Zika presented in a young, pregnant Florida woman as erythematous follicular macules and papules on the trunk and arms, scattered tender pink papules on the palms, and a few petechiae on the hard palate, according to a Jan. 11 report in the New England Journal of Medicine.

The report advises how Zika virus may present during pregnancy. “Medical providers on the front line should be aware of the constellation of symptoms in patients reporting travel to endemic areas, including areas in Southern Florida, where other non–travel-associated cases have been confirmed,” wrote investigators led by Lucy Chen, MD, of the University of Miami (N Engl J Med. 2017 Jan 11. doi: 10.1056/NEJMc1610614).

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Zika presented in a young, pregnant Florida woman as erythematous follicular macules and papules on the trunk and arms, scattered tender pink papules on the palms, and a few petechiae on the hard palate, according to a Jan. 11 report in the New England Journal of Medicine.

The report advises how Zika virus may present during pregnancy. “Medical providers on the front line should be aware of the constellation of symptoms in patients reporting travel to endemic areas, including areas in Southern Florida, where other non–travel-associated cases have been confirmed,” wrote investigators led by Lucy Chen, MD, of the University of Miami (N Engl J Med. 2017 Jan 11. doi: 10.1056/NEJMc1610614).

copyright Devonyu/Thinkstock

[email protected]

Zika presented in a young, pregnant Florida woman as erythematous follicular macules and papules on the trunk and arms, scattered tender pink papules on the palms, and a few petechiae on the hard palate, according to a Jan. 11 report in the New England Journal of Medicine.

The report advises how Zika virus may present during pregnancy. “Medical providers on the front line should be aware of the constellation of symptoms in patients reporting travel to endemic areas, including areas in Southern Florida, where other non–travel-associated cases have been confirmed,” wrote investigators led by Lucy Chen, MD, of the University of Miami (N Engl J Med. 2017 Jan 11. doi: 10.1056/NEJMc1610614).

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The use of antiplatelet agents in pregnant women at risk for preeclampsia reduces the risk of spontaneous preterm birth by about 7%, while moderate to very preterm birth at less than 34 weeks of gestation is reduced by 14%.

Those are key findings from a meta-analysis of data from 17 trials that evaluated the effect of antiplatelet agents to reduce preeclampsia.

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The use of antiplatelet agents in pregnant women at risk for preeclampsia reduces the risk of spontaneous preterm birth by about 7%, while moderate to very preterm birth at less than 34 weeks of gestation is reduced by 14%.

Those are key findings from a meta-analysis of data from 17 trials that evaluated the effect of antiplatelet agents to reduce preeclampsia.

copyright Sohel_Parvez_Haque/Thinkstock

[email protected]

The use of antiplatelet agents in pregnant women at risk for preeclampsia reduces the risk of spontaneous preterm birth by about 7%, while moderate to very preterm birth at less than 34 weeks of gestation is reduced by 14%.

Those are key findings from a meta-analysis of data from 17 trials that evaluated the effect of antiplatelet agents to reduce preeclampsia.

copyright Sohel_Parvez_Haque/Thinkstock

[email protected]

In women with prior mild gestational diabetes, subsequent pregnancies did not increase the frequency of metabolic syndrome but did increase the risk of type 2 diabetes, according to a review of 426 women 5-10 years after a GDM pregnancy.

The risk of diabetes was greatest if additional pregnancies were also complicated by mild gestational diabetes mellitus (GDM).

The investigators assessed women 5-10 years after they participated in a mild GDM treatment study. The goal was to assess the impact of subsequent pregnancies on cardiometabolic risks. GDM is a known risk factor for type 2 diabetes and metabolic syndrome, but it hasn’t been clear until know how subsequent pregnancies influence the risk, said investigators led by Michael Varner, MD, a professor at the University of Utah School of Medicine, Salt Lake City (Obstet Gynecol 2017;129:273-80).

Echoing previous studies of mild GDM, about a third of the women had metabolic syndrome at follow-up, but the number of subsequent pregnancies didn’t seem to make a difference. Among the 212 women with no additional pregnancies, 34% had metabolic syndrome; among the 143 with one pregnancy, 33% had metabolic syndrome; and among the 71 with two or more, 30% had metabolic syndrome, as defined by American Heart Association and National Heart, Lung, and Blood Institute criteria.

“Although we observed a high overall frequency of metabolic syndrome in our cohort, our data suggest that subsequent pregnancies do not increase a woman’s risk of developing metabolic syndrome,” Dr. Varner and his colleagues said.

However, subsequent pregnancies did affect diabetes risk; 5.2% of women with no additional pregnancies had diabetes at follow-up, versus 10.5% of women with one additional pregnancy and 11.3% of those with two or more. The risk of diabetes was greatest if a subsequent pregnancy was complicated by GDM (relative risk, 3.75; 95% confidence interval, 1.60-8.82), as was the case for about a third of the women who had additional pregnancies.

“The association with diabetes was driven mostly by subsequent pregnancy complicated with GDM,” the investigators said.

The findings “could be consistent with either a stronger genetic or an environmental predisposition to type II diabetes, [but] could also represent confounders that were not measured in this prospective observational follow-up study. ... Our data are limited ... by the fact that we do not know how many patients had metabolic syndrome at the time of the index pregnancy,” they said.

At follow-up during Feb. 2012-Sept. 2013, women with no additional pregnancies were a median 38 years old; women who had one pregnancy were a median of 35 years, and those with two or more a median of 33 years. The interval from participation in the parent study to participation in the follow-up study was 7 years in women with no or one additional pregnancy, and 8 years for women with two or more. There were no other significant differences among the groups. The average body mass index was about 29 kg/m²; 59% of the women were Hispanic.

The National Institutes of Health funded the work. The authors had no disclosures.
 

[email protected]

In women with prior mild gestational diabetes, subsequent pregnancies did not increase the frequency of metabolic syndrome but did increase the risk of type 2 diabetes, according to a review of 426 women 5-10 years after a GDM pregnancy.

The risk of diabetes was greatest if additional pregnancies were also complicated by mild gestational diabetes mellitus (GDM).

The investigators assessed women 5-10 years after they participated in a mild GDM treatment study. The goal was to assess the impact of subsequent pregnancies on cardiometabolic risks. GDM is a known risk factor for type 2 diabetes and metabolic syndrome, but it hasn’t been clear until know how subsequent pregnancies influence the risk, said investigators led by Michael Varner, MD, a professor at the University of Utah School of Medicine, Salt Lake City (Obstet Gynecol 2017;129:273-80).

Echoing previous studies of mild GDM, about a third of the women had metabolic syndrome at follow-up, but the number of subsequent pregnancies didn’t seem to make a difference. Among the 212 women with no additional pregnancies, 34% had metabolic syndrome; among the 143 with one pregnancy, 33% had metabolic syndrome; and among the 71 with two or more, 30% had metabolic syndrome, as defined by American Heart Association and National Heart, Lung, and Blood Institute criteria.

“Although we observed a high overall frequency of metabolic syndrome in our cohort, our data suggest that subsequent pregnancies do not increase a woman’s risk of developing metabolic syndrome,” Dr. Varner and his colleagues said.

