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COVID booster shot poll: People ‘don’t think they need one’

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Tue, 12/20/2022 - 10:49

The percentage of people in the U.S. getting the latest COVID-19 booster shot has crept up by single digits in the past couple months, despite health officials pleading for people to do so before the Christmas holiday. 

Now, a new poll shows why so few people are willing to roll up their sleeves again.

The most common reasons people give for not getting the latest booster shot is that they “don’t think they need one” (44%) and they “don’t think the benefits are worth it” (37%), according to poll results from the Kaiser Family Foundation. 

The data comes amid announcements by the Centers for Disease Control and Prevention that boosters reduced COVID-19 hospitalizations by up to 57% for U.S. adults and by up to 84% for people age 65 and older. Those figures are just the latest in a mountain of research reporting the public health benefits of COVID-19 vaccines.

Despite all of the statistical data, health officials’ recent vaccination campaigns have proven far from compelling. 

So far, just 15% of people age 12 and older have gotten the latest booster, and 36% of people age 65 and older have gotten it, the CDC’s vaccination trackershows.

Since the start of the pandemic, 1.1 million people in the U.S. have died from COVID-19, with the number of deaths currently rising by 400 per day, The New York Times COVID tracker shows.

Many experts continue to note the need for everyone to get booster shots regularly, but some advocate that perhaps a change in strategy is in order.

“What the administration should do is push for vaccinating people in high-risk groups, including those who are older, those who are immunocompromised and those who have comorbidities,” Paul Offitt, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN.

Federal regulators have announced they will meet Jan. 26 with a panel of vaccine advisors to examine the current recommended vaccination schedule as well as look at the effectiveness and composition of current vaccines and boosters, with an eye toward the make-up of next-generation shots.

Vaccines are the “best available protection” against hospitalization and death caused by COVID-19, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement announcing the planned meeting.

“Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” he said. “Therefore, it’s important to continue discussions about the optimal composition of COVID-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”

A version of this article first appeared on WebMD.com.

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The percentage of people in the U.S. getting the latest COVID-19 booster shot has crept up by single digits in the past couple months, despite health officials pleading for people to do so before the Christmas holiday. 

Now, a new poll shows why so few people are willing to roll up their sleeves again.

The most common reasons people give for not getting the latest booster shot is that they “don’t think they need one” (44%) and they “don’t think the benefits are worth it” (37%), according to poll results from the Kaiser Family Foundation. 

The data comes amid announcements by the Centers for Disease Control and Prevention that boosters reduced COVID-19 hospitalizations by up to 57% for U.S. adults and by up to 84% for people age 65 and older. Those figures are just the latest in a mountain of research reporting the public health benefits of COVID-19 vaccines.

Despite all of the statistical data, health officials’ recent vaccination campaigns have proven far from compelling. 

So far, just 15% of people age 12 and older have gotten the latest booster, and 36% of people age 65 and older have gotten it, the CDC’s vaccination trackershows.

Since the start of the pandemic, 1.1 million people in the U.S. have died from COVID-19, with the number of deaths currently rising by 400 per day, The New York Times COVID tracker shows.

Many experts continue to note the need for everyone to get booster shots regularly, but some advocate that perhaps a change in strategy is in order.

“What the administration should do is push for vaccinating people in high-risk groups, including those who are older, those who are immunocompromised and those who have comorbidities,” Paul Offitt, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN.

Federal regulators have announced they will meet Jan. 26 with a panel of vaccine advisors to examine the current recommended vaccination schedule as well as look at the effectiveness and composition of current vaccines and boosters, with an eye toward the make-up of next-generation shots.

Vaccines are the “best available protection” against hospitalization and death caused by COVID-19, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement announcing the planned meeting.

“Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” he said. “Therefore, it’s important to continue discussions about the optimal composition of COVID-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”

A version of this article first appeared on WebMD.com.

The percentage of people in the U.S. getting the latest COVID-19 booster shot has crept up by single digits in the past couple months, despite health officials pleading for people to do so before the Christmas holiday. 

Now, a new poll shows why so few people are willing to roll up their sleeves again.

The most common reasons people give for not getting the latest booster shot is that they “don’t think they need one” (44%) and they “don’t think the benefits are worth it” (37%), according to poll results from the Kaiser Family Foundation. 

The data comes amid announcements by the Centers for Disease Control and Prevention that boosters reduced COVID-19 hospitalizations by up to 57% for U.S. adults and by up to 84% for people age 65 and older. Those figures are just the latest in a mountain of research reporting the public health benefits of COVID-19 vaccines.

Despite all of the statistical data, health officials’ recent vaccination campaigns have proven far from compelling. 

So far, just 15% of people age 12 and older have gotten the latest booster, and 36% of people age 65 and older have gotten it, the CDC’s vaccination trackershows.

Since the start of the pandemic, 1.1 million people in the U.S. have died from COVID-19, with the number of deaths currently rising by 400 per day, The New York Times COVID tracker shows.

Many experts continue to note the need for everyone to get booster shots regularly, but some advocate that perhaps a change in strategy is in order.

“What the administration should do is push for vaccinating people in high-risk groups, including those who are older, those who are immunocompromised and those who have comorbidities,” Paul Offitt, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN.

Federal regulators have announced they will meet Jan. 26 with a panel of vaccine advisors to examine the current recommended vaccination schedule as well as look at the effectiveness and composition of current vaccines and boosters, with an eye toward the make-up of next-generation shots.

Vaccines are the “best available protection” against hospitalization and death caused by COVID-19, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement announcing the planned meeting.

“Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” he said. “Therefore, it’s important to continue discussions about the optimal composition of COVID-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”

A version of this article first appeared on WebMD.com.

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FDA will review pediatric indication for roflumilast cream

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Tue, 02/07/2023 - 16:37

 

Roflumilast cream 0.3% is under review by the Food and Drug Administration for the treatment of plaque psoriasis in children as young as 2 years, according to a press release from the manufacturer.

The company, Arcutis Biotherapeutics, announced the submission of a supplemental new drug application for approval of roflumilast cream (Zoryve), a topical phosphodiesterase-4 (PDE-4) inhibitor, to treat psoriasis in children aged 2-11 years. If approved, this would be the first such product for young children with plaque psoriasis, according to the press release. In July 2022, the FDA approved roflumilast cream 0.3% for the treatment of plaque psoriasis in people 12 years of age and older, including in intertriginous areas, based on data from the phase 3 DERMIS-1 and DERMIS-2 trials.

