This month a couple of studies evaluated the role of enasidenib and gemtuzumab in the therapy of patients with AML using clinical and non-clinical trial data. In a propensity score-matching (PSM) analysis, was enasidenib associated with better outcomes compared to standard of care (SoC). The study included adult patients with relapsed/refractory (R/R) AML with an isocitrate dehydrogenase 2 (IDH2) mutation ineligible for hematopoietic stem cell transplantation (HSCT) treated with enasidenib (n = 195) from the AG221 C-001 trial or SoC therapies (n = 78) from the French Chart Review study. The SoC regimens included azacytidine, decitabine, cytarabine containing regimens, and others. Enasidenib was associated with superior overall survival (OS) (hazard ratio [HR] 0.67; 95% CI 0.47-0.97) compared to SoC therapies in patients with R/R AML with IDH2 mutation who were ineligible for HSCT. The median OS was 9.26 months vs. 4.76 months for enasidenib and SoC respectively. The results of this study are not surprising given the data seen in clinical trials. Although not evaluated in this study, the quality of life for patients receiving enasidenib is better when compared to SoC regimens, such as 7 +3 (cytarabine + idarubicin). Other than the limitations of a PSM study, which are well acknowledged by the authors, the main weakness is this study did not include venetoclax in the SoC regimen. It remains unclear whether using venetoclax in the R/R setting in patients with IDH2 mutations would lead to similar outcomes.

The benefit of gemtuzumab ozogamicin (GO) was demonstrated again in a metanalysis that included 15 randomized controlled trials and 15 retrospective studies that compared GO (n = 4,768) with non-GO (n = 6,466) therapies in 11,234 patients with AML (n = 11,105) and high-risk myelodysplastic syndrome (MDS) (n = 129). GO showed superior survival outcomes in patients with AML or high-risk MDS than non-GO therapy, but higher doses increased the risk for early death. GO vs. non-GO arm showed improved overall survival (HR 0.86; P = .003), event-free survival (HR 0.86; P = .015), and relapse-free survival (HR 0.83; P = .001). However, GO vs. non-GO was associated with an increased risk for early death at a dose of ≥6 mg/m² (relative risk [RR] 2.01; P = .005), hepatic-related adverse effects (RR 1.29; P = .02), and bleeding (RR 1.13; P = .018). Finally, a study by the Polish adult leukemia group demonstrated the safety and efficacy of a low dose cytarabine + cladribine regimen. Treatment consisted of 5 mg/m² cladribine intravenously on day 1-5 (in the first cycle) and on days 1 to 3 (in the second cycle) combined with low dose cytarabine (40 mg) subcutaneously once daily on days 1–10. Patients may continue on low dose cytarabine after that if they have achieved at least a partial remission. Rates of overall response and 56-day mortality were 54.0% and 20.5%, respectively. The median overall survival was 6.9 months (95% CI 4.9-9.6) and superior in patients who achieved an objective response (HR 0.04; P < .0001) or partial remission (HR 0.31; P = .0002) compared to nonresponders.

In addition to the better therapies in the last decade, allogeneic hematopoietic stem cell transplantation (allo-HSCT) outcomes have also improved. In a retrospective analysis from the Japanese nationwide transplantation registry the outcomes of patients transplanted with unrelated cord blood (UCB) and Haplo transplant between 2007 to 2014 were worse when compared to patients who had a transplant between 2015 and 2018. For patients who had transplants between 2015 and 2018, the 3-year overall survival of mismatched unrelated donor (MMUD), unrelated cord blood (UCB), and Haplo groups were 60%, 66%, and 63%, respectively (P = .693). The rates of nonrelapse mortality (P = .147), relapse (P = .075), and graft-vs. host disease-free/relapse-free survival (P = .365) were also similar between the 3 groups. For patients with transplant between 2007 to 2014 the 3 year overall survival was 60%, 54%, and 47% for MMUD, UCB, and Haplo transplants respectively. Newer, better drugs, better tolerated regimens, and improved transplant outcomes were the result: many small gains lead to large improvements.

This month a couple of studies evaluated the role of enasidenib and gemtuzumab in the therapy of patients with AML using clinical and non-clinical trial data. In a propensity score-matching (PSM) analysis, was enasidenib associated with better outcomes compared to standard of care (SoC). The study included adult patients with relapsed/refractory (R/R) AML with an isocitrate dehydrogenase 2 (IDH2) mutation ineligible for hematopoietic stem cell transplantation (HSCT) treated with enasidenib (n = 195) from the AG221 C-001 trial or SoC therapies (n = 78) from the French Chart Review study. The SoC regimens included azacytidine, decitabine, cytarabine containing regimens, and others. Enasidenib was associated with superior overall survival (OS) (hazard ratio [HR] 0.67; 95% CI 0.47-0.97) compared to SoC therapies in patients with R/R AML with IDH2 mutation who were ineligible for HSCT. The median OS was 9.26 months vs. 4.76 months for enasidenib and SoC respectively. The results of this study are not surprising given the data seen in clinical trials. Although not evaluated in this study, the quality of life for patients receiving enasidenib is better when compared to SoC regimens, such as 7 +3 (cytarabine + idarubicin). Other than the limitations of a PSM study, which are well acknowledged by the authors, the main weakness is this study did not include venetoclax in the SoC regimen. It remains unclear whether using venetoclax in the R/R setting in patients with IDH2 mutations would lead to similar outcomes.

The benefit of gemtuzumab ozogamicin (GO) was demonstrated again in a metanalysis that included 15 randomized controlled trials and 15 retrospective studies that compared GO (n = 4,768) with non-GO (n = 6,466) therapies in 11,234 patients with AML (n = 11,105) and high-risk myelodysplastic syndrome (MDS) (n = 129). GO showed superior survival outcomes in patients with AML or high-risk MDS than non-GO therapy, but higher doses increased the risk for early death. GO vs. non-GO arm showed improved overall survival (HR 0.86; P = .003), event-free survival (HR 0.86; P = .015), and relapse-free survival (HR 0.83; P = .001). However, GO vs. non-GO was associated with an increased risk for early death at a dose of ≥6 mg/m² (relative risk [RR] 2.01; P = .005), hepatic-related adverse effects (RR 1.29; P = .02), and bleeding (RR 1.13; P = .018). Finally, a study by the Polish adult leukemia group demonstrated the safety and efficacy of a low dose cytarabine + cladribine regimen. Treatment consisted of 5 mg/m² cladribine intravenously on day 1-5 (in the first cycle) and on days 1 to 3 (in the second cycle) combined with low dose cytarabine (40 mg) subcutaneously once daily on days 1–10. Patients may continue on low dose cytarabine after that if they have achieved at least a partial remission. Rates of overall response and 56-day mortality were 54.0% and 20.5%, respectively. The median overall survival was 6.9 months (95% CI 4.9-9.6) and superior in patients who achieved an objective response (HR 0.04; P < .0001) or partial remission (HR 0.31; P = .0002) compared to nonresponders.

In addition to the better therapies in the last decade, allogeneic hematopoietic stem cell transplantation (allo-HSCT) outcomes have also improved. In a retrospective analysis from the Japanese nationwide transplantation registry the outcomes of patients transplanted with unrelated cord blood (UCB) and Haplo transplant between 2007 to 2014 were worse when compared to patients who had a transplant between 2015 and 2018. For patients who had transplants between 2015 and 2018, the 3-year overall survival of mismatched unrelated donor (MMUD), unrelated cord blood (UCB), and Haplo groups were 60%, 66%, and 63%, respectively (P = .693). The rates of nonrelapse mortality (P = .147), relapse (P = .075), and graft-vs. host disease-free/relapse-free survival (P = .365) were also similar between the 3 groups. For patients with transplant between 2007 to 2014 the 3 year overall survival was 60%, 54%, and 47% for MMUD, UCB, and Haplo transplants respectively. Newer, better drugs, better tolerated regimens, and improved transplant outcomes were the result: many small gains lead to large improvements.

This month a couple of studies evaluated the role of enasidenib and gemtuzumab in the therapy of patients with AML using clinical and non-clinical trial data. In a propensity score-matching (PSM) analysis, was enasidenib associated with better outcomes compared to standard of care (SoC). The study included adult patients with relapsed/refractory (R/R) AML with an isocitrate dehydrogenase 2 (IDH2) mutation ineligible for hematopoietic stem cell transplantation (HSCT) treated with enasidenib (n = 195) from the AG221 C-001 trial or SoC therapies (n = 78) from the French Chart Review study. The SoC regimens included azacytidine, decitabine, cytarabine containing regimens, and others. Enasidenib was associated with superior overall survival (OS) (hazard ratio [HR] 0.67; 95% CI 0.47-0.97) compared to SoC therapies in patients with R/R AML with IDH2 mutation who were ineligible for HSCT. The median OS was 9.26 months vs. 4.76 months for enasidenib and SoC respectively. The results of this study are not surprising given the data seen in clinical trials. Although not evaluated in this study, the quality of life for patients receiving enasidenib is better when compared to SoC regimens, such as 7 +3 (cytarabine + idarubicin). Other than the limitations of a PSM study, which are well acknowledged by the authors, the main weakness is this study did not include venetoclax in the SoC regimen. It remains unclear whether using venetoclax in the R/R setting in patients with IDH2 mutations would lead to similar outcomes.

The benefit of gemtuzumab ozogamicin (GO) was demonstrated again in a metanalysis that included 15 randomized controlled trials and 15 retrospective studies that compared GO (n = 4,768) with non-GO (n = 6,466) therapies in 11,234 patients with AML (n = 11,105) and high-risk myelodysplastic syndrome (MDS) (n = 129). GO showed superior survival outcomes in patients with AML or high-risk MDS than non-GO therapy, but higher doses increased the risk for early death. GO vs. non-GO arm showed improved overall survival (HR 0.86; P = .003), event-free survival (HR 0.86; P = .015), and relapse-free survival (HR 0.83; P = .001). However, GO vs. non-GO was associated with an increased risk for early death at a dose of ≥6 mg/m² (relative risk [RR] 2.01; P = .005), hepatic-related adverse effects (RR 1.29; P = .02), and bleeding (RR 1.13; P = .018). Finally, a study by the Polish adult leukemia group demonstrated the safety and efficacy of a low dose cytarabine + cladribine regimen. Treatment consisted of 5 mg/m² cladribine intravenously on day 1-5 (in the first cycle) and on days 1 to 3 (in the second cycle) combined with low dose cytarabine (40 mg) subcutaneously once daily on days 1–10. Patients may continue on low dose cytarabine after that if they have achieved at least a partial remission. Rates of overall response and 56-day mortality were 54.0% and 20.5%, respectively. The median overall survival was 6.9 months (95% CI 4.9-9.6) and superior in patients who achieved an objective response (HR 0.04; P < .0001) or partial remission (HR 0.31; P = .0002) compared to nonresponders.

In addition to the better therapies in the last decade, allogeneic hematopoietic stem cell transplantation (allo-HSCT) outcomes have also improved. In a retrospective analysis from the Japanese nationwide transplantation registry the outcomes of patients transplanted with unrelated cord blood (UCB) and Haplo transplant between 2007 to 2014 were worse when compared to patients who had a transplant between 2015 and 2018. For patients who had transplants between 2015 and 2018, the 3-year overall survival of mismatched unrelated donor (MMUD), unrelated cord blood (UCB), and Haplo groups were 60%, 66%, and 63%, respectively (P = .693). The rates of nonrelapse mortality (P = .147), relapse (P = .075), and graft-vs. host disease-free/relapse-free survival (P = .365) were also similar between the 3 groups. For patients with transplant between 2007 to 2014 the 3 year overall survival was 60%, 54%, and 47% for MMUD, UCB, and Haplo transplants respectively. Newer, better drugs, better tolerated regimens, and improved transplant outcomes were the result: many small gains lead to large improvements.

Q2. Correct answer: A.  
 
Rationale  
Tropical sprue occurs in patients from or travelers to endemic areas near the equator, such as Puerto Rico, Haiti, Cuba, Southeast Asia, and India for at least 2 weeks to a month and has a likely infectious etiology, but the exact organism(s) has not been identified. Patients may present with malabsorption, steatorrhea, weight loss, and fatigue. Laboratory testing shows anemia, B12 and folate deficiency, and increased fecal fat. Biopsies of the small bowel during upper endoscopy show villous blunting with negative celiac serologies. Treatment is a 3- to 6-month course of tetracycline 250 mg orally four times daily with folate 5 mg orally daily. The macrocytic anemia, normal iron studies, and low vitamin B12 and folate levels argue against celiac disease, so this patient is unlikely to respond to a gluten-free diet.  
 
References  
Ghoshal UC et. al. Curr Gastroenterol Rep. 2014;16(6):391.  
Batheja MJ et. al. Case Rep Gastroenterol. 2010 May 19;4(2):168-172.  
Jansson-Knodell CL et al. Mayo Clin Proc. 2018 Apr;93(4):509-517.

Q2. Correct answer: A.  
 
Rationale  
Tropical sprue occurs in patients from or travelers to endemic areas near the equator, such as Puerto Rico, Haiti, Cuba, Southeast Asia, and India for at least 2 weeks to a month and has a likely infectious etiology, but the exact organism(s) has not been identified. Patients may present with malabsorption, steatorrhea, weight loss, and fatigue. Laboratory testing shows anemia, B12 and folate deficiency, and increased fecal fat. Biopsies of the small bowel during upper endoscopy show villous blunting with negative celiac serologies. Treatment is a 3- to 6-month course of tetracycline 250 mg orally four times daily with folate 5 mg orally daily. The macrocytic anemia, normal iron studies, and low vitamin B12 and folate levels argue against celiac disease, so this patient is unlikely to respond to a gluten-free diet.  
 
References  
Ghoshal UC et. al. Curr Gastroenterol Rep. 2014;16(6):391.  
Batheja MJ et. al. Case Rep Gastroenterol. 2010 May 19;4(2):168-172.  
Jansson-Knodell CL et al. Mayo Clin Proc. 2018 Apr;93(4):509-517.

Q2. Correct answer: A.  
 
Rationale  
Tropical sprue occurs in patients from or travelers to endemic areas near the equator, such as Puerto Rico, Haiti, Cuba, Southeast Asia, and India for at least 2 weeks to a month and has a likely infectious etiology, but the exact organism(s) has not been identified. Patients may present with malabsorption, steatorrhea, weight loss, and fatigue. Laboratory testing shows anemia, B12 and folate deficiency, and increased fecal fat. Biopsies of the small bowel during upper endoscopy show villous blunting with negative celiac serologies. Treatment is a 3- to 6-month course of tetracycline 250 mg orally four times daily with folate 5 mg orally daily. The macrocytic anemia, normal iron studies, and low vitamin B12 and folate levels argue against celiac disease, so this patient is unlikely to respond to a gluten-free diet.  
 
References  
Ghoshal UC et. al. Curr Gastroenterol Rep. 2014;16(6):391.  
Batheja MJ et. al. Case Rep Gastroenterol. 2010 May 19;4(2):168-172.  
Jansson-Knodell CL et al. Mayo Clin Proc. 2018 Apr;93(4):509-517.

Correct answer: A. 
 
Rationale  
This patient has scromboid poisoning, which occurs when histidine is converted to histamine by bacterial enzymes in improperly refrigerated fish. Most cases in the United States are reported in Hawaii, Florida, and California and involve consumption of affected tuna, mackerel, mahi-mahi, sardines, herring, and other fish. Onset of symptoms occurs about 1 hour after eating the suspect fish; the patient may experience hot flashes, facial flushing, hives, upper body rash, perioral paresthesias or edema, palpitations, lightheadedness, nausea, vomiting, and abdominal pain. Symptoms typically resolve within 1 day, though some patients may experience a longer course. Supportive care and either oral or intravenous administration of antihistamines may be used to improve symptoms. Evaluation of airway patency is also important. Scromboid poisoning may be prevented by immediate refrigeration of fresh fish to below 40°C.  
Although ACE inhibitor induced angioedema may cause facial swelling, the time course of the disease and associated risk factors favor scromboid poisoning. Ingestion of Bacillus cereus or Staphylococcus aureus would not be expected to cause flushing, tachycardia, and upper body rash. Ciguatera poisoning has a less immediate onset of symptoms, is associated with neurologic symptoms, and has a more protracted course. This patient is not likely to have an allergy to seafood.  
 
Reference  
Hungerford JM. Toxicon. 2010 Aug 15;56(2):231-43.

Correct answer: A. 
 