However, subsequent pregnancies did affect diabetes risk; 5.2% of women with no additional pregnancies had diabetes at follow-up, versus 10.5% of women with one additional pregnancy and 11.3% of those with two or more. The risk of diabetes was greatest if a subsequent pregnancy was complicated by GDM (relative risk, 3.75; 95% confidence interval, 1.60-8.82), as was the case for about a third of the women who had additional pregnancies.

“The association with diabetes was driven mostly by subsequent pregnancy complicated with GDM,” the investigators said.

The findings “could be consistent with either a stronger genetic or an environmental predisposition to type II diabetes, [but] could also represent confounders that were not measured in this prospective observational follow-up study. ... Our data are limited ... by the fact that we do not know how many patients had metabolic syndrome at the time of the index pregnancy,” they said.

At follow-up during Feb. 2012-Sept. 2013, women with no additional pregnancies were a median 38 years old; women who had one pregnancy were a median of 35 years, and those with two or more a median of 33 years. The interval from participation in the parent study to participation in the follow-up study was 7 years in women with no or one additional pregnancy, and 8 years for women with two or more. There were no other significant differences among the groups. The average body mass index was about 29 kg/m²; 59% of the women were Hispanic.

The National Institutes of Health funded the work. The authors had no disclosures.
 

[email protected]

In women with prior mild gestational diabetes, subsequent pregnancies did not increase the frequency of metabolic syndrome but did increase the risk of type 2 diabetes, according to a review of 426 women 5-10 years after a GDM pregnancy.

The risk of diabetes was greatest if additional pregnancies were also complicated by mild gestational diabetes mellitus (GDM).

The investigators assessed women 5-10 years after they participated in a mild GDM treatment study. The goal was to assess the impact of subsequent pregnancies on cardiometabolic risks. GDM is a known risk factor for type 2 diabetes and metabolic syndrome, but it hasn’t been clear until know how subsequent pregnancies influence the risk, said investigators led by Michael Varner, MD, a professor at the University of Utah School of Medicine, Salt Lake City (Obstet Gynecol 2017;129:273-80).

Echoing previous studies of mild GDM, about a third of the women had metabolic syndrome at follow-up, but the number of subsequent pregnancies didn’t seem to make a difference. Among the 212 women with no additional pregnancies, 34% had metabolic syndrome; among the 143 with one pregnancy, 33% had metabolic syndrome; and among the 71 with two or more, 30% had metabolic syndrome, as defined by American Heart Association and National Heart, Lung, and Blood Institute criteria.

“Although we observed a high overall frequency of metabolic syndrome in our cohort, our data suggest that subsequent pregnancies do not increase a woman’s risk of developing metabolic syndrome,” Dr. Varner and his colleagues said.

However, subsequent pregnancies did affect diabetes risk; 5.2% of women with no additional pregnancies had diabetes at follow-up, versus 10.5% of women with one additional pregnancy and 11.3% of those with two or more. The risk of diabetes was greatest if a subsequent pregnancy was complicated by GDM (relative risk, 3.75; 95% confidence interval, 1.60-8.82), as was the case for about a third of the women who had additional pregnancies.

“The association with diabetes was driven mostly by subsequent pregnancy complicated with GDM,” the investigators said.

The findings “could be consistent with either a stronger genetic or an environmental predisposition to type II diabetes, [but] could also represent confounders that were not measured in this prospective observational follow-up study. ... Our data are limited ... by the fact that we do not know how many patients had metabolic syndrome at the time of the index pregnancy,” they said.

At follow-up during Feb. 2012-Sept. 2013, women with no additional pregnancies were a median 38 years old; women who had one pregnancy were a median of 35 years, and those with two or more a median of 33 years. The interval from participation in the parent study to participation in the follow-up study was 7 years in women with no or one additional pregnancy, and 8 years for women with two or more. There were no other significant differences among the groups. The average body mass index was about 29 kg/m²; 59% of the women were Hispanic.

The National Institutes of Health funded the work. The authors had no disclosures.
 

[email protected]

177Lu-Dotatate, a radionuclide related to octreotide, reduced the risk of disease progression or death by 79% in a phase III trial involving 229 adults with advanced, progressive midgut neuroendocrine tumors, investigators reported in the New England Journal of Medicine.

“The response rate of 18% in the 177Lu-Dotatate group (as compared with 3% in the control group) is also notable, given that response rates above 5% have not been observed in large randomized clinical trials of other systemic therapies in this patient population,” said Jonathan R. Strosberg, MD, of the Moffitt Cancer Center, Tampa, and his associates.

177Lu-Dotatate, a radionuclide related to octreotide, reduced the risk of disease progression or death by 79% in a phase III trial involving 229 adults with advanced, progressive midgut neuroendocrine tumors, investigators reported in the New England Journal of Medicine.

“The response rate of 18% in the 177Lu-Dotatate group (as compared with 3% in the control group) is also notable, given that response rates above 5% have not been observed in large randomized clinical trials of other systemic therapies in this patient population,” said Jonathan R. Strosberg, MD, of the Moffitt Cancer Center, Tampa, and his associates.

177Lu-Dotatate, a radionuclide related to octreotide, reduced the risk of disease progression or death by 79% in a phase III trial involving 229 adults with advanced, progressive midgut neuroendocrine tumors, investigators reported in the New England Journal of Medicine.

“The response rate of 18% in the 177Lu-Dotatate group (as compared with 3% in the control group) is also notable, given that response rates above 5% have not been observed in large randomized clinical trials of other systemic therapies in this patient population,” said Jonathan R. Strosberg, MD, of the Moffitt Cancer Center, Tampa, and his associates.

SAN DIEGO – More than 90% of the first patients with previously untreated chronic lymphocytic leukemia who received ibrutinib in an early study are alive and without disease progression 5 years later, investigators reported.

Among 31 treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) who were started on the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) in the phase Ib/II PCYC-1102/1103 study, the 5-year progression-free survival (PFS) rate was 92%, with the median PFS not reached. Estimated 5-year overall survival (OS) among these patients was also 92%, with the median not reached, Susan O’Brien, MD, of the University of California, Irvine, reported at the annual meeting of the American Society of Hematology.

The 5-year PFS rate for patients with relapsed/refractory disease who had received a median of four prior lines of therapy before starting on single-agent ibrutinib was 43%, with a median PFS of 52 months. In this group, the overall survival (OS) rate was 57%, with the median not reached.

“At 5 years of follow-up, there are very durable responses in treatment-naive and relapsed refractory patients. You saw that, in the treatment-naive group, there is, in fact, only one patient who has progressed so far,” Dr. O’Brien said.

In a separate study, investigators from the phase III RESONATE-2 trial reported updated safety and efficacy data showing that in first-line therapy for patients aged 65 years and older with CLL/SLL with active disease, ibrutinib was associated with significantly better PFS at 24 months, compared with chlorambucil.