The new submission is supported by data from two 4-week Maximal Usage Systemic Exposure (MUSE) studies in children ages 2-11 years with plaque psoriasis. In these phase 2, open-label studies, one study of children aged 2-5 years and another study of children aged 6-11 years, participants were treated with roflumilast cream 0.3% once daily for 4 weeks. The MUSE studies are also intended to fulfill postmarketing requirements for roflumilast, according to the company. The MUSE results were consistent with those from DERMIS-1 and DERMIS-2, according to the company press release. In DERMIS-1 and DERMIS-2, significantly more patients randomized to roflumilast met criteria for Investigators Global Success (IGA) scores after 8 weeks of daily treatment compared with placebo patients, and significantly more achieved a 75% reduction in Psoriasis Area and Severity Index (PASI) scores compared with those on placebo.

Common adverse events associated with roflumilast include diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. None of these have been reported in more than 3% of patients, the press release noted.

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Roflumilast cream 0.3% is under review by the Food and Drug Administration for the treatment of plaque psoriasis in children as young as 2 years, according to a press release from the manufacturer.

The company, Arcutis Biotherapeutics, announced the submission of a supplemental new drug application for approval of roflumilast cream (Zoryve), a topical phosphodiesterase-4 (PDE-4) inhibitor, to treat psoriasis in children aged 2-11 years. If approved, this would be the first such product for young children with plaque psoriasis, according to the press release. In July 2022, the FDA approved roflumilast cream 0.3% for the treatment of plaque psoriasis in people 12 years of age and older, including in intertriginous areas, based on data from the phase 3 DERMIS-1 and DERMIS-2 trials.

The new submission is supported by data from two 4-week Maximal Usage Systemic Exposure (MUSE) studies in children ages 2-11 years with plaque psoriasis. In these phase 2, open-label studies, one study of children aged 2-5 years and another study of children aged 6-11 years, participants were treated with roflumilast cream 0.3% once daily for 4 weeks. The MUSE studies are also intended to fulfill postmarketing requirements for roflumilast, according to the company. The MUSE results were consistent with those from DERMIS-1 and DERMIS-2, according to the company press release. In DERMIS-1 and DERMIS-2, significantly more patients randomized to roflumilast met criteria for Investigators Global Success (IGA) scores after 8 weeks of daily treatment compared with placebo patients, and significantly more achieved a 75% reduction in Psoriasis Area and Severity Index (PASI) scores compared with those on placebo.

Common adverse events associated with roflumilast include diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. None of these have been reported in more than 3% of patients, the press release noted.

 

Roflumilast cream 0.3% is under review by the Food and Drug Administration for the treatment of plaque psoriasis in children as young as 2 years, according to a press release from the manufacturer.

The company, Arcutis Biotherapeutics, announced the submission of a supplemental new drug application for approval of roflumilast cream (Zoryve), a topical phosphodiesterase-4 (PDE-4) inhibitor, to treat psoriasis in children aged 2-11 years. If approved, this would be the first such product for young children with plaque psoriasis, according to the press release. In July 2022, the FDA approved roflumilast cream 0.3% for the treatment of plaque psoriasis in people 12 years of age and older, including in intertriginous areas, based on data from the phase 3 DERMIS-1 and DERMIS-2 trials.

The new submission is supported by data from two 4-week Maximal Usage Systemic Exposure (MUSE) studies in children ages 2-11 years with plaque psoriasis. In these phase 2, open-label studies, one study of children aged 2-5 years and another study of children aged 6-11 years, participants were treated with roflumilast cream 0.3% once daily for 4 weeks. The MUSE studies are also intended to fulfill postmarketing requirements for roflumilast, according to the company. The MUSE results were consistent with those from DERMIS-1 and DERMIS-2, according to the company press release. In DERMIS-1 and DERMIS-2, significantly more patients randomized to roflumilast met criteria for Investigators Global Success (IGA) scores after 8 weeks of daily treatment compared with placebo patients, and significantly more achieved a 75% reduction in Psoriasis Area and Severity Index (PASI) scores compared with those on placebo.

Common adverse events associated with roflumilast include diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. None of these have been reported in more than 3% of patients, the press release noted.

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Rise of ‘alarming’ subvariants of COVID ‘worrisome’ for winter

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Wed, 12/21/2022 - 14:53

It’s a story perhaps more appropriate for Halloween than for the festive holiday season, given its scary implications. Four Omicron subvariants of the virus that causes COVID-19 will be the most common strains going from person to person in the winter of 2022-2023, new research predicts.

Not too dire so far, until the researchers’ other findings are considered.

The BQ.1, BQ1.1, XBB, and XBB.1 subvariants are the most resistant to neutralizing antibodies, researcher Qian Wang, PhD, and colleagues wrote in a study published online in the journal Cell. This means people have no or “markedly reduced” protection against infection from these four strains, even if they’ve already had COVID-19 or are vaccinated and boosted multiple times, including with a bivalent vaccine.

On top of that, all available monoclonal antibody treatments are mostly or completely ineffective against these subvariants.

What does that mean for the immediate future? The findings are definitely “worrisome,” said Eric Topol, MD, founder and director of the Scripps Translational Research Institute in La Jolla, Calif.

But evidence from other countries, specifically Singapore and France, show that at least two of these variants turned out not to be as damaging as expected, likely because of high numbers of people vaccinated or who survived previous infections, he said.

Still, there is little to celebrate in the new findings, except that COVID-19 vaccinations and prior infections can still reduce the risk for serious outcomes such as hospitalization and death, the researchers wrote.

In fact, Centers for Disease Control and Prevention data released on Dec. 16 shows that people who have received four shots of the original COVID-19 vaccines as well as the bivalent booster were 57% less likely to visit an urgent care clinic or emergency room, regardless of age. 

It comes at a time when BQ.1 and BQ.1.1 account for about 70% of the circulating variants, data show. In addition, hospitalizations are up 18% over the past 2 weeks and COVID-19 deaths are up 50% nationwide, The New York Times reported.

Globally, in many places, an “immunity wall” that has been built, Dr. Topol said. That may not be the case in the United States.  

“The problem in the United States, making it harder to predict, is that we have a very low rate of recent boosters, in the past 6 months, especially in seniors,” he said. For example, only 36% of Americans aged 65 years and older, the group with highest risk, have received an updated bivalent booster.
 

An evolving virus

The subvariants are successfully replacing BA.5, which reigned as one of the most common Omicron variants over the past year. The latest CDC data show that BA.5 now accounts for only about 10% of the circulating virus. The researchers wrote: “This rapid replacement of virus strains is raising the specter of yet another wave of infections in the coming months.”

BQ.1 and BQ.1.1 evolved directly from BA.5 – adding more and some novel mutations to the SARS-CoV-2 virus. XBB and XBB.1 are the “offspring” of a combination of two other strains, known as BJ.1 and BA.2.75.

