Doug Brunk

Hospitals that participated in the Southeast Michigan “See You in 7 Collaborative” experienced substantial reductions in 30-day readmission rates and Medicare payments related to heart failure (HF) care.

Increases in postdischarge 7-day follow-up were modest “but associated processes aimed at this goal may have improved the overall transition from inpatient to outpatient care,” Dr. Scott L. Hummel reported online Sept. 9 in JACC: Heart Failure. “Our study suggests that regional hospital collaboration to share best practices can be an effective strategy to reduce HF readmissions and associated costs.”

American Heart Association

Established in 2011, the Southeast Michigan See You in 7 Collaborative is an effort by the Greater Detroit Area Council, the American College of Cardiology’s Michigan Chapter, the Michigan Peer Review Organization, and 11 previously nonaffiliated hospitals to increase 7-day postdischarge follow-up and reduce all-cause 30-day readmission rates in HF patients. Over a 1-year period, Dr. Hummel, a cardiologist at the University of Michigan, Ann Arbor, and his associates examined the rates of 7-day follow-up and 30-day readmissions in Medicare fee-for-service HF patients among the 10 collaborating hospitals, and compared the findings to trends in the state’s 82 nonparticipating hospitals. The preintervention period studied was May 2011-April 2012; the intervention occurred from May 2012-April 2013.

During the intervention period, the rates of 7-day postdischarge follow-up increased significantly but remained low in both groups (from 31.1% to 34.4% in collaborating hospitals, and from 30.2% to 32.6% in nonparticipating hospitals). At the same time, the rates of unadjusted readmissions significantly decreased in both groups (from 29% to 27.3% in collaborating hospitals and from 26.4% to 25.8% in nonparticipating hospitals). The researchers also found that the mean risk-standardized 30-day, all-cause readmission rates improved significantly among collaborating hospitals (from 31.1% to 28.5%), but significantly less so among nonparticipating hospitals (from 26.7% to 26.1%).

Finally, combined Medicare payments for inpatient and 30 days of postdischarge care decreased by an average of $182 per beneficiary in collaborating hospitals and by $63 in nonparticipating hospitals (JACC Heart Fail. 2015 Sept 9; [doi:10.1016/j.jchf.2015.06.007]).

The researchers acknowledged certain limitations of the study, including its observational design and the fact that administrative data sets were used to determine the outcomes of interest. “Given the observational nature of the study, we cannot confirm that improvements in 7-day follow-up or 30-day readmission rates directly resulted from See You in 7 Collaborative participation,” they noted.

The study was funded in part by the Robert Wood Johnson Foundation. Dr. Hummel disclosed that he is supported by a grant from the National Heart, Lung, and Blood Institute. The remaining study authors reported having no financial disclosures.

[email protected]

Hospitals that participated in the Southeast Michigan “See You in 7 Collaborative” experienced substantial reductions in 30-day readmission rates and Medicare payments related to heart failure (HF) care.

Increases in postdischarge 7-day follow-up were modest “but associated processes aimed at this goal may have improved the overall transition from inpatient to outpatient care,” Dr. Scott L. Hummel reported online Sept. 9 in JACC: Heart Failure. “Our study suggests that regional hospital collaboration to share best practices can be an effective strategy to reduce HF readmissions and associated costs.”

American Heart Association

Established in 2011, the Southeast Michigan See You in 7 Collaborative is an effort by the Greater Detroit Area Council, the American College of Cardiology’s Michigan Chapter, the Michigan Peer Review Organization, and 11 previously nonaffiliated hospitals to increase 7-day postdischarge follow-up and reduce all-cause 30-day readmission rates in HF patients. Over a 1-year period, Dr. Hummel, a cardiologist at the University of Michigan, Ann Arbor, and his associates examined the rates of 7-day follow-up and 30-day readmissions in Medicare fee-for-service HF patients among the 10 collaborating hospitals, and compared the findings to trends in the state’s 82 nonparticipating hospitals. The preintervention period studied was May 2011-April 2012; the intervention occurred from May 2012-April 2013.

During the intervention period, the rates of 7-day postdischarge follow-up increased significantly but remained low in both groups (from 31.1% to 34.4% in collaborating hospitals, and from 30.2% to 32.6% in nonparticipating hospitals). At the same time, the rates of unadjusted readmissions significantly decreased in both groups (from 29% to 27.3% in collaborating hospitals and from 26.4% to 25.8% in nonparticipating hospitals). The researchers also found that the mean risk-standardized 30-day, all-cause readmission rates improved significantly among collaborating hospitals (from 31.1% to 28.5%), but significantly less so among nonparticipating hospitals (from 26.7% to 26.1%).

Finally, combined Medicare payments for inpatient and 30 days of postdischarge care decreased by an average of $182 per beneficiary in collaborating hospitals and by $63 in nonparticipating hospitals (JACC Heart Fail. 2015 Sept 9; [doi:10.1016/j.jchf.2015.06.007]).

The researchers acknowledged certain limitations of the study, including its observational design and the fact that administrative data sets were used to determine the outcomes of interest. “Given the observational nature of the study, we cannot confirm that improvements in 7-day follow-up or 30-day readmission rates directly resulted from See You in 7 Collaborative participation,” they noted.

The study was funded in part by the Robert Wood Johnson Foundation. Dr. Hummel disclosed that he is supported by a grant from the National Heart, Lung, and Blood Institute. The remaining study authors reported having no financial disclosures.

[email protected]

Hospitals that participated in the Southeast Michigan “See You in 7 Collaborative” experienced substantial reductions in 30-day readmission rates and Medicare payments related to heart failure (HF) care.

Increases in postdischarge 7-day follow-up were modest “but associated processes aimed at this goal may have improved the overall transition from inpatient to outpatient care,” Dr. Scott L. Hummel reported online Sept. 9 in JACC: Heart Failure. “Our study suggests that regional hospital collaboration to share best practices can be an effective strategy to reduce HF readmissions and associated costs.”

American Heart Association

Established in 2011, the Southeast Michigan See You in 7 Collaborative is an effort by the Greater Detroit Area Council, the American College of Cardiology’s Michigan Chapter, the Michigan Peer Review Organization, and 11 previously nonaffiliated hospitals to increase 7-day postdischarge follow-up and reduce all-cause 30-day readmission rates in HF patients. Over a 1-year period, Dr. Hummel, a cardiologist at the University of Michigan, Ann Arbor, and his associates examined the rates of 7-day follow-up and 30-day readmissions in Medicare fee-for-service HF patients among the 10 collaborating hospitals, and compared the findings to trends in the state’s 82 nonparticipating hospitals. The preintervention period studied was May 2011-April 2012; the intervention occurred from May 2012-April 2013.

During the intervention period, the rates of 7-day postdischarge follow-up increased significantly but remained low in both groups (from 31.1% to 34.4% in collaborating hospitals, and from 30.2% to 32.6% in nonparticipating hospitals). At the same time, the rates of unadjusted readmissions significantly decreased in both groups (from 29% to 27.3% in collaborating hospitals and from 26.4% to 25.8% in nonparticipating hospitals). The researchers also found that the mean risk-standardized 30-day, all-cause readmission rates improved significantly among collaborating hospitals (from 31.1% to 28.5%), but significantly less so among nonparticipating hospitals (from 26.7% to 26.1%).

Finally, combined Medicare payments for inpatient and 30 days of postdischarge care decreased by an average of $182 per beneficiary in collaborating hospitals and by $63 in nonparticipating hospitals (JACC Heart Fail. 2015 Sept 9; [doi:10.1016/j.jchf.2015.06.007]).

The researchers acknowledged certain limitations of the study, including its observational design and the fact that administrative data sets were used to determine the outcomes of interest. “Given the observational nature of the study, we cannot confirm that improvements in 7-day follow-up or 30-day readmission rates directly resulted from See You in 7 Collaborative participation,” they noted.

The study was funded in part by the Robert Wood Johnson Foundation. Dr. Hummel disclosed that he is supported by a grant from the National Heart, Lung, and Blood Institute. The remaining study authors reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – Dr. John J. Zone first began to study gluten sensitivity in 1977, an interest that left some of his clinician colleagues wondering why.

“Everybody told me I was crazy – that this was extremely rare. So I always say I was gluten when gluten wasn’t cool,” Dr. Zone, professor and chairman of dermatology at the University of Utah, Salt Lake City, told attendees at the annual meeting of the Pacific Dermatologic Association.

These days, it’s hard to shop in a food market without noticing all the gluten-free foods available, from pizza dough to beer. Many restaurants also serve gluten-free dishes. But is it hype, or is gluten sensitivity that common? Five percent of people in the United States “will say they are gluten sensitive,” he said. “In fact, 1% of Caucasians actually have celiac disease and 1% of Caucasians have gluten sensitivity that can be documented by challenge but don’t have celiac disease, while 3% have nothing.”

Gluten is a group of proteins contained in wheat, barley, and rye that is insoluble in water. Dr. Zone described celiac disease as a “spectrum of disease” characterized by inflammation of the small intestinal mucosa that occurs with the ingestion of gluten. The condition improves when gluten is removed from the diet. From a genetic standpoint, having a predisposition to express human leukocyte antigen-DQ2 or HLA-DQ8 is required for a diagnosis of celiac disease (CD). An estimated 20%-25% of whites “have that HLA background, but it is rare in Asians,” he said. “The receptors coded by HLA genes are essential for the processing of the gliadin antigen in CD.”

The hallmark for CD is a blood test for immunoglobulin A (IgA) anti-tissue transglutaminase antibodies, which are detectable in patients with untreated disease. “You should be able to get that test for $50 or $60 in any laboratory in the country,” Dr. Zone said. “It’s about 98% reliable. You also want to do a total serum IgA to rule out IgA-deficiency.”

CD clusters with other autoimmune disorders such as Addison’s disease, autoimmune thyroiditis, atrophic gastritis, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, and vitiligo. It’s also common in Down syndrome. “Many patients with histological inflammation have atypical intestinal symptoms or none at all,” he said. “Clinical studies have shown that only 15%-20% of CD patients identified by serology and confirmed by biopsy have classical symptoms of diarrhea and malabsorption.” The presenting symptom in patients with celiac disease may be limited to only aphthous stomatitis, eczema, alopecia areata, psoriasis, or diabetes, along with fatigue or anemia.

Researchers who analyzed the prevalence of CD in the United States estimated the risk to be 1:133 among individuals deemed not to be at risk, 1:56 in symptomatic patients, 1:39 in second-degree relatives, and 1:22 in first-degree relatives (Arch Intern Med. 2003;163[3]:286-92.). “We tested 2,100 people in Utah and found the prevalence among first-degree relatives was 1:12,” Dr. Zone said. “The point is that CD is common, not rare. It’s as common as psoriasis. It profoundly affects the immune system, which is the modulator of inflammatory skin disease.”

Dr. Zone reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – Dr. John J. Zone first began to study gluten sensitivity in 1977, an interest that left some of his clinician colleagues wondering why.

“Everybody told me I was crazy – that this was extremely rare. So I always say I was gluten when gluten wasn’t cool,” Dr. Zone, professor and chairman of dermatology at the University of Utah, Salt Lake City, told attendees at the annual meeting of the Pacific Dermatologic Association.

These days, it’s hard to shop in a food market without noticing all the gluten-free foods available, from pizza dough to beer. Many restaurants also serve gluten-free dishes. But is it hype, or is gluten sensitivity that common? Five percent of people in the United States “will say they are gluten sensitive,” he said. “In fact, 1% of Caucasians actually have celiac disease and 1% of Caucasians have gluten sensitivity that can be documented by challenge but don’t have celiac disease, while 3% have nothing.”

Gluten is a group of proteins contained in wheat, barley, and rye that is insoluble in water. Dr. Zone described celiac disease as a “spectrum of disease” characterized by inflammation of the small intestinal mucosa that occurs with the ingestion of gluten. The condition improves when gluten is removed from the diet. From a genetic standpoint, having a predisposition to express human leukocyte antigen-DQ2 or HLA-DQ8 is required for a diagnosis of celiac disease (CD). An estimated 20%-25% of whites “have that HLA background, but it is rare in Asians,” he said. “The receptors coded by HLA genes are essential for the processing of the gliadin antigen in CD.”

The hallmark for CD is a blood test for immunoglobulin A (IgA) anti-tissue transglutaminase antibodies, which are detectable in patients with untreated disease. “You should be able to get that test for $50 or $60 in any laboratory in the country,” Dr. Zone said. “It’s about 98% reliable. You also want to do a total serum IgA to rule out IgA-deficiency.”

CD clusters with other autoimmune disorders such as Addison’s disease, autoimmune thyroiditis, atrophic gastritis, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, and vitiligo. It’s also common in Down syndrome. “Many patients with histological inflammation have atypical intestinal symptoms or none at all,” he said. “Clinical studies have shown that only 15%-20% of CD patients identified by serology and confirmed by biopsy have classical symptoms of diarrhea and malabsorption.” The presenting symptom in patients with celiac disease may be limited to only aphthous stomatitis, eczema, alopecia areata, psoriasis, or diabetes, along with fatigue or anemia.

Researchers who analyzed the prevalence of CD in the United States estimated the risk to be 1:133 among individuals deemed not to be at risk, 1:56 in symptomatic patients, 1:39 in second-degree relatives, and 1:22 in first-degree relatives (Arch Intern Med. 2003;163[3]:286-92.). “We tested 2,100 people in Utah and found the prevalence among first-degree relatives was 1:12,” Dr. Zone said. “The point is that CD is common, not rare. It’s as common as psoriasis. It profoundly affects the immune system, which is the modulator of inflammatory skin disease.”

Dr. Zone reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – Dr. John J. Zone first began to study gluten sensitivity in 1977, an interest that left some of his clinician colleagues wondering why.

“Everybody told me I was crazy – that this was extremely rare. So I always say I was gluten when gluten wasn’t cool,” Dr. Zone, professor and chairman of dermatology at the University of Utah, Salt Lake City, told attendees at the annual meeting of the Pacific Dermatologic Association.

