Perspectives

As Ob.Gyn. News celebrates 50 years of publication, we’re taking a look back at our first year – 1966.

Not surprisingly, medicine looked a lot different in the mid-1960s, largely driven by the culture and technology of the time. A review of the 1966 issues of Obstetrics and Gynecology (the Green Journal), offers a snapshot of the state of the science.

With scientists still struggling to develop a rapid test to detect pregnancy, researchers from the Brookdale Hospital Center in Brooklyn, N.Y., detailed the possibility of using elevated breast temperature to get faster results. They compared 50 pregnant and 50 nonpregnant women and found a consistent rise in breast temperature in all pregnant women as early as 1 week after the first missed period. In the March issue, they concluded that the use of temperature difference between the breast and a baseline area on the anterior chest wall could be a rapid, simple, and accurate pregnancy test (Obstet Gynecol. 1966 Mar;27[3]:378-80).

In August, researchers from Australia published promising data on the use of ultrasonic echoscopic examination of the uterus in late pregnancy. They found that the technology was useful in determining fetal position and possible abnormalities and could be repeated as often as necessary to observe changes and growth. The big advantage, they noted, would be the opportunity to avoid excessive fetal exposure to x-rays (Obstet Gynecol. 1966 Aug;28[2]:164-9).

Advertising directed at physicians – in both the Green Journal and in Ob.Gyn. News – provided a glimpse into the practice of medicine at the time. Ob.gyns. saw ads for products such as Eskatrol – a capsule that contained dextroamphetamine sulfate and prochlorperazine – promoted to help women control appetite and “relieve the emotional stress that causes overeating.” And doctors also saw ads for oral contraceptives, first approved by the Food and Drug Administration in 1960.

Ob.gyn. practice was different culturally as well. In a regular column titled “After Office Hours,” published in the Green Journal in January 1966, Dr. Malcolm S. Allan explored a relatively new idea – husband-attended deliveries. Dr. Allan, of Wesson Maternity Hospital in Springfield, Mass., explained that his hospital had conducted a nationwide survey of chiefs of obstetrics after they received a petition seeking to allow husbands into the delivery room, as well as more flexibility for fathers to room in with the mother and baby. The survey, which included responses from 267 hospitals, showed that 81% of hospitals did not allow husbands in the delivery room (Obstet Gynecol. 1966 Jan;27[1]:146-8).

After reviewing the survey results and talking to experts in the area, Dr. Allan and the leadership at Wesson decided not to allow husbands to witness deliveries. He concluded that “some patients in some of these ‘off-beat’ programs are being allowed to assume too much authority for determining the medical management of their pregnancies, while leaving the obstetrician with the responsibility for a healthy outcome.”

But in other ways, not much has changed since 1966. The March edition of “After Office Hours” bemoaned a looming manpower crisis in obstetrics (Obstet Gynecol. 1966 Mar;27[3]:449-52). Dr. Jan Schneider of the University of Michigan, Ann Arbor, wrote that even using conservative estimates of population growth, by 1970 there would be 20,000 obstetricians in the United States delivering on average of 225 babies each, a strain on the workforce. What were some of the factors? An uneven distribution of obstetricians throughout the country and increasing specialization.

In another familiar theme, Dr. Schneider urged physicians to consider team care as one part of the solution, allowing nurse midwives to provide prenatal care and perform normal deliveries under physician supervision.

Some of the clinical debates going on in 1966 are still unresolved. Consider the September 1966 issue of the Green Journal, which features an interim report on contraception with an intrauterine bow inserted immediately postpartum (Obstet Gynecol. 1966 Sep;28[3]:329-31). Five decades later, only about 12 state Medicaid programs cover the cost of insertion of an IUD immediately postpartum. And in the August 1966 issue of the Green Journal, Dr. Carl J. Pauerstein asked, “Once a Section, Always a Trial of Labor?” (Obstet Gynecol. 1966 Aug;28[2]:273-6). A look at the recent Master Class on vaginal birth after cesarean shows that those same questions are still being debated today.

So what will physicians and patients say about obstetrics and gynecology practice 50 years from now?

1966 at a glance

The Surgeon General

In a report to U.S. Surgeon General William H. Stewart titled “Protecting and Improving Health through the Radiological Sciences,” the National Advisory Committee on Radiation warned about emerging problems in the use of ionizing radiation in medicine.

Births

According to data provided by the Centers for Disease Control and Prevention, in 1966, there were 3.6 million births, for a birth rate of 18.4 and a fertility rate of 90.8; 8.4% of births were to unmarried women.

Women get organized

Courtesy of the National Organization for Women

In June, Betty Friedan, Pauli Murray, and several other women launched the National Organization for Women at a conference in Washington, D.C., with Ms. Friedan famously writing N-O-W on a paper napkin.

Medical ethics

Dr. Henry K. Beecher published an article on ethics in the New England Journal of Medicine that is credited with spurring the federal government to set rules on human experimentation and informed consent, including establishment of Institutional Review Boards.

A safety net is born

Photo courtesy of White House

On July 1, 1966, Medicare coverage began, with more than 19 million beneficiaries.

The AMA

Courtesy of the American Medical Association

The American Medical Association published the first edition of the Current Procedural Terminology (CPT) code book, creating a system of standardized terms for medical procedures used in documentation. Also in 1966, the AMA encouraged doctors to promote exercise to improve health.

Planned Parenthood

The Planned Parenthood Federation of America awarded its first Margaret Sanger Award. In 1966, four men received the award, including the Rev. Martin Luther King Jr. and President Lyndon B. Johnson.

Pregnancy testing

The first radioimmunoassay for hCG (human chorionic gonadotropin) was described by A.R. Midgley, but the test could not distinguish between hCG and luteinizing hormone. A home pregnancy test was still a decade away.

Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

As Ob.Gyn. News celebrates 50 years of publication, we’re taking a look back at our first year – 1966.

Not surprisingly, medicine looked a lot different in the mid-1960s, largely driven by the culture and technology of the time. A review of the 1966 issues of Obstetrics and Gynecology (the Green Journal), offers a snapshot of the state of the science.

With scientists still struggling to develop a rapid test to detect pregnancy, researchers from the Brookdale Hospital Center in Brooklyn, N.Y., detailed the possibility of using elevated breast temperature to get faster results. They compared 50 pregnant and 50 nonpregnant women and found a consistent rise in breast temperature in all pregnant women as early as 1 week after the first missed period. In the March issue, they concluded that the use of temperature difference between the breast and a baseline area on the anterior chest wall could be a rapid, simple, and accurate pregnancy test (Obstet Gynecol. 1966 Mar;27[3]:378-80).

In August, researchers from Australia published promising data on the use of ultrasonic echoscopic examination of the uterus in late pregnancy. They found that the technology was useful in determining fetal position and possible abnormalities and could be repeated as often as necessary to observe changes and growth. The big advantage, they noted, would be the opportunity to avoid excessive fetal exposure to x-rays (Obstet Gynecol. 1966 Aug;28[2]:164-9).

Advertising directed at physicians – in both the Green Journal and in Ob.Gyn. News – provided a glimpse into the practice of medicine at the time. Ob.gyns. saw ads for products such as Eskatrol – a capsule that contained dextroamphetamine sulfate and prochlorperazine – promoted to help women control appetite and “relieve the emotional stress that causes overeating.” And doctors also saw ads for oral contraceptives, first approved by the Food and Drug Administration in 1960.

Ob.gyn. practice was different culturally as well. In a regular column titled “After Office Hours,” published in the Green Journal in January 1966, Dr. Malcolm S. Allan explored a relatively new idea – husband-attended deliveries. Dr. Allan, of Wesson Maternity Hospital in Springfield, Mass., explained that his hospital had conducted a nationwide survey of chiefs of obstetrics after they received a petition seeking to allow husbands into the delivery room, as well as more flexibility for fathers to room in with the mother and baby. The survey, which included responses from 267 hospitals, showed that 81% of hospitals did not allow husbands in the delivery room (Obstet Gynecol. 1966 Jan;27[1]:146-8).

After reviewing the survey results and talking to experts in the area, Dr. Allan and the leadership at Wesson decided not to allow husbands to witness deliveries. He concluded that “some patients in some of these ‘off-beat’ programs are being allowed to assume too much authority for determining the medical management of their pregnancies, while leaving the obstetrician with the responsibility for a healthy outcome.”

But in other ways, not much has changed since 1966. The March edition of “After Office Hours” bemoaned a looming manpower crisis in obstetrics (Obstet Gynecol. 1966 Mar;27[3]:449-52). Dr. Jan Schneider of the University of Michigan, Ann Arbor, wrote that even using conservative estimates of population growth, by 1970 there would be 20,000 obstetricians in the United States delivering on average of 225 babies each, a strain on the workforce. What were some of the factors? An uneven distribution of obstetricians throughout the country and increasing specialization.

In another familiar theme, Dr. Schneider urged physicians to consider team care as one part of the solution, allowing nurse midwives to provide prenatal care and perform normal deliveries under physician supervision.

Some of the clinical debates going on in 1966 are still unresolved. Consider the September 1966 issue of the Green Journal, which features an interim report on contraception with an intrauterine bow inserted immediately postpartum (Obstet Gynecol. 1966 Sep;28[3]:329-31). Five decades later, only about 12 state Medicaid programs cover the cost of insertion of an IUD immediately postpartum. And in the August 1966 issue of the Green Journal, Dr. Carl J. Pauerstein asked, “Once a Section, Always a Trial of Labor?” (Obstet Gynecol. 1966 Aug;28[2]:273-6). A look at the recent Master Class on vaginal birth after cesarean shows that those same questions are still being debated today.