The story sounds familiar to the researchers. “The rapid rise of these subvariants and their extensive array of spike mutations are reminiscent of the appearance of the first Omicron variant last year, thus raising concerns that they may further compromise the efficacy of current COVID-19 vaccines and monoclonal antibody therapeutics,” they wrote. “We now report findings that indicate that such concerns are, sadly, justified, especially so for the XBB and XBB.1 subvariants.”

To figure out how effective existing antibodies could be against these newer subvariants, Dr. Wang and colleagues used blood samples from five groups of people. They tested serum from people who had three doses of the original COVID-19 vaccine, four doses of the original vaccine, those who received a bivalent booster, people who experienced a breakthrough infection with the BA.2 Omicron variant, and those who had a breakthrough with a BA.4 or BA.5 variant.

Adding the new subvariants to these serum samples revealed that the existing antibodies in the blood were ineffective at wiping out or neutralizing BQ.1, BQ.1.1, XBB, and XBB.1.

The BQ.1 subvariant was six times more resistant to antibodies than BA.5, its parent strain, and XBB.1 was 63 times more resistant compared with its predecessor, BA.2.

This shift in the ability of vaccines to stop the subvariants “is particularly concerning,” the researchers wrote.
 

 

 

Wiping out treatments too

Dr. Wang and colleagues also tested how well a panel of 23 different monoclonal antibody drugs might work against the four subvariants. The therapies all worked well against the original Omicron variant and included some approved for use through the Food and Drug Administration emergency use authorization (EUA) program at the time of the study.

They found that 19 of these 23 monoclonal antibodies lost effectiveness “greatly or completely” against XBB and XBB.1, for example.

This is not the first time that monoclonal antibody therapies have gone from effective to ineffective. Previous variants have come out that no longer responded to treatment with bamlanivimab, etesevimab, imdevimab, casirivimab, tixagevimab, cilgavimab, and sotrovimab. Bebtelovimab now joins this list and is no longer available from Eli Lilly under EUA because of this lack of effectiveness.

The lack of an effective monoclonal antibody treatment “poses a serious problem for millions of immunocompromised individuals who do not respond robustly to COVID-19 vaccines,” the researchers wrote, adding that “the urgent need to develop active monoclonal antibodies for clinical use is obvious.”

A limitation of the study is that the work is done in blood samples. The effectiveness of COVID-19 vaccination against the BQ and XBB subvariants should be evaluated in people in clinical studies, the authors noted.

Also, the current study looked at how well antibodies could neutralize the viral strains, but future research, they added, should look at how well “cellular immunity” or other aspects of the immune system might protect people.

Going forward, the challenge remains to develop vaccines and treatments that offer broad protection as the coronavirus continues to evolve.

In an alarming ending, the researchers wrote: “We have collectively chased after SARS-CoV-2 variants for over 2 years, and yet, the virus continues to evolve and evade.”

A version of this article first appeared on Medscape.com.

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It’s a story perhaps more appropriate for Halloween than for the festive holiday season, given its scary implications. Four Omicron subvariants of the virus that causes COVID-19 will be the most common strains going from person to person in the winter of 2022-2023, new research predicts.

Not too dire so far, until the researchers’ other findings are considered.

The BQ.1, BQ1.1, XBB, and XBB.1 subvariants are the most resistant to neutralizing antibodies, researcher Qian Wang, PhD, and colleagues wrote in a study published online in the journal Cell. This means people have no or “markedly reduced” protection against infection from these four strains, even if they’ve already had COVID-19 or are vaccinated and boosted multiple times, including with a bivalent vaccine.

On top of that, all available monoclonal antibody treatments are mostly or completely ineffective against these subvariants.

What does that mean for the immediate future? The findings are definitely “worrisome,” said Eric Topol, MD, founder and director of the Scripps Translational Research Institute in La Jolla, Calif.

But evidence from other countries, specifically Singapore and France, show that at least two of these variants turned out not to be as damaging as expected, likely because of high numbers of people vaccinated or who survived previous infections, he said.

Still, there is little to celebrate in the new findings, except that COVID-19 vaccinations and prior infections can still reduce the risk for serious outcomes such as hospitalization and death, the researchers wrote.

In fact, Centers for Disease Control and Prevention data released on Dec. 16 shows that people who have received four shots of the original COVID-19 vaccines as well as the bivalent booster were 57% less likely to visit an urgent care clinic or emergency room, regardless of age. 

It comes at a time when BQ.1 and BQ.1.1 account for about 70% of the circulating variants, data show. In addition, hospitalizations are up 18% over the past 2 weeks and COVID-19 deaths are up 50% nationwide, The New York Times reported.

Globally, in many places, an “immunity wall” that has been built, Dr. Topol said. That may not be the case in the United States.  

“The problem in the United States, making it harder to predict, is that we have a very low rate of recent boosters, in the past 6 months, especially in seniors,” he said. For example, only 36% of Americans aged 65 years and older, the group with highest risk, have received an updated bivalent booster.
 

An evolving virus

The subvariants are successfully replacing BA.5, which reigned as one of the most common Omicron variants over the past year. The latest CDC data show that BA.5 now accounts for only about 10% of the circulating virus. The researchers wrote: “This rapid replacement of virus strains is raising the specter of yet another wave of infections in the coming months.”

BQ.1 and BQ.1.1 evolved directly from BA.5 – adding more and some novel mutations to the SARS-CoV-2 virus. XBB and XBB.1 are the “offspring” of a combination of two other strains, known as BJ.1 and BA.2.75.

The story sounds familiar to the researchers. “The rapid rise of these subvariants and their extensive array of spike mutations are reminiscent of the appearance of the first Omicron variant last year, thus raising concerns that they may further compromise the efficacy of current COVID-19 vaccines and monoclonal antibody therapeutics,” they wrote. “We now report findings that indicate that such concerns are, sadly, justified, especially so for the XBB and XBB.1 subvariants.”

To figure out how effective existing antibodies could be against these newer subvariants, Dr. Wang and colleagues used blood samples from five groups of people. They tested serum from people who had three doses of the original COVID-19 vaccine, four doses of the original vaccine, those who received a bivalent booster, people who experienced a breakthrough infection with the BA.2 Omicron variant, and those who had a breakthrough with a BA.4 or BA.5 variant.

Adding the new subvariants to these serum samples revealed that the existing antibodies in the blood were ineffective at wiping out or neutralizing BQ.1, BQ.1.1, XBB, and XBB.1.

The BQ.1 subvariant was six times more resistant to antibodies than BA.5, its parent strain, and XBB.1 was 63 times more resistant compared with its predecessor, BA.2.

This shift in the ability of vaccines to stop the subvariants “is particularly concerning,” the researchers wrote.
 

