MDedge Dermatology

Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
 

But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.

This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.

“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”

He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.

MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.

The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
 

The biosimilars are coming

By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.

Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”

Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.

It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”

Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.

“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”

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

Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
 

But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.

This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.

“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”

He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.

MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.

The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
 

The biosimilars are coming

By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.

Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”

Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.

It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”

Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.

“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”

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

Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
 

But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.

This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.

“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”

He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.

MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.

The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
 

The biosimilars are coming

By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.

Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”

Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.

It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”

Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.

“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”

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

Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.

Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

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

Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.

Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

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

Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.

Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

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

Key clinical point: Presence of concurrent atopic dermatitis (AD) significantly affects the biologic-free survival in patients with inflammatory bowel disease (IBD).

Major finding: Presence of concurrent AD was associated with a significantly shorter biologic-free survival in patients with IBD (adjusted hazard ratio [aHR] 1.743; P = .032), with the association being stronger in patients with ulcerative colitis (aHR 4.769; P = .004).

Study details: Findings are from a retrospective study including 61 adult patients with IBD and concurrent AD and 122 matched control individuals with IBD alone.

Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.

Source: Kim KW, et al, and Seoul National University Inflammatory Bowel Disease Research Network (SIRN) and Inflammatory Bowel Disease Research Group of Korean Association for the Study of Intestinal Disease (KASID). Atopic dermatitis is associated with the clinical course of inflammatory bowel disease. Scand J Gastroenterol. 2023;1-7 (May 11). doi: 10.1080/00365521.2023.2209688

Key clinical point: Presence of concurrent atopic dermatitis (AD) significantly affects the biologic-free survival in patients with inflammatory bowel disease (IBD).

Major finding: Presence of concurrent AD was associated with a significantly shorter biologic-free survival in patients with IBD (adjusted hazard ratio [aHR] 1.743; P = .032), with the association being stronger in patients with ulcerative colitis (aHR 4.769; P = .004).

Study details: Findings are from a retrospective study including 61 adult patients with IBD and concurrent AD and 122 matched control individuals with IBD alone.

Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.

Source: Kim KW, et al, and Seoul National University Inflammatory Bowel Disease Research Network (SIRN) and Inflammatory Bowel Disease Research Group of Korean Association for the Study of Intestinal Disease (KASID). Atopic dermatitis is associated with the clinical course of inflammatory bowel disease. Scand J Gastroenterol. 2023;1-7 (May 11). doi: 10.1080/00365521.2023.2209688

Key clinical point: Presence of concurrent atopic dermatitis (AD) significantly affects the biologic-free survival in patients with inflammatory bowel disease (IBD).

Major finding: Presence of concurrent AD was associated with a significantly shorter biologic-free survival in patients with IBD (adjusted hazard ratio [aHR] 1.743; P = .032), with the association being stronger in patients with ulcerative colitis (aHR 4.769; P = .004).

Study details: Findings are from a retrospective study including 61 adult patients with IBD and concurrent AD and 122 matched control individuals with IBD alone.

Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.

Source: Kim KW, et al, and Seoul National University Inflammatory Bowel Disease Research Network (SIRN) and Inflammatory Bowel Disease Research Group of Korean Association for the Study of Intestinal Disease (KASID). Atopic dermatitis is associated with the clinical course of inflammatory bowel disease. Scand J Gastroenterol. 2023;1-7 (May 11). doi: 10.1080/00365521.2023.2209688

Key clinical point: Dupilumab significantly improves disease signs and symptoms in children with severe atopic dermatitis (AD), including those not achieving a clear or almost clear skin by week 16.

Major finding: At week 16, a significantly higher proportion of children in the dupilumab 200 mg+topical corticosteroid (TCS) and dupilumab 300 mg+TCS vs placebo+TCS groups achieved a ≥50% improvement in the Eczema Area and Severity Index score (both P < .0001), with patients in both treatment groups with an Investigator’s Global Assessment score of >1 also showing significant improvements (P = .0002 and P < .0001, respectively). No new safety signals were reported.

Study details: This post hoc analysis of LIBERTY AD PEDS trial included 304 children age 6-11 years with severe AD who were randomly assigned to receive dupilumab 200 mg+TCS, dupilumab 300 mg+TCS, or placebo+TCS.

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Some authors reported ties with Sanofi-Regeneron and others. Six authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Siegfried EC et al. Dupilumab provides clinically meaningful responses in children aged 6–11 years with severe atopic dermatitis: Post hoc analysis results from a phase III trial. Am J Clin Dermatol. 2023 (Jun 10). doi: 10.1007/s40257-023-00791-7

Key clinical point: Dupilumab significantly improves disease signs and symptoms in children with severe atopic dermatitis (AD), including those not achieving a clear or almost clear skin by week 16.

Major finding: At week 16, a significantly higher proportion of children in the dupilumab 200 mg+topical corticosteroid (TCS) and dupilumab 300 mg+TCS vs placebo+TCS groups achieved a ≥50% improvement in the Eczema Area and Severity Index score (both P < .0001), with patients in both treatment groups with an Investigator’s Global Assessment score of >1 also showing significant improvements (P = .0002 and P < .0001, respectively). No new safety signals were reported.

