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Katharina Eikermann-Haerter, MD
Jes Olesen, MD
Jeffrey S. Mogil, PhD
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VIDEO: Off-label dupilumab finding a home in pediatric AD
KAUAI, HAWAII – Pediatric dermatologists aren’t waiting for Food and Drug Administration approval to try dupilumab (Dupixent) for their patients with severe atopic dermatitis.
It’s not approved in children, but the possibility of good control without the side effects of cyclosporine and other alternatives is too much to resist. A phase 2, company-sponsored study reported Eczema Area and Severity Index score improvements of up to 76% in pediatric patients treated with dupilumab, an interleukin-4 and IL-13 signaling blocker approved in 2017 for moderate to severe AD in adults.
Large pediatric trials are pending, but with results like that, “many of us just feel if it was our own kid, and we could get dupilumab, we would like to do that first,” said Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego.
It’s not just dupilumab that’s causing excitement. With almost 20 biologics in the pipeline, eczema seems poised to undergo a revolution in treatment much like psoriasis has in recent years.
Dr. Eichenfield explained (Eucrisa), a topical nonsteroidal phosphodiesterase-4 inhibitor approved for mild to moderate AD for children and adults ages two and older in December 2016, which doesn’t seem to have the duration limits of steroids, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Treatment of pediatric AD is “going to be a very different picture over the next few years,” he said.
Dr. Eichenfield is a consultant or investigator for many companies, including Regeneron/Sanofi, Genentech, Novartis, Pfizer, Lilly, and Allergan.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Pediatric dermatologists aren’t waiting for Food and Drug Administration approval to try dupilumab (Dupixent) for their patients with severe atopic dermatitis.
It’s not approved in children, but the possibility of good control without the side effects of cyclosporine and other alternatives is too much to resist. A phase 2, company-sponsored study reported Eczema Area and Severity Index score improvements of up to 76% in pediatric patients treated with dupilumab, an interleukin-4 and IL-13 signaling blocker approved in 2017 for moderate to severe AD in adults.
Large pediatric trials are pending, but with results like that, “many of us just feel if it was our own kid, and we could get dupilumab, we would like to do that first,” said Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego.
It’s not just dupilumab that’s causing excitement. With almost 20 biologics in the pipeline, eczema seems poised to undergo a revolution in treatment much like psoriasis has in recent years.
Dr. Eichenfield explained (Eucrisa), a topical nonsteroidal phosphodiesterase-4 inhibitor approved for mild to moderate AD for children and adults ages two and older in December 2016, which doesn’t seem to have the duration limits of steroids, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Treatment of pediatric AD is “going to be a very different picture over the next few years,” he said.
Dr. Eichenfield is a consultant or investigator for many companies, including Regeneron/Sanofi, Genentech, Novartis, Pfizer, Lilly, and Allergan.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Pediatric dermatologists aren’t waiting for Food and Drug Administration approval to try dupilumab (Dupixent) for their patients with severe atopic dermatitis.
It’s not approved in children, but the possibility of good control without the side effects of cyclosporine and other alternatives is too much to resist. A phase 2, company-sponsored study reported Eczema Area and Severity Index score improvements of up to 76% in pediatric patients treated with dupilumab, an interleukin-4 and IL-13 signaling blocker approved in 2017 for moderate to severe AD in adults.
Large pediatric trials are pending, but with results like that, “many of us just feel if it was our own kid, and we could get dupilumab, we would like to do that first,” said Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego.
It’s not just dupilumab that’s causing excitement. With almost 20 biologics in the pipeline, eczema seems poised to undergo a revolution in treatment much like psoriasis has in recent years.
Dr. Eichenfield explained (Eucrisa), a topical nonsteroidal phosphodiesterase-4 inhibitor approved for mild to moderate AD for children and adults ages two and older in December 2016, which doesn’t seem to have the duration limits of steroids, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Treatment of pediatric AD is “going to be a very different picture over the next few years,” he said.
Dr. Eichenfield is a consultant or investigator for many companies, including Regeneron/Sanofi, Genentech, Novartis, Pfizer, Lilly, and Allergan.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: The skinny on patch testing
KAUAI, HAWAII – .