 

 

Wiping out treatments too

Dr. Wang and colleagues also tested how well a panel of 23 different monoclonal antibody drugs might work against the four subvariants. The therapies all worked well against the original Omicron variant and included some approved for use through the Food and Drug Administration emergency use authorization (EUA) program at the time of the study.

They found that 19 of these 23 monoclonal antibodies lost effectiveness “greatly or completely” against XBB and XBB.1, for example.

This is not the first time that monoclonal antibody therapies have gone from effective to ineffective. Previous variants have come out that no longer responded to treatment with bamlanivimab, etesevimab, imdevimab, casirivimab, tixagevimab, cilgavimab, and sotrovimab. Bebtelovimab now joins this list and is no longer available from Eli Lilly under EUA because of this lack of effectiveness.

The lack of an effective monoclonal antibody treatment “poses a serious problem for millions of immunocompromised individuals who do not respond robustly to COVID-19 vaccines,” the researchers wrote, adding that “the urgent need to develop active monoclonal antibodies for clinical use is obvious.”

A limitation of the study is that the work is done in blood samples. The effectiveness of COVID-19 vaccination against the BQ and XBB subvariants should be evaluated in people in clinical studies, the authors noted.

Also, the current study looked at how well antibodies could neutralize the viral strains, but future research, they added, should look at how well “cellular immunity” or other aspects of the immune system might protect people.

Going forward, the challenge remains to develop vaccines and treatments that offer broad protection as the coronavirus continues to evolve.

In an alarming ending, the researchers wrote: “We have collectively chased after SARS-CoV-2 variants for over 2 years, and yet, the virus continues to evolve and evade.”

A version of this article first appeared on Medscape.com.

It’s a story perhaps more appropriate for Halloween than for the festive holiday season, given its scary implications. Four Omicron subvariants of the virus that causes COVID-19 will be the most common strains going from person to person in the winter of 2022-2023, new research predicts.

Not too dire so far, until the researchers’ other findings are considered.

The BQ.1, BQ1.1, XBB, and XBB.1 subvariants are the most resistant to neutralizing antibodies, researcher Qian Wang, PhD, and colleagues wrote in a study published online in the journal Cell. This means people have no or “markedly reduced” protection against infection from these four strains, even if they’ve already had COVID-19 or are vaccinated and boosted multiple times, including with a bivalent vaccine.

On top of that, all available monoclonal antibody treatments are mostly or completely ineffective against these subvariants.

What does that mean for the immediate future? The findings are definitely “worrisome,” said Eric Topol, MD, founder and director of the Scripps Translational Research Institute in La Jolla, Calif.

But evidence from other countries, specifically Singapore and France, show that at least two of these variants turned out not to be as damaging as expected, likely because of high numbers of people vaccinated or who survived previous infections, he said.

Still, there is little to celebrate in the new findings, except that COVID-19 vaccinations and prior infections can still reduce the risk for serious outcomes such as hospitalization and death, the researchers wrote.

In fact, Centers for Disease Control and Prevention data released on Dec. 16 shows that people who have received four shots of the original COVID-19 vaccines as well as the bivalent booster were 57% less likely to visit an urgent care clinic or emergency room, regardless of age. 

It comes at a time when BQ.1 and BQ.1.1 account for about 70% of the circulating variants, data show. In addition, hospitalizations are up 18% over the past 2 weeks and COVID-19 deaths are up 50% nationwide, The New York Times reported.

Globally, in many places, an “immunity wall” that has been built, Dr. Topol said. That may not be the case in the United States.  

“The problem in the United States, making it harder to predict, is that we have a very low rate of recent boosters, in the past 6 months, especially in seniors,” he said. For example, only 36% of Americans aged 65 years and older, the group with highest risk, have received an updated bivalent booster.
 

An evolving virus

The subvariants are successfully replacing BA.5, which reigned as one of the most common Omicron variants over the past year. The latest CDC data show that BA.5 now accounts for only about 10% of the circulating virus. The researchers wrote: “This rapid replacement of virus strains is raising the specter of yet another wave of infections in the coming months.”

BQ.1 and BQ.1.1 evolved directly from BA.5 – adding more and some novel mutations to the SARS-CoV-2 virus. XBB and XBB.1 are the “offspring” of a combination of two other strains, known as BJ.1 and BA.2.75.

The story sounds familiar to the researchers. “The rapid rise of these subvariants and their extensive array of spike mutations are reminiscent of the appearance of the first Omicron variant last year, thus raising concerns that they may further compromise the efficacy of current COVID-19 vaccines and monoclonal antibody therapeutics,” they wrote. “We now report findings that indicate that such concerns are, sadly, justified, especially so for the XBB and XBB.1 subvariants.”

To figure out how effective existing antibodies could be against these newer subvariants, Dr. Wang and colleagues used blood samples from five groups of people. They tested serum from people who had three doses of the original COVID-19 vaccine, four doses of the original vaccine, those who received a bivalent booster, people who experienced a breakthrough infection with the BA.2 Omicron variant, and those who had a breakthrough with a BA.4 or BA.5 variant.

Adding the new subvariants to these serum samples revealed that the existing antibodies in the blood were ineffective at wiping out or neutralizing BQ.1, BQ.1.1, XBB, and XBB.1.

The BQ.1 subvariant was six times more resistant to antibodies than BA.5, its parent strain, and XBB.1 was 63 times more resistant compared with its predecessor, BA.2.

This shift in the ability of vaccines to stop the subvariants “is particularly concerning,” the researchers wrote.
 

 

 

Wiping out treatments too

Dr. Wang and colleagues also tested how well a panel of 23 different monoclonal antibody drugs might work against the four subvariants. The therapies all worked well against the original Omicron variant and included some approved for use through the Food and Drug Administration emergency use authorization (EUA) program at the time of the study.

They found that 19 of these 23 monoclonal antibodies lost effectiveness “greatly or completely” against XBB and XBB.1, for example.

This is not the first time that monoclonal antibody therapies have gone from effective to ineffective. Previous variants have come out that no longer responded to treatment with bamlanivimab, etesevimab, imdevimab, casirivimab, tixagevimab, cilgavimab, and sotrovimab. Bebtelovimab now joins this list and is no longer available from Eli Lilly under EUA because of this lack of effectiveness.

The lack of an effective monoclonal antibody treatment “poses a serious problem for millions of immunocompromised individuals who do not respond robustly to COVID-19 vaccines,” the researchers wrote, adding that “the urgent need to develop active monoclonal antibodies for clinical use is obvious.”

A limitation of the study is that the work is done in blood samples. The effectiveness of COVID-19 vaccination against the BQ and XBB subvariants should be evaluated in people in clinical studies, the authors noted.

