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Associated Herpes Zoster Risk Varies With Psoriasis Therapies
SEOUL, SOUTH KOREA – Treatment of psoriasis patients with biologic agents isn’t associated with increased risk of herpes zoster, according to a large population-based Israeli study.
In contrast, the use of methotrexate, cyclosporine, acitretin, and systemic corticosteroids is associated with an increased risk of herpes zoster in psoriasis patients, Dr. Arnon D. Cohen said at the World Congress of Dermatology.
He reported on 22,330 psoriasis patients followed over 10 years at Clalit Health Services, Israel’s largest HMO. This was a real-world patient population, 53% of whom were female, in contrast to the highly selected populations in randomized clinical trials, which are typically 65%-69% male.
During nearly 220,000 person-years of follow-up there were 1,321 cases of herpes zoster. The baseline rate during periods when patients weren’t on any form of systemic therapy was 4.6 cases/1,000 patient-years. In contrast, the rate during cyclosporine therapy was more than 10-fold higher at 48.4 cases/1,000 patient-years.
Eighteen percent of psoriasis patients were on systemic corticosteroids at some point during the study period; that medication was associated with a herpes zoster rate of 25.7/1,000 patient-years of exposure. Other therapies that conferred significantly increased risk were methotrexate at 17 cases/1,000 patient-years and acitretin (Soriatane) at 5.4 cases/1,000 patient-years, reported Dr. Cohen, director of the department of quality measures at Clalit and a dermatologist at Ben-Gurion University of the Negev, Beer-Sheva, Israel.
In contrast, no cases of herpes zoster occurred in psoriasis patients on alefacept (Amevive), efalizumab (Raptiva) or adalimumab (Humira). Nor was the incidence increased beyond baseline in patients on PUVA, UVB, or etanercept (Enbrel).
In a Cox logistic regression analysis, systemic corticosteroid therapy was associated with a 2.4-fold increased risk of developing herpes zoster. Being female was associated with a significant 16% increase in risk. Infliximab (Remicade) therapy was associated with a 1.8-fold increase in risk, a trend that did not achieve statistical significance (P =.09).
Dr. Cohen and his coinvestigators conducted this study because, even though the biologic agents are recognized as conferring increased risk of tuberculosis and serious bacterial infections, very little is known about their association, if any, with viral infections.
Dr. Cohen declared having no relevant financial interests.
SEOUL, SOUTH KOREA – Treatment of psoriasis patients with biologic agents isn’t associated with increased risk of herpes zoster, according to a large population-based Israeli study.
In contrast, the use of methotrexate, cyclosporine, acitretin, and systemic corticosteroids is associated with an increased risk of herpes zoster in psoriasis patients, Dr. Arnon D. Cohen said at the World Congress of Dermatology.
He reported on 22,330 psoriasis patients followed over 10 years at Clalit Health Services, Israel’s largest HMO. This was a real-world patient population, 53% of whom were female, in contrast to the highly selected populations in randomized clinical trials, which are typically 65%-69% male.
During nearly 220,000 person-years of follow-up there were 1,321 cases of herpes zoster. The baseline rate during periods when patients weren’t on any form of systemic therapy was 4.6 cases/1,000 patient-years. In contrast, the rate during cyclosporine therapy was more than 10-fold higher at 48.4 cases/1,000 patient-years.
Eighteen percent of psoriasis patients were on systemic corticosteroids at some point during the study period; that medication was associated with a herpes zoster rate of 25.7/1,000 patient-years of exposure. Other therapies that conferred significantly increased risk were methotrexate at 17 cases/1,000 patient-years and acitretin (Soriatane) at 5.4 cases/1,000 patient-years, reported Dr. Cohen, director of the department of quality measures at Clalit and a dermatologist at Ben-Gurion University of the Negev, Beer-Sheva, Israel.
In contrast, no cases of herpes zoster occurred in psoriasis patients on alefacept (Amevive), efalizumab (Raptiva) or adalimumab (Humira). Nor was the incidence increased beyond baseline in patients on PUVA, UVB, or etanercept (Enbrel).
