FDA approves Caplyta to treat schizophrenia in adults

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Mon, 12/23/2019 - 12:13

The Food and Drug Administration has approved lumateperone for the treatment of schizophrenia in adults.

Lumateperone, an atypical antipsychotic, will be marketed by Intra-Cellular Therapies as Caplyta, according to a Dec. 23 statement from the company.

Approval of the drug was based on two placebo-controlled trials. In the first, 335 patients with schizophrenia were randomized to two doses of lumateperone, an active comparator, or placebo. Those randomized to the approved 42-mg dose of lumateperone showed a statistically significant reduction in total score on the Positive and Negative Syndrome Scale (PANSS), compared with patients in the other groups. The median age in this study was 42 years; 17% of patients were female, 19% were white, and 78% were black.

In the second study, 450 patients diagnosed with schizophrenia were randomized in a double-blind fashion to one of two doses of lumateperone or placebo. Patients taking the approved dose showed a statistically significant reduction from baseline to day 28 in PANSS total score. In this study, patients’ median age was 44 years; 23% were female, 26% were white, and 66% were black.



Treatment with lumateperone appears to feature a more favorable cardiometabolic profile than that of other approved antipsychotic agents.

Patients treated with lumateperone for at least a year showed significant reductions in LDL cholesterol, total cholesterol, serum prolactin, and body weight, compared with baseline values recorded when participants were on various standard-of-care antipsychotics prior to switching, Suresh Durgam, MD, reported at the annual congress of the European College of Neuropsychopharmacology. Other cardiometabolic parameters, including fasting blood glucose, insulin, triglycerides, and HDL cholesterol, showed only negligible change over the course of study, according to Dr. Durgam, a psychiatrist and senior vice president for late-stage clinical development and medical affairs at Intra-Cellular Therapies.

The most common adverse events with lumateperone were somnolence (24% vs. 10% on placebo) and dry mouth (6% vs. 2%).

Approval of lumateperone hit a snag last summer when the FDA canceled the Psychopharmacologic Drugs Advisory Committee meeting it previously had called for to review the new drug application for lumateperone. The agency said the meeting was canceled because of “new information regarding the application.”


At the time, Intra-Cellular Therapies noted that it had provided additional information to the FDA to meet agency requests. This information was related to nonclinical studies.

“The FDA canceled the advisory committee meeting to allow sufficient time to review this new and any forthcoming information as they continue” to review the new drug application for lumateperone, Intra-Cellular said a statement.

The company plans to launch Caplyta late in the first quarter of 2020.



Bruce Jancin and Kerry Dooley Young contributed to this report.

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The Food and Drug Administration has approved lumateperone for the treatment of schizophrenia in adults.

Lumateperone, an atypical antipsychotic, will be marketed by Intra-Cellular Therapies as Caplyta, according to a Dec. 23 statement from the company.

Approval of the drug was based on two placebo-controlled trials. In the first, 335 patients with schizophrenia were randomized to two doses of lumateperone, an active comparator, or placebo. Those randomized to the approved 42-mg dose of lumateperone showed a statistically significant reduction in total score on the Positive and Negative Syndrome Scale (PANSS), compared with patients in the other groups. The median age in this study was 42 years; 17% of patients were female, 19% were white, and 78% were black.

In the second study, 450 patients diagnosed with schizophrenia were randomized in a double-blind fashion to one of two doses of lumateperone or placebo. Patients taking the approved dose showed a statistically significant reduction from baseline to day 28 in PANSS total score. In this study, patients’ median age was 44 years; 23% were female, 26% were white, and 66% were black.



Treatment with lumateperone appears to feature a more favorable cardiometabolic profile than that of other approved antipsychotic agents.

Patients treated with lumateperone for at least a year showed significant reductions in LDL cholesterol, total cholesterol, serum prolactin, and body weight, compared with baseline values recorded when participants were on various standard-of-care antipsychotics prior to switching, Suresh Durgam, MD, reported at the annual congress of the European College of Neuropsychopharmacology. Other cardiometabolic parameters, including fasting blood glucose, insulin, triglycerides, and HDL cholesterol, showed only negligible change over the course of study, according to Dr. Durgam, a psychiatrist and senior vice president for late-stage clinical development and medical affairs at Intra-Cellular Therapies.

The most common adverse events with lumateperone were somnolence (24% vs. 10% on placebo) and dry mouth (6% vs. 2%).

Approval of lumateperone hit a snag last summer when the FDA canceled the Psychopharmacologic Drugs Advisory Committee meeting it previously had called for to review the new drug application for lumateperone. The agency said the meeting was canceled because of “new information regarding the application.”


At the time, Intra-Cellular Therapies noted that it had provided additional information to the FDA to meet agency requests. This information was related to nonclinical studies.

“The FDA canceled the advisory committee meeting to allow sufficient time to review this new and any forthcoming information as they continue” to review the new drug application for lumateperone, Intra-Cellular said a statement.

The company plans to launch Caplyta late in the first quarter of 2020.



Bruce Jancin and Kerry Dooley Young contributed to this report.

The Food and Drug Administration has approved lumateperone for the treatment of schizophrenia in adults.

Lumateperone, an atypical antipsychotic, will be marketed by Intra-Cellular Therapies as Caplyta, according to a Dec. 23 statement from the company.

Approval of the drug was based on two placebo-controlled trials. In the first, 335 patients with schizophrenia were randomized to two doses of lumateperone, an active comparator, or placebo. Those randomized to the approved 42-mg dose of lumateperone showed a statistically significant reduction in total score on the Positive and Negative Syndrome Scale (PANSS), compared with patients in the other groups. The median age in this study was 42 years; 17% of patients were female, 19% were white, and 78% were black.

In the second study, 450 patients diagnosed with schizophrenia were randomized in a double-blind fashion to one of two doses of lumateperone or placebo. Patients taking the approved dose showed a statistically significant reduction from baseline to day 28 in PANSS total score. In this study, patients’ median age was 44 years; 23% were female, 26% were white, and 66% were black.



Treatment with lumateperone appears to feature a more favorable cardiometabolic profile than that of other approved antipsychotic agents.

Patients treated with lumateperone for at least a year showed significant reductions in LDL cholesterol, total cholesterol, serum prolactin, and body weight, compared with baseline values recorded when participants were on various standard-of-care antipsychotics prior to switching, Suresh Durgam, MD, reported at the annual congress of the European College of Neuropsychopharmacology. Other cardiometabolic parameters, including fasting blood glucose, insulin, triglycerides, and HDL cholesterol, showed only negligible change over the course of study, according to Dr. Durgam, a psychiatrist and senior vice president for late-stage clinical development and medical affairs at Intra-Cellular Therapies.

The most common adverse events with lumateperone were somnolence (24% vs. 10% on placebo) and dry mouth (6% vs. 2%).

Approval of lumateperone hit a snag last summer when the FDA canceled the Psychopharmacologic Drugs Advisory Committee meeting it previously had called for to review the new drug application for lumateperone. The agency said the meeting was canceled because of “new information regarding the application.”


At the time, Intra-Cellular Therapies noted that it had provided additional information to the FDA to meet agency requests. This information was related to nonclinical studies.

