroenterologists should not be afraid of implementing total parenteral nutrition (TPN) perioperatively in these patients, Ms. Issokson said. “This can really help to improve outcomes and quality of life in our patients, and it’s something that we really should not shy away from,” she added in an interview. “If our patients are malnourished and meet the criteria for TPN, then we should really not be withholding it.” Patients with severe IBD who are not absorbing from their gut and can’t meet 60% of their needs by mouth are prime candidates for TPN, she said, referencing a 2019 study that reported that preoperative TPN in malnourished IBD patients resulted in a rate of overall noninfectious complications half that of no-TPN patients: 8.3% versus 16.8% (Gastroenterol Rep. 2019 Apr;7:107-14).

Carbohydrate loading before surgery is a big part of ERAS in these patients. “Surgery has a huge impact on the catabolic state of a patient,” Ms. Issokson said. “It’s similar to running a marathon; you wouldn’t go out and run a marathon without fueling up the night before with a whole bunch of carbohydrates. So we use this same strategy in our surgical patients.”

ERAS society guidelines call for 100 g of carbohydrates the night before and 50 g 2 hours before surgery in the form of a clear liquid beverage, along with permitting a light meal up to 6 hours before, with exceptions in gastroparesis, motility disorders, and emergency surgery.

Another key component of ERAS in IBD is early postoperative feeding. “Postoperatively we want to feed our patients as soon as possible,” Ms. Issokson said. ESPEN guidelines call for feeding patients with new nondiverted colorectal anastomosis within 4 hours. “Studies show that patients aren’t able to eat enough calories to help them recover postoperatively, so implementing an oral nutrition supplement might be helpful there,” she added.

Ms. Issokson is a Crohn’s & Colitis Foundation board member, and disclosed financial relationships with Orgain, RMEI, and Medscape.

SOURCE: Issokson K et al. Crohn’s & Colitis Congress 2020, Session Sp83.
 

AUSTIN, TEX. – Enhanced recovery after surgery (ERAS) protocols have been around for decades, but typically excluded patients having surgery for inflammatory bowel disease (IBD). However, recent studies have shown strategies to optimize these patients, including presurgery carbohydrate loading and early postsurgery feeding, can improve outcomes, according to a review of evidence presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“It’s really important that we implement strategies to help mitigate the impact that malnutrition is going to have on our perioperative patients, and one of the ways we do that is by using an ERAS or enhanced recovery after surgery protocol,” said Kelly Issokson, MS, RD, of Cedars-Sinai Medical Center, Los Angeles. She noted that patients with IBD are five times more likely to be malnourished than non-IBD patients, and those with fistulizing Crohn’s disease and bowel resections are at greatest risk (Inflamm Bowel Dis. 2008;14:1139-46).

“I constantly see patients who are kept NPO [nothing by mouth] 12 or 24 hours before surgery, maybe even longer sometimes, unfortunately,” she said. “We should really be minimizing that NPO to help mitigate the catabolic effect that surgery has on our patients and help them recover more quickly.”

To screen surgery patients for nutrition risk, Ms. Issokson said that gastroenterologists can ask two questions from the malnutrition screening tool: Did the patient have recent unintentional weight loss, and is the patient eating less because of poor appetite? A yes to either question merits referral to a registered dietician. Malnutrition, weight loss of 5%-10% of total body weight, and sarcopenia are predictors of surgical complications for IBD patients, the latter an independent predictor in patients aged 40 years and older.

The ERAS protocol involves optimizing preoperative and postoperative nutrition, she said. It has been linked with improved outcomes in elective colorectal surgery (World J Surg. 2014;38:1531-41), although the evidence in IBD isn’t as robust. She cited a retrospective study reported at the 2019 annual Digestive Disease Week of patients with Crohn’s disease that found no difference in readmissions, complications, or reoperations between ERAS and standard-care patients.

Preoperative nutrition optimization in ERAS involves anemia and fluid management, oral nutrition supplementation, and – based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2017 guidelines – delaying the operation where possible if the patient is malnourished. “Patients who receive preoperative nutrition support have been shown to have better outcomes postoperatively,” Ms. Issokson said, citing a meta-analysis of 1,111 Crohn’s disease patients that reported the complication rate was 20% in patients on nutrition support versus 60% for those on standard care; in those on enteral nutrition, the disparity was more pronounced: 21% versus 73% (Eur J Gastro Hep. 2018;30:997-1002).

Gastroenterologists should not be afraid of implementing total parenteral nutrition (TPN) perioperatively in these patients, Ms. Issokson said. “This can really help to improve outcomes and quality of life in our patients, and it’s something that we really should not shy away from,” she added in an interview. “If our patients are malnourished and meet the criteria for TPN, then we should really not be withholding it.” Patients with severe IBD who are not absorbing from their gut and can’t meet 60% of their needs by mouth are prime candidates for TPN, she said, referencing a 2019 study that reported that preoperative TPN in malnourished IBD patients resulted in a rate of overall noninfectious complications half that of no-TPN patients: 8.3% versus 16.8% (Gastroenterol Rep. 2019 Apr;7:107-14).

Carbohydrate loading before surgery is a big part of ERAS in these patients. “Surgery has a huge impact on the catabolic state of a patient,” Ms. Issokson said. “It’s similar to running a marathon; you wouldn’t go out and run a marathon without fueling up the night before with a whole bunch of carbohydrates. So we use this same strategy in our surgical patients.”