That’s sometimes the assumption, but it’s incorrect, according to Mark Davis, MD, chair of the department of dermatology at the Mayo Clinic, Rochester, Minn. Tixocortol is the marker for topical steroid allergy in many series of patch tests, but there is research showing that it is a marker for one class of topical steroids, and “there’s substantial literature saying that if you’re only reacting to tixocortol pivalate, it should be safe to use other classes of topical steroids,” he said.
It’s also important to remember that skin patch tests need to be checked on day 5, not just day 3; it’s the only way to differentiate a true skin allergy from mere skin irritation, and it does matter.
Dr. Davis explained those issues and more – including what to do with minor reactions and how to use the T.R.U.E. TEST kit – in an interview filled with pearls at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Meanwhile, during a presentation at the meeting, he noted two newer options to help allergic patients find skin care products they won’t react to: the Mayo Clinic’s SkinSAFE database and the Contact Allergen Management Program from the American Contact Dermatitis Society.
Dr. Davis had no disclosures.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – .
That’s sometimes the assumption, but it’s incorrect, according to Mark Davis, MD, chair of the department of dermatology at the Mayo Clinic, Rochester, Minn. Tixocortol is the marker for topical steroid allergy in many series of patch tests, but there is research showing that it is a marker for one class of topical steroids, and “there’s substantial literature saying that if you’re only reacting to tixocortol pivalate, it should be safe to use other classes of topical steroids,” he said.
It’s also important to remember that skin patch tests need to be checked on day 5, not just day 3; it’s the only way to differentiate a true skin allergy from mere skin irritation, and it does matter.
Dr. Davis explained those issues and more – including what to do with minor reactions and how to use the T.R.U.E. TEST kit – in an interview filled with pearls at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Meanwhile, during a presentation at the meeting, he noted two newer options to help allergic patients find skin care products they won’t react to: the Mayo Clinic’s SkinSAFE database and the Contact Allergen Management Program from the American Contact Dermatitis Society.
Dr. Davis had no disclosures.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – .
That’s sometimes the assumption, but it’s incorrect, according to Mark Davis, MD, chair of the department of dermatology at the Mayo Clinic, Rochester, Minn. Tixocortol is the marker for topical steroid allergy in many series of patch tests, but there is research showing that it is a marker for one class of topical steroids, and “there’s substantial literature saying that if you’re only reacting to tixocortol pivalate, it should be safe to use other classes of topical steroids,” he said.
It’s also important to remember that skin patch tests need to be checked on day 5, not just day 3; it’s the only way to differentiate a true skin allergy from mere skin irritation, and it does matter.
Dr. Davis explained those issues and more – including what to do with minor reactions and how to use the T.R.U.E. TEST kit – in an interview filled with pearls at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Meanwhile, during a presentation at the meeting, he noted two newer options to help allergic patients find skin care products they won’t react to: the Mayo Clinic’s SkinSAFE database and the Contact Allergen Management Program from the American Contact Dermatitis Society.
Dr. Davis had no disclosures.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Advanced practice providers take on many roles in MS care
SAN DIEGO – A new survey suggests that advanced practice providers who care for multiple sclerosis patients are highly satisfied with their jobs, which encompass a wide range of responsibilities.
Researchers received survey responses from 215 nurse practitioners and 395 physician assistants who answered Web questionnaires in 2016 and 2017. Of those who care for multiple sclerosis (MS) patients, 92.5% and 77.8% respectively said they provide at least 9 of 11 services, such as direct care, supportive services, and care coordination.
“Nurse practitioners in particular are providing lots of different services from diagnosis to education to symptom management,” said Michael T. Halpern, MD, PhD, MPH, of Temple University, Philadelphia. “Physician assistants are also providing a diverse range of MS services, but not as frequently as nurse practitioners.”
Dr. Halpern was the presenting author of the study reporting the survey results. He spoke in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis, where the study findings were presented.