Rationale  
This patient has scromboid poisoning, which occurs when histidine is converted to histamine by bacterial enzymes in improperly refrigerated fish. Most cases in the United States are reported in Hawaii, Florida, and California and involve consumption of affected tuna, mackerel, mahi-mahi, sardines, herring, and other fish. Onset of symptoms occurs about 1 hour after eating the suspect fish; the patient may experience hot flashes, facial flushing, hives, upper body rash, perioral paresthesias or edema, palpitations, lightheadedness, nausea, vomiting, and abdominal pain. Symptoms typically resolve within 1 day, though some patients may experience a longer course. Supportive care and either oral or intravenous administration of antihistamines may be used to improve symptoms. Evaluation of airway patency is also important. Scromboid poisoning may be prevented by immediate refrigeration of fresh fish to below 40°C.  
Although ACE inhibitor induced angioedema may cause facial swelling, the time course of the disease and associated risk factors favor scromboid poisoning. Ingestion of Bacillus cereus or Staphylococcus aureus would not be expected to cause flushing, tachycardia, and upper body rash. Ciguatera poisoning has a less immediate onset of symptoms, is associated with neurologic symptoms, and has a more protracted course. This patient is not likely to have an allergy to seafood.  
 
Reference  
Hungerford JM. Toxicon. 2010 Aug 15;56(2):231-43.

Correct answer: A. 
 
Rationale  
This patient has scromboid poisoning, which occurs when histidine is converted to histamine by bacterial enzymes in improperly refrigerated fish. Most cases in the United States are reported in Hawaii, Florida, and California and involve consumption of affected tuna, mackerel, mahi-mahi, sardines, herring, and other fish. Onset of symptoms occurs about 1 hour after eating the suspect fish; the patient may experience hot flashes, facial flushing, hives, upper body rash, perioral paresthesias or edema, palpitations, lightheadedness, nausea, vomiting, and abdominal pain. Symptoms typically resolve within 1 day, though some patients may experience a longer course. Supportive care and either oral or intravenous administration of antihistamines may be used to improve symptoms. Evaluation of airway patency is also important. Scromboid poisoning may be prevented by immediate refrigeration of fresh fish to below 40°C.  
Although ACE inhibitor induced angioedema may cause facial swelling, the time course of the disease and associated risk factors favor scromboid poisoning. Ingestion of Bacillus cereus or Staphylococcus aureus would not be expected to cause flushing, tachycardia, and upper body rash. Ciguatera poisoning has a less immediate onset of symptoms, is associated with neurologic symptoms, and has a more protracted course. This patient is not likely to have an allergy to seafood.  
 
Reference  
Hungerford JM. Toxicon. 2010 Aug 15;56(2):231-43.

Deucravacitinib, a novel inhibitor of tyrosine kinase 2 (TYK2), continues to demonstrate strong efficacy and acceptable safety after 52 weeks of follow-up, according to late-breaking data from two pivotal trials presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

From benefit reported on the two coprimary endpoints previously reported at 16 weeks, longer follow-up showed further gains out to 24 weeks and then persistent efficacy out to 52 weeks across these and multiple secondary endpoints, reported Richard Warren, MBChB, PhD, professor of dermatology and therapeutics, University of Manchester (England).

“This could be a unique oral therapy and an important treatment option for moderate to severe psoriasis,” Dr. Warren contended.

The multinational double-blind trials, called POETYK PSO-1 and PSO-2, enrolled 666 and 1,020 patients, respectively. The designs were similar. Patients with moderate to severe plaque psoriasis were randomly assigned in a 2:1:1 ratio to deucravacitinib (6 mg once daily), placebo, or apremilast (Otezla; 30 mg twice daily). At 16 weeks, those on placebo were switched to deucravacitinib.

For the coprimary endpoint of PASI 75 (75% clearance on the Psoriasis and Severity Index), the similar rate of response for deucravacitinib in the two studies (58.7%/53.6%) at week 16 was superior to the rates observed on both apremilast (35.1%/40.2%) and placebo (12.7%/9.4%).

By week 24, the proportion of deucravacitinib patients with a PASI 75 response had reached 69.3% and 58.7% in the POETYK PSO-1 and PSO-2 trials, respectively. The proportion of patients on apremilast with PASI 75 at this time point did not increase appreciably in one study and fell modestly in the other.

By week 52, the response rates achieved with deucravacitinib at week 24 were generally unchanged and nearly double those observed on apremilast.

The pattern of relative benefit on the other coprimary endpoint, which was a score of 0 or 1, signifying clear or almost clear skin on the static Physicians Global Assessment (sPGA), followed the same pattern. At week 16, 53.6% of patients had achieved sPGA 0/1. This was significantly higher than that observed on either apremilast or placebo, and this level of response was sustained through week 52.

When patients on placebo were switched to deucravacitinib at week 16, the PASI 75 response climbed quickly. There was complete catch-up by 32 weeks. In both groups, a PASI 75 response rate of about 65% or higher was maintained for the remainder of the study.

On a prespecified analysis, prior treatment exposure was not associated with any impact on the degree of response with deucravacitinib. This included a comparison between patients exposed to no prior biologic, one prior biologic, or two or more biologics, Dr. Warren reported.

Unlike patients in POETYK PSO-1, those with a PASI 75 response at 16 weeks in the POETYK PSO-2 trial were rerandomized to remain on deucravacitinib or switch to placebo. Designed to evaluate response durability, this analysis showed a relatively gradual decline in disease control.

“The median time to a loss of response was 12 weeks,” Dr. Warren said. He was referring in this case to the PASI 75 response, but the slope of decline was similar for sPGA score 0/1. At the end of 52 weeks, 31.3% of patients who had been rerandomized to placebo still maintained a PASI 75 while 80.4% of those who stayed on deucravacitinib still had PASI 75 clearance.

In the 52-week data from these two trials, several secondary endpoints have already been examined, and Dr. Warren said more analyses are coming. So far, the pattern of response has been similar for all endpoints.

Reporting on one as an example, Dr. Warren said that sPGA 0/1 for scalp psoriasis was achieved at week 16 by 70.3% of those randomly assigned to deucravacitinib versus 17.4% of those in the placebo arm. Among those switched from placebo to deucravacitinib at 16 weeks, the scalp response had caught up to that observed in those initiated on deucravacitinib by week 28. The response was sustained out to 52 weeks in both groups.

In the long-term trials, there have been no new safety concerns, according to Dr. Warren. He described this drug as “well tolerated,” adding that no significant laboratory abnormalities have been observed on long-term treatment. Although there has been a trend for increased risk of viral infections, such as herpes zoster, relative to apremilast, cases have so far been mild.

The Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has been approved for psoriatic arthritis, and numerous other JAK inhibitors are now in clinical trials for plaque psoriasis. These agents vary for their relative selectivity for JAK1, 2, and 3 kinases, but deucravacitinib is the first JAK inhibitor to reach clinical trials that target TYK2, which inhibits interleukin-23 and other cytokines implicated in the pathogenesis of plaque psoriasis.

“Deucravacitinib is very distinct from the other JAK inhibitors, and I think we are seeing this in the clinical studies,” Dr. Warren said. As a result of responses in the POETYK PRO trials that rival those achieved with monoclonal antibodies, he expects this drug, if approved, to be an important option for those with moderate to severe disease who prefer oral therapies.

Mark G. Lebwohl, MD, professor of dermatology and dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York, shares this opinion. In an interview, he emphasized the unique mechanism of deucravacitinib and its clinical potential.

“Unlike other less specific JAK inhibitors, deucravacitinib has a unique binding site on TYK2, the regulatory domain of the molecule. This makes deucravacitinib more targeted and therefore safer than other JAK inhibitors,” said Dr. Lebwohl.

“After cyclosporine, which has many side effects, deucravacitinib is the most effective oral therapy we have for psoriasis and one of the safest,” he added.

The POETYK PSO-1 and PSO-2 trials received funding from Bristol-Myers Squibb. Dr. Warren has financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, UCB, and Xenoport. Dr. Lebwohl has financial relationships with more than 20 pharmaceutical companies, including Bristol-Myers Squibb.

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

Deucravacitinib, a novel inhibitor of tyrosine kinase 2 (TYK2), continues to demonstrate strong efficacy and acceptable safety after 52 weeks of follow-up, according to late-breaking data from two pivotal trials presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

From benefit reported on the two coprimary endpoints previously reported at 16 weeks, longer follow-up showed further gains out to 24 weeks and then persistent efficacy out to 52 weeks across these and multiple secondary endpoints, reported Richard Warren, MBChB, PhD, professor of dermatology and therapeutics, University of Manchester (England).

“This could be a unique oral therapy and an important treatment option for moderate to severe psoriasis,” Dr. Warren contended.

The multinational double-blind trials, called POETYK PSO-1 and PSO-2, enrolled 666 and 1,020 patients, respectively. The designs were similar. Patients with moderate to severe plaque psoriasis were randomly assigned in a 2:1:1 ratio to deucravacitinib (6 mg once daily), placebo, or apremilast (Otezla; 30 mg twice daily). At 16 weeks, those on placebo were switched to deucravacitinib.

For the coprimary endpoint of PASI 75 (75% clearance on the Psoriasis and Severity Index), the similar rate of response for deucravacitinib in the two studies (58.7%/53.6%) at week 16 was superior to the rates observed on both apremilast (35.1%/40.2%) and placebo (12.7%/9.4%).

By week 24, the proportion of deucravacitinib patients with a PASI 75 response had reached 69.3% and 58.7% in the POETYK PSO-1 and PSO-2 trials, respectively. The proportion of patients on apremilast with PASI 75 at this time point did not increase appreciably in one study and fell modestly in the other.

By week 52, the response rates achieved with deucravacitinib at week 24 were generally unchanged and nearly double those observed on apremilast.

The pattern of relative benefit on the other coprimary endpoint, which was a score of 0 or 1, signifying clear or almost clear skin on the static Physicians Global Assessment (sPGA), followed the same pattern. At week 16, 53.6% of patients had achieved sPGA 0/1. This was significantly higher than that observed on either apremilast or placebo, and this level of response was sustained through week 52.

When patients on placebo were switched to deucravacitinib at week 16, the PASI 75 response climbed quickly. There was complete catch-up by 32 weeks. In both groups, a PASI 75 response rate of about 65% or higher was maintained for the remainder of the study.

On a prespecified analysis, prior treatment exposure was not associated with any impact on the degree of response with deucravacitinib. This included a comparison between patients exposed to no prior biologic, one prior biologic, or two or more biologics, Dr. Warren reported.

Unlike patients in POETYK PSO-1, those with a PASI 75 response at 16 weeks in the POETYK PSO-2 trial were rerandomized to remain on deucravacitinib or switch to placebo. Designed to evaluate response durability, this analysis showed a relatively gradual decline in disease control.

“The median time to a loss of response was 12 weeks,” Dr. Warren said. He was referring in this case to the PASI 75 response, but the slope of decline was similar for sPGA score 0/1. At the end of 52 weeks, 31.3% of patients who had been rerandomized to placebo still maintained a PASI 75 while 80.4% of those who stayed on deucravacitinib still had PASI 75 clearance.

In the 52-week data from these two trials, several secondary endpoints have already been examined, and Dr. Warren said more analyses are coming. So far, the pattern of response has been similar for all endpoints.

Reporting on one as an example, Dr. Warren said that sPGA 0/1 for scalp psoriasis was achieved at week 16 by 70.3% of those randomly assigned to deucravacitinib versus 17.4% of those in the placebo arm. Among those switched from placebo to deucravacitinib at 16 weeks, the scalp response had caught up to that observed in those initiated on deucravacitinib by week 28. The response was sustained out to 52 weeks in both groups.

In the long-term trials, there have been no new safety concerns, according to Dr. Warren. He described this drug as “well tolerated,” adding that no significant laboratory abnormalities have been observed on long-term treatment. Although there has been a trend for increased risk of viral infections, such as herpes zoster, relative to apremilast, cases have so far been mild.

The Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has been approved for psoriatic arthritis, and numerous other JAK inhibitors are now in clinical trials for plaque psoriasis. These agents vary for their relative selectivity for JAK1, 2, and 3 kinases, but deucravacitinib is the first JAK inhibitor to reach clinical trials that target TYK2, which inhibits interleukin-23 and other cytokines implicated in the pathogenesis of plaque psoriasis.

“Deucravacitinib is very distinct from the other JAK inhibitors, and I think we are seeing this in the clinical studies,” Dr. Warren said. As a result of responses in the POETYK PRO trials that rival those achieved with monoclonal antibodies, he expects this drug, if approved, to be an important option for those with moderate to severe disease who prefer oral therapies.

Mark G. Lebwohl, MD, professor of dermatology and dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York, shares this opinion. In an interview, he emphasized the unique mechanism of deucravacitinib and its clinical potential.

“Unlike other less specific JAK inhibitors, deucravacitinib has a unique binding site on TYK2, the regulatory domain of the molecule. This makes deucravacitinib more targeted and therefore safer than other JAK inhibitors,” said Dr. Lebwohl.

“After cyclosporine, which has many side effects, deucravacitinib is the most effective oral therapy we have for psoriasis and one of the safest,” he added.

The POETYK PSO-1 and PSO-2 trials received funding from Bristol-Myers Squibb. Dr. Warren has financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, UCB, and Xenoport. Dr. Lebwohl has financial relationships with more than 20 pharmaceutical companies, including Bristol-Myers Squibb.

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

Deucravacitinib, a novel inhibitor of tyrosine kinase 2 (TYK2), continues to demonstrate strong efficacy and acceptable safety after 52 weeks of follow-up, according to late-breaking data from two pivotal trials presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

From benefit reported on the two coprimary endpoints previously reported at 16 weeks, longer follow-up showed further gains out to 24 weeks and then persistent efficacy out to 52 weeks across these and multiple secondary endpoints, reported Richard Warren, MBChB, PhD, professor of dermatology and therapeutics, University of Manchester (England).

“This could be a unique oral therapy and an important treatment option for moderate to severe psoriasis,” Dr. Warren contended.

The multinational double-blind trials, called POETYK PSO-1 and PSO-2, enrolled 666 and 1,020 patients, respectively. The designs were similar. Patients with moderate to severe plaque psoriasis were randomly assigned in a 2:1:1 ratio to deucravacitinib (6 mg once daily), placebo, or apremilast (Otezla; 30 mg twice daily). At 16 weeks, those on placebo were switched to deucravacitinib.

For the coprimary endpoint of PASI 75 (75% clearance on the Psoriasis and Severity Index), the similar rate of response for deucravacitinib in the two studies (58.7%/53.6%) at week 16 was superior to the rates observed on both apremilast (35.1%/40.2%) and placebo (12.7%/9.4%).

By week 24, the proportion of deucravacitinib patients with a PASI 75 response had reached 69.3% and 58.7% in the POETYK PSO-1 and PSO-2 trials, respectively. The proportion of patients on apremilast with PASI 75 at this time point did not increase appreciably in one study and fell modestly in the other.

By week 52, the response rates achieved with deucravacitinib at week 24 were generally unchanged and nearly double those observed on apremilast.

The pattern of relative benefit on the other coprimary endpoint, which was a score of 0 or 1, signifying clear or almost clear skin on the static Physicians Global Assessment (sPGA), followed the same pattern. At week 16, 53.6% of patients had achieved sPGA 0/1. This was significantly higher than that observed on either apremilast or placebo, and this level of response was sustained through week 52.

When patients on placebo were switched to deucravacitinib at week 16, the PASI 75 response climbed quickly. There was complete catch-up by 32 weeks. In both groups, a PASI 75 response rate of about 65% or higher was maintained for the remainder of the study.

On a prespecified analysis, prior treatment exposure was not associated with any impact on the degree of response with deucravacitinib. This included a comparison between patients exposed to no prior biologic, one prior biologic, or two or more biologics, Dr. Warren reported.

Unlike patients in POETYK PSO-1, those with a PASI 75 response at 16 weeks in the POETYK PSO-2 trial were rerandomized to remain on deucravacitinib or switch to placebo. Designed to evaluate response durability, this analysis showed a relatively gradual decline in disease control.

“The median time to a loss of response was 12 weeks,” Dr. Warren said. He was referring in this case to the PASI 75 response, but the slope of decline was similar for sPGA score 0/1. At the end of 52 weeks, 31.3% of patients who had been rerandomized to placebo still maintained a PASI 75 while 80.4% of those who stayed on deucravacitinib still had PASI 75 clearance.

In the 52-week data from these two trials, several secondary endpoints have already been examined, and Dr. Warren said more analyses are coming. So far, the pattern of response has been similar for all endpoints.

Reporting on one as an example, Dr. Warren said that sPGA 0/1 for scalp psoriasis was achieved at week 16 by 70.3% of those randomly assigned to deucravacitinib versus 17.4% of those in the placebo arm. Among those switched from placebo to deucravacitinib at 16 weeks, the scalp response had caught up to that observed in those initiated on deucravacitinib by week 28. The response was sustained out to 52 weeks in both groups.

In the long-term trials, there have been no new safety concerns, according to Dr. Warren. He described this drug as “well tolerated,” adding that no significant laboratory abnormalities have been observed on long-term treatment. Although there has been a trend for increased risk of viral infections, such as herpes zoster, relative to apremilast, cases have so far been mild.

The Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has been approved for psoriatic arthritis, and numerous other JAK inhibitors are now in clinical trials for plaque psoriasis. These agents vary for their relative selectivity for JAK1, 2, and 3 kinases, but deucravacitinib is the first JAK inhibitor to reach clinical trials that target TYK2, which inhibits interleukin-23 and other cytokines implicated in the pathogenesis of plaque psoriasis.

“Deucravacitinib is very distinct from the other JAK inhibitors, and I think we are seeing this in the clinical studies,” Dr. Warren said. As a result of responses in the POETYK PRO trials that rival those achieved with monoclonal antibodies, he expects this drug, if approved, to be an important option for those with moderate to severe disease who prefer oral therapies.

Mark G. Lebwohl, MD, professor of dermatology and dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York, shares this opinion. In an interview, he emphasized the unique mechanism of deucravacitinib and its clinical potential.

“Unlike other less specific JAK inhibitors, deucravacitinib has a unique binding site on TYK2, the regulatory domain of the molecule. This makes deucravacitinib more targeted and therefore safer than other JAK inhibitors,” said Dr. Lebwohl.

“After cyclosporine, which has many side effects, deucravacitinib is the most effective oral therapy we have for psoriasis and one of the safest,” he added.

The POETYK PSO-1 and PSO-2 trials received funding from Bristol-Myers Squibb. Dr. Warren has financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, UCB, and Xenoport. Dr. Lebwohl has financial relationships with more than 20 pharmaceutical companies, including Bristol-Myers Squibb.

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

Introduction

There have been incident reports of cardiac-related adverse events (CrAE) from immune checkpoint inhibitors (ICPI); however, the true incidence and subsequent management of these potential side effects have not been defined. It is therefore important to study ICPI related cardiac dysfunction to assist in monitoring and surveillance of these patients.

Methods

63 patients who received nivolumab and pembrolizumab at Stratton VAMC Albany between January 2015 to December 2018 were studied. Retrospective chart review was done to identify the CrAE up to two-year post-therapy completion or discontinuation. Naranjo score was used to assess drug-related side effect. IRB approval was obtained.

Results 

CrAE were defined as new onset arrythmia identified on electrocardiogram, evidence of cardiomyopathy on echocardiogram, an acute coronary event, and hospitalizations from primary cardiac disorder following ICPI administration. Of the 63 patients, 6 patients developed CrAE. Our review showed 3 patients developed new arrythmias including 1 with atrial fibrillation, and 2 with atrial flutter. There was 1 case each of new heart failure with reduced ejection fraction and pericarditis with pericardial tamponade. 1 patient developed acute coronary syndrome in addition to complete heart block. Of the 6 patients, 2 had elevated brain natriuretic peptide (BNP) prior to onset of CrAE. Elevated markers including BNP and troponin-I were also seen in 13 patients with preexisting heart conditions without CrAE. Duration of therapy was variable for all patients with CrAE. Therapy was continued for 3 patients without recurrence of CrAE. Therapy was permanently discontinued in the patient who developed pericardial effusion (grade IV toxicity). The remaining 2 patients had additional concurrent immune-related toxicities that required discontinuation of therapy. Our analysis showed 25/63 patients with pre-existing cardiac conditions (including arrhythmia, heart failure or coronary artery disease) who did not develop new CrAE; however 6 of these patients required hospitalization for exacerbation related to these pre-existing conditions.

Conclusions

CrAE can occur with ICPIs, and vigilance is required in high-risk patient including those with pre-existing cardiac comorbidity. Further studies are required to establish if baseline screening EKG and echocardiogram should be obtained for all patients starting ICPI.

Introduction

There have been incident reports of cardiac-related adverse events (CrAE) from immune checkpoint inhibitors (ICPI); however, the true incidence and subsequent management of these potential side effects have not been defined. It is therefore important to study ICPI related cardiac dysfunction to assist in monitoring and surveillance of these patients.

Methods

63 patients who received nivolumab and pembrolizumab at Stratton VAMC Albany between January 2015 to December 2018 were studied. Retrospective chart review was done to identify the CrAE up to two-year post-therapy completion or discontinuation. Naranjo score was used to assess drug-related side effect. IRB approval was obtained.

Results 

CrAE were defined as new onset arrythmia identified on electrocardiogram, evidence of cardiomyopathy on echocardiogram, an acute coronary event, and hospitalizations from primary cardiac disorder following ICPI administration. Of the 63 patients, 6 patients developed CrAE. Our review showed 3 patients developed new arrythmias including 1 with atrial fibrillation, and 2 with atrial flutter. There was 1 case each of new heart failure with reduced ejection fraction and pericarditis with pericardial tamponade. 1 patient developed acute coronary syndrome in addition to complete heart block. Of the 6 patients, 2 had elevated brain natriuretic peptide (BNP) prior to onset of CrAE. Elevated markers including BNP and troponin-I were also seen in 13 patients with preexisting heart conditions without CrAE. Duration of therapy was variable for all patients with CrAE. Therapy was continued for 3 patients without recurrence of CrAE. Therapy was permanently discontinued in the patient who developed pericardial effusion (grade IV toxicity). The remaining 2 patients had additional concurrent immune-related toxicities that required discontinuation of therapy. Our analysis showed 25/63 patients with pre-existing cardiac conditions (including arrhythmia, heart failure or coronary artery disease) who did not develop new CrAE; however 6 of these patients required hospitalization for exacerbation related to these pre-existing conditions.

Conclusions

CrAE can occur with ICPIs, and vigilance is required in high-risk patient including those with pre-existing cardiac comorbidity. Further studies are required to establish if baseline screening EKG and echocardiogram should be obtained for all patients starting ICPI.

Introduction

There have been incident reports of cardiac-related adverse events (CrAE) from immune checkpoint inhibitors (ICPI); however, the true incidence and subsequent management of these potential side effects have not been defined. It is therefore important to study ICPI related cardiac dysfunction to assist in monitoring and surveillance of these patients.

Methods

63 patients who received nivolumab and pembrolizumab at Stratton VAMC Albany between January 2015 to December 2018 were studied. Retrospective chart review was done to identify the CrAE up to two-year post-therapy completion or discontinuation. Naranjo score was used to assess drug-related side effect. IRB approval was obtained.

Results 

CrAE were defined as new onset arrythmia identified on electrocardiogram, evidence of cardiomyopathy on echocardiogram, an acute coronary event, and hospitalizations from primary cardiac disorder following ICPI administration. Of the 63 patients, 6 patients developed CrAE. Our review showed 3 patients developed new arrythmias including 1 with atrial fibrillation, and 2 with atrial flutter. There was 1 case each of new heart failure with reduced ejection fraction and pericarditis with pericardial tamponade. 1 patient developed acute coronary syndrome in addition to complete heart block. Of the 6 patients, 2 had elevated brain natriuretic peptide (BNP) prior to onset of CrAE. Elevated markers including BNP and troponin-I were also seen in 13 patients with preexisting heart conditions without CrAE. Duration of therapy was variable for all patients with CrAE. Therapy was continued for 3 patients without recurrence of CrAE. Therapy was permanently discontinued in the patient who developed pericardial effusion (grade IV toxicity). The remaining 2 patients had additional concurrent immune-related toxicities that required discontinuation of therapy. Our analysis showed 25/63 patients with pre-existing cardiac conditions (including arrhythmia, heart failure or coronary artery disease) who did not develop new CrAE; however 6 of these patients required hospitalization for exacerbation related to these pre-existing conditions.

Conclusions

CrAE can occur with ICPIs, and vigilance is required in high-risk patient including those with pre-existing cardiac comorbidity. Further studies are required to establish if baseline screening EKG and echocardiogram should be obtained for all patients starting ICPI.

On April 1, Houston Methodist Hospital in Houston, Texas, announced a new policy that all of its staff would need to be vaccinated against COVID-19 by June 7 in order to hold onto their jobs. Most responded positively but an estimated 150 staff members who did not comply either resigned or were terminated. A lawsuit by employees opposed to the vaccine mandate was dismissed by Federal District Court Judge Lynn Hughes in June, although a subsequent lawsuit was filed Aug. 16.

Vaccines have been shown to dramatically reduce both the incidence and the severity of COVID infections. Vaccinations of health care workers, especially those who have direct contact with patients, are demonstrated to be effective strategies to significantly reduce, although not eliminate, the possibility of viral transmissions to patients – or to health care workers themselves – thus saving lives.

Hospitalists, in their central role in the care of hospitalized patients, and often with primary responsibility for managing their hospital’s COVID-19 caseloads, may find themselves encountering conversations about the vaccine, its safety, effectiveness, and mandates with their peers, other hospital staff, patients, and families, and their communities. They can play key roles in advocating for the vaccine, answering questions, clarifying the science, and dispelling misinformation – for those who are willing to listen.

Becker’s Hospital Review, which has kept an ongoing tally of announced vaccine mandate policies in hospitals, health systems, and health departments nationwide, reported on Aug. 13 that 1,850 or 30% of U.S. hospitals, had announced vaccine mandates.¹ Often exceptions can be made, such as for medical or religious reasons, or with other declarations or opt-out provisions. But in many settings, mandating COVID vaccinations won’t be easy.

Amith Skandhan, MD, SFHM, FACP, a hospitalist at Southeast Health Medical Center in Dothan, Ala., and a core faculty member in the internal medicine residency program at Alabama College of Osteopathic Medicine, said that implementing vaccine mandates will be more difficult in smaller health systems, in rural communities, and in states with lower vaccination rates and greater vaccine controversy.

Alabama has the lowest vaccination rates in the country, reflected in the recent rise in COVID cases and hospitalizations, even higher than during the surge of late 2020, Dr. Skandhan said. “In June we had one COVID patient in this hospital.” By late August the number was 119 COVID patients and climbing.

But where he works, in a health system where staffing is already spread thin, a vaccine mandate would be challenging. “What if our staff started leaving? It’s only 10 minutes from here to the Florida or Georgia border,” Dr. Skandhan said. Health care workers opposed to vaccinations would have the option of easily seeking work elsewhere.

When contacted for this article, he had been off work for several days but was mentally preparing himself to go back. “I’m not even following the [COVID-19] numbers but I am prepared for the worst. I know it will be mostly COVID. People just don’t realize what goes into this work.”

Dr. Skandhan, who said he was the third or fourth person in Alabama to receive the COVID vaccine, often finds himself feeling frustrated and angry – in the midst of a surge in cases that could have been prevented – that such a beneficial medical advance for bringing the pandemic under control became so politicized. “It is imperative that we find out why this mistrust exists and work to address it. It has to be done.”

Protecting health care professionals

On July 26, the Society of Hospital Medicine joined 50 other health care organizations including the American Medical Association, American Nurses Association, and American Academy of Pediatrics in advocating for all health care employers to require their employees to be vaccinated against COVID, in order to protect the safety of all patients and residents of health care facilities.²

“As an organization, we support vaccinating health care workers, including hospitalists, to help stop the spread of COVID-19 and the increasingly dominant Delta variant,” said SHM’s chief executive officer Eric E. Howell, MD, MHM, in a prepared statement. “We aim to uphold the highest standards among hospitalists and other health care providers to help protect our fellow health care professionals, our patients, and our communities.”

To that end, Dr. Skandhan has started conversations with hospital staff who he knows are not vaccinated. “For some, we’re not able to have a civil conversation, but in most cases I can help to persuade people.” The reasons people give for not getting vaccinated are not based in science, he said. “I am worried about the safety of our hospitalists and staff nurses.” But unvaccinated frontline workers are also putting their patients at risk. “Can we say why they’re hesitating? Can we have an honest discourse? If we can’t do that with our colleagues, how can we blame the patients?”

Dr. Skandhan encourages hospitalists to start simply in their own hospitals, trying to influence their own departments and colleagues. “If you can convince one or two more every week, you can start a chain reaction. Have that conversation. Use your trust.” For some hospitalized patients, the vaccination conversation comes too late, after their infection, but even some of them might consider obtaining it down the road or trying to persuade family members to get vaccinated.

Adult hospitalists, however, may not have received training in how to effectively address vaccine fears and misconceptions among their patients, he said. Because the patients they see in the hospital are already very sick, they don’t get a lot of practice talking about vaccines except, perhaps, for the influenza vaccine.

Pediatric hospitalists have more experience with such conversations involving their patients’ parents, Dr. Skandhan said. “It comes more naturally to them. We need to learn quickly from them about how to talk about vaccines with our patients.”

Pediatric training and experience

Anika Kumar, MD, FHM, FAAP, a pediatric hospitalist at the Cleveland Clinic and the pediatric editor of The Hospitalist, agrees that pediatricians and pediatric hospitalists often have received more training in how to lead vaccination conversations. She often talks about vaccines with the parents of hospitalized children relative to chicken pox, measles, and other diseases of childhood.

Pediatric hospitalists may also ask to administer the hepatitis B vaccine to newborn babies, along with other preventive treatments such as eye drops and vitamin K shots. “I often encourage the influenza vaccine prior to the patient’s hospital discharge, especially for kids with chronic conditions, asthma, diabetes, or premature birth. We talk about how the influenza vaccine isn’t perfect, but it helps to prevent more serious disease,” she said.

“A lot of vaccine hesitancy comes from misunderstandings about the role of vaccines,” she said. People forget that for years children have been getting vaccines before starting school. “Misinformation and opinions about vaccines have existed for decades. What’s new today is the abundance of sources for obtaining these opinions. My job is to inform families of scientific facts and to address their concerns.”

It has become more common recently for parents to say they don’t want their kids to get vaccinated, Dr. Kumar said. Another group is better described as vaccine hesitant and just needs more information. “I may not, by the time they leave the hospital, convince them to allow me to administer the vaccine. But in the discharge summary, I document that I had this conversation. I’ve done my due diligence and tried to start a larger dialogue. I say: ‘I encourage you to continue this discussion with the pediatrician you trust.’ I also communicate with the outpatient team,” she said.

“But it’s our responsibility, because we’re the ones seeing these patients, to do whatever we can to keep our patients from getting sick. A lot of challenging conversations we have with families are just trying to find out where they’re at with the issue – which can lead to productive dialogue.”

Ariel Carpenter, MD, a 4th-year resident in internal medicine and pediatrics at the University of Louisville (Ky.), and a future pediatric hospitalist, agreed that her combined training in med-peds has been helpful preparation for the vaccine conversation. That training has included techniques of motivational interviewing. In pediatrics, she explained, the communication is a little softer. “I try to approach my patients in a family-centered way.”

Dr. Carpenter recently wrote a personal essay for Louisville Medicine magazine from the perspective of growing up homeschooled by a mother who didn’t believe in vaccines.³ As a teenager, she independently obtained the complete childhood vaccine series so that she could do medical shadowing and volunteering. In medical school she became a passionate vaccine advocate, eventually persuading her mother to change her mind on the subject in time for the COVID vaccine.

“There’s not one answer to the vaccination dilemma,” she said. “Different approaches are required because there are so many different reasons for it. Based on my own life experience, I try to approach patients where they are – not from a place of data and science. What worked in my own family, and works with my patients, is first to establish trust. If they trust you, they’re more likely to listen. Simply ask their worries and concerns,” Dr. Carpenter said.

“A lot of them haven’t had the opportunity before to sit down with a physician they trust and have their worries listened to. They don’t feel heard in our medical system. So I remind myself that I need to understand my patients first – before inserting myself into the conversation.”

Many patients she sees are in an information bubble, with a very different understanding of the issue than their doctors. “A lot of well-meaning people feel they are making the safer choice. Very few truly don’t care about protecting others. But they don’t feel the urgency about that and see the vaccine as the scarier option right now.”

Frontline vaccine advocates

Hospitalists are the frontline advocates within their hospital system, in a position to lead, so they need to make vaccines a priority, Dr. Carpenter said. They should also make sure that their hospitals have ready access to the vaccine, so patients who agree to receive it are able to get it quickly. “In our hospital they can get the shot within a few hours if the opportunity arises. We stocked the Johnson & Johnson vaccine so that they wouldn’t have to connect with another health care provider in order to get a second dose.”

Hospitals should also invest in access to vaccine counseling training and personnel. “Fund a nurse clinician who can screen and counsel hospitalized patients for vaccination. If they meet resistance, they can then refer to the dedicated physician of the day to have the conversation,” she said. “But if we don’t mention it, patients will assume we don’t feel strongly about it.”

Because hospitalists are front and center in treating COVID, they need to be the experts and the people offering guidance, said Shyam Odeti, MD, SFHM, FAAFP, section chief for hospital medicine at the Carilion Clinic in Roanoke, Va. “What we’re trying to do is spread awareness. We educated physician groups, learners, and clinical teams during the initial phase, and now mostly patients and their families.” COVID vaccine reluctance is hard to overcome, Dr. Odeti said. People feel the vaccine was developed very quickly. But there are different ways to present it.