These days, it’s hard to shop in a food market without noticing all the gluten-free foods available, from pizza dough to beer. Many restaurants also serve gluten-free dishes. But is it hype, or is gluten sensitivity that common? Five percent of people in the United States “will say they are gluten sensitive,” he said. “In fact, 1% of Caucasians actually have celiac disease and 1% of Caucasians have gluten sensitivity that can be documented by challenge but don’t have celiac disease, while 3% have nothing.”

Gluten is a group of proteins contained in wheat, barley, and rye that is insoluble in water. Dr. Zone described celiac disease as a “spectrum of disease” characterized by inflammation of the small intestinal mucosa that occurs with the ingestion of gluten. The condition improves when gluten is removed from the diet. From a genetic standpoint, having a predisposition to express human leukocyte antigen-DQ2 or HLA-DQ8 is required for a diagnosis of celiac disease (CD). An estimated 20%-25% of whites “have that HLA background, but it is rare in Asians,” he said. “The receptors coded by HLA genes are essential for the processing of the gliadin antigen in CD.”

The hallmark for CD is a blood test for immunoglobulin A (IgA) anti-tissue transglutaminase antibodies, which are detectable in patients with untreated disease. “You should be able to get that test for $50 or $60 in any laboratory in the country,” Dr. Zone said. “It’s about 98% reliable. You also want to do a total serum IgA to rule out IgA-deficiency.”

CD clusters with other autoimmune disorders such as Addison’s disease, autoimmune thyroiditis, atrophic gastritis, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, and vitiligo. It’s also common in Down syndrome. “Many patients with histological inflammation have atypical intestinal symptoms or none at all,” he said. “Clinical studies have shown that only 15%-20% of CD patients identified by serology and confirmed by biopsy have classical symptoms of diarrhea and malabsorption.” The presenting symptom in patients with celiac disease may be limited to only aphthous stomatitis, eczema, alopecia areata, psoriasis, or diabetes, along with fatigue or anemia.

Researchers who analyzed the prevalence of CD in the United States estimated the risk to be 1:133 among individuals deemed not to be at risk, 1:56 in symptomatic patients, 1:39 in second-degree relatives, and 1:22 in first-degree relatives (Arch Intern Med. 2003;163[3]:286-92.). “We tested 2,100 people in Utah and found the prevalence among first-degree relatives was 1:12,” Dr. Zone said. “The point is that CD is common, not rare. It’s as common as psoriasis. It profoundly affects the immune system, which is the modulator of inflammatory skin disease.”

Dr. Zone reported having no financial disclosures.

[email protected]

Among patients with Chagas cardiomyopathy, trypanocidal therapy with benznidazole significantly reduced serum parasite detection but did not reduce cardiac clinical deterioration through 5 years of follow-up, a randomized trial showed.

Those are key findings from the Benznidazole Evaluation for Interrupting Trypanosomiasis (BENEFIT) trial, which were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1507574).

©CDC/Dr. Mae Melvin

According to lead study authors Dr. Carlos A. Morillo of the Population Health Research Institute at Hamilton Health Sciences and McMaster University, Hamilton, Ont., and Dr. Jose Antonio Marin-Neto of the division of cardiology at the Medical School of Riberao Preto, Brazil, Chagas cardiomyopathy develops in about one-quarter of patients infected with Trypanosoma cruzi. “The identification of T. cruzi antigens in inflamed myocardium with the use of sensitive techniques, such as immunohistochemical analysis and polymerase chain reaction (PCR) assay, suggests that parasite persistence may be an important factor that, in conjunction with individual host factors, triggers the inflammatory process,” they wrote. “In assessing whether trypanocidal therapy prevents or reduces cardiac disease, experimental models of chronic Chagas infection have shown that trypanocidal therapy attenuates the pathologic consequences by reducing the parasite burden. A few small observational and randomized studies involving patients with Chagas disease have shown that benznidazole reduced the circulating parasite load, enhances seroconversion, and may halt the progression of cardiomyopathy.”

In a study of 2,854 patients with chronic Chagas cardiomyopathy conducted at 49 centers in Argentina, Bolivia, Brazil, Columbia, and El Salvador, the researchers set out to evaluate the efficacy and safety of benznidazole, compared with placebo, in reducing the clinical outcomes in patients with chronic Chagas cardiomyopathy. Of the 2,854 patients, slightly more than half (1,431) received benznidazole, while the remaining 1,423 received placebo for up to 80 days and were followed for a mean of 5.4 years. The primary outcome was the first event of any of the components of the composite outcome of death, resuscitated cardiac arrest, sustained ventricular tachycardia, insertion of a pacemaker or implantable cardioverter-defibrillator, cardiac transplantation, new heart failure, stroke, or other thromboembolic event. Secondary outcomes included the response to treatment on the basis of results on PCR assay overall and according to geographic region.

The proportion of study participants who achieved the primary outcome was statistically similar between the two groups: 27.% in the benznidazole group, compared with 29.1% in the placebo group (adjusted hazard ratio of .092; P = .26). The researchers observed no significant between-group differences in any component of the primary outcome.

In terms of secondary outcomes, the rates of conversion to negative PCR results were 66.2% in the benznidazole group, compared with 33.5% in the placebo group at the end of treatment. Between-group differences were sustained at 2 years (55.4% and 35.3%, respectively) and at 5 years or more (46.7% vs. 33.1%; P less than .001 for all comparisons). At the same time, rates of PCR conversion varied according to geographic region. For example, the odds ratio for PCR conversion was highest in Brazil (odds ratio, 3.03 at 2 years and OR, 1.87 at 5 or more years) and lowest in Columbia and El Salvador (OR, 1.33 at 2 years and OR, 0.96 at 5 years). “Since we do not have genotype information, we had to infer that patients in certain geographic regions were likely to have distinct T. cruzi strains,” the authors wrote.

They acknowledged certain limitations of the study, including the fact that “variable responses to benznidazole have been reported previously and may have contributed to our neutral findings. Further analyses of stored blood samples by means of quantitative PCR and genotyping may provide a more precise characterization of T. cruzi that can be used to assess whether genotype influences the clinical response to benznidazole.”

They concluded that the current findings “do not challenge current guidelines that recommend treatment with trypanocidal therapy in the early stages of chronic Chagas infection. ... and should not detract from the pursuit of general goals for exploring more effective or earlier treatments with new drugs or drug combinations.”

The study was funded by several sources, including the Population Health Research Institute, the Canadian Institutes of Health Research, the United Nations Children’s Fund, and the World Bank. Dr. Morillo disclosed that he has received lecture fees from Bayer and Boehringer Ingelheim and grant support from Boston Scientific and Merck & Co. Another study author, Dr. Janis Lazdins, disclosed having received consulting fees from Merck. The remaining study authors reporting having no financial disclosures.

[email protected]

Among patients with Chagas cardiomyopathy, trypanocidal therapy with benznidazole significantly reduced serum parasite detection but did not reduce cardiac clinical deterioration through 5 years of follow-up, a randomized trial showed.

Those are key findings from the Benznidazole Evaluation for Interrupting Trypanosomiasis (BENEFIT) trial, which were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1507574).

©CDC/Dr. Mae Melvin

According to lead study authors Dr. Carlos A. Morillo of the Population Health Research Institute at Hamilton Health Sciences and McMaster University, Hamilton, Ont., and Dr. Jose Antonio Marin-Neto of the division of cardiology at the Medical School of Riberao Preto, Brazil, Chagas cardiomyopathy develops in about one-quarter of patients infected with Trypanosoma cruzi. “The identification of T. cruzi antigens in inflamed myocardium with the use of sensitive techniques, such as immunohistochemical analysis and polymerase chain reaction (PCR) assay, suggests that parasite persistence may be an important factor that, in conjunction with individual host factors, triggers the inflammatory process,” they wrote. “In assessing whether trypanocidal therapy prevents or reduces cardiac disease, experimental models of chronic Chagas infection have shown that trypanocidal therapy attenuates the pathologic consequences by reducing the parasite burden. A few small observational and randomized studies involving patients with Chagas disease have shown that benznidazole reduced the circulating parasite load, enhances seroconversion, and may halt the progression of cardiomyopathy.”

In a study of 2,854 patients with chronic Chagas cardiomyopathy conducted at 49 centers in Argentina, Bolivia, Brazil, Columbia, and El Salvador, the researchers set out to evaluate the efficacy and safety of benznidazole, compared with placebo, in reducing the clinical outcomes in patients with chronic Chagas cardiomyopathy. Of the 2,854 patients, slightly more than half (1,431) received benznidazole, while the remaining 1,423 received placebo for up to 80 days and were followed for a mean of 5.4 years. The primary outcome was the first event of any of the components of the composite outcome of death, resuscitated cardiac arrest, sustained ventricular tachycardia, insertion of a pacemaker or implantable cardioverter-defibrillator, cardiac transplantation, new heart failure, stroke, or other thromboembolic event. Secondary outcomes included the response to treatment on the basis of results on PCR assay overall and according to geographic region.

The proportion of study participants who achieved the primary outcome was statistically similar between the two groups: 27.% in the benznidazole group, compared with 29.1% in the placebo group (adjusted hazard ratio of .092; P = .26). The researchers observed no significant between-group differences in any component of the primary outcome.

In terms of secondary outcomes, the rates of conversion to negative PCR results were 66.2% in the benznidazole group, compared with 33.5% in the placebo group at the end of treatment. Between-group differences were sustained at 2 years (55.4% and 35.3%, respectively) and at 5 years or more (46.7% vs. 33.1%; P less than .001 for all comparisons). At the same time, rates of PCR conversion varied according to geographic region. For example, the odds ratio for PCR conversion was highest in Brazil (odds ratio, 3.03 at 2 years and OR, 1.87 at 5 or more years) and lowest in Columbia and El Salvador (OR, 1.33 at 2 years and OR, 0.96 at 5 years). “Since we do not have genotype information, we had to infer that patients in certain geographic regions were likely to have distinct T. cruzi strains,” the authors wrote.

They acknowledged certain limitations of the study, including the fact that “variable responses to benznidazole have been reported previously and may have contributed to our neutral findings. Further analyses of stored blood samples by means of quantitative PCR and genotyping may provide a more precise characterization of T. cruzi that can be used to assess whether genotype influences the clinical response to benznidazole.”

They concluded that the current findings “do not challenge current guidelines that recommend treatment with trypanocidal therapy in the early stages of chronic Chagas infection. ... and should not detract from the pursuit of general goals for exploring more effective or earlier treatments with new drugs or drug combinations.”

The study was funded by several sources, including the Population Health Research Institute, the Canadian Institutes of Health Research, the United Nations Children’s Fund, and the World Bank. Dr. Morillo disclosed that he has received lecture fees from Bayer and Boehringer Ingelheim and grant support from Boston Scientific and Merck & Co. Another study author, Dr. Janis Lazdins, disclosed having received consulting fees from Merck. The remaining study authors reporting having no financial disclosures.

[email protected]

Among patients with Chagas cardiomyopathy, trypanocidal therapy with benznidazole significantly reduced serum parasite detection but did not reduce cardiac clinical deterioration through 5 years of follow-up, a randomized trial showed.

Those are key findings from the Benznidazole Evaluation for Interrupting Trypanosomiasis (BENEFIT) trial, which were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1507574).

©CDC/Dr. Mae Melvin

According to lead study authors Dr. Carlos A. Morillo of the Population Health Research Institute at Hamilton Health Sciences and McMaster University, Hamilton, Ont., and Dr. Jose Antonio Marin-Neto of the division of cardiology at the Medical School of Riberao Preto, Brazil, Chagas cardiomyopathy develops in about one-quarter of patients infected with Trypanosoma cruzi. “The identification of T. cruzi antigens in inflamed myocardium with the use of sensitive techniques, such as immunohistochemical analysis and polymerase chain reaction (PCR) assay, suggests that parasite persistence may be an important factor that, in conjunction with individual host factors, triggers the inflammatory process,” they wrote. “In assessing whether trypanocidal therapy prevents or reduces cardiac disease, experimental models of chronic Chagas infection have shown that trypanocidal therapy attenuates the pathologic consequences by reducing the parasite burden. A few small observational and randomized studies involving patients with Chagas disease have shown that benznidazole reduced the circulating parasite load, enhances seroconversion, and may halt the progression of cardiomyopathy.”

In a study of 2,854 patients with chronic Chagas cardiomyopathy conducted at 49 centers in Argentina, Bolivia, Brazil, Columbia, and El Salvador, the researchers set out to evaluate the efficacy and safety of benznidazole, compared with placebo, in reducing the clinical outcomes in patients with chronic Chagas cardiomyopathy. Of the 2,854 patients, slightly more than half (1,431) received benznidazole, while the remaining 1,423 received placebo for up to 80 days and were followed for a mean of 5.4 years. The primary outcome was the first event of any of the components of the composite outcome of death, resuscitated cardiac arrest, sustained ventricular tachycardia, insertion of a pacemaker or implantable cardioverter-defibrillator, cardiac transplantation, new heart failure, stroke, or other thromboembolic event. Secondary outcomes included the response to treatment on the basis of results on PCR assay overall and according to geographic region.

The proportion of study participants who achieved the primary outcome was statistically similar between the two groups: 27.% in the benznidazole group, compared with 29.1% in the placebo group (adjusted hazard ratio of .092; P = .26). The researchers observed no significant between-group differences in any component of the primary outcome.

In terms of secondary outcomes, the rates of conversion to negative PCR results were 66.2% in the benznidazole group, compared with 33.5% in the placebo group at the end of treatment. Between-group differences were sustained at 2 years (55.4% and 35.3%, respectively) and at 5 years or more (46.7% vs. 33.1%; P less than .001 for all comparisons). At the same time, rates of PCR conversion varied according to geographic region. For example, the odds ratio for PCR conversion was highest in Brazil (odds ratio, 3.03 at 2 years and OR, 1.87 at 5 or more years) and lowest in Columbia and El Salvador (OR, 1.33 at 2 years and OR, 0.96 at 5 years). “Since we do not have genotype information, we had to infer that patients in certain geographic regions were likely to have distinct T. cruzi strains,” the authors wrote.

