MDedge Dermatology

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: Specific targeting of interleukin-13 alone with tralokinumab improved microbial diversity and reduced Staphylococcus aureus abundance in the lesional skin in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The 16-week tralokinumab treatment reduced S. aureus abundance by 20.7-fold (P < .0001), whereas placebo led to a non-statistically significant reduction. Tralokinumab also led to a significant increase in microbial diversity as early as week 8 (P < .001) and also at week 16 (P < .05).

Study details: The data come from the phase 3 ECZTRA 1 trial including 802 patients with moderate-to-severe AD who were randomly assigned to receive 300 mg subcutaneous tralokinumab or placebo.

Disclosures: This study and the ECZTRA 1 trial were funded by LEO Pharma A/S. Some authors declared serving as speakers, consultants, investigators, scientific advisors, or clinical study investigators or receiving institutional research grants from various sources, including LEO Pharma.

Source: Beck LA et al. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2022 (Dec 2). Doi: 10.1016/j.jaad.2022.11.047

Key clinical point: An exposure to topical calcineurin inhibitors did not increase the risk for cancer in patients with atopic dermatitis (AD), with findings being similar among infants, children, and adults.

Major finding: Compared with no exposure, topical calcineurin inhibitor exposure was not associated with an increased risk for cancer (odds ratio [OR] 1.03; 95% credible interval [CrI] 0.94-1.11), with neither pimecrolimus (OR 1.05; 95% CrI 0.94-1.15) nor tacrolimus (OR 0.99; 95% CrI 0.89-1.09) use revealing any association with increased cancer risk, across all age groups.

Study details: This was a systematic review and meta-analysis of 110 unique studies (52 randomized controlled trials and 69 nonrandomized studies) including 3.4 million patients with AD followed-up for a mean of 11 months.

Disclosures: This study was funded by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology. L Schneider declared receiving consulting fees and payments to her institutions from, serving on data safety monitoring and advisory boards for, and holding stock or stock options in various sources.

Source: Devasenapathy N et al for the AAAAI/ACAAI Joint Task Force on Practice Parameters for Atopic Dermatitis Guideline Development Group. Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: A systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 (Nov 9). Doi: 10.1016/S2352-4642(22)00283-8

Key clinical point: An exposure to topical calcineurin inhibitors did not increase the risk for cancer in patients with atopic dermatitis (AD), with findings being similar among infants, children, and adults.

Major finding: Compared with no exposure, topical calcineurin inhibitor exposure was not associated with an increased risk for cancer (odds ratio [OR] 1.03; 95% credible interval [CrI] 0.94-1.11), with neither pimecrolimus (OR 1.05; 95% CrI 0.94-1.15) nor tacrolimus (OR 0.99; 95% CrI 0.89-1.09) use revealing any association with increased cancer risk, across all age groups.

Study details: This was a systematic review and meta-analysis of 110 unique studies (52 randomized controlled trials and 69 nonrandomized studies) including 3.4 million patients with AD followed-up for a mean of 11 months.

Disclosures: This study was funded by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology. L Schneider declared receiving consulting fees and payments to her institutions from, serving on data safety monitoring and advisory boards for, and holding stock or stock options in various sources.

Source: Devasenapathy N et al for the AAAAI/ACAAI Joint Task Force on Practice Parameters for Atopic Dermatitis Guideline Development Group. Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: A systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 (Nov 9). Doi: 10.1016/S2352-4642(22)00283-8

Key clinical point: An exposure to topical calcineurin inhibitors did not increase the risk for cancer in patients with atopic dermatitis (AD), with findings being similar among infants, children, and adults.

Major finding: Compared with no exposure, topical calcineurin inhibitor exposure was not associated with an increased risk for cancer (odds ratio [OR] 1.03; 95% credible interval [CrI] 0.94-1.11), with neither pimecrolimus (OR 1.05; 95% CrI 0.94-1.15) nor tacrolimus (OR 0.99; 95% CrI 0.89-1.09) use revealing any association with increased cancer risk, across all age groups.

Study details: This was a systematic review and meta-analysis of 110 unique studies (52 randomized controlled trials and 69 nonrandomized studies) including 3.4 million patients with AD followed-up for a mean of 11 months.