“Like most doctors, I thought people would jump on a vaccine to get past the pandemic. I was surprised and then disappointed. Right now, the pandemic is among the unvaccinated. So we face these encounters, and we’re doing our best to overcome the misinformation. My organization is 100% supportive. We talk about these issues every day.”

Carilion, effective Oct. 1, has required unvaccinated employees to get weekly COVID tests and wear an N95 mask while working, and has developed Facebook pages, other social media, and an Internet presence to address these issues. “We’ve gone to the local African-American community with physician leaders active in that community. We had a Spanish language roundtable,” Dr. Odeti said.

Dr. Skandhan reported that the Wiregrass regional chapter of SHM recently organized a successful statewide community educational event aimed at empowering community leaders to address vaccine misinformation and mistrust. “We surveyed religious leaders and pastors regarding the causes of vaccine hesitancy and reached out to physicians active in community awareness.” Based on that input, a presentation by the faith leaders was developed. Legislators from the Alabama State Senate’s Healthcare Policy Committee were also invited to the presentation and discussion.
 

Trying to stay positive

It’s important to try to stay positive, Dr. Odeti said. “We have to be empathetic with every patient. We have to keep working at this, since there’s no way out of the pandemic except through vaccinations. But it all creates stress for hospitalists. Our job is made significantly more difficult by the vaccine controversy.”

Jennifer Cowart, MD, a hospitalist at Mayo Clinic in Jacksonville, Fla., has been outspoken in her community about vaccination and masking issues, talking to reporters, attending rallies and press conferences, posting on social media, and speaking in favor of mask policies at a local school board meeting. She is part of an informal local group called Doctors Fighting COVID, which meets online to strategize how to share its expertise, including writing a recent letter about masks to Jacksonville’s mayor.

“In July, when we saw the Delta variant surging locally, we held a webinar via local media, taking calls about the vaccine from the community. I’m trying not to make this a political issue, but we are health officials.” Dr. Cowart said she also tries not to raise her voice when speaking with vaccine opponents and tries to remain empathetic. “Even though inwardly I’m screaming, I try to stay calm. The misinformation is real. People are afraid and feeling pressure. I do my best, but I’m human, too.”

Hospitalists need to pull whatever levers they can to help advance understanding of vaccines, Dr. Cowart said. “In the hospital, our biggest issue is time. We often don’t have it, with a long list of patients to see. But every patient encounter is an opportunity to talk to patients, whether they have COVID or something else.” Sometimes, she might go back to a patient’s room after rounds to resume the conversation.

Hospital nurses have been trained and entrusted to do tobacco abatement counseling, she said, so why not mobilize them for vaccine education? “Or respiratory therapists, who do inhaler training, could talk about what it’s like to care for COVID patients. There’s a whole bunch of staff in the hospital who could be mobilized,” she said.

“I feel passionate about vaccines, as a hospitalist, as a medical educator, as a daughter, as a responsible member of society,” said Eileen Barrett, MD, MPH, SFHM, MACP, director of continuing medical education at the University of New Mexico, Albuquerque. “I see this as a personal and societal responsibility. When I speak about the vaccine among groups of doctors, I say we need to stay in our lane regarding our skills at interpreting the science and not undermining it.”

Some health care worker hesitancy is from distrust of pharmaceutical companies, or of federal agencies, she said. “Our research has highlighted to me the widespread inequity issues in our health care system. We should also take a long, hard look at how we teach the scientific method to health professionals. That will be part of a pandemic retrospective.”

Sometimes with people who are vaccine deliberative, whether health care workers or patients, there is a small window of opportunity. “We need to hear people and respond to them as people. Then, if they are willing to get vaccinated, we need to accomplish that as quickly and easily as possible,” Dr. Barrett said. “I see them make a face and say, ‘Well, okay, I’ll do it.’ We need to get the vaccine to them that same day. We should be able to accomplish that.”
 

References

1. Gamble M. 30% of US hospitals mandate vaccination for employment. Becker’s Hospital Review. 2021 Aug 13. www.beckershospitalreview.com/workforce/covid-19-vaccination-needed-to-work-at-30-of-us-hospitals.html .

2. Society of Hospital Medicine signs on to joint statement in support of health worker COVID-19 vaccine mandates. Press release. 2021 Jul 26. www.hospitalmedicine.org/news-publications/press-releases/society-of-hospital-medicine-signs-on-to-joint-statement-of-support-of-health-worker-covid-19-vaccine-mandates/.

3. Carpenter A. A physician’s lessons from an unvaccinated childhood. Louisville Medicine. 2021 July;69(2):26-7. https://viewer.joomag.com/louisville-medicine-volume-69-issue-2/0045988001624974172?short&.

Lessons for hospitalists from the vaccination controversy

1. Remain up-to-date on information about the COVID infection, its treatment, and vaccination efficacy data.

2. Hospitalists should take advantage of their positions to lead conversations in their facilities about the importance of COVID vaccinations.

3. Other professionals in the hospital, with some additional training and support, could take on the role of providing vaccine education and support – with a physician to back them up on difficult cases.

4. It’s important to listen to people’s concerns, try to build trust, and establish dialogue before starting to convey a lot of information. People need to feel heard.

5. If you are successful in persuading someone to take the vaccine, a shot should be promptly and easily accessible to them.

6. Pediatric hospitalists may have more experience and skill with vaccine discussions, which they should share with their peers who treat adults.

On April 1, Houston Methodist Hospital in Houston, Texas, announced a new policy that all of its staff would need to be vaccinated against COVID-19 by June 7 in order to hold onto their jobs. Most responded positively but an estimated 150 staff members who did not comply either resigned or were terminated. A lawsuit by employees opposed to the vaccine mandate was dismissed by Federal District Court Judge Lynn Hughes in June, although a subsequent lawsuit was filed Aug. 16.

Vaccines have been shown to dramatically reduce both the incidence and the severity of COVID infections. Vaccinations of health care workers, especially those who have direct contact with patients, are demonstrated to be effective strategies to significantly reduce, although not eliminate, the possibility of viral transmissions to patients – or to health care workers themselves – thus saving lives.

Hospitalists, in their central role in the care of hospitalized patients, and often with primary responsibility for managing their hospital’s COVID-19 caseloads, may find themselves encountering conversations about the vaccine, its safety, effectiveness, and mandates with their peers, other hospital staff, patients, and families, and their communities. They can play key roles in advocating for the vaccine, answering questions, clarifying the science, and dispelling misinformation – for those who are willing to listen.

Becker’s Hospital Review, which has kept an ongoing tally of announced vaccine mandate policies in hospitals, health systems, and health departments nationwide, reported on Aug. 13 that 1,850 or 30% of U.S. hospitals, had announced vaccine mandates.¹ Often exceptions can be made, such as for medical or religious reasons, or with other declarations or opt-out provisions. But in many settings, mandating COVID vaccinations won’t be easy.

Amith Skandhan, MD, SFHM, FACP, a hospitalist at Southeast Health Medical Center in Dothan, Ala., and a core faculty member in the internal medicine residency program at Alabama College of Osteopathic Medicine, said that implementing vaccine mandates will be more difficult in smaller health systems, in rural communities, and in states with lower vaccination rates and greater vaccine controversy.

Alabama has the lowest vaccination rates in the country, reflected in the recent rise in COVID cases and hospitalizations, even higher than during the surge of late 2020, Dr. Skandhan said. “In June we had one COVID patient in this hospital.” By late August the number was 119 COVID patients and climbing.

But where he works, in a health system where staffing is already spread thin, a vaccine mandate would be challenging. “What if our staff started leaving? It’s only 10 minutes from here to the Florida or Georgia border,” Dr. Skandhan said. Health care workers opposed to vaccinations would have the option of easily seeking work elsewhere.

When contacted for this article, he had been off work for several days but was mentally preparing himself to go back. “I’m not even following the [COVID-19] numbers but I am prepared for the worst. I know it will be mostly COVID. People just don’t realize what goes into this work.”

Dr. Skandhan, who said he was the third or fourth person in Alabama to receive the COVID vaccine, often finds himself feeling frustrated and angry – in the midst of a surge in cases that could have been prevented – that such a beneficial medical advance for bringing the pandemic under control became so politicized. “It is imperative that we find out why this mistrust exists and work to address it. It has to be done.”

Protecting health care professionals

On July 26, the Society of Hospital Medicine joined 50 other health care organizations including the American Medical Association, American Nurses Association, and American Academy of Pediatrics in advocating for all health care employers to require their employees to be vaccinated against COVID, in order to protect the safety of all patients and residents of health care facilities.²

“As an organization, we support vaccinating health care workers, including hospitalists, to help stop the spread of COVID-19 and the increasingly dominant Delta variant,” said SHM’s chief executive officer Eric E. Howell, MD, MHM, in a prepared statement. “We aim to uphold the highest standards among hospitalists and other health care providers to help protect our fellow health care professionals, our patients, and our communities.”

To that end, Dr. Skandhan has started conversations with hospital staff who he knows are not vaccinated. “For some, we’re not able to have a civil conversation, but in most cases I can help to persuade people.” The reasons people give for not getting vaccinated are not based in science, he said. “I am worried about the safety of our hospitalists and staff nurses.” But unvaccinated frontline workers are also putting their patients at risk. “Can we say why they’re hesitating? Can we have an honest discourse? If we can’t do that with our colleagues, how can we blame the patients?”

Dr. Skandhan encourages hospitalists to start simply in their own hospitals, trying to influence their own departments and colleagues. “If you can convince one or two more every week, you can start a chain reaction. Have that conversation. Use your trust.” For some hospitalized patients, the vaccination conversation comes too late, after their infection, but even some of them might consider obtaining it down the road or trying to persuade family members to get vaccinated.

Adult hospitalists, however, may not have received training in how to effectively address vaccine fears and misconceptions among their patients, he said. Because the patients they see in the hospital are already very sick, they don’t get a lot of practice talking about vaccines except, perhaps, for the influenza vaccine.

Pediatric hospitalists have more experience with such conversations involving their patients’ parents, Dr. Skandhan said. “It comes more naturally to them. We need to learn quickly from them about how to talk about vaccines with our patients.”

Pediatric training and experience

Anika Kumar, MD, FHM, FAAP, a pediatric hospitalist at the Cleveland Clinic and the pediatric editor of The Hospitalist, agrees that pediatricians and pediatric hospitalists often have received more training in how to lead vaccination conversations. She often talks about vaccines with the parents of hospitalized children relative to chicken pox, measles, and other diseases of childhood.

Pediatric hospitalists may also ask to administer the hepatitis B vaccine to newborn babies, along with other preventive treatments such as eye drops and vitamin K shots. “I often encourage the influenza vaccine prior to the patient’s hospital discharge, especially for kids with chronic conditions, asthma, diabetes, or premature birth. We talk about how the influenza vaccine isn’t perfect, but it helps to prevent more serious disease,” she said.

“A lot of vaccine hesitancy comes from misunderstandings about the role of vaccines,” she said. People forget that for years children have been getting vaccines before starting school. “Misinformation and opinions about vaccines have existed for decades. What’s new today is the abundance of sources for obtaining these opinions. My job is to inform families of scientific facts and to address their concerns.”

It has become more common recently for parents to say they don’t want their kids to get vaccinated, Dr. Kumar said. Another group is better described as vaccine hesitant and just needs more information. “I may not, by the time they leave the hospital, convince them to allow me to administer the vaccine. But in the discharge summary, I document that I had this conversation. I’ve done my due diligence and tried to start a larger dialogue. I say: ‘I encourage you to continue this discussion with the pediatrician you trust.’ I also communicate with the outpatient team,” she said.

“But it’s our responsibility, because we’re the ones seeing these patients, to do whatever we can to keep our patients from getting sick. A lot of challenging conversations we have with families are just trying to find out where they’re at with the issue – which can lead to productive dialogue.”

Ariel Carpenter, MD, a 4th-year resident in internal medicine and pediatrics at the University of Louisville (Ky.), and a future pediatric hospitalist, agreed that her combined training in med-peds has been helpful preparation for the vaccine conversation. That training has included techniques of motivational interviewing. In pediatrics, she explained, the communication is a little softer. “I try to approach my patients in a family-centered way.”

Dr. Carpenter recently wrote a personal essay for Louisville Medicine magazine from the perspective of growing up homeschooled by a mother who didn’t believe in vaccines.³ As a teenager, she independently obtained the complete childhood vaccine series so that she could do medical shadowing and volunteering. In medical school she became a passionate vaccine advocate, eventually persuading her mother to change her mind on the subject in time for the COVID vaccine.

“There’s not one answer to the vaccination dilemma,” she said. “Different approaches are required because there are so many different reasons for it. Based on my own life experience, I try to approach patients where they are – not from a place of data and science. What worked in my own family, and works with my patients, is first to establish trust. If they trust you, they’re more likely to listen. Simply ask their worries and concerns,” Dr. Carpenter said.

“A lot of them haven’t had the opportunity before to sit down with a physician they trust and have their worries listened to. They don’t feel heard in our medical system. So I remind myself that I need to understand my patients first – before inserting myself into the conversation.”

Many patients she sees are in an information bubble, with a very different understanding of the issue than their doctors. “A lot of well-meaning people feel they are making the safer choice. Very few truly don’t care about protecting others. But they don’t feel the urgency about that and see the vaccine as the scarier option right now.”

Frontline vaccine advocates

Hospitalists are the frontline advocates within their hospital system, in a position to lead, so they need to make vaccines a priority, Dr. Carpenter said. They should also make sure that their hospitals have ready access to the vaccine, so patients who agree to receive it are able to get it quickly. “In our hospital they can get the shot within a few hours if the opportunity arises. We stocked the Johnson & Johnson vaccine so that they wouldn’t have to connect with another health care provider in order to get a second dose.”

Hospitals should also invest in access to vaccine counseling training and personnel. “Fund a nurse clinician who can screen and counsel hospitalized patients for vaccination. If they meet resistance, they can then refer to the dedicated physician of the day to have the conversation,” she said. “But if we don’t mention it, patients will assume we don’t feel strongly about it.”

Because hospitalists are front and center in treating COVID, they need to be the experts and the people offering guidance, said Shyam Odeti, MD, SFHM, FAAFP, section chief for hospital medicine at the Carilion Clinic in Roanoke, Va. “What we’re trying to do is spread awareness. We educated physician groups, learners, and clinical teams during the initial phase, and now mostly patients and their families.” COVID vaccine reluctance is hard to overcome, Dr. Odeti said. People feel the vaccine was developed very quickly. But there are different ways to present it.

“Like most doctors, I thought people would jump on a vaccine to get past the pandemic. I was surprised and then disappointed. Right now, the pandemic is among the unvaccinated. So we face these encounters, and we’re doing our best to overcome the misinformation. My organization is 100% supportive. We talk about these issues every day.”

Carilion, effective Oct. 1, has required unvaccinated employees to get weekly COVID tests and wear an N95 mask while working, and has developed Facebook pages, other social media, and an Internet presence to address these issues. “We’ve gone to the local African-American community with physician leaders active in that community. We had a Spanish language roundtable,” Dr. Odeti said.

Dr. Skandhan reported that the Wiregrass regional chapter of SHM recently organized a successful statewide community educational event aimed at empowering community leaders to address vaccine misinformation and mistrust. “We surveyed religious leaders and pastors regarding the causes of vaccine hesitancy and reached out to physicians active in community awareness.” Based on that input, a presentation by the faith leaders was developed. Legislators from the Alabama State Senate’s Healthcare Policy Committee were also invited to the presentation and discussion.
 

Trying to stay positive

It’s important to try to stay positive, Dr. Odeti said. “We have to be empathetic with every patient. We have to keep working at this, since there’s no way out of the pandemic except through vaccinations. But it all creates stress for hospitalists. Our job is made significantly more difficult by the vaccine controversy.”

Jennifer Cowart, MD, a hospitalist at Mayo Clinic in Jacksonville, Fla., has been outspoken in her community about vaccination and masking issues, talking to reporters, attending rallies and press conferences, posting on social media, and speaking in favor of mask policies at a local school board meeting. She is part of an informal local group called Doctors Fighting COVID, which meets online to strategize how to share its expertise, including writing a recent letter about masks to Jacksonville’s mayor.

“In July, when we saw the Delta variant surging locally, we held a webinar via local media, taking calls about the vaccine from the community. I’m trying not to make this a political issue, but we are health officials.” Dr. Cowart said she also tries not to raise her voice when speaking with vaccine opponents and tries to remain empathetic. “Even though inwardly I’m screaming, I try to stay calm. The misinformation is real. People are afraid and feeling pressure. I do my best, but I’m human, too.”

Hospitalists need to pull whatever levers they can to help advance understanding of vaccines, Dr. Cowart said. “In the hospital, our biggest issue is time. We often don’t have it, with a long list of patients to see. But every patient encounter is an opportunity to talk to patients, whether they have COVID or something else.” Sometimes, she might go back to a patient’s room after rounds to resume the conversation.