“The FDA canceled the advisory committee meeting to allow sufficient time to review this new and any forthcoming information as they continue” to review the new drug application for lumateperone, Intra-Cellular said a statement.

The company plans to launch Caplyta late in the first quarter of 2020.



Bruce Jancin and Kerry Dooley Young contributed to this report.

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Synchronizing refills saves money, improves outcomes

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Tue, 05/03/2022 - 15:12

Synchronizing medication refills resulted in higher adherence, fewer hospitalizations, and lower health care costs in a cohort of patients with type 2 diabetes, according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.

Dr. Matthew K. Pickering, director of research and quality strategies and PQA
Denise Fulton/MDedge News
Dr. Matthew K. Pickering

Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.

Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).

The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).

Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”

Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.

In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.

“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”

Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.

Dr. Pickering disclosed no relevant conflicts of interest.

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Synchronizing medication refills resulted in higher adherence, fewer hospitalizations, and lower health care costs in a cohort of patients with type 2 diabetes, according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.

Dr. Matthew K. Pickering, director of research and quality strategies and PQA
Denise Fulton/MDedge News
Dr. Matthew K. Pickering

Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.

Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).

The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).

Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”

Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.

In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.

“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”

Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.

Dr. Pickering disclosed no relevant conflicts of interest.

Synchronizing medication refills resulted in higher adherence, fewer hospitalizations, and lower health care costs in a cohort of patients with type 2 diabetes, according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.

Dr. Matthew K. Pickering, director of research and quality strategies and PQA
Denise Fulton/MDedge News
Dr. Matthew K. Pickering

Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.

Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).

The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).

Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”

Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.

In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.

“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”

Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.

Dr. Pickering disclosed no relevant conflicts of interest.

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Management program improves adherence in specialty pharmacy patients

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Wed, 10/30/2019 - 10:46

Changes and enhancements to a patient management program increased engagement and improved medication adherence for specialty pharmacy patients, according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.

Patient management programs can help improve quality, satisfaction, and health outcomes for pharmacy patients, according to Brian MacDonald, PharmD, of Magellan Rx Management, and colleagues.

“The goal of a successful patient management program is to improve medication use and overall wellness, which can be achieved through patient engagement and empowerment,” they wrote in a poster presented at the meeting, adding that engaging patients can be a challenge.

Dr. MacDonald and colleagues analyzed claims data from January 2016 through April 2019 for more than 14,000 specialty pharmacy patients aged 18 years and older. Eligible patients – defined as those with at least one paid claim for a self-administered specialty drug in 10 eligible categories – were offered monthly coaching services via a patient management program. Baseline data were collected in 2016.

Over the course of the intervention, several changes were made to the patient management program in an effort to improve patient satisfaction.

Staffing was increased and priority was given to new patients. In addition, digital support tools were expanded, and staff engaged in continuous attempts to engage patients.

Patient engagement in the management program increased significantly from 21.6% in the baseline period to 33.4% during the intervention, and increased across all disease categories.

Patients eligible for the management program showed improved medication adherence, measured by the proportion of days covered, at 89.4% vs. 88.1% for ineligible patients. Further, a significantly greater percentage of eligible patients reached a target adherence of more than 85% over that same time period.

The investigators noted that a longer follow-up period may provide improved information on the impact of patient management programs on improved adherence and medical outcomes.

Magellan Rx Management funded the study. Dr. MacDonald and his colleagues are employees of the company.

SOURCE: MacDonald B et al. AMCP Nexus 2019, poster U11.

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Changes and enhancements to a patient management program increased engagement and improved medication adherence for specialty pharmacy patients, according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.

Patient management programs can help improve quality, satisfaction, and health outcomes for pharmacy patients, according to Brian MacDonald, PharmD, of Magellan Rx Management, and colleagues.

“The goal of a successful patient management program is to improve medication use and overall wellness, which can be achieved through patient engagement and empowerment,” they wrote in a poster presented at the meeting, adding that engaging patients can be a challenge.

Dr. MacDonald and colleagues analyzed claims data from January 2016 through April 2019 for more than 14,000 specialty pharmacy patients aged 18 years and older. Eligible patients – defined as those with at least one paid claim for a self-administered specialty drug in 10 eligible categories – were offered monthly coaching services via a patient management program. Baseline data were collected in 2016.

Over the course of the intervention, several changes were made to the patient management program in an effort to improve patient satisfaction.

Staffing was increased and priority was given to new patients. In addition, digital support tools were expanded, and staff engaged in continuous attempts to engage patients.

Patient engagement in the management program increased significantly from 21.6% in the baseline period to 33.4% during the intervention, and increased across all disease categories.

Patients eligible for the management program showed improved medication adherence, measured by the proportion of days covered, at 89.4% vs. 88.1% for ineligible patients. Further, a significantly greater percentage of eligible patients reached a target adherence of more than 85% over that same time period.

The investigators noted that a longer follow-up period may provide improved information on the impact of patient management programs on improved adherence and medical outcomes.

Magellan Rx Management funded the study. Dr. MacDonald and his colleagues are employees of the company.

SOURCE: MacDonald B et al. AMCP Nexus 2019, poster U11.

Changes and enhancements to a patient management program increased engagement and improved medication adherence for specialty pharmacy patients, according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.

Patient management programs can help improve quality, satisfaction, and health outcomes for pharmacy patients, according to Brian MacDonald, PharmD, of Magellan Rx Management, and colleagues.

“The goal of a successful patient management program is to improve medication use and overall wellness, which can be achieved through patient engagement and empowerment,” they wrote in a poster presented at the meeting, adding that engaging patients can be a challenge.

Dr. MacDonald and colleagues analyzed claims data from January 2016 through April 2019 for more than 14,000 specialty pharmacy patients aged 18 years and older. Eligible patients – defined as those with at least one paid claim for a self-administered specialty drug in 10 eligible categories – were offered monthly coaching services via a patient management program. Baseline data were collected in 2016.

Over the course of the intervention, several changes were made to the patient management program in an effort to improve patient satisfaction.

Staffing was increased and priority was given to new patients. In addition, digital support tools were expanded, and staff engaged in continuous attempts to engage patients.

Patient engagement in the management program increased significantly from 21.6% in the baseline period to 33.4% during the intervention, and increased across all disease categories.

Patients eligible for the management program showed improved medication adherence, measured by the proportion of days covered, at 89.4% vs. 88.1% for ineligible patients. Further, a significantly greater percentage of eligible patients reached a target adherence of more than 85% over that same time period.

The investigators noted that a longer follow-up period may provide improved information on the impact of patient management programs on improved adherence and medical outcomes.

Magellan Rx Management funded the study. Dr. MacDonald and his colleagues are employees of the company.

SOURCE: MacDonald B et al. AMCP Nexus 2019, poster U11.

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Vaping illness cases now over 150, CDC says

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Fri, 08/23/2019 - 12:12

 

More than 150 cases of severe lung illness possibly related to e-cigarette use in adolescents and young adults have been reported in 16 states, according to an Aug. 21 update from officials at the Centers for Disease Control and Prevention.

A young woman uses a vaping device
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Officials from the CDC and the Food and Drug Administration are working with state health officials to gather information on the cases as well as any products or substances that might be involved.

