MDedge Dermatology

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117

Key clinical point: Ruxolitinib cream demonstrated rapid and sustained improvement in itch in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream achieved ≥2-point reduction in itch numerical rating scale (NRS2) score as rapidly as within 12 hours (16.3% and 13.1% vs 6.9%; P < .05), with further improvements at week 8 (58.3% and 65.1% vs 29.4%; P < .0001). In patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream, time to achieve itch NRS2 score was shorter (5 and 4 vs 17 days).

Study details: Findings are from a pooled analysis of two phase 3 trials, TRuE-AD1 and TRuE-AD2, including 1249 patients with mild-to-moderate AD who were randomly assigned to receive ruxolitinib (0.75% or 1.5%) or vehicle cream twice daily for 8 weeks.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants or receiving research grants and honoraria from several sources.

Source: Blauvelt A et al. Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. J Eur Acad Dermatol Venereol. 2022 (Sep 6). Doi: 10.1111/jdv.18571

Key clinical point: Ruxolitinib cream demonstrated rapid and sustained improvement in itch in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream achieved ≥2-point reduction in itch numerical rating scale (NRS2) score as rapidly as within 12 hours (16.3% and 13.1% vs 6.9%; P < .05), with further improvements at week 8 (58.3% and 65.1% vs 29.4%; P < .0001). In patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream, time to achieve itch NRS2 score was shorter (5 and 4 vs 17 days).

Study details: Findings are from a pooled analysis of two phase 3 trials, TRuE-AD1 and TRuE-AD2, including 1249 patients with mild-to-moderate AD who were randomly assigned to receive ruxolitinib (0.75% or 1.5%) or vehicle cream twice daily for 8 weeks.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants or receiving research grants and honoraria from several sources.

Source: Blauvelt A et al. Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. J Eur Acad Dermatol Venereol. 2022 (Sep 6). Doi: 10.1111/jdv.18571

Key clinical point: Ruxolitinib cream demonstrated rapid and sustained improvement in itch in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream achieved ≥2-point reduction in itch numerical rating scale (NRS2) score as rapidly as within 12 hours (16.3% and 13.1% vs 6.9%; P < .05), with further improvements at week 8 (58.3% and 65.1% vs 29.4%; P < .0001). In patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream, time to achieve itch NRS2 score was shorter (5 and 4 vs 17 days).

Study details: Findings are from a pooled analysis of two phase 3 trials, TRuE-AD1 and TRuE-AD2, including 1249 patients with mild-to-moderate AD who were randomly assigned to receive ruxolitinib (0.75% or 1.5%) or vehicle cream twice daily for 8 weeks.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants or receiving research grants and honoraria from several sources.

Source: Blauvelt A et al. Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. J Eur Acad Dermatol Venereol. 2022 (Sep 6). Doi: 10.1111/jdv.18571

Key clinical point: Topical brepocitinib cream showed significant efficacy in reducing disease severity and was well-tolerated in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: The reduction in the mean Eczema Area and Severity Index at week 6 was significantly higher with 1% brepocitinib cream once daily (QD) vs vehicle QD (−70.1% vs −44.4%) and 1% brepocitinib  cream twice daily (BID) vs vehicle BID (−75.0% vs −47.6%; both P < .05). No serious adverse events or deaths were reported.

Study details: Findings are from a double-blind, dose-ranging, phase 2 study including 292 patients with mild-to-moderate AD who were randomly assigned to receive brepocitinib (0.1% QD, 0.3% QD or BID, 1.0% QD or BID, or 3.0% QD) or vehicle (QD or BID).

Disclosures: This study was sponsored by Pfizer Inc. Nine authors declared being shareholders and current or former employees of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Landis MN et al. Efficacy and safety of topical brepocitinib for the treatment of mild-to-moderate atopic dermatitis: A phase IIb, randomised, double-blind, vehicle-controlled, dose-ranging, and parallel-group study. Br J Dermatol. 2022 (Aug 20). Doi: 10.1111/bjd.21826

Key clinical point: Topical brepocitinib cream showed significant efficacy in reducing disease severity and was well-tolerated in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: The reduction in the mean Eczema Area and Severity Index at week 6 was significantly higher with 1% brepocitinib cream once daily (QD) vs vehicle QD (−70.1% vs −44.4%) and 1% brepocitinib  cream twice daily (BID) vs vehicle BID (−75.0% vs −47.6%; both P < .05). No serious adverse events or deaths were reported.