Hospital nurses have been trained and entrusted to do tobacco abatement counseling, she said, so why not mobilize them for vaccine education? “Or respiratory therapists, who do inhaler training, could talk about what it’s like to care for COVID patients. There’s a whole bunch of staff in the hospital who could be mobilized,” she said.

“I feel passionate about vaccines, as a hospitalist, as a medical educator, as a daughter, as a responsible member of society,” said Eileen Barrett, MD, MPH, SFHM, MACP, director of continuing medical education at the University of New Mexico, Albuquerque. “I see this as a personal and societal responsibility. When I speak about the vaccine among groups of doctors, I say we need to stay in our lane regarding our skills at interpreting the science and not undermining it.”

Some health care worker hesitancy is from distrust of pharmaceutical companies, or of federal agencies, she said. “Our research has highlighted to me the widespread inequity issues in our health care system. We should also take a long, hard look at how we teach the scientific method to health professionals. That will be part of a pandemic retrospective.”

Sometimes with people who are vaccine deliberative, whether health care workers or patients, there is a small window of opportunity. “We need to hear people and respond to them as people. Then, if they are willing to get vaccinated, we need to accomplish that as quickly and easily as possible,” Dr. Barrett said. “I see them make a face and say, ‘Well, okay, I’ll do it.’ We need to get the vaccine to them that same day. We should be able to accomplish that.”
 

References

1. Gamble M. 30% of US hospitals mandate vaccination for employment. Becker’s Hospital Review. 2021 Aug 13. www.beckershospitalreview.com/workforce/covid-19-vaccination-needed-to-work-at-30-of-us-hospitals.html .

2. Society of Hospital Medicine signs on to joint statement in support of health worker COVID-19 vaccine mandates. Press release. 2021 Jul 26. www.hospitalmedicine.org/news-publications/press-releases/society-of-hospital-medicine-signs-on-to-joint-statement-of-support-of-health-worker-covid-19-vaccine-mandates/.

3. Carpenter A. A physician’s lessons from an unvaccinated childhood. Louisville Medicine. 2021 July;69(2):26-7. https://viewer.joomag.com/louisville-medicine-volume-69-issue-2/0045988001624974172?short&.

Lessons for hospitalists from the vaccination controversy

1. Remain up-to-date on information about the COVID infection, its treatment, and vaccination efficacy data.

2. Hospitalists should take advantage of their positions to lead conversations in their facilities about the importance of COVID vaccinations.

3. Other professionals in the hospital, with some additional training and support, could take on the role of providing vaccine education and support – with a physician to back them up on difficult cases.

4. It’s important to listen to people’s concerns, try to build trust, and establish dialogue before starting to convey a lot of information. People need to feel heard.

5. If you are successful in persuading someone to take the vaccine, a shot should be promptly and easily accessible to them.

6. Pediatric hospitalists may have more experience and skill with vaccine discussions, which they should share with their peers who treat adults.

On April 1, Houston Methodist Hospital in Houston, Texas, announced a new policy that all of its staff would need to be vaccinated against COVID-19 by June 7 in order to hold onto their jobs. Most responded positively but an estimated 150 staff members who did not comply either resigned or were terminated. A lawsuit by employees opposed to the vaccine mandate was dismissed by Federal District Court Judge Lynn Hughes in June, although a subsequent lawsuit was filed Aug. 16.

Vaccines have been shown to dramatically reduce both the incidence and the severity of COVID infections. Vaccinations of health care workers, especially those who have direct contact with patients, are demonstrated to be effective strategies to significantly reduce, although not eliminate, the possibility of viral transmissions to patients – or to health care workers themselves – thus saving lives.

Hospitalists, in their central role in the care of hospitalized patients, and often with primary responsibility for managing their hospital’s COVID-19 caseloads, may find themselves encountering conversations about the vaccine, its safety, effectiveness, and mandates with their peers, other hospital staff, patients, and families, and their communities. They can play key roles in advocating for the vaccine, answering questions, clarifying the science, and dispelling misinformation – for those who are willing to listen.

Becker’s Hospital Review, which has kept an ongoing tally of announced vaccine mandate policies in hospitals, health systems, and health departments nationwide, reported on Aug. 13 that 1,850 or 30% of U.S. hospitals, had announced vaccine mandates.¹ Often exceptions can be made, such as for medical or religious reasons, or with other declarations or opt-out provisions. But in many settings, mandating COVID vaccinations won’t be easy.

Amith Skandhan, MD, SFHM, FACP, a hospitalist at Southeast Health Medical Center in Dothan, Ala., and a core faculty member in the internal medicine residency program at Alabama College of Osteopathic Medicine, said that implementing vaccine mandates will be more difficult in smaller health systems, in rural communities, and in states with lower vaccination rates and greater vaccine controversy.

Alabama has the lowest vaccination rates in the country, reflected in the recent rise in COVID cases and hospitalizations, even higher than during the surge of late 2020, Dr. Skandhan said. “In June we had one COVID patient in this hospital.” By late August the number was 119 COVID patients and climbing.

But where he works, in a health system where staffing is already spread thin, a vaccine mandate would be challenging. “What if our staff started leaving? It’s only 10 minutes from here to the Florida or Georgia border,” Dr. Skandhan said. Health care workers opposed to vaccinations would have the option of easily seeking work elsewhere.

When contacted for this article, he had been off work for several days but was mentally preparing himself to go back. “I’m not even following the [COVID-19] numbers but I am prepared for the worst. I know it will be mostly COVID. People just don’t realize what goes into this work.”

Dr. Skandhan, who said he was the third or fourth person in Alabama to receive the COVID vaccine, often finds himself feeling frustrated and angry – in the midst of a surge in cases that could have been prevented – that such a beneficial medical advance for bringing the pandemic under control became so politicized. “It is imperative that we find out why this mistrust exists and work to address it. It has to be done.”

Protecting health care professionals

On July 26, the Society of Hospital Medicine joined 50 other health care organizations including the American Medical Association, American Nurses Association, and American Academy of Pediatrics in advocating for all health care employers to require their employees to be vaccinated against COVID, in order to protect the safety of all patients and residents of health care facilities.²

“As an organization, we support vaccinating health care workers, including hospitalists, to help stop the spread of COVID-19 and the increasingly dominant Delta variant,” said SHM’s chief executive officer Eric E. Howell, MD, MHM, in a prepared statement. “We aim to uphold the highest standards among hospitalists and other health care providers to help protect our fellow health care professionals, our patients, and our communities.”

To that end, Dr. Skandhan has started conversations with hospital staff who he knows are not vaccinated. “For some, we’re not able to have a civil conversation, but in most cases I can help to persuade people.” The reasons people give for not getting vaccinated are not based in science, he said. “I am worried about the safety of our hospitalists and staff nurses.” But unvaccinated frontline workers are also putting their patients at risk. “Can we say why they’re hesitating? Can we have an honest discourse? If we can’t do that with our colleagues, how can we blame the patients?”

Dr. Skandhan encourages hospitalists to start simply in their own hospitals, trying to influence their own departments and colleagues. “If you can convince one or two more every week, you can start a chain reaction. Have that conversation. Use your trust.” For some hospitalized patients, the vaccination conversation comes too late, after their infection, but even some of them might consider obtaining it down the road or trying to persuade family members to get vaccinated.

Adult hospitalists, however, may not have received training in how to effectively address vaccine fears and misconceptions among their patients, he said. Because the patients they see in the hospital are already very sick, they don’t get a lot of practice talking about vaccines except, perhaps, for the influenza vaccine.

Pediatric hospitalists have more experience with such conversations involving their patients’ parents, Dr. Skandhan said. “It comes more naturally to them. We need to learn quickly from them about how to talk about vaccines with our patients.”

Pediatric training and experience

Anika Kumar, MD, FHM, FAAP, a pediatric hospitalist at the Cleveland Clinic and the pediatric editor of The Hospitalist, agrees that pediatricians and pediatric hospitalists often have received more training in how to lead vaccination conversations. She often talks about vaccines with the parents of hospitalized children relative to chicken pox, measles, and other diseases of childhood.

Pediatric hospitalists may also ask to administer the hepatitis B vaccine to newborn babies, along with other preventive treatments such as eye drops and vitamin K shots. “I often encourage the influenza vaccine prior to the patient’s hospital discharge, especially for kids with chronic conditions, asthma, diabetes, or premature birth. We talk about how the influenza vaccine isn’t perfect, but it helps to prevent more serious disease,” she said.

“A lot of vaccine hesitancy comes from misunderstandings about the role of vaccines,” she said. People forget that for years children have been getting vaccines before starting school. “Misinformation and opinions about vaccines have existed for decades. What’s new today is the abundance of sources for obtaining these opinions. My job is to inform families of scientific facts and to address their concerns.”

It has become more common recently for parents to say they don’t want their kids to get vaccinated, Dr. Kumar said. Another group is better described as vaccine hesitant and just needs more information. “I may not, by the time they leave the hospital, convince them to allow me to administer the vaccine. But in the discharge summary, I document that I had this conversation. I’ve done my due diligence and tried to start a larger dialogue. I say: ‘I encourage you to continue this discussion with the pediatrician you trust.’ I also communicate with the outpatient team,” she said.

“But it’s our responsibility, because we’re the ones seeing these patients, to do whatever we can to keep our patients from getting sick. A lot of challenging conversations we have with families are just trying to find out where they’re at with the issue – which can lead to productive dialogue.”

Ariel Carpenter, MD, a 4th-year resident in internal medicine and pediatrics at the University of Louisville (Ky.), and a future pediatric hospitalist, agreed that her combined training in med-peds has been helpful preparation for the vaccine conversation. That training has included techniques of motivational interviewing. In pediatrics, she explained, the communication is a little softer. “I try to approach my patients in a family-centered way.”

Dr. Carpenter recently wrote a personal essay for Louisville Medicine magazine from the perspective of growing up homeschooled by a mother who didn’t believe in vaccines.³ As a teenager, she independently obtained the complete childhood vaccine series so that she could do medical shadowing and volunteering. In medical school she became a passionate vaccine advocate, eventually persuading her mother to change her mind on the subject in time for the COVID vaccine.

“There’s not one answer to the vaccination dilemma,” she said. “Different approaches are required because there are so many different reasons for it. Based on my own life experience, I try to approach patients where they are – not from a place of data and science. What worked in my own family, and works with my patients, is first to establish trust. If they trust you, they’re more likely to listen. Simply ask their worries and concerns,” Dr. Carpenter said.

“A lot of them haven’t had the opportunity before to sit down with a physician they trust and have their worries listened to. They don’t feel heard in our medical system. So I remind myself that I need to understand my patients first – before inserting myself into the conversation.”

Many patients she sees are in an information bubble, with a very different understanding of the issue than their doctors. “A lot of well-meaning people feel they are making the safer choice. Very few truly don’t care about protecting others. But they don’t feel the urgency about that and see the vaccine as the scarier option right now.”

Frontline vaccine advocates

Hospitalists are the frontline advocates within their hospital system, in a position to lead, so they need to make vaccines a priority, Dr. Carpenter said. They should also make sure that their hospitals have ready access to the vaccine, so patients who agree to receive it are able to get it quickly. “In our hospital they can get the shot within a few hours if the opportunity arises. We stocked the Johnson & Johnson vaccine so that they wouldn’t have to connect with another health care provider in order to get a second dose.”

Hospitals should also invest in access to vaccine counseling training and personnel. “Fund a nurse clinician who can screen and counsel hospitalized patients for vaccination. If they meet resistance, they can then refer to the dedicated physician of the day to have the conversation,” she said. “But if we don’t mention it, patients will assume we don’t feel strongly about it.”

Because hospitalists are front and center in treating COVID, they need to be the experts and the people offering guidance, said Shyam Odeti, MD, SFHM, FAAFP, section chief for hospital medicine at the Carilion Clinic in Roanoke, Va. “What we’re trying to do is spread awareness. We educated physician groups, learners, and clinical teams during the initial phase, and now mostly patients and their families.” COVID vaccine reluctance is hard to overcome, Dr. Odeti said. People feel the vaccine was developed very quickly. But there are different ways to present it.

“Like most doctors, I thought people would jump on a vaccine to get past the pandemic. I was surprised and then disappointed. Right now, the pandemic is among the unvaccinated. So we face these encounters, and we’re doing our best to overcome the misinformation. My organization is 100% supportive. We talk about these issues every day.”

Carilion, effective Oct. 1, has required unvaccinated employees to get weekly COVID tests and wear an N95 mask while working, and has developed Facebook pages, other social media, and an Internet presence to address these issues. “We’ve gone to the local African-American community with physician leaders active in that community. We had a Spanish language roundtable,” Dr. Odeti said.

Dr. Skandhan reported that the Wiregrass regional chapter of SHM recently organized a successful statewide community educational event aimed at empowering community leaders to address vaccine misinformation and mistrust. “We surveyed religious leaders and pastors regarding the causes of vaccine hesitancy and reached out to physicians active in community awareness.” Based on that input, a presentation by the faith leaders was developed. Legislators from the Alabama State Senate’s Healthcare Policy Committee were also invited to the presentation and discussion.
 

Trying to stay positive

It’s important to try to stay positive, Dr. Odeti said. “We have to be empathetic with every patient. We have to keep working at this, since there’s no way out of the pandemic except through vaccinations. But it all creates stress for hospitalists. Our job is made significantly more difficult by the vaccine controversy.”

Jennifer Cowart, MD, a hospitalist at Mayo Clinic in Jacksonville, Fla., has been outspoken in her community about vaccination and masking issues, talking to reporters, attending rallies and press conferences, posting on social media, and speaking in favor of mask policies at a local school board meeting. She is part of an informal local group called Doctors Fighting COVID, which meets online to strategize how to share its expertise, including writing a recent letter about masks to Jacksonville’s mayor.

“In July, when we saw the Delta variant surging locally, we held a webinar via local media, taking calls about the vaccine from the community. I’m trying not to make this a political issue, but we are health officials.” Dr. Cowart said she also tries not to raise her voice when speaking with vaccine opponents and tries to remain empathetic. “Even though inwardly I’m screaming, I try to stay calm. The misinformation is real. People are afraid and feeling pressure. I do my best, but I’m human, too.”

Hospitalists need to pull whatever levers they can to help advance understanding of vaccines, Dr. Cowart said. “In the hospital, our biggest issue is time. We often don’t have it, with a long list of patients to see. But every patient encounter is an opportunity to talk to patients, whether they have COVID or something else.” Sometimes, she might go back to a patient’s room after rounds to resume the conversation.

Hospital nurses have been trained and entrusted to do tobacco abatement counseling, she said, so why not mobilize them for vaccine education? “Or respiratory therapists, who do inhaler training, could talk about what it’s like to care for COVID patients. There’s a whole bunch of staff in the hospital who could be mobilized,” she said.

“I feel passionate about vaccines, as a hospitalist, as a medical educator, as a daughter, as a responsible member of society,” said Eileen Barrett, MD, MPH, SFHM, MACP, director of continuing medical education at the University of New Mexico, Albuquerque. “I see this as a personal and societal responsibility. When I speak about the vaccine among groups of doctors, I say we need to stay in our lane regarding our skills at interpreting the science and not undermining it.”

Some health care worker hesitancy is from distrust of pharmaceutical companies, or of federal agencies, she said. “Our research has highlighted to me the widespread inequity issues in our health care system. We should also take a long, hard look at how we teach the scientific method to health professionals. That will be part of a pandemic retrospective.”

Sometimes with people who are vaccine deliberative, whether health care workers or patients, there is a small window of opportunity. “We need to hear people and respond to them as people. Then, if they are willing to get vaccinated, we need to accomplish that as quickly and easily as possible,” Dr. Barrett said. “I see them make a face and say, ‘Well, okay, I’ll do it.’ We need to get the vaccine to them that same day. We should be able to accomplish that.”
 

References

1. Gamble M. 30% of US hospitals mandate vaccination for employment. Becker’s Hospital Review. 2021 Aug 13. www.beckershospitalreview.com/workforce/covid-19-vaccination-needed-to-work-at-30-of-us-hospitals.html .

2. Society of Hospital Medicine signs on to joint statement in support of health worker COVID-19 vaccine mandates. Press release. 2021 Jul 26. www.hospitalmedicine.org/news-publications/press-releases/society-of-hospital-medicine-signs-on-to-joint-statement-of-support-of-health-worker-covid-19-vaccine-mandates/.

3. Carpenter A. A physician’s lessons from an unvaccinated childhood. Louisville Medicine. 2021 July;69(2):26-7. https://viewer.joomag.com/louisville-medicine-volume-69-issue-2/0045988001624974172?short&.