They acknowledged certain limitations of the study, including the fact that “variable responses to benznidazole have been reported previously and may have contributed to our neutral findings. Further analyses of stored blood samples by means of quantitative PCR and genotyping may provide a more precise characterization of T. cruzi that can be used to assess whether genotype influences the clinical response to benznidazole.”

They concluded that the current findings “do not challenge current guidelines that recommend treatment with trypanocidal therapy in the early stages of chronic Chagas infection. ... and should not detract from the pursuit of general goals for exploring more effective or earlier treatments with new drugs or drug combinations.”

The study was funded by several sources, including the Population Health Research Institute, the Canadian Institutes of Health Research, the United Nations Children’s Fund, and the World Bank. Dr. Morillo disclosed that he has received lecture fees from Bayer and Boehringer Ingelheim and grant support from Boston Scientific and Merck & Co. Another study author, Dr. Janis Lazdins, disclosed having received consulting fees from Merck. The remaining study authors reporting having no financial disclosures.

[email protected]

PARK CITY, UTAH – Since most people with psoriatic arthritis (PsA) develop psoriasis before joint symptoms, it’s helpful to have a simple screening test for the condition.

One of Dr. Philip Mease’s favorite PsA screening tools is the Psoriasis Epidemiology Screening Test (PEST), which was first described at the 2009 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and consists of five simple questions. They are: Have you ever had a swollen joint (or joints)? Has a doctor ever told you that you have arthritis? Do your fingernails or toes have holes or pits? Have you had pain in your heel? Have you had a finger or toe that was completely swollen and painful for no apparent reason? (Clin Exp Rheumatol. 2009;27:469-74).

“Just these five simple questions, or trying to remember a few of them, can help you in your review of systems,” Dr. Mease, director of arthritis research at Swedish Medical Center, Seattle, said at the annual meeting of the Pacific Dermatologic Association. “I think patients appreciate it when you look beyond the skin in your questioning. These can pick up [PsA] with a high sensitivity and specificity” of 0.92 and 0.78, respectively.

He went on to discuss current PsA treatment approaches. According to an evidence review that he and his associates in GRAPPA published in 2009, biologics (anti–tumor necrosis factor inhibitors) as a group were found to be effective in all five domains of the disease: peripheral arthritis, skin and nail disease, axial disease, dactylitis, and enthesitis, while the oral disease-modifying antirheumatic drugs (DMARDs) were effective for peripheral arthritis and skin and nail disease.

Other treatments that were found effective are: psoralen and UVA/UVB for skin and nail disease, physiotherapy for axial disease, intra-articular steroids for peripheral arthritis, and NSAIDs for peripheral arthritis and axial disease (J Rheum. 2009;33:1417-21). “Patients with mild disease can be tried on NSAIDs, especially in a patient with monoarticular disease, but for the most part we need to move on to using systemic medication,” he said. Updated recommendations from GRAPPA include new data regarding ustekinumab, apremilast, and secukinumab, as well as data on comorbidities (J Rheumatol. 2015;42[6]:1052-5).

According to Dr. Mease, controlled trials of DMARDs in PsA patients have yielded treatment effects that range from marginal in the joints to marginal or none at all in the skin. Data from the Methotrexate in Psoriatic Arthritis trial conducted in the United Kingdom and published in 2012 showed no evidence that methotrexate improves inflammatory synovitis in active PsA (Rheumatol. 2012;51:1368-77).

“There were issues with this trial, including the fact that it took 5 years to enroll patients, and many dropped out, so I don’t think it’s a very reliable study,” said Dr. Mease, who is also a professor of medicine in the division of rheumatology at the University of Washington, Seattle. “Currently, Amgen is in the process of starting a trial in which the goal is to enroll 840 subjects with early PsA who are being randomized to methotrexate alone, Enbrel alone, or Enbrel plus methotrexate. This, I think, is going to give us a better answer about the effectiveness of methotrexate. It will also teach us about whether there’s a value in combining an anti-TNF inhibitor with methotrexate. We still don’t know the answer to that question.”

The most recent data on methotrexate come from an open-label trial known as TICOPA, which used a tight control treatment paradigm through 48 weeks of treatment. A subanalysis of 188 patients treated with methotrexate through 12 weeks was presented at the 2015 meeting of the European League Against Rheumatism. It revealed that 41% of patients achieved an ACR 20, 22% achieved minimal disease activity, 62% experienced an improvement in dactylitis, and 25% experienced an improvement in enthesitis.

“So we have a few data suggesting that methotrexate may be modestly effective in treating PsA,” Dr. Mease said. “We often will start with methotrexate unless the patient has really aggressive disease activity. If they get some effect from the drug but not enough, we’ll often add a biologic agent but often keep some methotrexate in the background, even at 10 mg per week, in order to reduce immunogenicity from a biologic.”

Dr. Mease disclosed that he has received research grants, consultation fees, and/or speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB.

[email protected]

PARK CITY, UTAH – Since most people with psoriatic arthritis (PsA) develop psoriasis before joint symptoms, it’s helpful to have a simple screening test for the condition.

One of Dr. Philip Mease’s favorite PsA screening tools is the Psoriasis Epidemiology Screening Test (PEST), which was first described at the 2009 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and consists of five simple questions. They are: Have you ever had a swollen joint (or joints)? Has a doctor ever told you that you have arthritis? Do your fingernails or toes have holes or pits? Have you had pain in your heel? Have you had a finger or toe that was completely swollen and painful for no apparent reason? (Clin Exp Rheumatol. 2009;27:469-74).

“Just these five simple questions, or trying to remember a few of them, can help you in your review of systems,” Dr. Mease, director of arthritis research at Swedish Medical Center, Seattle, said at the annual meeting of the Pacific Dermatologic Association. “I think patients appreciate it when you look beyond the skin in your questioning. These can pick up [PsA] with a high sensitivity and specificity” of 0.92 and 0.78, respectively.

He went on to discuss current PsA treatment approaches. According to an evidence review that he and his associates in GRAPPA published in 2009, biologics (anti–tumor necrosis factor inhibitors) as a group were found to be effective in all five domains of the disease: peripheral arthritis, skin and nail disease, axial disease, dactylitis, and enthesitis, while the oral disease-modifying antirheumatic drugs (DMARDs) were effective for peripheral arthritis and skin and nail disease.

Other treatments that were found effective are: psoralen and UVA/UVB for skin and nail disease, physiotherapy for axial disease, intra-articular steroids for peripheral arthritis, and NSAIDs for peripheral arthritis and axial disease (J Rheum. 2009;33:1417-21). “Patients with mild disease can be tried on NSAIDs, especially in a patient with monoarticular disease, but for the most part we need to move on to using systemic medication,” he said. Updated recommendations from GRAPPA include new data regarding ustekinumab, apremilast, and secukinumab, as well as data on comorbidities (J Rheumatol. 2015;42[6]:1052-5).

According to Dr. Mease, controlled trials of DMARDs in PsA patients have yielded treatment effects that range from marginal in the joints to marginal or none at all in the skin. Data from the Methotrexate in Psoriatic Arthritis trial conducted in the United Kingdom and published in 2012 showed no evidence that methotrexate improves inflammatory synovitis in active PsA (Rheumatol. 2012;51:1368-77).

“There were issues with this trial, including the fact that it took 5 years to enroll patients, and many dropped out, so I don’t think it’s a very reliable study,” said Dr. Mease, who is also a professor of medicine in the division of rheumatology at the University of Washington, Seattle. “Currently, Amgen is in the process of starting a trial in which the goal is to enroll 840 subjects with early PsA who are being randomized to methotrexate alone, Enbrel alone, or Enbrel plus methotrexate. This, I think, is going to give us a better answer about the effectiveness of methotrexate. It will also teach us about whether there’s a value in combining an anti-TNF inhibitor with methotrexate. We still don’t know the answer to that question.”

The most recent data on methotrexate come from an open-label trial known as TICOPA, which used a tight control treatment paradigm through 48 weeks of treatment. A subanalysis of 188 patients treated with methotrexate through 12 weeks was presented at the 2015 meeting of the European League Against Rheumatism. It revealed that 41% of patients achieved an ACR 20, 22% achieved minimal disease activity, 62% experienced an improvement in dactylitis, and 25% experienced an improvement in enthesitis.

“So we have a few data suggesting that methotrexate may be modestly effective in treating PsA,” Dr. Mease said. “We often will start with methotrexate unless the patient has really aggressive disease activity. If they get some effect from the drug but not enough, we’ll often add a biologic agent but often keep some methotrexate in the background, even at 10 mg per week, in order to reduce immunogenicity from a biologic.”

Dr. Mease disclosed that he has received research grants, consultation fees, and/or speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB.

[email protected]

PARK CITY, UTAH – Since most people with psoriatic arthritis (PsA) develop psoriasis before joint symptoms, it’s helpful to have a simple screening test for the condition.

One of Dr. Philip Mease’s favorite PsA screening tools is the Psoriasis Epidemiology Screening Test (PEST), which was first described at the 2009 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and consists of five simple questions. They are: Have you ever had a swollen joint (or joints)? Has a doctor ever told you that you have arthritis? Do your fingernails or toes have holes or pits? Have you had pain in your heel? Have you had a finger or toe that was completely swollen and painful for no apparent reason? (Clin Exp Rheumatol. 2009;27:469-74).

“Just these five simple questions, or trying to remember a few of them, can help you in your review of systems,” Dr. Mease, director of arthritis research at Swedish Medical Center, Seattle, said at the annual meeting of the Pacific Dermatologic Association. “I think patients appreciate it when you look beyond the skin in your questioning. These can pick up [PsA] with a high sensitivity and specificity” of 0.92 and 0.78, respectively.

He went on to discuss current PsA treatment approaches. According to an evidence review that he and his associates in GRAPPA published in 2009, biologics (anti–tumor necrosis factor inhibitors) as a group were found to be effective in all five domains of the disease: peripheral arthritis, skin and nail disease, axial disease, dactylitis, and enthesitis, while the oral disease-modifying antirheumatic drugs (DMARDs) were effective for peripheral arthritis and skin and nail disease.

Other treatments that were found effective are: psoralen and UVA/UVB for skin and nail disease, physiotherapy for axial disease, intra-articular steroids for peripheral arthritis, and NSAIDs for peripheral arthritis and axial disease (J Rheum. 2009;33:1417-21). “Patients with mild disease can be tried on NSAIDs, especially in a patient with monoarticular disease, but for the most part we need to move on to using systemic medication,” he said. Updated recommendations from GRAPPA include new data regarding ustekinumab, apremilast, and secukinumab, as well as data on comorbidities (J Rheumatol. 2015;42[6]:1052-5).

According to Dr. Mease, controlled trials of DMARDs in PsA patients have yielded treatment effects that range from marginal in the joints to marginal or none at all in the skin. Data from the Methotrexate in Psoriatic Arthritis trial conducted in the United Kingdom and published in 2012 showed no evidence that methotrexate improves inflammatory synovitis in active PsA (Rheumatol. 2012;51:1368-77).

“There were issues with this trial, including the fact that it took 5 years to enroll patients, and many dropped out, so I don’t think it’s a very reliable study,” said Dr. Mease, who is also a professor of medicine in the division of rheumatology at the University of Washington, Seattle. “Currently, Amgen is in the process of starting a trial in which the goal is to enroll 840 subjects with early PsA who are being randomized to methotrexate alone, Enbrel alone, or Enbrel plus methotrexate. This, I think, is going to give us a better answer about the effectiveness of methotrexate. It will also teach us about whether there’s a value in combining an anti-TNF inhibitor with methotrexate. We still don’t know the answer to that question.”

The most recent data on methotrexate come from an open-label trial known as TICOPA, which used a tight control treatment paradigm through 48 weeks of treatment. A subanalysis of 188 patients treated with methotrexate through 12 weeks was presented at the 2015 meeting of the European League Against Rheumatism. It revealed that 41% of patients achieved an ACR 20, 22% achieved minimal disease activity, 62% experienced an improvement in dactylitis, and 25% experienced an improvement in enthesitis.

“So we have a few data suggesting that methotrexate may be modestly effective in treating PsA,” Dr. Mease said. “We often will start with methotrexate unless the patient has really aggressive disease activity. If they get some effect from the drug but not enough, we’ll often add a biologic agent but often keep some methotrexate in the background, even at 10 mg per week, in order to reduce immunogenicity from a biologic.”

Dr. Mease disclosed that he has received research grants, consultation fees, and/or speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB.

[email protected]

PARK CITY, UTAH – According to emerging evidence in the medical literature, Mycoplasma pneumoniae–induced rash and mucositis is a distinct clinical entity with a distinct etiology and a good prognosis.

At the annual meeting of the Pacific Dermatologic Association, Dr. Erin Mathes shared tips on how to distinguish potentially life-threatening causes of rash and mucositis in children. “You want to think about their age, demographics, and history of medication exposures,” said Dr. Mathes, a pediatric dermatologist at the University of California, San Francisco. “Kids are exposed to viruses and bacteria all the time when they’re in day care. Also think about fever, whether or not they’re sick or well appearing, and the morphology.”

According to a retrospective study of 55 children with Stevens-Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN) at the Hospital for Sick Children, Toronto, and Boston Children’s Hospital between 2000 and 2007, the top three causes of these rare conditions were antiepileptic drugs (29%), followed by M. pneumoniae infection (25%) and antibiotics (20%) (Pediatrics 2011;128[4]:723-8).

Dr. Mathes said that she learned from her mentor, Dr. Ilona Frieden, director of pediatric dermatology at UCSF Benioff Children’s Hospital, that in cases of M. pneumoniae-induced rash and mucositis (MIRM), 90% of the disease burden is the mucositis, and the remaining 10% is cutaneous findings. “So when you see mucositis far out of proportion to rash, think Mycoplasma,” Dr. Mathes said.

She and her associates at UCSF conducted a systematic review of all published cases on Mycoplasma-induced rash and mucositis and included 202 cases from 95 reports in the medical literature (J Am Acad Dermatol. 2015;72:239-45). The mean age of patients was 12 years, 66% were male, and most had a mucosal morphology (oral in 94% of cases, ocular in 82%, and genitourinary findings in 63%). “About one-third of patients had mucosal involvement alone, which is important to remember,” she said.