Study details: Findings are from a double-blind, dose-ranging, phase 2 study including 292 patients with mild-to-moderate AD who were randomly assigned to receive brepocitinib (0.1% QD, 0.3% QD or BID, 1.0% QD or BID, or 3.0% QD) or vehicle (QD or BID).

Disclosures: This study was sponsored by Pfizer Inc. Nine authors declared being shareholders and current or former employees of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Landis MN et al. Efficacy and safety of topical brepocitinib for the treatment of mild-to-moderate atopic dermatitis: A phase IIb, randomised, double-blind, vehicle-controlled, dose-ranging, and parallel-group study. Br J Dermatol. 2022 (Aug 20). Doi: 10.1111/bjd.21826

Key clinical point: Topical brepocitinib cream showed significant efficacy in reducing disease severity and was well-tolerated in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: The reduction in the mean Eczema Area and Severity Index at week 6 was significantly higher with 1% brepocitinib cream once daily (QD) vs vehicle QD (−70.1% vs −44.4%) and 1% brepocitinib  cream twice daily (BID) vs vehicle BID (−75.0% vs −47.6%; both P < .05). No serious adverse events or deaths were reported.

Study details: Findings are from a double-blind, dose-ranging, phase 2 study including 292 patients with mild-to-moderate AD who were randomly assigned to receive brepocitinib (0.1% QD, 0.3% QD or BID, 1.0% QD or BID, or 3.0% QD) or vehicle (QD or BID).

Disclosures: This study was sponsored by Pfizer Inc. Nine authors declared being shareholders and current or former employees of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Landis MN et al. Efficacy and safety of topical brepocitinib for the treatment of mild-to-moderate atopic dermatitis: A phase IIb, randomised, double-blind, vehicle-controlled, dose-ranging, and parallel-group study. Br J Dermatol. 2022 (Aug 20). Doi: 10.1111/bjd.21826

Key clinical point: The results of this meta-analysis do not demonstrate an elevated risk for incident venous thromboembolism (VTE) in patients with atopic dermatitis (AD), particularly among those receiving treatment with Janus kinase (JAK) inhibitors.

Major finding: The risk for incident VTE was similar among participants with vs without AD (pooled hazard ratio 0.95; 95% CI 0.62-1.45). Among patients with AD who received JAK inhibitors vs placebo /dupilumab, 0.05% vs 0.03% reported VTE (Mantel-Haenszel risk difference 0; 95% CI 0-0).

Study details: Findings are from a meta-analysis of two cohort studies including 458,206 participants with (n = 229,103) and without AD (n = 229,103) and 15 randomized controlled trials including 8787 patients with AD who received an interventional treatment with JAK inhibitors or a control treatment with dupilumab or placebo.

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

Source: Chen TL et al. Association of risk of incident venous thromboembolism with atopic dermatitis and treatment with Janus kinase inhibitors: A systematic review and meta-analysis. JAMA Dermatol. 2022;e223516 (Aug 24). Doi: 10.1001/jamadermatol.2022.3516

Key clinical point: The results of this meta-analysis do not demonstrate an elevated risk for incident venous thromboembolism (VTE) in patients with atopic dermatitis (AD), particularly among those receiving treatment with Janus kinase (JAK) inhibitors.

Major finding: The risk for incident VTE was similar among participants with vs without AD (pooled hazard ratio 0.95; 95% CI 0.62-1.45). Among patients with AD who received JAK inhibitors vs placebo /dupilumab, 0.05% vs 0.03% reported VTE (Mantel-Haenszel risk difference 0; 95% CI 0-0).

Study details: Findings are from a meta-analysis of two cohort studies including 458,206 participants with (n = 229,103) and without AD (n = 229,103) and 15 randomized controlled trials including 8787 patients with AD who received an interventional treatment with JAK inhibitors or a control treatment with dupilumab or placebo.