Lessons for hospitalists from the vaccination controversy

1. Remain up-to-date on information about the COVID infection, its treatment, and vaccination efficacy data.

2. Hospitalists should take advantage of their positions to lead conversations in their facilities about the importance of COVID vaccinations.

3. Other professionals in the hospital, with some additional training and support, could take on the role of providing vaccine education and support – with a physician to back them up on difficult cases.

4. It’s important to listen to people’s concerns, try to build trust, and establish dialogue before starting to convey a lot of information. People need to feel heard.

5. If you are successful in persuading someone to take the vaccine, a shot should be promptly and easily accessible to them.

6. Pediatric hospitalists may have more experience and skill with vaccine discussions, which they should share with their peers who treat adults.

A novel virus engineered to target malignant gliomas, which are particularly aggressive brain tumors, may prolong survival, according to a recent phase 1 study.

The findings, published June 29 in The Lancet Oncology, show early promise in targeting malignant gliomas, which have been notoriously difficult to treat. Only 1 in 4 patients are alive 2 years after diagnosis. The median overall survival from diagnosis is 14.6-16.7 months.

In a study of a novel therapy called NSC-CRAd-S-pk7 – an oncolytic adenovirus delivered across the blood-brain barrier by neural stem cells – overall survival improved by several months for patients with malignant gliomas.

“To my knowledge, this is the first time neural stem cells have been used as a delivery strategy for an oncolytic virus,” said Terence Burns, MD, PhD, associate professor of neurosurgery at the Mayo Clinic, Rochester, Minn., who was not involved in the research.

In this open-label, dose-escalation trial, researchers enrolled 12 patients with newly diagnosed malignant gliomas between April 2017 and November 2019. After neurosurgical tumor resection, patients were placed in one of three cohorts distinguished by dose of NSC-CRAd-S-pk7. Three patients received the lowest dose of 6.25×1010 viral particles administered by 5.00×10⁷ neural stem cells (NSCs), three received a more moderate dose of 1.25×10 viral particles administered by 1.00×108 NSCs, and the remaining six patients received a dose of 1.875×1011 viral particles administered by 1.50×108 NSCs. Within 10-14 days, the investigators also initiated treatment with temozolomide and radiotherapy.

The investigators report that after a median 18-month follow-up period, median progression-free survival was 9.1 months, and median overall survival of 18.4 months. In a subgroup of patients with unmethylated MGMT promoters – DNA repair enzymes that make tumor cells more resistant to treatment – median progression-free survival was 8.8 months, and median overall survival was 18.0 months.

There was no dose-limiting toxicity, and there were no treatment-related deaths. One patient developed viral meningitis, owing to the inadvertent ventricular injection of NSC-CRAd-S-pk7, and fully recovered after hospitalization.

Patients tolerated the treatment well, which is critical because “drugs that could fight gliomas might also have serious adverse effects,” first author Jawad Fares, MD, a postdoctoral fellow in neurological surgery at Northwestern University, Chicago, said in an interview.
 

A novel approach

A significant challenge to delivering drugs to the site of malignant gliomas is the blood-brain barrier, which blocks entry of many chemotherapeutic drugs.

“Because of this barrier, physicians often employ other strategies, such as direct injection in the brain cavity, but even with an injection, it is problematic to disseminate the drug so that the medication spreads throughout the tumor mass,” said Dr. Fares. “Our innovative approach, which employs the use of neural stem cells as shuttles to deliver viruses, seeks to address this problem. Neural stem cells tend to travel within hours to areas of injury, areas of stroke or brain tumors, and could disperse the oncolytic virus.”

Gliomas create an immunosuppressive tumor microenvironment, which uses tissue cells, blood vessels, immune cells, and other parts of the body to blunt antitumor immune responses. Using NSCs to deliver NSC-CRAd-S-pk7 directly to the tumor has the advantage of “giving the virus more time to replicate and kill tumor cells,” said Marta Alonso Roldán, MD, Clinica Universidad de Navarra, in Spain, in an interview.

Although NSC-CRAd-S-pk7 appeared to improve survival in this cohort by a few months, follow-up trials with larger sample sizes and control groups are necessary to demonstrate efficacy.

Moreover, patients in this trial may not be representative of the average patient, said Dr. Burns. “For instance, three of the patients had relatively small tumors in nicely operable areas with a high likelihood of getting a gross total resection. These things do stack your odds in favor of having a longer survival.”

Moving forward, “this trial sets the stage for a phase 2/3 study in which the efficacy of NSC-CRAd-S-pk7 in eliciting an antiglioma immune response and prolonging survival in a larger cohort of patients with controlled conditions can be explored,” Dr. Fares said.

The study was funded by the U.S. National Institutes of Health. Dr. Fares, Dr. Burns, and Dr. Roldán have disclosed no relevant financial relationships.

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

A novel virus engineered to target malignant gliomas, which are particularly aggressive brain tumors, may prolong survival, according to a recent phase 1 study.

The findings, published June 29 in The Lancet Oncology, show early promise in targeting malignant gliomas, which have been notoriously difficult to treat. Only 1 in 4 patients are alive 2 years after diagnosis. The median overall survival from diagnosis is 14.6-16.7 months.

In a study of a novel therapy called NSC-CRAd-S-pk7 – an oncolytic adenovirus delivered across the blood-brain barrier by neural stem cells – overall survival improved by several months for patients with malignant gliomas.

“To my knowledge, this is the first time neural stem cells have been used as a delivery strategy for an oncolytic virus,” said Terence Burns, MD, PhD, associate professor of neurosurgery at the Mayo Clinic, Rochester, Minn., who was not involved in the research.

In this open-label, dose-escalation trial, researchers enrolled 12 patients with newly diagnosed malignant gliomas between April 2017 and November 2019. After neurosurgical tumor resection, patients were placed in one of three cohorts distinguished by dose of NSC-CRAd-S-pk7. Three patients received the lowest dose of 6.25×1010 viral particles administered by 5.00×10⁷ neural stem cells (NSCs), three received a more moderate dose of 1.25×10 viral particles administered by 1.00×108 NSCs, and the remaining six patients received a dose of 1.875×1011 viral particles administered by 1.50×108 NSCs. Within 10-14 days, the investigators also initiated treatment with temozolomide and radiotherapy.

The investigators report that after a median 18-month follow-up period, median progression-free survival was 9.1 months, and median overall survival of 18.4 months. In a subgroup of patients with unmethylated MGMT promoters – DNA repair enzymes that make tumor cells more resistant to treatment – median progression-free survival was 8.8 months, and median overall survival was 18.0 months.

There was no dose-limiting toxicity, and there were no treatment-related deaths. One patient developed viral meningitis, owing to the inadvertent ventricular injection of NSC-CRAd-S-pk7, and fully recovered after hospitalization.

Patients tolerated the treatment well, which is critical because “drugs that could fight gliomas might also have serious adverse effects,” first author Jawad Fares, MD, a postdoctoral fellow in neurological surgery at Northwestern University, Chicago, said in an interview.
 

A novel approach

A significant challenge to delivering drugs to the site of malignant gliomas is the blood-brain barrier, which blocks entry of many chemotherapeutic drugs.

“Because of this barrier, physicians often employ other strategies, such as direct injection in the brain cavity, but even with an injection, it is problematic to disseminate the drug so that the medication spreads throughout the tumor mass,” said Dr. Fares. “Our innovative approach, which employs the use of neural stem cells as shuttles to deliver viruses, seeks to address this problem. Neural stem cells tend to travel within hours to areas of injury, areas of stroke or brain tumors, and could disperse the oncolytic virus.”

Gliomas create an immunosuppressive tumor microenvironment, which uses tissue cells, blood vessels, immune cells, and other parts of the body to blunt antitumor immune responses. Using NSCs to deliver NSC-CRAd-S-pk7 directly to the tumor has the advantage of “giving the virus more time to replicate and kill tumor cells,” said Marta Alonso Roldán, MD, Clinica Universidad de Navarra, in Spain, in an interview.

Although NSC-CRAd-S-pk7 appeared to improve survival in this cohort by a few months, follow-up trials with larger sample sizes and control groups are necessary to demonstrate efficacy.

Moreover, patients in this trial may not be representative of the average patient, said Dr. Burns. “For instance, three of the patients had relatively small tumors in nicely operable areas with a high likelihood of getting a gross total resection. These things do stack your odds in favor of having a longer survival.”

Moving forward, “this trial sets the stage for a phase 2/3 study in which the efficacy of NSC-CRAd-S-pk7 in eliciting an antiglioma immune response and prolonging survival in a larger cohort of patients with controlled conditions can be explored,” Dr. Fares said.

The study was funded by the U.S. National Institutes of Health. Dr. Fares, Dr. Burns, and Dr. Roldán have disclosed no relevant financial relationships.

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

A novel virus engineered to target malignant gliomas, which are particularly aggressive brain tumors, may prolong survival, according to a recent phase 1 study.

The findings, published June 29 in The Lancet Oncology, show early promise in targeting malignant gliomas, which have been notoriously difficult to treat. Only 1 in 4 patients are alive 2 years after diagnosis. The median overall survival from diagnosis is 14.6-16.7 months.

In a study of a novel therapy called NSC-CRAd-S-pk7 – an oncolytic adenovirus delivered across the blood-brain barrier by neural stem cells – overall survival improved by several months for patients with malignant gliomas.

“To my knowledge, this is the first time neural stem cells have been used as a delivery strategy for an oncolytic virus,” said Terence Burns, MD, PhD, associate professor of neurosurgery at the Mayo Clinic, Rochester, Minn., who was not involved in the research.

In this open-label, dose-escalation trial, researchers enrolled 12 patients with newly diagnosed malignant gliomas between April 2017 and November 2019. After neurosurgical tumor resection, patients were placed in one of three cohorts distinguished by dose of NSC-CRAd-S-pk7. Three patients received the lowest dose of 6.25×1010 viral particles administered by 5.00×10⁷ neural stem cells (NSCs), three received a more moderate dose of 1.25×10 viral particles administered by 1.00×108 NSCs, and the remaining six patients received a dose of 1.875×1011 viral particles administered by 1.50×108 NSCs. Within 10-14 days, the investigators also initiated treatment with temozolomide and radiotherapy.

The investigators report that after a median 18-month follow-up period, median progression-free survival was 9.1 months, and median overall survival of 18.4 months. In a subgroup of patients with unmethylated MGMT promoters – DNA repair enzymes that make tumor cells more resistant to treatment – median progression-free survival was 8.8 months, and median overall survival was 18.0 months.

There was no dose-limiting toxicity, and there were no treatment-related deaths. One patient developed viral meningitis, owing to the inadvertent ventricular injection of NSC-CRAd-S-pk7, and fully recovered after hospitalization.

Patients tolerated the treatment well, which is critical because “drugs that could fight gliomas might also have serious adverse effects,” first author Jawad Fares, MD, a postdoctoral fellow in neurological surgery at Northwestern University, Chicago, said in an interview.
 

A novel approach

A significant challenge to delivering drugs to the site of malignant gliomas is the blood-brain barrier, which blocks entry of many chemotherapeutic drugs.

“Because of this barrier, physicians often employ other strategies, such as direct injection in the brain cavity, but even with an injection, it is problematic to disseminate the drug so that the medication spreads throughout the tumor mass,” said Dr. Fares. “Our innovative approach, which employs the use of neural stem cells as shuttles to deliver viruses, seeks to address this problem. Neural stem cells tend to travel within hours to areas of injury, areas of stroke or brain tumors, and could disperse the oncolytic virus.”

Gliomas create an immunosuppressive tumor microenvironment, which uses tissue cells, blood vessels, immune cells, and other parts of the body to blunt antitumor immune responses. Using NSCs to deliver NSC-CRAd-S-pk7 directly to the tumor has the advantage of “giving the virus more time to replicate and kill tumor cells,” said Marta Alonso Roldán, MD, Clinica Universidad de Navarra, in Spain, in an interview.

Although NSC-CRAd-S-pk7 appeared to improve survival in this cohort by a few months, follow-up trials with larger sample sizes and control groups are necessary to demonstrate efficacy.

Moreover, patients in this trial may not be representative of the average patient, said Dr. Burns. “For instance, three of the patients had relatively small tumors in nicely operable areas with a high likelihood of getting a gross total resection. These things do stack your odds in favor of having a longer survival.”

Moving forward, “this trial sets the stage for a phase 2/3 study in which the efficacy of NSC-CRAd-S-pk7 in eliciting an antiglioma immune response and prolonging survival in a larger cohort of patients with controlled conditions can be explored,” Dr. Fares said.

The study was funded by the U.S. National Institutes of Health. Dr. Fares, Dr. Burns, and Dr. Roldán have disclosed no relevant financial relationships.

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

The number of U.S. adults who are at least partially vaccinated rose five percentage points to 72% in August, a slightly faster increase than in previous months, according to the latest monthly COVID-19 Vaccine Monitor report of the Kaiser Family Foundation (KFF).

The largest increases in vaccine uptake between July and September were among Hispanic adults and people aged 18-29 years. Roughly equal shares of adults now report being vaccinated across racial and ethnic groups: 71% of White adults, 70% of Black adults, and 73% of Hispanic adults.

Overall, the big takeaway of the latest Kaiser COVID-19 survey is that the partisan divide on all aspects of the pandemic, from vaccination status to attitudes toward vaccination and mask mandates, remains as wide as ever.

The only thing that Republicans, Democrats, and Independents mostly agree on is that COVID-19 will probably become an endemic disease like influenza. Seventy-nine percent of respondents agreed with that statement; 14% predicted that COVID-19 would probably be largely eliminated in future years, like polio.
 

Delta motivated many

The most important factor that recently led people toward being vaccinated against COVID-19 was the surge in cases, hospitalizations, and deaths due to the Delta variant, KFF reports.

Full approval of the Pfizer vaccine by the Food and Drug Administration and the increasing prevalence of vaccine mandates played secondary roles in the vaccination uptick.

Specifically, 10% of the recently vaccinated said the main reason they got shots was the increase in COVID-19 cases due to the Delta variant. Concern about reports of local hospitals and intensive care units filling up with COVID-19 patients was the main motivator for 12% of those who just got shots. Fourteen percent of the recently vaccinated got inoculated mainly because someone they knew had become seriously ill or had died from COVID-19.

The role of the Delta threat is also evident with regard to where those who were recently vaccinated live. Twenty-four percent of those who received their first dose of vaccine after June 1, 2021, reside in counties with a high COVID-19 case rate; 15% of them live in counties with a relatively low case rate.

Despite the recent surge in vaccinations, however, 7% of adults are still taking a wait-and-see approach; 4% said they’d get a shot only if required; and 12% said they definitely wouldn’t get vaccinated. The latter figure has barely budged since January of this year.

Ninety percent of Democrats said they had received at least one dose of the COVID-19 vaccine, vs. 68% of Independents, and 58% of Republicans.

Wealthier, better educated, urban, and older people were more likely to be vaccinated, with one exception: Sixty-eight percent of those aged 18-29 were vaccinated, vs. 66% of those aged 30-49. The group least likely to be vaccinated were uninsured people younger than 65, suggesting that some of them were unaware that the shot is free.
 

Partisan affiliation

Attitudes toward vaccine booster shots – which are now recommended for people older than 65, the immunocompromised, and certain frontline workers – largely fell along party lines and/or reflected whether respondents had been vaccinated.

Discussion of the boosters, KFF said, “appears to be a net positive for people who are already vaccinated, but a net negative for the unvaccinated. While a larger share of vaccinated adults say the information they have seen about boosters has been helpful (54%) than find it confusing (35%), among the unvaccinated almost twice as many find the information confusing as find it helpful (45% vs. 24%).”

Among fully vaccinated adults, 68% of Democrats say they’d definitely get a booster, and 20% say they probably would. Among Republicans, those percentages are 36% and 33%, respectively. Independents fall in between the other groups.

Although 82% of Democrats say the boosters show that scientists are continuing to make vaccines more effective, 52% of Republicans say that it shows that the vaccines are not working as well as promised.

Similarly, partisan attitudes emerged in questions about breakthrough infections. The fact that COVID-19 cases are fairly mild when they occur among persons who have been vaccinated indicates that the vaccines are working, said 87% of Democrats, but only 55% of Republicans agreed with that assessment.

In contrast, just 10% of Democrats but 39% of Republicans said that breakthrough infections mean the vaccines are not working.
 

Vaccine requirements

The public is more evenly divided on vaccine requirements. About 6 in 10 respondents said that vaccines should be required for health care workers (62%) and schoolteachers (58%). Slim majorities supported mandates for federal government employees (55%), college students (55%), and state and local government employees (54%).

On the question of whether employers in general should require their workers to be vaccinated, 48% of respondents said they should, and 50% said they should not.

Similarly, 52% said that all schools should mandate vaccines for eligible students; 46% didn’t approve of such requirements.

Three in four Democrats supported employer vaccine mandates, compared to 45% of Independents and just 20% of Republicans. Large partisan gaps were also seen for government, school, and health care vaccine mandates.