So what will physicians and patients say about obstetrics and gynecology practice 50 years from now?

1966 at a glance

The Surgeon General

In a report to U.S. Surgeon General William H. Stewart titled “Protecting and Improving Health through the Radiological Sciences,” the National Advisory Committee on Radiation warned about emerging problems in the use of ionizing radiation in medicine.

Births

According to data provided by the Centers for Disease Control and Prevention, in 1966, there were 3.6 million births, for a birth rate of 18.4 and a fertility rate of 90.8; 8.4% of births were to unmarried women.

Women get organized

Courtesy of the National Organization for Women

In June, Betty Friedan, Pauli Murray, and several other women launched the National Organization for Women at a conference in Washington, D.C., with Ms. Friedan famously writing N-O-W on a paper napkin.

Medical ethics

Dr. Henry K. Beecher published an article on ethics in the New England Journal of Medicine that is credited with spurring the federal government to set rules on human experimentation and informed consent, including establishment of Institutional Review Boards.

A safety net is born

Photo courtesy of White House

On July 1, 1966, Medicare coverage began, with more than 19 million beneficiaries.

The AMA

Courtesy of the American Medical Association

The American Medical Association published the first edition of the Current Procedural Terminology (CPT) code book, creating a system of standardized terms for medical procedures used in documentation. Also in 1966, the AMA encouraged doctors to promote exercise to improve health.

Planned Parenthood

The Planned Parenthood Federation of America awarded its first Margaret Sanger Award. In 1966, four men received the award, including the Rev. Martin Luther King Jr. and President Lyndon B. Johnson.

Pregnancy testing

The first radioimmunoassay for hCG (human chorionic gonadotropin) was described by A.R. Midgley, but the test could not distinguish between hCG and luteinizing hormone. A home pregnancy test was still a decade away.

Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

As Ob.Gyn. News celebrates 50 years of publication, we’re taking a look back at our first year – 1966.

Not surprisingly, medicine looked a lot different in the mid-1960s, largely driven by the culture and technology of the time. A review of the 1966 issues of Obstetrics and Gynecology (the Green Journal), offers a snapshot of the state of the science.

With scientists still struggling to develop a rapid test to detect pregnancy, researchers from the Brookdale Hospital Center in Brooklyn, N.Y., detailed the possibility of using elevated breast temperature to get faster results. They compared 50 pregnant and 50 nonpregnant women and found a consistent rise in breast temperature in all pregnant women as early as 1 week after the first missed period. In the March issue, they concluded that the use of temperature difference between the breast and a baseline area on the anterior chest wall could be a rapid, simple, and accurate pregnancy test (Obstet Gynecol. 1966 Mar;27[3]:378-80).

In August, researchers from Australia published promising data on the use of ultrasonic echoscopic examination of the uterus in late pregnancy. They found that the technology was useful in determining fetal position and possible abnormalities and could be repeated as often as necessary to observe changes and growth. The big advantage, they noted, would be the opportunity to avoid excessive fetal exposure to x-rays (Obstet Gynecol. 1966 Aug;28[2]:164-9).

Advertising directed at physicians – in both the Green Journal and in Ob.Gyn. News – provided a glimpse into the practice of medicine at the time. Ob.gyns. saw ads for products such as Eskatrol – a capsule that contained dextroamphetamine sulfate and prochlorperazine – promoted to help women control appetite and “relieve the emotional stress that causes overeating.” And doctors also saw ads for oral contraceptives, first approved by the Food and Drug Administration in 1960.

Ob.gyn. practice was different culturally as well. In a regular column titled “After Office Hours,” published in the Green Journal in January 1966, Dr. Malcolm S. Allan explored a relatively new idea – husband-attended deliveries. Dr. Allan, of Wesson Maternity Hospital in Springfield, Mass., explained that his hospital had conducted a nationwide survey of chiefs of obstetrics after they received a petition seeking to allow husbands into the delivery room, as well as more flexibility for fathers to room in with the mother and baby. The survey, which included responses from 267 hospitals, showed that 81% of hospitals did not allow husbands in the delivery room (Obstet Gynecol. 1966 Jan;27[1]:146-8).

After reviewing the survey results and talking to experts in the area, Dr. Allan and the leadership at Wesson decided not to allow husbands to witness deliveries. He concluded that “some patients in some of these ‘off-beat’ programs are being allowed to assume too much authority for determining the medical management of their pregnancies, while leaving the obstetrician with the responsibility for a healthy outcome.”

But in other ways, not much has changed since 1966. The March edition of “After Office Hours” bemoaned a looming manpower crisis in obstetrics (Obstet Gynecol. 1966 Mar;27[3]:449-52). Dr. Jan Schneider of the University of Michigan, Ann Arbor, wrote that even using conservative estimates of population growth, by 1970 there would be 20,000 obstetricians in the United States delivering on average of 225 babies each, a strain on the workforce. What were some of the factors? An uneven distribution of obstetricians throughout the country and increasing specialization.

In another familiar theme, Dr. Schneider urged physicians to consider team care as one part of the solution, allowing nurse midwives to provide prenatal care and perform normal deliveries under physician supervision.

Some of the clinical debates going on in 1966 are still unresolved. Consider the September 1966 issue of the Green Journal, which features an interim report on contraception with an intrauterine bow inserted immediately postpartum (Obstet Gynecol. 1966 Sep;28[3]:329-31). Five decades later, only about 12 state Medicaid programs cover the cost of insertion of an IUD immediately postpartum. And in the August 1966 issue of the Green Journal, Dr. Carl J. Pauerstein asked, “Once a Section, Always a Trial of Labor?” (Obstet Gynecol. 1966 Aug;28[2]:273-6). A look at the recent Master Class on vaginal birth after cesarean shows that those same questions are still being debated today.

So what will physicians and patients say about obstetrics and gynecology practice 50 years from now?

1966 at a glance

The Surgeon General

In a report to U.S. Surgeon General William H. Stewart titled “Protecting and Improving Health through the Radiological Sciences,” the National Advisory Committee on Radiation warned about emerging problems in the use of ionizing radiation in medicine.

Births

According to data provided by the Centers for Disease Control and Prevention, in 1966, there were 3.6 million births, for a birth rate of 18.4 and a fertility rate of 90.8; 8.4% of births were to unmarried women.

Women get organized

Courtesy of the National Organization for Women

In June, Betty Friedan, Pauli Murray, and several other women launched the National Organization for Women at a conference in Washington, D.C., with Ms. Friedan famously writing N-O-W on a paper napkin.

Medical ethics

Dr. Henry K. Beecher published an article on ethics in the New England Journal of Medicine that is credited with spurring the federal government to set rules on human experimentation and informed consent, including establishment of Institutional Review Boards.

A safety net is born

Photo courtesy of White House

On July 1, 1966, Medicare coverage began, with more than 19 million beneficiaries.

The AMA

Courtesy of the American Medical Association

The American Medical Association published the first edition of the Current Procedural Terminology (CPT) code book, creating a system of standardized terms for medical procedures used in documentation. Also in 1966, the AMA encouraged doctors to promote exercise to improve health.

Planned Parenthood

The Planned Parenthood Federation of America awarded its first Margaret Sanger Award. In 1966, four men received the award, including the Rev. Martin Luther King Jr. and President Lyndon B. Johnson.

Pregnancy testing

The first radioimmunoassay for hCG (human chorionic gonadotropin) was described by A.R. Midgley, but the test could not distinguish between hCG and luteinizing hormone. A home pregnancy test was still a decade away.

Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

On October 14, 2015, the US Food and Drug Administration declined to approve tofacitinib citrate, an oral rheumatoid arthritis drug, for the treatment of moderate to severe chronic plaque psoriasis. The FDA communicated its decision to the manufacturer in the form of a complete response letter, which typically outlines concerns and conditions that must be addressed in order to gain FDA approval following initial review of an application.

A recent press release indicated that the manufacturer is committed to pursuing approval of the product based on the strength of the clinical data for its treatment of psoriasis. The FDA generally does not disclose the contents of its complete response letters, but the manufacturer reported it has been asked to provide additional safety analyses of the drug for psoriasis and that it will work closely with the agency to gain the additional approval for treatment of patients with chronic plaque psoriasis.

What’s the Issue?

With the increasing number of psoriasis drugs on the market and in the pipeline, the risk-benefit profile of all drugs needs to be evaluated very carefully. Therefore, safety is the focal issue in all new drug development. Hopefully these issues with the FDA approval of tofacitinib citrate will be worked out so that we may have another oral option for our psoriasis patients. How will this development influence your approach to new therapies?

We want to know your views! Tell us what you think.

On October 14, 2015, the US Food and Drug Administration declined to approve tofacitinib citrate, an oral rheumatoid arthritis drug, for the treatment of moderate to severe chronic plaque psoriasis. The FDA communicated its decision to the manufacturer in the form of a complete response letter, which typically outlines concerns and conditions that must be addressed in order to gain FDA approval following initial review of an application.

A recent press release indicated that the manufacturer is committed to pursuing approval of the product based on the strength of the clinical data for its treatment of psoriasis. The FDA generally does not disclose the contents of its complete response letters, but the manufacturer reported it has been asked to provide additional safety analyses of the drug for psoriasis and that it will work closely with the agency to gain the additional approval for treatment of patients with chronic plaque psoriasis.

What’s the Issue?

With the increasing number of psoriasis drugs on the market and in the pipeline, the risk-benefit profile of all drugs needs to be evaluated very carefully. Therefore, safety is the focal issue in all new drug development. Hopefully these issues with the FDA approval of tofacitinib citrate will be worked out so that we may have another oral option for our psoriasis patients. How will this development influence your approach to new therapies?