In this study by Dr. O’Brien and colleagues, 31 patients with previously untreated CLL/SLL and 101 patients with relapsed/refractory disease (progression or no objective response within 24 months of starting on chemoimmunotherapy) were treated with oral ibrutinib once daily at doses of 420 mg or 840 mg until disease progression or unacceptable toxicity.

After 5 years of follow-up, 20 of the 31 treatment-naive patients (65%) and 30 of the 101 relapsed/refractory patients (30%) remained on ibrutinib therapy. The primary reasons for discontinuation among relapsed/refractory patients included progressive disease in 33%, adverse events in 21%, and investigator decision in 11%.

Best response rates in treatment-naive patients were 87% (29% complete response, 55% partial response, 3% partial response-L) and 89% in relapsed/refractory patients (10%, 76%, and 3%, respectively).

An analysis of survival by IGHV (immunoglobulin heavy chain variable) mutational status in patients with relapsed/refractory disease showed a 53% 5-year PFS rate among patients with mutated IGHV and a median PFS of 63 months, compared with 38% and 43 months for patients with unmutated IGHV. Respective 5-year overall survival rates were 66% (median OS, 63 months) and 55% (median not reached).

In an analysis of survival outcomes by chromosomal abnormalities detected by FISH (fluorescent in situ hybridization) among patients with relapsed/refractory disease, median PFS and OS rates were highest among patients with the 13q deletion, at 91% for both PFS and OS, compared with 80% for each in patients with trisomy 12, 33% and 61% for patients with deletion 11q, and 19% and 32% for patients with deletion 17p. In patients with no chromosomal abnormalities, the 5-year PFS rate was 66% (median not reached), and the 5-year OS rate was 83% (median not reached).

Among patients with complex karyotype, 90% of whom had relapsed refractory disease, the 5-year PFS rate was 36% (median 33 months), and the OS rate was 46% (median 57 months). In contrast, respective PFS and OS rates for patients without complex karyotype were 69% and 84%, with the median not reached in either survival category.

In multivariate analysis, only deletion 17p was identified as a significant predictor of PFS and OS.

Grade 3 or greater treatment-emergent adverse events occurred mostly frequently in the first year of therapy and declined thereafter. The most common grade 3 or greater events were hypertension, (26% of all patients), pneumonia (22%), neutropenia (17%), and atrial fibrillation (9%).

Paul M. Barr, MD, of the University of Rochester presented updated data from RESONATE-2, comparing ibrutinib with chlorambucil in patients 65 and older with newly diagnosed, active CLL/SLL.

At a median follow-up of 29 months, the rates of 2-year PFS were 89% for patients treated with ibrutinib (median PFS not reached) vs. 34% for chlorambucil (median PFS 15 months). This translated into a hazard ratio for ibrutinib of 0.121 (P less than .0001). The benefit of ibrutinib occurred without regard to IGHV status, and ibrutinib continues to demonstrate an OS benefit over chlorambucil with longer follow-up and crossover. Overall survival at 24 months was 95% for patients treated with ibrutinib (included 55 patients who were crossed over from chlorambucil) vs. 84% for patients treated with chlorambucil only.

“The depth of the responses has improved over time, now with 18% of patients achieving a CR with ibrutinib, and lastly, ibrutinib remains tolerable in this elderly population, with 79% of patients that are continuing on therapy,” Dr. Barr said.

Both studies were funded by Pharmacyclics. Dr. Barr and Dr. O’Brien disclosed serving as consultants to the company, and Dr. O’Brien further disclosed honoraria and research funding from Pharmacyclics.

SAN DIEGO – More than 90% of the first patients with previously untreated chronic lymphocytic leukemia who received ibrutinib in an early study are alive and without disease progression 5 years later, investigators reported.

Among 31 treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) who were started on the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) in the phase Ib/II PCYC-1102/1103 study, the 5-year progression-free survival (PFS) rate was 92%, with the median PFS not reached. Estimated 5-year overall survival (OS) among these patients was also 92%, with the median not reached, Susan O’Brien, MD, of the University of California, Irvine, reported at the annual meeting of the American Society of Hematology.

The 5-year PFS rate for patients with relapsed/refractory disease who had received a median of four prior lines of therapy before starting on single-agent ibrutinib was 43%, with a median PFS of 52 months. In this group, the overall survival (OS) rate was 57%, with the median not reached.

“At 5 years of follow-up, there are very durable responses in treatment-naive and relapsed refractory patients. You saw that, in the treatment-naive group, there is, in fact, only one patient who has progressed so far,” Dr. O’Brien said.

In a separate study, investigators from the phase III RESONATE-2 trial reported updated safety and efficacy data showing that in first-line therapy for patients aged 65 years and older with CLL/SLL with active disease, ibrutinib was associated with significantly better PFS at 24 months, compared with chlorambucil.

In this study by Dr. O’Brien and colleagues, 31 patients with previously untreated CLL/SLL and 101 patients with relapsed/refractory disease (progression or no objective response within 24 months of starting on chemoimmunotherapy) were treated with oral ibrutinib once daily at doses of 420 mg or 840 mg until disease progression or unacceptable toxicity.

After 5 years of follow-up, 20 of the 31 treatment-naive patients (65%) and 30 of the 101 relapsed/refractory patients (30%) remained on ibrutinib therapy. The primary reasons for discontinuation among relapsed/refractory patients included progressive disease in 33%, adverse events in 21%, and investigator decision in 11%.

Best response rates in treatment-naive patients were 87% (29% complete response, 55% partial response, 3% partial response-L) and 89% in relapsed/refractory patients (10%, 76%, and 3%, respectively).

An analysis of survival by IGHV (immunoglobulin heavy chain variable) mutational status in patients with relapsed/refractory disease showed a 53% 5-year PFS rate among patients with mutated IGHV and a median PFS of 63 months, compared with 38% and 43 months for patients with unmutated IGHV. Respective 5-year overall survival rates were 66% (median OS, 63 months) and 55% (median not reached).

In an analysis of survival outcomes by chromosomal abnormalities detected by FISH (fluorescent in situ hybridization) among patients with relapsed/refractory disease, median PFS and OS rates were highest among patients with the 13q deletion, at 91% for both PFS and OS, compared with 80% for each in patients with trisomy 12, 33% and 61% for patients with deletion 11q, and 19% and 32% for patients with deletion 17p. In patients with no chromosomal abnormalities, the 5-year PFS rate was 66% (median not reached), and the 5-year OS rate was 83% (median not reached).

Among patients with complex karyotype, 90% of whom had relapsed refractory disease, the 5-year PFS rate was 36% (median 33 months), and the OS rate was 46% (median 57 months). In contrast, respective PFS and OS rates for patients without complex karyotype were 69% and 84%, with the median not reached in either survival category.

In multivariate analysis, only deletion 17p was identified as a significant predictor of PFS and OS.

Grade 3 or greater treatment-emergent adverse events occurred mostly frequently in the first year of therapy and declined thereafter. The most common grade 3 or greater events were hypertension, (26% of all patients), pneumonia (22%), neutropenia (17%), and atrial fibrillation (9%).