Advanced practice providers also reported high levels of job satisfaction. About 80% in both groups reported being very or extremely satisfied with their careers and with their colleagues; 90% of nurse practitioners reported being very or extremely satisfied by their relationships with patients, as did 86% of physician assistants.
The providers “appear to really enjoy working with individuals with MS,” Dr. Halpern said. But he cautioned that there’s a need for additional training for these providers; some respondents said their lack of knowledge was a hindrance to care.
The study was funded by the National Multiple Sclerosis Society. Dr. Halpern reported no relevant disclosures.
SAN DIEGO – A new survey suggests that advanced practice providers who care for multiple sclerosis patients are highly satisfied with their jobs, which encompass a wide range of responsibilities.
Researchers received survey responses from 215 nurse practitioners and 395 physician assistants who answered Web questionnaires in 2016 and 2017. Of those who care for multiple sclerosis (MS) patients, 92.5% and 77.8% respectively said they provide at least 9 of 11 services, such as direct care, supportive services, and care coordination.
“Nurse practitioners in particular are providing lots of different services from diagnosis to education to symptom management,” said Michael T. Halpern, MD, PhD, MPH, of Temple University, Philadelphia. “Physician assistants are also providing a diverse range of MS services, but not as frequently as nurse practitioners.”
Dr. Halpern was the presenting author of the study reporting the survey results. He spoke in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis, where the study findings were presented.
Advanced practice providers also reported high levels of job satisfaction. About 80% in both groups reported being very or extremely satisfied with their careers and with their colleagues; 90% of nurse practitioners reported being very or extremely satisfied by their relationships with patients, as did 86% of physician assistants.
The providers “appear to really enjoy working with individuals with MS,” Dr. Halpern said. But he cautioned that there’s a need for additional training for these providers; some respondents said their lack of knowledge was a hindrance to care.
The study was funded by the National Multiple Sclerosis Society. Dr. Halpern reported no relevant disclosures.
SAN DIEGO – A new survey suggests that advanced practice providers who care for multiple sclerosis patients are highly satisfied with their jobs, which encompass a wide range of responsibilities.
Researchers received survey responses from 215 nurse practitioners and 395 physician assistants who answered Web questionnaires in 2016 and 2017. Of those who care for multiple sclerosis (MS) patients, 92.5% and 77.8% respectively said they provide at least 9 of 11 services, such as direct care, supportive services, and care coordination.
“Nurse practitioners in particular are providing lots of different services from diagnosis to education to symptom management,” said Michael T. Halpern, MD, PhD, MPH, of Temple University, Philadelphia. “Physician assistants are also providing a diverse range of MS services, but not as frequently as nurse practitioners.”
Dr. Halpern was the presenting author of the study reporting the survey results. He spoke in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis, where the study findings were presented.
Advanced practice providers also reported high levels of job satisfaction. About 80% in both groups reported being very or extremely satisfied with their careers and with their colleagues; 90% of nurse practitioners reported being very or extremely satisfied by their relationships with patients, as did 86% of physician assistants.
The providers “appear to really enjoy working with individuals with MS,” Dr. Halpern said. But he cautioned that there’s a need for additional training for these providers; some respondents said their lack of knowledge was a hindrance to care.
The study was funded by the National Multiple Sclerosis Society. Dr. Halpern reported no relevant disclosures.
REPORTING FROM ACTRIMS FORUM 2018
VIDEO: Painless PDT and other AK tricks
KAUAI, HAWAII – Imiquimod on the lip can be extremely painful, but it works wonders for actinic cheilitis, sometimes with only a few treatments.
Also, and how long patients stay under the lamp, advised Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
These are just a few of the tips Dr. Rosen shared in a presentation about AKs at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
In a video interview after his talk, he went into detail about the use of imiquimod for actinic cheilitis – AKs of the lip – and painless PDT, as well as how to discuss AKs with patients – and a quick, clever way to help distinguish AKs from squamous cell carcinoma.
Dr. Rosen is an adviser to Aclaris, Cipher, Pfizer, and Valeant.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Imiquimod on the lip can be extremely painful, but it works wonders for actinic cheilitis, sometimes with only a few treatments.