In contrast, 78% of the public favored requiring large employers to give their workers paid time off to get vaccinated and to recover from any side effects.
 

Twenty percent of workers under mandates

One in five workers said their employers require COVID-19 vaccination. Twenty-eight percent of employed people want their employers to require vaccination, and 50% don’t.

Again, the responses broke down along party lines, with 52% of Democrats, 21% of Independents, and 10% of Republicans favoring a vaccine mandate by their employers.

Most unvaccinated people didn’t support an employer mandate. A third of unvaccinated workers said they’d be likely to get vaccinated if their companies required it, but most of them said they would choose weekly testing if offered the option.

Being unable to use gyms, restaurants, or indoor entertainment venues that require vaccination was cited by 13% of the recently vaccinated as the main reason why they got shots.

The public was evenly divided on whether states or local governments should require such businesses to mandate that staff and customers show proof of vaccination. Although the views of the public were tied on this issue overall, 79% of Democrats, 43% of Independents, and 21% of Republicans supported having these kinds of businesses require proof of vaccination.

On school mask mandates, 56% of the respondents supported requiring all students and staff to wear masks. Favoring this kind of mandate were 83% of Democrats, 53% of Independents, and 29% of Republicans.

Partisanship also defined how Democrats and Republicans viewed the current high number of COVID-19 cases. Most Democrats blamed people who don’t wear masks and those who don’t get vaccinated, whereas Republicans were more likely to blame immigrants and tourists bringing COVID-19 into the United States.

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

The number of U.S. adults who are at least partially vaccinated rose five percentage points to 72% in August, a slightly faster increase than in previous months, according to the latest monthly COVID-19 Vaccine Monitor report of the Kaiser Family Foundation (KFF).

The largest increases in vaccine uptake between July and September were among Hispanic adults and people aged 18-29 years. Roughly equal shares of adults now report being vaccinated across racial and ethnic groups: 71% of White adults, 70% of Black adults, and 73% of Hispanic adults.

Overall, the big takeaway of the latest Kaiser COVID-19 survey is that the partisan divide on all aspects of the pandemic, from vaccination status to attitudes toward vaccination and mask mandates, remains as wide as ever.

The only thing that Republicans, Democrats, and Independents mostly agree on is that COVID-19 will probably become an endemic disease like influenza. Seventy-nine percent of respondents agreed with that statement; 14% predicted that COVID-19 would probably be largely eliminated in future years, like polio.
 

Delta motivated many

The most important factor that recently led people toward being vaccinated against COVID-19 was the surge in cases, hospitalizations, and deaths due to the Delta variant, KFF reports.

Full approval of the Pfizer vaccine by the Food and Drug Administration and the increasing prevalence of vaccine mandates played secondary roles in the vaccination uptick.

Specifically, 10% of the recently vaccinated said the main reason they got shots was the increase in COVID-19 cases due to the Delta variant. Concern about reports of local hospitals and intensive care units filling up with COVID-19 patients was the main motivator for 12% of those who just got shots. Fourteen percent of the recently vaccinated got inoculated mainly because someone they knew had become seriously ill or had died from COVID-19.

The role of the Delta threat is also evident with regard to where those who were recently vaccinated live. Twenty-four percent of those who received their first dose of vaccine after June 1, 2021, reside in counties with a high COVID-19 case rate; 15% of them live in counties with a relatively low case rate.

Despite the recent surge in vaccinations, however, 7% of adults are still taking a wait-and-see approach; 4% said they’d get a shot only if required; and 12% said they definitely wouldn’t get vaccinated. The latter figure has barely budged since January of this year.

Ninety percent of Democrats said they had received at least one dose of the COVID-19 vaccine, vs. 68% of Independents, and 58% of Republicans.

Wealthier, better educated, urban, and older people were more likely to be vaccinated, with one exception: Sixty-eight percent of those aged 18-29 were vaccinated, vs. 66% of those aged 30-49. The group least likely to be vaccinated were uninsured people younger than 65, suggesting that some of them were unaware that the shot is free.
 

Partisan affiliation

Attitudes toward vaccine booster shots – which are now recommended for people older than 65, the immunocompromised, and certain frontline workers – largely fell along party lines and/or reflected whether respondents had been vaccinated.

Discussion of the boosters, KFF said, “appears to be a net positive for people who are already vaccinated, but a net negative for the unvaccinated. While a larger share of vaccinated adults say the information they have seen about boosters has been helpful (54%) than find it confusing (35%), among the unvaccinated almost twice as many find the information confusing as find it helpful (45% vs. 24%).”

Among fully vaccinated adults, 68% of Democrats say they’d definitely get a booster, and 20% say they probably would. Among Republicans, those percentages are 36% and 33%, respectively. Independents fall in between the other groups.

Although 82% of Democrats say the boosters show that scientists are continuing to make vaccines more effective, 52% of Republicans say that it shows that the vaccines are not working as well as promised.

Similarly, partisan attitudes emerged in questions about breakthrough infections. The fact that COVID-19 cases are fairly mild when they occur among persons who have been vaccinated indicates that the vaccines are working, said 87% of Democrats, but only 55% of Republicans agreed with that assessment.

In contrast, just 10% of Democrats but 39% of Republicans said that breakthrough infections mean the vaccines are not working.
 

Vaccine requirements

The public is more evenly divided on vaccine requirements. About 6 in 10 respondents said that vaccines should be required for health care workers (62%) and schoolteachers (58%). Slim majorities supported mandates for federal government employees (55%), college students (55%), and state and local government employees (54%).

On the question of whether employers in general should require their workers to be vaccinated, 48% of respondents said they should, and 50% said they should not.

Similarly, 52% said that all schools should mandate vaccines for eligible students; 46% didn’t approve of such requirements.

Three in four Democrats supported employer vaccine mandates, compared to 45% of Independents and just 20% of Republicans. Large partisan gaps were also seen for government, school, and health care vaccine mandates.

In contrast, 78% of the public favored requiring large employers to give their workers paid time off to get vaccinated and to recover from any side effects.
 

Twenty percent of workers under mandates

One in five workers said their employers require COVID-19 vaccination. Twenty-eight percent of employed people want their employers to require vaccination, and 50% don’t.

Again, the responses broke down along party lines, with 52% of Democrats, 21% of Independents, and 10% of Republicans favoring a vaccine mandate by their employers.

Most unvaccinated people didn’t support an employer mandate. A third of unvaccinated workers said they’d be likely to get vaccinated if their companies required it, but most of them said they would choose weekly testing if offered the option.

Being unable to use gyms, restaurants, or indoor entertainment venues that require vaccination was cited by 13% of the recently vaccinated as the main reason why they got shots.

The public was evenly divided on whether states or local governments should require such businesses to mandate that staff and customers show proof of vaccination. Although the views of the public were tied on this issue overall, 79% of Democrats, 43% of Independents, and 21% of Republicans supported having these kinds of businesses require proof of vaccination.

On school mask mandates, 56% of the respondents supported requiring all students and staff to wear masks. Favoring this kind of mandate were 83% of Democrats, 53% of Independents, and 29% of Republicans.

Partisanship also defined how Democrats and Republicans viewed the current high number of COVID-19 cases. Most Democrats blamed people who don’t wear masks and those who don’t get vaccinated, whereas Republicans were more likely to blame immigrants and tourists bringing COVID-19 into the United States.

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

The number of U.S. adults who are at least partially vaccinated rose five percentage points to 72% in August, a slightly faster increase than in previous months, according to the latest monthly COVID-19 Vaccine Monitor report of the Kaiser Family Foundation (KFF).

The largest increases in vaccine uptake between July and September were among Hispanic adults and people aged 18-29 years. Roughly equal shares of adults now report being vaccinated across racial and ethnic groups: 71% of White adults, 70% of Black adults, and 73% of Hispanic adults.

Overall, the big takeaway of the latest Kaiser COVID-19 survey is that the partisan divide on all aspects of the pandemic, from vaccination status to attitudes toward vaccination and mask mandates, remains as wide as ever.

The only thing that Republicans, Democrats, and Independents mostly agree on is that COVID-19 will probably become an endemic disease like influenza. Seventy-nine percent of respondents agreed with that statement; 14% predicted that COVID-19 would probably be largely eliminated in future years, like polio.
 

Delta motivated many

The most important factor that recently led people toward being vaccinated against COVID-19 was the surge in cases, hospitalizations, and deaths due to the Delta variant, KFF reports.

Full approval of the Pfizer vaccine by the Food and Drug Administration and the increasing prevalence of vaccine mandates played secondary roles in the vaccination uptick.

Specifically, 10% of the recently vaccinated said the main reason they got shots was the increase in COVID-19 cases due to the Delta variant. Concern about reports of local hospitals and intensive care units filling up with COVID-19 patients was the main motivator for 12% of those who just got shots. Fourteen percent of the recently vaccinated got inoculated mainly because someone they knew had become seriously ill or had died from COVID-19.

The role of the Delta threat is also evident with regard to where those who were recently vaccinated live. Twenty-four percent of those who received their first dose of vaccine after June 1, 2021, reside in counties with a high COVID-19 case rate; 15% of them live in counties with a relatively low case rate.

Despite the recent surge in vaccinations, however, 7% of adults are still taking a wait-and-see approach; 4% said they’d get a shot only if required; and 12% said they definitely wouldn’t get vaccinated. The latter figure has barely budged since January of this year.

Ninety percent of Democrats said they had received at least one dose of the COVID-19 vaccine, vs. 68% of Independents, and 58% of Republicans.

Wealthier, better educated, urban, and older people were more likely to be vaccinated, with one exception: Sixty-eight percent of those aged 18-29 were vaccinated, vs. 66% of those aged 30-49. The group least likely to be vaccinated were uninsured people younger than 65, suggesting that some of them were unaware that the shot is free.
 

Partisan affiliation

Attitudes toward vaccine booster shots – which are now recommended for people older than 65, the immunocompromised, and certain frontline workers – largely fell along party lines and/or reflected whether respondents had been vaccinated.

Discussion of the boosters, KFF said, “appears to be a net positive for people who are already vaccinated, but a net negative for the unvaccinated. While a larger share of vaccinated adults say the information they have seen about boosters has been helpful (54%) than find it confusing (35%), among the unvaccinated almost twice as many find the information confusing as find it helpful (45% vs. 24%).”

Among fully vaccinated adults, 68% of Democrats say they’d definitely get a booster, and 20% say they probably would. Among Republicans, those percentages are 36% and 33%, respectively. Independents fall in between the other groups.

Although 82% of Democrats say the boosters show that scientists are continuing to make vaccines more effective, 52% of Republicans say that it shows that the vaccines are not working as well as promised.

Similarly, partisan attitudes emerged in questions about breakthrough infections. The fact that COVID-19 cases are fairly mild when they occur among persons who have been vaccinated indicates that the vaccines are working, said 87% of Democrats, but only 55% of Republicans agreed with that assessment.

In contrast, just 10% of Democrats but 39% of Republicans said that breakthrough infections mean the vaccines are not working.
 

Vaccine requirements

The public is more evenly divided on vaccine requirements. About 6 in 10 respondents said that vaccines should be required for health care workers (62%) and schoolteachers (58%). Slim majorities supported mandates for federal government employees (55%), college students (55%), and state and local government employees (54%).

On the question of whether employers in general should require their workers to be vaccinated, 48% of respondents said they should, and 50% said they should not.

Similarly, 52% said that all schools should mandate vaccines for eligible students; 46% didn’t approve of such requirements.

Three in four Democrats supported employer vaccine mandates, compared to 45% of Independents and just 20% of Republicans. Large partisan gaps were also seen for government, school, and health care vaccine mandates.

In contrast, 78% of the public favored requiring large employers to give their workers paid time off to get vaccinated and to recover from any side effects.
 

Twenty percent of workers under mandates

One in five workers said their employers require COVID-19 vaccination. Twenty-eight percent of employed people want their employers to require vaccination, and 50% don’t.

Again, the responses broke down along party lines, with 52% of Democrats, 21% of Independents, and 10% of Republicans favoring a vaccine mandate by their employers.

Most unvaccinated people didn’t support an employer mandate. A third of unvaccinated workers said they’d be likely to get vaccinated if their companies required it, but most of them said they would choose weekly testing if offered the option.

Being unable to use gyms, restaurants, or indoor entertainment venues that require vaccination was cited by 13% of the recently vaccinated as the main reason why they got shots.

The public was evenly divided on whether states or local governments should require such businesses to mandate that staff and customers show proof of vaccination. Although the views of the public were tied on this issue overall, 79% of Democrats, 43% of Independents, and 21% of Republicans supported having these kinds of businesses require proof of vaccination.

On school mask mandates, 56% of the respondents supported requiring all students and staff to wear masks. Favoring this kind of mandate were 83% of Democrats, 53% of Independents, and 29% of Republicans.

Partisanship also defined how Democrats and Republicans viewed the current high number of COVID-19 cases. Most Democrats blamed people who don’t wear masks and those who don’t get vaccinated, whereas Republicans were more likely to blame immigrants and tourists bringing COVID-19 into the United States.

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

Juvenile xanthogranuloma (JXG) is a benign disorder presenting as firm, yellow-red skin papules or nodules, usually in infancy or early childhood. It derives its name based on its yellowish color and the histologic finding of lipid-filled histiocytes. In fact, it is a form of non-Langerhans’ cell histiocytosis. It most commonly presents on the head, neck, and trunk, but can arise anywhere on the body as demonstrated by this case. While often pink to reddish early on, the characteristic yellow or orange, brown appearance over time is common, occasionally with overlying telangiectasia, and ranging in size from 1 mm to 2 cm. While typically asymptomatic, it is possible for lesions to itch. JXG is usually self-limiting, and spontaneously resolves over several years. On dermoscopy (with polarized light), it has a characteristic “setting sun” appearance because of its central yellow area surrounded by a reddish periphery.

David Schairer, MD

JXGs have been associated with neurofibromatosis-1 and a “triple association” of NF-1, JXG, and juvenile myelomonocytic leukemia (JMML) has been debated. Many cases are diagnosed on clinical grounds without histologic confirmation, so while the absolute incidence is unknown, they are not uncommon.
 

What is on the differential?

Spitz nevus is a melanocytic lesion which typically presents as a sharply circumscribed, dome-shaped, pink-red or brown papule or nodule, and is composed of large epithelioid and/or spindled cells. These nevi can present with a spectrum of morphology and biologic activity; commonly with benign melanocytic proliferations and a symmetric appearance or, rarely, with atypical tumors or lesions, characterized as Spitzoid melanomas. The yellowish color of JXG is distinct from the appearance of Spitz tumors.

Molluscum contagiosum is a common pox viral infection seen in children that presents with round, flat-topped firm papules on the skin and distinctive whitish centers with or without umbilication. Like JXG, molluscum contagiosum papules may grow over time and cause pruritus. However, this diagnosis is less likely given the absence of other lesions on the skin, lack of known contacts with similar lesions, and yellowish color without a more typical appearance of molluscum.

Dermatofibromas occur in people of all ages, although more commonly between the ages of 20 and 40 and in those with a history of trauma at the lesion. Like JXGs, dermatofibromas tend to be firm, solitary papules or nodules. They usually are hyperpigmented, and classically “dimple when pinched” as they are fixed to the subcutaneous tissue. However, this patient’s age, lack of trauma, and the lesion morphology are not consistent with dermatofibromas.

Like XJGs, mastocytomas commonly present in the first 2 years of life with maculopapular or nodular lesions that itch. However, the history of new-onset itch in recent months as the lesion grew larger and the yellow color on dermoscopy are more consistent with JXG.

Eruptive xanthomas typically appear suddenly as multiple erythematous yellow, dome-shaped papules on the extensor surfaces of the extremities, buttocks, and hands. They are usually present with hypertriglyceridemia and are very rare in young children. The presence of a solitary lesion in a 6-month-old patient without a history of lipid abnormalities favors the diagnosis of XJG.
 

Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Kleinman is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology, University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Kleinman have no relevant financial disclosures.

References

Hernandez-Martin A et al. J Am Acad Dermatol. 1997 Mar;36(3 Pt 1):355-67.

Prendiville J. Lumps, bumps and hamartomas in “Neonatal and Infant Dermatology,” 3rd ed. (Philadelphia: Elsevier, 2015).

Püttgen KB. Juvenile xanthogranuloma. UpToDate, 2021.

Schaffer JV. Am J Clin Dermatol. 2021 Mar;22(2):205-20.

