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A newly devised, validated prognostic tool – the Burkitt Lymphoma International Prognostic Index – can consistently identify low-risk patients who might benefit from treatment de-escalation, and high-risk patients who are unlikely to be cured with current therapies and may require novel approaches, investigators said.

In a cohort of patients treated at international sites, patients with a low-risk score on the BL-IPI had a 3-year progression-free survival (PFS) rate of 96%, and 3-year overall survival rate (OS) of 99%. In contrast, the 3-year PFS rate for patients in the high-risk category was 63%, and the 3-year OS rate was 64%, reported Adam J Olszewski, MD, from the Lifespan Cancer Institute at Rhode Island Hospital and The Miriam Hospital, both in Providence.

“The Burkitt Lymphoma International Prognostic Index – or the ‘BLI-PI’ [‘blippy’] as it was inevitably called – is a novel prognostic index that is specific to Burkitt lymphoma. It has been validated with sufficient calibration and discrimination in external data sets to allow for simple stratification and comparison of risk distribution in geographically diverse cohorts,” he said in an oral abstract presented virtually during the annual meeting of the American Society of Hematology.
 

Inconsistent criteria

There is a need for a Burkitt-specific index, he said, because of significant differences in age, stage at presentation, and abnormal lactate dehydrogenase (LDH) levels between patients with Burkitt and those with diffuse large B-cell lymphoma (DLBCL), and because historical definitions of “low-risk” Burkitt lymphoma have been inconsistent, with less than 10% of patients falling into this group, leaving the remainder in a undifferentiated “high-risk” category.

“Burkitt lymphoma is considered highly curable, but current therapy requires administration of dose-intense chemoimmunotherapy for which there are many chemotherapy backbone regimens developed across the world, and used mostly locally. These are often studied in phase 2 studies with limited sample sizes, which makes it difficult to compare populations across trials,” Dr. Olszewski said.

A validated prognostic index can help clinicians and researchers compare cohorts and can be used to help design future trials, he added.

To devise the BL-IPI, the investigators first selected a retrospective cohort of 570 adults with Burkitt lymphoma treated at 30 U.S. centers for whom data on outcomes were available.

They determined the best prognostic cutoffs for age, LDH, hemoglobin and albumin levels, and identified independent risk factors using stepwise selection in Cox regression and lasso regression analysis, a machine learning approach. The variables included age; sex; HIV-positivity status; loss of MYC rearrangement; performance status; stage; nodal involvement; marrow involvement; central nervous system involvement; and LDH, hemoglobin, and albumin levels.

For validation, they pooled data from European, Canadian, Australian, and U.K. studies to identify 457 patients for whom retrospective treatment and outcomes data were available.

The derivation and validation cohorts were similar in most respects, expect for a higher proportion of patients with Eastern Cooperative Oncology Group performance status scores of 2 or higher in the validation cohort (22% vs. 35%), and a higher proportion of patients with CNS involvement in the U.S.-based derivation cohort (19% vs. 10%, respectively).

Therapy also differed markedly between the U.S. and international cohorts, with about 30% each of U.S. patients receiving either the CODOX-M/IVAC (cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate/ifosfamide, etoposide, and high-dose cytarabine) regimen, DA-EPOCH-R (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) regimen, or hCVAD/MA (fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine) regimen, and the remaining 10% receiving other, unspecified therapy.

In contrast, 65% of the patients in the international (validation) cohort received CODOX-M/IVAC, 10% and 9%, respectively, received DA-EPOCH-R and hCVAD/MA, and 16% receiving other regimens.

Rituximab was administered to 91% of U.S. and 95% of international patients.
 

Higher survival rates outside US

Both PFS and OS were higher in the international versus U.S. cohort. At a median follow-up of 45 months, the PFS rate in the United States was 65%, and the OS rate was 70%.

In the international cohort, after a median follow-up of 52 months, the PFS rate was 75%, and the OS rate was 76%, the investigators found.

Reasons for the differences may be because of differences in treatment regimens, socioeconomic and racial disparities in the United States versus other countries, or to decentralized Burkitt lymphoma therapy in the United States, Dr. Olszewski said.

In univariate analysis, factors significantly predictive of worse PFS included age 40 years or older, ECOG performance status 2 or greater, stage 3 or 4 disease, marrow involvement, CNS involvement, LDH more than three times the upper limit of normal, and hemoglobin <11.5 g/dL (P < .001 for all preceding), as well as albumin <3.5 g/dL (P = .001).

“However, the multivariable analysis was more complicated, because many of these factors were overlapping, and most patients with high LDH also had advanced disease, and this group also encompassed patients who had bone marrow and CNS involvement,” he said.

Using the two types of regression analysis mentioned before, investigators identified ECOG performance status 2 or greater (P = .001), age 40 and older (P = .005), LDH greater than three times the upper limit of normal (P < .001) and CNS involvement (P = .002) as significant predictors for worse outcomes in multivariable analysis, and were included in the final model.

“We initially had five groups according to the number of these factors, but we observed that the survival curves for patients with two, three, or four factors were overlapping, and not significantly different, so ultimately we had three risk groups. In the derivation (U.S.) cohort, patients in the low-risk group, with no risk factors, a 3-year PFS of 92%, compared with 72% for patients with one risk factor (intermediate risk), and 53% for patients with two to four risk factors (high risk).

Respective hazard ratios for worse PFS in the low-, intermediate-, and high-risk groups were 1 (reference), 4.15 (95% confidence interval, 1.99-8.68), and 8.83 (95% CI, 4.32-18.03).

Respective HR for worse OS was 1, 7.06 (95% CI, 2.55-19.53), and 15.12 (95% CI, 5.58-40.99).

There were no significant differences in either PFS or OS when either LDH or stage was added into the model.

The BL-IPI was prognostic for PFS and OS in all subgroups, including HIV-positive or -negative patients, those with MYC rearrangements, stage 1 or 2 versus stage 3 or 4, or those treated with rituximab versus those who were not.

As noted before, 3-year PFS rates in the validation cohort for low, intermediate, high-risk groups were 96%, 82%, and 63% respectively, and 3-year OS rates were 99%, 85%, and 64%.
 

Why the CNS discrepancy?

In the question and answer session following the presentation, comoderator Christopher J. Melani, MD, from the Lymphoid Malignancies Branch at the National Cancer Institute in Bethesda, Md., said that “it was interesting to see the difference between CNS involvement in both the U.S. and the international cohort,” and asked whether Dr. Olszweski could elaborate on whether baseline CNS involvement was assessed by contrast-enhanced MRI of flow cytometry studies of cerebrospinal fluid.

“Could some of these differences between the U.S. and the international cohort be from the baseline assessment differing between the two?” he asked.

Dr. Olszewski replied that the retrospective nature of the data precluded capturing those data, but added that “I do suspect there may be some differences in the way that central nervous system is staged in different countries. In the United States the use of flow cytometry is more commonly employed, but we don’t know how it is used internationally. We do not know how often this is staged radiographically.”

Asked by others who viewed the presentation whether extranodal disease or peripheral blood involvement were prognostic in the final model, Dr. Olszewski replied that “one has to understand that, when one constructs a prognostic index, there is a balance between trying to input as much information as possible and to create something that is useful, clinically meaningful, and accurate.”

He said that, despite trying different models with different factors, “we couldn’t get the discrimination to be much better than the basic model that we ultimately created, so we favored using a more parsimonious model.”

No study funding source was reported. Dr. Olszewski reported research funding from Spectrum Pharmaceuticals, Genentech, TG Therapeutics, and Adaptive Biotechnologies. Dr. Melani reported having no relevant conflicts of interest.

SOURCE: Olszewski AJ et al. ASH 2020, Abstract 705.

A newly devised, validated prognostic tool – the Burkitt Lymphoma International Prognostic Index – can consistently identify low-risk patients who might benefit from treatment de-escalation, and high-risk patients who are unlikely to be cured with current therapies and may require novel approaches, investigators said.

In a cohort of patients treated at international sites, patients with a low-risk score on the BL-IPI had a 3-year progression-free survival (PFS) rate of 96%, and 3-year overall survival rate (OS) of 99%. In contrast, the 3-year PFS rate for patients in the high-risk category was 63%, and the 3-year OS rate was 64%, reported Adam J Olszewski, MD, from the Lifespan Cancer Institute at Rhode Island Hospital and The Miriam Hospital, both in Providence.

“The Burkitt Lymphoma International Prognostic Index – or the ‘BLI-PI’ [‘blippy’] as it was inevitably called – is a novel prognostic index that is specific to Burkitt lymphoma. It has been validated with sufficient calibration and discrimination in external data sets to allow for simple stratification and comparison of risk distribution in geographically diverse cohorts,” he said in an oral abstract presented virtually during the annual meeting of the American Society of Hematology.
 

Inconsistent criteria

There is a need for a Burkitt-specific index, he said, because of significant differences in age, stage at presentation, and abnormal lactate dehydrogenase (LDH) levels between patients with Burkitt and those with diffuse large B-cell lymphoma (DLBCL), and because historical definitions of “low-risk” Burkitt lymphoma have been inconsistent, with less than 10% of patients falling into this group, leaving the remainder in a undifferentiated “high-risk” category.

“Burkitt lymphoma is considered highly curable, but current therapy requires administration of dose-intense chemoimmunotherapy for which there are many chemotherapy backbone regimens developed across the world, and used mostly locally. These are often studied in phase 2 studies with limited sample sizes, which makes it difficult to compare populations across trials,” Dr. Olszewski said.

A validated prognostic index can help clinicians and researchers compare cohorts and can be used to help design future trials, he added.

To devise the BL-IPI, the investigators first selected a retrospective cohort of 570 adults with Burkitt lymphoma treated at 30 U.S. centers for whom data on outcomes were available.

They determined the best prognostic cutoffs for age, LDH, hemoglobin and albumin levels, and identified independent risk factors using stepwise selection in Cox regression and lasso regression analysis, a machine learning approach. The variables included age; sex; HIV-positivity status; loss of MYC rearrangement; performance status; stage; nodal involvement; marrow involvement; central nervous system involvement; and LDH, hemoglobin, and albumin levels.

For validation, they pooled data from European, Canadian, Australian, and U.K. studies to identify 457 patients for whom retrospective treatment and outcomes data were available.