Paul M. Barr, MD, of the University of Rochester presented updated data from RESONATE-2, comparing ibrutinib with chlorambucil in patients 65 and older with newly diagnosed, active CLL/SLL.

At a median follow-up of 29 months, the rates of 2-year PFS were 89% for patients treated with ibrutinib (median PFS not reached) vs. 34% for chlorambucil (median PFS 15 months). This translated into a hazard ratio for ibrutinib of 0.121 (P less than .0001). The benefit of ibrutinib occurred without regard to IGHV status, and ibrutinib continues to demonstrate an OS benefit over chlorambucil with longer follow-up and crossover. Overall survival at 24 months was 95% for patients treated with ibrutinib (included 55 patients who were crossed over from chlorambucil) vs. 84% for patients treated with chlorambucil only.

“The depth of the responses has improved over time, now with 18% of patients achieving a CR with ibrutinib, and lastly, ibrutinib remains tolerable in this elderly population, with 79% of patients that are continuing on therapy,” Dr. Barr said.

Both studies were funded by Pharmacyclics. Dr. Barr and Dr. O’Brien disclosed serving as consultants to the company, and Dr. O’Brien further disclosed honoraria and research funding from Pharmacyclics.

SAN DIEGO – More than 90% of the first patients with previously untreated chronic lymphocytic leukemia who received ibrutinib in an early study are alive and without disease progression 5 years later, investigators reported.

Among 31 treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) who were started on the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) in the phase Ib/II PCYC-1102/1103 study, the 5-year progression-free survival (PFS) rate was 92%, with the median PFS not reached. Estimated 5-year overall survival (OS) among these patients was also 92%, with the median not reached, Susan O’Brien, MD, of the University of California, Irvine, reported at the annual meeting of the American Society of Hematology.

The 5-year PFS rate for patients with relapsed/refractory disease who had received a median of four prior lines of therapy before starting on single-agent ibrutinib was 43%, with a median PFS of 52 months. In this group, the overall survival (OS) rate was 57%, with the median not reached.

“At 5 years of follow-up, there are very durable responses in treatment-naive and relapsed refractory patients. You saw that, in the treatment-naive group, there is, in fact, only one patient who has progressed so far,” Dr. O’Brien said.

In a separate study, investigators from the phase III RESONATE-2 trial reported updated safety and efficacy data showing that in first-line therapy for patients aged 65 years and older with CLL/SLL with active disease, ibrutinib was associated with significantly better PFS at 24 months, compared with chlorambucil.

In this study by Dr. O’Brien and colleagues, 31 patients with previously untreated CLL/SLL and 101 patients with relapsed/refractory disease (progression or no objective response within 24 months of starting on chemoimmunotherapy) were treated with oral ibrutinib once daily at doses of 420 mg or 840 mg until disease progression or unacceptable toxicity.

After 5 years of follow-up, 20 of the 31 treatment-naive patients (65%) and 30 of the 101 relapsed/refractory patients (30%) remained on ibrutinib therapy. The primary reasons for discontinuation among relapsed/refractory patients included progressive disease in 33%, adverse events in 21%, and investigator decision in 11%.

Best response rates in treatment-naive patients were 87% (29% complete response, 55% partial response, 3% partial response-L) and 89% in relapsed/refractory patients (10%, 76%, and 3%, respectively).

An analysis of survival by IGHV (immunoglobulin heavy chain variable) mutational status in patients with relapsed/refractory disease showed a 53% 5-year PFS rate among patients with mutated IGHV and a median PFS of 63 months, compared with 38% and 43 months for patients with unmutated IGHV. Respective 5-year overall survival rates were 66% (median OS, 63 months) and 55% (median not reached).

In an analysis of survival outcomes by chromosomal abnormalities detected by FISH (fluorescent in situ hybridization) among patients with relapsed/refractory disease, median PFS and OS rates were highest among patients with the 13q deletion, at 91% for both PFS and OS, compared with 80% for each in patients with trisomy 12, 33% and 61% for patients with deletion 11q, and 19% and 32% for patients with deletion 17p. In patients with no chromosomal abnormalities, the 5-year PFS rate was 66% (median not reached), and the 5-year OS rate was 83% (median not reached).

Among patients with complex karyotype, 90% of whom had relapsed refractory disease, the 5-year PFS rate was 36% (median 33 months), and the OS rate was 46% (median 57 months). In contrast, respective PFS and OS rates for patients without complex karyotype were 69% and 84%, with the median not reached in either survival category.

In multivariate analysis, only deletion 17p was identified as a significant predictor of PFS and OS.

Grade 3 or greater treatment-emergent adverse events occurred mostly frequently in the first year of therapy and declined thereafter. The most common grade 3 or greater events were hypertension, (26% of all patients), pneumonia (22%), neutropenia (17%), and atrial fibrillation (9%).

Paul M. Barr, MD, of the University of Rochester presented updated data from RESONATE-2, comparing ibrutinib with chlorambucil in patients 65 and older with newly diagnosed, active CLL/SLL.

At a median follow-up of 29 months, the rates of 2-year PFS were 89% for patients treated with ibrutinib (median PFS not reached) vs. 34% for chlorambucil (median PFS 15 months). This translated into a hazard ratio for ibrutinib of 0.121 (P less than .0001). The benefit of ibrutinib occurred without regard to IGHV status, and ibrutinib continues to demonstrate an OS benefit over chlorambucil with longer follow-up and crossover. Overall survival at 24 months was 95% for patients treated with ibrutinib (included 55 patients who were crossed over from chlorambucil) vs. 84% for patients treated with chlorambucil only.

“The depth of the responses has improved over time, now with 18% of patients achieving a CR with ibrutinib, and lastly, ibrutinib remains tolerable in this elderly population, with 79% of patients that are continuing on therapy,” Dr. Barr said.

Both studies were funded by Pharmacyclics. Dr. Barr and Dr. O’Brien disclosed serving as consultants to the company, and Dr. O’Brien further disclosed honoraria and research funding from Pharmacyclics.

A few years ago I audited a college course on leadership taught by Angus King (I-ME), former governor and now independent Senator from Maine. He emphasized that an important characteristic of effective leaders is that they show up for work. They are there, present, on the scene. Attempting to lead in absentia is seldom successful. Knowledge gathered firsthand can be critical when it’s decision-making time. And the connectedness fostered by the leader’s physical presence can bolster morale in a crisis.

Being a parent is more complex than simply being a leader, but showing up is just as important to being a good parent as it is to being an effective leader. Most parents already believe that “being there” is important, and feel guilty when they have obligations that prevent them from maintaining a perfect attendance record.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].

A few years ago I audited a college course on leadership taught by Angus King (I-ME), former governor and now independent Senator from Maine. He emphasized that an important characteristic of effective leaders is that they show up for work. They are there, present, on the scene. Attempting to lead in absentia is seldom successful. Knowledge gathered firsthand can be critical when it’s decision-making time. And the connectedness fostered by the leader’s physical presence can bolster morale in a crisis.

Being a parent is more complex than simply being a leader, but showing up is just as important to being a good parent as it is to being an effective leader. Most parents already believe that “being there” is important, and feel guilty when they have obligations that prevent them from maintaining a perfect attendance record.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].