In a Cox logistic regression analysis, systemic corticosteroid therapy was associated with a 2.4-fold increased risk of developing herpes zoster. Being female was associated with a significant 16% increase in risk. Infliximab (Remicade) therapy was associated with a 1.8-fold increase in risk, a trend that did not achieve statistical significance (P =.09).
Dr. Cohen and his coinvestigators conducted this study because, even though the biologic agents are recognized as conferring increased risk of tuberculosis and serious bacterial infections, very little is known about their association, if any, with viral infections.
Dr. Cohen declared having no relevant financial interests.
SEOUL, SOUTH KOREA – Treatment of psoriasis patients with biologic agents isn’t associated with increased risk of herpes zoster, according to a large population-based Israeli study.
In contrast, the use of methotrexate, cyclosporine, acitretin, and systemic corticosteroids is associated with an increased risk of herpes zoster in psoriasis patients, Dr. Arnon D. Cohen said at the World Congress of Dermatology.
He reported on 22,330 psoriasis patients followed over 10 years at Clalit Health Services, Israel’s largest HMO. This was a real-world patient population, 53% of whom were female, in contrast to the highly selected populations in randomized clinical trials, which are typically 65%-69% male.
During nearly 220,000 person-years of follow-up there were 1,321 cases of herpes zoster. The baseline rate during periods when patients weren’t on any form of systemic therapy was 4.6 cases/1,000 patient-years. In contrast, the rate during cyclosporine therapy was more than 10-fold higher at 48.4 cases/1,000 patient-years.
Eighteen percent of psoriasis patients were on systemic corticosteroids at some point during the study period; that medication was associated with a herpes zoster rate of 25.7/1,000 patient-years of exposure. Other therapies that conferred significantly increased risk were methotrexate at 17 cases/1,000 patient-years and acitretin (Soriatane) at 5.4 cases/1,000 patient-years, reported Dr. Cohen, director of the department of quality measures at Clalit and a dermatologist at Ben-Gurion University of the Negev, Beer-Sheva, Israel.
In contrast, no cases of herpes zoster occurred in psoriasis patients on alefacept (Amevive), efalizumab (Raptiva) or adalimumab (Humira). Nor was the incidence increased beyond baseline in patients on PUVA, UVB, or etanercept (Enbrel).
In a Cox logistic regression analysis, systemic corticosteroid therapy was associated with a 2.4-fold increased risk of developing herpes zoster. Being female was associated with a significant 16% increase in risk. Infliximab (Remicade) therapy was associated with a 1.8-fold increase in risk, a trend that did not achieve statistical significance (P =.09).
Dr. Cohen and his coinvestigators conducted this study because, even though the biologic agents are recognized as conferring increased risk of tuberculosis and serious bacterial infections, very little is known about their association, if any, with viral infections.
Dr. Cohen declared having no relevant financial interests.
FROM THE WORLD CONGRESS OF DERMATOLOGY
Major Finding: No cases of herpes zoster occurred in psoriasis patients on alefacept (Amevive), efalizumab (Raptiva) or adalimumab (Humira).
Data Source: A population-based study of 22,330 psoriasis patients followed over 10 years at Clalit Health Services, Israel’s largest HMO.
Disclosures: Dr. Cohen reported having no financial conflicts.
Universal HIV Screening Encouraged by AIDS Expert
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we’re caught in this time warp where we’re not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it’s not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We’ve been there. We know this is going to happen. And yet we’re sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical. In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn’t supported by randomized controlled trial evidence. It’s better for the patient’s health, and it’s better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don’t have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we’re caught in this time warp where we’re not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it’s not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We’ve been there. We know this is going to happen. And yet we’re sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical. In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn’t supported by randomized controlled trial evidence. It’s better for the patient’s health, and it’s better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don’t have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we’re caught in this time warp where we’re not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it’s not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We’ve been there. We know this is going to happen. And yet we’re sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical. In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn’t supported by randomized controlled trial evidence. It’s better for the patient’s health, and it’s better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don’t have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
EXPERT ANALYSIS FROM THE WORLD CONGRESS OF DERMATOLOGY
Universal HIV Screening Encouraged by Dr. Marcus Conant
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we're caught in this time warp where we're not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it's not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We've been there. We know this is going to happen. And yet we're sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical.