The derivation and validation cohorts were similar in most respects, expect for a higher proportion of patients with Eastern Cooperative Oncology Group performance status scores of 2 or higher in the validation cohort (22% vs. 35%), and a higher proportion of patients with CNS involvement in the U.S.-based derivation cohort (19% vs. 10%, respectively).

Therapy also differed markedly between the U.S. and international cohorts, with about 30% each of U.S. patients receiving either the CODOX-M/IVAC (cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate/ifosfamide, etoposide, and high-dose cytarabine) regimen, DA-EPOCH-R (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) regimen, or hCVAD/MA (fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine) regimen, and the remaining 10% receiving other, unspecified therapy.

In contrast, 65% of the patients in the international (validation) cohort received CODOX-M/IVAC, 10% and 9%, respectively, received DA-EPOCH-R and hCVAD/MA, and 16% receiving other regimens.

Rituximab was administered to 91% of U.S. and 95% of international patients.
 

Higher survival rates outside US

Both PFS and OS were higher in the international versus U.S. cohort. At a median follow-up of 45 months, the PFS rate in the United States was 65%, and the OS rate was 70%.

In the international cohort, after a median follow-up of 52 months, the PFS rate was 75%, and the OS rate was 76%, the investigators found.

Reasons for the differences may be because of differences in treatment regimens, socioeconomic and racial disparities in the United States versus other countries, or to decentralized Burkitt lymphoma therapy in the United States, Dr. Olszewski said.

In univariate analysis, factors significantly predictive of worse PFS included age 40 years or older, ECOG performance status 2 or greater, stage 3 or 4 disease, marrow involvement, CNS involvement, LDH more than three times the upper limit of normal, and hemoglobin <11.5 g/dL (P < .001 for all preceding), as well as albumin <3.5 g/dL (P = .001).

“However, the multivariable analysis was more complicated, because many of these factors were overlapping, and most patients with high LDH also had advanced disease, and this group also encompassed patients who had bone marrow and CNS involvement,” he said.

Using the two types of regression analysis mentioned before, investigators identified ECOG performance status 2 or greater (P = .001), age 40 and older (P = .005), LDH greater than three times the upper limit of normal (P < .001) and CNS involvement (P = .002) as significant predictors for worse outcomes in multivariable analysis, and were included in the final model.

“We initially had five groups according to the number of these factors, but we observed that the survival curves for patients with two, three, or four factors were overlapping, and not significantly different, so ultimately we had three risk groups. In the derivation (U.S.) cohort, patients in the low-risk group, with no risk factors, a 3-year PFS of 92%, compared with 72% for patients with one risk factor (intermediate risk), and 53% for patients with two to four risk factors (high risk).

Respective hazard ratios for worse PFS in the low-, intermediate-, and high-risk groups were 1 (reference), 4.15 (95% confidence interval, 1.99-8.68), and 8.83 (95% CI, 4.32-18.03).

Respective HR for worse OS was 1, 7.06 (95% CI, 2.55-19.53), and 15.12 (95% CI, 5.58-40.99).

There were no significant differences in either PFS or OS when either LDH or stage was added into the model.

The BL-IPI was prognostic for PFS and OS in all subgroups, including HIV-positive or -negative patients, those with MYC rearrangements, stage 1 or 2 versus stage 3 or 4, or those treated with rituximab versus those who were not.

As noted before, 3-year PFS rates in the validation cohort for low, intermediate, high-risk groups were 96%, 82%, and 63% respectively, and 3-year OS rates were 99%, 85%, and 64%.
 

Why the CNS discrepancy?

In the question and answer session following the presentation, comoderator Christopher J. Melani, MD, from the Lymphoid Malignancies Branch at the National Cancer Institute in Bethesda, Md., said that “it was interesting to see the difference between CNS involvement in both the U.S. and the international cohort,” and asked whether Dr. Olszweski could elaborate on whether baseline CNS involvement was assessed by contrast-enhanced MRI of flow cytometry studies of cerebrospinal fluid.

“Could some of these differences between the U.S. and the international cohort be from the baseline assessment differing between the two?” he asked.

Dr. Olszewski replied that the retrospective nature of the data precluded capturing those data, but added that “I do suspect there may be some differences in the way that central nervous system is staged in different countries. In the United States the use of flow cytometry is more commonly employed, but we don’t know how it is used internationally. We do not know how often this is staged radiographically.”

Asked by others who viewed the presentation whether extranodal disease or peripheral blood involvement were prognostic in the final model, Dr. Olszewski replied that “one has to understand that, when one constructs a prognostic index, there is a balance between trying to input as much information as possible and to create something that is useful, clinically meaningful, and accurate.”

He said that, despite trying different models with different factors, “we couldn’t get the discrimination to be much better than the basic model that we ultimately created, so we favored using a more parsimonious model.”

No study funding source was reported. Dr. Olszewski reported research funding from Spectrum Pharmaceuticals, Genentech, TG Therapeutics, and Adaptive Biotechnologies. Dr. Melani reported having no relevant conflicts of interest.

SOURCE: Olszewski AJ et al. ASH 2020, Abstract 705.

A newly devised, validated prognostic tool – the Burkitt Lymphoma International Prognostic Index – can consistently identify low-risk patients who might benefit from treatment de-escalation, and high-risk patients who are unlikely to be cured with current therapies and may require novel approaches, investigators said.

In a cohort of patients treated at international sites, patients with a low-risk score on the BL-IPI had a 3-year progression-free survival (PFS) rate of 96%, and 3-year overall survival rate (OS) of 99%. In contrast, the 3-year PFS rate for patients in the high-risk category was 63%, and the 3-year OS rate was 64%, reported Adam J Olszewski, MD, from the Lifespan Cancer Institute at Rhode Island Hospital and The Miriam Hospital, both in Providence.

“The Burkitt Lymphoma International Prognostic Index – or the ‘BLI-PI’ [‘blippy’] as it was inevitably called – is a novel prognostic index that is specific to Burkitt lymphoma. It has been validated with sufficient calibration and discrimination in external data sets to allow for simple stratification and comparison of risk distribution in geographically diverse cohorts,” he said in an oral abstract presented virtually during the annual meeting of the American Society of Hematology.
 

Inconsistent criteria

There is a need for a Burkitt-specific index, he said, because of significant differences in age, stage at presentation, and abnormal lactate dehydrogenase (LDH) levels between patients with Burkitt and those with diffuse large B-cell lymphoma (DLBCL), and because historical definitions of “low-risk” Burkitt lymphoma have been inconsistent, with less than 10% of patients falling into this group, leaving the remainder in a undifferentiated “high-risk” category.

“Burkitt lymphoma is considered highly curable, but current therapy requires administration of dose-intense chemoimmunotherapy for which there are many chemotherapy backbone regimens developed across the world, and used mostly locally. These are often studied in phase 2 studies with limited sample sizes, which makes it difficult to compare populations across trials,” Dr. Olszewski said.

A validated prognostic index can help clinicians and researchers compare cohorts and can be used to help design future trials, he added.

To devise the BL-IPI, the investigators first selected a retrospective cohort of 570 adults with Burkitt lymphoma treated at 30 U.S. centers for whom data on outcomes were available.

They determined the best prognostic cutoffs for age, LDH, hemoglobin and albumin levels, and identified independent risk factors using stepwise selection in Cox regression and lasso regression analysis, a machine learning approach. The variables included age; sex; HIV-positivity status; loss of MYC rearrangement; performance status; stage; nodal involvement; marrow involvement; central nervous system involvement; and LDH, hemoglobin, and albumin levels.

For validation, they pooled data from European, Canadian, Australian, and U.K. studies to identify 457 patients for whom retrospective treatment and outcomes data were available.

The derivation and validation cohorts were similar in most respects, expect for a higher proportion of patients with Eastern Cooperative Oncology Group performance status scores of 2 or higher in the validation cohort (22% vs. 35%), and a higher proportion of patients with CNS involvement in the U.S.-based derivation cohort (19% vs. 10%, respectively).

Therapy also differed markedly between the U.S. and international cohorts, with about 30% each of U.S. patients receiving either the CODOX-M/IVAC (cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate/ifosfamide, etoposide, and high-dose cytarabine) regimen, DA-EPOCH-R (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) regimen, or hCVAD/MA (fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine) regimen, and the remaining 10% receiving other, unspecified therapy.

In contrast, 65% of the patients in the international (validation) cohort received CODOX-M/IVAC, 10% and 9%, respectively, received DA-EPOCH-R and hCVAD/MA, and 16% receiving other regimens.

Rituximab was administered to 91% of U.S. and 95% of international patients.
 

Higher survival rates outside US

Both PFS and OS were higher in the international versus U.S. cohort. At a median follow-up of 45 months, the PFS rate in the United States was 65%, and the OS rate was 70%.

In the international cohort, after a median follow-up of 52 months, the PFS rate was 75%, and the OS rate was 76%, the investigators found.

Reasons for the differences may be because of differences in treatment regimens, socioeconomic and racial disparities in the United States versus other countries, or to decentralized Burkitt lymphoma therapy in the United States, Dr. Olszewski said.

In univariate analysis, factors significantly predictive of worse PFS included age 40 years or older, ECOG performance status 2 or greater, stage 3 or 4 disease, marrow involvement, CNS involvement, LDH more than three times the upper limit of normal, and hemoglobin <11.5 g/dL (P < .001 for all preceding), as well as albumin <3.5 g/dL (P = .001).

“However, the multivariable analysis was more complicated, because many of these factors were overlapping, and most patients with high LDH also had advanced disease, and this group also encompassed patients who had bone marrow and CNS involvement,” he said.

Using the two types of regression analysis mentioned before, investigators identified ECOG performance status 2 or greater (P = .001), age 40 and older (P = .005), LDH greater than three times the upper limit of normal (P < .001) and CNS involvement (P = .002) as significant predictors for worse outcomes in multivariable analysis, and were included in the final model.

“We initially had five groups according to the number of these factors, but we observed that the survival curves for patients with two, three, or four factors were overlapping, and not significantly different, so ultimately we had three risk groups. In the derivation (U.S.) cohort, patients in the low-risk group, with no risk factors, a 3-year PFS of 92%, compared with 72% for patients with one risk factor (intermediate risk), and 53% for patients with two to four risk factors (high risk).