We want to know your views! Tell us what you think.

On October 14, 2015, the US Food and Drug Administration declined to approve tofacitinib citrate, an oral rheumatoid arthritis drug, for the treatment of moderate to severe chronic plaque psoriasis. The FDA communicated its decision to the manufacturer in the form of a complete response letter, which typically outlines concerns and conditions that must be addressed in order to gain FDA approval following initial review of an application.

A recent press release indicated that the manufacturer is committed to pursuing approval of the product based on the strength of the clinical data for its treatment of psoriasis. The FDA generally does not disclose the contents of its complete response letters, but the manufacturer reported it has been asked to provide additional safety analyses of the drug for psoriasis and that it will work closely with the agency to gain the additional approval for treatment of patients with chronic plaque psoriasis.

What’s the Issue?

With the increasing number of psoriasis drugs on the market and in the pipeline, the risk-benefit profile of all drugs needs to be evaluated very carefully. Therefore, safety is the focal issue in all new drug development. Hopefully these issues with the FDA approval of tofacitinib citrate will be worked out so that we may have another oral option for our psoriasis patients. How will this development influence your approach to new therapies?

We want to know your views! Tell us what you think.

Following a phase III, open-label trial conducted by Andtbacka et al (J Clin Oncol. 2015;33:2780-2788), the US Food and Drug Administration recently approved the first oncolytic immunotherapy talimogene laherparepvec (T-VEC) for the treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with advanced melanoma (stage IIIB/C–stage IV) following initial surgery.

A group of 436 patients with injectable melanomas (melanomas that are accessible via a percutaneous injection) that were not surgically resectable were randomly assigned (2:1) to treatment with intralesional T-VEC or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). The primary endpoint of the study was durable response rate (DRR), defined as objective response lasting continuously for 6 months or longer. Secondary endpoints included overall survival (OS) and overall response rate.

Talimogene laherparepvec was shown to extend DRRs compared to GM-CSF. Durable response rates were significantly higher with T-VEC (16.3%; 95% confidence interval [CI], 12.1%–20.5%) versus GM-CSF (2.1%; 95% CI, 0%–4.5%)(odds ratio, 8.9; P<.001).

In the OS analysis, a 4.4-month extension with T-VEC was observed; however, this was not deemed to be statistically significant (P=.051). The median OS was 23.3 months (95% CI, 19.5–29.6 months) with T-VEC and 18.9 months (95% CI, 16.0–23.7 months) with GM-CSF (hazard ratio, 0.79; 95% CI, 0.62–1.00; P=.051). Overall response rate also was higher in the T-VEC arm (26.4%; 95% CI, 21.4%–31.5%) versus GM-CSF (5.7%; 95% CI, 1.9%–9.5%).

Talimogene laherparepvec is a herpes simplex virus type 1–derived oncolytic immunotherapy designed to replicate within tumors and produce GM-CSF, which enhances systemic antitumor immune responses and induces tumor lysis.

In this study, T-VEC efficacy was greatest in patients with stage IIIB, IIIC, or IVM1a melanomas and in patients with treatment-naive disease. Differences in DRRs in patients with stage IIIB/C melanomas were 33% in the T-VEC group versus 0% for patients treated with GM-CSF alone. In the stage IVM1a group, DRR was 16% with T-VEC versus 2% with GM-CSF. The difference between both treatments was smaller in more advanced melanomas (IVM1b group, 3% vs 4%; IVM1c, 7% vs 3%). In the first-line treatment, the DRR with T-VEC was 24% versus 0% with GM-CSF. In the second-line and beyond, the DRR with T-VEC was 10% compared to 4% for GM-CSF.

The main adverse events seen in this study were fatigue, chills, and pyrexia. Serious adverse events occurred in 25.7% and 13.4% of participants in the T-VEC and GM-CSF arms, respectively, with disease progression (3.1% vs 1.6%) and cellulitis (2.4% vs 0.8%) being the most common. Six immune-mediated events occurred in the T-VEC group compared to 3 in the GM-CSF group.

Twelve patient deaths occurred within 30 days of the last dose of T-VEC; 9 were associated with progressive disease and the other 3 were associated with myocardial infarction, cardiac arrest, and sepsis, respectively. Four patient deaths were reported in the GM-CSF arm within the same 30 days.

What’s the Issue?

Immunotherapy represents a promising treatment option for metastatic melanoma. These promising results along with the US Food and Drug Administration’s approval of T-VEC will lead to further studies of the uses of T-VEC in combination with other therapies, including a phase I/II study to assess T-VEC in combination with ipilimumab for unresected melanomas (NCT01740297) and a phase III study of T-VEC in combination with pembrolizumab for unresected melanomas (NCT02263508). It is important for dermatologists to be familiar with the new frontier of melanoma treatments. How will these new immunotherapies affect your treatment of melanoma?

We want to know your views! Tell us what you think.

Following a phase III, open-label trial conducted by Andtbacka et al (J Clin Oncol. 2015;33:2780-2788), the US Food and Drug Administration recently approved the first oncolytic immunotherapy talimogene laherparepvec (T-VEC) for the treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with advanced melanoma (stage IIIB/C–stage IV) following initial surgery.

A group of 436 patients with injectable melanomas (melanomas that are accessible via a percutaneous injection) that were not surgically resectable were randomly assigned (2:1) to treatment with intralesional T-VEC or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). The primary endpoint of the study was durable response rate (DRR), defined as objective response lasting continuously for 6 months or longer. Secondary endpoints included overall survival (OS) and overall response rate.

Talimogene laherparepvec was shown to extend DRRs compared to GM-CSF. Durable response rates were significantly higher with T-VEC (16.3%; 95% confidence interval [CI], 12.1%–20.5%) versus GM-CSF (2.1%; 95% CI, 0%–4.5%)(odds ratio, 8.9; P<.001).

In the OS analysis, a 4.4-month extension with T-VEC was observed; however, this was not deemed to be statistically significant (P=.051). The median OS was 23.3 months (95% CI, 19.5–29.6 months) with T-VEC and 18.9 months (95% CI, 16.0–23.7 months) with GM-CSF (hazard ratio, 0.79; 95% CI, 0.62–1.00; P=.051). Overall response rate also was higher in the T-VEC arm (26.4%; 95% CI, 21.4%–31.5%) versus GM-CSF (5.7%; 95% CI, 1.9%–9.5%).

Talimogene laherparepvec is a herpes simplex virus type 1–derived oncolytic immunotherapy designed to replicate within tumors and produce GM-CSF, which enhances systemic antitumor immune responses and induces tumor lysis.

In this study, T-VEC efficacy was greatest in patients with stage IIIB, IIIC, or IVM1a melanomas and in patients with treatment-naive disease. Differences in DRRs in patients with stage IIIB/C melanomas were 33% in the T-VEC group versus 0% for patients treated with GM-CSF alone. In the stage IVM1a group, DRR was 16% with T-VEC versus 2% with GM-CSF. The difference between both treatments was smaller in more advanced melanomas (IVM1b group, 3% vs 4%; IVM1c, 7% vs 3%). In the first-line treatment, the DRR with T-VEC was 24% versus 0% with GM-CSF. In the second-line and beyond, the DRR with T-VEC was 10% compared to 4% for GM-CSF.

The main adverse events seen in this study were fatigue, chills, and pyrexia. Serious adverse events occurred in 25.7% and 13.4% of participants in the T-VEC and GM-CSF arms, respectively, with disease progression (3.1% vs 1.6%) and cellulitis (2.4% vs 0.8%) being the most common. Six immune-mediated events occurred in the T-VEC group compared to 3 in the GM-CSF group.

Twelve patient deaths occurred within 30 days of the last dose of T-VEC; 9 were associated with progressive disease and the other 3 were associated with myocardial infarction, cardiac arrest, and sepsis, respectively. Four patient deaths were reported in the GM-CSF arm within the same 30 days.

What’s the Issue?

Immunotherapy represents a promising treatment option for metastatic melanoma. These promising results along with the US Food and Drug Administration’s approval of T-VEC will lead to further studies of the uses of T-VEC in combination with other therapies, including a phase I/II study to assess T-VEC in combination with ipilimumab for unresected melanomas (NCT01740297) and a phase III study of T-VEC in combination with pembrolizumab for unresected melanomas (NCT02263508). It is important for dermatologists to be familiar with the new frontier of melanoma treatments. How will these new immunotherapies affect your treatment of melanoma?

We want to know your views! Tell us what you think.

Following a phase III, open-label trial conducted by Andtbacka et al (J Clin Oncol. 2015;33:2780-2788), the US Food and Drug Administration recently approved the first oncolytic immunotherapy talimogene laherparepvec (T-VEC) for the treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with advanced melanoma (stage IIIB/C–stage IV) following initial surgery.

A group of 436 patients with injectable melanomas (melanomas that are accessible via a percutaneous injection) that were not surgically resectable were randomly assigned (2:1) to treatment with intralesional T-VEC or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). The primary endpoint of the study was durable response rate (DRR), defined as objective response lasting continuously for 6 months or longer. Secondary endpoints included overall survival (OS) and overall response rate.

Talimogene laherparepvec was shown to extend DRRs compared to GM-CSF. Durable response rates were significantly higher with T-VEC (16.3%; 95% confidence interval [CI], 12.1%–20.5%) versus GM-CSF (2.1%; 95% CI, 0%–4.5%)(odds ratio, 8.9; P<.001).

