MDedge Dermatology

The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.

“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”

An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.

While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”

However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.

“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.

“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.

The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.

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

The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.

“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”

An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.

While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”

However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.

“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.

“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.

The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.

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

The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.

“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”

An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.

While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”

However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.

“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.

“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.

The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.

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

In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.

In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib. 

Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.

Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
 

In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.

In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib. 

Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.

Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
 

In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.

In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib. 

Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.

Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
 

Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.

The global incidence of dengue in 2024 is the highest on record, reported the agency.

In the Americas, more than 9.7 million cases of dengue have been reported in the first 6 months of 2024 — more than double the 4.6 million cases reported in all of 2023.

In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.

The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.

Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.

The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
 

Monitoring for Dengue

With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:

• Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
• Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
• Ensure timely reporting of dengue cases to public health authorities.
• Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.

Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.

Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
 

Disease Progression

Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.

One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.

Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.

“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.

The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.

The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.

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

Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.

The global incidence of dengue in 2024 is the highest on record, reported the agency.

In the Americas, more than 9.7 million cases of dengue have been reported in the first 6 months of 2024 — more than double the 4.6 million cases reported in all of 2023.

In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.

The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.

Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.

The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
 

Monitoring for Dengue

With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:

• Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
• Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
• Ensure timely reporting of dengue cases to public health authorities.
• Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.

Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.

Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
 

Disease Progression

Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.

One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.

Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.

“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.

The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.

The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.

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

Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.

The global incidence of dengue in 2024 is the highest on record, reported the agency.

In the Americas, more than 9.7 million cases of dengue have been reported in the first 6 months of 2024 — more than double the 4.6 million cases reported in all of 2023.

In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.

The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.

Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.

The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
 

Monitoring for Dengue

With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:

• Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
• Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
• Ensure timely reporting of dengue cases to public health authorities.
• Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.

Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.

Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
 

Disease Progression

Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.

One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.

Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.

“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.

The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.

The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.

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

Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.

Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.

Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.

Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.

Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source

Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.

Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.

Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.

Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.

Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source

Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.

Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.

Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.

Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.

Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source

Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.

Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.

Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.

Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.

Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source

Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.

Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.

Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.

Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.

Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source

Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.

Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.

Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.

Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.

Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source

Key clinical point: Patients with polycystic ovary syndrome (PCOS) had a significantly increased risk for atopic dermatitis (AD), and patients with AD had a significantly increased risk for PCOS.

Major finding: The risk of developing AD was significantly higher in patients with PCOS (adjusted odds ratio [aOR] 1.99; P < .001) than in control participants. Similarly, the risk of developing PCOS was significantly higher in patients with AD (aOR 1.86; P < .001) than in control participants.

Study details: This nested case-control study included 3234 participants with PCOS who were matched with 12,936 control participants without PCOS using nearest-neighbor propensity-score matching, of whom 293 (4.55%) with PCOS and 588 (9.06%) without PCOS had AD.

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

Source: Kim IH, Andrade LF, Haq Z, et al. Association of polycystic ovary syndrome with atopic dermatitis: A case control study. Arch Dermatol Res. 2024;316:258. doi: 10.1007/s00403-024-03102-0 Source

Key clinical point: Patients with polycystic ovary syndrome (PCOS) had a significantly increased risk for atopic dermatitis (AD), and patients with AD had a significantly increased risk for PCOS.

Major finding: The risk of developing AD was significantly higher in patients with PCOS (adjusted odds ratio [aOR] 1.99; P < .001) than in control participants. Similarly, the risk of developing PCOS was significantly higher in patients with AD (aOR 1.86; P < .001) than in control participants.

Study details: This nested case-control study included 3234 participants with PCOS who were matched with 12,936 control participants without PCOS using nearest-neighbor propensity-score matching, of whom 293 (4.55%) with PCOS and 588 (9.06%) without PCOS had AD.

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

Source: Kim IH, Andrade LF, Haq Z, et al. Association of polycystic ovary syndrome with atopic dermatitis: A case control study. Arch Dermatol Res. 2024;316:258. doi: 10.1007/s00403-024-03102-0 Source

Key clinical point: Patients with polycystic ovary syndrome (PCOS) had a significantly increased risk for atopic dermatitis (AD), and patients with AD had a significantly increased risk for PCOS.

Major finding: The risk of developing AD was significantly higher in patients with PCOS (adjusted odds ratio [aOR] 1.99; P < .001) than in control participants. Similarly, the risk of developing PCOS was significantly higher in patients with AD (aOR 1.86; P < .001) than in control participants.

Study details: This nested case-control study included 3234 participants with PCOS who were matched with 12,936 control participants without PCOS using nearest-neighbor propensity-score matching, of whom 293 (4.55%) with PCOS and 588 (9.06%) without PCOS had AD.

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

Source: Kim IH, Andrade LF, Haq Z, et al. Association of polycystic ovary syndrome with atopic dermatitis: A case control study. Arch Dermatol Res. 2024;316:258. doi: 10.1007/s00403-024-03102-0 Source

Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.

Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.

Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.

Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 Source

Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.

Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.

Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.

Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 Source

Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.

Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.

Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.

Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 Source

Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.

Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD  (OR 20.4; P < .001) vs those with mild AD.

Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).

Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.

Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source

Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.

Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD  (OR 20.4; P < .001) vs those with mild AD.

Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).

Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.

Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source

Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.

Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD  (OR 20.4; P < .001) vs those with mild AD.

Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).

Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.

Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source

Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).

Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.

Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.

Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.

Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi:  10.1016/j.jaad.2024.05.023 Source