Respective hazard ratios for worse PFS in the low-, intermediate-, and high-risk groups were 1 (reference), 4.15 (95% confidence interval, 1.99-8.68), and 8.83 (95% CI, 4.32-18.03).

Respective HR for worse OS was 1, 7.06 (95% CI, 2.55-19.53), and 15.12 (95% CI, 5.58-40.99).

There were no significant differences in either PFS or OS when either LDH or stage was added into the model.

The BL-IPI was prognostic for PFS and OS in all subgroups, including HIV-positive or -negative patients, those with MYC rearrangements, stage 1 or 2 versus stage 3 or 4, or those treated with rituximab versus those who were not.

As noted before, 3-year PFS rates in the validation cohort for low, intermediate, high-risk groups were 96%, 82%, and 63% respectively, and 3-year OS rates were 99%, 85%, and 64%.
 

Why the CNS discrepancy?

In the question and answer session following the presentation, comoderator Christopher J. Melani, MD, from the Lymphoid Malignancies Branch at the National Cancer Institute in Bethesda, Md., said that “it was interesting to see the difference between CNS involvement in both the U.S. and the international cohort,” and asked whether Dr. Olszweski could elaborate on whether baseline CNS involvement was assessed by contrast-enhanced MRI of flow cytometry studies of cerebrospinal fluid.

“Could some of these differences between the U.S. and the international cohort be from the baseline assessment differing between the two?” he asked.

Dr. Olszewski replied that the retrospective nature of the data precluded capturing those data, but added that “I do suspect there may be some differences in the way that central nervous system is staged in different countries. In the United States the use of flow cytometry is more commonly employed, but we don’t know how it is used internationally. We do not know how often this is staged radiographically.”

Asked by others who viewed the presentation whether extranodal disease or peripheral blood involvement were prognostic in the final model, Dr. Olszewski replied that “one has to understand that, when one constructs a prognostic index, there is a balance between trying to input as much information as possible and to create something that is useful, clinically meaningful, and accurate.”

He said that, despite trying different models with different factors, “we couldn’t get the discrimination to be much better than the basic model that we ultimately created, so we favored using a more parsimonious model.”

No study funding source was reported. Dr. Olszewski reported research funding from Spectrum Pharmaceuticals, Genentech, TG Therapeutics, and Adaptive Biotechnologies. Dr. Melani reported having no relevant conflicts of interest.

SOURCE: Olszewski AJ et al. ASH 2020, Abstract 705.

In heavily pretreated pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL), venetoclax plus navitoclax with chemotherapy was well tolerated with promising responses, according to results of a phase 1 trial. Delayed count recovery, however, stated lead author Jeffrey E. Rubnitz, MD, PhD, St. Jude’s Children’s Research Hospital, Memphis, remained a key safety concern.
 

Unmet medical need

Despite intensive chemotherapy and novel therapeutics, Dr. Rubnitz said in a virtual oral presentation at the annual meeting of the American Society of Hematology, patients with relapsed or refractory ALL and LL have a poor prognosis and represent an unmet medical need. Venetoclax, a potent, highly selective oral B-cell lymphoma 2 inhibitor, and navitoclax, an oral BCL-2, BCL-XL, and BCL-W inhibitor, directly bind their BCL-2 family member targets to promote apoptosis. In ALL preclinical models, venetoclax and navitoclax have demonstrated antileukemic effects, which suggests dependence on BCL-2 family members. Venetoclax efficacy associated with BCL-2 family inhibition may be potentiated and dose-limiting thrombocytopenia associated with standard-dose navitoclax monotherapy may be avoided by adding venetoclax to low-dose navitoclax. Previous reports of an ongoing phase 1, multicenter, open-label, dose-escalation study in an adult and pediatric population (NCT03181126), Dr. Rubnitz noted, showed the venetoclax/navitoclax/chemotherapy combination to be well tolerated with promising response rates. In the current report, Dr. Rubnitz presented data on the safety, tolerability, pharmacokinetics, and antitumor activity of the triplet regimen in the subgroup of pediatric patients.

The study included pediatric patients (ages, 4-18 years and weight ≥20 kg) receiving venetoclax (weight-adjusted equivalent of 400 mg daily) and navitoclax at three dose levels (25, 50, 100 mg) for patients weighing ≥45 kg and two dose levels (25, 50 mg) for patients weighing <45 kg. At investigator’s discretion, patients could receive chemotherapy (polyethylene glycosylated–asparaginase, vincristine, and dexamethasone). The primary outcomes were safety (including incidence of dose-limiting toxicities and adverse events) and pharmacokinetics. A safety expansion cohort assessed a 21-day dosing schedule of venetoclax at 400 mg followed by 7 days off plus navitoclax at 50 mg (patients ≥45 kg) or 25 mg (patients <45 kg).

Investigators enrolled 18 patients <18 years (median age, 10 years; range, 6-16; 56% male), with 12 in the dose-escalation cohort and 6 in the safety-expansion cohort. Three patients had prior chimeric antigen receptor (CAR) T treatment and four had received prior stem cell transplantation. In the overall cohort, B-cell ALL was most common (n = 13, 72%), with T-cell ALL (n = 3, 17%) and LL (n = 2, 11%) following. The median number of prior therapies was 2 (range 1-6). All patients received chemotherapy.
 

Grade 3-4 adverse events

Venetoclax-related grade 3-4 adverse events occurred in 56% of patients. Similarly, navitoclax-related grade 3-4 events were reported in 56% of patients. Navitoclax dose-limiting toxicities occurred in two patients (11%), delayed count recovery on 25 mg and sepsis on 50 mg. No grade 5 adverse events and tumor lysis syndrome were reported.

Among secondary endpoint efficacy parameters, complete responses, CRs with incomplete marrow recovery (CRi) and CRs without platelet recovery (CRp) combined occurred in 62% of B-ALL patients (8/13), 33% of T-cell ALL patients (1/3) and in 50% of LL patients (1/2). Separately, CRs/CRis/CRps occurred in 33%/22%/0% of all patients, respectively.

Subsequently, 5 of 18 (28%) of patients proceeded to stem cell transplantation and 3 (17%) to CAR T. Eight patients (44%) died from disease progression.
 

BH3 profiling

BH3 profiling revealed that at baseline, patients with B-cell ALL had more diversity in BCL-2 and BCL-XL dependency than did patients with T-cell ALL or early T-cell precursor ALL. The fact that responses were observed in patients who were BCL-2 or BCL-XL dependent, Dr. Rubnitz said, supports the use of venetoclax plus navitoclax in these patients. Analysis of these results led to a recommended phase 2 dose for pediatric patients of 400 mg venetoclax with 25 mg navitoclax (for patients weighing <45 kg) or 50 mg navitoclax (for patients weighing 45 kg or more).

Dr. Rubnitz concluded: “Venetoclax plus navitoclax plus chemotherapy was well tolerated in pediatric patients with relapsed/refractory ALL or LL, with promising response rates observed in a heavily pretreated pediatric population.”

Asked whether the combination might be used also before the refractory setting, in a minimal residual disease (MRD) setting, Dr. Rubnitz replied: “We have a lot of safety data on venetoclax but very little on navitoclax. The next trial, being developed by Seth Karol, MD, will include relapsed patients. MRD-positive patients will also be eligible for enrollment.” To a further question as to whether guiding titration via BH3 profiling would lead to improved outcomes, Dr. Rubnitz said, “I think BH3 profiling can be used to identify which patients will respond to these drugs, but we are still a long way from using it for titrating the doses and dose ratios for the two drugs.”

Dr. Rubnitz disclosed research funding from AbbVie.

SOURCE: Rubnitz JE et al. ASH 2020, Abstract 466.

In heavily pretreated pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL), venetoclax plus navitoclax with chemotherapy was well tolerated with promising responses, according to results of a phase 1 trial. Delayed count recovery, however, stated lead author Jeffrey E. Rubnitz, MD, PhD, St. Jude’s Children’s Research Hospital, Memphis, remained a key safety concern.
 

Unmet medical need

Despite intensive chemotherapy and novel therapeutics, Dr. Rubnitz said in a virtual oral presentation at the annual meeting of the American Society of Hematology, patients with relapsed or refractory ALL and LL have a poor prognosis and represent an unmet medical need. Venetoclax, a potent, highly selective oral B-cell lymphoma 2 inhibitor, and navitoclax, an oral BCL-2, BCL-XL, and BCL-W inhibitor, directly bind their BCL-2 family member targets to promote apoptosis. In ALL preclinical models, venetoclax and navitoclax have demonstrated antileukemic effects, which suggests dependence on BCL-2 family members. Venetoclax efficacy associated with BCL-2 family inhibition may be potentiated and dose-limiting thrombocytopenia associated with standard-dose navitoclax monotherapy may be avoided by adding venetoclax to low-dose navitoclax. Previous reports of an ongoing phase 1, multicenter, open-label, dose-escalation study in an adult and pediatric population (NCT03181126), Dr. Rubnitz noted, showed the venetoclax/navitoclax/chemotherapy combination to be well tolerated with promising response rates. In the current report, Dr. Rubnitz presented data on the safety, tolerability, pharmacokinetics, and antitumor activity of the triplet regimen in the subgroup of pediatric patients.

The study included pediatric patients (ages, 4-18 years and weight ≥20 kg) receiving venetoclax (weight-adjusted equivalent of 400 mg daily) and navitoclax at three dose levels (25, 50, 100 mg) for patients weighing ≥45 kg and two dose levels (25, 50 mg) for patients weighing <45 kg. At investigator’s discretion, patients could receive chemotherapy (polyethylene glycosylated–asparaginase, vincristine, and dexamethasone). The primary outcomes were safety (including incidence of dose-limiting toxicities and adverse events) and pharmacokinetics. A safety expansion cohort assessed a 21-day dosing schedule of venetoclax at 400 mg followed by 7 days off plus navitoclax at 50 mg (patients ≥45 kg) or 25 mg (patients <45 kg).