Also, and how long patients stay under the lamp, advised Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
These are just a few of the tips Dr. Rosen shared in a presentation about AKs at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
In a video interview after his talk, he went into detail about the use of imiquimod for actinic cheilitis – AKs of the lip – and painless PDT, as well as how to discuss AKs with patients – and a quick, clever way to help distinguish AKs from squamous cell carcinoma.
Dr. Rosen is an adviser to Aclaris, Cipher, Pfizer, and Valeant.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Imiquimod on the lip can be extremely painful, but it works wonders for actinic cheilitis, sometimes with only a few treatments.
Also, and how long patients stay under the lamp, advised Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
These are just a few of the tips Dr. Rosen shared in a presentation about AKs at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
In a video interview after his talk, he went into detail about the use of imiquimod for actinic cheilitis – AKs of the lip – and painless PDT, as well as how to discuss AKs with patients – and a quick, clever way to help distinguish AKs from squamous cell carcinoma.
Dr. Rosen is an adviser to Aclaris, Cipher, Pfizer, and Valeant.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: What to monitor during isotretinoin treatment
KAUAI, HAWAII – Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center, Morristown, N.J., recently changed how she monitors patients on isotretinoin.
The latest research indicates that ongoing CBCs really aren’t necessary, and that GGT (gamma-glutamyl transferase), which is liver specific, is a far better option than ALT/AST to keep tabs on the liver. Creatine kinase can’t be ignored, either, especially in young, athletic patients, because of the risk of rhabdomyolysis.
In a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Baldwin explained the thinking behind her new approach, plus what else needs to be monitored and for how long – and the level of creatine kinase that should raise a red flag for clinicians.
Dr. Baldwin is a speaker, advisor, and/or investigator for a number of companies, including Allergan, Galderma, and La Roche Posay.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center, Morristown, N.J., recently changed how she monitors patients on isotretinoin.
The latest research indicates that ongoing CBCs really aren’t necessary, and that GGT (gamma-glutamyl transferase), which is liver specific, is a far better option than ALT/AST to keep tabs on the liver. Creatine kinase can’t be ignored, either, especially in young, athletic patients, because of the risk of rhabdomyolysis.
In a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Baldwin explained the thinking behind her new approach, plus what else needs to be monitored and for how long – and the level of creatine kinase that should raise a red flag for clinicians.
Dr. Baldwin is a speaker, advisor, and/or investigator for a number of companies, including Allergan, Galderma, and La Roche Posay.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center, Morristown, N.J., recently changed how she monitors patients on isotretinoin.
The latest research indicates that ongoing CBCs really aren’t necessary, and that GGT (gamma-glutamyl transferase), which is liver specific, is a far better option than ALT/AST to keep tabs on the liver. Creatine kinase can’t be ignored, either, especially in young, athletic patients, because of the risk of rhabdomyolysis.
In a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Baldwin explained the thinking behind her new approach, plus what else needs to be monitored and for how long – and the level of creatine kinase that should raise a red flag for clinicians.
Dr. Baldwin is a speaker, advisor, and/or investigator for a number of companies, including Allergan, Galderma, and La Roche Posay.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Rivaroxaban plus aspirin halves ischemic strokes
LOS ANGELES – Combined treatment with a low dosage of the anticoagulant rivaroxaban plus aspirin cut the incidence of ischemic strokes nearly in half, compared with aspirin alone, in a multicenter, randomized trial of more than 27,000 patients with stable atherosclerotic vascular disease.
This dramatic reduction in ischemic strokes as well as in all-cause strokes by adding low-dose rivaroxaban(Xarelto) occurred without any significant increase in hemorrhagic strokes but with a small increase in total major bleeding events, such as gastrointestinal bleeds, Mike Sharma, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
“There was a consistent effect across all strata of stroke risk. For patients who had a prior stroke, it’s pretty clear to use rivaroxaban plus aspirin because it had a big benefit” with no increase in intracranial hemorrhages, Dr. Sharma said in a video interview.