In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn't supported by randomized controlled trial evidence. It's better for the patient's health, and it's better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don't have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we're caught in this time warp where we're not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it's not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We've been there. We know this is going to happen. And yet we're sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical.
In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn't supported by randomized controlled trial evidence. It's better for the patient's health, and it's better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don't have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we're caught in this time warp where we're not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it's not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We've been there. We know this is going to happen. And yet we're sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical.
In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn't supported by randomized controlled trial evidence. It's better for the patient's health, and it's better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don't have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
EXPERT ANALYSIS FROM THE WORLD CONGRESS OF DERMATOLOGY
Universal HIV Screening Encouraged by AIDS Expert
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we’re caught in this time warp where we’re not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it’s not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We’ve been there. We know this is going to happen. And yet we’re sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical. In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn’t supported by randomized controlled trial evidence. It’s better for the patient’s health, and it’s better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don’t have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we’re caught in this time warp where we’re not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it’s not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We’ve been there. We know this is going to happen. And yet we’re sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical. In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn’t supported by randomized controlled trial evidence. It’s better for the patient’s health, and it’s better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don’t have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
SEOUL, SOUTH KOREA – It is time for a new strategy aimed at preventing HIV infection in the United States, an AIDS expert said at the World Congress of Dermatology.
This strategy ought to be built around universal testing, treatment starting at the moment of diagnosis, and public health monitoring of compliance, said Dr. Marcus Conant, a dermatologist at the University of California, San Francisco, who in 1981 was among the first physicians to identify AIDS and was a cofounder of the San Francisco AIDS Foundation.
The current prevention strategy has been in place since the 1980s. It is based on education about the use of condoms and other safe sex practices, along with voluntary testing for HIV – and it is simply not working.
Roughly 58,000 new cases of HIV have occurred annually in the United States over the past 15 years, with no drop-off trend. It is a prevention strategy that was developed when the epidemic was centered in the gay community. Now the epidemic is moving toward black and Hispanic individuals, who are poorly educated about HIV risk and don’t ask to be tested for HIV because they do not realize they are at risk.
"What was true 30 years ago is no longer true today, and yet we’re caught in this time warp where we’re not changing how we approach the disease. My message really is what we were doing 30 years ago was applicable then, but it’s not applicable today," Dr. Conant said.
Today, one-third of HIV-positive individuals do not know they are infected. Another one-third are aware they are HIV positive but are not on highly active antiretroviral therapy (HAART), most often because they lack health insurance coverage. But it is the remaining third of HIV-infected individuals – those on drug therapy – who are of greatest concern, because only 19% of them have an undetectable viral load. The other 81% on drugs are potentially transmitting partially or totally resistant virus to their sex partners.
"It begs the question of how many years will it take until the virus in America is totally resistant to all of the drugs we currently have. We saw this happen with penicillin and Staphylococcus aureus. We’ve been there. We know this is going to happen. And yet we’re sitting here watching it happen and doing very little about it," Dr. Conant said.
"With 58,000 newly infected individuals per year, and with only 19% of those being treated having undetectable viral loads, we are sitting on a prescription for disaster. Resistance is going to become a huge problem in the next decade," he warned.
Recent studies have demonstrated that early initiation of HAART results in longer survival, fewer side effects, and better compliance. Plus, patients having an undetectable viral load are at lower risk of transmitting the disease to a sex partner. That is why Dr. Conant believes that stopping the HIV epidemic requires testing everyone, treating everyone who is infected, and monitoring all infected individuals in order to strongly encourage maintaining an undetectable viral load.