Investigators enrolled 18 patients <18 years (median age, 10 years; range, 6-16; 56% male), with 12 in the dose-escalation cohort and 6 in the safety-expansion cohort. Three patients had prior chimeric antigen receptor (CAR) T treatment and four had received prior stem cell transplantation. In the overall cohort, B-cell ALL was most common (n = 13, 72%), with T-cell ALL (n = 3, 17%) and LL (n = 2, 11%) following. The median number of prior therapies was 2 (range 1-6). All patients received chemotherapy.
 

Grade 3-4 adverse events

Venetoclax-related grade 3-4 adverse events occurred in 56% of patients. Similarly, navitoclax-related grade 3-4 events were reported in 56% of patients. Navitoclax dose-limiting toxicities occurred in two patients (11%), delayed count recovery on 25 mg and sepsis on 50 mg. No grade 5 adverse events and tumor lysis syndrome were reported.

Among secondary endpoint efficacy parameters, complete responses, CRs with incomplete marrow recovery (CRi) and CRs without platelet recovery (CRp) combined occurred in 62% of B-ALL patients (8/13), 33% of T-cell ALL patients (1/3) and in 50% of LL patients (1/2). Separately, CRs/CRis/CRps occurred in 33%/22%/0% of all patients, respectively.

Subsequently, 5 of 18 (28%) of patients proceeded to stem cell transplantation and 3 (17%) to CAR T. Eight patients (44%) died from disease progression.
 

BH3 profiling

BH3 profiling revealed that at baseline, patients with B-cell ALL had more diversity in BCL-2 and BCL-XL dependency than did patients with T-cell ALL or early T-cell precursor ALL. The fact that responses were observed in patients who were BCL-2 or BCL-XL dependent, Dr. Rubnitz said, supports the use of venetoclax plus navitoclax in these patients. Analysis of these results led to a recommended phase 2 dose for pediatric patients of 400 mg venetoclax with 25 mg navitoclax (for patients weighing <45 kg) or 50 mg navitoclax (for patients weighing 45 kg or more).

Dr. Rubnitz concluded: “Venetoclax plus navitoclax plus chemotherapy was well tolerated in pediatric patients with relapsed/refractory ALL or LL, with promising response rates observed in a heavily pretreated pediatric population.”

Asked whether the combination might be used also before the refractory setting, in a minimal residual disease (MRD) setting, Dr. Rubnitz replied: “We have a lot of safety data on venetoclax but very little on navitoclax. The next trial, being developed by Seth Karol, MD, will include relapsed patients. MRD-positive patients will also be eligible for enrollment.” To a further question as to whether guiding titration via BH3 profiling would lead to improved outcomes, Dr. Rubnitz said, “I think BH3 profiling can be used to identify which patients will respond to these drugs, but we are still a long way from using it for titrating the doses and dose ratios for the two drugs.”

Dr. Rubnitz disclosed research funding from AbbVie.

SOURCE: Rubnitz JE et al. ASH 2020, Abstract 466.

In heavily pretreated pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL), venetoclax plus navitoclax with chemotherapy was well tolerated with promising responses, according to results of a phase 1 trial. Delayed count recovery, however, stated lead author Jeffrey E. Rubnitz, MD, PhD, St. Jude’s Children’s Research Hospital, Memphis, remained a key safety concern.
 

Unmet medical need

Despite intensive chemotherapy and novel therapeutics, Dr. Rubnitz said in a virtual oral presentation at the annual meeting of the American Society of Hematology, patients with relapsed or refractory ALL and LL have a poor prognosis and represent an unmet medical need. Venetoclax, a potent, highly selective oral B-cell lymphoma 2 inhibitor, and navitoclax, an oral BCL-2, BCL-XL, and BCL-W inhibitor, directly bind their BCL-2 family member targets to promote apoptosis. In ALL preclinical models, venetoclax and navitoclax have demonstrated antileukemic effects, which suggests dependence on BCL-2 family members. Venetoclax efficacy associated with BCL-2 family inhibition may be potentiated and dose-limiting thrombocytopenia associated with standard-dose navitoclax monotherapy may be avoided by adding venetoclax to low-dose navitoclax. Previous reports of an ongoing phase 1, multicenter, open-label, dose-escalation study in an adult and pediatric population (NCT03181126), Dr. Rubnitz noted, showed the venetoclax/navitoclax/chemotherapy combination to be well tolerated with promising response rates. In the current report, Dr. Rubnitz presented data on the safety, tolerability, pharmacokinetics, and antitumor activity of the triplet regimen in the subgroup of pediatric patients.

The study included pediatric patients (ages, 4-18 years and weight ≥20 kg) receiving venetoclax (weight-adjusted equivalent of 400 mg daily) and navitoclax at three dose levels (25, 50, 100 mg) for patients weighing ≥45 kg and two dose levels (25, 50 mg) for patients weighing <45 kg. At investigator’s discretion, patients could receive chemotherapy (polyethylene glycosylated–asparaginase, vincristine, and dexamethasone). The primary outcomes were safety (including incidence of dose-limiting toxicities and adverse events) and pharmacokinetics. A safety expansion cohort assessed a 21-day dosing schedule of venetoclax at 400 mg followed by 7 days off plus navitoclax at 50 mg (patients ≥45 kg) or 25 mg (patients <45 kg).

Investigators enrolled 18 patients <18 years (median age, 10 years; range, 6-16; 56% male), with 12 in the dose-escalation cohort and 6 in the safety-expansion cohort. Three patients had prior chimeric antigen receptor (CAR) T treatment and four had received prior stem cell transplantation. In the overall cohort, B-cell ALL was most common (n = 13, 72%), with T-cell ALL (n = 3, 17%) and LL (n = 2, 11%) following. The median number of prior therapies was 2 (range 1-6). All patients received chemotherapy.
 

Grade 3-4 adverse events

Venetoclax-related grade 3-4 adverse events occurred in 56% of patients. Similarly, navitoclax-related grade 3-4 events were reported in 56% of patients. Navitoclax dose-limiting toxicities occurred in two patients (11%), delayed count recovery on 25 mg and sepsis on 50 mg. No grade 5 adverse events and tumor lysis syndrome were reported.

Among secondary endpoint efficacy parameters, complete responses, CRs with incomplete marrow recovery (CRi) and CRs without platelet recovery (CRp) combined occurred in 62% of B-ALL patients (8/13), 33% of T-cell ALL patients (1/3) and in 50% of LL patients (1/2). Separately, CRs/CRis/CRps occurred in 33%/22%/0% of all patients, respectively.

Subsequently, 5 of 18 (28%) of patients proceeded to stem cell transplantation and 3 (17%) to CAR T. Eight patients (44%) died from disease progression.
 

BH3 profiling

BH3 profiling revealed that at baseline, patients with B-cell ALL had more diversity in BCL-2 and BCL-XL dependency than did patients with T-cell ALL or early T-cell precursor ALL. The fact that responses were observed in patients who were BCL-2 or BCL-XL dependent, Dr. Rubnitz said, supports the use of venetoclax plus navitoclax in these patients. Analysis of these results led to a recommended phase 2 dose for pediatric patients of 400 mg venetoclax with 25 mg navitoclax (for patients weighing <45 kg) or 50 mg navitoclax (for patients weighing 45 kg or more).

Dr. Rubnitz concluded: “Venetoclax plus navitoclax plus chemotherapy was well tolerated in pediatric patients with relapsed/refractory ALL or LL, with promising response rates observed in a heavily pretreated pediatric population.”

Asked whether the combination might be used also before the refractory setting, in a minimal residual disease (MRD) setting, Dr. Rubnitz replied: “We have a lot of safety data on venetoclax but very little on navitoclax. The next trial, being developed by Seth Karol, MD, will include relapsed patients. MRD-positive patients will also be eligible for enrollment.” To a further question as to whether guiding titration via BH3 profiling would lead to improved outcomes, Dr. Rubnitz said, “I think BH3 profiling can be used to identify which patients will respond to these drugs, but we are still a long way from using it for titrating the doses and dose ratios for the two drugs.”

Dr. Rubnitz disclosed research funding from AbbVie.

SOURCE: Rubnitz JE et al. ASH 2020, Abstract 466.

Eczema herpeticum and staphylococcal scalded skin syndrome can be emergencies in children and require immediate care, warned dermatologist George Hightower, MD, PhD, in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Eczema herpeticum is a condition in which a herpes simplex virus (HSV-1 or HSV-2) is superimposed over preexisting eczema. “The infection may be primary and sustained from a close contact or result in some of our older patients from reactivation and spread through autoinoculation,” said Dr. Hightower, of Rady Children’s Hospital and the University of California, both in San Diego.

Signs, he said, include acute worsening of atopic dermatitis with new-onset vesicles, pustules, and “punched-out” hemorrhagic crusted erosions. “Presentation ranges from mild to transient to life threatening.”

Potential complications include meningitis, encephalitis, hepatitis, and chronic conjunctivitis. “That’s why immediate ophthalmological evaluation is needed when there’s involvement on the face near the eye,” he said.

As for management and care, “where I have concern for HSV patients, I get HSV [polymerase chain reaction] as well as a bacterial culture,” he said. But even before the results are available, empiric treatment with acyclovir can be appropriate. “It’s got to be systemic for these kids with severe involvement,” he said, and they should also be started on medication for staphylococci and streptococci.

During his presentation, Dr. Hightower also highlighted staphylococcal scalded skin syndrome. Patients with the disease commonly have concurrent skin pain (which can appear to be fussiness), fever, irritability, malaise, and poor feeding. Examination may reveal widespread erythema with accentuation at folds/peeling at hands and large sheets of superficial peeling scale with diffuse erythema.

Widespread skin involvement “results not from the presence of staph throughout the skin, but the exotoxin that it produces that becomes systemic,” he said. “Clinical diagnosis is supported by presence of S. aureus on bacterial culture, but the presence of staph is not necessary to make the diagnosis. When in doubt, histopathology is helpful. But again, it’s not necessary to make the diagnosis.”

Cases can be managed with a first- or second-generation cephalosporin, he said. Alternative therapies include antistaphylococcus penicillinase-resistant penicillins (oxacillin or nafcillin) or vancomycin.