A total of 153 potential cases were reported between June 28 and Aug. 20 in 16 states – California, Connecticut, Florida, Illinois, Indiana, Iowa, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, Texas, Utah, and Wisconsin.

Health officials have yet to find a cause for these illnesses; however, all patients have reported e-cigarette use or vaping, according to a CDC statement. Evidence to date does not seem to indicate that an infectious agent is the cause.

In general, patients have reported a gradual onset of symptoms including shortness of breath and/or chest pain that increased over days or weeks before hospital admission. Gastrointestinal symptoms including vomiting, diarrhea, and fatigue have been reported by some.

Many patients reported using products containing tetrahydrocannabinol, though no specific or consistent product has been linked definitively.

While cases reported across the country seem to be similar, there is no evidence currently indicating they have a common cause, according to the CDC statement.

The CDC is urging health care professionals to report possible cases to their state or local health department and the FDA is urging the public to provide detailed reports of any unusual or unexpected health concerns related to tobacco use or e-cigarette use through its Safety Reporting Portal.

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More than 150 cases of severe lung illness possibly related to e-cigarette use in adolescents and young adults have been reported in 16 states, according to an Aug. 21 update from officials at the Centers for Disease Control and Prevention.

A young woman uses a vaping device
licsiren/iStock/Getty Images

Officials from the CDC and the Food and Drug Administration are working with state health officials to gather information on the cases as well as any products or substances that might be involved.

A total of 153 potential cases were reported between June 28 and Aug. 20 in 16 states – California, Connecticut, Florida, Illinois, Indiana, Iowa, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, Texas, Utah, and Wisconsin.

Health officials have yet to find a cause for these illnesses; however, all patients have reported e-cigarette use or vaping, according to a CDC statement. Evidence to date does not seem to indicate that an infectious agent is the cause.

In general, patients have reported a gradual onset of symptoms including shortness of breath and/or chest pain that increased over days or weeks before hospital admission. Gastrointestinal symptoms including vomiting, diarrhea, and fatigue have been reported by some.

Many patients reported using products containing tetrahydrocannabinol, though no specific or consistent product has been linked definitively.

While cases reported across the country seem to be similar, there is no evidence currently indicating they have a common cause, according to the CDC statement.

The CDC is urging health care professionals to report possible cases to their state or local health department and the FDA is urging the public to provide detailed reports of any unusual or unexpected health concerns related to tobacco use or e-cigarette use through its Safety Reporting Portal.

 

More than 150 cases of severe lung illness possibly related to e-cigarette use in adolescents and young adults have been reported in 16 states, according to an Aug. 21 update from officials at the Centers for Disease Control and Prevention.

A young woman uses a vaping device
licsiren/iStock/Getty Images

Officials from the CDC and the Food and Drug Administration are working with state health officials to gather information on the cases as well as any products or substances that might be involved.

A total of 153 potential cases were reported between June 28 and Aug. 20 in 16 states – California, Connecticut, Florida, Illinois, Indiana, Iowa, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, Texas, Utah, and Wisconsin.

Health officials have yet to find a cause for these illnesses; however, all patients have reported e-cigarette use or vaping, according to a CDC statement. Evidence to date does not seem to indicate that an infectious agent is the cause.

In general, patients have reported a gradual onset of symptoms including shortness of breath and/or chest pain that increased over days or weeks before hospital admission. Gastrointestinal symptoms including vomiting, diarrhea, and fatigue have been reported by some.

Many patients reported using products containing tetrahydrocannabinol, though no specific or consistent product has been linked definitively.

While cases reported across the country seem to be similar, there is no evidence currently indicating they have a common cause, according to the CDC statement.

The CDC is urging health care professionals to report possible cases to their state or local health department and the FDA is urging the public to provide detailed reports of any unusual or unexpected health concerns related to tobacco use or e-cigarette use through its Safety Reporting Portal.

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Comorbidities are important in psoriasis care

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Tue, 02/07/2023 - 16:53

– Pay attention to comorbidities in your psoriasis patients because there may not be anyone else doing so.

“Many of our patients don’t have primary care physicians; many are untreated for psoriasis. They come to a clinical trial to get treated – some of them may not have insurance – so it is important for us to watch for these comorbidities,” Kristina C. Duffin, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Yet, that does not seem to be happening consistently, according to Dr. Duffin, of the department of dermatology at the University of Utah, Salt Lake City. One in five dermatologists admitted to never screening or referring their psoriasis patients for management of cardiovascular risks in a 2015 survey (J Am Acad Dermatol. 2015 doi: 10.1016/j.jaad.2015.07.029).

Often patients at the start of biologic therapy are counseled about the risk for developing tuberculosis, yet the lifetime risk for doing so in the United States is 0.3%. Similarly, patients are often counseled on the risk for developing lymphoma, even though the excess risk for developing lymphoma that can be attributed to psoriasis treatment is 7.9 per 100,000 psoriasis patients per year. That screening seems to be driven by warnings issued in direct-to-consumer advertising, Dr. Duffin suggested.

“Although psoriasis patients have an increased relative risk of lymphoma, the absolute risk attributable to psoriasis is low,” Dr. Duffin pointed out.

Some of the comorbidities she advised dermatologists to watch for are described below.
 

Psoriatic arthritis

Psoriatic arthritis is the most important psoriasis comorbidity, Dr. Duffin said. Between 20% and 30% of psoriasis patients will develop psoriatic arthritis.

In a study of 1,511 patients in 48 centers in Germany, 21% of psoriasis patients were diagnosed with psoriatic arthritis and of those, more than 95% had active arthritis and 53% had five or more affected joints (Br J Dermatol. 2009;160[5]:1040-7).

The GRAPPA app is an easy, free screening tool for psoriatic arthritis; patients who score 3 or more out of 5 items on the psoriasis epidemiology screening tool (PEST) are deemed positive for psoriatic arthritis, Dr. Duffin noted.
 

Cardiovascular disease

Psoriasis patients are at increased risk of myocardial infarction, stroke, cardiovascular death, diabetes, and chronic kidney disease, Dr. Duffin said. In fact, CV risk from severe psoriasis is similar to the risk conferred by diabetes.

She added that there is epidemiologic evidence for CV risk modification with several of the biologics approved for psoriasis.
 

Hypertension

Hypertension is prevalent and more severe in psoriasis patients, Dr. Duffin said, citing a 2011 case-control study of electronic medical records at the University of California, Davis. Psoriasis patients with hypertension were 5 times more likely than patients without psoriasis to be on one antihypertensive medication, 9.5 times more likely to be on two, and almost 20 times more likely to be on four antihypertensive medications (PLoS One. 2011 Mar 29;6[3]:e18227. doi: 10.1371/journal.pone.0018227).

Importantly, few primary care physicians and cardiologists are aware of the increased risk for hypertension in psoriasis patients.

Less than half (45%) of primary care physicians and 57% of cardiologists reported they were aware that psoriasis was associated with worse cardiovascular outcome, and only 43% of physicians reported screening psoriasis patients for hypertension starting at age 20 years, according to a 2012 survey of 251 physicians (J Am Acad Dermatol. 2012 Sep;67[3]:357-62).

Dr. Duffin called on dermatologists to ensure that the primary care physicians they work with understand these increased risks.