“We think these results will fundamentally change how we approach stroke prevention,” added Dr. Sharma, a stroke neurologist in the Population Health Research Institute of McMaster University in Hamilton, Ont.
The results he reported came from a secondary analysis of data collected in the COMPASS (Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease) trial, which enrolled 27,395 patients with stable coronary or peripheral artery disease at 602 centers in 33 countries.
The primary outcome of the trial, reported in 2017, was the combined rate of cardiovascular death, MI, or stroke during an average 23 months of follow-up, which occurred in 4.1% of patients treated with 2.5 mg rivaroxaban twice daily plus 100 mg aspirin once daily, 4.9% of patients who received 5.0 mg rivaroxaban twice daily, and 5.4% in patients who received 100 mg aspirin daily, a statistically significant 24% relative risk reduction in the combined treatment group, compared with aspirin only. The rivaroxaban only–treated patients did not significantly differ from the control patients who received only aspirin (N Engl J Med. 2017 Oct 5;377[14]:1319-30). The main results showed a 1.2% increase in the rate of major bleeds in patients treated with rivaroxaban plus aspirin, compared with aspirin only, but the rate of nonfatal symptomatic intracranial hemorrhages was identical in the two treatment groups.
The new results Dr. Sharma reported at the conference focused on various measures of stroke. The rate of all strokes was 42% lower among the patients treated with rivaroxaban plus aspirin, compared with the aspirin alone patients, and ischemic strokes were 49% lower with the dual therapy, compared with aspirin only. Both differences were statistically significant. In contrast, the rivaroxaban alone regimen did not significantly reduce all-cause strokes. It did significantly reduce ischemic strokes, compared with aspirin only, but it also significantly increased hemorrhagic strokes, compared with aspirin only, an adverse effect not caused by the combination of low-dose rivaroxaban plus aspirin.
Rivaroxaban plus aspirin surpassed aspirin alone for preventing both mild and severe strokes and for preventing strokes both in patients with a history of a prior stroke and in those who never had a prior stroke. The stroke reduction produced by rivaroxaban plus aspirin was greatest in the highest risk patients – those with a prior stroke. On the combined regimen, these patients had an average stroke incidence of 0.7% per year, compared with an annual 3.4% rate among the patients on aspirin only, a 2.7% absolute reduction by using rivaroxaban plus aspirin that translated into a number needed to treat of 37 patients with a history of stroke to prevent one new stroke per year.
The 2017 report of the main COMPASS results included a net clinical benefit analysis that factored together the primary endpoint events and major bleeding events. The net rate of all these events was 4.7% with rivaroxaban plus aspirin and 5.9% with aspirin only, a statistically significant 20% relative risk reduction for all adverse outcomes with dual therapy. This net clinical benefit suggests that adding rivaroxaban has a cost-effective benefit. Assessment of rivaroxaban’s cost benefit in COMPASS is in process, Dr. Sharma said.
Rivaroxaban received Food and Drug Administration marketing approval in 2011 for preventing deep vein thrombosis and preventing stroke in patients with atrial fibrillation at dosages higher than what was used in COMPASS. The approved rivaroxaban dosage for preventing deep vein thrombosis is 10 mg/day, and 20 mg/day for preventing stroke in atrial fibrillation patients. The 2.5-mg formulation of rivaroxaban that was given twice daily had the best safety and efficacy in COMPASS, but it is not available now on the U.S. market, although it is available in Europe. Johnson & Johnson, which markets rivaroxaban globally with Bayer, submitted an application to the FDA in December for marketing approval of the 2.5-mg formulation in twice-daily dosing for use as in the COMPASS trial.
COMPASS was sponsored by Bayer, the company that markets rivaroxaban in collaboration with Johnson & Johnson. Dr. Sharma has been a consultant or adviser to Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, and Daiichi-Sankyo.
SOURCE: Sharma M et al. ISC 2018, Abstract LB7.
LOS ANGELES – Combined treatment with a low dosage of the anticoagulant rivaroxaban plus aspirin cut the incidence of ischemic strokes nearly in half, compared with aspirin alone, in a multicenter, randomized trial of more than 27,000 patients with stable atherosclerotic vascular disease.