A few years ago I audited a college course on leadership taught by Angus King (I-ME), former governor and now independent Senator from Maine. He emphasized that an important characteristic of effective leaders is that they show up for work. They are there, present, on the scene. Attempting to lead in absentia is seldom successful. Knowledge gathered firsthand can be critical when it’s decision-making time. And the connectedness fostered by the leader’s physical presence can bolster morale in a crisis.

Being a parent is more complex than simply being a leader, but showing up is just as important to being a good parent as it is to being an effective leader. Most parents already believe that “being there” is important, and feel guilty when they have obligations that prevent them from maintaining a perfect attendance record.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Liver stiffness is very accurate for predicting liver-related events in HIV-infected patients with chronic hepatitis C infection, according to a Spanish study.

copyright alexskopje/Thinkstock

[email protected]

On Twitter @richpizzi

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Liver stiffness is very accurate for predicting liver-related events in HIV-infected patients with chronic hepatitis C infection, according to a Spanish study.

copyright alexskopje/Thinkstock

[email protected]

On Twitter @richpizzi

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Liver stiffness is very accurate for predicting liver-related events in HIV-infected patients with chronic hepatitis C infection, according to a Spanish study.

copyright alexskopje/Thinkstock

[email protected]

On Twitter @richpizzi

Gluten-free food products have inundated the marketplace in recent years as the food industry has responded to greater awareness of celiac sprue disease and wheat sensitivity. Gluten is the primary form of wheat protein.

Wheat is a versatile and globally popular member of the Poaceae or Gramineae family known as grasses; it is of the Triticum species with Triticum aestivum and Triticum vulgare being particularly pervasive.¹ In traditional Iranian medicine, the topical application of wheat germ oil has been used to treat psoriasis.²

Moisturization

In 2008, N. Akhtar and Y. Yazan investigated the effects of a stable emulsion containing two ingredients included to exert anti-aging effects: vitamin C and wheat protein. The antioxidant vitamin C was entrapped in the inner aqueous phase of the water-in-oil-in-water emulsion while wheat protein was incorporated in the oily phase. The investigators prepared and applied stable emulsions to the cheeks of 11 volunteers over 4 weeks, finding that the formulation increased skin moisture.⁷

Melanoma and wheat supplementation

Demidov et al. reported in 2008 on a randomized, pilot, phase II clinical trial to assess the impact of the adjuvant use of a fermented wheat germ extract nutraceutical (Avemar) in high-risk cutaneous melanoma patients. Investigators compared the efficacy of dacarbazine-based adjuvant chemotherapy on survival parameters of melanoma patients to that of the identical treatment supplemented with a 1-year administration of fermented wheat germ extract nutraceutical (FWGE), which is generally recognized as safe. They reported that after a 7-year follow-up, significant differences favoring the nutraceutical group were observed in progression-free and overall survival. Including nutraceutical as an adjuvant treatment for such patients was recommended by the authors.⁸

Telekes et al. noted that nutraceutical is registered as a special nutriment for cancer patients in Hungary that has exhibited potent anticancer activity on cell lines and immunomodulatory activity in vivo.⁹ In 2005, Boros et al. reported that orally administered FWGE suppressed metastatic tumor dissemination and proliferation during and after chemotherapy, surgery, or radiation, with benefits seen in some human cancers and cultured cells as well as some autoimmune disorders and in chemical carcinogenesis prevention.¹⁰

Hypersensitivity and allergic reactions

The risks of sensitization to topical wheat proteins are thought to be higher in patients with atopic dermatitis, who have an impaired skin barrier.¹ Indeed, Codreanu et al. have suggested that topical products containing food proteins of known allergenicity (including wheat) are contraindicated for neonates and infants with atopic dermatitis.¹¹

In 2015, Bonciolini et al. studied 17 patients (13 females and 4 males, median age 36 years) with nonceliac gluten sensitivity presenting with nonspecific skin lesions. The eczema-, psoriasis-, or dermatitis herpetiformis-like lesions on the extensor surfaces of the upper and lower limbs, especially, were confirmed histologically, but immunopathological evaluations revealed pervasive C3 deposits along the dermoepidermal junction in a microgranular/granular pattern (82%). Notably, all of the patients improved markedly after initiating a gluten-free diet.¹²

In 2014, Fukutomi et al. conducted a case-control study of Japanese women aged 20-54 years (157 cases) who self-reported wheat allergy to ascertain the epidemiologic relationship between food allergy to wheat after exposure to facial soaps containing hydrolyzed wheat protein. There were 449 age-matched controls without wheat allergy. Participants answered a Web-based questionnaire about their use of skin and hair care products. The investigators found that current use of the facial soap Cha no Shizuku (Drop of Tea), which contains hydrolyzed wheat protein, was significantly linked to a greater risk of wheat allergy, with use of the soap more frequent in consumers whose wheat allergy had newly emerged (11% vs. 6% in controls).¹³

Cha no Shizuku had earlier been implicated in provoking hundreds of cases of allergic reactions between 2009 and June 2013. R. Teshima noted that the soap contains acid-hydrolyzed wheat protein produced from gluten after partial hydrolysis with hydrogen chloride at 95 ° C for 40 minutes.¹⁴

It is worth noting that case reports of allergic reactions to facial soap containing hydrolyzed wheat protein continue to appear. Iseki et al. described in 2014 a 38-year-old woman who experienced irregular headaches, sleepiness, and an episode of facial rash eruption after daily use for about 1 year of a facial soap with hydrolyzed wheat proteins (Glupearl 19s, which is also used in Cha no Shizuku). The investigators added that the patient’s serum contained wheat-specific IgE antibodies. Symptoms disappeared after the patient abstained from wheat.¹⁵

In 2012, Tammaro studied cutaneous hypersensitivity to gluten in 14 female patients (aged 12-60 years) with celiac disease who presented with eczema on the face, neck, and arms, after topical application of gluten-containing emollient cream, bath or face powder, or contact with foods containing wheat and durum. Five of the patients tested positive for wheat and durum wheat, while none of the 14 control patients tested positive. Improvement in cutaneous lesions, with no relapses during a 6-month follow-up, resulted when these patients used gluten-free cream and bath powder, and wore gloves before handling wheat-containing food.¹⁶

In 2011, Celakovská et al. studied the impact of wheat allergy in 179 adults with atopic eczema (128 females, 51 males; average age 26 years), using open exposure and double-blind, placebo-controlled food challenge tests, as well as specific serum IgE, skin prick, and atopy patch tests. The double-blind, placebo-controlled food challenge test showed that the course of atopic eczema was exacerbated by wheat allergy in eight patients (4.5%). A positive trend revealing that the course of atopic eczema was impacted by wheat allergy emerged during follow-up (at 3, 6, 9, and 12 months).¹⁷

Contact urticaria also has been reported to have been induced by hydrolyzed wheat proteins in cosmetics and is notable for the potential to precede food allergies.^2,3 A wide variety of protein hydrolysates found in hair products have been associated with inducing contact urticaria, particularly in patients with atopic dermatitis.⁴

In 2006, Laurière et al. studied nine female patients without common wheat allergy who presented with contact urticaria to cosmetics containing hydrolyzed wheat proteins; six also had experienced generalized urticaria or anaphylaxis in response to foods containing such wheat proteins. Analyses revealed the importance of hydrolysis in augmenting the allergenicity of wheat proteins through contact or consumption.¹⁸ Immediate contact urticaria in reaction to hydrolyzed wheat protein in topical products also has been reported in a child.¹⁹

Conclusion

Can the presence of wheat hydrolysates in personal care products adversely affect a patient with celiac sprue or wheat sensitivity? The short answer appears to be “yes.” Given the use of hydrolyzed wheat protein in various skin care products, it is important that consumers who have celiac disease or sensitivity to wheat be advised to avoid skin care formulations with such active ingredients. On the positive side of the wheat ledger, there are some indications (albeit in very limited research) that the plant protein may impart beneficial health effects. Much more research is necessary to delineate the full impact of wheat on skin health.