“Commit to including a comment in consultation letters or letters back to primary care physicians that talks about the cardiovascular risks of the disease,” she said.

Dr. Duffin reported that she is a consultant and has received grant or contracted research support for many companies that manufacture dermatologic therapies.

SDEF and this news organization are owned by the same parent company.

dfulton@mdedge.com

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– Pay attention to comorbidities in your psoriasis patients because there may not be anyone else doing so.

“Many of our patients don’t have primary care physicians; many are untreated for psoriasis. They come to a clinical trial to get treated – some of them may not have insurance – so it is important for us to watch for these comorbidities,” Kristina C. Duffin, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Yet, that does not seem to be happening consistently, according to Dr. Duffin, of the department of dermatology at the University of Utah, Salt Lake City. One in five dermatologists admitted to never screening or referring their psoriasis patients for management of cardiovascular risks in a 2015 survey (J Am Acad Dermatol. 2015 doi: 10.1016/j.jaad.2015.07.029).

Often patients at the start of biologic therapy are counseled about the risk for developing tuberculosis, yet the lifetime risk for doing so in the United States is 0.3%. Similarly, patients are often counseled on the risk for developing lymphoma, even though the excess risk for developing lymphoma that can be attributed to psoriasis treatment is 7.9 per 100,000 psoriasis patients per year. That screening seems to be driven by warnings issued in direct-to-consumer advertising, Dr. Duffin suggested.

“Although psoriasis patients have an increased relative risk of lymphoma, the absolute risk attributable to psoriasis is low,” Dr. Duffin pointed out.

Some of the comorbidities she advised dermatologists to watch for are described below.
 

Psoriatic arthritis

Psoriatic arthritis is the most important psoriasis comorbidity, Dr. Duffin said. Between 20% and 30% of psoriasis patients will develop psoriatic arthritis.

In a study of 1,511 patients in 48 centers in Germany, 21% of psoriasis patients were diagnosed with psoriatic arthritis and of those, more than 95% had active arthritis and 53% had five or more affected joints (Br J Dermatol. 2009;160[5]:1040-7).

The GRAPPA app is an easy, free screening tool for psoriatic arthritis; patients who score 3 or more out of 5 items on the psoriasis epidemiology screening tool (PEST) are deemed positive for psoriatic arthritis, Dr. Duffin noted.
 

Cardiovascular disease

Psoriasis patients are at increased risk of myocardial infarction, stroke, cardiovascular death, diabetes, and chronic kidney disease, Dr. Duffin said. In fact, CV risk from severe psoriasis is similar to the risk conferred by diabetes.

She added that there is epidemiologic evidence for CV risk modification with several of the biologics approved for psoriasis.
 

Hypertension

Hypertension is prevalent and more severe in psoriasis patients, Dr. Duffin said, citing a 2011 case-control study of electronic medical records at the University of California, Davis. Psoriasis patients with hypertension were 5 times more likely than patients without psoriasis to be on one antihypertensive medication, 9.5 times more likely to be on two, and almost 20 times more likely to be on four antihypertensive medications (PLoS One. 2011 Mar 29;6[3]:e18227. doi: 10.1371/journal.pone.0018227).

Importantly, few primary care physicians and cardiologists are aware of the increased risk for hypertension in psoriasis patients.

Less than half (45%) of primary care physicians and 57% of cardiologists reported they were aware that psoriasis was associated with worse cardiovascular outcome, and only 43% of physicians reported screening psoriasis patients for hypertension starting at age 20 years, according to a 2012 survey of 251 physicians (J Am Acad Dermatol. 2012 Sep;67[3]:357-62).

Dr. Duffin called on dermatologists to ensure that the primary care physicians they work with understand these increased risks.

“Commit to including a comment in consultation letters or letters back to primary care physicians that talks about the cardiovascular risks of the disease,” she said.

Dr. Duffin reported that she is a consultant and has received grant or contracted research support for many companies that manufacture dermatologic therapies.

SDEF and this news organization are owned by the same parent company.

dfulton@mdedge.com

– Pay attention to comorbidities in your psoriasis patients because there may not be anyone else doing so.

“Many of our patients don’t have primary care physicians; many are untreated for psoriasis. They come to a clinical trial to get treated – some of them may not have insurance – so it is important for us to watch for these comorbidities,” Kristina C. Duffin, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Yet, that does not seem to be happening consistently, according to Dr. Duffin, of the department of dermatology at the University of Utah, Salt Lake City. One in five dermatologists admitted to never screening or referring their psoriasis patients for management of cardiovascular risks in a 2015 survey (J Am Acad Dermatol. 2015 doi: 10.1016/j.jaad.2015.07.029).

Often patients at the start of biologic therapy are counseled about the risk for developing tuberculosis, yet the lifetime risk for doing so in the United States is 0.3%. Similarly, patients are often counseled on the risk for developing lymphoma, even though the excess risk for developing lymphoma that can be attributed to psoriasis treatment is 7.9 per 100,000 psoriasis patients per year. That screening seems to be driven by warnings issued in direct-to-consumer advertising, Dr. Duffin suggested.

“Although psoriasis patients have an increased relative risk of lymphoma, the absolute risk attributable to psoriasis is low,” Dr. Duffin pointed out.

Some of the comorbidities she advised dermatologists to watch for are described below.
 

Psoriatic arthritis

Psoriatic arthritis is the most important psoriasis comorbidity, Dr. Duffin said. Between 20% and 30% of psoriasis patients will develop psoriatic arthritis.

In a study of 1,511 patients in 48 centers in Germany, 21% of psoriasis patients were diagnosed with psoriatic arthritis and of those, more than 95% had active arthritis and 53% had five or more affected joints (Br J Dermatol. 2009;160[5]:1040-7).

The GRAPPA app is an easy, free screening tool for psoriatic arthritis; patients who score 3 or more out of 5 items on the psoriasis epidemiology screening tool (PEST) are deemed positive for psoriatic arthritis, Dr. Duffin noted.
 

Cardiovascular disease

Psoriasis patients are at increased risk of myocardial infarction, stroke, cardiovascular death, diabetes, and chronic kidney disease, Dr. Duffin said. In fact, CV risk from severe psoriasis is similar to the risk conferred by diabetes.

She added that there is epidemiologic evidence for CV risk modification with several of the biologics approved for psoriasis.
 

Hypertension

Hypertension is prevalent and more severe in psoriasis patients, Dr. Duffin said, citing a 2011 case-control study of electronic medical records at the University of California, Davis. Psoriasis patients with hypertension were 5 times more likely than patients without psoriasis to be on one antihypertensive medication, 9.5 times more likely to be on two, and almost 20 times more likely to be on four antihypertensive medications (PLoS One. 2011 Mar 29;6[3]:e18227. doi: 10.1371/journal.pone.0018227).

Importantly, few primary care physicians and cardiologists are aware of the increased risk for hypertension in psoriasis patients.

Less than half (45%) of primary care physicians and 57% of cardiologists reported they were aware that psoriasis was associated with worse cardiovascular outcome, and only 43% of physicians reported screening psoriasis patients for hypertension starting at age 20 years, according to a 2012 survey of 251 physicians (J Am Acad Dermatol. 2012 Sep;67[3]:357-62).