This dramatic reduction in ischemic strokes as well as in all-cause strokes by adding low-dose rivaroxaban(Xarelto) occurred without any significant increase in hemorrhagic strokes but with a small increase in total major bleeding events, such as gastrointestinal bleeds, Mike Sharma, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
“There was a consistent effect across all strata of stroke risk. For patients who had a prior stroke, it’s pretty clear to use rivaroxaban plus aspirin because it had a big benefit” with no increase in intracranial hemorrhages, Dr. Sharma said in a video interview.
“We think these results will fundamentally change how we approach stroke prevention,” added Dr. Sharma, a stroke neurologist in the Population Health Research Institute of McMaster University in Hamilton, Ont.
The results he reported came from a secondary analysis of data collected in the COMPASS (Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease) trial, which enrolled 27,395 patients with stable coronary or peripheral artery disease at 602 centers in 33 countries.
The primary outcome of the trial, reported in 2017, was the combined rate of cardiovascular death, MI, or stroke during an average 23 months of follow-up, which occurred in 4.1% of patients treated with 2.5 mg rivaroxaban twice daily plus 100 mg aspirin once daily, 4.9% of patients who received 5.0 mg rivaroxaban twice daily, and 5.4% in patients who received 100 mg aspirin daily, a statistically significant 24% relative risk reduction in the combined treatment group, compared with aspirin only. The rivaroxaban only–treated patients did not significantly differ from the control patients who received only aspirin (N Engl J Med. 2017 Oct 5;377[14]:1319-30). The main results showed a 1.2% increase in the rate of major bleeds in patients treated with rivaroxaban plus aspirin, compared with aspirin only, but the rate of nonfatal symptomatic intracranial hemorrhages was identical in the two treatment groups.
The new results Dr. Sharma reported at the conference focused on various measures of stroke. The rate of all strokes was 42% lower among the patients treated with rivaroxaban plus aspirin, compared with the aspirin alone patients, and ischemic strokes were 49% lower with the dual therapy, compared with aspirin only. Both differences were statistically significant. In contrast, the rivaroxaban alone regimen did not significantly reduce all-cause strokes. It did significantly reduce ischemic strokes, compared with aspirin only, but it also significantly increased hemorrhagic strokes, compared with aspirin only, an adverse effect not caused by the combination of low-dose rivaroxaban plus aspirin.
Rivaroxaban plus aspirin surpassed aspirin alone for preventing both mild and severe strokes and for preventing strokes both in patients with a history of a prior stroke and in those who never had a prior stroke. The stroke reduction produced by rivaroxaban plus aspirin was greatest in the highest risk patients – those with a prior stroke. On the combined regimen, these patients had an average stroke incidence of 0.7% per year, compared with an annual 3.4% rate among the patients on aspirin only, a 2.7% absolute reduction by using rivaroxaban plus aspirin that translated into a number needed to treat of 37 patients with a history of stroke to prevent one new stroke per year.
The 2017 report of the main COMPASS results included a net clinical benefit analysis that factored together the primary endpoint events and major bleeding events. The net rate of all these events was 4.7% with rivaroxaban plus aspirin and 5.9% with aspirin only, a statistically significant 20% relative risk reduction for all adverse outcomes with dual therapy. This net clinical benefit suggests that adding rivaroxaban has a cost-effective benefit. Assessment of rivaroxaban’s cost benefit in COMPASS is in process, Dr. Sharma said.
Rivaroxaban received Food and Drug Administration marketing approval in 2011 for preventing deep vein thrombosis and preventing stroke in patients with atrial fibrillation at dosages higher than what was used in COMPASS. The approved rivaroxaban dosage for preventing deep vein thrombosis is 10 mg/day, and 20 mg/day for preventing stroke in atrial fibrillation patients. The 2.5-mg formulation of rivaroxaban that was given twice daily had the best safety and efficacy in COMPASS, but it is not available now on the U.S. market, although it is available in Europe. Johnson & Johnson, which markets rivaroxaban globally with Bayer, submitted an application to the FDA in December for marketing approval of the 2.5-mg formulation in twice-daily dosing for use as in the COMPASS trial.