The patients’ skin involvement was generally mild; 46% was considered to be sparse or scattered, and 19% had moderate involvement. Extensive skin involvement “is rare, but it can happen,” Dr. Mathes said. Outcomes for the 202 patients were “generally good,” with 81% having no sequelae. The rates of recurrence and mucosal complications such as scarring around the mouth were both 8%, the rate of pigmentary alterations was 6%, and the rate of mortality was 3%, “but those cases were prior to the introduction of antibiotics in the 1940s,” she emphasized. “Children, in general, are not dying of Mycoplasma-associated rash and mucositis.”

A study published on July 25, 2015 in Pediatrics (doi:10.1542/peds.2015-0278) described an outbreak of eight Mycoplasma-associated SJS cases at Children’s Hospital Colorado, Aurora, that occurred over a 2-month period. In a case-control analysis comparing hospitalized SJS cases with and without evidence of M. pneumoniae infection, the researchers found that cases of Mycoplasma-associated SJS were significantly more likely to have pneumonia (odds ratio, 10), preceding respiratory symptoms (OR, 30), an erythrocyte sedimentation rate of greater than 35 mg/dL (OR, 22.8), and fewer than three affected skin sites (OR, 4.5).

Dr. Mathes was part of a research team that published diagnostic criteria for MIRM. These include less than 10% body surface area affected, involvement of two or more mucosal sites, the presence of few vesiculobullous lesions/scattered atypical targets with or without targetoid lesions, and clinical and laboratory evidence of atypical pneumonia (J Am Acad Dermatol. 2015;72:239-45).

“Rare cases can have more body surface area detachment, or no rash at all,” she said.

Existing tests for Mycoplasma infection are “not that great,” she continued. “It depends on the manufacturer and what is used as the gold standard.” IgM and IgG have specificity ranges from 25% to 100% and sensitivity ranges from 52% to 100%, she said, while polymerase chain reaction is rapidly becoming the gold standard. “That is usually from a nasal wash or bronchoalveolar lavage. It is very sensitive, but is almost too sensitive, because you can actually shed bacteria in your nasal pharynx for 4 months after an infection. That can lead to false positives.”

At UCSF, Dr. Mathes and her colleagues tend to treat MIRM cases with azithromycin followed by supportive care. “We occasionally use steroids but rarely use IVIG [intravenous immunoglobulin],” she said.

Dr. Mathes reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – According to emerging evidence in the medical literature, Mycoplasma pneumoniae–induced rash and mucositis is a distinct clinical entity with a distinct etiology and a good prognosis.

At the annual meeting of the Pacific Dermatologic Association, Dr. Erin Mathes shared tips on how to distinguish potentially life-threatening causes of rash and mucositis in children. “You want to think about their age, demographics, and history of medication exposures,” said Dr. Mathes, a pediatric dermatologist at the University of California, San Francisco. “Kids are exposed to viruses and bacteria all the time when they’re in day care. Also think about fever, whether or not they’re sick or well appearing, and the morphology.”

According to a retrospective study of 55 children with Stevens-Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN) at the Hospital for Sick Children, Toronto, and Boston Children’s Hospital between 2000 and 2007, the top three causes of these rare conditions were antiepileptic drugs (29%), followed by M. pneumoniae infection (25%) and antibiotics (20%) (Pediatrics 2011;128[4]:723-8).

Dr. Mathes said that she learned from her mentor, Dr. Ilona Frieden, director of pediatric dermatology at UCSF Benioff Children’s Hospital, that in cases of M. pneumoniae-induced rash and mucositis (MIRM), 90% of the disease burden is the mucositis, and the remaining 10% is cutaneous findings. “So when you see mucositis far out of proportion to rash, think Mycoplasma,” Dr. Mathes said.

She and her associates at UCSF conducted a systematic review of all published cases on Mycoplasma-induced rash and mucositis and included 202 cases from 95 reports in the medical literature (J Am Acad Dermatol. 2015;72:239-45). The mean age of patients was 12 years, 66% were male, and most had a mucosal morphology (oral in 94% of cases, ocular in 82%, and genitourinary findings in 63%). “About one-third of patients had mucosal involvement alone, which is important to remember,” she said.

The patients’ skin involvement was generally mild; 46% was considered to be sparse or scattered, and 19% had moderate involvement. Extensive skin involvement “is rare, but it can happen,” Dr. Mathes said. Outcomes for the 202 patients were “generally good,” with 81% having no sequelae. The rates of recurrence and mucosal complications such as scarring around the mouth were both 8%, the rate of pigmentary alterations was 6%, and the rate of mortality was 3%, “but those cases were prior to the introduction of antibiotics in the 1940s,” she emphasized. “Children, in general, are not dying of Mycoplasma-associated rash and mucositis.”

A study published on July 25, 2015 in Pediatrics (doi:10.1542/peds.2015-0278) described an outbreak of eight Mycoplasma-associated SJS cases at Children’s Hospital Colorado, Aurora, that occurred over a 2-month period. In a case-control analysis comparing hospitalized SJS cases with and without evidence of M. pneumoniae infection, the researchers found that cases of Mycoplasma-associated SJS were significantly more likely to have pneumonia (odds ratio, 10), preceding respiratory symptoms (OR, 30), an erythrocyte sedimentation rate of greater than 35 mg/dL (OR, 22.8), and fewer than three affected skin sites (OR, 4.5).

Dr. Mathes was part of a research team that published diagnostic criteria for MIRM. These include less than 10% body surface area affected, involvement of two or more mucosal sites, the presence of few vesiculobullous lesions/scattered atypical targets with or without targetoid lesions, and clinical and laboratory evidence of atypical pneumonia (J Am Acad Dermatol. 2015;72:239-45).

“Rare cases can have more body surface area detachment, or no rash at all,” she said.

Existing tests for Mycoplasma infection are “not that great,” she continued. “It depends on the manufacturer and what is used as the gold standard.” IgM and IgG have specificity ranges from 25% to 100% and sensitivity ranges from 52% to 100%, she said, while polymerase chain reaction is rapidly becoming the gold standard. “That is usually from a nasal wash or bronchoalveolar lavage. It is very sensitive, but is almost too sensitive, because you can actually shed bacteria in your nasal pharynx for 4 months after an infection. That can lead to false positives.”

At UCSF, Dr. Mathes and her colleagues tend to treat MIRM cases with azithromycin followed by supportive care. “We occasionally use steroids but rarely use IVIG [intravenous immunoglobulin],” she said.

Dr. Mathes reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – According to emerging evidence in the medical literature, Mycoplasma pneumoniae–induced rash and mucositis is a distinct clinical entity with a distinct etiology and a good prognosis.

At the annual meeting of the Pacific Dermatologic Association, Dr. Erin Mathes shared tips on how to distinguish potentially life-threatening causes of rash and mucositis in children. “You want to think about their age, demographics, and history of medication exposures,” said Dr. Mathes, a pediatric dermatologist at the University of California, San Francisco. “Kids are exposed to viruses and bacteria all the time when they’re in day care. Also think about fever, whether or not they’re sick or well appearing, and the morphology.”

According to a retrospective study of 55 children with Stevens-Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN) at the Hospital for Sick Children, Toronto, and Boston Children’s Hospital between 2000 and 2007, the top three causes of these rare conditions were antiepileptic drugs (29%), followed by M. pneumoniae infection (25%) and antibiotics (20%) (Pediatrics 2011;128[4]:723-8).

Dr. Mathes said that she learned from her mentor, Dr. Ilona Frieden, director of pediatric dermatology at UCSF Benioff Children’s Hospital, that in cases of M. pneumoniae-induced rash and mucositis (MIRM), 90% of the disease burden is the mucositis, and the remaining 10% is cutaneous findings. “So when you see mucositis far out of proportion to rash, think Mycoplasma,” Dr. Mathes said.

She and her associates at UCSF conducted a systematic review of all published cases on Mycoplasma-induced rash and mucositis and included 202 cases from 95 reports in the medical literature (J Am Acad Dermatol. 2015;72:239-45). The mean age of patients was 12 years, 66% were male, and most had a mucosal morphology (oral in 94% of cases, ocular in 82%, and genitourinary findings in 63%). “About one-third of patients had mucosal involvement alone, which is important to remember,” she said.

The patients’ skin involvement was generally mild; 46% was considered to be sparse or scattered, and 19% had moderate involvement. Extensive skin involvement “is rare, but it can happen,” Dr. Mathes said. Outcomes for the 202 patients were “generally good,” with 81% having no sequelae. The rates of recurrence and mucosal complications such as scarring around the mouth were both 8%, the rate of pigmentary alterations was 6%, and the rate of mortality was 3%, “but those cases were prior to the introduction of antibiotics in the 1940s,” she emphasized. “Children, in general, are not dying of Mycoplasma-associated rash and mucositis.”

A study published on July 25, 2015 in Pediatrics (doi:10.1542/peds.2015-0278) described an outbreak of eight Mycoplasma-associated SJS cases at Children’s Hospital Colorado, Aurora, that occurred over a 2-month period. In a case-control analysis comparing hospitalized SJS cases with and without evidence of M. pneumoniae infection, the researchers found that cases of Mycoplasma-associated SJS were significantly more likely to have pneumonia (odds ratio, 10), preceding respiratory symptoms (OR, 30), an erythrocyte sedimentation rate of greater than 35 mg/dL (OR, 22.8), and fewer than three affected skin sites (OR, 4.5).

Dr. Mathes was part of a research team that published diagnostic criteria for MIRM. These include less than 10% body surface area affected, involvement of two or more mucosal sites, the presence of few vesiculobullous lesions/scattered atypical targets with or without targetoid lesions, and clinical and laboratory evidence of atypical pneumonia (J Am Acad Dermatol. 2015;72:239-45).

“Rare cases can have more body surface area detachment, or no rash at all,” she said.

Existing tests for Mycoplasma infection are “not that great,” she continued. “It depends on the manufacturer and what is used as the gold standard.” IgM and IgG have specificity ranges from 25% to 100% and sensitivity ranges from 52% to 100%, she said, while polymerase chain reaction is rapidly becoming the gold standard. “That is usually from a nasal wash or bronchoalveolar lavage. It is very sensitive, but is almost too sensitive, because you can actually shed bacteria in your nasal pharynx for 4 months after an infection. That can lead to false positives.”

At UCSF, Dr. Mathes and her colleagues tend to treat MIRM cases with azithromycin followed by supportive care. “We occasionally use steroids but rarely use IVIG [intravenous immunoglobulin],” she said.

Dr. Mathes reported having no financial disclosures.

[email protected]

Intravenous administration of cyclosporine just before percutaneous coronary intervention was not associated with a reduced risk of adverse outcomes at 1 year in a study of patients who underwent the procedure after experiencing an acute anterior ST-segment elevation myocardial infarction.

Findings from the multicenter, randomized study, known as the Does Cyclosporine Improve Clinical Outcome in ST Elevation Myocardial Infarction Patients (CIRCUS) trial, were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1505489).

For the phase 3 trial, Dr. Michel Ovize and associates investigated whether a single intravenous dose of cyclosporine, administered just before PCI, would improve clinical outcomes and prevent left adverse left ventricular modeling at 1 year in patients with anterior STEMI.

“Growing evidence from experimental studies and small-size proof-of-concept clinical trials shows that reperfusion injury contributes greatly to the final infarct size,” the researchers wrote. “Preclinical studies indicate that the opening of the mitochondrial permeability transition pore (PTP) in the inner mitochondrial membrane plays a major role in reperfusion injury. Either genetic or pharmacologic inhibition of cyclophilin D, a major component of the PTP, reduces the severity of myocardial reperfusion injury.”

Dr. Ovize of the Clinical Investigation Center of Lyon, France, and his associates chose to test cyclosporine, a pharmacologic inhibitor of cyclophilin D, after a phase 2 trial conducted by the same researchers found that administration of cyclosporine immediately before PCI reduced the myocardial infarct size in patients with STEMI. In CIRCUS, which was conducted from April 2011 through February 2014 at 42 hospitals in three countries, 475 patients with an acute anterior STEMI who were undergoing PCI within 12 hours of symptom onset received IV cyclosporine at a dose of 2.5 mg/kg of body weight, while 495 patients received placebo. The primary outcome was a composite of death from any cause, worsening of heart failure during initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year.

At baseline, the mean age of patients was 60 years, 82% were men, and their mean body mass index was 27 kg/m². One year of follow-up data was available for 395 patients in the cyclosporine group and 396 in the placebo group. The researchers found no significant differences between the two groups in the proportion who experienced a primary outcome event (59% in the cyclosporine group vs. 58% in the control group) or in the rate of all-cause mortality (7.1% vs. 6.6%).

There were also no differences between groups in the rate of initial worsening of heart failure or rehospitalization for heart failure at 1 year (22.8% vs. 22.7%). In addition, a similar proportion of patients in both groups experienced adverse left ventricular remodeling (42.8% vs. 40.7%).

“One important limitation of this trial is that we included in the primary outcome the nonclinical outcome of adverse left ventricular remodeling, which accounted for a substantial proportion of the primary outcome rate,” the researchers wrote. “Left ventricular remodeling is a surrogate outcome – one that was not successfully measured in 17.4% of the trial participants. However, in secondary analyses, no beneficial effect of cyclosporine was detected on any of the hard clinical outcomes.”

They went on to note that nearly one of four patients in CIRCUS died or was hospitalized for heart failure, “a reminder of the substantial residual risk in this population and the persistent room for improvement in the medical treatment of high-risk patients with STEMI. The results of this trial do not challenge the concept that reperfusion injury is clinically important. Recent phase 2 trials that have used either ischemic or pharmacologic postconditioning suggest that interventions applied at the time of reperfusion can limit infarct size and improve functional recovery. Their effect on clinical outcome remains to be determined in phase 3 studies.”

The study was supported by grants from the French Ministry of Health and Research National Program and NeuroVive Pharmaceutical. Dr. Ovize disclosed that he is a consultant for NueroVive Pharmaceutical.