Dr. Duffin called on dermatologists to ensure that the primary care physicians they work with understand these increased risks.

“Commit to including a comment in consultation letters or letters back to primary care physicians that talks about the cardiovascular risks of the disease,” she said.

Dr. Duffin reported that she is a consultant and has received grant or contracted research support for many companies that manufacture dermatologic therapies.

SDEF and this news organization are owned by the same parent company.

dfulton@mdedge.com

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Think barrier repair for acne patients

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– It’s time to start thinking about barrier repair in acne patients, Hilary E. Baldwin, MD, asserts.

Dr. Hilary Baldwin, medical director, Acne Treatment and Research Center, Morristown, NJ
Dr. Hilary Baldwin

“We think about barrier repair with our psoriasis patients, with our dermatitis patients, and our rosacea patients, but we don’t talk about it much with our acne patients,” Dr. Baldwin said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Now there is increasing evidence that acne pathophysiology may include a barrier defect.”

Both topical and systemic medications exacerbate the problem, because they are so drying, added Dr. Baldwin, medical director of the Acne Treatment & Research Center in Morristown, N.J. Benzoyl peroxide has been shown to increase transepidermal water loss (TEWL) and deplete tocopherol levels in the stratum corneum, while topical retinoids thin the stratum corneum, increase epidermal fragility, and increase TEWL.

The barrier defect may actually decrease medication use – patients are irritated and they stop taking their medication. “An improved barrier may increase the use of medication and also improve acne,” she said.

She described the results of an Internet-based survey of 200 acne patients aged 15-40 years who had been prescribed clindamycin/benzoyl peroxide 5% within the last 6 months (J Drugs Dermatol. 2011 Jun;10[6]:605-8). The researchers found that side effects lead to suboptimal use of the topical medication, as patients reported spot application, use only in flares, infrequent use, and discontinuation.

Further, 31% of patients complained to their doctors’ offices about dryness, 23% said their doctors did not understand the potential side effects, 21% lost confidence in their doctors, 11% said they were less likely to see their doctors again, and 41% reported using moisturizer to combat dryness and erythema.

“No acne visit is complete without a discussion of skin care,” Dr. Baldwin said. Quality moisturization is a must for acne patients and has been shown to improve TEWL, normalize ceramides, and repair the microbiome.

“I recommend moisturizers with ceramides, hyaluronic acid, and certainly moisturizers that have been shown to be noncomedogenic,” Dr. Baldwin said. “Most acne patients aren’t willing to use a cream moisturizer during the day – they just feel too greasy – so I have them use a cream in the evening when they are home and a lotion in the morning.”

Lines of jars of skin care products. The view from the top.
PainterSaba/iStock/Getty Images


While there has been one very specific study of using a moisturizer before topical medications, there is no good data for this practice, Dr. Baldwin said. “Clearly, though, using a moisturizer reduces irritation, so I prefer to have my patients put on the moisturizer at a different time, but if that doesn’t work, I have them put it on before the medication.”

Dr. Baldwin indicated that she is on the speakers bureau for LaRoche Posay, Galderma, and Valeant, and had received grant and/or contracted research support from Dermira and Valeant.

SDEF and this news organization are owned by the same parent company.

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– It’s time to start thinking about barrier repair in acne patients, Hilary E. Baldwin, MD, asserts.

Dr. Hilary Baldwin, medical director, Acne Treatment and Research Center, Morristown, NJ
Dr. Hilary Baldwin

“We think about barrier repair with our psoriasis patients, with our dermatitis patients, and our rosacea patients, but we don’t talk about it much with our acne patients,” Dr. Baldwin said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Now there is increasing evidence that acne pathophysiology may include a barrier defect.”

Both topical and systemic medications exacerbate the problem, because they are so drying, added Dr. Baldwin, medical director of the Acne Treatment & Research Center in Morristown, N.J. Benzoyl peroxide has been shown to increase transepidermal water loss (TEWL) and deplete tocopherol levels in the stratum corneum, while topical retinoids thin the stratum corneum, increase epidermal fragility, and increase TEWL.

The barrier defect may actually decrease medication use – patients are irritated and they stop taking their medication. “An improved barrier may increase the use of medication and also improve acne,” she said.

She described the results of an Internet-based survey of 200 acne patients aged 15-40 years who had been prescribed clindamycin/benzoyl peroxide 5% within the last 6 months (J Drugs Dermatol. 2011 Jun;10[6]:605-8). The researchers found that side effects lead to suboptimal use of the topical medication, as patients reported spot application, use only in flares, infrequent use, and discontinuation.

Further, 31% of patients complained to their doctors’ offices about dryness, 23% said their doctors did not understand the potential side effects, 21% lost confidence in their doctors, 11% said they were less likely to see their doctors again, and 41% reported using moisturizer to combat dryness and erythema.

“No acne visit is complete without a discussion of skin care,” Dr. Baldwin said. Quality moisturization is a must for acne patients and has been shown to improve TEWL, normalize ceramides, and repair the microbiome.

“I recommend moisturizers with ceramides, hyaluronic acid, and certainly moisturizers that have been shown to be noncomedogenic,” Dr. Baldwin said. “Most acne patients aren’t willing to use a cream moisturizer during the day – they just feel too greasy – so I have them use a cream in the evening when they are home and a lotion in the morning.”

Lines of jars of skin care products. The view from the top.
PainterSaba/iStock/Getty Images


While there has been one very specific study of using a moisturizer before topical medications, there is no good data for this practice, Dr. Baldwin said. “Clearly, though, using a moisturizer reduces irritation, so I prefer to have my patients put on the moisturizer at a different time, but if that doesn’t work, I have them put it on before the medication.”

Dr. Baldwin indicated that she is on the speakers bureau for LaRoche Posay, Galderma, and Valeant, and had received grant and/or contracted research support from Dermira and Valeant.

SDEF and this news organization are owned by the same parent company.

 

– It’s time to start thinking about barrier repair in acne patients, Hilary E. Baldwin, MD, asserts.

Dr. Hilary Baldwin, medical director, Acne Treatment and Research Center, Morristown, NJ
Dr. Hilary Baldwin

“We think about barrier repair with our psoriasis patients, with our dermatitis patients, and our rosacea patients, but we don’t talk about it much with our acne patients,” Dr. Baldwin said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Now there is increasing evidence that acne pathophysiology may include a barrier defect.”

Both topical and systemic medications exacerbate the problem, because they are so drying, added Dr. Baldwin, medical director of the Acne Treatment & Research Center in Morristown, N.J. Benzoyl peroxide has been shown to increase transepidermal water loss (TEWL) and deplete tocopherol levels in the stratum corneum, while topical retinoids thin the stratum corneum, increase epidermal fragility, and increase TEWL.

The barrier defect may actually decrease medication use – patients are irritated and they stop taking their medication. “An improved barrier may increase the use of medication and also improve acne,” she said.

She described the results of an Internet-based survey of 200 acne patients aged 15-40 years who had been prescribed clindamycin/benzoyl peroxide 5% within the last 6 months (J Drugs Dermatol. 2011 Jun;10[6]:605-8). The researchers found that side effects lead to suboptimal use of the topical medication, as patients reported spot application, use only in flares, infrequent use, and discontinuation.