COMPASS was sponsored by Bayer, the company that markets rivaroxaban in collaboration with Johnson & Johnson. Dr. Sharma has been a consultant or adviser to Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, and Daiichi-Sankyo.
SOURCE: Sharma M et al. ISC 2018, Abstract LB7.
LOS ANGELES – Combined treatment with a low dosage of the anticoagulant rivaroxaban plus aspirin cut the incidence of ischemic strokes nearly in half, compared with aspirin alone, in a multicenter, randomized trial of more than 27,000 patients with stable atherosclerotic vascular disease.
This dramatic reduction in ischemic strokes as well as in all-cause strokes by adding low-dose rivaroxaban(Xarelto) occurred without any significant increase in hemorrhagic strokes but with a small increase in total major bleeding events, such as gastrointestinal bleeds, Mike Sharma, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
“There was a consistent effect across all strata of stroke risk. For patients who had a prior stroke, it’s pretty clear to use rivaroxaban plus aspirin because it had a big benefit” with no increase in intracranial hemorrhages, Dr. Sharma said in a video interview.
“We think these results will fundamentally change how we approach stroke prevention,” added Dr. Sharma, a stroke neurologist in the Population Health Research Institute of McMaster University in Hamilton, Ont.
The results he reported came from a secondary analysis of data collected in the COMPASS (Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease) trial, which enrolled 27,395 patients with stable coronary or peripheral artery disease at 602 centers in 33 countries.
The primary outcome of the trial, reported in 2017, was the combined rate of cardiovascular death, MI, or stroke during an average 23 months of follow-up, which occurred in 4.1% of patients treated with 2.5 mg rivaroxaban twice daily plus 100 mg aspirin once daily, 4.9% of patients who received 5.0 mg rivaroxaban twice daily, and 5.4% in patients who received 100 mg aspirin daily, a statistically significant 24% relative risk reduction in the combined treatment group, compared with aspirin only. The rivaroxaban only–treated patients did not significantly differ from the control patients who received only aspirin (N Engl J Med. 2017 Oct 5;377[14]:1319-30). The main results showed a 1.2% increase in the rate of major bleeds in patients treated with rivaroxaban plus aspirin, compared with aspirin only, but the rate of nonfatal symptomatic intracranial hemorrhages was identical in the two treatment groups.
The new results Dr. Sharma reported at the conference focused on various measures of stroke. The rate of all strokes was 42% lower among the patients treated with rivaroxaban plus aspirin, compared with the aspirin alone patients, and ischemic strokes were 49% lower with the dual therapy, compared with aspirin only. Both differences were statistically significant. In contrast, the rivaroxaban alone regimen did not significantly reduce all-cause strokes. It did significantly reduce ischemic strokes, compared with aspirin only, but it also significantly increased hemorrhagic strokes, compared with aspirin only, an adverse effect not caused by the combination of low-dose rivaroxaban plus aspirin.
Rivaroxaban plus aspirin surpassed aspirin alone for preventing both mild and severe strokes and for preventing strokes both in patients with a history of a prior stroke and in those who never had a prior stroke. The stroke reduction produced by rivaroxaban plus aspirin was greatest in the highest risk patients – those with a prior stroke. On the combined regimen, these patients had an average stroke incidence of 0.7% per year, compared with an annual 3.4% rate among the patients on aspirin only, a 2.7% absolute reduction by using rivaroxaban plus aspirin that translated into a number needed to treat of 37 patients with a history of stroke to prevent one new stroke per year.
The 2017 report of the main COMPASS results included a net clinical benefit analysis that factored together the primary endpoint events and major bleeding events. The net rate of all these events was 4.7% with rivaroxaban plus aspirin and 5.9% with aspirin only, a statistically significant 20% relative risk reduction for all adverse outcomes with dual therapy. This net clinical benefit suggests that adding rivaroxaban has a cost-effective benefit. Assessment of rivaroxaban’s cost benefit in COMPASS is in process, Dr. Sharma said.