While Dr. Hightower doesn’t use clindamycin in these patients, he said it’s an option that some dermatologists consider because of its antistaphylococcus activity. “Historically, people thought it may decrease exotoxin production. The big concern if you are going to use clindamycin is that there are high rates of community resistance,” he said. “So you want to be careful that you know your resistance patterns wherever you are. Follow up on culture to make sure that you have adequate coverage for the bug that the kiddo in front of you has.”

Dr. Hightower reported no relevant disclosures. MedscapeLive and this news organization are owned by the same parent company.

Eczema herpeticum and staphylococcal scalded skin syndrome can be emergencies in children and require immediate care, warned dermatologist George Hightower, MD, PhD, in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Eczema herpeticum is a condition in which a herpes simplex virus (HSV-1 or HSV-2) is superimposed over preexisting eczema. “The infection may be primary and sustained from a close contact or result in some of our older patients from reactivation and spread through autoinoculation,” said Dr. Hightower, of Rady Children’s Hospital and the University of California, both in San Diego.

Signs, he said, include acute worsening of atopic dermatitis with new-onset vesicles, pustules, and “punched-out” hemorrhagic crusted erosions. “Presentation ranges from mild to transient to life threatening.”

Potential complications include meningitis, encephalitis, hepatitis, and chronic conjunctivitis. “That’s why immediate ophthalmological evaluation is needed when there’s involvement on the face near the eye,” he said.

As for management and care, “where I have concern for HSV patients, I get HSV [polymerase chain reaction] as well as a bacterial culture,” he said. But even before the results are available, empiric treatment with acyclovir can be appropriate. “It’s got to be systemic for these kids with severe involvement,” he said, and they should also be started on medication for staphylococci and streptococci.

During his presentation, Dr. Hightower also highlighted staphylococcal scalded skin syndrome. Patients with the disease commonly have concurrent skin pain (which can appear to be fussiness), fever, irritability, malaise, and poor feeding. Examination may reveal widespread erythema with accentuation at folds/peeling at hands and large sheets of superficial peeling scale with diffuse erythema.

Widespread skin involvement “results not from the presence of staph throughout the skin, but the exotoxin that it produces that becomes systemic,” he said. “Clinical diagnosis is supported by presence of S. aureus on bacterial culture, but the presence of staph is not necessary to make the diagnosis. When in doubt, histopathology is helpful. But again, it’s not necessary to make the diagnosis.”

Cases can be managed with a first- or second-generation cephalosporin, he said. Alternative therapies include antistaphylococcus penicillinase-resistant penicillins (oxacillin or nafcillin) or vancomycin.

While Dr. Hightower doesn’t use clindamycin in these patients, he said it’s an option that some dermatologists consider because of its antistaphylococcus activity. “Historically, people thought it may decrease exotoxin production. The big concern if you are going to use clindamycin is that there are high rates of community resistance,” he said. “So you want to be careful that you know your resistance patterns wherever you are. Follow up on culture to make sure that you have adequate coverage for the bug that the kiddo in front of you has.”

Dr. Hightower reported no relevant disclosures. MedscapeLive and this news organization are owned by the same parent company.

Eczema herpeticum and staphylococcal scalded skin syndrome can be emergencies in children and require immediate care, warned dermatologist George Hightower, MD, PhD, in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Eczema herpeticum is a condition in which a herpes simplex virus (HSV-1 or HSV-2) is superimposed over preexisting eczema. “The infection may be primary and sustained from a close contact or result in some of our older patients from reactivation and spread through autoinoculation,” said Dr. Hightower, of Rady Children’s Hospital and the University of California, both in San Diego.

Signs, he said, include acute worsening of atopic dermatitis with new-onset vesicles, pustules, and “punched-out” hemorrhagic crusted erosions. “Presentation ranges from mild to transient to life threatening.”

Potential complications include meningitis, encephalitis, hepatitis, and chronic conjunctivitis. “That’s why immediate ophthalmological evaluation is needed when there’s involvement on the face near the eye,” he said.

As for management and care, “where I have concern for HSV patients, I get HSV [polymerase chain reaction] as well as a bacterial culture,” he said. But even before the results are available, empiric treatment with acyclovir can be appropriate. “It’s got to be systemic for these kids with severe involvement,” he said, and they should also be started on medication for staphylococci and streptococci.

During his presentation, Dr. Hightower also highlighted staphylococcal scalded skin syndrome. Patients with the disease commonly have concurrent skin pain (which can appear to be fussiness), fever, irritability, malaise, and poor feeding. Examination may reveal widespread erythema with accentuation at folds/peeling at hands and large sheets of superficial peeling scale with diffuse erythema.

Widespread skin involvement “results not from the presence of staph throughout the skin, but the exotoxin that it produces that becomes systemic,” he said. “Clinical diagnosis is supported by presence of S. aureus on bacterial culture, but the presence of staph is not necessary to make the diagnosis. When in doubt, histopathology is helpful. But again, it’s not necessary to make the diagnosis.”

Cases can be managed with a first- or second-generation cephalosporin, he said. Alternative therapies include antistaphylococcus penicillinase-resistant penicillins (oxacillin or nafcillin) or vancomycin.

While Dr. Hightower doesn’t use clindamycin in these patients, he said it’s an option that some dermatologists consider because of its antistaphylococcus activity. “Historically, people thought it may decrease exotoxin production. The big concern if you are going to use clindamycin is that there are high rates of community resistance,” he said. “So you want to be careful that you know your resistance patterns wherever you are. Follow up on culture to make sure that you have adequate coverage for the bug that the kiddo in front of you has.”

Dr. Hightower reported no relevant disclosures. MedscapeLive and this news organization are owned by the same parent company.

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

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

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

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

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

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

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
 

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

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
 

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

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
 

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

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

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

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

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

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

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

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

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

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

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

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

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

With the onset of the COVID-19 pandemic, there has been a rapid uptick in virtual recovery programs and telemedicine counseling sessions for patients with substance use disorders (SUDs). New research shows that these programs are acceptable and effective alternatives to in-person sessions.

FatCamera/E+

Study results from three research teams at the University of South Carolina School of Medicine Greenville (USCSM-G) show that SUD counselors in the state were satisfied with their experience with telehealth and virtual recovery meetings.

In one of the studies, five counselors who utilized a virtual meeting platform after the COVID-19 pandemic made in-person visits unsafe were surveyed. The respondents said they much preferred in-person meetings. However, they could also see that virtual meetings were filling an important need for their patients.

Two other studies echoed the results from the first. Clinicians who were leery of the new technology at first became more enthusiastic after they gained experience using it.

“We have lived in a society where there has been one right way, which has always been in-person meetings for recovery, such as Alcoholics Anonymous. It is a very structured process,” lead author Haley Fulton, a fourth-year medical student at USCSM-G, said in an interview.

“The onset of COVID really upended a lot of things, but ... now there may not be just one right way for recovery. There are alternatives to offer,” Ms. Fulton said.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry, which was held online this year because of the pandemic.
 

Huge need

“Virtual meetings may not be ideal, but some version of recovery is better than none. If we can make these meetings accessible to more people, this could promote recovery from substance use disorder,” Ms. Fulton said.

There is a huge need for counseling, and past research has shown that failure to attend meetings can precipitate relapse in many individuals.

In Ms. Fulton’s study, counselors were asked to describe how they perceived the efficacy of virtual recovery meetings, compared with that of in-person meetings.

The investigators analyzed how often certain words, phrases, or issues came up during seven in-person recovery meetings held before the COVID-19 pandemic as well as observational data from seven virtual recovery-support meetings held during the pandemic.

On the pro side, the respondents cited convenience, comfort at home, and increased accessibility to counseling for patients.

In addition, because there was no need to travel, virtual meetings were cost effective. Such meetings could expand the recovery world, inasmuch as individuals could attend recovery meetings in other parts of the country.

Perceived disadvantages included challenges involving technology, because learning new apps such as Zoom could be a problem for some patients. Distractions at home and lack of privacy were also cited, but for many, the most important drawback to virtual meetings was the lessening of emotional connection with others.
 

Impact on SUD treatment

In a second study, another team from USCSM-G reported similar findings when it explored the impact of telehealth on counselors as well as on patients who were undergoing SUD treatment during the pandemic.

Led by fourth-year medical students Elizabeth Whiteside and Kyleigh Connolly, the researchers assessed data from a focus group of six behavioral health counselors representing rural and city agencies throughout South Carolina.

Themes that emerged included concerns about mental health – counselors and patients were experiencing increased stress, depression, and anxiety.

“People had to now home school, there were job layoffs, increased responsibilities at home. Also, Narcan [naloxone] distribution was decreased, and this contributed to rising overdose rates,” Ms. Whiteside said in an interview.

The focus group concluded that the advantages of telehealth included greater ability to accept new patients, an increase in scheduling flexibility, and cost-effectiveness because it obviated the need for child care or transportation.

Disadvantages included problems involving privacy, because for many patients who were undergoing SUD recovery, it was impossible to be alone in a room or a designated area of their own.

The counselors also felt strongly that in-person care was needed for certain patients.

“Before COVID happened, [health care] barriers included transport to the actual center and finding care for children,” Ms. Connolly said in an interview.

“That’s where telehealth really bridged the gap for these people, and it actually became a lot easier for them to get in contact with their counselors, get into group meetings, and access other services,” she said.

Many of the study participants were not very optimistic about telehealth at first, Ms. Connolly noted. “They felt a little odd going on telehealth at first, but by the end, everybody said that they loved having it.”

“One of the things that came out often was that patients felt they could be more open and honest because they weren’t looking their counselor right in the face. They didn’t feel so horrible sharing,” Ms. Whiteside added.

Some counselors reported that some clients shared more details with them and that there was an ease of connecting. If a patient was a few minutes late to an appointment, telehealth would put in a call to find out where that patient was.

The counselors also had the ability to determine which of their patients would be good candidates for telehealth counseling and which patients would not do well with telehealth and would instead need in-patient care.

“This is something that really helped the experience go better for the counselors. They were able to determine which patient fit the mold for telehealth working for them. Obviously, patients who have more acute periods of mental health problems would do better with in-person care,” Ms. Whiteside said.
 

Here to stay?

In the third study from USCSM-G, investigators evaluated data from a focus group of four providers of medications for opioid use disorder (MOUD) who practiced in urban and rural areas throughout the state.