Also, the current study looked at how well antibodies could neutralize the viral strains, but future research, they added, should look at how well “cellular immunity” or other aspects of the immune system might protect people.

Going forward, the challenge remains to develop vaccines and treatments that offer broad protection as the coronavirus continues to evolve.

In an alarming ending, the researchers wrote: “We have collectively chased after SARS-CoV-2 variants for over 2 years, and yet, the virus continues to evolve and evade.”

A version of this article first appeared on Medscape.com.

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Hair supplements

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Mon, 12/19/2022 - 10:38

Recent attention has been given to supplements taken to treat hair loss as the first comprehensive review has been published in JAMA Dermatology in November 2022.

Drake and colleagues evaluated the safety and efficacy of nutritional supplements for treating hair loss. In a systematic database review from inception to Oct. 20, 2021, they evaluated and compiled the findings of all dietary and nutritional interventions for treatment of hair loss among individuals without a known baseline nutritional deficiency. Thirty articles were included, including 17 randomized clinical trials, 11 clinical trials, and 2 case series.

Dr. Naissan O. Wesley

They found the highest-quality evidence showing the most potential benefit were for 12 of the 20 nutritional interventions in their review: Pumpkin seed oil capsules, omega-3 and -6 combined with antioxidants, tocotrienol, Pantogar, capsaicin and isoflavone, Viviscal (multiple formulations), Nourkrin, Nutrafol, apple nutraceutical, Lambdapil, total glucosides of paeony and compound glycyrrhizin tablets, and zinc. Vitamin D3, kimchi and cheonggukjang, and Forti5 had lower-quality evidence for disease course improvement. Adverse effects associated with the supplements were described as mild and rare.

In practice, for patients with nonscarring alopecia, I typically check screening labs for hair loss, in addition to the clinical exam, before starting treatment (including supplements), as addressing the underlying reason, if found, is always paramount. These labs are best performed when the patient is not taking biotin, as biotin has been shown numerous times to potentially be associated with endocrine lab abnormalities, most commonly thyroid-stimulating hormone, especially at higher doses, as well as troponin levels. Some over-the-counter hair supplements will contain much higher doses than the recommended 30 micrograms per day.



Separately, if ferritin levels are within normal range, but below 50 mcg/L, supplementation with Slow Fe or another slow-release iron supplement may also result in improved hair growth. Ferritin levels are typically rechecked 6 months after supplementation to see if levels of 50 mcg/L or above have been achieved.

Another point to consider before beginning supplementation is to educate patients about potential effects of supplementation, including increased hair growth in other areas besides the scalp. For some patients who are self-conscious about potential hirsutism, this could be an issue, whereas for others, this risk does not outweigh the benefit. Unwanted hair growth, should it occur, may also be addressed with hair removal methods including shaving, waxing, plucking, threading, depilatories, prescription eflornithine cream (Vaniqa), or laser hair removal if desired.

Our armamentarium for treating hair loss includes: addressing underlying systemic causes; topical treatments including topical minoxidil; oral supplements; platelet-rich plasma injections; prescription oral medications including finasteride in men or postmenopausal women or off-label oral minoxidil; and hair transplant surgery if warranted. Having this thorough review of the most common hair supplements currently available is extremely helpful and valuable in our specialty.

Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. Write to them at [email protected]. This month’s column is by Dr. Wesley. She had no relevant disclosures.

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Recent attention has been given to supplements taken to treat hair loss as the first comprehensive review has been published in JAMA Dermatology in November 2022.

Drake and colleagues evaluated the safety and efficacy of nutritional supplements for treating hair loss. In a systematic database review from inception to Oct. 20, 2021, they evaluated and compiled the findings of all dietary and nutritional interventions for treatment of hair loss among individuals without a known baseline nutritional deficiency. Thirty articles were included, including 17 randomized clinical trials, 11 clinical trials, and 2 case series.

Dr. Naissan O. Wesley

They found the highest-quality evidence showing the most potential benefit were for 12 of the 20 nutritional interventions in their review: Pumpkin seed oil capsules, omega-3 and -6 combined with antioxidants, tocotrienol, Pantogar, capsaicin and isoflavone, Viviscal (multiple formulations), Nourkrin, Nutrafol, apple nutraceutical, Lambdapil, total glucosides of paeony and compound glycyrrhizin tablets, and zinc. Vitamin D3, kimchi and cheonggukjang, and Forti5 had lower-quality evidence for disease course improvement. Adverse effects associated with the supplements were described as mild and rare.

In practice, for patients with nonscarring alopecia, I typically check screening labs for hair loss, in addition to the clinical exam, before starting treatment (including supplements), as addressing the underlying reason, if found, is always paramount. These labs are best performed when the patient is not taking biotin, as biotin has been shown numerous times to potentially be associated with endocrine lab abnormalities, most commonly thyroid-stimulating hormone, especially at higher doses, as well as troponin levels. Some over-the-counter hair supplements will contain much higher doses than the recommended 30 micrograms per day.



Separately, if ferritin levels are within normal range, but below 50 mcg/L, supplementation with Slow Fe or another slow-release iron supplement may also result in improved hair growth. Ferritin levels are typically rechecked 6 months after supplementation to see if levels of 50 mcg/L or above have been achieved.

Another point to consider before beginning supplementation is to educate patients about potential effects of supplementation, including increased hair growth in other areas besides the scalp. For some patients who are self-conscious about potential hirsutism, this could be an issue, whereas for others, this risk does not outweigh the benefit. Unwanted hair growth, should it occur, may also be addressed with hair removal methods including shaving, waxing, plucking, threading, depilatories, prescription eflornithine cream (Vaniqa), or laser hair removal if desired.

Our armamentarium for treating hair loss includes: addressing underlying systemic causes; topical treatments including topical minoxidil; oral supplements; platelet-rich plasma injections; prescription oral medications including finasteride in men or postmenopausal women or off-label oral minoxidil; and hair transplant surgery if warranted. Having this thorough review of the most common hair supplements currently available is extremely helpful and valuable in our specialty.

Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. Write to them at [email protected]. This month’s column is by Dr. Wesley. She had no relevant disclosures.

Recent attention has been given to supplements taken to treat hair loss as the first comprehensive review has been published in JAMA Dermatology in November 2022.

Drake and colleagues evaluated the safety and efficacy of nutritional supplements for treating hair loss. In a systematic database review from inception to Oct. 20, 2021, they evaluated and compiled the findings of all dietary and nutritional interventions for treatment of hair loss among individuals without a known baseline nutritional deficiency. Thirty articles were included, including 17 randomized clinical trials, 11 clinical trials, and 2 case series.