[email protected]

Intravenous administration of cyclosporine just before percutaneous coronary intervention was not associated with a reduced risk of adverse outcomes at 1 year in a study of patients who underwent the procedure after experiencing an acute anterior ST-segment elevation myocardial infarction.

Findings from the multicenter, randomized study, known as the Does Cyclosporine Improve Clinical Outcome in ST Elevation Myocardial Infarction Patients (CIRCUS) trial, were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1505489).

For the phase 3 trial, Dr. Michel Ovize and associates investigated whether a single intravenous dose of cyclosporine, administered just before PCI, would improve clinical outcomes and prevent left adverse left ventricular modeling at 1 year in patients with anterior STEMI.

“Growing evidence from experimental studies and small-size proof-of-concept clinical trials shows that reperfusion injury contributes greatly to the final infarct size,” the researchers wrote. “Preclinical studies indicate that the opening of the mitochondrial permeability transition pore (PTP) in the inner mitochondrial membrane plays a major role in reperfusion injury. Either genetic or pharmacologic inhibition of cyclophilin D, a major component of the PTP, reduces the severity of myocardial reperfusion injury.”

Dr. Ovize of the Clinical Investigation Center of Lyon, France, and his associates chose to test cyclosporine, a pharmacologic inhibitor of cyclophilin D, after a phase 2 trial conducted by the same researchers found that administration of cyclosporine immediately before PCI reduced the myocardial infarct size in patients with STEMI. In CIRCUS, which was conducted from April 2011 through February 2014 at 42 hospitals in three countries, 475 patients with an acute anterior STEMI who were undergoing PCI within 12 hours of symptom onset received IV cyclosporine at a dose of 2.5 mg/kg of body weight, while 495 patients received placebo. The primary outcome was a composite of death from any cause, worsening of heart failure during initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year.

At baseline, the mean age of patients was 60 years, 82% were men, and their mean body mass index was 27 kg/m². One year of follow-up data was available for 395 patients in the cyclosporine group and 396 in the placebo group. The researchers found no significant differences between the two groups in the proportion who experienced a primary outcome event (59% in the cyclosporine group vs. 58% in the control group) or in the rate of all-cause mortality (7.1% vs. 6.6%).

There were also no differences between groups in the rate of initial worsening of heart failure or rehospitalization for heart failure at 1 year (22.8% vs. 22.7%). In addition, a similar proportion of patients in both groups experienced adverse left ventricular remodeling (42.8% vs. 40.7%).

“One important limitation of this trial is that we included in the primary outcome the nonclinical outcome of adverse left ventricular remodeling, which accounted for a substantial proportion of the primary outcome rate,” the researchers wrote. “Left ventricular remodeling is a surrogate outcome – one that was not successfully measured in 17.4% of the trial participants. However, in secondary analyses, no beneficial effect of cyclosporine was detected on any of the hard clinical outcomes.”

They went on to note that nearly one of four patients in CIRCUS died or was hospitalized for heart failure, “a reminder of the substantial residual risk in this population and the persistent room for improvement in the medical treatment of high-risk patients with STEMI. The results of this trial do not challenge the concept that reperfusion injury is clinically important. Recent phase 2 trials that have used either ischemic or pharmacologic postconditioning suggest that interventions applied at the time of reperfusion can limit infarct size and improve functional recovery. Their effect on clinical outcome remains to be determined in phase 3 studies.”

The study was supported by grants from the French Ministry of Health and Research National Program and NeuroVive Pharmaceutical. Dr. Ovize disclosed that he is a consultant for NueroVive Pharmaceutical.

[email protected]

Intravenous administration of cyclosporine just before percutaneous coronary intervention was not associated with a reduced risk of adverse outcomes at 1 year in a study of patients who underwent the procedure after experiencing an acute anterior ST-segment elevation myocardial infarction.

Findings from the multicenter, randomized study, known as the Does Cyclosporine Improve Clinical Outcome in ST Elevation Myocardial Infarction Patients (CIRCUS) trial, were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1505489).

For the phase 3 trial, Dr. Michel Ovize and associates investigated whether a single intravenous dose of cyclosporine, administered just before PCI, would improve clinical outcomes and prevent left adverse left ventricular modeling at 1 year in patients with anterior STEMI.

“Growing evidence from experimental studies and small-size proof-of-concept clinical trials shows that reperfusion injury contributes greatly to the final infarct size,” the researchers wrote. “Preclinical studies indicate that the opening of the mitochondrial permeability transition pore (PTP) in the inner mitochondrial membrane plays a major role in reperfusion injury. Either genetic or pharmacologic inhibition of cyclophilin D, a major component of the PTP, reduces the severity of myocardial reperfusion injury.”

Dr. Ovize of the Clinical Investigation Center of Lyon, France, and his associates chose to test cyclosporine, a pharmacologic inhibitor of cyclophilin D, after a phase 2 trial conducted by the same researchers found that administration of cyclosporine immediately before PCI reduced the myocardial infarct size in patients with STEMI. In CIRCUS, which was conducted from April 2011 through February 2014 at 42 hospitals in three countries, 475 patients with an acute anterior STEMI who were undergoing PCI within 12 hours of symptom onset received IV cyclosporine at a dose of 2.5 mg/kg of body weight, while 495 patients received placebo. The primary outcome was a composite of death from any cause, worsening of heart failure during initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year.

At baseline, the mean age of patients was 60 years, 82% were men, and their mean body mass index was 27 kg/m². One year of follow-up data was available for 395 patients in the cyclosporine group and 396 in the placebo group. The researchers found no significant differences between the two groups in the proportion who experienced a primary outcome event (59% in the cyclosporine group vs. 58% in the control group) or in the rate of all-cause mortality (7.1% vs. 6.6%).

There were also no differences between groups in the rate of initial worsening of heart failure or rehospitalization for heart failure at 1 year (22.8% vs. 22.7%). In addition, a similar proportion of patients in both groups experienced adverse left ventricular remodeling (42.8% vs. 40.7%).

“One important limitation of this trial is that we included in the primary outcome the nonclinical outcome of adverse left ventricular remodeling, which accounted for a substantial proportion of the primary outcome rate,” the researchers wrote. “Left ventricular remodeling is a surrogate outcome – one that was not successfully measured in 17.4% of the trial participants. However, in secondary analyses, no beneficial effect of cyclosporine was detected on any of the hard clinical outcomes.”

They went on to note that nearly one of four patients in CIRCUS died or was hospitalized for heart failure, “a reminder of the substantial residual risk in this population and the persistent room for improvement in the medical treatment of high-risk patients with STEMI. The results of this trial do not challenge the concept that reperfusion injury is clinically important. Recent phase 2 trials that have used either ischemic or pharmacologic postconditioning suggest that interventions applied at the time of reperfusion can limit infarct size and improve functional recovery. Their effect on clinical outcome remains to be determined in phase 3 studies.”

The study was supported by grants from the French Ministry of Health and Research National Program and NeuroVive Pharmaceutical. Dr. Ovize disclosed that he is a consultant for NueroVive Pharmaceutical.

[email protected]

PARK CITY, UTAH – When an otherwise healthy 75-year-old patient presents with persistent pruritus as the chief complaint, the first thing to do is rule out specific dermatologic disorders, according to Dr. Kevin C. Wang.

“Thankfully, most of the patients complaining of pruritus have visible dermatoses,” Dr. Wang said at the annual meeting of the Pacific Dermatologic Association. “According to a review of more than 150 elderly patients in the outpatient setting who presented with a chief complaint of persistent pruritus, the five most common diagnoses were atopic-like dermatosis, lichen simplex chronicus/prurigo nodularis, subacute prurigo, transient acantholytic dermatosis, and neuropathic disease.”

Treatment directed at the primary element triggering the pruritus is most effective. “The best treatment for these patients will likely involve multiple modalities/combination therapy, as there is no one major pathway pathophysiologically,” said Dr. Wang of the department of dermatology at Stanford (Calif.) University and the Palo Alto VA Hospital.

“Pruritus can be quite debilitating,” said Dr. Wang, who also is the principal investigator of a research lab at Stanford. “I have not met an itchy patient who has said that it has not ruined their lives somehow: whether it’s their work, social life, things that they like to do. Also, many elderly veterans are already quite debilitated functionally in the first place, so it is a huge problem.”

An estimated 2% of all dermatology visits are for pruritus, “but it’s probably more than that, because a lot of those complaints don’t come up until you ask the patient in person,” he said. “This issue is also important because as physicians we really don’t have any specific ‘itch blockers.’ We just use drugs developed for other conditions that happen to work, but not often enough.”

Dr. Wang then went on to share some of the concepts raised in a 2011 article by Dr. Timothy G. Berger and Dr. Martin Steinhoff of the University of California, San Francisco. They suggested that pruritic conditions afflicting the elderly are the results of a variety of age-related changes they termed “eruptions of senescence” (Semin Cutan Med Surg. 2011;30[2]:113-7).

As people age, Dr. Wang said, the immune system “becomes much more proinflammatory, including significant aberration of T- and B-cell populations. More importantly, the immune system develops an allergic Th2 phenotype, where you have loss of naive T cells as the immune repertoire becomes populated with ‘committed’ T and B cells, and a preponderance of Th2 cells. This means you have an impaired ability to respond to new antigens, with a greater propensity for autoimmune responses, and lingering, low-grade inflammation.”

Aging also brings structural changes to the epidermal barrier, he continued. Specifically, the surface pH becomes less acidic. This is problematic because enzymes that are required to process lipids function best at acidic pH. “You also have a reduction in the rate of barrier repair, and decreased production of filaggrin and aquaporin-3,” he said. “In combination, this impaired barrier has two direct consequences: Barrier failure may lead to increased development of contact dermatitis, because the impaired barrier may not prevent penetration of potential antigens into the epidermis, and when the barrier fails, the cytokines released to induce barrier repair are proinflammatory, resulting in dermatitis.”

He reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – When an otherwise healthy 75-year-old patient presents with persistent pruritus as the chief complaint, the first thing to do is rule out specific dermatologic disorders, according to Dr. Kevin C. Wang.

“Thankfully, most of the patients complaining of pruritus have visible dermatoses,” Dr. Wang said at the annual meeting of the Pacific Dermatologic Association. “According to a review of more than 150 elderly patients in the outpatient setting who presented with a chief complaint of persistent pruritus, the five most common diagnoses were atopic-like dermatosis, lichen simplex chronicus/prurigo nodularis, subacute prurigo, transient acantholytic dermatosis, and neuropathic disease.”

Treatment directed at the primary element triggering the pruritus is most effective. “The best treatment for these patients will likely involve multiple modalities/combination therapy, as there is no one major pathway pathophysiologically,” said Dr. Wang of the department of dermatology at Stanford (Calif.) University and the Palo Alto VA Hospital.

“Pruritus can be quite debilitating,” said Dr. Wang, who also is the principal investigator of a research lab at Stanford. “I have not met an itchy patient who has said that it has not ruined their lives somehow: whether it’s their work, social life, things that they like to do. Also, many elderly veterans are already quite debilitated functionally in the first place, so it is a huge problem.”

An estimated 2% of all dermatology visits are for pruritus, “but it’s probably more than that, because a lot of those complaints don’t come up until you ask the patient in person,” he said. “This issue is also important because as physicians we really don’t have any specific ‘itch blockers.’ We just use drugs developed for other conditions that happen to work, but not often enough.”

Dr. Wang then went on to share some of the concepts raised in a 2011 article by Dr. Timothy G. Berger and Dr. Martin Steinhoff of the University of California, San Francisco. They suggested that pruritic conditions afflicting the elderly are the results of a variety of age-related changes they termed “eruptions of senescence” (Semin Cutan Med Surg. 2011;30[2]:113-7).

As people age, Dr. Wang said, the immune system “becomes much more proinflammatory, including significant aberration of T- and B-cell populations. More importantly, the immune system develops an allergic Th2 phenotype, where you have loss of naive T cells as the immune repertoire becomes populated with ‘committed’ T and B cells, and a preponderance of Th2 cells. This means you have an impaired ability to respond to new antigens, with a greater propensity for autoimmune responses, and lingering, low-grade inflammation.”

Aging also brings structural changes to the epidermal barrier, he continued. Specifically, the surface pH becomes less acidic. This is problematic because enzymes that are required to process lipids function best at acidic pH. “You also have a reduction in the rate of barrier repair, and decreased production of filaggrin and aquaporin-3,” he said. “In combination, this impaired barrier has two direct consequences: Barrier failure may lead to increased development of contact dermatitis, because the impaired barrier may not prevent penetration of potential antigens into the epidermis, and when the barrier fails, the cytokines released to induce barrier repair are proinflammatory, resulting in dermatitis.”

He reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – When an otherwise healthy 75-year-old patient presents with persistent pruritus as the chief complaint, the first thing to do is rule out specific dermatologic disorders, according to Dr. Kevin C. Wang.

“Thankfully, most of the patients complaining of pruritus have visible dermatoses,” Dr. Wang said at the annual meeting of the Pacific Dermatologic Association. “According to a review of more than 150 elderly patients in the outpatient setting who presented with a chief complaint of persistent pruritus, the five most common diagnoses were atopic-like dermatosis, lichen simplex chronicus/prurigo nodularis, subacute prurigo, transient acantholytic dermatosis, and neuropathic disease.”

Treatment directed at the primary element triggering the pruritus is most effective. “The best treatment for these patients will likely involve multiple modalities/combination therapy, as there is no one major pathway pathophysiologically,” said Dr. Wang of the department of dermatology at Stanford (Calif.) University and the Palo Alto VA Hospital.

“Pruritus can be quite debilitating,” said Dr. Wang, who also is the principal investigator of a research lab at Stanford. “I have not met an itchy patient who has said that it has not ruined their lives somehow: whether it’s their work, social life, things that they like to do. Also, many elderly veterans are already quite debilitated functionally in the first place, so it is a huge problem.”

An estimated 2% of all dermatology visits are for pruritus, “but it’s probably more than that, because a lot of those complaints don’t come up until you ask the patient in person,” he said. “This issue is also important because as physicians we really don’t have any specific ‘itch blockers.’ We just use drugs developed for other conditions that happen to work, but not often enough.”