Further, 31% of patients complained to their doctors’ offices about dryness, 23% said their doctors did not understand the potential side effects, 21% lost confidence in their doctors, 11% said they were less likely to see their doctors again, and 41% reported using moisturizer to combat dryness and erythema.

“No acne visit is complete without a discussion of skin care,” Dr. Baldwin said. Quality moisturization is a must for acne patients and has been shown to improve TEWL, normalize ceramides, and repair the microbiome.

“I recommend moisturizers with ceramides, hyaluronic acid, and certainly moisturizers that have been shown to be noncomedogenic,” Dr. Baldwin said. “Most acne patients aren’t willing to use a cream moisturizer during the day – they just feel too greasy – so I have them use a cream in the evening when they are home and a lotion in the morning.”

Lines of jars of skin care products. The view from the top.
PainterSaba/iStock/Getty Images


While there has been one very specific study of using a moisturizer before topical medications, there is no good data for this practice, Dr. Baldwin said. “Clearly, though, using a moisturizer reduces irritation, so I prefer to have my patients put on the moisturizer at a different time, but if that doesn’t work, I have them put it on before the medication.”

Dr. Baldwin indicated that she is on the speakers bureau for LaRoche Posay, Galderma, and Valeant, and had received grant and/or contracted research support from Dermira and Valeant.

SDEF and this news organization are owned by the same parent company.

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Investigational agent VT-1161 looks promising for onychomycosis

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– An investigational oral therapy for onychomycosis could be on the horizon as a new treatment option.

VT-1161 is a cytochrome P51 (CYP51) inhibitor with potent in vitro activity against several species of tinea and yeast, David M. Pariser, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. It is highly selective for fungal CYP51 over human cytochrome P enzymes.

Dr. David M. Pariser
Dr. David M. Pariser


Dr. Pariser served as an investigator for the RENOVATE trial, a randomized, double-blind, placebo-controlled phase 2 trial of VT-1161 in 259 patients with onychomycosis. Patients enrolled were aged 18-70 years, with a mean age of 49. Most were men (80%) and white (85%), as is typical in trials for onychomycosis drugs, noted Dr. Pariser, professor of dermatology at Eastern Virginia Medical School in Norfolk.

Distal subungual onychomycosis was evident in 25%-75% of the nail, and patients needed 2 mm of clear nail to be included in the trial. Disease was confirmed by positive KOH staining and culture.

Patients were randomized into four active treatment groups; a fifth received placebo. All active treatment groups were started on 14 days of a daily loading dose of VT-1161, with one arm getting 300 mg per day and one getting 600 mg per day.

After the loading dose, two groups were treated for 12 weeks with VT-1161 (weekly doses of 300 mg and 600 mg); two other groups had treatment extended out to 24 weeks.

Few patients, roughly 20% in each treatment arm, had achieved the primary endpoint, a complete cure (0% nail involvement and negative KOH stain and culture) at the end of active treatment, Dr. Pariser said.

“I personally think that all of these onychomycosis studies should be carried out for longer than a year, up to 2 years, even if you were able to get rid of all the fungus, because that’s how long it’s going to take for the nail to grow out, especially in older patients with slower nail growth,” Dr. Pariser said.

At 48 weeks, approximately 40% of patients in each active treatment arm achieved complete cure, Dr. Pariser noted. “The results indicated that there was not a lot of difference in outcomes based on the dose the patient received.”

About 60%-70% of treated patients sustained mycologic cure of onychomycosis at 60 weeks.

No serious drug-related adverse events were seen in the study, and no patients dropped out because of lab abnormalities, including liver function tests. Other adverse events were rare and occurred equally in the treatment and placebo arms and consisted of dermatitis, headache, and cough. Nausea, cough, and dysgeusia each occurred in 2% of patients and could have been related to the study drug, Dr. Pariser said.

Looking at both mycologic and complete cure rates of available onychomycosis treatments, the results from the RENOVATE trial are comparable to approved systemic therapies, and superior to topicals, he said.

Dr. Pariser disclosed serving as an investigator for pharmaceutical manufactures Viamet (maker of VT-1161), Valeant, and Ancor/Pharmaderm.

SDEF and this news organization are owned by the same parent company.

dfulton@mdedge.com
 

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– An investigational oral therapy for onychomycosis could be on the horizon as a new treatment option.

VT-1161 is a cytochrome P51 (CYP51) inhibitor with potent in vitro activity against several species of tinea and yeast, David M. Pariser, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. It is highly selective for fungal CYP51 over human cytochrome P enzymes.

Dr. David M. Pariser
Dr. David M. Pariser


Dr. Pariser served as an investigator for the RENOVATE trial, a randomized, double-blind, placebo-controlled phase 2 trial of VT-1161 in 259 patients with onychomycosis. Patients enrolled were aged 18-70 years, with a mean age of 49. Most were men (80%) and white (85%), as is typical in trials for onychomycosis drugs, noted Dr. Pariser, professor of dermatology at Eastern Virginia Medical School in Norfolk.

Distal subungual onychomycosis was evident in 25%-75% of the nail, and patients needed 2 mm of clear nail to be included in the trial. Disease was confirmed by positive KOH staining and culture.

Patients were randomized into four active treatment groups; a fifth received placebo. All active treatment groups were started on 14 days of a daily loading dose of VT-1161, with one arm getting 300 mg per day and one getting 600 mg per day.

After the loading dose, two groups were treated for 12 weeks with VT-1161 (weekly doses of 300 mg and 600 mg); two other groups had treatment extended out to 24 weeks.

Few patients, roughly 20% in each treatment arm, had achieved the primary endpoint, a complete cure (0% nail involvement and negative KOH stain and culture) at the end of active treatment, Dr. Pariser said.

“I personally think that all of these onychomycosis studies should be carried out for longer than a year, up to 2 years, even if you were able to get rid of all the fungus, because that’s how long it’s going to take for the nail to grow out, especially in older patients with slower nail growth,” Dr. Pariser said.

At 48 weeks, approximately 40% of patients in each active treatment arm achieved complete cure, Dr. Pariser noted. “The results indicated that there was not a lot of difference in outcomes based on the dose the patient received.”

About 60%-70% of treated patients sustained mycologic cure of onychomycosis at 60 weeks.

No serious drug-related adverse events were seen in the study, and no patients dropped out because of lab abnormalities, including liver function tests. Other adverse events were rare and occurred equally in the treatment and placebo arms and consisted of dermatitis, headache, and cough. Nausea, cough, and dysgeusia each occurred in 2% of patients and could have been related to the study drug, Dr. Pariser said.

Looking at both mycologic and complete cure rates of available onychomycosis treatments, the results from the RENOVATE trial are comparable to approved systemic therapies, and superior to topicals, he said.

Dr. Pariser disclosed serving as an investigator for pharmaceutical manufactures Viamet (maker of VT-1161), Valeant, and Ancor/Pharmaderm.

SDEF and this news organization are owned by the same parent company.

dfulton@mdedge.com
 

 

– An investigational oral therapy for onychomycosis could be on the horizon as a new treatment option.

VT-1161 is a cytochrome P51 (CYP51) inhibitor with potent in vitro activity against several species of tinea and yeast, David M. Pariser, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. It is highly selective for fungal CYP51 over human cytochrome P enzymes.

