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Can this patient get IV contrast?
A 59-year-old man is admitted with abdominal pain. He has a history of pancreatitis. A contrast CT scan is ordered. He reports a history of severe shellfish allergy when the radiology tech checks him in for the procedure. You are paged regarding what to do:
A) Continue with scan as ordered.
B) Switch to MRI scan.
C) Switch to MRI scan with gadolinium.
D) Continue with CT with contrast, give dose of Solu-Medrol.
E) Continue with CT with contrast give IV diphenhydramine.
The correct answer here is A, This patient can receive his scan and receive contrast as ordered.
The mistaken thought was that shellfish contains iodine, so allergy to shellfish was likely to portend allergy to iodine.
Allergy to shellfish is caused by individual proteins that are definitely not in iodine-containing contrast.1 Beaty et al. studied the prevalence of the belief that allergy to shellfish is tied to iodine allergy in a survey given to 231 faculty radiologists and interventional cardiologists.2 Almost 70% responded that they inquire about seafood allergy before procedures that require iodine contrast, and 37% reported they would withhold the contrast or premedicate patients if they had a seafood allergy.
In a more recent study, Westermann-Clark and colleagues surveyed 252 health professionals before and after an educational intervention to dispel the myth of shellfish allergy and iodinated contrast reactions.3 Before the intervention, 66% of participants felt it was important to ask about shellfish allergies and 93% felt it was important to ask about iodine allergies; 26% responded that they would withhold iodinated contrast material in patients with a shellfish allergy, and 56% would withhold in patients with an iodine allergy. A total of 62% reported they would premedicate patients with a shellfish allergy and 75% would premedicate patients with an iodine allergy. The numbers declined dramatically after the educational intervention.
Patients who have seafood allergy have a higher rate of reactions to iodinated contrast, but not at a higher rate than do patients with other food allergies or asthma.4 Most radiology departments do not screen for other food allergies despite the fact these allergies have the same increased risk as for patients with a seafood/shellfish allergy. These patients are more allergic, and in general, are more likely to have reactions. The American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering low- or iso-osmolar radiocontrast media or pretreating with either antihistamines or steroids in patients with a history of seafood allergy.5
There is no evidence that iodine causes allergic reactions. It makes sense that iodine does not cause allergic reactions, as it is an essential component in the human body, in thyroid hormone and in amino acids.6 Patients with dermatitis following topical application of iodine preparations such as povidone-iodide are not reacting to the iodine.
Van Ketel and van den Berg patch-tested patients with a history of dermatitis after exposure to povidone-iodine.7 All patients reacted to patch testing with povidone-iodine, but none reacted to direct testing to iodine (0/5 with patch testing of potassium iodide and 0/3 with testing with iodine tincture).
Take home points:
- It is unnecessary and unhelpful to ask patients about seafood allergies before ordering radiologic studies involving contrast.
- Iodine allergy does not exist.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Narayan AK et al. Avoiding contrast-enhanced computed tomography scans in patients with shellfish allergies. J Hosp Med. 2016 Jun;11(6):435-7.
2. Beaty AD et al. Seafood allergy and radiocontrast media: Are physicians propagating a myth? Am J Med. 2008 Feb;121(2):158.e1-4.
3. Westermann-Clark E et al. Debunking myths about “allergy” to radiocontrast media in an academic institution. Postgrad Med. 2015 Apr;127(3):295-300.
4. Coakley FV and DM Panicek. Iodine allergy: An oyster without a pearl? AJR Am J Roentgenol. 1997 Oct;169(4):951-2.
5. American Academy of Allergy, Asthma & Immunology recommendations on low- or iso-osmolar radiocontrast media.
6. Schabelman E and M Witting. The relationship of radiocontrast, iodine, and seafood allergies: A medical myth exposed. J Emerg Med. 2010 Nov;39(5):701-7.
7. van Ketel WG and WH van den Berg. Sensitization to povidone-iodine. Dermatol Clin. 1990 Jan;8(1):107-9.
A 59-year-old man is admitted with abdominal pain. He has a history of pancreatitis. A contrast CT scan is ordered. He reports a history of severe shellfish allergy when the radiology tech checks him in for the procedure. You are paged regarding what to do:
A) Continue with scan as ordered.
B) Switch to MRI scan.
C) Switch to MRI scan with gadolinium.
D) Continue with CT with contrast, give dose of Solu-Medrol.
E) Continue with CT with contrast give IV diphenhydramine.
The correct answer here is A, This patient can receive his scan and receive contrast as ordered.
The mistaken thought was that shellfish contains iodine, so allergy to shellfish was likely to portend allergy to iodine.
Allergy to shellfish is caused by individual proteins that are definitely not in iodine-containing contrast.1 Beaty et al. studied the prevalence of the belief that allergy to shellfish is tied to iodine allergy in a survey given to 231 faculty radiologists and interventional cardiologists.2 Almost 70% responded that they inquire about seafood allergy before procedures that require iodine contrast, and 37% reported they would withhold the contrast or premedicate patients if they had a seafood allergy.
In a more recent study, Westermann-Clark and colleagues surveyed 252 health professionals before and after an educational intervention to dispel the myth of shellfish allergy and iodinated contrast reactions.3 Before the intervention, 66% of participants felt it was important to ask about shellfish allergies and 93% felt it was important to ask about iodine allergies; 26% responded that they would withhold iodinated contrast material in patients with a shellfish allergy, and 56% would withhold in patients with an iodine allergy. A total of 62% reported they would premedicate patients with a shellfish allergy and 75% would premedicate patients with an iodine allergy. The numbers declined dramatically after the educational intervention.
Patients who have seafood allergy have a higher rate of reactions to iodinated contrast, but not at a higher rate than do patients with other food allergies or asthma.4 Most radiology departments do not screen for other food allergies despite the fact these allergies have the same increased risk as for patients with a seafood/shellfish allergy. These patients are more allergic, and in general, are more likely to have reactions. The American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering low- or iso-osmolar radiocontrast media or pretreating with either antihistamines or steroids in patients with a history of seafood allergy.5
There is no evidence that iodine causes allergic reactions. It makes sense that iodine does not cause allergic reactions, as it is an essential component in the human body, in thyroid hormone and in amino acids.6 Patients with dermatitis following topical application of iodine preparations such as povidone-iodide are not reacting to the iodine.
Van Ketel and van den Berg patch-tested patients with a history of dermatitis after exposure to povidone-iodine.7 All patients reacted to patch testing with povidone-iodine, but none reacted to direct testing to iodine (0/5 with patch testing of potassium iodide and 0/3 with testing with iodine tincture).
Take home points:
- It is unnecessary and unhelpful to ask patients about seafood allergies before ordering radiologic studies involving contrast.
- Iodine allergy does not exist.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Narayan AK et al. Avoiding contrast-enhanced computed tomography scans in patients with shellfish allergies. J Hosp Med. 2016 Jun;11(6):435-7.
2. Beaty AD et al. Seafood allergy and radiocontrast media: Are physicians propagating a myth? Am J Med. 2008 Feb;121(2):158.e1-4.
3. Westermann-Clark E et al. Debunking myths about “allergy” to radiocontrast media in an academic institution. Postgrad Med. 2015 Apr;127(3):295-300.
4. Coakley FV and DM Panicek. Iodine allergy: An oyster without a pearl? AJR Am J Roentgenol. 1997 Oct;169(4):951-2.
5. American Academy of Allergy, Asthma & Immunology recommendations on low- or iso-osmolar radiocontrast media.
6. Schabelman E and M Witting. The relationship of radiocontrast, iodine, and seafood allergies: A medical myth exposed. J Emerg Med. 2010 Nov;39(5):701-7.
7. van Ketel WG and WH van den Berg. Sensitization to povidone-iodine. Dermatol Clin. 1990 Jan;8(1):107-9.
A 59-year-old man is admitted with abdominal pain. He has a history of pancreatitis. A contrast CT scan is ordered. He reports a history of severe shellfish allergy when the radiology tech checks him in for the procedure. You are paged regarding what to do:
A) Continue with scan as ordered.
B) Switch to MRI scan.
C) Switch to MRI scan with gadolinium.
D) Continue with CT with contrast, give dose of Solu-Medrol.
E) Continue with CT with contrast give IV diphenhydramine.
The correct answer here is A, This patient can receive his scan and receive contrast as ordered.
The mistaken thought was that shellfish contains iodine, so allergy to shellfish was likely to portend allergy to iodine.
Allergy to shellfish is caused by individual proteins that are definitely not in iodine-containing contrast.1 Beaty et al. studied the prevalence of the belief that allergy to shellfish is tied to iodine allergy in a survey given to 231 faculty radiologists and interventional cardiologists.2 Almost 70% responded that they inquire about seafood allergy before procedures that require iodine contrast, and 37% reported they would withhold the contrast or premedicate patients if they had a seafood allergy.
In a more recent study, Westermann-Clark and colleagues surveyed 252 health professionals before and after an educational intervention to dispel the myth of shellfish allergy and iodinated contrast reactions.3 Before the intervention, 66% of participants felt it was important to ask about shellfish allergies and 93% felt it was important to ask about iodine allergies; 26% responded that they would withhold iodinated contrast material in patients with a shellfish allergy, and 56% would withhold in patients with an iodine allergy. A total of 62% reported they would premedicate patients with a shellfish allergy and 75% would premedicate patients with an iodine allergy. The numbers declined dramatically after the educational intervention.
Patients who have seafood allergy have a higher rate of reactions to iodinated contrast, but not at a higher rate than do patients with other food allergies or asthma.4 Most radiology departments do not screen for other food allergies despite the fact these allergies have the same increased risk as for patients with a seafood/shellfish allergy. These patients are more allergic, and in general, are more likely to have reactions. The American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering low- or iso-osmolar radiocontrast media or pretreating with either antihistamines or steroids in patients with a history of seafood allergy.5
There is no evidence that iodine causes allergic reactions. It makes sense that iodine does not cause allergic reactions, as it is an essential component in the human body, in thyroid hormone and in amino acids.6 Patients with dermatitis following topical application of iodine preparations such as povidone-iodide are not reacting to the iodine.
Van Ketel and van den Berg patch-tested patients with a history of dermatitis after exposure to povidone-iodine.7 All patients reacted to patch testing with povidone-iodine, but none reacted to direct testing to iodine (0/5 with patch testing of potassium iodide and 0/3 with testing with iodine tincture).
Take home points:
- It is unnecessary and unhelpful to ask patients about seafood allergies before ordering radiologic studies involving contrast.
- Iodine allergy does not exist.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Narayan AK et al. Avoiding contrast-enhanced computed tomography scans in patients with shellfish allergies. J Hosp Med. 2016 Jun;11(6):435-7.
2. Beaty AD et al. Seafood allergy and radiocontrast media: Are physicians propagating a myth? Am J Med. 2008 Feb;121(2):158.e1-4.
3. Westermann-Clark E et al. Debunking myths about “allergy” to radiocontrast media in an academic institution. Postgrad Med. 2015 Apr;127(3):295-300.
4. Coakley FV and DM Panicek. Iodine allergy: An oyster without a pearl? AJR Am J Roentgenol. 1997 Oct;169(4):951-2.
5. American Academy of Allergy, Asthma & Immunology recommendations on low- or iso-osmolar radiocontrast media.
6. Schabelman E and M Witting. The relationship of radiocontrast, iodine, and seafood allergies: A medical myth exposed. J Emerg Med. 2010 Nov;39(5):701-7.
7. van Ketel WG and WH van den Berg. Sensitization to povidone-iodine. Dermatol Clin. 1990 Jan;8(1):107-9.
Meta-analysis highlights safety concerns with interleukin inhibition
MAUI, HAWAII – The use of interleukin inhibitors for treatment of rheumatologic diseases doubles a patient’s risk of serious infections, according to a comprehensive systematic review and meta-analysis of 74 randomized, placebo-controlled trials presented by Jawad Bilal, MBBS, at the 2020 Rheumatology Winter Clinical Symposium.
The meta-analysis, which incorporated 29,214 patients with a variety of rheumatic diseases, demonstrated that patients receiving interleukin (IL) inhibitors had a 1.97-fold increased risk of serious infections, a finding accompanied by a high degree of statistical certainty. The number-needed-to-harm was 67 patients treated for a median of 24 weeks in order to generate one additional serious infection.
“That number-needed-to-harm is a significant finding because having a serious infection means by definition you’re getting admitted to the hospital and receiving IV antibiotics,” Dr. Bilal observed in an interview.