Juvenile xanthogranuloma (JXG) is a benign disorder presenting as firm, yellow-red skin papules or nodules, usually in infancy or early childhood. It derives its name based on its yellowish color and the histologic finding of lipid-filled histiocytes. In fact, it is a form of non-Langerhans’ cell histiocytosis. It most commonly presents on the head, neck, and trunk, but can arise anywhere on the body as demonstrated by this case. While often pink to reddish early on, the characteristic yellow or orange, brown appearance over time is common, occasionally with overlying telangiectasia, and ranging in size from 1 mm to 2 cm. While typically asymptomatic, it is possible for lesions to itch. JXG is usually self-limiting, and spontaneously resolves over several years. On dermoscopy (with polarized light), it has a characteristic “setting sun” appearance because of its central yellow area surrounded by a reddish periphery.

David Schairer, MD

JXGs have been associated with neurofibromatosis-1 and a “triple association” of NF-1, JXG, and juvenile myelomonocytic leukemia (JMML) has been debated. Many cases are diagnosed on clinical grounds without histologic confirmation, so while the absolute incidence is unknown, they are not uncommon.
 

What is on the differential?

Spitz nevus is a melanocytic lesion which typically presents as a sharply circumscribed, dome-shaped, pink-red or brown papule or nodule, and is composed of large epithelioid and/or spindled cells. These nevi can present with a spectrum of morphology and biologic activity; commonly with benign melanocytic proliferations and a symmetric appearance or, rarely, with atypical tumors or lesions, characterized as Spitzoid melanomas. The yellowish color of JXG is distinct from the appearance of Spitz tumors.

Molluscum contagiosum is a common pox viral infection seen in children that presents with round, flat-topped firm papules on the skin and distinctive whitish centers with or without umbilication. Like JXG, molluscum contagiosum papules may grow over time and cause pruritus. However, this diagnosis is less likely given the absence of other lesions on the skin, lack of known contacts with similar lesions, and yellowish color without a more typical appearance of molluscum.

Dermatofibromas occur in people of all ages, although more commonly between the ages of 20 and 40 and in those with a history of trauma at the lesion. Like JXGs, dermatofibromas tend to be firm, solitary papules or nodules. They usually are hyperpigmented, and classically “dimple when pinched” as they are fixed to the subcutaneous tissue. However, this patient’s age, lack of trauma, and the lesion morphology are not consistent with dermatofibromas.

Like XJGs, mastocytomas commonly present in the first 2 years of life with maculopapular or nodular lesions that itch. However, the history of new-onset itch in recent months as the lesion grew larger and the yellow color on dermoscopy are more consistent with JXG.

Eruptive xanthomas typically appear suddenly as multiple erythematous yellow, dome-shaped papules on the extensor surfaces of the extremities, buttocks, and hands. They are usually present with hypertriglyceridemia and are very rare in young children. The presence of a solitary lesion in a 6-month-old patient without a history of lipid abnormalities favors the diagnosis of XJG.
 

Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Kleinman is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology, University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Kleinman have no relevant financial disclosures.

References

Hernandez-Martin A et al. J Am Acad Dermatol. 1997 Mar;36(3 Pt 1):355-67.

Prendiville J. Lumps, bumps and hamartomas in “Neonatal and Infant Dermatology,” 3rd ed. (Philadelphia: Elsevier, 2015).

Püttgen KB. Juvenile xanthogranuloma. UpToDate, 2021.

Schaffer JV. Am J Clin Dermatol. 2021 Mar;22(2):205-20.

Juvenile xanthogranuloma (JXG) is a benign disorder presenting as firm, yellow-red skin papules or nodules, usually in infancy or early childhood. It derives its name based on its yellowish color and the histologic finding of lipid-filled histiocytes. In fact, it is a form of non-Langerhans’ cell histiocytosis. It most commonly presents on the head, neck, and trunk, but can arise anywhere on the body as demonstrated by this case. While often pink to reddish early on, the characteristic yellow or orange, brown appearance over time is common, occasionally with overlying telangiectasia, and ranging in size from 1 mm to 2 cm. While typically asymptomatic, it is possible for lesions to itch. JXG is usually self-limiting, and spontaneously resolves over several years. On dermoscopy (with polarized light), it has a characteristic “setting sun” appearance because of its central yellow area surrounded by a reddish periphery.

David Schairer, MD

JXGs have been associated with neurofibromatosis-1 and a “triple association” of NF-1, JXG, and juvenile myelomonocytic leukemia (JMML) has been debated. Many cases are diagnosed on clinical grounds without histologic confirmation, so while the absolute incidence is unknown, they are not uncommon.
 

What is on the differential?

Spitz nevus is a melanocytic lesion which typically presents as a sharply circumscribed, dome-shaped, pink-red or brown papule or nodule, and is composed of large epithelioid and/or spindled cells. These nevi can present with a spectrum of morphology and biologic activity; commonly with benign melanocytic proliferations and a symmetric appearance or, rarely, with atypical tumors or lesions, characterized as Spitzoid melanomas. The yellowish color of JXG is distinct from the appearance of Spitz tumors.

Molluscum contagiosum is a common pox viral infection seen in children that presents with round, flat-topped firm papules on the skin and distinctive whitish centers with or without umbilication. Like JXG, molluscum contagiosum papules may grow over time and cause pruritus. However, this diagnosis is less likely given the absence of other lesions on the skin, lack of known contacts with similar lesions, and yellowish color without a more typical appearance of molluscum.

Dermatofibromas occur in people of all ages, although more commonly between the ages of 20 and 40 and in those with a history of trauma at the lesion. Like JXGs, dermatofibromas tend to be firm, solitary papules or nodules. They usually are hyperpigmented, and classically “dimple when pinched” as they are fixed to the subcutaneous tissue. However, this patient’s age, lack of trauma, and the lesion morphology are not consistent with dermatofibromas.

Like XJGs, mastocytomas commonly present in the first 2 years of life with maculopapular or nodular lesions that itch. However, the history of new-onset itch in recent months as the lesion grew larger and the yellow color on dermoscopy are more consistent with JXG.

Eruptive xanthomas typically appear suddenly as multiple erythematous yellow, dome-shaped papules on the extensor surfaces of the extremities, buttocks, and hands. They are usually present with hypertriglyceridemia and are very rare in young children. The presence of a solitary lesion in a 6-month-old patient without a history of lipid abnormalities favors the diagnosis of XJG.
 

Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Kleinman is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology, University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Kleinman have no relevant financial disclosures.

References

Hernandez-Martin A et al. J Am Acad Dermatol. 1997 Mar;36(3 Pt 1):355-67.

Prendiville J. Lumps, bumps and hamartomas in “Neonatal and Infant Dermatology,” 3rd ed. (Philadelphia: Elsevier, 2015).

Püttgen KB. Juvenile xanthogranuloma. UpToDate, 2021.

Schaffer JV. Am J Clin Dermatol. 2021 Mar;22(2):205-20.

The U.S. Department of Veteran Affairs (VA) has been unable to provide genetic counseling to veterans at the same level as the civilian community, and other gaps exist, a genetic counselor told oncologist and hematologist colleagues. The good news is that telemedicine is turning out to be a valuable and proven way to reach veterans who need this kind of care, she said, although certain patients are being left behind.

“To me, telehealth is no doubt the way to go. But it is really important that we continue to look into these disparities, what's causing them, and how we can find a path forward,” said

Deborah Hartzfeld, MS, CGC, of the Genomic Medicine Service based in Salt Lake City, Utah. She spoke in a presentation at the 2021 annual meeting of the Association of VA Hematology/Oncology (AVAHO) that was held virtually and in person in Denver, Colorado, from September 24 to September 26, 2021.

As Harzfeld explained, the genetic counselor workforce is expanding along with the number of indications for genetic testing, especially in cancer, “where the need for germline genetic testing for inherited cancer genes becomes broader every year.”

Genetic counselors are a homogenous group, she said, as revealed by a 2021 survey of most of the nation’s 5,629 certified generic counselors. The North American survey, by the National Society of Genetic Counselors, found that 94% of respondents identified themselves as female, and 90% were white/non-Hispanic.  

The survey report also noted that “the genetic counseling profession has grown by over 100% in the last 10 years and is expected to grow another 100% over the next 10 years. By 2025 there should be nearly 7,500 certified genetic counselors, and by 2030 there are likely to be over 10,000.”

Genetic counseling within the VA has also grown rapidly. In 2010, Harzfeld said, about 737 veterans were referred for the service. In 2020, the number was about 10,000, with about half referred for personal or family history of cancer.

The VA has 18 genetic counselors, not all of whom are actively seeing patients or working full time, she said. “Per the National Society of Genetic Counselors, there's one clinical genetic counselor per 100,000 people in the general population,” she said. “It's one for about 474,000 in the VA.”

Wait times for genetic counseling within the VA exceed Mission Act standards outside of urgent referrals in matters such as surgical or medical management, she said. “We usually see those patients within a week, but other folks have to wait or are referred into the community. It remains unclear how many of our patients could access care easily in the community or what the wait times at any individual VA will be.”

Fortunately, she said, telemedicine has increased access to genetic counseling within the general population and the VA, Harzfeld said. “A recent systematic evidence review found providing genetic counseling via video or telephone is comparable to in-person care, it increases access and it's likely feasible and acceptable to major stakeholders. It's worth noting that the data in this evidence review was collected prior to COVID-19 when fewer programs were using telehealth.”

Genetic counseling works especially well via telehealth because counselors don’t perform physical examinations, she said. “Prior to COVID, service probably saw maybe 4 VVC [VA Video Connect] appointments per month for genetic counseling. Now, VVC makes up about 70% of our new patient encounters. About 25% are telephone and about 5% are clinical video telehealth where the veteran goes into their clinic to be seated in front of the machine.”

Research has suggested that non-White patients are 40 to 50% less likely to be referred to telehealth for genetic counseling vs. in-person encounters, she said, although women in general (including black women) are more likely to be referred.

Harzfeld highlighted several challenges facing genetic counseling in the VA. She notes that contracted laboratories aren’t “really set up to be experts in germline genetic testing, so they’re not as nimble, and their test catalogs are not most likely going to be as comprehensive enough for what is needed.” Also, she said, “test ordering can be quite burdensome.”

“We need to continue working with various partners to increase access and the ease of ordering genetic testing,” she said.

Hartzfeld reports no disclosures.

The U.S. Department of Veteran Affairs (VA) has been unable to provide genetic counseling to veterans at the same level as the civilian community, and other gaps exist, a genetic counselor told oncologist and hematologist colleagues. The good news is that telemedicine is turning out to be a valuable and proven way to reach veterans who need this kind of care, she said, although certain patients are being left behind.

“To me, telehealth is no doubt the way to go. But it is really important that we continue to look into these disparities, what's causing them, and how we can find a path forward,” said

Deborah Hartzfeld, MS, CGC, of the Genomic Medicine Service based in Salt Lake City, Utah. She spoke in a presentation at the 2021 annual meeting of the Association of VA Hematology/Oncology (AVAHO) that was held virtually and in person in Denver, Colorado, from September 24 to September 26, 2021.

As Harzfeld explained, the genetic counselor workforce is expanding along with the number of indications for genetic testing, especially in cancer, “where the need for germline genetic testing for inherited cancer genes becomes broader every year.”

Genetic counselors are a homogenous group, she said, as revealed by a 2021 survey of most of the nation’s 5,629 certified generic counselors. The North American survey, by the National Society of Genetic Counselors, found that 94% of respondents identified themselves as female, and 90% were white/non-Hispanic.  

The survey report also noted that “the genetic counseling profession has grown by over 100% in the last 10 years and is expected to grow another 100% over the next 10 years. By 2025 there should be nearly 7,500 certified genetic counselors, and by 2030 there are likely to be over 10,000.”

Genetic counseling within the VA has also grown rapidly. In 2010, Harzfeld said, about 737 veterans were referred for the service. In 2020, the number was about 10,000, with about half referred for personal or family history of cancer.

The VA has 18 genetic counselors, not all of whom are actively seeing patients or working full time, she said. “Per the National Society of Genetic Counselors, there's one clinical genetic counselor per 100,000 people in the general population,” she said. “It's one for about 474,000 in the VA.”

Wait times for genetic counseling within the VA exceed Mission Act standards outside of urgent referrals in matters such as surgical or medical management, she said. “We usually see those patients within a week, but other folks have to wait or are referred into the community. It remains unclear how many of our patients could access care easily in the community or what the wait times at any individual VA will be.”

Fortunately, she said, telemedicine has increased access to genetic counseling within the general population and the VA, Harzfeld said. “A recent systematic evidence review found providing genetic counseling via video or telephone is comparable to in-person care, it increases access and it's likely feasible and acceptable to major stakeholders. It's worth noting that the data in this evidence review was collected prior to COVID-19 when fewer programs were using telehealth.”

Genetic counseling works especially well via telehealth because counselors don’t perform physical examinations, she said. “Prior to COVID, service probably saw maybe 4 VVC [VA Video Connect] appointments per month for genetic counseling. Now, VVC makes up about 70% of our new patient encounters. About 25% are telephone and about 5% are clinical video telehealth where the veteran goes into their clinic to be seated in front of the machine.”

Research has suggested that non-White patients are 40 to 50% less likely to be referred to telehealth for genetic counseling vs. in-person encounters, she said, although women in general (including black women) are more likely to be referred.

Harzfeld highlighted several challenges facing genetic counseling in the VA. She notes that contracted laboratories aren’t “really set up to be experts in germline genetic testing, so they’re not as nimble, and their test catalogs are not most likely going to be as comprehensive enough for what is needed.” Also, she said, “test ordering can be quite burdensome.”

“We need to continue working with various partners to increase access and the ease of ordering genetic testing,” she said.

Hartzfeld reports no disclosures.

The U.S. Department of Veteran Affairs (VA) has been unable to provide genetic counseling to veterans at the same level as the civilian community, and other gaps exist, a genetic counselor told oncologist and hematologist colleagues. The good news is that telemedicine is turning out to be a valuable and proven way to reach veterans who need this kind of care, she said, although certain patients are being left behind.

“To me, telehealth is no doubt the way to go. But it is really important that we continue to look into these disparities, what's causing them, and how we can find a path forward,” said

Deborah Hartzfeld, MS, CGC, of the Genomic Medicine Service based in Salt Lake City, Utah. She spoke in a presentation at the 2021 annual meeting of the Association of VA Hematology/Oncology (AVAHO) that was held virtually and in person in Denver, Colorado, from September 24 to September 26, 2021.

As Harzfeld explained, the genetic counselor workforce is expanding along with the number of indications for genetic testing, especially in cancer, “where the need for germline genetic testing for inherited cancer genes becomes broader every year.”

Genetic counselors are a homogenous group, she said, as revealed by a 2021 survey of most of the nation’s 5,629 certified generic counselors. The North American survey, by the National Society of Genetic Counselors, found that 94% of respondents identified themselves as female, and 90% were white/non-Hispanic.  

The survey report also noted that “the genetic counseling profession has grown by over 100% in the last 10 years and is expected to grow another 100% over the next 10 years. By 2025 there should be nearly 7,500 certified genetic counselors, and by 2030 there are likely to be over 10,000.”

Genetic counseling within the VA has also grown rapidly. In 2010, Harzfeld said, about 737 veterans were referred for the service. In 2020, the number was about 10,000, with about half referred for personal or family history of cancer.

The VA has 18 genetic counselors, not all of whom are actively seeing patients or working full time, she said. “Per the National Society of Genetic Counselors, there's one clinical genetic counselor per 100,000 people in the general population,” she said. “It's one for about 474,000 in the VA.”

Wait times for genetic counseling within the VA exceed Mission Act standards outside of urgent referrals in matters such as surgical or medical management, she said. “We usually see those patients within a week, but other folks have to wait or are referred into the community. It remains unclear how many of our patients could access care easily in the community or what the wait times at any individual VA will be.”

Fortunately, she said, telemedicine has increased access to genetic counseling within the general population and the VA, Harzfeld said. “A recent systematic evidence review found providing genetic counseling via video or telephone is comparable to in-person care, it increases access and it's likely feasible and acceptable to major stakeholders. It's worth noting that the data in this evidence review was collected prior to COVID-19 when fewer programs were using telehealth.”

Genetic counseling works especially well via telehealth because counselors don’t perform physical examinations, she said. “Prior to COVID, service probably saw maybe 4 VVC [VA Video Connect] appointments per month for genetic counseling. Now, VVC makes up about 70% of our new patient encounters. About 25% are telephone and about 5% are clinical video telehealth where the veteran goes into their clinic to be seated in front of the machine.”

Research has suggested that non-White patients are 40 to 50% less likely to be referred to telehealth for genetic counseling vs. in-person encounters, she said, although women in general (including black women) are more likely to be referred.

Harzfeld highlighted several challenges facing genetic counseling in the VA. She notes that contracted laboratories aren’t “really set up to be experts in germline genetic testing, so they’re not as nimble, and their test catalogs are not most likely going to be as comprehensive enough for what is needed.” Also, she said, “test ordering can be quite burdensome.”

“We need to continue working with various partners to increase access and the ease of ordering genetic testing,” she said.

Hartzfeld reports no disclosures.