ERAS society guidelines call for 100 g of carbohydrates the night before and 50 g 2 hours before surgery in the form of a clear liquid beverage, along with permitting a light meal up to 6 hours before, with exceptions in gastroparesis, motility disorders, and emergency surgery.

Another key component of ERAS in IBD is early postoperative feeding. “Postoperatively we want to feed our patients as soon as possible,” Ms. Issokson said. ESPEN guidelines call for feeding patients with new nondiverted colorectal anastomosis within 4 hours. “Studies show that patients aren’t able to eat enough calories to help them recover postoperatively, so implementing an oral nutrition supplement might be helpful there,” she added.

Ms. Issokson is a Crohn’s & Colitis Foundation board member, and disclosed financial relationships with Orgain, RMEI, and Medscape.

SOURCE: Issokson K et al. Crohn’s & Colitis Congress 2020, Session Sp83.
 

AUSTIN, TEX. – Enhanced recovery after surgery (ERAS) protocols have been around for decades, but typically excluded patients having surgery for inflammatory bowel disease (IBD). However, recent studies have shown strategies to optimize these patients, including presurgery carbohydrate loading and early postsurgery feeding, can improve outcomes, according to a review of evidence presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“It’s really important that we implement strategies to help mitigate the impact that malnutrition is going to have on our perioperative patients, and one of the ways we do that is by using an ERAS or enhanced recovery after surgery protocol,” said Kelly Issokson, MS, RD, of Cedars-Sinai Medical Center, Los Angeles. She noted that patients with IBD are five times more likely to be malnourished than non-IBD patients, and those with fistulizing Crohn’s disease and bowel resections are at greatest risk (Inflamm Bowel Dis. 2008;14:1139-46).

“I constantly see patients who are kept NPO [nothing by mouth] 12 or 24 hours before surgery, maybe even longer sometimes, unfortunately,” she said. “We should really be minimizing that NPO to help mitigate the catabolic effect that surgery has on our patients and help them recover more quickly.”

To screen surgery patients for nutrition risk, Ms. Issokson said that gastroenterologists can ask two questions from the malnutrition screening tool: Did the patient have recent unintentional weight loss, and is the patient eating less because of poor appetite? A yes to either question merits referral to a registered dietician. Malnutrition, weight loss of 5%-10% of total body weight, and sarcopenia are predictors of surgical complications for IBD patients, the latter an independent predictor in patients aged 40 years and older.

The ERAS protocol involves optimizing preoperative and postoperative nutrition, she said. It has been linked with improved outcomes in elective colorectal surgery (World J Surg. 2014;38:1531-41), although the evidence in IBD isn’t as robust. She cited a retrospective study reported at the 2019 annual Digestive Disease Week of patients with Crohn’s disease that found no difference in readmissions, complications, or reoperations between ERAS and standard-care patients.

Preoperative nutrition optimization in ERAS involves anemia and fluid management, oral nutrition supplementation, and – based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2017 guidelines – delaying the operation where possible if the patient is malnourished. “Patients who receive preoperative nutrition support have been shown to have better outcomes postoperatively,” Ms. Issokson said, citing a meta-analysis of 1,111 Crohn’s disease patients that reported the complication rate was 20% in patients on nutrition support versus 60% for those on standard care; in those on enteral nutrition, the disparity was more pronounced: 21% versus 73% (Eur J Gastro Hep. 2018;30:997-1002).

Gastroenterologists should not be afraid of implementing total parenteral nutrition (TPN) perioperatively in these patients, Ms. Issokson said. “This can really help to improve outcomes and quality of life in our patients, and it’s something that we really should not shy away from,” she added in an interview. “If our patients are malnourished and meet the criteria for TPN, then we should really not be withholding it.” Patients with severe IBD who are not absorbing from their gut and can’t meet 60% of their needs by mouth are prime candidates for TPN, she said, referencing a 2019 study that reported that preoperative TPN in malnourished IBD patients resulted in a rate of overall noninfectious complications half that of no-TPN patients: 8.3% versus 16.8% (Gastroenterol Rep. 2019 Apr;7:107-14).

Carbohydrate loading before surgery is a big part of ERAS in these patients. “Surgery has a huge impact on the catabolic state of a patient,” Ms. Issokson said. “It’s similar to running a marathon; you wouldn’t go out and run a marathon without fueling up the night before with a whole bunch of carbohydrates. So we use this same strategy in our surgical patients.”

ERAS society guidelines call for 100 g of carbohydrates the night before and 50 g 2 hours before surgery in the form of a clear liquid beverage, along with permitting a light meal up to 6 hours before, with exceptions in gastroparesis, motility disorders, and emergency surgery.

Another key component of ERAS in IBD is early postoperative feeding. “Postoperatively we want to feed our patients as soon as possible,” Ms. Issokson said. ESPEN guidelines call for feeding patients with new nondiverted colorectal anastomosis within 4 hours. “Studies show that patients aren’t able to eat enough calories to help them recover postoperatively, so implementing an oral nutrition supplement might be helpful there,” she added.

Ms. Issokson is a Crohn’s & Colitis Foundation board member, and disclosed financial relationships with Orgain, RMEI, and Medscape.

SOURCE: Issokson K et al. Crohn’s & Colitis Congress 2020, Session Sp83.
 

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.