The meta-analysis also found that IL inhibition was associated with a 2.35-fold increased risk of opportunistic infections and a 1.52-fold higher risk of developing cancer, both findings with statistical significance (P =.03) but only moderate certainty because fewer of those events were captured in the trials compared to the numbers of serious infections, explained Dr. Bilal of the University of Arizona, Tucson.
For opportunistic infections, the number-needed-to-harm was 250 patients treated with an IL inhibitor for a median of 54 weeks in order to result in one additional opportunistic infection. For cancer, the number-needed-to-harm was 250 for a median of 24 weeks.
Dr. Bilal noted that while the IL inhibitors are drugs of established efficacy in rheumatologic diseases, their safety has not previously undergone anything approaching the comprehensive scrutiny carried out in this meta-analysis. The meta-analysis, which included all published placebo-controlled randomized trials and their extension studies, employed rigorous methodology in accord with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) statement and the GRADE approach to data analysis. Studies of IL inhibitors in patients with dermatologic and GI diseases were excluded from the meta-analysis.
He offered a caveat regarding the cancer risk findings: “Our analysis showed that the cancer risk is increased, but the results are not conclusive because we only had a few years of data. With cancer, you really need at least 8-10 years of data. So the real-world experience with the interleukin inhibitors in the large registries is what’s going to tell if the cancer risk is really increased or not. In the meantime, we all have to be cautious.”
The number of serious infections collected in the meta-analysis afforded sufficient statistical power for the investigators to break down differential risks based on individual drugs and indications. Among the drugs associated with significantly increased risk of serious infections were anakinra, with an odds ratio of 2.67, compared with placebo; secukinumab with an OR of 2.43; and tocilizumab with an OR or 1.76. Ustekinumab and ixekizumab were associated with 2.57- and 3.89-fold increased risks, respectively, but the number of rheumatology patients treated with those two biologics wasn’t large enough for those findings to achieve statistical significance.
Rheumatoid arthritis patients who received an IL inhibitor rather than placebo had a 1.98-fold increased risk of serious infection, while those with psoriatic arthritis had a 2.21-fold increased risk. Patients treated for SLE had a 6.44-fold increased risk, and those with juvenile idiopathic arthritis had a 5.37-fold higher risk, but the margins for error were such that those results weren’t statistically significant.
“I think this study is going to help clinicians and patients when they’re trying to weigh the risks and benefits of IL inhibitors, especially if they already have risk factors, like a recent history of serious infection or a history of cancer or of opportunistic infection,” Dr. Bilal commented.
A study limitation was that he and his coinvestigators had to lump together the various IL inhibitors in order to gain statistical power, even though the drugs work differently, he noted.
Dr. Bilal reported having no financial conflicts regarding his study, the full details of which have been published (JAMA Netw Open. 2019 Oct 2. doi: 10.1001/jamanetworkopen.2019.13102).
MAUI, HAWAII – The use of interleukin inhibitors for treatment of rheumatologic diseases doubles a patient’s risk of serious infections, according to a comprehensive systematic review and meta-analysis of 74 randomized, placebo-controlled trials presented by Jawad Bilal, MBBS, at the 2020 Rheumatology Winter Clinical Symposium.
The meta-analysis, which incorporated 29,214 patients with a variety of rheumatic diseases, demonstrated that patients receiving interleukin (IL) inhibitors had a 1.97-fold increased risk of serious infections, a finding accompanied by a high degree of statistical certainty. The number-needed-to-harm was 67 patients treated for a median of 24 weeks in order to generate one additional serious infection.
“That number-needed-to-harm is a significant finding because having a serious infection means by definition you’re getting admitted to the hospital and receiving IV antibiotics,” Dr. Bilal observed in an interview.
The meta-analysis also found that IL inhibition was associated with a 2.35-fold increased risk of opportunistic infections and a 1.52-fold higher risk of developing cancer, both findings with statistical significance (P =.03) but only moderate certainty because fewer of those events were captured in the trials compared to the numbers of serious infections, explained Dr. Bilal of the University of Arizona, Tucson.
For opportunistic infections, the number-needed-to-harm was 250 patients treated with an IL inhibitor for a median of 54 weeks in order to result in one additional opportunistic infection. For cancer, the number-needed-to-harm was 250 for a median of 24 weeks.
Dr. Bilal noted that while the IL inhibitors are drugs of established efficacy in rheumatologic diseases, their safety has not previously undergone anything approaching the comprehensive scrutiny carried out in this meta-analysis. The meta-analysis, which included all published placebo-controlled randomized trials and their extension studies, employed rigorous methodology in accord with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) statement and the GRADE approach to data analysis. Studies of IL inhibitors in patients with dermatologic and GI diseases were excluded from the meta-analysis.
He offered a caveat regarding the cancer risk findings: “Our analysis showed that the cancer risk is increased, but the results are not conclusive because we only had a few years of data. With cancer, you really need at least 8-10 years of data. So the real-world experience with the interleukin inhibitors in the large registries is what’s going to tell if the cancer risk is really increased or not. In the meantime, we all have to be cautious.”
The number of serious infections collected in the meta-analysis afforded sufficient statistical power for the investigators to break down differential risks based on individual drugs and indications. Among the drugs associated with significantly increased risk of serious infections were anakinra, with an odds ratio of 2.67, compared with placebo; secukinumab with an OR of 2.43; and tocilizumab with an OR or 1.76. Ustekinumab and ixekizumab were associated with 2.57- and 3.89-fold increased risks, respectively, but the number of rheumatology patients treated with those two biologics wasn’t large enough for those findings to achieve statistical significance.
Rheumatoid arthritis patients who received an IL inhibitor rather than placebo had a 1.98-fold increased risk of serious infection, while those with psoriatic arthritis had a 2.21-fold increased risk. Patients treated for SLE had a 6.44-fold increased risk, and those with juvenile idiopathic arthritis had a 5.37-fold higher risk, but the margins for error were such that those results weren’t statistically significant.
“I think this study is going to help clinicians and patients when they’re trying to weigh the risks and benefits of IL inhibitors, especially if they already have risk factors, like a recent history of serious infection or a history of cancer or of opportunistic infection,” Dr. Bilal commented.
A study limitation was that he and his coinvestigators had to lump together the various IL inhibitors in order to gain statistical power, even though the drugs work differently, he noted.
Dr. Bilal reported having no financial conflicts regarding his study, the full details of which have been published (JAMA Netw Open. 2019 Oct 2. doi: 10.1001/jamanetworkopen.2019.13102).
MAUI, HAWAII – The use of interleukin inhibitors for treatment of rheumatologic diseases doubles a patient’s risk of serious infections, according to a comprehensive systematic review and meta-analysis of 74 randomized, placebo-controlled trials presented by Jawad Bilal, MBBS, at the 2020 Rheumatology Winter Clinical Symposium.
The meta-analysis, which incorporated 29,214 patients with a variety of rheumatic diseases, demonstrated that patients receiving interleukin (IL) inhibitors had a 1.97-fold increased risk of serious infections, a finding accompanied by a high degree of statistical certainty. The number-needed-to-harm was 67 patients treated for a median of 24 weeks in order to generate one additional serious infection.
“That number-needed-to-harm is a significant finding because having a serious infection means by definition you’re getting admitted to the hospital and receiving IV antibiotics,” Dr. Bilal observed in an interview.
The meta-analysis also found that IL inhibition was associated with a 2.35-fold increased risk of opportunistic infections and a 1.52-fold higher risk of developing cancer, both findings with statistical significance (P =.03) but only moderate certainty because fewer of those events were captured in the trials compared to the numbers of serious infections, explained Dr. Bilal of the University of Arizona, Tucson.
For opportunistic infections, the number-needed-to-harm was 250 patients treated with an IL inhibitor for a median of 54 weeks in order to result in one additional opportunistic infection. For cancer, the number-needed-to-harm was 250 for a median of 24 weeks.
Dr. Bilal noted that while the IL inhibitors are drugs of established efficacy in rheumatologic diseases, their safety has not previously undergone anything approaching the comprehensive scrutiny carried out in this meta-analysis. The meta-analysis, which included all published placebo-controlled randomized trials and their extension studies, employed rigorous methodology in accord with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) statement and the GRADE approach to data analysis. Studies of IL inhibitors in patients with dermatologic and GI diseases were excluded from the meta-analysis.
He offered a caveat regarding the cancer risk findings: “Our analysis showed that the cancer risk is increased, but the results are not conclusive because we only had a few years of data. With cancer, you really need at least 8-10 years of data. So the real-world experience with the interleukin inhibitors in the large registries is what’s going to tell if the cancer risk is really increased or not. In the meantime, we all have to be cautious.”
The number of serious infections collected in the meta-analysis afforded sufficient statistical power for the investigators to break down differential risks based on individual drugs and indications. Among the drugs associated with significantly increased risk of serious infections were anakinra, with an odds ratio of 2.67, compared with placebo; secukinumab with an OR of 2.43; and tocilizumab with an OR or 1.76. Ustekinumab and ixekizumab were associated with 2.57- and 3.89-fold increased risks, respectively, but the number of rheumatology patients treated with those two biologics wasn’t large enough for those findings to achieve statistical significance.
Rheumatoid arthritis patients who received an IL inhibitor rather than placebo had a 1.98-fold increased risk of serious infection, while those with psoriatic arthritis had a 2.21-fold increased risk. Patients treated for SLE had a 6.44-fold increased risk, and those with juvenile idiopathic arthritis had a 5.37-fold higher risk, but the margins for error were such that those results weren’t statistically significant.
“I think this study is going to help clinicians and patients when they’re trying to weigh the risks and benefits of IL inhibitors, especially if they already have risk factors, like a recent history of serious infection or a history of cancer or of opportunistic infection,” Dr. Bilal commented.
A study limitation was that he and his coinvestigators had to lump together the various IL inhibitors in order to gain statistical power, even though the drugs work differently, he noted.
Dr. Bilal reported having no financial conflicts regarding his study, the full details of which have been published (JAMA Netw Open. 2019 Oct 2. doi: 10.1001/jamanetworkopen.2019.13102).
REPORTING FROM RWCS 2020
HLA gene variant predicts anti-TNF antibodies in Crohn’s
MAUI, HAWAII – A variant in the human leukocyte antigen gene – DQA1*05 – almost doubled the risk of antibodies forming against tumor necrosis factor (TNF) inhibitors in Crohn’s disease patients, irrespective of concomitant immunomodulator use, according to a report in Gastroenterology.
“Pretreatment genetic testing for HLA-DQA1*05 may help personalize the choice of anti-TNF and the need for combination therapy,” concluded investigators led by Aleksejs Sazonovs, of the Wellcome Sanger Institute in Hinxton, England.
The same variant increases the risk of celiac disease, and it is included in commercial celiac genotyping assays. The allele is carried by about 40% of Europeans.
“This is turning into a hot topic; people are talking about it, [and it’s] blowing up on Twitter,” said Edward Loftus, MD, a professor and consultant in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn. “It turns out this is really a significant predictor of immunogenicity. Whatever your risk of developing antibodies, it’s going to double if you have this HLA marker, and it’s common.
“I think we are going to start [stratifying] our decision on combination [or] monotherapy based on this,” added Dr. Loftus, speaking at the Gastroenterology Updates, IBD, Liver Disease Conference. “I would argue that, if your patient has this marker, it would be criminal to give that patient infliximab monotherapy.”
The finding also begs the question of whether to bypass anti-TNFs altogether if a patient has the marker, Dr. Loftus noted, and just use ustekinumab, vedolizumab, or another agent.
Checking for celiac disease in inflammatory bowel disease isn’t unusual and involves the same gene variant, he added, so payer coverage shouldn’t be much of a problem.
The investigators ran a genome-wide association study on 1,418 biologic-naive Crohn’s patients starting infliximab or adalimumab therapy. Patients were in their 30s, on average, with a disease duration of about 3 years; there were about equal numbers of men and women.
A total of 44% of patients developed antidrug antibodies within a year. Overall, the rate of immunogenicity – defined as an antidrug antibody titer of at least 10 AU/mL – was nearly doubled in HLA-DQA1*05 carriers (hazard ratio, 1.90; 95% confidence interval, 1.60-2.25).
The association was consistent for patients treated with adalimumab (HR, 1.89; 95% CI, 1.32-2.70) or infliximab (HR, 1.92; 95% CI, 1.57-2.33) and for patients treated with anti-TNF therapy alone (HR, 1.75; 95% CI, 1.37-2.22) or in combination with an immunomodulator, usually azathioprine (HR, 2.01; 95% CI, 1.57-2.58).