Dr. Wang then went on to share some of the concepts raised in a 2011 article by Dr. Timothy G. Berger and Dr. Martin Steinhoff of the University of California, San Francisco. They suggested that pruritic conditions afflicting the elderly are the results of a variety of age-related changes they termed “eruptions of senescence” (Semin Cutan Med Surg. 2011;30[2]:113-7).

As people age, Dr. Wang said, the immune system “becomes much more proinflammatory, including significant aberration of T- and B-cell populations. More importantly, the immune system develops an allergic Th2 phenotype, where you have loss of naive T cells as the immune repertoire becomes populated with ‘committed’ T and B cells, and a preponderance of Th2 cells. This means you have an impaired ability to respond to new antigens, with a greater propensity for autoimmune responses, and lingering, low-grade inflammation.”

Aging also brings structural changes to the epidermal barrier, he continued. Specifically, the surface pH becomes less acidic. This is problematic because enzymes that are required to process lipids function best at acidic pH. “You also have a reduction in the rate of barrier repair, and decreased production of filaggrin and aquaporin-3,” he said. “In combination, this impaired barrier has two direct consequences: Barrier failure may lead to increased development of contact dermatitis, because the impaired barrier may not prevent penetration of potential antigens into the epidermis, and when the barrier fails, the cytokines released to induce barrier repair are proinflammatory, resulting in dermatitis.”

He reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – In her practice as a pediatric dermatologist, Dr. Sheryll L. Vanderhooft sees her share of children who present with molluscum contagiosum and warts. At the annual meeting of the Pacific Dermatologic Association, she shared her approach to caring for patients who present with these two common conditions.

The root cause of molluscum contagiosum is a poxvirus infection that spreads by skin-to-skin contact. It takes an average of 6 months to 2 years for the host immune response to occur. “During that time parents panic and some need a lot of hand-holding,” said Dr. Vanderhooft, professor of pediatric dermatology at the University of Utah School of Medicine, Salt Lake City. “They seek treatment primarily due to associated dermatitis triggered or exacerbated by the virus. There’s also the risk of spreading the condition to other children and the stigma of visible lesions.”

No FDA-approved therapies for molluscum contagiosum currently exist. “There are many options, but none of them are guaranteed to hasten resolution,” she said. “This is a very important point to deliver to parents before you start trying to do a lot of therapy.” Common treatment options are cryotherapy and cantharadin destruction, curettage, treatment with topical imiquimod or retinoids, oral cimetidine, and injections of Candida antigen.

According to two retrospective studies of Candida antigen injection, complete clearance occurred in 56% of patients after an average of 3 treatments, while partial clearance occurred in 28-38% of patients after an average of 4 treatments (Pediatr. Dermatol. 2008; 25:189-92 and Pediatr. Dermatol 2011; 28:254-8). The main side effect was local pain from the injections.

Courtesy Dr. Sarah Cipriano

Antiviral and antitumor effects are seen with imiquimod cream through activation of the innate immunity and upregulation of cytokines, such as interferon-alpha, Dr. Vanderhooft said. It’s FDA approved for genital and perianal warts in patients older than 12 years of age, as well as for actinic keratosis, superficial basal cell carcinoma, and antiviral-resistant HSV in patients older than 12 years of age. In a prospective study, researchers compared imiquimod cream 5 times per week up to 16 weeks, with cryotherapy for the treatment of molluscum contagiosum in children (Pediatr. Dermatol. 2010; 27[4]:388-94). More than half of patients (60%) achieved clearance by week 6 and 92% achieved clearance by week 12. There were no relapses observed at six months. “Liquid nitrogen cleared the lesions faster, but caused more post-inflammatory dyspigmentation, and there were a few relapses in this group,” Dr. Vanderhooft said.

The downside to imiquimod treatment is that it requires prolonged use, it’s expensive, “and a lot of insurance companies will not pay for it because it’s not FDA approved for young children,” she said. “It can also cause irritant dermatitis, which is a difficult problem when you already have a kid who may be atopic and you’re trying to treat molluscum.” Also, according to the package insert for Aldara cream, imiquimod administered three times per week for 16 weeks was not shown to be superior to vehicle alone in two randomized, controlled trials that were completed in 2006 but never published. There were 323 children in one study, with complete clearance at 18 weeks in 24% of children treated with imiquimod, compared with 26% of children treated with vehicle alone. There were 379 in the second study with complete clearance in 24% and 28% of children, respectively.

Children who were treated with imiquimod in these two studies were more likely to experience application site reactions, otitis media, and conjunctivitis. In addition, a pharmacokinetic study of 22 children with molluscum involving at least 10% of body surface area showed systemically detectable drug levels after single and multiple doses 3 times a week for 4 weeks. The findings from these three studies led to changes in the FDA approved package insert in 2008. Section 1.4 of the “indications and usage” section of the package insert now reads: “Aldara cream has been evaluated in children ages 2012 years with molluscum contagiosum and these studies failed to demonstrate efficacy.” With that in mind, Dr. Vanderhooft’s recommendation “is to either stop prescribing it in children or prescribe it once daily or twice daily as tolerated, not every other day.”

While molluscum contagiosum is caused by a poxvirus, warts are growths on the skin caused by infection with human papillomavirus (HPV). On average, 75% of children will develop immunity to HPV within 3 years, “whether you do nothing, or whether you try to treat it,” she said. “Parents seek treatment when they are large, spreading, or causing social stigma. There are many treatment options, but none are guaranteed to hasten resolution. This needs to be driven home to patients when you’re counseling them.” Numerous treatment options exist, ranging from destruction with cryotherapy and pulsed-dye laser to salicylic acid and various topical or injectable agents. The only FDA-approved option is imiquimod cream, which is approved for genital and perianal warts only in patients 12 years of age and older.

In Dr. Vanderhooft’s experience, Candida antigen injections benefit some patients. After injection of 0.3 mL of Candida antigen into 1 or 2 warts at monthly intervals, researchers in one study observed complete clearance in 87% of patients after an average of 3.5 treatments, while 7% demonstrated no improvement after an average of 3.75 treatments (Pediatr. Dermatol. 2008; 25: 189-92).

Zinc supplementation is another option, she said. In a randomized trial, researchers who evaluated oral zinc supplementation versus placebo for two months found complete clearance in 20 out of 23 patients in the treatment group (87%), compared with none of the 20 patients in the placebo group (Br. J. Dermatol; 2002; 146[3]:423-31). All patients in the zinc group reported nausea. “That’s what has limited zinc therapy in my patient population,” Dr. Vanderhooft said.

In a more recent study, researchers conducted a placebo-controlled study of zinc sulfate 10 mg/kg per day up to 600 mg per day for up to two months (J. Am. Acad. Dermatol. 2009; 60[4]:706-8). Complete clearance of all warts was achieved in 78% of patients in the treatment group, compared with 13% in the placebo group. No recurrence of warts was observed at the six-month follow-up.

Topical 5-FU for warts has also been evaluated. One study of once or twice daily application of 5-FU under occlusion for 6 weeks demonstrated improvement in 88% of patients, including 13% with complete clearance (Br. J. Dermatol; 2011; 165[2]:233-46). No blood levels of the drug were detected. “It’s thought to be safe and well-tolerated, but over-the-counter salicylic acid has better efficacy and is quite a bit cheaper,” Dr. Vanderhooft said.

Another strategy for recalcitrant warts involves administration of squaric acid dibutyl ester. In a recent retrospective chart review conducted over a 10.5-year period, researchers evaluated 72 children with recalcitrant warts who had failed therapy with multiple agents and were followed for a period of 6 months to 11 years (Pediatr. Dermatol. 2015; 32:85-90). The protocol involved sensitizing the children to 2% squaric acid dibutyl ester (SADBE). The treatment then started two weeks later, with 0.4% SADBE applied 3 times per week initially, with an extra day added per week as tolerated to reach daily use if possible. The researchers found that 40 of the 48 (83%) patients in whom treatment outcomes could be obtained reported complete resolution of their warts. Seventy percent of patients used a maximum concentration of 0.4% SADBE and 60% of patients reported no adverse effects. The average time to reduction in size of warts was 2.6 months after sensitization, and treatment continued for a mean of 8 months.

Dr. Vanderhooft reported having no financial disclosures.

PARK CITY, UTAH – In her practice as a pediatric dermatologist, Dr. Sheryll L. Vanderhooft sees her share of children who present with molluscum contagiosum and warts. At the annual meeting of the Pacific Dermatologic Association, she shared her approach to caring for patients who present with these two common conditions.

The root cause of molluscum contagiosum is a poxvirus infection that spreads by skin-to-skin contact. It takes an average of 6 months to 2 years for the host immune response to occur. “During that time parents panic and some need a lot of hand-holding,” said Dr. Vanderhooft, professor of pediatric dermatology at the University of Utah School of Medicine, Salt Lake City. “They seek treatment primarily due to associated dermatitis triggered or exacerbated by the virus. There’s also the risk of spreading the condition to other children and the stigma of visible lesions.”

No FDA-approved therapies for molluscum contagiosum currently exist. “There are many options, but none of them are guaranteed to hasten resolution,” she said. “This is a very important point to deliver to parents before you start trying to do a lot of therapy.” Common treatment options are cryotherapy and cantharadin destruction, curettage, treatment with topical imiquimod or retinoids, oral cimetidine, and injections of Candida antigen.

According to two retrospective studies of Candida antigen injection, complete clearance occurred in 56% of patients after an average of 3 treatments, while partial clearance occurred in 28-38% of patients after an average of 4 treatments (Pediatr. Dermatol. 2008; 25:189-92 and Pediatr. Dermatol 2011; 28:254-8). The main side effect was local pain from the injections.

Courtesy Dr. Sarah Cipriano

Antiviral and antitumor effects are seen with imiquimod cream through activation of the innate immunity and upregulation of cytokines, such as interferon-alpha, Dr. Vanderhooft said. It’s FDA approved for genital and perianal warts in patients older than 12 years of age, as well as for actinic keratosis, superficial basal cell carcinoma, and antiviral-resistant HSV in patients older than 12 years of age. In a prospective study, researchers compared imiquimod cream 5 times per week up to 16 weeks, with cryotherapy for the treatment of molluscum contagiosum in children (Pediatr. Dermatol. 2010; 27[4]:388-94). More than half of patients (60%) achieved clearance by week 6 and 92% achieved clearance by week 12. There were no relapses observed at six months. “Liquid nitrogen cleared the lesions faster, but caused more post-inflammatory dyspigmentation, and there were a few relapses in this group,” Dr. Vanderhooft said.

The downside to imiquimod treatment is that it requires prolonged use, it’s expensive, “and a lot of insurance companies will not pay for it because it’s not FDA approved for young children,” she said. “It can also cause irritant dermatitis, which is a difficult problem when you already have a kid who may be atopic and you’re trying to treat molluscum.” Also, according to the package insert for Aldara cream, imiquimod administered three times per week for 16 weeks was not shown to be superior to vehicle alone in two randomized, controlled trials that were completed in 2006 but never published. There were 323 children in one study, with complete clearance at 18 weeks in 24% of children treated with imiquimod, compared with 26% of children treated with vehicle alone. There were 379 in the second study with complete clearance in 24% and 28% of children, respectively.

Children who were treated with imiquimod in these two studies were more likely to experience application site reactions, otitis media, and conjunctivitis. In addition, a pharmacokinetic study of 22 children with molluscum involving at least 10% of body surface area showed systemically detectable drug levels after single and multiple doses 3 times a week for 4 weeks. The findings from these three studies led to changes in the FDA approved package insert in 2008. Section 1.4 of the “indications and usage” section of the package insert now reads: “Aldara cream has been evaluated in children ages 2012 years with molluscum contagiosum and these studies failed to demonstrate efficacy.” With that in mind, Dr. Vanderhooft’s recommendation “is to either stop prescribing it in children or prescribe it once daily or twice daily as tolerated, not every other day.”

While molluscum contagiosum is caused by a poxvirus, warts are growths on the skin caused by infection with human papillomavirus (HPV). On average, 75% of children will develop immunity to HPV within 3 years, “whether you do nothing, or whether you try to treat it,” she said. “Parents seek treatment when they are large, spreading, or causing social stigma. There are many treatment options, but none are guaranteed to hasten resolution. This needs to be driven home to patients when you’re counseling them.” Numerous treatment options exist, ranging from destruction with cryotherapy and pulsed-dye laser to salicylic acid and various topical or injectable agents. The only FDA-approved option is imiquimod cream, which is approved for genital and perianal warts only in patients 12 years of age and older.

In Dr. Vanderhooft’s experience, Candida antigen injections benefit some patients. After injection of 0.3 mL of Candida antigen into 1 or 2 warts at monthly intervals, researchers in one study observed complete clearance in 87% of patients after an average of 3.5 treatments, while 7% demonstrated no improvement after an average of 3.75 treatments (Pediatr. Dermatol. 2008; 25: 189-92).

Zinc supplementation is another option, she said. In a randomized trial, researchers who evaluated oral zinc supplementation versus placebo for two months found complete clearance in 20 out of 23 patients in the treatment group (87%), compared with none of the 20 patients in the placebo group (Br. J. Dermatol; 2002; 146[3]:423-31). All patients in the zinc group reported nausea. “That’s what has limited zinc therapy in my patient population,” Dr. Vanderhooft said.

In a more recent study, researchers conducted a placebo-controlled study of zinc sulfate 10 mg/kg per day up to 600 mg per day for up to two months (J. Am. Acad. Dermatol. 2009; 60[4]:706-8). Complete clearance of all warts was achieved in 78% of patients in the treatment group, compared with 13% in the placebo group. No recurrence of warts was observed at the six-month follow-up.

Topical 5-FU for warts has also been evaluated. One study of once or twice daily application of 5-FU under occlusion for 6 weeks demonstrated improvement in 88% of patients, including 13% with complete clearance (Br. J. Dermatol; 2011; 165[2]:233-46). No blood levels of the drug were detected. “It’s thought to be safe and well-tolerated, but over-the-counter salicylic acid has better efficacy and is quite a bit cheaper,” Dr. Vanderhooft said.