Rivaroxaban received Food and Drug Administration marketing approval in 2011 for preventing deep vein thrombosis and preventing stroke in patients with atrial fibrillation at dosages higher than what was used in COMPASS. The approved rivaroxaban dosage for preventing deep vein thrombosis is 10 mg/day, and 20 mg/day for preventing stroke in atrial fibrillation patients. The 2.5-mg formulation of rivaroxaban that was given twice daily had the best safety and efficacy in COMPASS, but it is not available now on the U.S. market, although it is available in Europe. Johnson & Johnson, which markets rivaroxaban globally with Bayer, submitted an application to the FDA in December for marketing approval of the 2.5-mg formulation in twice-daily dosing for use as in the COMPASS trial.
COMPASS was sponsored by Bayer, the company that markets rivaroxaban in collaboration with Johnson & Johnson. Dr. Sharma has been a consultant or adviser to Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, and Daiichi-Sankyo.
SOURCE: Sharma M et al. ISC 2018, Abstract LB7.
REPORTING FROM ISC 2018
Key clinical point: Rivaroxaban plus aspirin cuts strokes in patients with stable atherosclerotic vascular disease.
Major finding: Rivaroxaban plus aspirin cut the rate of ischemic strokes by 49%, compared with aspirin only.
Study details: Secondary analysis from the COMPASS trial, a multicenter, randomized trial with 27,395 patients.
Disclosures: COMPASS was sponsored by Bayer, the company that markets rivaroxaban in collaboration with Johnson & Johnson. Dr. Sharma has been a consultant or adviser to Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, and Daiichi-Sankyo.
Source: Sharma M et al. ISC 2018, Abstract LB7.
VIDEO: Dupilumab or cyclosporine for treating atopic dermatitis?
KAUAI, HAWAII – Sometimes, older is better, according to Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland.
Dr. Simpson was a key investigator in trials that were the basis of dupilumab’s approval in 2017 for adults with moderate to severe atopic dermatitis (AD), but there’s still a role for cyclosporine and other old standbys, he said in a video interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
He said he’s asked all the time how to pick a systemic treatment for AD when topicals aren’t doing the trick. In the interview, he explained how dupilumab (Dupixent) fits into the picture, and how to select the right systemic therapy for the right patient. There are not a lot of data yet pointing to one option over the others for first-line treatment; a lot of it comes down to clinical smarts and patient preference.
Dr. Simpson is a consultant and/or investigator for a number of companies, including Eli Lilly, Pfizer, Novartis, and dupilumab manufacturer, Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Sometimes, older is better, according to Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland.
Dr. Simpson was a key investigator in trials that were the basis of dupilumab’s approval in 2017 for adults with moderate to severe atopic dermatitis (AD), but there’s still a role for cyclosporine and other old standbys, he said in a video interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
He said he’s asked all the time how to pick a systemic treatment for AD when topicals aren’t doing the trick. In the interview, he explained how dupilumab (Dupixent) fits into the picture, and how to select the right systemic therapy for the right patient. There are not a lot of data yet pointing to one option over the others for first-line treatment; a lot of it comes down to clinical smarts and patient preference.
Dr. Simpson is a consultant and/or investigator for a number of companies, including Eli Lilly, Pfizer, Novartis, and dupilumab manufacturer, Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Sometimes, older is better, according to Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland.
Dr. Simpson was a key investigator in trials that were the basis of dupilumab’s approval in 2017 for adults with moderate to severe atopic dermatitis (AD), but there’s still a role for cyclosporine and other old standbys, he said in a video interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
He said he’s asked all the time how to pick a systemic treatment for AD when topicals aren’t doing the trick. In the interview, he explained how dupilumab (Dupixent) fits into the picture, and how to select the right systemic therapy for the right patient. There are not a lot of data yet pointing to one option over the others for first-line treatment; a lot of it comes down to clinical smarts and patient preference.
Dr. Simpson is a consultant and/or investigator for a number of companies, including Eli Lilly, Pfizer, Novartis, and dupilumab manufacturer, Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