Everybody, regardless of age, who has blood drawn for any reason – a routine physical exam, pregnancy, induction into the military – should have that blood sample tested for HIV, he said. Pooled polymerase chain reaction testing of low-risk groups, such as women, could be done to make universal testing more economical. In any case, the pharmaceutical industry could easily foot the bill for universal testing. By identifying the one-third of HIV-positive individuals who do not know they’re infected, the drug companies stand to make a fortune in increased sales of HAART, according to Dr. Conant.
Current U.S. guidelines call for initiating HAART in HIV-positive patients with a CD4 count below 350 cells/mm3. But it makes more sense to begin treatment as soon as someone is found to be HIV positive, even though this practice isn’t supported by randomized controlled trial evidence. It’s better for the patient’s health, and it’s better for society because effective therapy stops transmission of the disease, he said.
All HIV-positive individuals could be logged into a computer-based tracking system so local public health departments could identify those who don’t have an undetectable viral load and visit them to find out why, Dr. Conant proposed.
He said he had no relevant financial disclosures.
EXPERT ANALYSIS FROM THE WORLD CONGRESS OF DERMATOLOGY
Individual Counseling Improves Hand Eczema in Health Professionals
SEOUL, SOUTH KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It's a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also need to learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
SEOUL, SOUTH KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It's a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also need to learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
SEOUL, SOUTH KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It's a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also need to learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
FROM THE WORLD CONGRESS OF DERMATOLOGY
Major Finding: A 20- to 25-minute counseling session led to significantly improved Hand Eczema Severity Index and Dermatology Life Quality Index scores.
Data Source: Randomized, single-blind, multicenter Danish trial involving 253 physicians, nurses, and lab technicians with hand eczema.
Disclosures: Dr. Ibler declared having no financial conflicts.
Individual Counseling Improves Hand Eczema in Health Professionals
SEOUL, KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It’s a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
SEOUL, KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It’s a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
SEOUL, KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It’s a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
FROM THE WORLD CONGRESS OF DERMATOLOGY
Major Finding: A 20- to 25-minute counseling session led to significantly improved Hand Eczema Severity Index and Dermatology Life Quality Index scores.
Data Source: Randomized, single-blind, multicenter Danish trial involving 253 physicians, nurses, and lab technicians with hand eczema.
Disclosures: Dr. Ibler declared having no financial conflicts.
Individual Counseling Improves Hand Eczema in Health Professionals
SEOUL, KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It’s a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
SEOUL, KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It’s a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
SEOUL, KOREA – A brief individual counseling session brought significant clinical improvement to physicians and other health care professionals with occupational hand eczema in a Danish randomized clinical trial.
At the core of the 20- to 25-minute one-on-one counseling intervention was instruction in a skin protection program, Dr. Kristina Sophie Ibler explained at the World Congress of Dermatology.
She presented results of the Hand Eczema Trial (HET), which she described as the first clinical trial of secondary prevention of occupational hand eczema in health care workers. The multicenter, single-blind study involved 253 physicians, nurses, and lab technicians with hand eczema of less than 12 months duration. Participants were stratified according to their profession, hospital, and skin disease severity.
The secondary prevention trial was undertaken because hand eczema is the most common occupational skin disease in Denmark, with an incidence of 0.56 cases per 1,000 individuals annually. The prevalence of hand eczema among health care professionals is roughly 30%. It’s a chronic condition that entails substantial sick leave, impaired quality of life, and even permanent work disability, observed Dr. Ibler, a dermatologist at the University of Copenhagen.
All participants in HET were assessed at baseline for disease severity using the standardized Hand Eczema Severity Index. They also completed the Dermatology Life Quality Index and filled out a brief questionnaire on their knowledge regarding skin protective behavior.
The intervention arm underwent patch and skin prick testing to the standard series supplemented by latex and chlorhexidine. Blood tests were obtained looking for elevated levels of specific IgE for latex, chlorhexidine, and ethylene oxide. Based on the results, patients were classified as having irritant or allergic contact dermatitis, atopic dermatitis, or endogenous dermatitis.