In the OS analysis, a 4.4-month extension with T-VEC was observed; however, this was not deemed to be statistically significant (P=.051). The median OS was 23.3 months (95% CI, 19.5–29.6 months) with T-VEC and 18.9 months (95% CI, 16.0–23.7 months) with GM-CSF (hazard ratio, 0.79; 95% CI, 0.62–1.00; P=.051). Overall response rate also was higher in the T-VEC arm (26.4%; 95% CI, 21.4%–31.5%) versus GM-CSF (5.7%; 95% CI, 1.9%–9.5%).

Talimogene laherparepvec is a herpes simplex virus type 1–derived oncolytic immunotherapy designed to replicate within tumors and produce GM-CSF, which enhances systemic antitumor immune responses and induces tumor lysis.

In this study, T-VEC efficacy was greatest in patients with stage IIIB, IIIC, or IVM1a melanomas and in patients with treatment-naive disease. Differences in DRRs in patients with stage IIIB/C melanomas were 33% in the T-VEC group versus 0% for patients treated with GM-CSF alone. In the stage IVM1a group, DRR was 16% with T-VEC versus 2% with GM-CSF. The difference between both treatments was smaller in more advanced melanomas (IVM1b group, 3% vs 4%; IVM1c, 7% vs 3%). In the first-line treatment, the DRR with T-VEC was 24% versus 0% with GM-CSF. In the second-line and beyond, the DRR with T-VEC was 10% compared to 4% for GM-CSF.

The main adverse events seen in this study were fatigue, chills, and pyrexia. Serious adverse events occurred in 25.7% and 13.4% of participants in the T-VEC and GM-CSF arms, respectively, with disease progression (3.1% vs 1.6%) and cellulitis (2.4% vs 0.8%) being the most common. Six immune-mediated events occurred in the T-VEC group compared to 3 in the GM-CSF group.

Twelve patient deaths occurred within 30 days of the last dose of T-VEC; 9 were associated with progressive disease and the other 3 were associated with myocardial infarction, cardiac arrest, and sepsis, respectively. Four patient deaths were reported in the GM-CSF arm within the same 30 days.

What’s the Issue?

Immunotherapy represents a promising treatment option for metastatic melanoma. These promising results along with the US Food and Drug Administration’s approval of T-VEC will lead to further studies of the uses of T-VEC in combination with other therapies, including a phase I/II study to assess T-VEC in combination with ipilimumab for unresected melanomas (NCT01740297) and a phase III study of T-VEC in combination with pembrolizumab for unresected melanomas (NCT02263508). It is important for dermatologists to be familiar with the new frontier of melanoma treatments. How will these new immunotherapies affect your treatment of melanoma?

We want to know your views! Tell us what you think.

As more patients undergo facial rejuvenation procedures for a more youthful look, there is a growing demand for rejuvenation of the décolletage (neck and chest) to achieve a more natural and seamless transition from the skin of the face to the chest. The same modalities that are used on the face to treat skin rhytides, texture, and discoloration have been used successfully in the décolletage area.

Vanaman and Fabi (Plast Reconstr Surg. 2015;136[suppl 5]:276S-281S) recently reviewed the chest anatomy and discussed the safe and effective use of cosmetic injectables alone or in combination with other modalities to address rhytides of the décolletage. The relatively low density of skin pilosebaceous units on the chest allows for slower healing and thus makes the area more vulnerable to scarring with the use of more invasive resurfacing modalities (eg, deeper chemical peels, ablative lasers). The use of cosmetic injectables offers a safer treatment option of chest rhytides. Furthermore, proper candidate selection excludes patients with known sensitivity to cosmetic injectables or their components, history of keloid or hypertrophic scar formation, and active inflammation in the treatment area.

Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, semipermanent, synthetic soft tissue biostimulator that promotes neocollagenesis by fibroblasts over time (3–6 months). The manufacturer’s recommendation for PLLA reconstitution is at least 2 hours prior to injection with sterile water of no less than 5 mL dilution. Vanaman and Fabi reported usually diluting the day prior to injection with 16 mL total volume. This technique showed the greatest improvement in chest rhytides with no adverse events reported in a retrospective analysis. Poly-L-lactic acid should be injected in a retrograde linear fashion in the plane of the subcutaneous fat, with injection boundaries on the suprasternal notch superiorly, the midclavicular line laterally, and the fourth rib inferolaterally for rejuvenation of the décolletage.

Nodule formation is a well-known complication of PLLA injection, although pain, bruising, edema, pruritus, and hematomas are more commonly seen. The risk of nodule formation can be decreased using several techniques, including avoiding overcorrection and excessive use of product in each individual session, avoiding intradermal injection, diluting to more than 5 mL with reconstitution at least overnight, massaging the area posttreatment (in office by the clinician and at home by the patient), and scheduling treatment sessions at least 4 weeks apart. Usually, 3 to 4 treatments are required and the results can last 2 years or longer without touch-ups.

Nonanimal stabilized hyaluronic acid (NASHA) fillers also can be used to correct chest rhytides; however, using NASHA fillers requires more syringes and results typically last only 6 to 8 months, making it more cost effective to use 2 to 3 vials of PLLA. Moreover, in Vanaman and Fabi’s experience, PLLA is associated with fewer nodules, possibly due to the depth of injection of PLLA into the subcutaneous fat versus injection into the deep dermis with NASHA fillers. Vanaman and Fabi currently are investigating the use of calcium hydroxylapatite fillers alone or in combination with an energy-based modality (microfocused ultrasound) with visualization in the treatment of rhytides in the décolletage.

What’s the Issue?

The availability of many modalities to keep facial skin looking fresh and rejuvenated has led to an increased demand for products and procedures to rejuvenate the décolletage. It is important for dermatologists to acknowledge the more delicate nature of the décolletage versus the face. Less invasive modalities such as cosmetic injectables can be employed in a safe and effective manner to correct rhytides of the chest with proper techniques, products, and patient selection. For a more natural transition from the skin of the face to the décolletage, it also may be necessary to adopt a multimodal approach by using botulinum toxin and fillers, as well as going beyond correction of rhytides to address skin texture and discoloration with chemical peels and lasers. Have you seen an increased demand for procedures to rejuvenate the décolletage in your practice?

We want to know your views! Tell us what you think.

As more patients undergo facial rejuvenation procedures for a more youthful look, there is a growing demand for rejuvenation of the décolletage (neck and chest) to achieve a more natural and seamless transition from the skin of the face to the chest. The same modalities that are used on the face to treat skin rhytides, texture, and discoloration have been used successfully in the décolletage area.

Vanaman and Fabi (Plast Reconstr Surg. 2015;136[suppl 5]:276S-281S) recently reviewed the chest anatomy and discussed the safe and effective use of cosmetic injectables alone or in combination with other modalities to address rhytides of the décolletage. The relatively low density of skin pilosebaceous units on the chest allows for slower healing and thus makes the area more vulnerable to scarring with the use of more invasive resurfacing modalities (eg, deeper chemical peels, ablative lasers). The use of cosmetic injectables offers a safer treatment option of chest rhytides. Furthermore, proper candidate selection excludes patients with known sensitivity to cosmetic injectables or their components, history of keloid or hypertrophic scar formation, and active inflammation in the treatment area.

Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, semipermanent, synthetic soft tissue biostimulator that promotes neocollagenesis by fibroblasts over time (3–6 months). The manufacturer’s recommendation for PLLA reconstitution is at least 2 hours prior to injection with sterile water of no less than 5 mL dilution. Vanaman and Fabi reported usually diluting the day prior to injection with 16 mL total volume. This technique showed the greatest improvement in chest rhytides with no adverse events reported in a retrospective analysis. Poly-L-lactic acid should be injected in a retrograde linear fashion in the plane of the subcutaneous fat, with injection boundaries on the suprasternal notch superiorly, the midclavicular line laterally, and the fourth rib inferolaterally for rejuvenation of the décolletage.

Nodule formation is a well-known complication of PLLA injection, although pain, bruising, edema, pruritus, and hematomas are more commonly seen. The risk of nodule formation can be decreased using several techniques, including avoiding overcorrection and excessive use of product in each individual session, avoiding intradermal injection, diluting to more than 5 mL with reconstitution at least overnight, massaging the area posttreatment (in office by the clinician and at home by the patient), and scheduling treatment sessions at least 4 weeks apart. Usually, 3 to 4 treatments are required and the results can last 2 years or longer without touch-ups.

Nonanimal stabilized hyaluronic acid (NASHA) fillers also can be used to correct chest rhytides; however, using NASHA fillers requires more syringes and results typically last only 6 to 8 months, making it more cost effective to use 2 to 3 vials of PLLA. Moreover, in Vanaman and Fabi’s experience, PLLA is associated with fewer nodules, possibly due to the depth of injection of PLLA into the subcutaneous fat versus injection into the deep dermis with NASHA fillers. Vanaman and Fabi currently are investigating the use of calcium hydroxylapatite fillers alone or in combination with an energy-based modality (microfocused ultrasound) with visualization in the treatment of rhytides in the décolletage.

What’s the Issue?

The availability of many modalities to keep facial skin looking fresh and rejuvenated has led to an increased demand for products and procedures to rejuvenate the décolletage. It is important for dermatologists to acknowledge the more delicate nature of the décolletage versus the face. Less invasive modalities such as cosmetic injectables can be employed in a safe and effective manner to correct rhytides of the chest with proper techniques, products, and patient selection. For a more natural transition from the skin of the face to the décolletage, it also may be necessary to adopt a multimodal approach by using botulinum toxin and fillers, as well as going beyond correction of rhytides to address skin texture and discoloration with chemical peels and lasers. Have you seen an increased demand for procedures to rejuvenate the décolletage in your practice?