I thank my dermatologist colleague Sharon E. Jacob, MD, at the University of Miami, for suggesting this topic.

References

1. Dermatitis. 2013 Nov-Dec;24(6):291-5.

2. Iran J Med Sci. 2016 May;41(3 Suppl):S54.

3. Contact Dermatitis. 2007 Feb;56(2):119-20.

4. Ann Dermatol Venereol. 2010 Apr;137(4):281-4.

5. Allergy. 1998 Nov;53(11):1078-82.

6. J Drugs Dermatol. 2013 Sep;12(9 Suppl):s133-6.

7. Pak J Pharm Sci. 2008 Jan;21(1):45-50.

8. Cancer Biother Radiopharm. 2008 Aug;23(4):477-82.

9. Nutr Cancer. 2009;61(6):891-9.

10. Ann N Y Acad Sci. 2005 Jun;1051:529-42.

11. Eur Ann Allergy Clin Immunol. 2006 Apr;38(4):126-30.

12. Nutrients. 2015 Sep 15;7(9):7798-805.

13. Allergy. 2014 Oct;69(10):1405-11.

14. Yakugaku Zasshi. 2014;134(1):33-8.

15. Intern Med. 2014;53(2):151-4.

16. Dermatitis. 2012 Sep-Oct;23(5):220-1.

17. Acta Medica (Hradec Kralove). 2011;54(4):157-62.

18. Contact Dermatitis. 2006 May;54(5):283-9.

19. Contact Dermatitis. 2013 Jun;68(6):379-80.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. Dr. Baumann also developed and owns the Baumann Skin Type Solution skin typing systems and related products.

Gluten-free food products have inundated the marketplace in recent years as the food industry has responded to greater awareness of celiac sprue disease and wheat sensitivity. Gluten is the primary form of wheat protein.

Wheat is a versatile and globally popular member of the Poaceae or Gramineae family known as grasses; it is of the Triticum species with Triticum aestivum and Triticum vulgare being particularly pervasive.¹ In traditional Iranian medicine, the topical application of wheat germ oil has been used to treat psoriasis.²

Moisturization

In 2008, N. Akhtar and Y. Yazan investigated the effects of a stable emulsion containing two ingredients included to exert anti-aging effects: vitamin C and wheat protein. The antioxidant vitamin C was entrapped in the inner aqueous phase of the water-in-oil-in-water emulsion while wheat protein was incorporated in the oily phase. The investigators prepared and applied stable emulsions to the cheeks of 11 volunteers over 4 weeks, finding that the formulation increased skin moisture.⁷

Melanoma and wheat supplementation

Demidov et al. reported in 2008 on a randomized, pilot, phase II clinical trial to assess the impact of the adjuvant use of a fermented wheat germ extract nutraceutical (Avemar) in high-risk cutaneous melanoma patients. Investigators compared the efficacy of dacarbazine-based adjuvant chemotherapy on survival parameters of melanoma patients to that of the identical treatment supplemented with a 1-year administration of fermented wheat germ extract nutraceutical (FWGE), which is generally recognized as safe. They reported that after a 7-year follow-up, significant differences favoring the nutraceutical group were observed in progression-free and overall survival. Including nutraceutical as an adjuvant treatment for such patients was recommended by the authors.⁸

Telekes et al. noted that nutraceutical is registered as a special nutriment for cancer patients in Hungary that has exhibited potent anticancer activity on cell lines and immunomodulatory activity in vivo.⁹ In 2005, Boros et al. reported that orally administered FWGE suppressed metastatic tumor dissemination and proliferation during and after chemotherapy, surgery, or radiation, with benefits seen in some human cancers and cultured cells as well as some autoimmune disorders and in chemical carcinogenesis prevention.¹⁰

Hypersensitivity and allergic reactions

The risks of sensitization to topical wheat proteins are thought to be higher in patients with atopic dermatitis, who have an impaired skin barrier.¹ Indeed, Codreanu et al. have suggested that topical products containing food proteins of known allergenicity (including wheat) are contraindicated for neonates and infants with atopic dermatitis.¹¹

In 2015, Bonciolini et al. studied 17 patients (13 females and 4 males, median age 36 years) with nonceliac gluten sensitivity presenting with nonspecific skin lesions. The eczema-, psoriasis-, or dermatitis herpetiformis-like lesions on the extensor surfaces of the upper and lower limbs, especially, were confirmed histologically, but immunopathological evaluations revealed pervasive C3 deposits along the dermoepidermal junction in a microgranular/granular pattern (82%). Notably, all of the patients improved markedly after initiating a gluten-free diet.¹²

In 2014, Fukutomi et al. conducted a case-control study of Japanese women aged 20-54 years (157 cases) who self-reported wheat allergy to ascertain the epidemiologic relationship between food allergy to wheat after exposure to facial soaps containing hydrolyzed wheat protein. There were 449 age-matched controls without wheat allergy. Participants answered a Web-based questionnaire about their use of skin and hair care products. The investigators found that current use of the facial soap Cha no Shizuku (Drop of Tea), which contains hydrolyzed wheat protein, was significantly linked to a greater risk of wheat allergy, with use of the soap more frequent in consumers whose wheat allergy had newly emerged (11% vs. 6% in controls).¹³

Cha no Shizuku had earlier been implicated in provoking hundreds of cases of allergic reactions between 2009 and June 2013. R. Teshima noted that the soap contains acid-hydrolyzed wheat protein produced from gluten after partial hydrolysis with hydrogen chloride at 95 ° C for 40 minutes.¹⁴

It is worth noting that case reports of allergic reactions to facial soap containing hydrolyzed wheat protein continue to appear. Iseki et al. described in 2014 a 38-year-old woman who experienced irregular headaches, sleepiness, and an episode of facial rash eruption after daily use for about 1 year of a facial soap with hydrolyzed wheat proteins (Glupearl 19s, which is also used in Cha no Shizuku). The investigators added that the patient’s serum contained wheat-specific IgE antibodies. Symptoms disappeared after the patient abstained from wheat.¹⁵