The individual counseling session included a demonstration of proper hand-washing technique and instruction in applying moisturizers containing a fluorescent agent so that investigators could assess whether participants were washing correctly. The counseling stressed reducing the number of hand washings per day, substituting a hand disinfectant whenever possible. A perfume-free emollient is to be applied three times during the work day: once upon arrival, so that the emollient has at least half an hour or so to take effect before protective gloves need to be donned, again at lunch time, and just before going home. The moisturizer should also be applied just before going to bed.
Patients also learn to consistently wear protective rubber gloves while doing wet work in the clinic or laboratory, as well as when preparing food or cleaning. If they have a latex allergy, their protective gloves should be vinyl. Any time protective gloves are to be worn for longer than 5-10 minutes, a pair of thin cotton gloves needs to be worn underneath in order to minimize humidity.
After roughly 5 months, the active intervention group had statistically and clinically significant reductions in their Hand Eczema Severity Index score as well as significant improvements in their quality-of-life scores and self-evaluated disease severity. They also reported an increase in skin-protective behaviors, including the routine use of protective gloves teamed with cotton under-gloves, frequent application of emollients, and less hand-washing at work.
Dr. Ibler declared having no financial conflicts.
FROM THE WORLD CONGRESS OF DERMATOLOGY
Major Finding: A 20- to 25-minute counseling session led to significantly improved Hand Eczema Severity Index and Dermatology Life Quality Index scores.
Data Source: Randomized, single-blind, multicenter Danish trial involving 253 physicians, nurses, and lab technicians with hand eczema.
Disclosures: Dr. Ibler declared having no financial conflicts.
Ustekinumab 4-Year Data Show No Increased Cardiovascular Risk
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials was not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern physicians need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern physicians need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern physicians need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials was not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials was not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
FROM THE WORLD CONGRESS OF DERMATOLOGY
Major Finding: The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on ustekinumab for at least 4 years was 0.38 events per 100 patient-years.
Data Source: Ongoing open-label extension of major clinical trials of more than 6,700 patient-years of follow-up.
Disclosures: Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
Ustekinumab 4-Year Data Show No Increased Cardiovascular Risk
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials was not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern physicians need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern physicians need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern physicians need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials was not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials was not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
FROM THE WORLD CONGRESS OF DERMATOLOGY
Major Finding: The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on ustekinumab for at least 4 years was 0.38 events per 100 patient-years.
Data Source: Ongoing open-label extension of major clinical trials of more than 6,700 patient-years of follow-up.
Disclosures: Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
Ustekinumab 4-Year Data Show No Increased Cardiovascular Risk
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials has not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern dermatologists need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern dermatologists need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
at least 5 years of data with large patient numbers are needed to come
to a definitive conclusion regarding safety, said Dr. Alan Menter.
Caution
is appropriate in light of a meta-analysis recently conducted [by him
and his colleagues] of the phase II and III clinical trials of tumor
necrosis factor inhibitors, along with data that could be gained from
pharmaceutical companies.
The as-yet unpublished analysis,
carried out independently of the pharmaceutical industry, suggested a
potential problem involving acceleration of coronary artery disease with
the IL-12/23 inhibitors that has not been seen before with anti-TNF
agents. This is a concern dermatologists need to pay attention to as
additional data on IL-12/23 inhibitors become available.
Dr. Menter
is chairman of the division of dermatology at Baylor University Medical
Center in Dallas. He has served as a consultant and speaker for and/or
participated in clinical trials sponsored by Abbott, Biogen Idec,
Bristol-Myers Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and
Wyeth.
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials has not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
SEOUL, SOUTH KOREA – Results from a 4-year ustekinumab follow-up study paint a reassuring safety picture, with no evidence of cumulative toxicity, according to Dr. Kristian Reich.
Particularly welcome was the finding that a possible increased risk of major adverse cardiovascular events (MACE) noted during the initial placebo-controlled phase of the clinical trials has not been borne out at the 4-year follow-up mark.