We want to know your views! Tell us what you think.

As more patients undergo facial rejuvenation procedures for a more youthful look, there is a growing demand for rejuvenation of the décolletage (neck and chest) to achieve a more natural and seamless transition from the skin of the face to the chest. The same modalities that are used on the face to treat skin rhytides, texture, and discoloration have been used successfully in the décolletage area.

Vanaman and Fabi (Plast Reconstr Surg. 2015;136[suppl 5]:276S-281S) recently reviewed the chest anatomy and discussed the safe and effective use of cosmetic injectables alone or in combination with other modalities to address rhytides of the décolletage. The relatively low density of skin pilosebaceous units on the chest allows for slower healing and thus makes the area more vulnerable to scarring with the use of more invasive resurfacing modalities (eg, deeper chemical peels, ablative lasers). The use of cosmetic injectables offers a safer treatment option of chest rhytides. Furthermore, proper candidate selection excludes patients with known sensitivity to cosmetic injectables or their components, history of keloid or hypertrophic scar formation, and active inflammation in the treatment area.

Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, semipermanent, synthetic soft tissue biostimulator that promotes neocollagenesis by fibroblasts over time (3–6 months). The manufacturer’s recommendation for PLLA reconstitution is at least 2 hours prior to injection with sterile water of no less than 5 mL dilution. Vanaman and Fabi reported usually diluting the day prior to injection with 16 mL total volume. This technique showed the greatest improvement in chest rhytides with no adverse events reported in a retrospective analysis. Poly-L-lactic acid should be injected in a retrograde linear fashion in the plane of the subcutaneous fat, with injection boundaries on the suprasternal notch superiorly, the midclavicular line laterally, and the fourth rib inferolaterally for rejuvenation of the décolletage.

Nodule formation is a well-known complication of PLLA injection, although pain, bruising, edema, pruritus, and hematomas are more commonly seen. The risk of nodule formation can be decreased using several techniques, including avoiding overcorrection and excessive use of product in each individual session, avoiding intradermal injection, diluting to more than 5 mL with reconstitution at least overnight, massaging the area posttreatment (in office by the clinician and at home by the patient), and scheduling treatment sessions at least 4 weeks apart. Usually, 3 to 4 treatments are required and the results can last 2 years or longer without touch-ups.

Nonanimal stabilized hyaluronic acid (NASHA) fillers also can be used to correct chest rhytides; however, using NASHA fillers requires more syringes and results typically last only 6 to 8 months, making it more cost effective to use 2 to 3 vials of PLLA. Moreover, in Vanaman and Fabi’s experience, PLLA is associated with fewer nodules, possibly due to the depth of injection of PLLA into the subcutaneous fat versus injection into the deep dermis with NASHA fillers. Vanaman and Fabi currently are investigating the use of calcium hydroxylapatite fillers alone or in combination with an energy-based modality (microfocused ultrasound) with visualization in the treatment of rhytides in the décolletage.

What’s the Issue?

The availability of many modalities to keep facial skin looking fresh and rejuvenated has led to an increased demand for products and procedures to rejuvenate the décolletage. It is important for dermatologists to acknowledge the more delicate nature of the décolletage versus the face. Less invasive modalities such as cosmetic injectables can be employed in a safe and effective manner to correct rhytides of the chest with proper techniques, products, and patient selection. For a more natural transition from the skin of the face to the décolletage, it also may be necessary to adopt a multimodal approach by using botulinum toxin and fillers, as well as going beyond correction of rhytides to address skin texture and discoloration with chemical peels and lasers. Have you seen an increased demand for procedures to rejuvenate the décolletage in your practice?

We want to know your views! Tell us what you think.

Sedentary living, supported by the number of hours spent sitting at work and at home each day, has been associated with increased risk for cardiovascular disease, diabetes, and premature mortality. Buckley et al (Br J Sports Med. 2015;49:1357-1362) provided guidelines for employers regarding interventions that may promote the avoidance of prolonged periods of sedentary work in a consensus statement that was commissioned by Public Health England and the Active Working Community Interest Company (who launched the Get Britain Standing campaign). The authors recommended initially aiming to accumulate at least 2 hours of standing and light activity (such as walking around the office) during work hours, with the eventual goal of 4 hours per day; however, they also cautioned that this positive adaptive process may lead to musculoskeletal sensations and fatigue in some individuals who may not be accustomed to standing-based work.

Buckley et al also suggested that employers should encourage goal that promote good health, such as improving nutrition and reducing alcohol consumption, smoking, and stress. Additionally, the authors highly recommended adjustable desk stations that allow employees to alternate between standing and seated work. Finally, Buckley et al commented that prolonged static standing postures, similar to prolonged static seated positions, also should be avoided.

Buckley et al also noted that workplaces that have initiated these interventions have seen improvement in cardiometabolic, musculoskeletal, and mental health risks in employees. Additionally, the productivity, quality, and efficiency of the work improved and employees experienced a greater sense of collaboration. Incorporating interventions to eliminate sitting for prolonged periods in the workplace resulted in cost savings for health services for both the employees and the employer in the groups studied by Buckley et al.

What’s the Issue?

Like other physicians and health care providers, dermatologists may be working longer hours, dealing with increased administrative demands that require electronic or hand-written documentation, and spending more time sitting each day to accomplish activities that do not involve direct patient care. Incorporating planned periods of activity (eg, standing breaks) in the workday for both themselves and their office personnel may be an effective intervention for dermatologists to use to avoid sitting for prolonged periods of time. Additionally, changing the ergonomic design of the office and workstations with adjustable desks and counter tops that allow employees to alternate between sitting and standing may encourage staff to not only become less sedentary but possibly more productive as well. Is it time for dermatologists to “stand up” for themselves?

We want to know your views! Tell us what you think.

Sedentary living, supported by the number of hours spent sitting at work and at home each day, has been associated with increased risk for cardiovascular disease, diabetes, and premature mortality. Buckley et al (Br J Sports Med. 2015;49:1357-1362) provided guidelines for employers regarding interventions that may promote the avoidance of prolonged periods of sedentary work in a consensus statement that was commissioned by Public Health England and the Active Working Community Interest Company (who launched the Get Britain Standing campaign). The authors recommended initially aiming to accumulate at least 2 hours of standing and light activity (such as walking around the office) during work hours, with the eventual goal of 4 hours per day; however, they also cautioned that this positive adaptive process may lead to musculoskeletal sensations and fatigue in some individuals who may not be accustomed to standing-based work.

Buckley et al also suggested that employers should encourage goal that promote good health, such as improving nutrition and reducing alcohol consumption, smoking, and stress. Additionally, the authors highly recommended adjustable desk stations that allow employees to alternate between standing and seated work. Finally, Buckley et al commented that prolonged static standing postures, similar to prolonged static seated positions, also should be avoided.

Buckley et al also noted that workplaces that have initiated these interventions have seen improvement in cardiometabolic, musculoskeletal, and mental health risks in employees. Additionally, the productivity, quality, and efficiency of the work improved and employees experienced a greater sense of collaboration. Incorporating interventions to eliminate sitting for prolonged periods in the workplace resulted in cost savings for health services for both the employees and the employer in the groups studied by Buckley et al.

What’s the Issue?

Like other physicians and health care providers, dermatologists may be working longer hours, dealing with increased administrative demands that require electronic or hand-written documentation, and spending more time sitting each day to accomplish activities that do not involve direct patient care. Incorporating planned periods of activity (eg, standing breaks) in the workday for both themselves and their office personnel may be an effective intervention for dermatologists to use to avoid sitting for prolonged periods of time. Additionally, changing the ergonomic design of the office and workstations with adjustable desks and counter tops that allow employees to alternate between sitting and standing may encourage staff to not only become less sedentary but possibly more productive as well. Is it time for dermatologists to “stand up” for themselves?

We want to know your views! Tell us what you think.

Sedentary living, supported by the number of hours spent sitting at work and at home each day, has been associated with increased risk for cardiovascular disease, diabetes, and premature mortality. Buckley et al (Br J Sports Med. 2015;49:1357-1362) provided guidelines for employers regarding interventions that may promote the avoidance of prolonged periods of sedentary work in a consensus statement that was commissioned by Public Health England and the Active Working Community Interest Company (who launched the Get Britain Standing campaign). The authors recommended initially aiming to accumulate at least 2 hours of standing and light activity (such as walking around the office) during work hours, with the eventual goal of 4 hours per day; however, they also cautioned that this positive adaptive process may lead to musculoskeletal sensations and fatigue in some individuals who may not be accustomed to standing-based work.

Buckley et al also suggested that employers should encourage goal that promote good health, such as improving nutrition and reducing alcohol consumption, smoking, and stress. Additionally, the authors highly recommended adjustable desk stations that allow employees to alternate between standing and seated work. Finally, Buckley et al commented that prolonged static standing postures, similar to prolonged static seated positions, also should be avoided.

Buckley et al also noted that workplaces that have initiated these interventions have seen improvement in cardiometabolic, musculoskeletal, and mental health risks in employees. Additionally, the productivity, quality, and efficiency of the work improved and employees experienced a greater sense of collaboration. Incorporating interventions to eliminate sitting for prolonged periods in the workplace resulted in cost savings for health services for both the employees and the employer in the groups studied by Buckley et al.

What’s the Issue?