Dr. Naissan O. Wesley

They found the highest-quality evidence showing the most potential benefit were for 12 of the 20 nutritional interventions in their review: Pumpkin seed oil capsules, omega-3 and -6 combined with antioxidants, tocotrienol, Pantogar, capsaicin and isoflavone, Viviscal (multiple formulations), Nourkrin, Nutrafol, apple nutraceutical, Lambdapil, total glucosides of paeony and compound glycyrrhizin tablets, and zinc. Vitamin D3, kimchi and cheonggukjang, and Forti5 had lower-quality evidence for disease course improvement. Adverse effects associated with the supplements were described as mild and rare.

In practice, for patients with nonscarring alopecia, I typically check screening labs for hair loss, in addition to the clinical exam, before starting treatment (including supplements), as addressing the underlying reason, if found, is always paramount. These labs are best performed when the patient is not taking biotin, as biotin has been shown numerous times to potentially be associated with endocrine lab abnormalities, most commonly thyroid-stimulating hormone, especially at higher doses, as well as troponin levels. Some over-the-counter hair supplements will contain much higher doses than the recommended 30 micrograms per day.



Separately, if ferritin levels are within normal range, but below 50 mcg/L, supplementation with Slow Fe or another slow-release iron supplement may also result in improved hair growth. Ferritin levels are typically rechecked 6 months after supplementation to see if levels of 50 mcg/L or above have been achieved.

Another point to consider before beginning supplementation is to educate patients about potential effects of supplementation, including increased hair growth in other areas besides the scalp. For some patients who are self-conscious about potential hirsutism, this could be an issue, whereas for others, this risk does not outweigh the benefit. Unwanted hair growth, should it occur, may also be addressed with hair removal methods including shaving, waxing, plucking, threading, depilatories, prescription eflornithine cream (Vaniqa), or laser hair removal if desired.

Our armamentarium for treating hair loss includes: addressing underlying systemic causes; topical treatments including topical minoxidil; oral supplements; platelet-rich plasma injections; prescription oral medications including finasteride in men or postmenopausal women or off-label oral minoxidil; and hair transplant surgery if warranted. Having this thorough review of the most common hair supplements currently available is extremely helpful and valuable in our specialty.

Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. Write to them at [email protected]. This month’s column is by Dr. Wesley. She had no relevant disclosures.

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‘Dr. Pimple Popper’ offers tips for building a social media presence

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– In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.

Dr. Sandra Lee

“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”

Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.

Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, Dr. Lee formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.53 million subscribers over the course of a few years. She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.

About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”

Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:

Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”



Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”

Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”

Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”

Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”

Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.

Dr. Lee reported having no relevant disclosures.

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– In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.

Dr. Sandra Lee

“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”

Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.

Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, Dr. Lee formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.53 million subscribers over the course of a few years. She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.

About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”

Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:

Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”



Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”

Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”

Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”

Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”

Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.

Dr. Lee reported having no relevant disclosures.

– In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.

Dr. Sandra Lee

“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”

Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.

Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, Dr. Lee formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.53 million subscribers over the course of a few years. She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.

About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”

Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:

Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”



Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”

Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”

Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”

Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”

Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.

Dr. Lee reported having no relevant disclosures.

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FDA approves Idacio as eighth adalimumab biosimilar in U.S.

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A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

A version of this article first appeared on Medscape.com.

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A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

A version of this article first appeared on Medscape.com.

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

A version of this article first appeared on Medscape.com.

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Dupilumab significantly improves markers of AD severity in pediatric patients

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Thu, 12/15/2022 - 13:00

A registry-based study provides further evidence that treatment with dupilumab significantly reduces severity and symptoms of atopic dermatitis (AD) in clinical practice.

Dupilumab also decreased severity-associated biomarkers in pediatric patients with moderate to severe AD, researchers in the Netherlands reported.

Obtaining serum biomarkers is not the current standard in everyday practice, but studying them may improve understanding of who might respond best to dupilumab, said Jessica Hui, MD, a pediatric allergist and immunologist at National Jewish Health in Denver, in an email comment to this news organization.

“AD is heterogeneous, as each patient may have different presentations and underlying biology,” said Dr. Hui, who wasn’t involved in the research. “Studying biomarkers can eventually assist us in providing targeted therapy to each individual patient.”

Dr. Hui added, “As blood biomarkers can inform us of severity and treatment response, we can be hopeful that this will assist us in the management of AD patients in the future.”
 

Examining effect on disease severity

Dupilumab, a monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is approved in Europe and the United States to treat moderate to severe AD in patients 6 months of age or older, and to treat certain other inflammatory conditions.

Phase 3 studies show that dupilumab is effective for improving AD symptoms and quality of life in pediatric patients, but few clinical practice studies have researched the effect of the therapy on severity- and disease-related biomarkers in this population, the study authors write.

The study was published online in Pediatric Allergy Immunology.

In a new study, a team led by Esmé Kamphuis, MD, of the University of Groningen, the Netherlands, and colleagues evaluated the efficacy and safety of a 28-week dupilumab treatment course in 61 pediatric patients with moderate to severe AD. Additionally, the investigators examined the effect of this treatment regimen on serum biomarkers associated with disease severity.

Patients in the study were registered in the multicenter BioDay registry, which includes patients with moderate to severe AD receiving biologics or small-molecule agents. The AD cohort included children between 6 and 12 years of age (n = 16) and adolescents between 12 and less than 18 years of age (n = 45), all of whom received dupilumab on a dosing regimen indicated by age and body weight.

Over one-third (36.1%) of dupilumab-treated patients achieved an Investigator Global Assessment score of “almost clear” by 28 weeks of treatment. Approximately 75.4% of patients reached an Eczema Area and Severity Index (EASI) of 50, 49.2% reached EASI-75, and 24.6% reached EASI-90 at the 7-month follow-up.

Among patient-reported outcomes, 84.7% experienced improvements of 4 or more points on the Patient-Oriented Eczema Measure after the 28-week dupilumab treatment. In addition, improvements of 4 or more points on the Numeric Rating Scale for pruritus and pain were achieved by 45.3% and 77.4% of patients, respectively.

The most frequently reported side effects included conjunctivitis (n = 10) and headache (n = 4).

Of the 19 severity-associated serum biomarkers measured at baseline, week 4, and week 16, markers related to AD severity and treatment response significantly decreased during treatment (thymus- and activation-regulated chemokine, pulmonary and activation-regulated chemokine, periostin, soluble IL-2 receptor alpha).

A predicted EASI, calculated from selected biomarkers, demonstrated a significant association with disease severity in the cohort.
 

 

 

Implications for practice

When asked to comment on the study findings, Raegan Hunt, MD, the division chief of pediatric dermatology at Texas Children’s Hospital in Houston, said it is important to validate the changes in AD serum biomarkers in pediatric patients on dupilumab therapy, given that this treatment has historically been better studied in adults.