The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on the interleukin-12/23 antagonist for at least 4 years – 0.38 events per 100 patient-years – was significantly lower than expected based upon their Framingham Risk Score or U.K. General Practice Research Database (GPRD) profile, Dr. Reich said at the World Congress of Dermatology.
This finding is consistent with the notion that reducing systemic inflammation in patients with moderate to severe psoriasis via highly effective biologic therapy may reduce their disease-related cardiovascular risk to a level similar to, and perhaps even lower than, that of the general population, observed Dr. Reich, professor of dermatology at Georg-August University in Göttingen, Germany.
He noted the ustekinumab (Stelara) safety data from the ongoing open-label extensions of major randomized clinical trials includes 1,129 psoriasis patients on the biologic agent for at least 3 years and 619 treated for 4 years or more. Total follow-up exceeds 6,700 patient-years.
"This is one of the largest long-term databases for any biologic therapy for psoriasis so far," he pointed out.
Key findings from the 4-year analysis were reported in the following areas:
• MACE. Participants in the ustekinumab clinical trials program had a substantial burden of cardiovascular risk factors: a 48% baseline prevalence of obesity, along with hypertension in 27% of patients, dyslipidemia in 20%, a past or current history of smoking in 63%, and a family history of early coronary disease in 12%. Nearly 70% were men.
The 24 MACE events observed through 4 years of ustekinumab therapy compares with an expected 47 events based upon Framingham Risk Score and 70 expected events among similar psoriasis patients not on biologic therapy in the GPRD. This translates to an adjusted 49% risk reduction in ustekinumab-treated patients compared with Framingham expectation, and a 66% relative risk reduction compared with expectation for psoriasis patients in the GPRD.
The 4-year MACE rate with ustekinumab compares favorably with rates observed with other biologic agents in psoriasis patients. For example, the combined rate of MI or stroke in 506 Canadian psoriasis patients treated with etanercept (Enbrel) for up to 4 years was 0.84 events per 100 patient-years. And in a comprehensive 4-year adalimumab (Humira) safety report Dr. Reich presented at the world congress, the MACE rate was similar to the 0.38 per 100-patient-years seen with ustekinumab.
• Serious infections. The serious infection rate in the ustekinumab analysis was 1.1 events per 100 patient-years of exposure, compared with 1.3 events per 100 patient-years in the latest adalimumab analysis, and 1.6 per 100 patient-years of exposure to etanercept in an open-label extension phase of two phase-III trials totaling 912 patients.
"There's no indication that the serious infection rate with ustekinumab is increased beyond that expected with anti–tumor necrosis factor agents. And the per-year ustekinumab analysis shows no evidence of cumulative immunosuppression that would show up in a rising serious infection rate over time; it's absolutely stable over time," he said.
• Nonmelanoma skin cancer. The cumulative rate was 0.6 cases per 100 patient-years of exposure to ustekinumab, compared with 0.7 per 100 patient-years in the adalimumab analysis. As with serious infections, there was no sign of an increased rate of nonmelanoma skin cancers year by year with ustekinumab.
• Other malignancies. The rate of 0.6 per 100 patient-years of exposure to ustekinumab translated to an observed 41 events through 4 years of follow-up, closely similar to the 39 cases to be expected in a healthy population based on extrapolation from the National Cancer Institute's Surveillance, Epidemiology, and End Results database.
Follow-up of participants in the open-label extension of the ustekinumab clinical trials in psoriasis will continue through 5 years of exposure, with additional safety data accruing from clinical trials in psoriatic arthritis, according to Dr. Reich.
Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.
FROM THE WORLD CONGRESS OF DERMATOLOGY
Major Finding: The observed combined rate of MI, stroke, and cardiovascular death in psoriasis patients on ustekinumab for at least 4 years was 0.38 events per 100 patient-years.
Data Source: Ongoing open-label extension of major clinical trials of more than 6,700 patient-years of follow-up.
Disclosures: Dr. Reich is a consultant to Janssen, which markets ustekinumab outside the United States.