Study details: This post hoc analysis of LIBERTY AD PEDS trial included 304 children age 6-11 years with severe AD who were randomly assigned to receive dupilumab 200 mg+TCS, dupilumab 300 mg+TCS, or placebo+TCS.

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Some authors reported ties with Sanofi-Regeneron and others. Six authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Siegfried EC et al. Dupilumab provides clinically meaningful responses in children aged 6–11 years with severe atopic dermatitis: Post hoc analysis results from a phase III trial. Am J Clin Dermatol. 2023 (Jun 10). doi: 10.1007/s40257-023-00791-7

Key clinical point: Dupilumab significantly improves disease signs and symptoms in children with severe atopic dermatitis (AD), including those not achieving a clear or almost clear skin by week 16.

Major finding: At week 16, a significantly higher proportion of children in the dupilumab 200 mg+topical corticosteroid (TCS) and dupilumab 300 mg+TCS vs placebo+TCS groups achieved a ≥50% improvement in the Eczema Area and Severity Index score (both P < .0001), with patients in both treatment groups with an Investigator’s Global Assessment score of >1 also showing significant improvements (P = .0002 and P < .0001, respectively). No new safety signals were reported.

Study details: This post hoc analysis of LIBERTY AD PEDS trial included 304 children age 6-11 years with severe AD who were randomly assigned to receive dupilumab 200 mg+TCS, dupilumab 300 mg+TCS, or placebo+TCS.

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Some authors reported ties with Sanofi-Regeneron and others. Six authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Siegfried EC et al. Dupilumab provides clinically meaningful responses in children aged 6–11 years with severe atopic dermatitis: Post hoc analysis results from a phase III trial. Am J Clin Dermatol. 2023 (Jun 10). doi: 10.1007/s40257-023-00791-7

Key clinical point: Abrocitinib and upadacitinib demonstrated acceptable safety profiles and provided greater improvements in disease signs and symptoms compared with dupilumab as early as week 2 in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients in the abrocitinib/upadacitinib vs dupilumab group achieved a ≥75% improvement in Eczema Area and Severity Index scores and ≥4-point improvement in Peak Pruritus Numerical Rating Scale scores at 2 weeks (relative risk [RR] 1.92 and RR 1.87, respectively; both P < .001) and the end of therapy (RR 1.12; P = .002 and RR 1.20; P < .001, respectively). Although the severe adverse event rate was higher in the abrocitinib/upadacitinib vs dupilumab group (P = .043), the treatment-emergent adverse event rate leading to treatment discontinuation was similar.

Study details: This meta-analysis of three randomized controlled trials included 2256 patients with moderate-to-severe AD who received abrocitinib, upadacitinib, or dupilumab.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Gao Q et al. Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. Heliyon. 2023;9:E16704 (Jun 2). doi: 10.1016/j.heliyon.2023.e16704/p>

Key clinical point: Abrocitinib and upadacitinib demonstrated acceptable safety profiles and provided greater improvements in disease signs and symptoms compared with dupilumab as early as week 2 in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients in the abrocitinib/upadacitinib vs dupilumab group achieved a ≥75% improvement in Eczema Area and Severity Index scores and ≥4-point improvement in Peak Pruritus Numerical Rating Scale scores at 2 weeks (relative risk [RR] 1.92 and RR 1.87, respectively; both P < .001) and the end of therapy (RR 1.12; P = .002 and RR 1.20; P < .001, respectively). Although the severe adverse event rate was higher in the abrocitinib/upadacitinib vs dupilumab group (P = .043), the treatment-emergent adverse event rate leading to treatment discontinuation was similar.

Study details: This meta-analysis of three randomized controlled trials included 2256 patients with moderate-to-severe AD who received abrocitinib, upadacitinib, or dupilumab.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Gao Q et al. Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. Heliyon. 2023;9:E16704 (Jun 2). doi: 10.1016/j.heliyon.2023.e16704/p>

Key clinical point: Abrocitinib and upadacitinib demonstrated acceptable safety profiles and provided greater improvements in disease signs and symptoms compared with dupilumab as early as week 2 in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients in the abrocitinib/upadacitinib vs dupilumab group achieved a ≥75% improvement in Eczema Area and Severity Index scores and ≥4-point improvement in Peak Pruritus Numerical Rating Scale scores at 2 weeks (relative risk [RR] 1.92 and RR 1.87, respectively; both P < .001) and the end of therapy (RR 1.12; P = .002 and RR 1.20; P < .001, respectively). Although the severe adverse event rate was higher in the abrocitinib/upadacitinib vs dupilumab group (P = .043), the treatment-emergent adverse event rate leading to treatment discontinuation was similar.

Study details: This meta-analysis of three randomized controlled trials included 2256 patients with moderate-to-severe AD who received abrocitinib, upadacitinib, or dupilumab.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Gao Q et al. Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. Heliyon. 2023;9:E16704 (Jun 2). doi: 10.1016/j.heliyon.2023.e16704/p>

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

Disclosures: This study was supported by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Eight authors declared being employees of or holding stock or stock options in AbbVie.

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

Disclosures: This study was supported by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Eight authors declared being employees of or holding stock or stock options in AbbVie.

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

Disclosures: This study was supported by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Eight authors declared being employees of or holding stock or stock options in AbbVie.

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w