The respondents reflected on their experiences in using telemedicine for prescribing MOUD.

As in the previous studies, the providers had positive experiences with telemedicine. It increased patient access, participation, and satisfaction with treatment, and the benefits of telemedicine outweighed its potential limitations.

Still, technology was cited as a barrier to care, especially in rural areas.

“We found that there was a lack of good internet in certain rural parts of South Carolina, and that lack of the proper electronic devices ... could also make it difficult to access telemedicine,” lead author Kellie Shell said in an interview.

As noted in the other studies, the providers expressed a desire that telemedicine incorporate safeguards that would enable clinicians to identify a particular patient’s location in order that authorities could be dispatched if an emergency were to arise.

The clinicians also said that monitoring for diversion and performing pill counts were more difficult to do via telemedicine.

“We definitely have to improve infrastructure, especially in rural areas, so that all people have access to telemedicine,” Ms. Shell said.

“Overall, the providers were won over with telemedicine, and some predicted telehealth and virtual visits were here to stay, even after COVID,” she added.

The three posters provide useful insight into the potential advantages and disadvantages of telehealth in SUD settings, experts said.
 

Telehealth data ‘very limited’

Commenting on the research, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, noted that “there is such limited information” about the use of telehealth for patients with SUD.

“These insights are helpful for us to start understanding the things that need to be considered, including clinician attitudes and perceptions,” said Dr. Lin, who was not involved with the studies.

“It will be key to have data as use of telemedicine increases during COVID-19 to help us see exactly how it should be used and to better understand the actual impacts and whether or not it is increasing accessibility, and for which patients,” she added.

David Kan, MD, chief medical officer at Bright Heart Health, San Ramon, Calif., has had experience with telehealth for SUD and has found that conducting pill counts with his patients has not been a problem.

“The Shell poster covers telemedicine well,” Dr. Kan said in an interview.

However, “I disagree with their point that diversion prevention is harder via telemedicine. In my experience, it is easier, as you can do pill or wrapper counts almost on demand. You can also do daily observed dosing with pill counts if diversion is suspected,” he said.

Dr. Kan also suggested ways to cope with problems involving privacy. “Privacy concerns are always an issue but can be mitigated with headphones and a scan of the room with the telehealth technology if a privacy concern arises.”

He acknowledged that in-person meetings, especially through well-established programs, such as Alcoholics Anonymous (AA), will always be important. But he pointed out that people are finding ways to meet safely and have in-person connections.

“The AA has been providing virtual recovery meetings long before COVID. The common complaint is the loss of fellowship associated with recovery groups. I don’t know of a way to get around this short of vaccines,” Dr. Kan said. However, “people have adapted impressively with masked outdoor meetings and other forms of safe gathering.”

The investigators, Dr. Lin, and Dr. Kan reported no relevant financial relationships.
 

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

With the onset of the COVID-19 pandemic, there has been a rapid uptick in virtual recovery programs and telemedicine counseling sessions for patients with substance use disorders (SUDs). New research shows that these programs are acceptable and effective alternatives to in-person sessions.

FatCamera/E+

Study results from three research teams at the University of South Carolina School of Medicine Greenville (USCSM-G) show that SUD counselors in the state were satisfied with their experience with telehealth and virtual recovery meetings.

In one of the studies, five counselors who utilized a virtual meeting platform after the COVID-19 pandemic made in-person visits unsafe were surveyed. The respondents said they much preferred in-person meetings. However, they could also see that virtual meetings were filling an important need for their patients.

Two other studies echoed the results from the first. Clinicians who were leery of the new technology at first became more enthusiastic after they gained experience using it.

“We have lived in a society where there has been one right way, which has always been in-person meetings for recovery, such as Alcoholics Anonymous. It is a very structured process,” lead author Haley Fulton, a fourth-year medical student at USCSM-G, said in an interview.

“The onset of COVID really upended a lot of things, but ... now there may not be just one right way for recovery. There are alternatives to offer,” Ms. Fulton said.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry, which was held online this year because of the pandemic.
 

Huge need

“Virtual meetings may not be ideal, but some version of recovery is better than none. If we can make these meetings accessible to more people, this could promote recovery from substance use disorder,” Ms. Fulton said.

There is a huge need for counseling, and past research has shown that failure to attend meetings can precipitate relapse in many individuals.

In Ms. Fulton’s study, counselors were asked to describe how they perceived the efficacy of virtual recovery meetings, compared with that of in-person meetings.

The investigators analyzed how often certain words, phrases, or issues came up during seven in-person recovery meetings held before the COVID-19 pandemic as well as observational data from seven virtual recovery-support meetings held during the pandemic.

On the pro side, the respondents cited convenience, comfort at home, and increased accessibility to counseling for patients.

In addition, because there was no need to travel, virtual meetings were cost effective. Such meetings could expand the recovery world, inasmuch as individuals could attend recovery meetings in other parts of the country.

Perceived disadvantages included challenges involving technology, because learning new apps such as Zoom could be a problem for some patients. Distractions at home and lack of privacy were also cited, but for many, the most important drawback to virtual meetings was the lessening of emotional connection with others.
 

Impact on SUD treatment

In a second study, another team from USCSM-G reported similar findings when it explored the impact of telehealth on counselors as well as on patients who were undergoing SUD treatment during the pandemic.

Led by fourth-year medical students Elizabeth Whiteside and Kyleigh Connolly, the researchers assessed data from a focus group of six behavioral health counselors representing rural and city agencies throughout South Carolina.

Themes that emerged included concerns about mental health – counselors and patients were experiencing increased stress, depression, and anxiety.

“People had to now home school, there were job layoffs, increased responsibilities at home. Also, Narcan [naloxone] distribution was decreased, and this contributed to rising overdose rates,” Ms. Whiteside said in an interview.

The focus group concluded that the advantages of telehealth included greater ability to accept new patients, an increase in scheduling flexibility, and cost-effectiveness because it obviated the need for child care or transportation.

Disadvantages included problems involving privacy, because for many patients who were undergoing SUD recovery, it was impossible to be alone in a room or a designated area of their own.

The counselors also felt strongly that in-person care was needed for certain patients.

“Before COVID happened, [health care] barriers included transport to the actual center and finding care for children,” Ms. Connolly said in an interview.

“That’s where telehealth really bridged the gap for these people, and it actually became a lot easier for them to get in contact with their counselors, get into group meetings, and access other services,” she said.

Many of the study participants were not very optimistic about telehealth at first, Ms. Connolly noted. “They felt a little odd going on telehealth at first, but by the end, everybody said that they loved having it.”

“One of the things that came out often was that patients felt they could be more open and honest because they weren’t looking their counselor right in the face. They didn’t feel so horrible sharing,” Ms. Whiteside added.

Some counselors reported that some clients shared more details with them and that there was an ease of connecting. If a patient was a few minutes late to an appointment, telehealth would put in a call to find out where that patient was.

The counselors also had the ability to determine which of their patients would be good candidates for telehealth counseling and which patients would not do well with telehealth and would instead need in-patient care.

“This is something that really helped the experience go better for the counselors. They were able to determine which patient fit the mold for telehealth working for them. Obviously, patients who have more acute periods of mental health problems would do better with in-person care,” Ms. Whiteside said.
 

Here to stay?

In the third study from USCSM-G, investigators evaluated data from a focus group of four providers of medications for opioid use disorder (MOUD) who practiced in urban and rural areas throughout the state.

The respondents reflected on their experiences in using telemedicine for prescribing MOUD.

As in the previous studies, the providers had positive experiences with telemedicine. It increased patient access, participation, and satisfaction with treatment, and the benefits of telemedicine outweighed its potential limitations.

Still, technology was cited as a barrier to care, especially in rural areas.

“We found that there was a lack of good internet in certain rural parts of South Carolina, and that lack of the proper electronic devices ... could also make it difficult to access telemedicine,” lead author Kellie Shell said in an interview.

As noted in the other studies, the providers expressed a desire that telemedicine incorporate safeguards that would enable clinicians to identify a particular patient’s location in order that authorities could be dispatched if an emergency were to arise.

The clinicians also said that monitoring for diversion and performing pill counts were more difficult to do via telemedicine.

“We definitely have to improve infrastructure, especially in rural areas, so that all people have access to telemedicine,” Ms. Shell said.

“Overall, the providers were won over with telemedicine, and some predicted telehealth and virtual visits were here to stay, even after COVID,” she added.

The three posters provide useful insight into the potential advantages and disadvantages of telehealth in SUD settings, experts said.
 

Telehealth data ‘very limited’

Commenting on the research, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, noted that “there is such limited information” about the use of telehealth for patients with SUD.

“These insights are helpful for us to start understanding the things that need to be considered, including clinician attitudes and perceptions,” said Dr. Lin, who was not involved with the studies.

“It will be key to have data as use of telemedicine increases during COVID-19 to help us see exactly how it should be used and to better understand the actual impacts and whether or not it is increasing accessibility, and for which patients,” she added.

David Kan, MD, chief medical officer at Bright Heart Health, San Ramon, Calif., has had experience with telehealth for SUD and has found that conducting pill counts with his patients has not been a problem.

“The Shell poster covers telemedicine well,” Dr. Kan said in an interview.

However, “I disagree with their point that diversion prevention is harder via telemedicine. In my experience, it is easier, as you can do pill or wrapper counts almost on demand. You can also do daily observed dosing with pill counts if diversion is suspected,” he said.

Dr. Kan also suggested ways to cope with problems involving privacy. “Privacy concerns are always an issue but can be mitigated with headphones and a scan of the room with the telehealth technology if a privacy concern arises.”

He acknowledged that in-person meetings, especially through well-established programs, such as Alcoholics Anonymous (AA), will always be important. But he pointed out that people are finding ways to meet safely and have in-person connections.

“The AA has been providing virtual recovery meetings long before COVID. The common complaint is the loss of fellowship associated with recovery groups. I don’t know of a way to get around this short of vaccines,” Dr. Kan said. However, “people have adapted impressively with masked outdoor meetings and other forms of safe gathering.”

The investigators, Dr. Lin, and Dr. Kan reported no relevant financial relationships.
 

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

With the onset of the COVID-19 pandemic, there has been a rapid uptick in virtual recovery programs and telemedicine counseling sessions for patients with substance use disorders (SUDs). New research shows that these programs are acceptable and effective alternatives to in-person sessions.