The highest rates of immunogenicity, 92% at 1 year, were in HLA-DQA1*05 carriers on infliximab monotherapy. The lowest rates, 10% at 1 year, were in adalimumab patients on combination therapy who didn’t carry the variant. HLA-DQA1*05 was also associated with lower drug persistence rates.
The specific alleles HLA-DQA1*05:01 and HLA-DQA1*05:05 mediated most of the risk.
The study authors advised that “all patients treated with an anti-TNF should be prescribed an immunomodulator to lower the risk of immunogenicity.” Among HLA-DQA1*05 carriers “in whom immunomodulators are contraindicated or not tolerated, clinicians might advise against the use of anti-TNF drugs, particularly infliximab.”
In contrast, “patients who do not carry HLA-DQA1*05 might be given the choice between adalimumab or infliximab combination therapy,” the investigators said. “Patients without the risk allele and a history of adverse drug reactions to thiopurines and/or methotrexate, or who are at high risk of opportunistic infections, might be spared the additional risks of combination therapy and treated with adalimumab monotherapy.”
The mechanism for the association is unknown, the authors said.
The work was funded by the British Society of Gastroenterology, AbbVie, Merck, Pfizer, and others. The authors disclosed numerous ties to those or other pharmaceutical companies. Two authors were employees of AbbVie, marketer of the branded adalimumab Humira.
SOURCE: Sazonovs A et al. Gastroenterology. 2020 Jan;158(1):189-99.
MAUI, HAWAII – A variant in the human leukocyte antigen gene – DQA1*05 – almost doubled the risk of antibodies forming against tumor necrosis factor (TNF) inhibitors in Crohn’s disease patients, irrespective of concomitant immunomodulator use, according to a report in Gastroenterology.
“Pretreatment genetic testing for HLA-DQA1*05 may help personalize the choice of anti-TNF and the need for combination therapy,” concluded investigators led by Aleksejs Sazonovs, of the Wellcome Sanger Institute in Hinxton, England.
The same variant increases the risk of celiac disease, and it is included in commercial celiac genotyping assays. The allele is carried by about 40% of Europeans.
“This is turning into a hot topic; people are talking about it, [and it’s] blowing up on Twitter,” said Edward Loftus, MD, a professor and consultant in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn. “It turns out this is really a significant predictor of immunogenicity. Whatever your risk of developing antibodies, it’s going to double if you have this HLA marker, and it’s common.
“I think we are going to start [stratifying] our decision on combination [or] monotherapy based on this,” added Dr. Loftus, speaking at the Gastroenterology Updates, IBD, Liver Disease Conference. “I would argue that, if your patient has this marker, it would be criminal to give that patient infliximab monotherapy.”
The finding also begs the question of whether to bypass anti-TNFs altogether if a patient has the marker, Dr. Loftus noted, and just use ustekinumab, vedolizumab, or another agent.
Checking for celiac disease in inflammatory bowel disease isn’t unusual and involves the same gene variant, he added, so payer coverage shouldn’t be much of a problem.
The investigators ran a genome-wide association study on 1,418 biologic-naive Crohn’s patients starting infliximab or adalimumab therapy. Patients were in their 30s, on average, with a disease duration of about 3 years; there were about equal numbers of men and women.
A total of 44% of patients developed antidrug antibodies within a year. Overall, the rate of immunogenicity – defined as an antidrug antibody titer of at least 10 AU/mL – was nearly doubled in HLA-DQA1*05 carriers (hazard ratio, 1.90; 95% confidence interval, 1.60-2.25).
The association was consistent for patients treated with adalimumab (HR, 1.89; 95% CI, 1.32-2.70) or infliximab (HR, 1.92; 95% CI, 1.57-2.33) and for patients treated with anti-TNF therapy alone (HR, 1.75; 95% CI, 1.37-2.22) or in combination with an immunomodulator, usually azathioprine (HR, 2.01; 95% CI, 1.57-2.58).
The highest rates of immunogenicity, 92% at 1 year, were in HLA-DQA1*05 carriers on infliximab monotherapy. The lowest rates, 10% at 1 year, were in adalimumab patients on combination therapy who didn’t carry the variant. HLA-DQA1*05 was also associated with lower drug persistence rates.
The specific alleles HLA-DQA1*05:01 and HLA-DQA1*05:05 mediated most of the risk.
The study authors advised that “all patients treated with an anti-TNF should be prescribed an immunomodulator to lower the risk of immunogenicity.” Among HLA-DQA1*05 carriers “in whom immunomodulators are contraindicated or not tolerated, clinicians might advise against the use of anti-TNF drugs, particularly infliximab.”
In contrast, “patients who do not carry HLA-DQA1*05 might be given the choice between adalimumab or infliximab combination therapy,” the investigators said. “Patients without the risk allele and a history of adverse drug reactions to thiopurines and/or methotrexate, or who are at high risk of opportunistic infections, might be spared the additional risks of combination therapy and treated with adalimumab monotherapy.”
The mechanism for the association is unknown, the authors said.
The work was funded by the British Society of Gastroenterology, AbbVie, Merck, Pfizer, and others. The authors disclosed numerous ties to those or other pharmaceutical companies. Two authors were employees of AbbVie, marketer of the branded adalimumab Humira.
SOURCE: Sazonovs A et al. Gastroenterology. 2020 Jan;158(1):189-99.
MAUI, HAWAII – A variant in the human leukocyte antigen gene – DQA1*05 – almost doubled the risk of antibodies forming against tumor necrosis factor (TNF) inhibitors in Crohn’s disease patients, irrespective of concomitant immunomodulator use, according to a report in Gastroenterology.
“Pretreatment genetic testing for HLA-DQA1*05 may help personalize the choice of anti-TNF and the need for combination therapy,” concluded investigators led by Aleksejs Sazonovs, of the Wellcome Sanger Institute in Hinxton, England.
The same variant increases the risk of celiac disease, and it is included in commercial celiac genotyping assays. The allele is carried by about 40% of Europeans.
“This is turning into a hot topic; people are talking about it, [and it’s] blowing up on Twitter,” said Edward Loftus, MD, a professor and consultant in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn. “It turns out this is really a significant predictor of immunogenicity. Whatever your risk of developing antibodies, it’s going to double if you have this HLA marker, and it’s common.
“I think we are going to start [stratifying] our decision on combination [or] monotherapy based on this,” added Dr. Loftus, speaking at the Gastroenterology Updates, IBD, Liver Disease Conference. “I would argue that, if your patient has this marker, it would be criminal to give that patient infliximab monotherapy.”
The finding also begs the question of whether to bypass anti-TNFs altogether if a patient has the marker, Dr. Loftus noted, and just use ustekinumab, vedolizumab, or another agent.
Checking for celiac disease in inflammatory bowel disease isn’t unusual and involves the same gene variant, he added, so payer coverage shouldn’t be much of a problem.
The investigators ran a genome-wide association study on 1,418 biologic-naive Crohn’s patients starting infliximab or adalimumab therapy. Patients were in their 30s, on average, with a disease duration of about 3 years; there were about equal numbers of men and women.
A total of 44% of patients developed antidrug antibodies within a year. Overall, the rate of immunogenicity – defined as an antidrug antibody titer of at least 10 AU/mL – was nearly doubled in HLA-DQA1*05 carriers (hazard ratio, 1.90; 95% confidence interval, 1.60-2.25).
The association was consistent for patients treated with adalimumab (HR, 1.89; 95% CI, 1.32-2.70) or infliximab (HR, 1.92; 95% CI, 1.57-2.33) and for patients treated with anti-TNF therapy alone (HR, 1.75; 95% CI, 1.37-2.22) or in combination with an immunomodulator, usually azathioprine (HR, 2.01; 95% CI, 1.57-2.58).
The highest rates of immunogenicity, 92% at 1 year, were in HLA-DQA1*05 carriers on infliximab monotherapy. The lowest rates, 10% at 1 year, were in adalimumab patients on combination therapy who didn’t carry the variant. HLA-DQA1*05 was also associated with lower drug persistence rates.
The specific alleles HLA-DQA1*05:01 and HLA-DQA1*05:05 mediated most of the risk.
The study authors advised that “all patients treated with an anti-TNF should be prescribed an immunomodulator to lower the risk of immunogenicity.” Among HLA-DQA1*05 carriers “in whom immunomodulators are contraindicated or not tolerated, clinicians might advise against the use of anti-TNF drugs, particularly infliximab.”
In contrast, “patients who do not carry HLA-DQA1*05 might be given the choice between adalimumab or infliximab combination therapy,” the investigators said. “Patients without the risk allele and a history of adverse drug reactions to thiopurines and/or methotrexate, or who are at high risk of opportunistic infections, might be spared the additional risks of combination therapy and treated with adalimumab monotherapy.”
The mechanism for the association is unknown, the authors said.
The work was funded by the British Society of Gastroenterology, AbbVie, Merck, Pfizer, and others. The authors disclosed numerous ties to those or other pharmaceutical companies. Two authors were employees of AbbVie, marketer of the branded adalimumab Humira.
SOURCE: Sazonovs A et al. Gastroenterology. 2020 Jan;158(1):189-99.
REPORTING FROM GUILD 2020
Expert: Eliminating HCV ‘sounds ambitious, but I think it’s possible’
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
REPORTING FROM NPA 2020
Crohn’s & Colitis Congress has passed, DDW ahead
In late January, the Crohn’s & Colitis Foundation teamed with AGA to present the Crohn’s & Colitis Congress® in Austin, Tex. Each year, this is the premier gathering for IBD experts and the rest of us to catch up on the substantial progress we are making in treating patients with IBD. This month, we highlight a number of articles from the Congress, including results showing how a focused IBD quality initiative reduced emergency department visits, an article about the effects of IBD on fertility, and the link between stress and ulcerative colitis flares. All of these articles are worth reading, since they can help our care of patients. On agau.gastro.org, you can access slides from the Congress.
Several more articles deserve mention. Three articles from the AGA journals highlight new information about colorectal cancer prevention and the U.S. Multi-Society Task Force on Colorectal Cancer has updated colonoscopy follow-up guidance. In our practice management section, we provide a step-by-step guide to changes in evaluation and management (E/M) coding – these changes are the most impactful since the Medicare E/M documentation specifications first appeared.
We have 2 months left before Digestive Disease Week® (DDW). Each year, DDW marks the end of our AGA Institute President’s term and the beginning of another’s epoch. Hashem B. El-Serag will pass the gavel to Bishr Omary – both great friends and great gastroenterologists. I am happy to see that Gail Hecht follows me as this year’s AGA Julius Friedenwald Medal recipient (AGA’s highest honor). She, too, is a great friend and role model for me and many others. DDW returns to Chicago in early May, and once again will be the world’s best gathering of physicians and scientists dedicated to digestive diseases.
John I. Allen, MD, MBA, AGAF
Editor in Chief
In late January, the Crohn’s & Colitis Foundation teamed with AGA to present the Crohn’s & Colitis Congress® in Austin, Tex. Each year, this is the premier gathering for IBD experts and the rest of us to catch up on the substantial progress we are making in treating patients with IBD. This month, we highlight a number of articles from the Congress, including results showing how a focused IBD quality initiative reduced emergency department visits, an article about the effects of IBD on fertility, and the link between stress and ulcerative colitis flares. All of these articles are worth reading, since they can help our care of patients. On agau.gastro.org, you can access slides from the Congress.
Several more articles deserve mention. Three articles from the AGA journals highlight new information about colorectal cancer prevention and the U.S. Multi-Society Task Force on Colorectal Cancer has updated colonoscopy follow-up guidance. In our practice management section, we provide a step-by-step guide to changes in evaluation and management (E/M) coding – these changes are the most impactful since the Medicare E/M documentation specifications first appeared.
We have 2 months left before Digestive Disease Week® (DDW). Each year, DDW marks the end of our AGA Institute President’s term and the beginning of another’s epoch. Hashem B. El-Serag will pass the gavel to Bishr Omary – both great friends and great gastroenterologists. I am happy to see that Gail Hecht follows me as this year’s AGA Julius Friedenwald Medal recipient (AGA’s highest honor). She, too, is a great friend and role model for me and many others. DDW returns to Chicago in early May, and once again will be the world’s best gathering of physicians and scientists dedicated to digestive diseases.