Another strategy for recalcitrant warts involves administration of squaric acid dibutyl ester. In a recent retrospective chart review conducted over a 10.5-year period, researchers evaluated 72 children with recalcitrant warts who had failed therapy with multiple agents and were followed for a period of 6 months to 11 years (Pediatr. Dermatol. 2015; 32:85-90). The protocol involved sensitizing the children to 2% squaric acid dibutyl ester (SADBE). The treatment then started two weeks later, with 0.4% SADBE applied 3 times per week initially, with an extra day added per week as tolerated to reach daily use if possible. The researchers found that 40 of the 48 (83%) patients in whom treatment outcomes could be obtained reported complete resolution of their warts. Seventy percent of patients used a maximum concentration of 0.4% SADBE and 60% of patients reported no adverse effects. The average time to reduction in size of warts was 2.6 months after sensitization, and treatment continued for a mean of 8 months.

Dr. Vanderhooft reported having no financial disclosures.

PARK CITY, UTAH – In her practice as a pediatric dermatologist, Dr. Sheryll L. Vanderhooft sees her share of children who present with molluscum contagiosum and warts. At the annual meeting of the Pacific Dermatologic Association, she shared her approach to caring for patients who present with these two common conditions.

The root cause of molluscum contagiosum is a poxvirus infection that spreads by skin-to-skin contact. It takes an average of 6 months to 2 years for the host immune response to occur. “During that time parents panic and some need a lot of hand-holding,” said Dr. Vanderhooft, professor of pediatric dermatology at the University of Utah School of Medicine, Salt Lake City. “They seek treatment primarily due to associated dermatitis triggered or exacerbated by the virus. There’s also the risk of spreading the condition to other children and the stigma of visible lesions.”

No FDA-approved therapies for molluscum contagiosum currently exist. “There are many options, but none of them are guaranteed to hasten resolution,” she said. “This is a very important point to deliver to parents before you start trying to do a lot of therapy.” Common treatment options are cryotherapy and cantharadin destruction, curettage, treatment with topical imiquimod or retinoids, oral cimetidine, and injections of Candida antigen.

According to two retrospective studies of Candida antigen injection, complete clearance occurred in 56% of patients after an average of 3 treatments, while partial clearance occurred in 28-38% of patients after an average of 4 treatments (Pediatr. Dermatol. 2008; 25:189-92 and Pediatr. Dermatol 2011; 28:254-8). The main side effect was local pain from the injections.

Courtesy Dr. Sarah Cipriano

Antiviral and antitumor effects are seen with imiquimod cream through activation of the innate immunity and upregulation of cytokines, such as interferon-alpha, Dr. Vanderhooft said. It’s FDA approved for genital and perianal warts in patients older than 12 years of age, as well as for actinic keratosis, superficial basal cell carcinoma, and antiviral-resistant HSV in patients older than 12 years of age. In a prospective study, researchers compared imiquimod cream 5 times per week up to 16 weeks, with cryotherapy for the treatment of molluscum contagiosum in children (Pediatr. Dermatol. 2010; 27[4]:388-94). More than half of patients (60%) achieved clearance by week 6 and 92% achieved clearance by week 12. There were no relapses observed at six months. “Liquid nitrogen cleared the lesions faster, but caused more post-inflammatory dyspigmentation, and there were a few relapses in this group,” Dr. Vanderhooft said.

The downside to imiquimod treatment is that it requires prolonged use, it’s expensive, “and a lot of insurance companies will not pay for it because it’s not FDA approved for young children,” she said. “It can also cause irritant dermatitis, which is a difficult problem when you already have a kid who may be atopic and you’re trying to treat molluscum.” Also, according to the package insert for Aldara cream, imiquimod administered three times per week for 16 weeks was not shown to be superior to vehicle alone in two randomized, controlled trials that were completed in 2006 but never published. There were 323 children in one study, with complete clearance at 18 weeks in 24% of children treated with imiquimod, compared with 26% of children treated with vehicle alone. There were 379 in the second study with complete clearance in 24% and 28% of children, respectively.

Children who were treated with imiquimod in these two studies were more likely to experience application site reactions, otitis media, and conjunctivitis. In addition, a pharmacokinetic study of 22 children with molluscum involving at least 10% of body surface area showed systemically detectable drug levels after single and multiple doses 3 times a week for 4 weeks. The findings from these three studies led to changes in the FDA approved package insert in 2008. Section 1.4 of the “indications and usage” section of the package insert now reads: “Aldara cream has been evaluated in children ages 2012 years with molluscum contagiosum and these studies failed to demonstrate efficacy.” With that in mind, Dr. Vanderhooft’s recommendation “is to either stop prescribing it in children or prescribe it once daily or twice daily as tolerated, not every other day.”

While molluscum contagiosum is caused by a poxvirus, warts are growths on the skin caused by infection with human papillomavirus (HPV). On average, 75% of children will develop immunity to HPV within 3 years, “whether you do nothing, or whether you try to treat it,” she said. “Parents seek treatment when they are large, spreading, or causing social stigma. There are many treatment options, but none are guaranteed to hasten resolution. This needs to be driven home to patients when you’re counseling them.” Numerous treatment options exist, ranging from destruction with cryotherapy and pulsed-dye laser to salicylic acid and various topical or injectable agents. The only FDA-approved option is imiquimod cream, which is approved for genital and perianal warts only in patients 12 years of age and older.

In Dr. Vanderhooft’s experience, Candida antigen injections benefit some patients. After injection of 0.3 mL of Candida antigen into 1 or 2 warts at monthly intervals, researchers in one study observed complete clearance in 87% of patients after an average of 3.5 treatments, while 7% demonstrated no improvement after an average of 3.75 treatments (Pediatr. Dermatol. 2008; 25: 189-92).

Zinc supplementation is another option, she said. In a randomized trial, researchers who evaluated oral zinc supplementation versus placebo for two months found complete clearance in 20 out of 23 patients in the treatment group (87%), compared with none of the 20 patients in the placebo group (Br. J. Dermatol; 2002; 146[3]:423-31). All patients in the zinc group reported nausea. “That’s what has limited zinc therapy in my patient population,” Dr. Vanderhooft said.

In a more recent study, researchers conducted a placebo-controlled study of zinc sulfate 10 mg/kg per day up to 600 mg per day for up to two months (J. Am. Acad. Dermatol. 2009; 60[4]:706-8). Complete clearance of all warts was achieved in 78% of patients in the treatment group, compared with 13% in the placebo group. No recurrence of warts was observed at the six-month follow-up.

Topical 5-FU for warts has also been evaluated. One study of once or twice daily application of 5-FU under occlusion for 6 weeks demonstrated improvement in 88% of patients, including 13% with complete clearance (Br. J. Dermatol; 2011; 165[2]:233-46). No blood levels of the drug were detected. “It’s thought to be safe and well-tolerated, but over-the-counter salicylic acid has better efficacy and is quite a bit cheaper,” Dr. Vanderhooft said.

Another strategy for recalcitrant warts involves administration of squaric acid dibutyl ester. In a recent retrospective chart review conducted over a 10.5-year period, researchers evaluated 72 children with recalcitrant warts who had failed therapy with multiple agents and were followed for a period of 6 months to 11 years (Pediatr. Dermatol. 2015; 32:85-90). The protocol involved sensitizing the children to 2% squaric acid dibutyl ester (SADBE). The treatment then started two weeks later, with 0.4% SADBE applied 3 times per week initially, with an extra day added per week as tolerated to reach daily use if possible. The researchers found that 40 of the 48 (83%) patients in whom treatment outcomes could be obtained reported complete resolution of their warts. Seventy percent of patients used a maximum concentration of 0.4% SADBE and 60% of patients reported no adverse effects. The average time to reduction in size of warts was 2.6 months after sensitization, and treatment continued for a mean of 8 months.

Dr. Vanderhooft reported having no financial disclosures.

PARK CITY, UTAH – In her practice as a pediatric dermatologist, Dr. Sheryll L. Vanderhooft sees her share of children who present with molluscum contagiosum and warts. At the annual meeting of the Pacific Dermatologic Association, she shared her approach to caring for patients who present with these two common conditions.

The root cause of molluscum contagiosum is a poxvirus infection that spreads by skin-to-skin contact. It takes an average of 6 months to 2 years for the host immune response to occur. “During that time parents panic and some need a lot of hand-holding,” said Dr. Vanderhooft, professor of pediatric dermatology at the University of Utah School of Medicine, Salt Lake City. “They seek treatment primarily due to associated dermatitis triggered or exacerbated by the virus. There’s also the risk of spreading the condition to other children and the stigma of visible lesions.”

No FDA-approved therapies for molluscum contagiosum currently exist. “There are many options, but none of them are guaranteed to hasten resolution,” she said. “This is a very important point to deliver to parents before you start trying to do a lot of therapy.” Common treatment options are cryotherapy and cantharadin destruction, curettage, treatment with topical imiquimod or retinoids, oral cimetidine, and injections of Candida antigen.

According to two retrospective studies of Candida antigen injection, complete clearance occurred in 56% of patients after an average of 3 treatments, while partial clearance occurred in 28-38% of patients after an average of 4 treatments (Pediatr. Dermatol. 2008; 25:189-92 and Pediatr. Dermatol 2011; 28:254-8). The main side effect was local pain from the injections.

Courtesy Dr. Sarah Cipriano

Antiviral and antitumor effects are seen with imiquimod cream through activation of the innate immunity and upregulation of cytokines, such as interferon-alpha, Dr. Vanderhooft said. It’s FDA approved for genital and perianal warts in patients older than 12 years of age, as well as for actinic keratosis, superficial basal cell carcinoma, and antiviral-resistant HSV in patients older than 12 years of age. In a prospective study, researchers compared imiquimod cream 5 times per week up to 16 weeks, with cryotherapy for the treatment of molluscum contagiosum in children (Pediatr. Dermatol. 2010; 27[4]:388-94). More than half of patients (60%) achieved clearance by week 6 and 92% achieved clearance by week 12. There were no relapses observed at six months. “Liquid nitrogen cleared the lesions faster, but caused more post-inflammatory dyspigmentation, and there were a few relapses in this group,” Dr. Vanderhooft said.

The downside to imiquimod treatment is that it requires prolonged use, it’s expensive, “and a lot of insurance companies will not pay for it because it’s not FDA approved for young children,” she said. “It can also cause irritant dermatitis, which is a difficult problem when you already have a kid who may be atopic and you’re trying to treat molluscum.” Also, according to the package insert for Aldara cream, imiquimod administered three times per week for 16 weeks was not shown to be superior to vehicle alone in two randomized, controlled trials that were completed in 2006 but never published. There were 323 children in one study, with complete clearance at 18 weeks in 24% of children treated with imiquimod, compared with 26% of children treated with vehicle alone. There were 379 in the second study with complete clearance in 24% and 28% of children, respectively.

Children who were treated with imiquimod in these two studies were more likely to experience application site reactions, otitis media, and conjunctivitis. In addition, a pharmacokinetic study of 22 children with molluscum involving at least 10% of body surface area showed systemically detectable drug levels after single and multiple doses 3 times a week for 4 weeks. The findings from these three studies led to changes in the FDA approved package insert in 2008. Section 1.4 of the “indications and usage” section of the package insert now reads: “Aldara cream has been evaluated in children ages 2012 years with molluscum contagiosum and these studies failed to demonstrate efficacy.” With that in mind, Dr. Vanderhooft’s recommendation “is to either stop prescribing it in children or prescribe it once daily or twice daily as tolerated, not every other day.”

While molluscum contagiosum is caused by a poxvirus, warts are growths on the skin caused by infection with human papillomavirus (HPV). On average, 75% of children will develop immunity to HPV within 3 years, “whether you do nothing, or whether you try to treat it,” she said. “Parents seek treatment when they are large, spreading, or causing social stigma. There are many treatment options, but none are guaranteed to hasten resolution. This needs to be driven home to patients when you’re counseling them.” Numerous treatment options exist, ranging from destruction with cryotherapy and pulsed-dye laser to salicylic acid and various topical or injectable agents. The only FDA-approved option is imiquimod cream, which is approved for genital and perianal warts only in patients 12 years of age and older.

In Dr. Vanderhooft’s experience, Candida antigen injections benefit some patients. After injection of 0.3 mL of Candida antigen into 1 or 2 warts at monthly intervals, researchers in one study observed complete clearance in 87% of patients after an average of 3.5 treatments, while 7% demonstrated no improvement after an average of 3.75 treatments (Pediatr. Dermatol. 2008; 25: 189-92).

Zinc supplementation is another option, she said. In a randomized trial, researchers who evaluated oral zinc supplementation versus placebo for two months found complete clearance in 20 out of 23 patients in the treatment group (87%), compared with none of the 20 patients in the placebo group (Br. J. Dermatol; 2002; 146[3]:423-31). All patients in the zinc group reported nausea. “That’s what has limited zinc therapy in my patient population,” Dr. Vanderhooft said.

In a more recent study, researchers conducted a placebo-controlled study of zinc sulfate 10 mg/kg per day up to 600 mg per day for up to two months (J. Am. Acad. Dermatol. 2009; 60[4]:706-8). Complete clearance of all warts was achieved in 78% of patients in the treatment group, compared with 13% in the placebo group. No recurrence of warts was observed at the six-month follow-up.

Topical 5-FU for warts has also been evaluated. One study of once or twice daily application of 5-FU under occlusion for 6 weeks demonstrated improvement in 88% of patients, including 13% with complete clearance (Br. J. Dermatol; 2011; 165[2]:233-46). No blood levels of the drug were detected. “It’s thought to be safe and well-tolerated, but over-the-counter salicylic acid has better efficacy and is quite a bit cheaper,” Dr. Vanderhooft said.

Another strategy for recalcitrant warts involves administration of squaric acid dibutyl ester. In a recent retrospective chart review conducted over a 10.5-year period, researchers evaluated 72 children with recalcitrant warts who had failed therapy with multiple agents and were followed for a period of 6 months to 11 years (Pediatr. Dermatol. 2015; 32:85-90). The protocol involved sensitizing the children to 2% squaric acid dibutyl ester (SADBE). The treatment then started two weeks later, with 0.4% SADBE applied 3 times per week initially, with an extra day added per week as tolerated to reach daily use if possible. The researchers found that 40 of the 48 (83%) patients in whom treatment outcomes could be obtained reported complete resolution of their warts. Seventy percent of patients used a maximum concentration of 0.4% SADBE and 60% of patients reported no adverse effects. The average time to reduction in size of warts was 2.6 months after sensitization, and treatment continued for a mean of 8 months.