FatCamera/E+

Study results from three research teams at the University of South Carolina School of Medicine Greenville (USCSM-G) show that SUD counselors in the state were satisfied with their experience with telehealth and virtual recovery meetings.

In one of the studies, five counselors who utilized a virtual meeting platform after the COVID-19 pandemic made in-person visits unsafe were surveyed. The respondents said they much preferred in-person meetings. However, they could also see that virtual meetings were filling an important need for their patients.

Two other studies echoed the results from the first. Clinicians who were leery of the new technology at first became more enthusiastic after they gained experience using it.

“We have lived in a society where there has been one right way, which has always been in-person meetings for recovery, such as Alcoholics Anonymous. It is a very structured process,” lead author Haley Fulton, a fourth-year medical student at USCSM-G, said in an interview.

“The onset of COVID really upended a lot of things, but ... now there may not be just one right way for recovery. There are alternatives to offer,” Ms. Fulton said.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry, which was held online this year because of the pandemic.
 

Huge need

“Virtual meetings may not be ideal, but some version of recovery is better than none. If we can make these meetings accessible to more people, this could promote recovery from substance use disorder,” Ms. Fulton said.

There is a huge need for counseling, and past research has shown that failure to attend meetings can precipitate relapse in many individuals.

In Ms. Fulton’s study, counselors were asked to describe how they perceived the efficacy of virtual recovery meetings, compared with that of in-person meetings.

The investigators analyzed how often certain words, phrases, or issues came up during seven in-person recovery meetings held before the COVID-19 pandemic as well as observational data from seven virtual recovery-support meetings held during the pandemic.

On the pro side, the respondents cited convenience, comfort at home, and increased accessibility to counseling for patients.

In addition, because there was no need to travel, virtual meetings were cost effective. Such meetings could expand the recovery world, inasmuch as individuals could attend recovery meetings in other parts of the country.

Perceived disadvantages included challenges involving technology, because learning new apps such as Zoom could be a problem for some patients. Distractions at home and lack of privacy were also cited, but for many, the most important drawback to virtual meetings was the lessening of emotional connection with others.
 

Impact on SUD treatment

In a second study, another team from USCSM-G reported similar findings when it explored the impact of telehealth on counselors as well as on patients who were undergoing SUD treatment during the pandemic.

Led by fourth-year medical students Elizabeth Whiteside and Kyleigh Connolly, the researchers assessed data from a focus group of six behavioral health counselors representing rural and city agencies throughout South Carolina.

Themes that emerged included concerns about mental health – counselors and patients were experiencing increased stress, depression, and anxiety.

“People had to now home school, there were job layoffs, increased responsibilities at home. Also, Narcan [naloxone] distribution was decreased, and this contributed to rising overdose rates,” Ms. Whiteside said in an interview.

The focus group concluded that the advantages of telehealth included greater ability to accept new patients, an increase in scheduling flexibility, and cost-effectiveness because it obviated the need for child care or transportation.

Disadvantages included problems involving privacy, because for many patients who were undergoing SUD recovery, it was impossible to be alone in a room or a designated area of their own.

The counselors also felt strongly that in-person care was needed for certain patients.

“Before COVID happened, [health care] barriers included transport to the actual center and finding care for children,” Ms. Connolly said in an interview.

“That’s where telehealth really bridged the gap for these people, and it actually became a lot easier for them to get in contact with their counselors, get into group meetings, and access other services,” she said.

Many of the study participants were not very optimistic about telehealth at first, Ms. Connolly noted. “They felt a little odd going on telehealth at first, but by the end, everybody said that they loved having it.”

“One of the things that came out often was that patients felt they could be more open and honest because they weren’t looking their counselor right in the face. They didn’t feel so horrible sharing,” Ms. Whiteside added.

Some counselors reported that some clients shared more details with them and that there was an ease of connecting. If a patient was a few minutes late to an appointment, telehealth would put in a call to find out where that patient was.

The counselors also had the ability to determine which of their patients would be good candidates for telehealth counseling and which patients would not do well with telehealth and would instead need in-patient care.

“This is something that really helped the experience go better for the counselors. They were able to determine which patient fit the mold for telehealth working for them. Obviously, patients who have more acute periods of mental health problems would do better with in-person care,” Ms. Whiteside said.
 

Here to stay?

In the third study from USCSM-G, investigators evaluated data from a focus group of four providers of medications for opioid use disorder (MOUD) who practiced in urban and rural areas throughout the state.

The respondents reflected on their experiences in using telemedicine for prescribing MOUD.

As in the previous studies, the providers had positive experiences with telemedicine. It increased patient access, participation, and satisfaction with treatment, and the benefits of telemedicine outweighed its potential limitations.

Still, technology was cited as a barrier to care, especially in rural areas.

“We found that there was a lack of good internet in certain rural parts of South Carolina, and that lack of the proper electronic devices ... could also make it difficult to access telemedicine,” lead author Kellie Shell said in an interview.

As noted in the other studies, the providers expressed a desire that telemedicine incorporate safeguards that would enable clinicians to identify a particular patient’s location in order that authorities could be dispatched if an emergency were to arise.

The clinicians also said that monitoring for diversion and performing pill counts were more difficult to do via telemedicine.

“We definitely have to improve infrastructure, especially in rural areas, so that all people have access to telemedicine,” Ms. Shell said.

“Overall, the providers were won over with telemedicine, and some predicted telehealth and virtual visits were here to stay, even after COVID,” she added.

The three posters provide useful insight into the potential advantages and disadvantages of telehealth in SUD settings, experts said.
 

Telehealth data ‘very limited’

Commenting on the research, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, noted that “there is such limited information” about the use of telehealth for patients with SUD.

“These insights are helpful for us to start understanding the things that need to be considered, including clinician attitudes and perceptions,” said Dr. Lin, who was not involved with the studies.

“It will be key to have data as use of telemedicine increases during COVID-19 to help us see exactly how it should be used and to better understand the actual impacts and whether or not it is increasing accessibility, and for which patients,” she added.

David Kan, MD, chief medical officer at Bright Heart Health, San Ramon, Calif., has had experience with telehealth for SUD and has found that conducting pill counts with his patients has not been a problem.

“The Shell poster covers telemedicine well,” Dr. Kan said in an interview.

However, “I disagree with their point that diversion prevention is harder via telemedicine. In my experience, it is easier, as you can do pill or wrapper counts almost on demand. You can also do daily observed dosing with pill counts if diversion is suspected,” he said.

Dr. Kan also suggested ways to cope with problems involving privacy. “Privacy concerns are always an issue but can be mitigated with headphones and a scan of the room with the telehealth technology if a privacy concern arises.”

He acknowledged that in-person meetings, especially through well-established programs, such as Alcoholics Anonymous (AA), will always be important. But he pointed out that people are finding ways to meet safely and have in-person connections.

“The AA has been providing virtual recovery meetings long before COVID. The common complaint is the loss of fellowship associated with recovery groups. I don’t know of a way to get around this short of vaccines,” Dr. Kan said. However, “people have adapted impressively with masked outdoor meetings and other forms of safe gathering.”

The investigators, Dr. Lin, and Dr. Kan reported no relevant financial relationships.
 

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

An investigational chimeric antigen receptor T-cell (CAR T-cell) construct targeting two antigens on multiple myeloma cells showed promise in a first-in-humans trial, investigators said.

Among 16 patients with relapsed/refractory, heavily pretreated multiple myeloma who received the dual-targeting construct GC012F, the overall response rate was 93.8%, and all of six patients who received the cells at the highest of three dose levels had stringent complete responses (sCR) and were negative for minimal residual disease (MRD) at 6 months follow-up, reported Weijun Fu, MD, PhD, from Shanghai (China) Changzheng Hospital in an oral abstract presented during the virtual American Society of Hematology annual meeting.

GC012F is a novel CAR-T cell platform targeting both the B-cell maturation antigen (BCMA), which is universally expressed on malignant plasma cells, and CD19, which is expressed on both multiple myeloma cells and progenitors, Dr. Fu said.

“Targeting CD19 can trigger elimination of malignant cells by CAR T. Our preclinical work demonstrated more effective elimination of multiple myeloma clone-forming cells by BCMA and CD19 dual CAR T, so targeting both BCMA and CD19 antigens could improve efficacy and reduce relapse,” he said.

The construct is created using the FasTCAR platform that, according to manufacturer Gracell Biotechnologies (Shanghai), allows for cell culturing and expansion within 24-36 hours, rather than 2-3 weeks required for other CAR T-cell products.
 

Investigator-initiated trial

In a phase 1 investigator-initiated trial, 16 patients with a median age of 56 (range 27-71) years were enrolled. The patients all had relapsed or refractory multiple myeloma according to 2016 International Myeloma Working Group criteria, with a life expectancy of at least 3 months and adequate organ function.

The median time since diagnosis was 3 years (range 1-10). All but one of the 16 patients had high-risk disease, 3 had double-hit disease (the presence of two deletions, gain of function, or p53 mutation), and 5 patients had one or more extramedullary plasmacytomas. Four of the patients had received therapy with an anti-CD38 monoclonal antibody.

Following lymphodepletion with fludarabine and cyclophosphamide, the patients received the CAR T cells in a single infusion at dose levels of either 1, 2, or 3 times 10⁵ cells/kg.

As of the cutoff date in July 2020, 15 of the 16 patients had a clinical response, including 9 with a CR or sCR, and 6 with a very good partial response (VGPR). As noted before, all of the six patients treated at the highest dose level had a sCR. At the median follow-up of 7.3 months, the median duration of response had not been reached.

Among all patients evaluable for response at month 1 (14 patients), 11 were MRD negative by flow cytometry. At month 3 all 11 evaluable patients were MRD negative, and all of 10 patients evaluable at 6 months were also MRD negative.

As with other CAR T-cell constructs, all patients developed the cytokine-release syndrome (CRS), with grade 1 or 2 severity in 14 patients, and grade 3 in 2 patients. The median time to onset of CRS was 6 days (range 2-10), and the median duration was 4 days (range 1-8 days).

No cases of immune effector cell–associated neurotoxicity syndrome (ICANS) were observed.