John I. Allen, MD, MBA, AGAF
Editor in Chief
In late January, the Crohn’s & Colitis Foundation teamed with AGA to present the Crohn’s & Colitis Congress® in Austin, Tex. Each year, this is the premier gathering for IBD experts and the rest of us to catch up on the substantial progress we are making in treating patients with IBD. This month, we highlight a number of articles from the Congress, including results showing how a focused IBD quality initiative reduced emergency department visits, an article about the effects of IBD on fertility, and the link between stress and ulcerative colitis flares. All of these articles are worth reading, since they can help our care of patients. On agau.gastro.org, you can access slides from the Congress.
Several more articles deserve mention. Three articles from the AGA journals highlight new information about colorectal cancer prevention and the U.S. Multi-Society Task Force on Colorectal Cancer has updated colonoscopy follow-up guidance. In our practice management section, we provide a step-by-step guide to changes in evaluation and management (E/M) coding – these changes are the most impactful since the Medicare E/M documentation specifications first appeared.
We have 2 months left before Digestive Disease Week® (DDW). Each year, DDW marks the end of our AGA Institute President’s term and the beginning of another’s epoch. Hashem B. El-Serag will pass the gavel to Bishr Omary – both great friends and great gastroenterologists. I am happy to see that Gail Hecht follows me as this year’s AGA Julius Friedenwald Medal recipient (AGA’s highest honor). She, too, is a great friend and role model for me and many others. DDW returns to Chicago in early May, and once again will be the world’s best gathering of physicians and scientists dedicated to digestive diseases.
John I. Allen, MD, MBA, AGAF
Editor in Chief
Incidence of cardiovascular events is doubled in patients with MS
WEST PALM BEACH, FLA. – The incidence rate of many cardiovascular events is more than doubled in patients with multiple sclerosis (MS), compared with matched controls without MS, according to a study presented at ACTRIMS Forum 2020. The risk of a major adverse cardiac event (MACE) – that is, a first myocardial infarction, stroke, or cardiac arrest – is approximately twofold higher. Venous thromboembolism and peripheral vascular disease also occur at notably increased rates, reported Rebecca Persson, MPH, and colleagues at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Ms. Persson is an epidemiologist at the Boston Collaborative Drug Surveillance Program in Lexington, Mass.
Vascular comorbidities are more prevalent in patients with MS than in the general population, but few studies have reported on the incidence of cardiovascular disease after MS diagnosis. To describe rates of incident cardiovascular disease after MS diagnosis and compare them with rates in a matched population without MS, the researchers analyzed data from a U.S. Department of Defense database.
The study included a cohort of 6,406 patients with MS diagnosed and treated during Jan. 2004–Aug. 2017 who had at least one prescription for an MS disease-modifying treatment.
A cohort of 66,281 patients without MS were matched to the patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. The researchers excluded patients with a history of cardiovascular disease or select comorbidities such as dyslipidemia, atrial fibrillation, or a disorder related to peripheral vascular disease. They also excluded patients with a history of treated hypertension or treated type 2 diabetes, defined as diagnosis and treatment within 90 days of each other.
Researchers considered a patient to have a cardiovascular disease outcome – including MI, stroke, cardiac arrest, heart failure, angina or unspecified ischemic heart disease, transient ischemic attack or unspecified cerebrovascular disease, venous thromboembolism, peripheral vascular disease, pericardial disease, bradycardia or heart block, or arrhythmia other than atrial fibrillation or atrial flutter – if the disease was recorded five or more times.
The researchers followed patients from cohort entry until study outcome (separate for each outcome), loss of eligibility, death, or end of data collection. Ms. Persson and colleagues calculated incidence rates (IRs) using the Byar method and incidence rate ratios (IRRs) using Poisson regression for each outcome.
The median age at MS diagnosis or at the matched date was 38 years, and 71% were female. The median duration of record after patients entered the cohort was 7.2 years for patients with MS and 5.3 years for patients without MS.
The IRs of all cardiovascular disease types, with the exception of bradycardia or heart block, were higher for patients with MS, compared with non-MS patients, the researchers reported. Many cardiovascular disease outcomes had IRRs greater than 2. “The incidence of MI was higher among MS patients than among non-MS patients,” the researchers said (IR, 12.4 vs. 5.9 per 10,000 person-years; IRR, 2.11).
“Risk of MACE and risk of stroke were higher among MS patients than among non-MS patients,” the researchers said. Relative risks also were higher among women than among men (2.47 vs. 1.55 for MACE, and 2.19 vs. 1.71 for stroke). When the investigators performed a sensitivity analysis to address the possibility that physicians might misdiagnosis MS symptoms as stroke, the rate of stroke was attenuated among patients with MS, but remained elevated relative to the rate among patients without MS (IRR, 1.63).
The IR of venous thromboembolism was more than 2 times higher among patients with MS than among non-MS patients (38.4 vs. 15.1 per 10,000 person-years; IRR, 2.54), as was the risk of peripheral vascular disease (14.9 vs. 6.0 per 10,000 person-years; IRR, 2.49). The relative risk of peripheral vascular disease was higher in women than men, and the risk in patients with MS increased after age 40 years.
The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four of Ms. Persson’s coauthors are employees of BMS, and one works for a company that has a business relationship with Celgene.
SOURCE: Persson R et al. ACTRIMS Forum 2020. Abstract P082.
WEST PALM BEACH, FLA. – The incidence rate of many cardiovascular events is more than doubled in patients with multiple sclerosis (MS), compared with matched controls without MS, according to a study presented at ACTRIMS Forum 2020. The risk of a major adverse cardiac event (MACE) – that is, a first myocardial infarction, stroke, or cardiac arrest – is approximately twofold higher. Venous thromboembolism and peripheral vascular disease also occur at notably increased rates, reported Rebecca Persson, MPH, and colleagues at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Ms. Persson is an epidemiologist at the Boston Collaborative Drug Surveillance Program in Lexington, Mass.
Vascular comorbidities are more prevalent in patients with MS than in the general population, but few studies have reported on the incidence of cardiovascular disease after MS diagnosis. To describe rates of incident cardiovascular disease after MS diagnosis and compare them with rates in a matched population without MS, the researchers analyzed data from a U.S. Department of Defense database.
The study included a cohort of 6,406 patients with MS diagnosed and treated during Jan. 2004–Aug. 2017 who had at least one prescription for an MS disease-modifying treatment.
A cohort of 66,281 patients without MS were matched to the patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. The researchers excluded patients with a history of cardiovascular disease or select comorbidities such as dyslipidemia, atrial fibrillation, or a disorder related to peripheral vascular disease. They also excluded patients with a history of treated hypertension or treated type 2 diabetes, defined as diagnosis and treatment within 90 days of each other.
Researchers considered a patient to have a cardiovascular disease outcome – including MI, stroke, cardiac arrest, heart failure, angina or unspecified ischemic heart disease, transient ischemic attack or unspecified cerebrovascular disease, venous thromboembolism, peripheral vascular disease, pericardial disease, bradycardia or heart block, or arrhythmia other than atrial fibrillation or atrial flutter – if the disease was recorded five or more times.
The researchers followed patients from cohort entry until study outcome (separate for each outcome), loss of eligibility, death, or end of data collection. Ms. Persson and colleagues calculated incidence rates (IRs) using the Byar method and incidence rate ratios (IRRs) using Poisson regression for each outcome.
The median age at MS diagnosis or at the matched date was 38 years, and 71% were female. The median duration of record after patients entered the cohort was 7.2 years for patients with MS and 5.3 years for patients without MS.
The IRs of all cardiovascular disease types, with the exception of bradycardia or heart block, were higher for patients with MS, compared with non-MS patients, the researchers reported. Many cardiovascular disease outcomes had IRRs greater than 2. “The incidence of MI was higher among MS patients than among non-MS patients,” the researchers said (IR, 12.4 vs. 5.9 per 10,000 person-years; IRR, 2.11).
“Risk of MACE and risk of stroke were higher among MS patients than among non-MS patients,” the researchers said. Relative risks also were higher among women than among men (2.47 vs. 1.55 for MACE, and 2.19 vs. 1.71 for stroke). When the investigators performed a sensitivity analysis to address the possibility that physicians might misdiagnosis MS symptoms as stroke, the rate of stroke was attenuated among patients with MS, but remained elevated relative to the rate among patients without MS (IRR, 1.63).
The IR of venous thromboembolism was more than 2 times higher among patients with MS than among non-MS patients (38.4 vs. 15.1 per 10,000 person-years; IRR, 2.54), as was the risk of peripheral vascular disease (14.9 vs. 6.0 per 10,000 person-years; IRR, 2.49). The relative risk of peripheral vascular disease was higher in women than men, and the risk in patients with MS increased after age 40 years.
The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four of Ms. Persson’s coauthors are employees of BMS, and one works for a company that has a business relationship with Celgene.
SOURCE: Persson R et al. ACTRIMS Forum 2020. Abstract P082.
WEST PALM BEACH, FLA. – The incidence rate of many cardiovascular events is more than doubled in patients with multiple sclerosis (MS), compared with matched controls without MS, according to a study presented at ACTRIMS Forum 2020. The risk of a major adverse cardiac event (MACE) – that is, a first myocardial infarction, stroke, or cardiac arrest – is approximately twofold higher. Venous thromboembolism and peripheral vascular disease also occur at notably increased rates, reported Rebecca Persson, MPH, and colleagues at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Ms. Persson is an epidemiologist at the Boston Collaborative Drug Surveillance Program in Lexington, Mass.
Vascular comorbidities are more prevalent in patients with MS than in the general population, but few studies have reported on the incidence of cardiovascular disease after MS diagnosis. To describe rates of incident cardiovascular disease after MS diagnosis and compare them with rates in a matched population without MS, the researchers analyzed data from a U.S. Department of Defense database.
The study included a cohort of 6,406 patients with MS diagnosed and treated during Jan. 2004–Aug. 2017 who had at least one prescription for an MS disease-modifying treatment.
A cohort of 66,281 patients without MS were matched to the patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. The researchers excluded patients with a history of cardiovascular disease or select comorbidities such as dyslipidemia, atrial fibrillation, or a disorder related to peripheral vascular disease. They also excluded patients with a history of treated hypertension or treated type 2 diabetes, defined as diagnosis and treatment within 90 days of each other.
Researchers considered a patient to have a cardiovascular disease outcome – including MI, stroke, cardiac arrest, heart failure, angina or unspecified ischemic heart disease, transient ischemic attack or unspecified cerebrovascular disease, venous thromboembolism, peripheral vascular disease, pericardial disease, bradycardia or heart block, or arrhythmia other than atrial fibrillation or atrial flutter – if the disease was recorded five or more times.
The researchers followed patients from cohort entry until study outcome (separate for each outcome), loss of eligibility, death, or end of data collection. Ms. Persson and colleagues calculated incidence rates (IRs) using the Byar method and incidence rate ratios (IRRs) using Poisson regression for each outcome.
The median age at MS diagnosis or at the matched date was 38 years, and 71% were female. The median duration of record after patients entered the cohort was 7.2 years for patients with MS and 5.3 years for patients without MS.
The IRs of all cardiovascular disease types, with the exception of bradycardia or heart block, were higher for patients with MS, compared with non-MS patients, the researchers reported. Many cardiovascular disease outcomes had IRRs greater than 2. “The incidence of MI was higher among MS patients than among non-MS patients,” the researchers said (IR, 12.4 vs. 5.9 per 10,000 person-years; IRR, 2.11).
“Risk of MACE and risk of stroke were higher among MS patients than among non-MS patients,” the researchers said. Relative risks also were higher among women than among men (2.47 vs. 1.55 for MACE, and 2.19 vs. 1.71 for stroke). When the investigators performed a sensitivity analysis to address the possibility that physicians might misdiagnosis MS symptoms as stroke, the rate of stroke was attenuated among patients with MS, but remained elevated relative to the rate among patients without MS (IRR, 1.63).
The IR of venous thromboembolism was more than 2 times higher among patients with MS than among non-MS patients (38.4 vs. 15.1 per 10,000 person-years; IRR, 2.54), as was the risk of peripheral vascular disease (14.9 vs. 6.0 per 10,000 person-years; IRR, 2.49). The relative risk of peripheral vascular disease was higher in women than men, and the risk in patients with MS increased after age 40 years.
The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four of Ms. Persson’s coauthors are employees of BMS, and one works for a company that has a business relationship with Celgene.
SOURCE: Persson R et al. ACTRIMS Forum 2020. Abstract P082.
REPORTING FROM ACTRIMS FORUM 2020
Oncology dominates clinical trial landscape
Oncology will account for a substantial majority of clinical trials to be launched in 2020, as well as accounting for most of those to be completed this year, according to a new analysis.