Dr. David M. Pariser
Dr. David M. Pariser


Dr. Pariser served as an investigator for the RENOVATE trial, a randomized, double-blind, placebo-controlled phase 2 trial of VT-1161 in 259 patients with onychomycosis. Patients enrolled were aged 18-70 years, with a mean age of 49. Most were men (80%) and white (85%), as is typical in trials for onychomycosis drugs, noted Dr. Pariser, professor of dermatology at Eastern Virginia Medical School in Norfolk.

Distal subungual onychomycosis was evident in 25%-75% of the nail, and patients needed 2 mm of clear nail to be included in the trial. Disease was confirmed by positive KOH staining and culture.

Patients were randomized into four active treatment groups; a fifth received placebo. All active treatment groups were started on 14 days of a daily loading dose of VT-1161, with one arm getting 300 mg per day and one getting 600 mg per day.

After the loading dose, two groups were treated for 12 weeks with VT-1161 (weekly doses of 300 mg and 600 mg); two other groups had treatment extended out to 24 weeks.

Few patients, roughly 20% in each treatment arm, had achieved the primary endpoint, a complete cure (0% nail involvement and negative KOH stain and culture) at the end of active treatment, Dr. Pariser said.

“I personally think that all of these onychomycosis studies should be carried out for longer than a year, up to 2 years, even if you were able to get rid of all the fungus, because that’s how long it’s going to take for the nail to grow out, especially in older patients with slower nail growth,” Dr. Pariser said.

At 48 weeks, approximately 40% of patients in each active treatment arm achieved complete cure, Dr. Pariser noted. “The results indicated that there was not a lot of difference in outcomes based on the dose the patient received.”

About 60%-70% of treated patients sustained mycologic cure of onychomycosis at 60 weeks.

No serious drug-related adverse events were seen in the study, and no patients dropped out because of lab abnormalities, including liver function tests. Other adverse events were rare and occurred equally in the treatment and placebo arms and consisted of dermatitis, headache, and cough. Nausea, cough, and dysgeusia each occurred in 2% of patients and could have been related to the study drug, Dr. Pariser said.

Looking at both mycologic and complete cure rates of available onychomycosis treatments, the results from the RENOVATE trial are comparable to approved systemic therapies, and superior to topicals, he said.

Dr. Pariser disclosed serving as an investigator for pharmaceutical manufactures Viamet (maker of VT-1161), Valeant, and Ancor/Pharmaderm.

SDEF and this news organization are owned by the same parent company.

dfulton@mdedge.com
 

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Several PT modalities are useful in Parkinson’s, movement disorders

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Sensory receptor stimulation therapy can help certain patients with Parkinson’s disease improve posture and gait issues, according to Ben Weinstock, DPT, who specializes in physical therapy for patients with movement disorders.

Dr. Weinstock will present an update on several physical therapy modalities that can be useful for patients with Parkinson’s disease on Oct. 19 at the International Conference on Parkinson’s Disease and Movement Disorders in New York.

“Up to 70% of people with Parkinson’s disease are exercise intolerant,” Dr. Weinstock said in an interview. “As such, we must provide interventions that can keep them moving and avoid sedentary behavior.”

Manual stimulation of points on the foot can improve freezing of gait as well as normalize stride length, according to research published by Italian investigators in 2015 (Int J Rehabil Res. 2015 Sep. doi: 10.1097/MRR.0000000000000120) while electrical stimulation of acupuncture points on the ear and body assisted with motor and nonmotor Parkinson’s symptoms, based on a 2017 study (Front Hum Neurosci. 2017. doi: 10.3389/fnhum.2017.00338).

Advances in manual pressure therapy as well as using Kinesio taping to improve posture also will be addressed by Dr. Weinstock, who is in private practice in New York.

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Sensory receptor stimulation therapy can help certain patients with Parkinson’s disease improve posture and gait issues, according to Ben Weinstock, DPT, who specializes in physical therapy for patients with movement disorders.

Dr. Weinstock will present an update on several physical therapy modalities that can be useful for patients with Parkinson’s disease on Oct. 19 at the International Conference on Parkinson’s Disease and Movement Disorders in New York.

“Up to 70% of people with Parkinson’s disease are exercise intolerant,” Dr. Weinstock said in an interview. “As such, we must provide interventions that can keep them moving and avoid sedentary behavior.”

Manual stimulation of points on the foot can improve freezing of gait as well as normalize stride length, according to research published by Italian investigators in 2015 (Int J Rehabil Res. 2015 Sep. doi: 10.1097/MRR.0000000000000120) while electrical stimulation of acupuncture points on the ear and body assisted with motor and nonmotor Parkinson’s symptoms, based on a 2017 study (Front Hum Neurosci. 2017. doi: 10.3389/fnhum.2017.00338).

Advances in manual pressure therapy as well as using Kinesio taping to improve posture also will be addressed by Dr. Weinstock, who is in private practice in New York.

 

Sensory receptor stimulation therapy can help certain patients with Parkinson’s disease improve posture and gait issues, according to Ben Weinstock, DPT, who specializes in physical therapy for patients with movement disorders.

Dr. Weinstock will present an update on several physical therapy modalities that can be useful for patients with Parkinson’s disease on Oct. 19 at the International Conference on Parkinson’s Disease and Movement Disorders in New York.

“Up to 70% of people with Parkinson’s disease are exercise intolerant,” Dr. Weinstock said in an interview. “As such, we must provide interventions that can keep them moving and avoid sedentary behavior.”

Manual stimulation of points on the foot can improve freezing of gait as well as normalize stride length, according to research published by Italian investigators in 2015 (Int J Rehabil Res. 2015 Sep. doi: 10.1097/MRR.0000000000000120) while electrical stimulation of acupuncture points on the ear and body assisted with motor and nonmotor Parkinson’s symptoms, based on a 2017 study (Front Hum Neurosci. 2017. doi: 10.3389/fnhum.2017.00338).

Advances in manual pressure therapy as well as using Kinesio taping to improve posture also will be addressed by Dr. Weinstock, who is in private practice in New York.

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Research highlights the use of neurofilament light chain as a biomarker

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Mon, 01/07/2019 - 13:19

 

Recent research has pointed to a role for measuring neurofilament light (Nf-L) chain levels to predict disease severity in multiple sclerosis (MS). Several papers presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis in Berlin will describe new developments on the topic.

A highlighted session on the congress’s last day explores recent development in progressive MS. While much of the research on using Nf-L as a biomarker focuses on relapsing remitting MS, researchers from University Hospital, Basel, Switzerland, and Novartis used data from placebo-controlled, phase 3 trials of fingolimod (INFORMS) and siponimod (EXPAND) to learn how to use biomarkers to track brain atrophy in patients with primary and secondary progressive MS. Hear the results from lead researcher Jens Kuhle, MD, in Hall A at 10:30 a.m. (local time) on Friday, Oct. 12.



Nf-L also is being looked at as a way to suss out treatment failure. Researchers with the Swiss MS Cohort Study will present their study of Nf-L as a biomarker of suboptimal treatment response in patients with relapsing remitting MS on established disease-modifying therapy. Their findings will be presented by Özguer Yaldizli, MD, also of University Hospital, also in Hall A, at 8:30 a.m. (local time) on Friday, Oct. 12.