One patient treated at the middle dose level presented with fever and died shortly after day 78 of an unknown cause during the COVID-19 pandemic. Two patients died of extramedullary disease; each had achieved MRD negativity.

Investigators continue to follow the patients and are enrolling new patients in the ongoing study.
 

‘Interesting approach’

Sandy W. Wong, MD, from the Helen Diller Family Comprehensive Cancer Center at the University of California San Francisco, who was not involved in the study, said in an interview that the dual-targeted approach is interesting, in light of a case report presented at ASH 2020 of a patient with multiple myeloma who had a partial response to CAR T-cell therapy with a different construct and who developed a subsequent biallelic loss of BCMA that resulted in resistance to CAR T-cell therapy.

“This raises the idea that, if we perhaps had a dual-targeted CAR T, perhaps we will prolong progression-free survival, in order to avoid antigen escape. So I do think the concept is very interesting and does deserve further study,” she said.

CD19 is thought to be expressed on myeloma stem cells, “so the question is: Are patients not being cured because there is a reservoir of myeloma cells, and targeting CD19 is thought to get at this putative myeloma stem cell? but that remains to be seen,” she added.

Dr. Wong comoderated the session where Dr. Fu presented the data.

The study was supported by participating medical centers and Gracell Biotechnologies. Dr. Fu and Dr. Wong reported no relevant conflicts of interest to disclose.

SOURCE: Jiang H et al. ASH 2020, Abstract 178.

An investigational chimeric antigen receptor T-cell (CAR T-cell) construct targeting two antigens on multiple myeloma cells showed promise in a first-in-humans trial, investigators said.

Among 16 patients with relapsed/refractory, heavily pretreated multiple myeloma who received the dual-targeting construct GC012F, the overall response rate was 93.8%, and all of six patients who received the cells at the highest of three dose levels had stringent complete responses (sCR) and were negative for minimal residual disease (MRD) at 6 months follow-up, reported Weijun Fu, MD, PhD, from Shanghai (China) Changzheng Hospital in an oral abstract presented during the virtual American Society of Hematology annual meeting.

GC012F is a novel CAR-T cell platform targeting both the B-cell maturation antigen (BCMA), which is universally expressed on malignant plasma cells, and CD19, which is expressed on both multiple myeloma cells and progenitors, Dr. Fu said.

“Targeting CD19 can trigger elimination of malignant cells by CAR T. Our preclinical work demonstrated more effective elimination of multiple myeloma clone-forming cells by BCMA and CD19 dual CAR T, so targeting both BCMA and CD19 antigens could improve efficacy and reduce relapse,” he said.

The construct is created using the FasTCAR platform that, according to manufacturer Gracell Biotechnologies (Shanghai), allows for cell culturing and expansion within 24-36 hours, rather than 2-3 weeks required for other CAR T-cell products.
 

Investigator-initiated trial

In a phase 1 investigator-initiated trial, 16 patients with a median age of 56 (range 27-71) years were enrolled. The patients all had relapsed or refractory multiple myeloma according to 2016 International Myeloma Working Group criteria, with a life expectancy of at least 3 months and adequate organ function.

The median time since diagnosis was 3 years (range 1-10). All but one of the 16 patients had high-risk disease, 3 had double-hit disease (the presence of two deletions, gain of function, or p53 mutation), and 5 patients had one or more extramedullary plasmacytomas. Four of the patients had received therapy with an anti-CD38 monoclonal antibody.

Following lymphodepletion with fludarabine and cyclophosphamide, the patients received the CAR T cells in a single infusion at dose levels of either 1, 2, or 3 times 10⁵ cells/kg.

As of the cutoff date in July 2020, 15 of the 16 patients had a clinical response, including 9 with a CR or sCR, and 6 with a very good partial response (VGPR). As noted before, all of the six patients treated at the highest dose level had a sCR. At the median follow-up of 7.3 months, the median duration of response had not been reached.

Among all patients evaluable for response at month 1 (14 patients), 11 were MRD negative by flow cytometry. At month 3 all 11 evaluable patients were MRD negative, and all of 10 patients evaluable at 6 months were also MRD negative.

As with other CAR T-cell constructs, all patients developed the cytokine-release syndrome (CRS), with grade 1 or 2 severity in 14 patients, and grade 3 in 2 patients. The median time to onset of CRS was 6 days (range 2-10), and the median duration was 4 days (range 1-8 days).

No cases of immune effector cell–associated neurotoxicity syndrome (ICANS) were observed.

One patient treated at the middle dose level presented with fever and died shortly after day 78 of an unknown cause during the COVID-19 pandemic. Two patients died of extramedullary disease; each had achieved MRD negativity.

Investigators continue to follow the patients and are enrolling new patients in the ongoing study.
 

‘Interesting approach’

Sandy W. Wong, MD, from the Helen Diller Family Comprehensive Cancer Center at the University of California San Francisco, who was not involved in the study, said in an interview that the dual-targeted approach is interesting, in light of a case report presented at ASH 2020 of a patient with multiple myeloma who had a partial response to CAR T-cell therapy with a different construct and who developed a subsequent biallelic loss of BCMA that resulted in resistance to CAR T-cell therapy.

“This raises the idea that, if we perhaps had a dual-targeted CAR T, perhaps we will prolong progression-free survival, in order to avoid antigen escape. So I do think the concept is very interesting and does deserve further study,” she said.

CD19 is thought to be expressed on myeloma stem cells, “so the question is: Are patients not being cured because there is a reservoir of myeloma cells, and targeting CD19 is thought to get at this putative myeloma stem cell? but that remains to be seen,” she added.

Dr. Wong comoderated the session where Dr. Fu presented the data.

The study was supported by participating medical centers and Gracell Biotechnologies. Dr. Fu and Dr. Wong reported no relevant conflicts of interest to disclose.

SOURCE: Jiang H et al. ASH 2020, Abstract 178.

An investigational chimeric antigen receptor T-cell (CAR T-cell) construct targeting two antigens on multiple myeloma cells showed promise in a first-in-humans trial, investigators said.

Among 16 patients with relapsed/refractory, heavily pretreated multiple myeloma who received the dual-targeting construct GC012F, the overall response rate was 93.8%, and all of six patients who received the cells at the highest of three dose levels had stringent complete responses (sCR) and were negative for minimal residual disease (MRD) at 6 months follow-up, reported Weijun Fu, MD, PhD, from Shanghai (China) Changzheng Hospital in an oral abstract presented during the virtual American Society of Hematology annual meeting.

GC012F is a novel CAR-T cell platform targeting both the B-cell maturation antigen (BCMA), which is universally expressed on malignant plasma cells, and CD19, which is expressed on both multiple myeloma cells and progenitors, Dr. Fu said.

“Targeting CD19 can trigger elimination of malignant cells by CAR T. Our preclinical work demonstrated more effective elimination of multiple myeloma clone-forming cells by BCMA and CD19 dual CAR T, so targeting both BCMA and CD19 antigens could improve efficacy and reduce relapse,” he said.

The construct is created using the FasTCAR platform that, according to manufacturer Gracell Biotechnologies (Shanghai), allows for cell culturing and expansion within 24-36 hours, rather than 2-3 weeks required for other CAR T-cell products.
 

Investigator-initiated trial

In a phase 1 investigator-initiated trial, 16 patients with a median age of 56 (range 27-71) years were enrolled. The patients all had relapsed or refractory multiple myeloma according to 2016 International Myeloma Working Group criteria, with a life expectancy of at least 3 months and adequate organ function.

The median time since diagnosis was 3 years (range 1-10). All but one of the 16 patients had high-risk disease, 3 had double-hit disease (the presence of two deletions, gain of function, or p53 mutation), and 5 patients had one or more extramedullary plasmacytomas. Four of the patients had received therapy with an anti-CD38 monoclonal antibody.

Following lymphodepletion with fludarabine and cyclophosphamide, the patients received the CAR T cells in a single infusion at dose levels of either 1, 2, or 3 times 10⁵ cells/kg.

As of the cutoff date in July 2020, 15 of the 16 patients had a clinical response, including 9 with a CR or sCR, and 6 with a very good partial response (VGPR). As noted before, all of the six patients treated at the highest dose level had a sCR. At the median follow-up of 7.3 months, the median duration of response had not been reached.

Among all patients evaluable for response at month 1 (14 patients), 11 were MRD negative by flow cytometry. At month 3 all 11 evaluable patients were MRD negative, and all of 10 patients evaluable at 6 months were also MRD negative.

As with other CAR T-cell constructs, all patients developed the cytokine-release syndrome (CRS), with grade 1 or 2 severity in 14 patients, and grade 3 in 2 patients. The median time to onset of CRS was 6 days (range 2-10), and the median duration was 4 days (range 1-8 days).

No cases of immune effector cell–associated neurotoxicity syndrome (ICANS) were observed.

One patient treated at the middle dose level presented with fever and died shortly after day 78 of an unknown cause during the COVID-19 pandemic. Two patients died of extramedullary disease; each had achieved MRD negativity.

Investigators continue to follow the patients and are enrolling new patients in the ongoing study.
 

‘Interesting approach’

Sandy W. Wong, MD, from the Helen Diller Family Comprehensive Cancer Center at the University of California San Francisco, who was not involved in the study, said in an interview that the dual-targeted approach is interesting, in light of a case report presented at ASH 2020 of a patient with multiple myeloma who had a partial response to CAR T-cell therapy with a different construct and who developed a subsequent biallelic loss of BCMA that resulted in resistance to CAR T-cell therapy.

“This raises the idea that, if we perhaps had a dual-targeted CAR T, perhaps we will prolong progression-free survival, in order to avoid antigen escape. So I do think the concept is very interesting and does deserve further study,” she said.

CD19 is thought to be expressed on myeloma stem cells, “so the question is: Are patients not being cured because there is a reservoir of myeloma cells, and targeting CD19 is thought to get at this putative myeloma stem cell? but that remains to be seen,” she added.

Dr. Wong comoderated the session where Dr. Fu presented the data.

The study was supported by participating medical centers and Gracell Biotechnologies. Dr. Fu and Dr. Wong reported no relevant conflicts of interest to disclose.

SOURCE: Jiang H et al. ASH 2020, Abstract 178.