Like other physicians and health care providers, dermatologists may be working longer hours, dealing with increased administrative demands that require electronic or hand-written documentation, and spending more time sitting each day to accomplish activities that do not involve direct patient care. Incorporating planned periods of activity (eg, standing breaks) in the workday for both themselves and their office personnel may be an effective intervention for dermatologists to use to avoid sitting for prolonged periods of time. Additionally, changing the ergonomic design of the office and workstations with adjustable desks and counter tops that allow employees to alternate between sitting and standing may encourage staff to not only become less sedentary but possibly more productive as well. Is it time for dermatologists to “stand up” for themselves?

We want to know your views! Tell us what you think.

In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.

Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.

For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.

What’s the Issue?

It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,¹ there is nonetheless a wide-open and inviting playing field for effective therapies.

Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?

We want to know your views! Tell us what you think.

In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.

Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.

For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.

What’s the Issue?

It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,¹ there is nonetheless a wide-open and inviting playing field for effective therapies.

Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?

We want to know your views! Tell us what you think.

In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.

Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.

For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.

What’s the Issue?

It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,¹ there is nonetheless a wide-open and inviting playing field for effective therapies.

Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?

We want to know your views! Tell us what you think.

While psoriasis is a known risk factor for depression, depression can also exacerbate or trigger psoriasis. This relationship between depression and psoriasis, however, remains to be fully explored.

In an article published online on September 30 in JAMA Dermatology , Cohen et al examined the association between psoriasis and major depression in the US population. The authors conducted a population-based study that utilized individuals who were participating in the National Health and Nutrition Examination Survey from 2009 through 2012.

The authors identified 351 (2.8%) cases of psoriasis and 968 (7.8%) cases of major depression in the 12,382 participants included in the study. Of the patients with psoriasis, 58 (16.5%) met criteria for major depression. The mean (standard deviation) Patient Health Questionnaire-9 score was significantly higher among patients with a history of psoriasis than those without psoriasis (4.54 [5.7] vs 3.22 [4.3], P<.001). After adjustment for sex, age, race, body mass index, physical activity level, smoking history, alcohol use, history of myocardial infarction, history of stroke, and history of diabetes mellitus (odds ratio, 2.09 [95% confidence interval, 1.41–3.11], P<.001), psoriasis was significantly associated with major depression. Having a history of cardiovascular events did not modify the risk of major depression for patients with psoriasis. The investigators also found that the risk of major depression was not significantly different between patients with limited vs extensive psoriasis (odds ratio, 0.66 [95% confidence interval, 0.18–2.44], P=.53).

What’s the Issue?

We know that psoriasis is associated with depression. This study, however, has some surprising findings. The severity of psoriasis was unrelated to the risk of major depression. Additionally, cardiovascular events did not seem to impact major depression in participants with psoriasis. Therefore, all patients with psoriasis, regardless of severity, may be at risk for major depression. Will these findings impact your evaluation of psychological issues in individuals with psoriasis?

We want to know your views! Tell us what you think.

While psoriasis is a known risk factor for depression, depression can also exacerbate or trigger psoriasis. This relationship between depression and psoriasis, however, remains to be fully explored.

In an article published online on September 30 in JAMA Dermatology , Cohen et al examined the association between psoriasis and major depression in the US population. The authors conducted a population-based study that utilized individuals who were participating in the National Health and Nutrition Examination Survey from 2009 through 2012.

The authors identified 351 (2.8%) cases of psoriasis and 968 (7.8%) cases of major depression in the 12,382 participants included in the study. Of the patients with psoriasis, 58 (16.5%) met criteria for major depression. The mean (standard deviation) Patient Health Questionnaire-9 score was significantly higher among patients with a history of psoriasis than those without psoriasis (4.54 [5.7] vs 3.22 [4.3], P<.001). After adjustment for sex, age, race, body mass index, physical activity level, smoking history, alcohol use, history of myocardial infarction, history of stroke, and history of diabetes mellitus (odds ratio, 2.09 [95% confidence interval, 1.41–3.11], P<.001), psoriasis was significantly associated with major depression. Having a history of cardiovascular events did not modify the risk of major depression for patients with psoriasis. The investigators also found that the risk of major depression was not significantly different between patients with limited vs extensive psoriasis (odds ratio, 0.66 [95% confidence interval, 0.18–2.44], P=.53).

What’s the Issue?

We know that psoriasis is associated with depression. This study, however, has some surprising findings. The severity of psoriasis was unrelated to the risk of major depression. Additionally, cardiovascular events did not seem to impact major depression in participants with psoriasis. Therefore, all patients with psoriasis, regardless of severity, may be at risk for major depression. Will these findings impact your evaluation of psychological issues in individuals with psoriasis?

We want to know your views! Tell us what you think.

While psoriasis is a known risk factor for depression, depression can also exacerbate or trigger psoriasis. This relationship between depression and psoriasis, however, remains to be fully explored.

In an article published online on September 30 in JAMA Dermatology , Cohen et al examined the association between psoriasis and major depression in the US population. The authors conducted a population-based study that utilized individuals who were participating in the National Health and Nutrition Examination Survey from 2009 through 2012.

The authors identified 351 (2.8%) cases of psoriasis and 968 (7.8%) cases of major depression in the 12,382 participants included in the study. Of the patients with psoriasis, 58 (16.5%) met criteria for major depression. The mean (standard deviation) Patient Health Questionnaire-9 score was significantly higher among patients with a history of psoriasis than those without psoriasis (4.54 [5.7] vs 3.22 [4.3], P<.001). After adjustment for sex, age, race, body mass index, physical activity level, smoking history, alcohol use, history of myocardial infarction, history of stroke, and history of diabetes mellitus (odds ratio, 2.09 [95% confidence interval, 1.41–3.11], P<.001), psoriasis was significantly associated with major depression. Having a history of cardiovascular events did not modify the risk of major depression for patients with psoriasis. The investigators also found that the risk of major depression was not significantly different between patients with limited vs extensive psoriasis (odds ratio, 0.66 [95% confidence interval, 0.18–2.44], P=.53).

What’s the Issue?

We know that psoriasis is associated with depression. This study, however, has some surprising findings. The severity of psoriasis was unrelated to the risk of major depression. Additionally, cardiovascular events did not seem to impact major depression in participants with psoriasis. Therefore, all patients with psoriasis, regardless of severity, may be at risk for major depression. Will these findings impact your evaluation of psychological issues in individuals with psoriasis?

We want to know your views! Tell us what you think.

While the pathophysiology of acne vulgaris is, at a minimum, complex (and that’s putting it lightly), it is generally accepted that androgens such as dihydrotestosterone (DHT) can play a prominent role, especially in adult women with acne. Although it is not approved by the US Food and Drug Administration, the utilization of antiandrogens such as spironolactone (see my discussion of spironolactone use in adult females in the October issue of Cutis) has become standard practice for many US dermatologists who treat this patient population. Joined only by combined oral contraceptives, antihormonal therapies for acne are somewhat limited. Therefore, effective as well as safe additions are needed.

In a study published online on July 20 in Dermato-Endocrinology, Riyanto et al evaluated the potential of orally administered soy isoflavones for treatment of acne in adult women based on both lesion count over time and corresponding changes in DHT levels. Soy isoflavones such as genistein, daidzein, and glycitein have established effects on androgen metabolism through inhibition of 3β-hydroxysteroid dehydrogenase, 17β-hydroxysteroid dehydrogenase, and the 5α-reductases. The study was double-blinded and conducted over 12 weeks, and various confounders were accounted for, including body mass index and menstrual irregularities; however, the sample size was relatively small (N=40), with participants equally randomized to treatment with either a placebo or the soybean isoflavone (160 mg daily). The results were determined to be significant (P<.05) based on the statistical analysis, which found that the isoflavone group had a lower lesion count after 12 weeks as well as a drop in serum DHT levels. Baseline lesion counts and serum DHT levels were not statistically significant when compared to the placebo group.

What’s the Issue?

Am I saying you should recommend to all of your adult female acne patients that they should run out and buy soy isoflavone supplements? Probably not. Forgetting even the study limitations, we face a daily struggle with reproducibility when it comes to over-the-counter supplements given these products are not regulated with the same scrutiny as prescription products or devices. Unfortunately, the degree of variability between 1 manufacturer to another can be broad, with shelf life stability often being the greatest issue. Are all soy isoflavone supplements created equal? I don’t know, and I can assure you that most regulatory bodies don’t know either. Walking down the vitamin aisle with countless versions of the same product can be acne inducing in itself.

The data is certainly interesting and novel for this disease state. A larger study certainly is warranted, although as we increase the number of studies, I wonder if we will receive mixed data as witnessed with the breast cancer prevention studies with soy; some showed intake was advantageous, other did not (see suggested readings below if interested in learning more). To end on a positive note, the way I see it is that soy isoflavones could possibly become a cheaper addition to—not a replacement for—our vast yet active ingredient–lacking armament of acne treatments. Time will hopefully tell. How do you think these study results will impact the treatment of acne?

We want to know your views! Tell us what you think.

Suggested Readings

• Travis RC, Allen NE, Appleby PN, et al. A prospective study of vegetarianism and isoflavone intake in relation to breast cancer risk in British women. Int J Cancer. 2008;122:705-710.
• Key TJ, Sharp GB, Appleby PN, et al. Soya foods and breast cancer risk: a prospective study in Hiroshima and Nagasaki, Japan. Br J Cancer. 1999;81:1248-1256.
• Zaineddin AK, Buck K, Vrieling A, et al. The association between dietary lignans, phytoestrogen-rich foods, and fiber intake and postmenopausal breast cancer risk: a German case-control study. Nutr Cancer. 2012;64:652-665.