“A large number of early stage clinical trials within this field are likely to be due to the demand for novel therapeutic approaches addressing unmet medical need,” commented Mohamed Abukar, pharma analyst at GlobalData.
Most oncology studies planned to start in 2020 are phase 1 and 2, and 61.9% are industry sponsored. Eli Lilly and Novartis have announced the most upcoming studies.
Among the new drugs being evaluated in these clinical trials, four of the top seven drugs in phase 1–3 development are monoclonal antibodies, with the most studies being conducted on the experimental agents ZW25 (Zymeworks) and KSI-301 (Kodiak Sciences), the report notes.
As for clinical trials due for completion this year, many are funded by nonindustry sources, with Memorial Sloan Kettering Cancer Center accounting for the most number of trials.
Top Indications Explored in Clinical Trials
Oncology also accounts for eight of the top ten indications for clinical trials planned to start in 2020, with solid tumors, breast cancer, and non–small cell lung cancer accounting for the second, third, and fourth top spots, respectively, regardless of sponsor type.
However, for industry-sponsored clinical trials, the predominant area is solid tumors for new investigations to start this year, followed by breast cancer, then pain.
“This is attributed to the manner in which the burden of cancer worldwide necessitates industry investment to allow for capitalization on the increasing market size,” Abukar said.
This article first appeared on Medscape.com.
Oncology will account for a substantial majority of clinical trials to be launched in 2020, as well as accounting for most of those to be completed this year, according to a new analysis.
“A large number of early stage clinical trials within this field are likely to be due to the demand for novel therapeutic approaches addressing unmet medical need,” commented Mohamed Abukar, pharma analyst at GlobalData.
Most oncology studies planned to start in 2020 are phase 1 and 2, and 61.9% are industry sponsored. Eli Lilly and Novartis have announced the most upcoming studies.
Among the new drugs being evaluated in these clinical trials, four of the top seven drugs in phase 1–3 development are monoclonal antibodies, with the most studies being conducted on the experimental agents ZW25 (Zymeworks) and KSI-301 (Kodiak Sciences), the report notes.
As for clinical trials due for completion this year, many are funded by nonindustry sources, with Memorial Sloan Kettering Cancer Center accounting for the most number of trials.
Top Indications Explored in Clinical Trials
Oncology also accounts for eight of the top ten indications for clinical trials planned to start in 2020, with solid tumors, breast cancer, and non–small cell lung cancer accounting for the second, third, and fourth top spots, respectively, regardless of sponsor type.
However, for industry-sponsored clinical trials, the predominant area is solid tumors for new investigations to start this year, followed by breast cancer, then pain.
“This is attributed to the manner in which the burden of cancer worldwide necessitates industry investment to allow for capitalization on the increasing market size,” Abukar said.
This article first appeared on Medscape.com.
Oncology will account for a substantial majority of clinical trials to be launched in 2020, as well as accounting for most of those to be completed this year, according to a new analysis.
“A large number of early stage clinical trials within this field are likely to be due to the demand for novel therapeutic approaches addressing unmet medical need,” commented Mohamed Abukar, pharma analyst at GlobalData.
Most oncology studies planned to start in 2020 are phase 1 and 2, and 61.9% are industry sponsored. Eli Lilly and Novartis have announced the most upcoming studies.
Among the new drugs being evaluated in these clinical trials, four of the top seven drugs in phase 1–3 development are monoclonal antibodies, with the most studies being conducted on the experimental agents ZW25 (Zymeworks) and KSI-301 (Kodiak Sciences), the report notes.
As for clinical trials due for completion this year, many are funded by nonindustry sources, with Memorial Sloan Kettering Cancer Center accounting for the most number of trials.
Top Indications Explored in Clinical Trials
Oncology also accounts for eight of the top ten indications for clinical trials planned to start in 2020, with solid tumors, breast cancer, and non–small cell lung cancer accounting for the second, third, and fourth top spots, respectively, regardless of sponsor type.
However, for industry-sponsored clinical trials, the predominant area is solid tumors for new investigations to start this year, followed by breast cancer, then pain.
“This is attributed to the manner in which the burden of cancer worldwide necessitates industry investment to allow for capitalization on the increasing market size,” Abukar said.
This article first appeared on Medscape.com.
Cutaneous Collagenous Vasculopathy
To the Editor:
Cutaneous collagenous vasculopathy (CCV) is a rare idiopathic microangiopathy characterized by diffuse blanchable telangiectases that usually develop in late adulthood. It appears morphologically identical to generalized essential telangiectasia (GET), but skin biopsy characteristically shows dilated superficial blood vessels in the papillary dermis that are surrounded by a thickened layer of type IV collagen.1 We report a case of CCV occurring in an elderly white man.
A 72-year-old man presented with an asymptomatic rash on the arms, legs, and abdomen of 3 years’ duration. His medical history was remarkable for hypothyroidism, hypertension, reflex sympathetic dystrophy syndrome, coronary artery disease, and nonmelanoma skin cancer. He denied any changes in medications or illnesses prior to onset of the rash. Physical examination revealed diffuse, erythematous, blanchable telangiectases on the arms, legs, and trunk (Figure 1). No petechiae, atrophy, or epidermal changes were appreciated. Darier sign was negative.
Hematoxylin and eosin–stained sections of skin from the abdomen showed an unremarkable epidermis overlying a superficial dermis with dilated blood vessels with thickened walls that contained eosinophilic amorphous hyaline material (Figure 2A). This material stained positive with Masson trichrome (Figure 2B), a finding that was consistent with increased collagen fiber deposition within the vessel walls. Phosphotungstic acid–hematoxylin and Congo red stains were negative. No histologic features of a vaso-occlusive disorder or vasculitis were identified. These histologic findings were consistent with the rare diagnosis of CCV.
Cutaneous collagenous vasculopathy is a rare idiopathic microangiopathy that was first reported by Salama and Rosenthal1 in 2000. They reported the case of a 54-year-old man with spreading, asymptomatic, generalized cutaneous telangiectases of 5 years’ duration. Similar to our patient, skin biopsy showed dilated superficial dermal vasculature with deposition of eosinophilic hyaline material, which stained positive with periodic acid–Schiff with diastase and exhibited immunoreactivity to type IV collagen.1
A PubMed search of articles indexed for MEDLINE using the search term cutaneous collagenous vasculopathy yielded 19 additional patients with biopsy-proven CCV.2-6 The condition has shown no gender prevalence but generally is seen in middle-aged or elderly white individuals, with the exception of a white pediatric patient.4 Cutaneous collagenous vasculopathy usually presents as telangiectases on the legs that progress to involve the trunk and arms while sparing the head and neck, nail beds, and mucous membranes.5 However, it also has been described as first presenting on the bilateral breasts2 as well as a nonprogressive localization on the thigh.6
Skin biopsy is essential to differentiate CCV from GET, which appears morphologically identical. Cutaneous collagenous vasculopathy may be underreported as a result of clinician choice not to biopsy due to a presumptive diagnosis of GET.3 Successful treatment with a pulsed dye laser has been reported,7 though the extent of disease may make complete destruction of the lesions difficult to accomplish. Although it is theorized that CCV may be a marker for underlying systemic disease or even a genetic defect causing abnormal collagen deposition, its cause has yet to be ascertained.5 Previously reported patients have had a variety of comorbidities, including several cases of type 2 diabetes mellitus.6 Another patient was reported to have recently started treatment with an angiotensin receptor blocker prior to onset of CCV.5
Our case contributes to the small series of reported patients with this rare diagnosis and further suggests that it may be underreported at this time. Similar to previously reported cases, our patient was an elderly white individual. Although our patient had long-standing iatrogenic hypothyroidism, no recent medication changes or underlying comorbidities could be tied to the development of CCV. Further studies are needed to determine if this disease process is associated with any underlying systemic illnesses, medications, or family history.
- Salama S, Rosenthal D. Cutaneous collagenous vasculopathy with generalized telangiectasia: an immunohistochemical and ultrastructural study. J Cutan Pathol. 2000;27:40-48.
- Borroni RG, Derlino F, Agozzino M, et al. Hypothermic cutaneous collagenous vasculopathy with centrifugal spreading [published online March 31, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1444-1446.
- Moulonguet I, Hershkovitch D, Fraitag S. Widespread cutaneous telangiectasias: challenge. Am J Dermatopathol. 2013;35:661-662, 688-669.
- Lloyd BM, Pruden SJ 2nd, Lind AC, et al. Cutaneous collagenous vasculopathy: report of the first pediatric case. Pediatr Dermatol. 2011;28:598-599.
- Kanitakis J, Faisant M, Wagschal D, et al. Cutaneous collagenous vasculopathy: ultrastructural and immunohistochemical study of a new case. Am J Clin Dermatol. 2010;11:63-66.
- Davis TL, Mandal RV, Bevona C, et al. Collagenous vasculopathy: a report of three cases. J Cutan Pathol. 2008;35:967-970.
- Echeverría B, Sanmartín O, Botella-Estrada R, et al. Cutaneous collagenous vasculopathy successfully treated with pulsed dye laser. Int J Dermatol. 2012;51:1359-1362.
To the Editor:
Cutaneous collagenous vasculopathy (CCV) is a rare idiopathic microangiopathy characterized by diffuse blanchable telangiectases that usually develop in late adulthood. It appears morphologically identical to generalized essential telangiectasia (GET), but skin biopsy characteristically shows dilated superficial blood vessels in the papillary dermis that are surrounded by a thickened layer of type IV collagen.1 We report a case of CCV occurring in an elderly white man.
A 72-year-old man presented with an asymptomatic rash on the arms, legs, and abdomen of 3 years’ duration. His medical history was remarkable for hypothyroidism, hypertension, reflex sympathetic dystrophy syndrome, coronary artery disease, and nonmelanoma skin cancer. He denied any changes in medications or illnesses prior to onset of the rash. Physical examination revealed diffuse, erythematous, blanchable telangiectases on the arms, legs, and trunk (Figure 1). No petechiae, atrophy, or epidermal changes were appreciated. Darier sign was negative.
Hematoxylin and eosin–stained sections of skin from the abdomen showed an unremarkable epidermis overlying a superficial dermis with dilated blood vessels with thickened walls that contained eosinophilic amorphous hyaline material (Figure 2A). This material stained positive with Masson trichrome (Figure 2B), a finding that was consistent with increased collagen fiber deposition within the vessel walls. Phosphotungstic acid–hematoxylin and Congo red stains were negative. No histologic features of a vaso-occlusive disorder or vasculitis were identified. These histologic findings were consistent with the rare diagnosis of CCV.
Cutaneous collagenous vasculopathy is a rare idiopathic microangiopathy that was first reported by Salama and Rosenthal1 in 2000. They reported the case of a 54-year-old man with spreading, asymptomatic, generalized cutaneous telangiectases of 5 years’ duration. Similar to our patient, skin biopsy showed dilated superficial dermal vasculature with deposition of eosinophilic hyaline material, which stained positive with periodic acid–Schiff with diastase and exhibited immunoreactivity to type IV collagen.1
A PubMed search of articles indexed for MEDLINE using the search term cutaneous collagenous vasculopathy yielded 19 additional patients with biopsy-proven CCV.2-6 The condition has shown no gender prevalence but generally is seen in middle-aged or elderly white individuals, with the exception of a white pediatric patient.4 Cutaneous collagenous vasculopathy usually presents as telangiectases on the legs that progress to involve the trunk and arms while sparing the head and neck, nail beds, and mucous membranes.5 However, it also has been described as first presenting on the bilateral breasts2 as well as a nonprogressive localization on the thigh.6
Skin biopsy is essential to differentiate CCV from GET, which appears morphologically identical. Cutaneous collagenous vasculopathy may be underreported as a result of clinician choice not to biopsy due to a presumptive diagnosis of GET.3 Successful treatment with a pulsed dye laser has been reported,7 though the extent of disease may make complete destruction of the lesions difficult to accomplish. Although it is theorized that CCV may be a marker for underlying systemic disease or even a genetic defect causing abnormal collagen deposition, its cause has yet to be ascertained.5 Previously reported patients have had a variety of comorbidities, including several cases of type 2 diabetes mellitus.6 Another patient was reported to have recently started treatment with an angiotensin receptor blocker prior to onset of CCV.5
Our case contributes to the small series of reported patients with this rare diagnosis and further suggests that it may be underreported at this time. Similar to previously reported cases, our patient was an elderly white individual. Although our patient had long-standing iatrogenic hypothyroidism, no recent medication changes or underlying comorbidities could be tied to the development of CCV. Further studies are needed to determine if this disease process is associated with any underlying systemic illnesses, medications, or family history.