In 2012, Tammaro studied cutaneous hypersensitivity to gluten in 14 female patients (aged 12-60 years) with celiac disease who presented with eczema on the face, neck, and arms, after topical application of gluten-containing emollient cream, bath or face powder, or contact with foods containing wheat and durum. Five of the patients tested positive for wheat and durum wheat, while none of the 14 control patients tested positive. Improvement in cutaneous lesions, with no relapses during a 6-month follow-up, resulted when these patients used gluten-free cream and bath powder, and wore gloves before handling wheat-containing food.¹⁶

In 2011, Celakovská et al. studied the impact of wheat allergy in 179 adults with atopic eczema (128 females, 51 males; average age 26 years), using open exposure and double-blind, placebo-controlled food challenge tests, as well as specific serum IgE, skin prick, and atopy patch tests. The double-blind, placebo-controlled food challenge test showed that the course of atopic eczema was exacerbated by wheat allergy in eight patients (4.5%). A positive trend revealing that the course of atopic eczema was impacted by wheat allergy emerged during follow-up (at 3, 6, 9, and 12 months).¹⁷

Contact urticaria also has been reported to have been induced by hydrolyzed wheat proteins in cosmetics and is notable for the potential to precede food allergies.^2,3 A wide variety of protein hydrolysates found in hair products have been associated with inducing contact urticaria, particularly in patients with atopic dermatitis.⁴

In 2006, Laurière et al. studied nine female patients without common wheat allergy who presented with contact urticaria to cosmetics containing hydrolyzed wheat proteins; six also had experienced generalized urticaria or anaphylaxis in response to foods containing such wheat proteins. Analyses revealed the importance of hydrolysis in augmenting the allergenicity of wheat proteins through contact or consumption.¹⁸ Immediate contact urticaria in reaction to hydrolyzed wheat protein in topical products also has been reported in a child.¹⁹

Conclusion

Can the presence of wheat hydrolysates in personal care products adversely affect a patient with celiac sprue or wheat sensitivity? The short answer appears to be “yes.” Given the use of hydrolyzed wheat protein in various skin care products, it is important that consumers who have celiac disease or sensitivity to wheat be advised to avoid skin care formulations with such active ingredients. On the positive side of the wheat ledger, there are some indications (albeit in very limited research) that the plant protein may impart beneficial health effects. Much more research is necessary to delineate the full impact of wheat on skin health.

I thank my dermatologist colleague Sharon E. Jacob, MD, at the University of Miami, for suggesting this topic.

References

1. Dermatitis. 2013 Nov-Dec;24(6):291-5.

2. Iran J Med Sci. 2016 May;41(3 Suppl):S54.

3. Contact Dermatitis. 2007 Feb;56(2):119-20.

4. Ann Dermatol Venereol. 2010 Apr;137(4):281-4.

5. Allergy. 1998 Nov;53(11):1078-82.

6. J Drugs Dermatol. 2013 Sep;12(9 Suppl):s133-6.

7. Pak J Pharm Sci. 2008 Jan;21(1):45-50.

8. Cancer Biother Radiopharm. 2008 Aug;23(4):477-82.

9. Nutr Cancer. 2009;61(6):891-9.

10. Ann N Y Acad Sci. 2005 Jun;1051:529-42.

11. Eur Ann Allergy Clin Immunol. 2006 Apr;38(4):126-30.

12. Nutrients. 2015 Sep 15;7(9):7798-805.

13. Allergy. 2014 Oct;69(10):1405-11.

14. Yakugaku Zasshi. 2014;134(1):33-8.

15. Intern Med. 2014;53(2):151-4.

16. Dermatitis. 2012 Sep-Oct;23(5):220-1.

17. Acta Medica (Hradec Kralove). 2011;54(4):157-62.

18. Contact Dermatitis. 2006 May;54(5):283-9.

19. Contact Dermatitis. 2013 Jun;68(6):379-80.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. Dr. Baumann also developed and owns the Baumann Skin Type Solution skin typing systems and related products.

Gluten-free food products have inundated the marketplace in recent years as the food industry has responded to greater awareness of celiac sprue disease and wheat sensitivity. Gluten is the primary form of wheat protein.

Wheat is a versatile and globally popular member of the Poaceae or Gramineae family known as grasses; it is of the Triticum species with Triticum aestivum and Triticum vulgare being particularly pervasive.¹ In traditional Iranian medicine, the topical application of wheat germ oil has been used to treat psoriasis.²

Moisturization

In 2008, N. Akhtar and Y. Yazan investigated the effects of a stable emulsion containing two ingredients included to exert anti-aging effects: vitamin C and wheat protein. The antioxidant vitamin C was entrapped in the inner aqueous phase of the water-in-oil-in-water emulsion while wheat protein was incorporated in the oily phase. The investigators prepared and applied stable emulsions to the cheeks of 11 volunteers over 4 weeks, finding that the formulation increased skin moisture.⁷

Melanoma and wheat supplementation

Demidov et al. reported in 2008 on a randomized, pilot, phase II clinical trial to assess the impact of the adjuvant use of a fermented wheat germ extract nutraceutical (Avemar) in high-risk cutaneous melanoma patients. Investigators compared the efficacy of dacarbazine-based adjuvant chemotherapy on survival parameters of melanoma patients to that of the identical treatment supplemented with a 1-year administration of fermented wheat germ extract nutraceutical (FWGE), which is generally recognized as safe. They reported that after a 7-year follow-up, significant differences favoring the nutraceutical group were observed in progression-free and overall survival. Including nutraceutical as an adjuvant treatment for such patients was recommended by the authors.⁸

Telekes et al. noted that nutraceutical is registered as a special nutriment for cancer patients in Hungary that has exhibited potent anticancer activity on cell lines and immunomodulatory activity in vivo.⁹ In 2005, Boros et al. reported that orally administered FWGE suppressed metastatic tumor dissemination and proliferation during and after chemotherapy, surgery, or radiation, with benefits seen in some human cancers and cultured cells as well as some autoimmune disorders and in chemical carcinogenesis prevention.¹⁰

Hypersensitivity and allergic reactions

The risks of sensitization to topical wheat proteins are thought to be higher in patients with atopic dermatitis, who have an impaired skin barrier.¹ Indeed, Codreanu et al. have suggested that topical products containing food proteins of known allergenicity (including wheat) are contraindicated for neonates and infants with atopic dermatitis.¹¹

In 2015, Bonciolini et al. studied 17 patients (13 females and 4 males, median age 36 years) with nonceliac gluten sensitivity presenting with nonspecific skin lesions. The eczema-, psoriasis-, or dermatitis herpetiformis-like lesions on the extensor surfaces of the upper and lower limbs, especially, were confirmed histologically, but immunopathological evaluations revealed pervasive C3 deposits along the dermoepidermal junction in a microgranular/granular pattern (82%). Notably, all of the patients improved markedly after initiating a gluten-free diet.¹²