While the pathophysiology of acne vulgaris is, at a minimum, complex (and that’s putting it lightly), it is generally accepted that androgens such as dihydrotestosterone (DHT) can play a prominent role, especially in adult women with acne. Although it is not approved by the US Food and Drug Administration, the utilization of antiandrogens such as spironolactone (see my discussion of spironolactone use in adult females in the October issue of Cutis) has become standard practice for many US dermatologists who treat this patient population. Joined only by combined oral contraceptives, antihormonal therapies for acne are somewhat limited. Therefore, effective as well as safe additions are needed.

In a study published online on July 20 in Dermato-Endocrinology, Riyanto et al evaluated the potential of orally administered soy isoflavones for treatment of acne in adult women based on both lesion count over time and corresponding changes in DHT levels. Soy isoflavones such as genistein, daidzein, and glycitein have established effects on androgen metabolism through inhibition of 3β-hydroxysteroid dehydrogenase, 17β-hydroxysteroid dehydrogenase, and the 5α-reductases. The study was double-blinded and conducted over 12 weeks, and various confounders were accounted for, including body mass index and menstrual irregularities; however, the sample size was relatively small (N=40), with participants equally randomized to treatment with either a placebo or the soybean isoflavone (160 mg daily). The results were determined to be significant (P<.05) based on the statistical analysis, which found that the isoflavone group had a lower lesion count after 12 weeks as well as a drop in serum DHT levels. Baseline lesion counts and serum DHT levels were not statistically significant when compared to the placebo group.

What’s the Issue?

Am I saying you should recommend to all of your adult female acne patients that they should run out and buy soy isoflavone supplements? Probably not. Forgetting even the study limitations, we face a daily struggle with reproducibility when it comes to over-the-counter supplements given these products are not regulated with the same scrutiny as prescription products or devices. Unfortunately, the degree of variability between 1 manufacturer to another can be broad, with shelf life stability often being the greatest issue. Are all soy isoflavone supplements created equal? I don’t know, and I can assure you that most regulatory bodies don’t know either. Walking down the vitamin aisle with countless versions of the same product can be acne inducing in itself.

The data is certainly interesting and novel for this disease state. A larger study certainly is warranted, although as we increase the number of studies, I wonder if we will receive mixed data as witnessed with the breast cancer prevention studies with soy; some showed intake was advantageous, other did not (see suggested readings below if interested in learning more). To end on a positive note, the way I see it is that soy isoflavones could possibly become a cheaper addition to—not a replacement for—our vast yet active ingredient–lacking armament of acne treatments. Time will hopefully tell. How do you think these study results will impact the treatment of acne?

We want to know your views! Tell us what you think.

Suggested Readings

• Travis RC, Allen NE, Appleby PN, et al. A prospective study of vegetarianism and isoflavone intake in relation to breast cancer risk in British women. Int J Cancer. 2008;122:705-710.
• Key TJ, Sharp GB, Appleby PN, et al. Soya foods and breast cancer risk: a prospective study in Hiroshima and Nagasaki, Japan. Br J Cancer. 1999;81:1248-1256.
• Zaineddin AK, Buck K, Vrieling A, et al. The association between dietary lignans, phytoestrogen-rich foods, and fiber intake and postmenopausal breast cancer risk: a German case-control study. Nutr Cancer. 2012;64:652-665.

While the pathophysiology of acne vulgaris is, at a minimum, complex (and that’s putting it lightly), it is generally accepted that androgens such as dihydrotestosterone (DHT) can play a prominent role, especially in adult women with acne. Although it is not approved by the US Food and Drug Administration, the utilization of antiandrogens such as spironolactone (see my discussion of spironolactone use in adult females in the October issue of Cutis) has become standard practice for many US dermatologists who treat this patient population. Joined only by combined oral contraceptives, antihormonal therapies for acne are somewhat limited. Therefore, effective as well as safe additions are needed.

In a study published online on July 20 in Dermato-Endocrinology, Riyanto et al evaluated the potential of orally administered soy isoflavones for treatment of acne in adult women based on both lesion count over time and corresponding changes in DHT levels. Soy isoflavones such as genistein, daidzein, and glycitein have established effects on androgen metabolism through inhibition of 3β-hydroxysteroid dehydrogenase, 17β-hydroxysteroid dehydrogenase, and the 5α-reductases. The study was double-blinded and conducted over 12 weeks, and various confounders were accounted for, including body mass index and menstrual irregularities; however, the sample size was relatively small (N=40), with participants equally randomized to treatment with either a placebo or the soybean isoflavone (160 mg daily). The results were determined to be significant (P<.05) based on the statistical analysis, which found that the isoflavone group had a lower lesion count after 12 weeks as well as a drop in serum DHT levels. Baseline lesion counts and serum DHT levels were not statistically significant when compared to the placebo group.

What’s the Issue?

Am I saying you should recommend to all of your adult female acne patients that they should run out and buy soy isoflavone supplements? Probably not. Forgetting even the study limitations, we face a daily struggle with reproducibility when it comes to over-the-counter supplements given these products are not regulated with the same scrutiny as prescription products or devices. Unfortunately, the degree of variability between 1 manufacturer to another can be broad, with shelf life stability often being the greatest issue. Are all soy isoflavone supplements created equal? I don’t know, and I can assure you that most regulatory bodies don’t know either. Walking down the vitamin aisle with countless versions of the same product can be acne inducing in itself.

The data is certainly interesting and novel for this disease state. A larger study certainly is warranted, although as we increase the number of studies, I wonder if we will receive mixed data as witnessed with the breast cancer prevention studies with soy; some showed intake was advantageous, other did not (see suggested readings below if interested in learning more). To end on a positive note, the way I see it is that soy isoflavones could possibly become a cheaper addition to—not a replacement for—our vast yet active ingredient–lacking armament of acne treatments. Time will hopefully tell. How do you think these study results will impact the treatment of acne?

We want to know your views! Tell us what you think.

Suggested Readings

• Travis RC, Allen NE, Appleby PN, et al. A prospective study of vegetarianism and isoflavone intake in relation to breast cancer risk in British women. Int J Cancer. 2008;122:705-710.
• Key TJ, Sharp GB, Appleby PN, et al. Soya foods and breast cancer risk: a prospective study in Hiroshima and Nagasaki, Japan. Br J Cancer. 1999;81:1248-1256.
• Zaineddin AK, Buck K, Vrieling A, et al. The association between dietary lignans, phytoestrogen-rich foods, and fiber intake and postmenopausal breast cancer risk: a German case-control study. Nutr Cancer. 2012;64:652-665.

With the advent of tumor necrosis factor (TNF) inhibitors, one of the major topics of discussion is the relationship of the drug class with new or worsening multiple sclerosis (MS). Exacerbation of previously quiescent MS and the onset of other demyelinating diseases such as optic neuritis have been reported in patients taking TNF inhibitors. Symptoms included paraesthesia, visual disturbance, and confusion.

Therefore, controversy surrounds the use of TNF-α inhibitors in patients who are more predisposed to developing MS, specifically first-degree relatives of MS patients. The American Academy of Dermatology guidelines for TNF inhibitors state the following: “Because there is an association between anti-TNF therapy and demyelinating diseases (ie, MS), TNF inhibitors should not be used in patients with MS or other demyelinating diseases; first-degree relatives of patients with MS have an increased risk of developing MS, with a sibling relative risk of between 18 and 36, evidence strongly suggests that TNF inhibitors should not be used in first-degree relatives of patients with MS.”

Mansouri et al (J Drugs Dermatol. 2015;14:876-878) presented data suggesting that the number needed to treat is at least an order of magnitude smaller than the number needed to harm across all comparisons of anti–TNF-α agents and first-degree relative relationships. Based on these data, the authors suggest that physicians could weigh the treatment options available and work closely with neurological colleagues when prescribing anti–TNF-α therapy in this patient population, which could be an alternative approach to practicing absolute prohibition of anti–TNF-α agents in patients who have a first-degree relative with MS.

What’s the issue?

This article presents interesting data concerning the risk-benefit of using TNF inhibitors in a potential at-risk population. We are fortunate to have many treatment options available, but in many cases, a TNF inhibitor may be preferable. How will this information affect your use of TNF inhibitors in patients with a first-degree relative with MS?

We want to know your views! Tell us what you think.

With the advent of tumor necrosis factor (TNF) inhibitors, one of the major topics of discussion is the relationship of the drug class with new or worsening multiple sclerosis (MS). Exacerbation of previously quiescent MS and the onset of other demyelinating diseases such as optic neuritis have been reported in patients taking TNF inhibitors. Symptoms included paraesthesia, visual disturbance, and confusion.

Therefore, controversy surrounds the use of TNF-α inhibitors in patients who are more predisposed to developing MS, specifically first-degree relatives of MS patients. The American Academy of Dermatology guidelines for TNF inhibitors state the following: “Because there is an association between anti-TNF therapy and demyelinating diseases (ie, MS), TNF inhibitors should not be used in patients with MS or other demyelinating diseases; first-degree relatives of patients with MS have an increased risk of developing MS, with a sibling relative risk of between 18 and 36, evidence strongly suggests that TNF inhibitors should not be used in first-degree relatives of patients with MS.”

Mansouri et al (J Drugs Dermatol. 2015;14:876-878) presented data suggesting that the number needed to treat is at least an order of magnitude smaller than the number needed to harm across all comparisons of anti–TNF-α agents and first-degree relative relationships. Based on these data, the authors suggest that physicians could weigh the treatment options available and work closely with neurological colleagues when prescribing anti–TNF-α therapy in this patient population, which could be an alternative approach to practicing absolute prohibition of anti–TNF-α agents in patients who have a first-degree relative with MS.