To the Editor:
Cutaneous collagenous vasculopathy (CCV) is a rare idiopathic microangiopathy characterized by diffuse blanchable telangiectases that usually develop in late adulthood. It appears morphologically identical to generalized essential telangiectasia (GET), but skin biopsy characteristically shows dilated superficial blood vessels in the papillary dermis that are surrounded by a thickened layer of type IV collagen.1 We report a case of CCV occurring in an elderly white man.
A 72-year-old man presented with an asymptomatic rash on the arms, legs, and abdomen of 3 years’ duration. His medical history was remarkable for hypothyroidism, hypertension, reflex sympathetic dystrophy syndrome, coronary artery disease, and nonmelanoma skin cancer. He denied any changes in medications or illnesses prior to onset of the rash. Physical examination revealed diffuse, erythematous, blanchable telangiectases on the arms, legs, and trunk (Figure 1). No petechiae, atrophy, or epidermal changes were appreciated. Darier sign was negative.
Hematoxylin and eosin–stained sections of skin from the abdomen showed an unremarkable epidermis overlying a superficial dermis with dilated blood vessels with thickened walls that contained eosinophilic amorphous hyaline material (Figure 2A). This material stained positive with Masson trichrome (Figure 2B), a finding that was consistent with increased collagen fiber deposition within the vessel walls. Phosphotungstic acid–hematoxylin and Congo red stains were negative. No histologic features of a vaso-occlusive disorder or vasculitis were identified. These histologic findings were consistent with the rare diagnosis of CCV.
Cutaneous collagenous vasculopathy is a rare idiopathic microangiopathy that was first reported by Salama and Rosenthal1 in 2000. They reported the case of a 54-year-old man with spreading, asymptomatic, generalized cutaneous telangiectases of 5 years’ duration. Similar to our patient, skin biopsy showed dilated superficial dermal vasculature with deposition of eosinophilic hyaline material, which stained positive with periodic acid–Schiff with diastase and exhibited immunoreactivity to type IV collagen.1
A PubMed search of articles indexed for MEDLINE using the search term cutaneous collagenous vasculopathy yielded 19 additional patients with biopsy-proven CCV.2-6 The condition has shown no gender prevalence but generally is seen in middle-aged or elderly white individuals, with the exception of a white pediatric patient.4 Cutaneous collagenous vasculopathy usually presents as telangiectases on the legs that progress to involve the trunk and arms while sparing the head and neck, nail beds, and mucous membranes.5 However, it also has been described as first presenting on the bilateral breasts2 as well as a nonprogressive localization on the thigh.6
Skin biopsy is essential to differentiate CCV from GET, which appears morphologically identical. Cutaneous collagenous vasculopathy may be underreported as a result of clinician choice not to biopsy due to a presumptive diagnosis of GET.3 Successful treatment with a pulsed dye laser has been reported,7 though the extent of disease may make complete destruction of the lesions difficult to accomplish. Although it is theorized that CCV may be a marker for underlying systemic disease or even a genetic defect causing abnormal collagen deposition, its cause has yet to be ascertained.5 Previously reported patients have had a variety of comorbidities, including several cases of type 2 diabetes mellitus.6 Another patient was reported to have recently started treatment with an angiotensin receptor blocker prior to onset of CCV.5
Our case contributes to the small series of reported patients with this rare diagnosis and further suggests that it may be underreported at this time. Similar to previously reported cases, our patient was an elderly white individual. Although our patient had long-standing iatrogenic hypothyroidism, no recent medication changes or underlying comorbidities could be tied to the development of CCV. Further studies are needed to determine if this disease process is associated with any underlying systemic illnesses, medications, or family history.
- Salama S, Rosenthal D. Cutaneous collagenous vasculopathy with generalized telangiectasia: an immunohistochemical and ultrastructural study. J Cutan Pathol. 2000;27:40-48.
- Borroni RG, Derlino F, Agozzino M, et al. Hypothermic cutaneous collagenous vasculopathy with centrifugal spreading [published online March 31, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1444-1446.
- Moulonguet I, Hershkovitch D, Fraitag S. Widespread cutaneous telangiectasias: challenge. Am J Dermatopathol. 2013;35:661-662, 688-669.
- Lloyd BM, Pruden SJ 2nd, Lind AC, et al. Cutaneous collagenous vasculopathy: report of the first pediatric case. Pediatr Dermatol. 2011;28:598-599.
- Kanitakis J, Faisant M, Wagschal D, et al. Cutaneous collagenous vasculopathy: ultrastructural and immunohistochemical study of a new case. Am J Clin Dermatol. 2010;11:63-66.
- Davis TL, Mandal RV, Bevona C, et al. Collagenous vasculopathy: a report of three cases. J Cutan Pathol. 2008;35:967-970.
- Echeverría B, Sanmartín O, Botella-Estrada R, et al. Cutaneous collagenous vasculopathy successfully treated with pulsed dye laser. Int J Dermatol. 2012;51:1359-1362.
- Salama S, Rosenthal D. Cutaneous collagenous vasculopathy with generalized telangiectasia: an immunohistochemical and ultrastructural study. J Cutan Pathol. 2000;27:40-48.
- Borroni RG, Derlino F, Agozzino M, et al. Hypothermic cutaneous collagenous vasculopathy with centrifugal spreading [published online March 31, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1444-1446.
- Moulonguet I, Hershkovitch D, Fraitag S. Widespread cutaneous telangiectasias: challenge. Am J Dermatopathol. 2013;35:661-662, 688-669.
- Lloyd BM, Pruden SJ 2nd, Lind AC, et al. Cutaneous collagenous vasculopathy: report of the first pediatric case. Pediatr Dermatol. 2011;28:598-599.
- Kanitakis J, Faisant M, Wagschal D, et al. Cutaneous collagenous vasculopathy: ultrastructural and immunohistochemical study of a new case. Am J Clin Dermatol. 2010;11:63-66.
- Davis TL, Mandal RV, Bevona C, et al. Collagenous vasculopathy: a report of three cases. J Cutan Pathol. 2008;35:967-970.
- Echeverría B, Sanmartín O, Botella-Estrada R, et al. Cutaneous collagenous vasculopathy successfully treated with pulsed dye laser. Int J Dermatol. 2012;51:1359-1362.
Practice Points
- Cutaneous collagenous vasculopathy (CCV) should be in the differential diagnosis of widespread telangiectases.
- Biopsy is needed to differentiate between CCV and generalized essential telangiectasia because of their similar clinical features.
- There may be underlying comorbidities associated with CCV, but the exact cause of the condition has yet to be found.
Innovations to expect at HM20
Course director Dr. Benji Mathews offers highlights
Benji K. Mathews, MD, SFHM, CLHM, chief of hospital medicine at Regions Hospital, HealthPartners, in St. Paul, Minn., and director of point of care ultrasound (POCUS) for hospital medicine at HealthPartners, is the course director for the Society of Hospital Medicine’s 2020 Annual Conference (HM20), which will be held April 16-18 in San Diego.
Dr. Mathews, also an associate professor of medicine at the University of Minnesota, Minneapolis, sat down with the Hospitalist to discuss the role of the course director in formulating the HM20 agenda, as well as highlighting some exciting educational sessions, workshops, and other events during the annual conference.
In your role as course director for HM20, did you have a particular theme you wanted to emphasize?
We did not go with a single theme, because we’re trying to provide a comprehensive educational and networking opportunity, so trying to focus the conference on a single theme a year in advance did not seem very prudent. There are multiple themes, from health disparities to technology to education. For a field like hospital medicine that’s rapidly evolving, we thought it best to keep it open and instead further develop the conference tracks: What new tracks can be created, what older tracks can be maintained because they have been highly successful, and which tracks do we retire?
Can you discuss some of the tracks at HM20?
The new track we have this year is the Technology track. That track will examine current and future technology that will impact care delivery, including telehealth, wearables, apps for digital learning, and for clinicians at the bedside. Innovation is at the core of hospital medicine, and we’re constantly exploring how to deliver efficient, timely, and effective care. “Future-casting” is important, and this track speaks to that.
There are some old standards that I would also recommend. The “Great Debate” is one of the hardest to finalize, because while you can create a great session topic and title, we need to find two talented speakers for a debate, as that is very different than a presentation. The speakers take opposing sides on clinical decisions, the latest literature reviews, best practices, and the audience gets to vote. Topics we’re using this year include “Procalcitonin: Friend or Foe,” “Guidelines Controversies in Inpatient Care,” and “POCUS vs. Physical Exam – Tech vs. Tradition.” Some of the debaters include Carrie Herzke, MD, of Johns Hopkins University, Baltimore; Daniel Dressler, MD, of Emory University, Atlanta; Jordan Messler, MD, of Morton Plant Hospital in Clearwater, Fla.; and Michelle Guidry, MD, of the Southeast Louisiana Veterans Health Care System and Tulane University, both in New Orleans; Ria Dancel, MD, from the University of North Carolina, and Michael Janjigian, MD, from NYU Langone Health.
One of the highlights this year is that we’re trying to bring more gender equity into our speaker lineup. Rarely will we have only two male speakers at a session, and I don’t think we have any all-male panels, jokingly called “manels” in the past.
Are there some “tried-and-true” tracks or sessions that are returning in HM20?
I’d like to highlight the Clinical Mastery track. That was a new track last year, and has returned this year. That track is focused on helping hospitalists become expert diagnosticians at the bedside. “Pitfalls, Myths and Pearls in Diagnostic Reasoning” is one session to note in that track, with Dr. Gopi Astik, Dr. Andrew Olson, and Dr. Reza Manesh. Another special focus this year within Clinical Mastery will be on using the rational clinical exam to augment your diagnostic skills.
When programming the annual conference, how do you balance the needs of community hospitalists with academic hospitalists?
The value we have on the annual conference committee is that there are a fair number of community hospitalists, advance practice clinicians, representation from med-peds, and family practice, for instance. Generally, there is a wide sampling of the decision makers from across the specialty helping to program the conference – we have great academic institutions, but we have representation from the larger impressive community as well. That said, it is hard to curate content that is solely for a specific subset of hospitalists without marginalizing other subsets. We don’t want to isolate people. A lot of our Rapid Fire topics are geared toward frontline hospitalists. This is content that will directly impact hospitalists as they care for patients. And some of the content that we’re bringing in this year with more emphasis are in health equity and disparities. Academic groups study this, however frontline clinicians from both academic and community settings deal with this every day, relating to both patients and staff. For example, in regard to patients, we have content focused on caring for the LGBTQ community, sessions on refugee health, as well as hospitalists and global health. We have an emphasis on diversity and inclusion in the workplace, with speakers from both community and academic settings. There will be good sessions with gender equity themes, practical tips in promotion and hiring practices. There are a couple workshops on gender equity; one to note is “Top 10 Ways for Men + Women to Engage in Gender Equity.”
Can you speak to the content that is targeted at nurse practitioners and physician assistants?
This is near and dear to my heart as I’m from an institution that has a positive history of strong partnerships with our advance practice clinician colleagues. Our goal this year was to continue to highlight nurse practitioners and physician assistants in a track dedicated to them. We have a core session called “Training Day: How to Onboard and Operationalize an Advanced Practice Provider Workforce” – this is a “bread-and-butter” session presented by speakers who have built programs from the ground up. Other important sessions address how to advance the careers of NPs and PAs – “Professional Development for NP/PAs” – and on mentorship, which emphasizes a culture of partnership on projects like providing high quality, safe care.
Are there any workshops that attendees should take note of?
One I would like to highlight is “Survive! The POCUS Apocalypse Adventure.” This highly anticipated offering is preregistration required, hosted for the first time on day 1 of the main conference. The workshop will introduce the gamification of POCUS to hospitalists. Each participant will be expected to perform ultrasound examinations and interpret their findings in order to gather clues that will lead to the cure for a zombie apocalypse! There are a lot of innovations this year in programming the Annual Conference, and gamification might be considered risky but I think it has a very good chance of success with entertainment and learning combined into one amazing workshop.
What are some other innovations that the annual conference committee has planned for 2020?