In 2014, Fukutomi et al. conducted a case-control study of Japanese women aged 20-54 years (157 cases) who self-reported wheat allergy to ascertain the epidemiologic relationship between food allergy to wheat after exposure to facial soaps containing hydrolyzed wheat protein. There were 449 age-matched controls without wheat allergy. Participants answered a Web-based questionnaire about their use of skin and hair care products. The investigators found that current use of the facial soap Cha no Shizuku (Drop of Tea), which contains hydrolyzed wheat protein, was significantly linked to a greater risk of wheat allergy, with use of the soap more frequent in consumers whose wheat allergy had newly emerged (11% vs. 6% in controls).¹³

Cha no Shizuku had earlier been implicated in provoking hundreds of cases of allergic reactions between 2009 and June 2013. R. Teshima noted that the soap contains acid-hydrolyzed wheat protein produced from gluten after partial hydrolysis with hydrogen chloride at 95 ° C for 40 minutes.¹⁴

It is worth noting that case reports of allergic reactions to facial soap containing hydrolyzed wheat protein continue to appear. Iseki et al. described in 2014 a 38-year-old woman who experienced irregular headaches, sleepiness, and an episode of facial rash eruption after daily use for about 1 year of a facial soap with hydrolyzed wheat proteins (Glupearl 19s, which is also used in Cha no Shizuku). The investigators added that the patient’s serum contained wheat-specific IgE antibodies. Symptoms disappeared after the patient abstained from wheat.¹⁵

In 2012, Tammaro studied cutaneous hypersensitivity to gluten in 14 female patients (aged 12-60 years) with celiac disease who presented with eczema on the face, neck, and arms, after topical application of gluten-containing emollient cream, bath or face powder, or contact with foods containing wheat and durum. Five of the patients tested positive for wheat and durum wheat, while none of the 14 control patients tested positive. Improvement in cutaneous lesions, with no relapses during a 6-month follow-up, resulted when these patients used gluten-free cream and bath powder, and wore gloves before handling wheat-containing food.¹⁶

In 2011, Celakovská et al. studied the impact of wheat allergy in 179 adults with atopic eczema (128 females, 51 males; average age 26 years), using open exposure and double-blind, placebo-controlled food challenge tests, as well as specific serum IgE, skin prick, and atopy patch tests. The double-blind, placebo-controlled food challenge test showed that the course of atopic eczema was exacerbated by wheat allergy in eight patients (4.5%). A positive trend revealing that the course of atopic eczema was impacted by wheat allergy emerged during follow-up (at 3, 6, 9, and 12 months).¹⁷

Contact urticaria also has been reported to have been induced by hydrolyzed wheat proteins in cosmetics and is notable for the potential to precede food allergies.^2,3 A wide variety of protein hydrolysates found in hair products have been associated with inducing contact urticaria, particularly in patients with atopic dermatitis.⁴

In 2006, Laurière et al. studied nine female patients without common wheat allergy who presented with contact urticaria to cosmetics containing hydrolyzed wheat proteins; six also had experienced generalized urticaria or anaphylaxis in response to foods containing such wheat proteins. Analyses revealed the importance of hydrolysis in augmenting the allergenicity of wheat proteins through contact or consumption.¹⁸ Immediate contact urticaria in reaction to hydrolyzed wheat protein in topical products also has been reported in a child.¹⁹

Conclusion

Can the presence of wheat hydrolysates in personal care products adversely affect a patient with celiac sprue or wheat sensitivity? The short answer appears to be “yes.” Given the use of hydrolyzed wheat protein in various skin care products, it is important that consumers who have celiac disease or sensitivity to wheat be advised to avoid skin care formulations with such active ingredients. On the positive side of the wheat ledger, there are some indications (albeit in very limited research) that the plant protein may impart beneficial health effects. Much more research is necessary to delineate the full impact of wheat on skin health.

I thank my dermatologist colleague Sharon E. Jacob, MD, at the University of Miami, for suggesting this topic.

References

1. Dermatitis. 2013 Nov-Dec;24(6):291-5.

2. Iran J Med Sci. 2016 May;41(3 Suppl):S54.

3. Contact Dermatitis. 2007 Feb;56(2):119-20.

4. Ann Dermatol Venereol. 2010 Apr;137(4):281-4.

5. Allergy. 1998 Nov;53(11):1078-82.

6. J Drugs Dermatol. 2013 Sep;12(9 Suppl):s133-6.

7. Pak J Pharm Sci. 2008 Jan;21(1):45-50.

8. Cancer Biother Radiopharm. 2008 Aug;23(4):477-82.

9. Nutr Cancer. 2009;61(6):891-9.

10. Ann N Y Acad Sci. 2005 Jun;1051:529-42.

11. Eur Ann Allergy Clin Immunol. 2006 Apr;38(4):126-30.

12. Nutrients. 2015 Sep 15;7(9):7798-805.

13. Allergy. 2014 Oct;69(10):1405-11.

14. Yakugaku Zasshi. 2014;134(1):33-8.

15. Intern Med. 2014;53(2):151-4.

16. Dermatitis. 2012 Sep-Oct;23(5):220-1.

17. Acta Medica (Hradec Kralove). 2011;54(4):157-62.

18. Contact Dermatitis. 2006 May;54(5):283-9.

19. Contact Dermatitis. 2013 Jun;68(6):379-80.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. Dr. Baumann also developed and owns the Baumann Skin Type Solution skin typing systems and related products.

Although endocrinologists are often the go-to specialists for hormone therapy, more than 80% of those surveyed had no training in how to treat transgender patients, a study showed.

Meanwhile, more than a quarter of endocrinology fellowship directors surveyed said their programs don’t offer education in transgender care.

Although endocrinologists are often the go-to specialists for hormone therapy, more than 80% of those surveyed had no training in how to treat transgender patients, a study showed.

Meanwhile, more than a quarter of endocrinology fellowship directors surveyed said their programs don’t offer education in transgender care.

Although endocrinologists are often the go-to specialists for hormone therapy, more than 80% of those surveyed had no training in how to treat transgender patients, a study showed.

Meanwhile, more than a quarter of endocrinology fellowship directors surveyed said their programs don’t offer education in transgender care.

Clinical question: What is the prevalence of outpatient treatment of acute pulmonary embolism (PE)?

Background: PE traditionally is perceived as a serious condition requiring hospitalization. Many studies, however, have shown that outpatient treatment of PE in low-risk, compliant patients is safe. Several scoring systems have been derived to identify patients with PE who are at low risk of adverse events and may be candidates for home treatment.

Clinical question: What is the prevalence of outpatient treatment of acute pulmonary embolism (PE)?

Background: PE traditionally is perceived as a serious condition requiring hospitalization. Many studies, however, have shown that outpatient treatment of PE in low-risk, compliant patients is safe. Several scoring systems have been derived to identify patients with PE who are at low risk of adverse events and may be candidates for home treatment.

Clinical question: What is the prevalence of outpatient treatment of acute pulmonary embolism (PE)?

Background: PE traditionally is perceived as a serious condition requiring hospitalization. Many studies, however, have shown that outpatient treatment of PE in low-risk, compliant patients is safe. Several scoring systems have been derived to identify patients with PE who are at low risk of adverse events and may be candidates for home treatment.