What’s the issue?

This article presents interesting data concerning the risk-benefit of using TNF inhibitors in a potential at-risk population. We are fortunate to have many treatment options available, but in many cases, a TNF inhibitor may be preferable. How will this information affect your use of TNF inhibitors in patients with a first-degree relative with MS?

We want to know your views! Tell us what you think.

With the advent of tumor necrosis factor (TNF) inhibitors, one of the major topics of discussion is the relationship of the drug class with new or worsening multiple sclerosis (MS). Exacerbation of previously quiescent MS and the onset of other demyelinating diseases such as optic neuritis have been reported in patients taking TNF inhibitors. Symptoms included paraesthesia, visual disturbance, and confusion.

Therefore, controversy surrounds the use of TNF-α inhibitors in patients who are more predisposed to developing MS, specifically first-degree relatives of MS patients. The American Academy of Dermatology guidelines for TNF inhibitors state the following: “Because there is an association between anti-TNF therapy and demyelinating diseases (ie, MS), TNF inhibitors should not be used in patients with MS or other demyelinating diseases; first-degree relatives of patients with MS have an increased risk of developing MS, with a sibling relative risk of between 18 and 36, evidence strongly suggests that TNF inhibitors should not be used in first-degree relatives of patients with MS.”

Mansouri et al (J Drugs Dermatol. 2015;14:876-878) presented data suggesting that the number needed to treat is at least an order of magnitude smaller than the number needed to harm across all comparisons of anti–TNF-α agents and first-degree relative relationships. Based on these data, the authors suggest that physicians could weigh the treatment options available and work closely with neurological colleagues when prescribing anti–TNF-α therapy in this patient population, which could be an alternative approach to practicing absolute prohibition of anti–TNF-α agents in patients who have a first-degree relative with MS.

What’s the issue?

This article presents interesting data concerning the risk-benefit of using TNF inhibitors in a potential at-risk population. We are fortunate to have many treatment options available, but in many cases, a TNF inhibitor may be preferable. How will this information affect your use of TNF inhibitors in patients with a first-degree relative with MS?

We want to know your views! Tell us what you think.

Noninvasive cosmetic surgery procedures continue to increase in number, according to the American Society of Plastic Surgeons. Furthermore, these procedures are being performed in the offices of a growing number of physician specialties. As demand increases and offices become busy, there is increased delegation of these procedures to nurses, physician assistants, aestheticians, and medical assistants.

Austin et al (Dermatol Surg. 2015;41:827-832.) performed an Internet-based survey of physician members of the American Society for Dermatologic Surgery, the American Society for Laser Medicine and Surgery, and the American Society for Aesthetic Plastic Surgery to evaluate the delegation practices among the various specialties. The survey asked for physician training, age, gender, residency, and geographic location, as well as a breakdown of how much of their practice involved cosmetic procedures. Respondents were asked if they delegate procedures, to whom do they delegate (eg, registered nurse, physician assistant, MAs), and which procedures they delegate. A point system was used to give a score based on the perceived level of education and/or training of the person delegated to perform a procedure: do not delegate (1); physician assistant or nurse practitioner (2); registered nurse (3); and MA, aesthetician, or other (4).

Respondents included 823 physicians: 521 dermatologists and 302 nondermatologists. Of the respondents, 291 of dermatologists (55.9%) and 223 of nondermatologist physicians (73.8%) delegated cosmetic procedures. Procedures most often delegated by dermatologists compared to nondermatologists included chemical peels, neuromodulator and filler injections, laser hair removal, pulsed dye laser, tattoo removal, intense pulsed light, nonablative factional laser, and sclerotherapy.

The outcome of this survey shows that delegating certain cosmetic procedures is common, with more than half of all survey respondents delegating at least 1 cosmetic procedure. Dermatologists, as a whole, delegated less frequently than nondermatologist physicians, and when they did, dermatologists delegated to higher-level providers compared to nondermatologists. Medical practices in which the focus is primarily cosmetic and in those in which the physician is older also were more likely to delegate procedures.

What’s the issue?

There is tremendous variability between states about who is competent to perform many of the noninvasive cosmetic procedures. Some state medical boards specify the type of provider and the procedures allowed, while other states have no policy. However, this rule is changing, and there are more regulations being brought before the state medical boards with the goal of ensuring patient safety. As the demand for noninvasive procedures continues to grow, there will be an increase in the number of nonphysician providers performing these procedures. Patient safety should be at the forefront of all legislation, but at the same time there should be training courses and oversight boards to allow for safe delegation. Do you see yourself delegating more of these noninvasive procedures in the future?

We want to know your views! Tell us what you think.

Noninvasive cosmetic surgery procedures continue to increase in number, according to the American Society of Plastic Surgeons. Furthermore, these procedures are being performed in the offices of a growing number of physician specialties. As demand increases and offices become busy, there is increased delegation of these procedures to nurses, physician assistants, aestheticians, and medical assistants.

Austin et al (Dermatol Surg. 2015;41:827-832.) performed an Internet-based survey of physician members of the American Society for Dermatologic Surgery, the American Society for Laser Medicine and Surgery, and the American Society for Aesthetic Plastic Surgery to evaluate the delegation practices among the various specialties. The survey asked for physician training, age, gender, residency, and geographic location, as well as a breakdown of how much of their practice involved cosmetic procedures. Respondents were asked if they delegate procedures, to whom do they delegate (eg, registered nurse, physician assistant, MAs), and which procedures they delegate. A point system was used to give a score based on the perceived level of education and/or training of the person delegated to perform a procedure: do not delegate (1); physician assistant or nurse practitioner (2); registered nurse (3); and MA, aesthetician, or other (4).

Respondents included 823 physicians: 521 dermatologists and 302 nondermatologists. Of the respondents, 291 of dermatologists (55.9%) and 223 of nondermatologist physicians (73.8%) delegated cosmetic procedures. Procedures most often delegated by dermatologists compared to nondermatologists included chemical peels, neuromodulator and filler injections, laser hair removal, pulsed dye laser, tattoo removal, intense pulsed light, nonablative factional laser, and sclerotherapy.

The outcome of this survey shows that delegating certain cosmetic procedures is common, with more than half of all survey respondents delegating at least 1 cosmetic procedure. Dermatologists, as a whole, delegated less frequently than nondermatologist physicians, and when they did, dermatologists delegated to higher-level providers compared to nondermatologists. Medical practices in which the focus is primarily cosmetic and in those in which the physician is older also were more likely to delegate procedures.

What’s the issue?

There is tremendous variability between states about who is competent to perform many of the noninvasive cosmetic procedures. Some state medical boards specify the type of provider and the procedures allowed, while other states have no policy. However, this rule is changing, and there are more regulations being brought before the state medical boards with the goal of ensuring patient safety. As the demand for noninvasive procedures continues to grow, there will be an increase in the number of nonphysician providers performing these procedures. Patient safety should be at the forefront of all legislation, but at the same time there should be training courses and oversight boards to allow for safe delegation. Do you see yourself delegating more of these noninvasive procedures in the future?

We want to know your views! Tell us what you think.

Noninvasive cosmetic surgery procedures continue to increase in number, according to the American Society of Plastic Surgeons. Furthermore, these procedures are being performed in the offices of a growing number of physician specialties. As demand increases and offices become busy, there is increased delegation of these procedures to nurses, physician assistants, aestheticians, and medical assistants.

Austin et al (Dermatol Surg. 2015;41:827-832.) performed an Internet-based survey of physician members of the American Society for Dermatologic Surgery, the American Society for Laser Medicine and Surgery, and the American Society for Aesthetic Plastic Surgery to evaluate the delegation practices among the various specialties. The survey asked for physician training, age, gender, residency, and geographic location, as well as a breakdown of how much of their practice involved cosmetic procedures. Respondents were asked if they delegate procedures, to whom do they delegate (eg, registered nurse, physician assistant, MAs), and which procedures they delegate. A point system was used to give a score based on the perceived level of education and/or training of the person delegated to perform a procedure: do not delegate (1); physician assistant or nurse practitioner (2); registered nurse (3); and MA, aesthetician, or other (4).

Respondents included 823 physicians: 521 dermatologists and 302 nondermatologists. Of the respondents, 291 of dermatologists (55.9%) and 223 of nondermatologist physicians (73.8%) delegated cosmetic procedures. Procedures most often delegated by dermatologists compared to nondermatologists included chemical peels, neuromodulator and filler injections, laser hair removal, pulsed dye laser, tattoo removal, intense pulsed light, nonablative factional laser, and sclerotherapy.

The outcome of this survey shows that delegating certain cosmetic procedures is common, with more than half of all survey respondents delegating at least 1 cosmetic procedure. Dermatologists, as a whole, delegated less frequently than nondermatologist physicians, and when they did, dermatologists delegated to higher-level providers compared to nondermatologists. Medical practices in which the focus is primarily cosmetic and in those in which the physician is older also were more likely to delegate procedures.

What’s the issue?

There is tremendous variability between states about who is competent to perform many of the noninvasive cosmetic procedures. Some state medical boards specify the type of provider and the procedures allowed, while other states have no policy. However, this rule is changing, and there are more regulations being brought before the state medical boards with the goal of ensuring patient safety. As the demand for noninvasive procedures continues to grow, there will be an increase in the number of nonphysician providers performing these procedures. Patient safety should be at the forefront of all legislation, but at the same time there should be training courses and oversight boards to allow for safe delegation. Do you see yourself delegating more of these noninvasive procedures in the future?

We want to know your views! Tell us what you think.