Another exciting innovation is what we call “Breakfast with an Expert.” This is a new rapid-fire didactic session format where we have three experts speak on different hot topics, such as “Nutritional Counseling” (led by Kate Shafto, MD), “Things I Wish I Knew Earlier in my Career” (Brad Sharpe, MD), and “Case-Based Controversies in Ethics” (Hannah Lipman, MD). These take place on the very first day of the conference, before the opening general session. Attendees can grab their breakfast and listen to any of these sessions before they head into the plenary. Hospitalists have asked for more content, so we’re adding these as a response to that hunger for more educational content. This format is supposed to be a bit cozier, with more Q&A.
Another aspect of HM20 to highlight is the Simulation Center. The Sim Center is a space that hosts a variety of hospital medicine skill development areas. This is an interactive center where attendees can learn to perform bedside procedures and learn hands-on skills with diagnostic point-of-care ultrasound during the first 2 days of the conference. The Sim Center is slightly different than the precourses, in that we are offering 1-hour blocks of small-group instruction for which attendees preregister. This aligns with larger SHM efforts to encourage hospitalists to be more confident with bedside procedures, and engage with SHM’s ultrasound offerings, including the certificate of completion program.
To register for the 2020 Annual Conference, including precourses, visit https://shmannualconference.org/register/.
Course director Dr. Benji Mathews offers highlights
Course director Dr. Benji Mathews offers highlights
Benji K. Mathews, MD, SFHM, CLHM, chief of hospital medicine at Regions Hospital, HealthPartners, in St. Paul, Minn., and director of point of care ultrasound (POCUS) for hospital medicine at HealthPartners, is the course director for the Society of Hospital Medicine’s 2020 Annual Conference (HM20), which will be held April 16-18 in San Diego.
Dr. Mathews, also an associate professor of medicine at the University of Minnesota, Minneapolis, sat down with the Hospitalist to discuss the role of the course director in formulating the HM20 agenda, as well as highlighting some exciting educational sessions, workshops, and other events during the annual conference.
In your role as course director for HM20, did you have a particular theme you wanted to emphasize?
We did not go with a single theme, because we’re trying to provide a comprehensive educational and networking opportunity, so trying to focus the conference on a single theme a year in advance did not seem very prudent. There are multiple themes, from health disparities to technology to education. For a field like hospital medicine that’s rapidly evolving, we thought it best to keep it open and instead further develop the conference tracks: What new tracks can be created, what older tracks can be maintained because they have been highly successful, and which tracks do we retire?
Can you discuss some of the tracks at HM20?
The new track we have this year is the Technology track. That track will examine current and future technology that will impact care delivery, including telehealth, wearables, apps for digital learning, and for clinicians at the bedside. Innovation is at the core of hospital medicine, and we’re constantly exploring how to deliver efficient, timely, and effective care. “Future-casting” is important, and this track speaks to that.
There are some old standards that I would also recommend. The “Great Debate” is one of the hardest to finalize, because while you can create a great session topic and title, we need to find two talented speakers for a debate, as that is very different than a presentation. The speakers take opposing sides on clinical decisions, the latest literature reviews, best practices, and the audience gets to vote. Topics we’re using this year include “Procalcitonin: Friend or Foe,” “Guidelines Controversies in Inpatient Care,” and “POCUS vs. Physical Exam – Tech vs. Tradition.” Some of the debaters include Carrie Herzke, MD, of Johns Hopkins University, Baltimore; Daniel Dressler, MD, of Emory University, Atlanta; Jordan Messler, MD, of Morton Plant Hospital in Clearwater, Fla.; and Michelle Guidry, MD, of the Southeast Louisiana Veterans Health Care System and Tulane University, both in New Orleans; Ria Dancel, MD, from the University of North Carolina, and Michael Janjigian, MD, from NYU Langone Health.
One of the highlights this year is that we’re trying to bring more gender equity into our speaker lineup. Rarely will we have only two male speakers at a session, and I don’t think we have any all-male panels, jokingly called “manels” in the past.
Are there some “tried-and-true” tracks or sessions that are returning in HM20?
I’d like to highlight the Clinical Mastery track. That was a new track last year, and has returned this year. That track is focused on helping hospitalists become expert diagnosticians at the bedside. “Pitfalls, Myths and Pearls in Diagnostic Reasoning” is one session to note in that track, with Dr. Gopi Astik, Dr. Andrew Olson, and Dr. Reza Manesh. Another special focus this year within Clinical Mastery will be on using the rational clinical exam to augment your diagnostic skills.
When programming the annual conference, how do you balance the needs of community hospitalists with academic hospitalists?
The value we have on the annual conference committee is that there are a fair number of community hospitalists, advance practice clinicians, representation from med-peds, and family practice, for instance. Generally, there is a wide sampling of the decision makers from across the specialty helping to program the conference – we have great academic institutions, but we have representation from the larger impressive community as well. That said, it is hard to curate content that is solely for a specific subset of hospitalists without marginalizing other subsets. We don’t want to isolate people. A lot of our Rapid Fire topics are geared toward frontline hospitalists. This is content that will directly impact hospitalists as they care for patients. And some of the content that we’re bringing in this year with more emphasis are in health equity and disparities. Academic groups study this, however frontline clinicians from both academic and community settings deal with this every day, relating to both patients and staff. For example, in regard to patients, we have content focused on caring for the LGBTQ community, sessions on refugee health, as well as hospitalists and global health. We have an emphasis on diversity and inclusion in the workplace, with speakers from both community and academic settings. There will be good sessions with gender equity themes, practical tips in promotion and hiring practices. There are a couple workshops on gender equity; one to note is “Top 10 Ways for Men + Women to Engage in Gender Equity.”
Can you speak to the content that is targeted at nurse practitioners and physician assistants?
This is near and dear to my heart as I’m from an institution that has a positive history of strong partnerships with our advance practice clinician colleagues. Our goal this year was to continue to highlight nurse practitioners and physician assistants in a track dedicated to them. We have a core session called “Training Day: How to Onboard and Operationalize an Advanced Practice Provider Workforce” – this is a “bread-and-butter” session presented by speakers who have built programs from the ground up. Other important sessions address how to advance the careers of NPs and PAs – “Professional Development for NP/PAs” – and on mentorship, which emphasizes a culture of partnership on projects like providing high quality, safe care.
Are there any workshops that attendees should take note of?
One I would like to highlight is “Survive! The POCUS Apocalypse Adventure.” This highly anticipated offering is preregistration required, hosted for the first time on day 1 of the main conference. The workshop will introduce the gamification of POCUS to hospitalists. Each participant will be expected to perform ultrasound examinations and interpret their findings in order to gather clues that will lead to the cure for a zombie apocalypse! There are a lot of innovations this year in programming the Annual Conference, and gamification might be considered risky but I think it has a very good chance of success with entertainment and learning combined into one amazing workshop.
What are some other innovations that the annual conference committee has planned for 2020?
Another exciting innovation is what we call “Breakfast with an Expert.” This is a new rapid-fire didactic session format where we have three experts speak on different hot topics, such as “Nutritional Counseling” (led by Kate Shafto, MD), “Things I Wish I Knew Earlier in my Career” (Brad Sharpe, MD), and “Case-Based Controversies in Ethics” (Hannah Lipman, MD). These take place on the very first day of the conference, before the opening general session. Attendees can grab their breakfast and listen to any of these sessions before they head into the plenary. Hospitalists have asked for more content, so we’re adding these as a response to that hunger for more educational content. This format is supposed to be a bit cozier, with more Q&A.
Another aspect of HM20 to highlight is the Simulation Center. The Sim Center is a space that hosts a variety of hospital medicine skill development areas. This is an interactive center where attendees can learn to perform bedside procedures and learn hands-on skills with diagnostic point-of-care ultrasound during the first 2 days of the conference. The Sim Center is slightly different than the precourses, in that we are offering 1-hour blocks of small-group instruction for which attendees preregister. This aligns with larger SHM efforts to encourage hospitalists to be more confident with bedside procedures, and engage with SHM’s ultrasound offerings, including the certificate of completion program.
To register for the 2020 Annual Conference, including precourses, visit https://shmannualconference.org/register/.
Benji K. Mathews, MD, SFHM, CLHM, chief of hospital medicine at Regions Hospital, HealthPartners, in St. Paul, Minn., and director of point of care ultrasound (POCUS) for hospital medicine at HealthPartners, is the course director for the Society of Hospital Medicine’s 2020 Annual Conference (HM20), which will be held April 16-18 in San Diego.
Dr. Mathews, also an associate professor of medicine at the University of Minnesota, Minneapolis, sat down with the Hospitalist to discuss the role of the course director in formulating the HM20 agenda, as well as highlighting some exciting educational sessions, workshops, and other events during the annual conference.
In your role as course director for HM20, did you have a particular theme you wanted to emphasize?
We did not go with a single theme, because we’re trying to provide a comprehensive educational and networking opportunity, so trying to focus the conference on a single theme a year in advance did not seem very prudent. There are multiple themes, from health disparities to technology to education. For a field like hospital medicine that’s rapidly evolving, we thought it best to keep it open and instead further develop the conference tracks: What new tracks can be created, what older tracks can be maintained because they have been highly successful, and which tracks do we retire?
Can you discuss some of the tracks at HM20?
The new track we have this year is the Technology track. That track will examine current and future technology that will impact care delivery, including telehealth, wearables, apps for digital learning, and for clinicians at the bedside. Innovation is at the core of hospital medicine, and we’re constantly exploring how to deliver efficient, timely, and effective care. “Future-casting” is important, and this track speaks to that.
There are some old standards that I would also recommend. The “Great Debate” is one of the hardest to finalize, because while you can create a great session topic and title, we need to find two talented speakers for a debate, as that is very different than a presentation. The speakers take opposing sides on clinical decisions, the latest literature reviews, best practices, and the audience gets to vote. Topics we’re using this year include “Procalcitonin: Friend or Foe,” “Guidelines Controversies in Inpatient Care,” and “POCUS vs. Physical Exam – Tech vs. Tradition.” Some of the debaters include Carrie Herzke, MD, of Johns Hopkins University, Baltimore; Daniel Dressler, MD, of Emory University, Atlanta; Jordan Messler, MD, of Morton Plant Hospital in Clearwater, Fla.; and Michelle Guidry, MD, of the Southeast Louisiana Veterans Health Care System and Tulane University, both in New Orleans; Ria Dancel, MD, from the University of North Carolina, and Michael Janjigian, MD, from NYU Langone Health.
One of the highlights this year is that we’re trying to bring more gender equity into our speaker lineup. Rarely will we have only two male speakers at a session, and I don’t think we have any all-male panels, jokingly called “manels” in the past.
Are there some “tried-and-true” tracks or sessions that are returning in HM20?
I’d like to highlight the Clinical Mastery track. That was a new track last year, and has returned this year. That track is focused on helping hospitalists become expert diagnosticians at the bedside. “Pitfalls, Myths and Pearls in Diagnostic Reasoning” is one session to note in that track, with Dr. Gopi Astik, Dr. Andrew Olson, and Dr. Reza Manesh. Another special focus this year within Clinical Mastery will be on using the rational clinical exam to augment your diagnostic skills.
When programming the annual conference, how do you balance the needs of community hospitalists with academic hospitalists?
The value we have on the annual conference committee is that there are a fair number of community hospitalists, advance practice clinicians, representation from med-peds, and family practice, for instance. Generally, there is a wide sampling of the decision makers from across the specialty helping to program the conference – we have great academic institutions, but we have representation from the larger impressive community as well. That said, it is hard to curate content that is solely for a specific subset of hospitalists without marginalizing other subsets. We don’t want to isolate people. A lot of our Rapid Fire topics are geared toward frontline hospitalists. This is content that will directly impact hospitalists as they care for patients. And some of the content that we’re bringing in this year with more emphasis are in health equity and disparities. Academic groups study this, however frontline clinicians from both academic and community settings deal with this every day, relating to both patients and staff. For example, in regard to patients, we have content focused on caring for the LGBTQ community, sessions on refugee health, as well as hospitalists and global health. We have an emphasis on diversity and inclusion in the workplace, with speakers from both community and academic settings. There will be good sessions with gender equity themes, practical tips in promotion and hiring practices. There are a couple workshops on gender equity; one to note is “Top 10 Ways for Men + Women to Engage in Gender Equity.”
Can you speak to the content that is targeted at nurse practitioners and physician assistants?
This is near and dear to my heart as I’m from an institution that has a positive history of strong partnerships with our advance practice clinician colleagues. Our goal this year was to continue to highlight nurse practitioners and physician assistants in a track dedicated to them. We have a core session called “Training Day: How to Onboard and Operationalize an Advanced Practice Provider Workforce” – this is a “bread-and-butter” session presented by speakers who have built programs from the ground up. Other important sessions address how to advance the careers of NPs and PAs – “Professional Development for NP/PAs” – and on mentorship, which emphasizes a culture of partnership on projects like providing high quality, safe care.