“This study adds to daily practice outcomes data, which in many cases is more relevant to the everyday care of patients than structured clinical trial data,” said Dr. Hunt, an associate professor at the Baylor College of Medicine, Houston.

Dr. Hunt, who didn’t participate in the study, noted that more research is needed on the adverse effects of dupilumab in the pediatric AD population.

Dr. Hui added that there is a lack of clear understanding of the exact underlying mechanisms for certain side effects, such as conjunctivitis, warranting further study.

The study’s BioDay registry is funded by Sanofi/Regeneron, AbbVie, Leo Pharma, Pfizer, and Eli Lilly. Several study coauthors report relationships with several pharmaceutical companies. Dr. Hunt and Dr. Hui report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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A registry-based study provides further evidence that treatment with dupilumab significantly reduces severity and symptoms of atopic dermatitis (AD) in clinical practice.

Dupilumab also decreased severity-associated biomarkers in pediatric patients with moderate to severe AD, researchers in the Netherlands reported.

Obtaining serum biomarkers is not the current standard in everyday practice, but studying them may improve understanding of who might respond best to dupilumab, said Jessica Hui, MD, a pediatric allergist and immunologist at National Jewish Health in Denver, in an email comment to this news organization.

“AD is heterogeneous, as each patient may have different presentations and underlying biology,” said Dr. Hui, who wasn’t involved in the research. “Studying biomarkers can eventually assist us in providing targeted therapy to each individual patient.”

Dr. Hui added, “As blood biomarkers can inform us of severity and treatment response, we can be hopeful that this will assist us in the management of AD patients in the future.”
 

Examining effect on disease severity

Dupilumab, a monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is approved in Europe and the United States to treat moderate to severe AD in patients 6 months of age or older, and to treat certain other inflammatory conditions.

Phase 3 studies show that dupilumab is effective for improving AD symptoms and quality of life in pediatric patients, but few clinical practice studies have researched the effect of the therapy on severity- and disease-related biomarkers in this population, the study authors write.

The study was published online in Pediatric Allergy Immunology.

In a new study, a team led by Esmé Kamphuis, MD, of the University of Groningen, the Netherlands, and colleagues evaluated the efficacy and safety of a 28-week dupilumab treatment course in 61 pediatric patients with moderate to severe AD. Additionally, the investigators examined the effect of this treatment regimen on serum biomarkers associated with disease severity.

Patients in the study were registered in the multicenter BioDay registry, which includes patients with moderate to severe AD receiving biologics or small-molecule agents. The AD cohort included children between 6 and 12 years of age (n = 16) and adolescents between 12 and less than 18 years of age (n = 45), all of whom received dupilumab on a dosing regimen indicated by age and body weight.

Over one-third (36.1%) of dupilumab-treated patients achieved an Investigator Global Assessment score of “almost clear” by 28 weeks of treatment. Approximately 75.4% of patients reached an Eczema Area and Severity Index (EASI) of 50, 49.2% reached EASI-75, and 24.6% reached EASI-90 at the 7-month follow-up.

Among patient-reported outcomes, 84.7% experienced improvements of 4 or more points on the Patient-Oriented Eczema Measure after the 28-week dupilumab treatment. In addition, improvements of 4 or more points on the Numeric Rating Scale for pruritus and pain were achieved by 45.3% and 77.4% of patients, respectively.

The most frequently reported side effects included conjunctivitis (n = 10) and headache (n = 4).

Of the 19 severity-associated serum biomarkers measured at baseline, week 4, and week 16, markers related to AD severity and treatment response significantly decreased during treatment (thymus- and activation-regulated chemokine, pulmonary and activation-regulated chemokine, periostin, soluble IL-2 receptor alpha).

A predicted EASI, calculated from selected biomarkers, demonstrated a significant association with disease severity in the cohort.
 

 

 

Implications for practice

When asked to comment on the study findings, Raegan Hunt, MD, the division chief of pediatric dermatology at Texas Children’s Hospital in Houston, said it is important to validate the changes in AD serum biomarkers in pediatric patients on dupilumab therapy, given that this treatment has historically been better studied in adults.

“This study adds to daily practice outcomes data, which in many cases is more relevant to the everyday care of patients than structured clinical trial data,” said Dr. Hunt, an associate professor at the Baylor College of Medicine, Houston.

Dr. Hunt, who didn’t participate in the study, noted that more research is needed on the adverse effects of dupilumab in the pediatric AD population.

Dr. Hui added that there is a lack of clear understanding of the exact underlying mechanisms for certain side effects, such as conjunctivitis, warranting further study.

The study’s BioDay registry is funded by Sanofi/Regeneron, AbbVie, Leo Pharma, Pfizer, and Eli Lilly. Several study coauthors report relationships with several pharmaceutical companies. Dr. Hunt and Dr. Hui report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A registry-based study provides further evidence that treatment with dupilumab significantly reduces severity and symptoms of atopic dermatitis (AD) in clinical practice.

Dupilumab also decreased severity-associated biomarkers in pediatric patients with moderate to severe AD, researchers in the Netherlands reported.

Obtaining serum biomarkers is not the current standard in everyday practice, but studying them may improve understanding of who might respond best to dupilumab, said Jessica Hui, MD, a pediatric allergist and immunologist at National Jewish Health in Denver, in an email comment to this news organization.

“AD is heterogeneous, as each patient may have different presentations and underlying biology,” said Dr. Hui, who wasn’t involved in the research. “Studying biomarkers can eventually assist us in providing targeted therapy to each individual patient.”

Dr. Hui added, “As blood biomarkers can inform us of severity and treatment response, we can be hopeful that this will assist us in the management of AD patients in the future.”
 

Examining effect on disease severity

Dupilumab, a monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is approved in Europe and the United States to treat moderate to severe AD in patients 6 months of age or older, and to treat certain other inflammatory conditions.

Phase 3 studies show that dupilumab is effective for improving AD symptoms and quality of life in pediatric patients, but few clinical practice studies have researched the effect of the therapy on severity- and disease-related biomarkers in this population, the study authors write.

The study was published online in Pediatric Allergy Immunology.

In a new study, a team led by Esmé Kamphuis, MD, of the University of Groningen, the Netherlands, and colleagues evaluated the efficacy and safety of a 28-week dupilumab treatment course in 61 pediatric patients with moderate to severe AD. Additionally, the investigators examined the effect of this treatment regimen on serum biomarkers associated with disease severity.

Patients in the study were registered in the multicenter BioDay registry, which includes patients with moderate to severe AD receiving biologics or small-molecule agents. The AD cohort included children between 6 and 12 years of age (n = 16) and adolescents between 12 and less than 18 years of age (n = 45), all of whom received dupilumab on a dosing regimen indicated by age and body weight.