Disclosures: This study was funded by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology. L Schneider declared receiving consulting fees and payments to her institutions from, serving on data safety monitoring and advisory boards for, and holding stock or stock options in various sources.

Source: Devasenapathy N et al for the AAAAI/ACAAI Joint Task Force on Practice Parameters for Atopic Dermatitis Guideline Development Group. Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: A systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 (Nov 9). Doi: 10.1016/S2352-4642(22)00283-8

Key clinical point: Treatment with rocatinlimab, a novel monoclonal antibody, significantly improved disease severity at all dosing regimens in patients with moderate-to-severe atopic dermatitis (AD) inadequately controlled with topical therapy, which was maintained in most patients even after treatment discontinuation.

Major finding: The least-squares mean percent reductions in the Eczema Area and Severity Index at week 16 were significantly greater with 150 mg rocatinlimab every 4 weeks vs placebo (−48.3% vs −15.0%; P  =  .0003), with all other active rocatinlimab dose regimens vs placebo showing improvement (all P < .05) and most patients showing sustained response during off-drug follow-up.

Study details: The data come from a multicenter phase 2b study including 274 patients with moderate-to-severe AD and inadequate response or intolerance to topical medications and who were randomly assigned to receive rocatinlimab or placebo.

Disclosures: This study was funded by Kyowa Kirin. Some authors reported ties with various sources, including Kyowa Kirin. E Esfandiari declared being an employee of Kyowa Kirin.

Source: Guttman-Yassky E et al. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: A multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2022 (Dec 9). Doi: 10.1016/S0140-6736(22)02037-2

Key clinical point: Treatment with rocatinlimab, a novel monoclonal antibody, significantly improved disease severity at all dosing regimens in patients with moderate-to-severe atopic dermatitis (AD) inadequately controlled with topical therapy, which was maintained in most patients even after treatment discontinuation.

Major finding: The least-squares mean percent reductions in the Eczema Area and Severity Index at week 16 were significantly greater with 150 mg rocatinlimab every 4 weeks vs placebo (−48.3% vs −15.0%; P  =  .0003), with all other active rocatinlimab dose regimens vs placebo showing improvement (all P < .05) and most patients showing sustained response during off-drug follow-up.

Study details: The data come from a multicenter phase 2b study including 274 patients with moderate-to-severe AD and inadequate response or intolerance to topical medications and who were randomly assigned to receive rocatinlimab or placebo.

Disclosures: This study was funded by Kyowa Kirin. Some authors reported ties with various sources, including Kyowa Kirin. E Esfandiari declared being an employee of Kyowa Kirin.

Source: Guttman-Yassky E et al. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: A multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2022 (Dec 9). Doi: 10.1016/S0140-6736(22)02037-2

Key clinical point: Treatment with rocatinlimab, a novel monoclonal antibody, significantly improved disease severity at all dosing regimens in patients with moderate-to-severe atopic dermatitis (AD) inadequately controlled with topical therapy, which was maintained in most patients even after treatment discontinuation.

Major finding: The least-squares mean percent reductions in the Eczema Area and Severity Index at week 16 were significantly greater with 150 mg rocatinlimab every 4 weeks vs placebo (−48.3% vs −15.0%; P  =  .0003), with all other active rocatinlimab dose regimens vs placebo showing improvement (all P < .05) and most patients showing sustained response during off-drug follow-up.

Study details: The data come from a multicenter phase 2b study including 274 patients with moderate-to-severe AD and inadequate response or intolerance to topical medications and who were randomly assigned to receive rocatinlimab or placebo.

Disclosures: This study was funded by Kyowa Kirin. Some authors reported ties with various sources, including Kyowa Kirin. E Esfandiari declared being an employee of Kyowa Kirin.

Source: Guttman-Yassky E et al. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: A multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2022 (Dec 9). Doi: 10.1016/S0140-6736(22)02037-2

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.

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.

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.

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.

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.

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.

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.

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.

SAN DIEGO – 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.

“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.

SAN DIEGO – 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.

“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.

SAN DIEGO – 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.

“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.

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.

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 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.

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.