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

Source: Chen TL et al. Association of risk of incident venous thromboembolism with atopic dermatitis and treatment with Janus kinase inhibitors: A systematic review and meta-analysis. JAMA Dermatol. 2022;e223516 (Aug 24). Doi: 10.1001/jamadermatol.2022.3516

Key clinical point: The results of this meta-analysis do not demonstrate an elevated risk for incident venous thromboembolism (VTE) in patients with atopic dermatitis (AD), particularly among those receiving treatment with Janus kinase (JAK) inhibitors.

Major finding: The risk for incident VTE was similar among participants with vs without AD (pooled hazard ratio 0.95; 95% CI 0.62-1.45). Among patients with AD who received JAK inhibitors vs placebo /dupilumab, 0.05% vs 0.03% reported VTE (Mantel-Haenszel risk difference 0; 95% CI 0-0).

Study details: Findings are from a meta-analysis of two cohort studies including 458,206 participants with (n = 229,103) and without AD (n = 229,103) and 15 randomized controlled trials including 8787 patients with AD who received an interventional treatment with JAK inhibitors or a control treatment with dupilumab or placebo.

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

Source: Chen TL et al. Association of risk of incident venous thromboembolism with atopic dermatitis and treatment with Janus kinase inhibitors: A systematic review and meta-analysis. JAMA Dermatol. 2022;e223516 (Aug 24). Doi: 10.1001/jamadermatol.2022.3516

Key clinical point: Dupilumab demonstrated good overall drug survival for up to 3 years in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab showed good overall drug survival rates at 1-year (90.3%), 2-year (85.9%), and 3-year (78.6%). The use of immunosuppressant drugs at baseline was associated with shorter drug survival owing to ineffectiveness (hazard ratio [HR] 2.64; 95% CI 1.10-6.37) and adverse events (HR 2.69; 95% CI 1.32-5.48).

Study details: Findings are from an analysis of the BioDay registry data of 715 adult patients with moderate-to-severe AD who received dupilumab and were followed-up for ≥4 weeks.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. The authors declared receiving grants, personal fees, speaking fees, financial support or nonfinancial support from several sources.

Source: Spekhorst LS et al. Dupilumab drug survival and associated predictors in patients with moderate to severe atopic dermatitis: Long-term results from the daily practice BioDay registry. JAMA Dermatol. 2022;e223014 (Aug 10). Doi: 10.1001/jamadermatol.2022.3014

Key clinical point: Dupilumab demonstrated good overall drug survival for up to 3 years in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab showed good overall drug survival rates at 1-year (90.3%), 2-year (85.9%), and 3-year (78.6%). The use of immunosuppressant drugs at baseline was associated with shorter drug survival owing to ineffectiveness (hazard ratio [HR] 2.64; 95% CI 1.10-6.37) and adverse events (HR 2.69; 95% CI 1.32-5.48).

Study details: Findings are from an analysis of the BioDay registry data of 715 adult patients with moderate-to-severe AD who received dupilumab and were followed-up for ≥4 weeks.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. The authors declared receiving grants, personal fees, speaking fees, financial support or nonfinancial support from several sources.

Source: Spekhorst LS et al. Dupilumab drug survival and associated predictors in patients with moderate to severe atopic dermatitis: Long-term results from the daily practice BioDay registry. JAMA Dermatol. 2022;e223014 (Aug 10). Doi: 10.1001/jamadermatol.2022.3014

Key clinical point: Dupilumab demonstrated good overall drug survival for up to 3 years in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab showed good overall drug survival rates at 1-year (90.3%), 2-year (85.9%), and 3-year (78.6%). The use of immunosuppressant drugs at baseline was associated with shorter drug survival owing to ineffectiveness (hazard ratio [HR] 2.64; 95% CI 1.10-6.37) and adverse events (HR 2.69; 95% CI 1.32-5.48).

Study details: Findings are from an analysis of the BioDay registry data of 715 adult patients with moderate-to-severe AD who received dupilumab and were followed-up for ≥4 weeks.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. The authors declared receiving grants, personal fees, speaking fees, financial support or nonfinancial support from several sources.