Are there any workshops that attendees should take note of?
One I would like to highlight is “Survive! The POCUS Apocalypse Adventure.” This highly anticipated offering is preregistration required, hosted for the first time on day 1 of the main conference. The workshop will introduce the gamification of POCUS to hospitalists. Each participant will be expected to perform ultrasound examinations and interpret their findings in order to gather clues that will lead to the cure for a zombie apocalypse! There are a lot of innovations this year in programming the Annual Conference, and gamification might be considered risky but I think it has a very good chance of success with entertainment and learning combined into one amazing workshop.
What are some other innovations that the annual conference committee has planned for 2020?
Another exciting innovation is what we call “Breakfast with an Expert.” This is a new rapid-fire didactic session format where we have three experts speak on different hot topics, such as “Nutritional Counseling” (led by Kate Shafto, MD), “Things I Wish I Knew Earlier in my Career” (Brad Sharpe, MD), and “Case-Based Controversies in Ethics” (Hannah Lipman, MD). These take place on the very first day of the conference, before the opening general session. Attendees can grab their breakfast and listen to any of these sessions before they head into the plenary. Hospitalists have asked for more content, so we’re adding these as a response to that hunger for more educational content. This format is supposed to be a bit cozier, with more Q&A.
Another aspect of HM20 to highlight is the Simulation Center. The Sim Center is a space that hosts a variety of hospital medicine skill development areas. This is an interactive center where attendees can learn to perform bedside procedures and learn hands-on skills with diagnostic point-of-care ultrasound during the first 2 days of the conference. The Sim Center is slightly different than the precourses, in that we are offering 1-hour blocks of small-group instruction for which attendees preregister. This aligns with larger SHM efforts to encourage hospitalists to be more confident with bedside procedures, and engage with SHM’s ultrasound offerings, including the certificate of completion program.
To register for the 2020 Annual Conference, including precourses, visit https://shmannualconference.org/register/.
Medicaid expansion linked to more early cancer diagnoses
Cancer patients in states that opted to expand Medicaid insurance coverage under the Affordable Care Act saw a slightly better rate of early diagnosis, compared with patients in states that refused expansion, according to a new study. However, time to treatment was similar in states that opted for expansion and states that did not.
Samuel U. Takvorian, MD, of the University of Pennsylvania, Philadelphia, and colleagues reported these results in JAMA Network Open.
The researchers used the National Cancer Database to examine the changes in health insurance coverage and cancer health outcomes in nonelderly patients following implementation of the Affordable Care Act in January 2014. The investigators identified records for 925,543 patients who had new-onset breast (59%), colon (15%), or non–small cell lung (27%) cancer between 2011 and 2016. The patients’ mean age was 55 years (range, 40-64 years), 79% were women, 14% were black, and 6% were Hispanic.
The researchers looked at insurance status, cancer stage at diagnosis, and treatment initiation within 30 and 90 days of diagnosis. The cohort was equally divided between residents of Medicaid expansion states (48%) and nonexpansion states (52%).
Using a statistical technique that mimics a controlled experiment, the investigators found the percentage of uninsured patients decreased more in the expansion states (adjusted difference-in-differences, −0.7 percentage points; 95% confidence interval, −1.2 to −0.3; P = .001), compared with nonexpansion states. Expansion states also had a greater increase in early-stage cancer diagnoses (adjusted DID, 0.8; 95% CI 0.3-1.2; P = .001) and a greater decrease in advanced-stage cancer diagnoses (adjusted DID, −0.5; 95% CI, −0.9 to −0.2; P = .003).
Among the 848,329 patients who underwent cancer treatment within a year of diagnosis, the percentage initiating treatment within 30 days declined from 52.7% before to 48% after Medicaid expansion in states opting in (unadjusted DID, −4.7; percentage points, 95% CI; −5.1 to −4.5). States that did not expand their Medicaid programs, meanwhile, saw the share decline from 56.9% to 51.5% in the same time period (adjusted DID, −5.4; 95% CI, −5.6 to −5.1). There was no statistically significant difference in timely treatment associated with Medicaid expansion (adjusted DID, 0.6; 95% CI, −0.2 to 1.4; P = .14).
The researchers speculated that the lack of significant between-group differences in time to treatment, despite an improvement in early-stage diagnoses associated with Medicaid expansion, could reflect a cancer care system strained by a surge in insured patients, overall increases in cancer prevalence and complexity of care, a shortage of workers, or a mixture of factors.
In a related editorial, Sue Fu, MD, of Stanford (Calif.) University, and colleagues wrote that, while the findings of increased early diagnosis seen in the study are promising, the time to treatment results are “puzzling” and deserve further consideration.
Time to treatment is important in cancer, as longer times are associated with increased mortality, Dr. Fu and colleagues noted. Slowing times to cancer treatment is a systemic problem in the United States that has been documented since the mid-2000s. Paradoxically, expanded insurance coverage could contribute to increasing time to treatment even after timely diagnosis by adding administrative burdens leading to longer wait times. “Newly insured and underinsured individuals may be particularly vulnerable to this,” the editorialists wrote.
Dr. Takvorian and colleagues noted as weaknesses of their study its observational design, a limited range of ages and cancers included, and an inability to adjust for state-level effects.
This study was funded by the National Cancer Institute and the Agency for Health Research and Quality. The authors of the study and the editorial disclosed no relevant conflicts of interest.
SOURCES: Takvorian SU et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921653; Fu S et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921690.
Cancer patients in states that opted to expand Medicaid insurance coverage under the Affordable Care Act saw a slightly better rate of early diagnosis, compared with patients in states that refused expansion, according to a new study. However, time to treatment was similar in states that opted for expansion and states that did not.
Samuel U. Takvorian, MD, of the University of Pennsylvania, Philadelphia, and colleagues reported these results in JAMA Network Open.
The researchers used the National Cancer Database to examine the changes in health insurance coverage and cancer health outcomes in nonelderly patients following implementation of the Affordable Care Act in January 2014. The investigators identified records for 925,543 patients who had new-onset breast (59%), colon (15%), or non–small cell lung (27%) cancer between 2011 and 2016. The patients’ mean age was 55 years (range, 40-64 years), 79% were women, 14% were black, and 6% were Hispanic.
The researchers looked at insurance status, cancer stage at diagnosis, and treatment initiation within 30 and 90 days of diagnosis. The cohort was equally divided between residents of Medicaid expansion states (48%) and nonexpansion states (52%).
Using a statistical technique that mimics a controlled experiment, the investigators found the percentage of uninsured patients decreased more in the expansion states (adjusted difference-in-differences, −0.7 percentage points; 95% confidence interval, −1.2 to −0.3; P = .001), compared with nonexpansion states. Expansion states also had a greater increase in early-stage cancer diagnoses (adjusted DID, 0.8; 95% CI 0.3-1.2; P = .001) and a greater decrease in advanced-stage cancer diagnoses (adjusted DID, −0.5; 95% CI, −0.9 to −0.2; P = .003).
Among the 848,329 patients who underwent cancer treatment within a year of diagnosis, the percentage initiating treatment within 30 days declined from 52.7% before to 48% after Medicaid expansion in states opting in (unadjusted DID, −4.7; percentage points, 95% CI; −5.1 to −4.5). States that did not expand their Medicaid programs, meanwhile, saw the share decline from 56.9% to 51.5% in the same time period (adjusted DID, −5.4; 95% CI, −5.6 to −5.1). There was no statistically significant difference in timely treatment associated with Medicaid expansion (adjusted DID, 0.6; 95% CI, −0.2 to 1.4; P = .14).
The researchers speculated that the lack of significant between-group differences in time to treatment, despite an improvement in early-stage diagnoses associated with Medicaid expansion, could reflect a cancer care system strained by a surge in insured patients, overall increases in cancer prevalence and complexity of care, a shortage of workers, or a mixture of factors.
In a related editorial, Sue Fu, MD, of Stanford (Calif.) University, and colleagues wrote that, while the findings of increased early diagnosis seen in the study are promising, the time to treatment results are “puzzling” and deserve further consideration.
Time to treatment is important in cancer, as longer times are associated with increased mortality, Dr. Fu and colleagues noted. Slowing times to cancer treatment is a systemic problem in the United States that has been documented since the mid-2000s. Paradoxically, expanded insurance coverage could contribute to increasing time to treatment even after timely diagnosis by adding administrative burdens leading to longer wait times. “Newly insured and underinsured individuals may be particularly vulnerable to this,” the editorialists wrote.
Dr. Takvorian and colleagues noted as weaknesses of their study its observational design, a limited range of ages and cancers included, and an inability to adjust for state-level effects.
This study was funded by the National Cancer Institute and the Agency for Health Research and Quality. The authors of the study and the editorial disclosed no relevant conflicts of interest.
SOURCES: Takvorian SU et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921653; Fu S et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921690.
Cancer patients in states that opted to expand Medicaid insurance coverage under the Affordable Care Act saw a slightly better rate of early diagnosis, compared with patients in states that refused expansion, according to a new study. However, time to treatment was similar in states that opted for expansion and states that did not.
Samuel U. Takvorian, MD, of the University of Pennsylvania, Philadelphia, and colleagues reported these results in JAMA Network Open.
The researchers used the National Cancer Database to examine the changes in health insurance coverage and cancer health outcomes in nonelderly patients following implementation of the Affordable Care Act in January 2014. The investigators identified records for 925,543 patients who had new-onset breast (59%), colon (15%), or non–small cell lung (27%) cancer between 2011 and 2016. The patients’ mean age was 55 years (range, 40-64 years), 79% were women, 14% were black, and 6% were Hispanic.
The researchers looked at insurance status, cancer stage at diagnosis, and treatment initiation within 30 and 90 days of diagnosis. The cohort was equally divided between residents of Medicaid expansion states (48%) and nonexpansion states (52%).
Using a statistical technique that mimics a controlled experiment, the investigators found the percentage of uninsured patients decreased more in the expansion states (adjusted difference-in-differences, −0.7 percentage points; 95% confidence interval, −1.2 to −0.3; P = .001), compared with nonexpansion states. Expansion states also had a greater increase in early-stage cancer diagnoses (adjusted DID, 0.8; 95% CI 0.3-1.2; P = .001) and a greater decrease in advanced-stage cancer diagnoses (adjusted DID, −0.5; 95% CI, −0.9 to −0.2; P = .003).
Among the 848,329 patients who underwent cancer treatment within a year of diagnosis, the percentage initiating treatment within 30 days declined from 52.7% before to 48% after Medicaid expansion in states opting in (unadjusted DID, −4.7; percentage points, 95% CI; −5.1 to −4.5). States that did not expand their Medicaid programs, meanwhile, saw the share decline from 56.9% to 51.5% in the same time period (adjusted DID, −5.4; 95% CI, −5.6 to −5.1). There was no statistically significant difference in timely treatment associated with Medicaid expansion (adjusted DID, 0.6; 95% CI, −0.2 to 1.4; P = .14).
The researchers speculated that the lack of significant between-group differences in time to treatment, despite an improvement in early-stage diagnoses associated with Medicaid expansion, could reflect a cancer care system strained by a surge in insured patients, overall increases in cancer prevalence and complexity of care, a shortage of workers, or a mixture of factors.
In a related editorial, Sue Fu, MD, of Stanford (Calif.) University, and colleagues wrote that, while the findings of increased early diagnosis seen in the study are promising, the time to treatment results are “puzzling” and deserve further consideration.
Time to treatment is important in cancer, as longer times are associated with increased mortality, Dr. Fu and colleagues noted. Slowing times to cancer treatment is a systemic problem in the United States that has been documented since the mid-2000s. Paradoxically, expanded insurance coverage could contribute to increasing time to treatment even after timely diagnosis by adding administrative burdens leading to longer wait times. “Newly insured and underinsured individuals may be particularly vulnerable to this,” the editorialists wrote.
Dr. Takvorian and colleagues noted as weaknesses of their study its observational design, a limited range of ages and cancers included, and an inability to adjust for state-level effects.
This study was funded by the National Cancer Institute and the Agency for Health Research and Quality. The authors of the study and the editorial disclosed no relevant conflicts of interest.
SOURCES: Takvorian SU et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921653; Fu S et al. JAMA Netw Open. 2020 Feb 5;3(2):e1921690.
FROM JAMA NETWORK OPEN