Follow #ECTRIMS2018 on Twitter to see live highlights and perspective from researchers and meeting attendees.

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Recent research has pointed to a role for measuring neurofilament light (Nf-L) chain levels to predict disease severity in multiple sclerosis (MS). Several papers presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis in Berlin will describe new developments on the topic.

A highlighted session on the congress’s last day explores recent development in progressive MS. While much of the research on using Nf-L as a biomarker focuses on relapsing remitting MS, researchers from University Hospital, Basel, Switzerland, and Novartis used data from placebo-controlled, phase 3 trials of fingolimod (INFORMS) and siponimod (EXPAND) to learn how to use biomarkers to track brain atrophy in patients with primary and secondary progressive MS. Hear the results from lead researcher Jens Kuhle, MD, in Hall A at 10:30 a.m. (local time) on Friday, Oct. 12.



Nf-L also is being looked at as a way to suss out treatment failure. Researchers with the Swiss MS Cohort Study will present their study of Nf-L as a biomarker of suboptimal treatment response in patients with relapsing remitting MS on established disease-modifying therapy. Their findings will be presented by Özguer Yaldizli, MD, also of University Hospital, also in Hall A, at 8:30 a.m. (local time) on Friday, Oct. 12.

Follow #ECTRIMS2018 on Twitter to see live highlights and perspective from researchers and meeting attendees.

 

Recent research has pointed to a role for measuring neurofilament light (Nf-L) chain levels to predict disease severity in multiple sclerosis (MS). Several papers presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis in Berlin will describe new developments on the topic.

A highlighted session on the congress’s last day explores recent development in progressive MS. While much of the research on using Nf-L as a biomarker focuses on relapsing remitting MS, researchers from University Hospital, Basel, Switzerland, and Novartis used data from placebo-controlled, phase 3 trials of fingolimod (INFORMS) and siponimod (EXPAND) to learn how to use biomarkers to track brain atrophy in patients with primary and secondary progressive MS. Hear the results from lead researcher Jens Kuhle, MD, in Hall A at 10:30 a.m. (local time) on Friday, Oct. 12.



Nf-L also is being looked at as a way to suss out treatment failure. Researchers with the Swiss MS Cohort Study will present their study of Nf-L as a biomarker of suboptimal treatment response in patients with relapsing remitting MS on established disease-modifying therapy. Their findings will be presented by Özguer Yaldizli, MD, also of University Hospital, also in Hall A, at 8:30 a.m. (local time) on Friday, Oct. 12.

Follow #ECTRIMS2018 on Twitter to see live highlights and perspective from researchers and meeting attendees.

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Revised McDonald criteria to be explored at ECTRIMS

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The revised McDonald criteria, issued less than a year ago in December 2017, should allow for earlier diagnosis and treatment of multiple sclerosis, but also could be leading to overdiagnosis and misdiagnosis.

A recent study published in JAMA Neurology found that sensitivity for the 2017 criteria was greater (68% vs. 36% for the 2010 criteria) but specificity was not (61% vs. 85%, respectively), based on a study of several hundred patients in the Netherlands with clinically isolated syndrome.

The ins and outs and pros and cons of the revised McDonald criteria will be discussed in two sessions at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

A highlighted session on Saturday, Oct. 10, at 2:30 p.m. (local time) entitled “Burning Debate: The new McDonald diagnostic criteria are controversial making them difficult to use in clinical practice” aims to shed some light. After an introduction from Emmanuelle Waubant, MD, professor of neurology at the University of California, San Francisco, the topic will be debated by Jiwon Oh, MD, of the University of Toronto and Frauke Zipp, MD, of the University of Mainz (Germany). The experts will take questions from the audience as well as via Twitter. Ask your questions using the meeting hashtag #ECTRIMS2018. Find the session in Hall B.

Five new papers on the impact of the revised criteria will be presented in Hall A on Sunday, Oct. 11, at 8:30 a.m. (local time). Among the investigators presenting are Roos M. van der Vuurst de Vries, MD, from the department of neurology at Erasmus Medical Center in Rotterdam, the Netherlands, who authored the recent JAMA Neurology paper, and Wallace Brownlee, MD, of University College London.

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The revised McDonald criteria, issued less than a year ago in December 2017, should allow for earlier diagnosis and treatment of multiple sclerosis, but also could be leading to overdiagnosis and misdiagnosis.

A recent study published in JAMA Neurology found that sensitivity for the 2017 criteria was greater (68% vs. 36% for the 2010 criteria) but specificity was not (61% vs. 85%, respectively), based on a study of several hundred patients in the Netherlands with clinically isolated syndrome.

The ins and outs and pros and cons of the revised McDonald criteria will be discussed in two sessions at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

A highlighted session on Saturday, Oct. 10, at 2:30 p.m. (local time) entitled “Burning Debate: The new McDonald diagnostic criteria are controversial making them difficult to use in clinical practice” aims to shed some light. After an introduction from Emmanuelle Waubant, MD, professor of neurology at the University of California, San Francisco, the topic will be debated by Jiwon Oh, MD, of the University of Toronto and Frauke Zipp, MD, of the University of Mainz (Germany). The experts will take questions from the audience as well as via Twitter. Ask your questions using the meeting hashtag #ECTRIMS2018. Find the session in Hall B.

Five new papers on the impact of the revised criteria will be presented in Hall A on Sunday, Oct. 11, at 8:30 a.m. (local time). Among the investigators presenting are Roos M. van der Vuurst de Vries, MD, from the department of neurology at Erasmus Medical Center in Rotterdam, the Netherlands, who authored the recent JAMA Neurology paper, and Wallace Brownlee, MD, of University College London.

 

The revised McDonald criteria, issued less than a year ago in December 2017, should allow for earlier diagnosis and treatment of multiple sclerosis, but also could be leading to overdiagnosis and misdiagnosis.

A recent study published in JAMA Neurology found that sensitivity for the 2017 criteria was greater (68% vs. 36% for the 2010 criteria) but specificity was not (61% vs. 85%, respectively), based on a study of several hundred patients in the Netherlands with clinically isolated syndrome.

The ins and outs and pros and cons of the revised McDonald criteria will be discussed in two sessions at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

A highlighted session on Saturday, Oct. 10, at 2:30 p.m. (local time) entitled “Burning Debate: The new McDonald diagnostic criteria are controversial making them difficult to use in clinical practice” aims to shed some light. After an introduction from Emmanuelle Waubant, MD, professor of neurology at the University of California, San Francisco, the topic will be debated by Jiwon Oh, MD, of the University of Toronto and Frauke Zipp, MD, of the University of Mainz (Germany). The experts will take questions from the audience as well as via Twitter. Ask your questions using the meeting hashtag #ECTRIMS2018. Find the session in Hall B.

Five new papers on the impact of the revised criteria will be presented in Hall A on Sunday, Oct. 11, at 8:30 a.m. (local time). Among the investigators presenting are Roos M. van der Vuurst de Vries, MD, from the department of neurology at Erasmus Medical Center in Rotterdam, the Netherlands, who authored the recent JAMA Neurology paper, and Wallace Brownlee, MD, of University College London.

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