Dr. Vanderhooft reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – In her practice as a pediatric dermatologist, Dr. Sheryll L. Vanderhooft sees her share of children who present with molluscum contagiosum and warts. At the annual meeting of the Pacific Dermatologic Association, she shared her approach to caring for patients who present with these two common conditions.

The root cause of molluscum contagiosum is a poxvirus infection that spreads by skin-to-skin contact. It takes an average of 6 months to 2 years for the host immune response to occur. “During that time parents panic and some need a lot of hand-holding,” said Dr. Vanderhooft, professor of pediatric dermatology at the University of Utah School of Medicine, Salt Lake City. “They seek treatment primarily due to associated dermatitis triggered or exacerbated by the virus. There’s also the risk of spreading the condition to other children and the stigma of visible lesions.”

No FDA-approved therapies for molluscum contagiosum currently exist. “There are many options, but none of them are guaranteed to hasten resolution,” she said. “This is a very important point to deliver to parents before you start trying to do a lot of therapy.” Common treatment options are cryotherapy and cantharadin destruction, curettage, treatment with topical imiquimod or retinoids, oral cimetidine, and injections of Candida antigen.

According to two retrospective studies of Candida antigen injection, complete clearance occurred in 56% of patients after an average of 3 treatments, while partial clearance occurred in 28-38% of patients after an average of 4 treatments (Pediatr. Dermatol. 2008; 25:189-92 and Pediatr. Dermatol 2011; 28:254-8). The main side effect was local pain from the injections.

Courtesy Dr. Sarah Cipriano

Antiviral and antitumor effects are seen with imiquimod cream through activation of the innate immunity and upregulation of cytokines, such as interferon-alpha, Dr. Vanderhooft said. It’s FDA approved for genital and perianal warts in patients older than 12 years of age, as well as for actinic keratosis, superficial basal cell carcinoma, and antiviral-resistant HSV in patients older than 12 years of age. In a prospective study, researchers compared imiquimod cream 5 times per week up to 16 weeks, with cryotherapy for the treatment of molluscum contagiosum in children (Pediatr. Dermatol. 2010; 27[4]:388-94). More than half of patients (60%) achieved clearance by week 6 and 92% achieved clearance by week 12. There were no relapses observed at six months. “Liquid nitrogen cleared the lesions faster, but caused more post-inflammatory dyspigmentation, and there were a few relapses in this group,” Dr. Vanderhooft said.

The downside to imiquimod treatment is that it requires prolonged use, it’s expensive, “and a lot of insurance companies will not pay for it because it’s not FDA approved for young children,” she said. “It can also cause irritant dermatitis, which is a difficult problem when you already have a kid who may be atopic and you’re trying to treat molluscum.” Also, according to the package insert for Aldara cream, imiquimod administered three times per week for 16 weeks was not shown to be superior to vehicle alone in two randomized, controlled trials that were completed in 2006 but never published. There were 323 children in one study, with complete clearance at 18 weeks in 24% of children treated with imiquimod, compared with 26% of children treated with vehicle alone. There were 379 in the second study with complete clearance in 24% and 28% of children, respectively.

Children who were treated with imiquimod in these two studies were more likely to experience application site reactions, otitis media, and conjunctivitis. In addition, a pharmacokinetic study of 22 children with molluscum involving at least 10% of body surface area showed systemically detectable drug levels after single and multiple doses 3 times a week for 4 weeks. The findings from these three studies led to changes in the FDA approved package insert in 2008. Section 1.4 of the “indications and usage” section of the package insert now reads: “Aldara cream has been evaluated in children ages 2012 years with molluscum contagiosum and these studies failed to demonstrate efficacy.” With that in mind, Dr. Vanderhooft’s recommendation “is to either stop prescribing it in children or prescribe it once daily or twice daily as tolerated, not every other day.”

While molluscum contagiosum is caused by a poxvirus, warts are growths on the skin caused by infection with human papillomavirus (HPV). On average, 75% of children will develop immunity to HPV within 3 years, “whether you do nothing, or whether you try to treat it,” she said. “Parents seek treatment when they are large, spreading, or causing social stigma. There are many treatment options, but none are guaranteed to hasten resolution. This needs to be driven home to patients when you’re counseling them.” Numerous treatment options exist, ranging from destruction with cryotherapy and pulsed-dye laser to salicylic acid and various topical or injectable agents. The only FDA-approved option is imiquimod cream, which is approved for genital and perianal warts only in patients 12 years of age and older.

In Dr. Vanderhooft’s experience, Candida antigen injections benefit some patients. After injection of 0.3 mL of Candida antigen into 1 or 2 warts at monthly intervals, researchers in one study observed complete clearance in 87% of patients after an average of 3.5 treatments, while 7% demonstrated no improvement after an average of 3.75 treatments (Pediatr. Dermatol. 2008; 25: 189-92).

Zinc supplementation is another option, she said. In a randomized trial, researchers who evaluated oral zinc supplementation versus placebo for two months found complete clearance in 20 out of 23 patients in the treatment group (87%), compared with none of the 20 patients in the placebo group (Br. J. Dermatol; 2002; 146[3]:423-31). All patients in the zinc group reported nausea. “That’s what has limited zinc therapy in my patient population,” Dr. Vanderhooft said.

In a more recent study, researchers conducted a placebo-controlled study of zinc sulfate 10 mg/kg per day up to 600 mg per day for up to two months (J. Am. Acad. Dermatol. 2009; 60[4]:706-8). Complete clearance of all warts was achieved in 78% of patients in the treatment group, compared with 13% in the placebo group. No recurrence of warts was observed at the six-month follow-up.

Topical 5-FU for warts has also been evaluated. One study of once or twice daily application of 5-FU under occlusion for 6 weeks demonstrated improvement in 88% of patients, including 13% with complete clearance (Br. J. Dermatol; 2011; 165[2]:233-46). No blood levels of the drug were detected. “It’s thought to be safe and well-tolerated, but over-the-counter salicylic acid has better efficacy and is quite a bit cheaper,” Dr. Vanderhooft said.

Another strategy for recalcitrant warts involves administration of squaric acid dibutyl ester. In a recent retrospective chart review conducted over a 10.5-year period, researchers evaluated 72 children with recalcitrant warts who had failed therapy with multiple agents and were followed for a period of 6 months to 11 years (Pediatr. Dermatol. 2015; 32:85-90). The protocol involved sensitizing the children to 2% squaric acid dibutyl ester (SADBE). The treatment then started two weeks later, with 0.4% SADBE applied 3 times per week initially, with an extra day added per week as tolerated to reach daily use if possible. The researchers found that 40 of the 48 (83%) patients in whom treatment outcomes could be obtained reported complete resolution of their warts. Seventy percent of patients used a maximum concentration of 0.4% SADBE and 60% of patients reported no adverse effects. The average time to reduction in size of warts was 2.6 months after sensitization, and treatment continued for a mean of 8 months.

Dr. Vanderhooft reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – In her practice as a pediatric dermatologist, Dr. Sheryll L. Vanderhooft sees her share of children who present with molluscum contagiosum and warts. At the annual meeting of the Pacific Dermatologic Association, she shared her approach to caring for patients who present with these two common conditions.

The root cause of molluscum contagiosum is a poxvirus infection that spreads by skin-to-skin contact. It takes an average of 6 months to 2 years for the host immune response to occur. “During that time parents panic and some need a lot of hand-holding,” said Dr. Vanderhooft, professor of pediatric dermatology at the University of Utah School of Medicine, Salt Lake City. “They seek treatment primarily due to associated dermatitis triggered or exacerbated by the virus. There’s also the risk of spreading the condition to other children and the stigma of visible lesions.”

No FDA-approved therapies for molluscum contagiosum currently exist. “There are many options, but none of them are guaranteed to hasten resolution,” she said. “This is a very important point to deliver to parents before you start trying to do a lot of therapy.” Common treatment options are cryotherapy and cantharadin destruction, curettage, treatment with topical imiquimod or retinoids, oral cimetidine, and injections of Candida antigen.

According to two retrospective studies of Candida antigen injection, complete clearance occurred in 56% of patients after an average of 3 treatments, while partial clearance occurred in 28-38% of patients after an average of 4 treatments (Pediatr. Dermatol. 2008; 25:189-92 and Pediatr. Dermatol 2011; 28:254-8). The main side effect was local pain from the injections.

Courtesy Dr. Sarah Cipriano

Antiviral and antitumor effects are seen with imiquimod cream through activation of the innate immunity and upregulation of cytokines, such as interferon-alpha, Dr. Vanderhooft said. It’s FDA approved for genital and perianal warts in patients older than 12 years of age, as well as for actinic keratosis, superficial basal cell carcinoma, and antiviral-resistant HSV in patients older than 12 years of age. In a prospective study, researchers compared imiquimod cream 5 times per week up to 16 weeks, with cryotherapy for the treatment of molluscum contagiosum in children (Pediatr. Dermatol. 2010; 27[4]:388-94). More than half of patients (60%) achieved clearance by week 6 and 92% achieved clearance by week 12. There were no relapses observed at six months. “Liquid nitrogen cleared the lesions faster, but caused more post-inflammatory dyspigmentation, and there were a few relapses in this group,” Dr. Vanderhooft said.

The downside to imiquimod treatment is that it requires prolonged use, it’s expensive, “and a lot of insurance companies will not pay for it because it’s not FDA approved for young children,” she said. “It can also cause irritant dermatitis, which is a difficult problem when you already have a kid who may be atopic and you’re trying to treat molluscum.” Also, according to the package insert for Aldara cream, imiquimod administered three times per week for 16 weeks was not shown to be superior to vehicle alone in two randomized, controlled trials that were completed in 2006 but never published. There were 323 children in one study, with complete clearance at 18 weeks in 24% of children treated with imiquimod, compared with 26% of children treated with vehicle alone. There were 379 in the second study with complete clearance in 24% and 28% of children, respectively.

Children who were treated with imiquimod in these two studies were more likely to experience application site reactions, otitis media, and conjunctivitis. In addition, a pharmacokinetic study of 22 children with molluscum involving at least 10% of body surface area showed systemically detectable drug levels after single and multiple doses 3 times a week for 4 weeks. The findings from these three studies led to changes in the FDA approved package insert in 2008. Section 1.4 of the “indications and usage” section of the package insert now reads: “Aldara cream has been evaluated in children ages 2012 years with molluscum contagiosum and these studies failed to demonstrate efficacy.” With that in mind, Dr. Vanderhooft’s recommendation “is to either stop prescribing it in children or prescribe it once daily or twice daily as tolerated, not every other day.”

While molluscum contagiosum is caused by a poxvirus, warts are growths on the skin caused by infection with human papillomavirus (HPV). On average, 75% of children will develop immunity to HPV within 3 years, “whether you do nothing, or whether you try to treat it,” she said. “Parents seek treatment when they are large, spreading, or causing social stigma. There are many treatment options, but none are guaranteed to hasten resolution. This needs to be driven home to patients when you’re counseling them.” Numerous treatment options exist, ranging from destruction with cryotherapy and pulsed-dye laser to salicylic acid and various topical or injectable agents. The only FDA-approved option is imiquimod cream, which is approved for genital and perianal warts only in patients 12 years of age and older.

In Dr. Vanderhooft’s experience, Candida antigen injections benefit some patients. After injection of 0.3 mL of Candida antigen into 1 or 2 warts at monthly intervals, researchers in one study observed complete clearance in 87% of patients after an average of 3.5 treatments, while 7% demonstrated no improvement after an average of 3.75 treatments (Pediatr. Dermatol. 2008; 25: 189-92).

Zinc supplementation is another option, she said. In a randomized trial, researchers who evaluated oral zinc supplementation versus placebo for two months found complete clearance in 20 out of 23 patients in the treatment group (87%), compared with none of the 20 patients in the placebo group (Br. J. Dermatol; 2002; 146[3]:423-31). All patients in the zinc group reported nausea. “That’s what has limited zinc therapy in my patient population,” Dr. Vanderhooft said.

In a more recent study, researchers conducted a placebo-controlled study of zinc sulfate 10 mg/kg per day up to 600 mg per day for up to two months (J. Am. Acad. Dermatol. 2009; 60[4]:706-8). Complete clearance of all warts was achieved in 78% of patients in the treatment group, compared with 13% in the placebo group. No recurrence of warts was observed at the six-month follow-up.

Topical 5-FU for warts has also been evaluated. One study of once or twice daily application of 5-FU under occlusion for 6 weeks demonstrated improvement in 88% of patients, including 13% with complete clearance (Br. J. Dermatol; 2011; 165[2]:233-46). No blood levels of the drug were detected. “It’s thought to be safe and well-tolerated, but over-the-counter salicylic acid has better efficacy and is quite a bit cheaper,” Dr. Vanderhooft said.

Another strategy for recalcitrant warts involves administration of squaric acid dibutyl ester. In a recent retrospective chart review conducted over a 10.5-year period, researchers evaluated 72 children with recalcitrant warts who had failed therapy with multiple agents and were followed for a period of 6 months to 11 years (Pediatr. Dermatol. 2015; 32:85-90). The protocol involved sensitizing the children to 2% squaric acid dibutyl ester (SADBE). The treatment then started two weeks later, with 0.4% SADBE applied 3 times per week initially, with an extra day added per week as tolerated to reach daily use if possible. The researchers found that 40 of the 48 (83%) patients in whom treatment outcomes could be obtained reported complete resolution of their warts. Seventy percent of patients used a maximum concentration of 0.4% SADBE and 60% of patients reported no adverse effects. The average time to reduction in size of warts was 2.6 months after sensitization, and treatment continued for a mean of 8 months.

Dr. Vanderhooft reported having no financial disclosures.

[email protected]