Over one-third (36.1%) of dupilumab-treated patients achieved an Investigator Global Assessment score of “almost clear” by 28 weeks of treatment. Approximately 75.4% of patients reached an Eczema Area and Severity Index (EASI) of 50, 49.2% reached EASI-75, and 24.6% reached EASI-90 at the 7-month follow-up.

Among patient-reported outcomes, 84.7% experienced improvements of 4 or more points on the Patient-Oriented Eczema Measure after the 28-week dupilumab treatment. In addition, improvements of 4 or more points on the Numeric Rating Scale for pruritus and pain were achieved by 45.3% and 77.4% of patients, respectively.

The most frequently reported side effects included conjunctivitis (n = 10) and headache (n = 4).

Of the 19 severity-associated serum biomarkers measured at baseline, week 4, and week 16, markers related to AD severity and treatment response significantly decreased during treatment (thymus- and activation-regulated chemokine, pulmonary and activation-regulated chemokine, periostin, soluble IL-2 receptor alpha).

A predicted EASI, calculated from selected biomarkers, demonstrated a significant association with disease severity in the cohort.
 

 

 

Implications for practice

When asked to comment on the study findings, Raegan Hunt, MD, the division chief of pediatric dermatology at Texas Children’s Hospital in Houston, said it is important to validate the changes in AD serum biomarkers in pediatric patients on dupilumab therapy, given that this treatment has historically been better studied in adults.

“This study adds to daily practice outcomes data, which in many cases is more relevant to the everyday care of patients than structured clinical trial data,” said Dr. Hunt, an associate professor at the Baylor College of Medicine, Houston.

Dr. Hunt, who didn’t participate in the study, noted that more research is needed on the adverse effects of dupilumab in the pediatric AD population.

Dr. Hui added that there is a lack of clear understanding of the exact underlying mechanisms for certain side effects, such as conjunctivitis, warranting further study.

The study’s BioDay registry is funded by Sanofi/Regeneron, AbbVie, Leo Pharma, Pfizer, and Eli Lilly. Several study coauthors report relationships with several pharmaceutical companies. Dr. Hunt and Dr. Hui report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Ustekinumab matches TNF inhibitors for psoriatic arthritis in 3-year, real-world study

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The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

Dr. Laure Gossec

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.



Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

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The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

Dr. Laure Gossec

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.



Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

Dr. Laure Gossec

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.



Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

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Updated materials and mentoring can boost diversity in dermatology

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Thu, 12/15/2022 - 16:47

Improving diversity in dermatology starts with education, Susan C. Taylor, MD, said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar, where she led a panel discussion on opportunities to improve diversity in the specialty.

The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.

Dr. Susan C. Taylor

Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.

The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.

Dr. Nada M. Elbuluk


The underrepresentation of teaching images, combined with the lack of data on epidemiology and treatment, can translate to poorer quality of care for skin of color patients and contribute to more misdiagnoses in these populations, Dr. Elbuluk emphasized.

Cultural competency and workforce diversity are ongoing issues in dermatology, added Valerie D. Callender, MD, professor of dermatology at Howard University, Washington, and medical director of the Callender Dermatology & Cosmetic Center in Glenn Dale, Md.

“We know that patients of color seek physicians of color,” she said. “We need to target our residents’ interest in dermatology,” and all physicians need to be comfortable with treating patients of all races, she added.



Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.

Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.

Dr. Cheryl M. Burgess

Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.

“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.

Dr. Andrew F. Alexis

Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.

Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.

Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.

The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.

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Improving diversity in dermatology starts with education, Susan C. Taylor, MD, said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar, where she led a panel discussion on opportunities to improve diversity in the specialty.

The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.

Dr. Susan C. Taylor

Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.

The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.

Dr. Nada M. Elbuluk


The underrepresentation of teaching images, combined with the lack of data on epidemiology and treatment, can translate to poorer quality of care for skin of color patients and contribute to more misdiagnoses in these populations, Dr. Elbuluk emphasized.

Cultural competency and workforce diversity are ongoing issues in dermatology, added Valerie D. Callender, MD, professor of dermatology at Howard University, Washington, and medical director of the Callender Dermatology & Cosmetic Center in Glenn Dale, Md.

“We know that patients of color seek physicians of color,” she said. “We need to target our residents’ interest in dermatology,” and all physicians need to be comfortable with treating patients of all races, she added.



Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.

Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.

Dr. Cheryl M. Burgess

Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.

“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.

Dr. Andrew F. Alexis

Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.

Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.

Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.

The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.

Improving diversity in dermatology starts with education, Susan C. Taylor, MD, said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar, where she led a panel discussion on opportunities to improve diversity in the specialty.

The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.

Dr. Susan C. Taylor

Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.

The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.

Dr. Nada M. Elbuluk


The underrepresentation of teaching images, combined with the lack of data on epidemiology and treatment, can translate to poorer quality of care for skin of color patients and contribute to more misdiagnoses in these populations, Dr. Elbuluk emphasized.

Cultural competency and workforce diversity are ongoing issues in dermatology, added Valerie D. Callender, MD, professor of dermatology at Howard University, Washington, and medical director of the Callender Dermatology & Cosmetic Center in Glenn Dale, Md.

“We know that patients of color seek physicians of color,” she said. “We need to target our residents’ interest in dermatology,” and all physicians need to be comfortable with treating patients of all races, she added.



Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.

Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.

Dr. Cheryl M. Burgess

Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.

“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.

Dr. Andrew F. Alexis

Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.

Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.

Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.

The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.

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Experts dispel incorrect dogmas in aesthetic medicine

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Thu, 12/15/2022 - 16:47

At least once a week, dermatologist Kelly Stankiewicz, MD, meets with patients who believe that fillers can help them achieve any lip shape. Some reach for their smartphones to show her images and say: “I want my lips to look just like this.”

Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”

Dr. Kelly Stankiewicz

During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.

Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”



Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.

Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”

Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”

Dr. Omar A. Ibrahimi

Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”

Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”

Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.

Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”

Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”

Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.

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At least once a week, dermatologist Kelly Stankiewicz, MD, meets with patients who believe that fillers can help them achieve any lip shape. Some reach for their smartphones to show her images and say: “I want my lips to look just like this.”

Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”

Dr. Kelly Stankiewicz

During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.

Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”



Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.

Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”

Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”

Dr. Omar A. Ibrahimi

Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”

Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”

Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.

Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”

Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”

Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.

At least once a week, dermatologist Kelly Stankiewicz, MD, meets with patients who believe that fillers can help them achieve any lip shape. Some reach for their smartphones to show her images and say: “I want my lips to look just like this.”

Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”

Dr. Kelly Stankiewicz

During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.

Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”



Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.

Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”

Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”

Dr. Omar A. Ibrahimi

Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”

Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”

Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.

Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”

Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”

Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.

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