Source: Spekhorst LS et al. Dupilumab drug survival and associated predictors in patients with moderate to severe atopic dermatitis: Long-term results from the daily practice BioDay registry. JAMA Dermatol. 2022;e223014 (Aug 10). Doi: 10.1001/jamadermatol.2022.3014

The psoriasis clinical trials listed below are all phase 3 and recruiting participants as of July 19, 2022. For additional information on the study design, eligibility criteria, and contacts/locations, visit ClinicalTrials.gov.

GENERALIZED PUSTULAR PSORIASIS

Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (GEMINI2)

ClinicalTrials.gov Identifier: NCT05366855

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

ClinicalTrials.gov Identifier: NCT05200247

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have No Other Treatment Options

ClinicalTrials.gov Identifier: NCT05239039

Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

ClinicalTrials.gov Identifier: NCT05352893

NAIL PSORIASIS

Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

ClinicalTrials.gov Identifier: NCT03897075

PALMOPLANTAR PUSTULOSIS

Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

ClinicalTrials.gov Identifier: NCT05174065

PLAQUE PSORIASIS

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04175613

A Phase III Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04839328

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

ClinicalTrials.gov Identifier: NCT04435600

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Adolescent Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04772079

Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults

ClinicalTrials.gov Identifier: NCT05203315

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04728360

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT05020249

Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (STELLAR-2)

ClinicalTrials.gov Identifier: NCT05335356

A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)(CIMcare)

ClinicalTrials.gov Identifier: NCT04123795

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT03997786

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

ClinicalTrials.gov Identifier: NCT05172726

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR)

ClinicalTrials.gov Identifier: NCT03451851

PSORIATIC ARTHRITIS

Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (AgAIN)

ClinicalTrials.gov Identifier: NCT04632927

A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

ClinicalTrials.gov Identifier: NCT05092269

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

ClinicalTrials.gov Identifier: NCT05083182

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT05046431

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04991116

To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04957550

PSORIATIC ARTHRITIS (continued)

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)

ClinicalTrials.gov Identifier: NCT04936308

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

ClinicalTrials.gov Identifier: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

ClinicalTrials.gov Identifier: NCT04908189

A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX) ClinicalTrials.gov Identifier: NCT04882098 Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

ClinicalTrials.gov Identifier: NCT04804553

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04610476

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04527380

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

ClinicalTrials.gov Identifier: NCT04314544

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti- TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

ClinicalTrials.gov Identifier: NCT04314531

The psoriasis clinical trials listed below are all phase 3 and recruiting participants as of July 19, 2022. For additional information on the study design, eligibility criteria, and contacts/locations, visit ClinicalTrials.gov.

GENERALIZED PUSTULAR PSORIASIS

Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (GEMINI2)

ClinicalTrials.gov Identifier: NCT05366855

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

ClinicalTrials.gov Identifier: NCT05200247

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have No Other Treatment Options

ClinicalTrials.gov Identifier: NCT05239039

Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

ClinicalTrials.gov Identifier: NCT05352893

NAIL PSORIASIS

Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

ClinicalTrials.gov Identifier: NCT03897075

PALMOPLANTAR PUSTULOSIS

Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

ClinicalTrials.gov Identifier: NCT05174065

PLAQUE PSORIASIS

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04175613

A Phase III Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04839328

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

ClinicalTrials.gov Identifier: NCT04435600

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Adolescent Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04772079

Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults

ClinicalTrials.gov Identifier: NCT05203315

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04728360

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT05020249

Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (STELLAR-2)

ClinicalTrials.gov Identifier: NCT05335356

A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)(CIMcare)

ClinicalTrials.gov Identifier: NCT04123795

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT03997786

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

ClinicalTrials.gov Identifier: NCT05172726

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR)

ClinicalTrials.gov Identifier: NCT03451851

PSORIATIC ARTHRITIS

Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (AgAIN)

ClinicalTrials.gov Identifier: NCT04632927

A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

ClinicalTrials.gov Identifier: NCT05092269

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

ClinicalTrials.gov Identifier: NCT05083182

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT05046431

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04991116

To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04957550

PSORIATIC ARTHRITIS (continued)

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)

ClinicalTrials.gov Identifier: NCT04936308

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

ClinicalTrials.gov Identifier: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

ClinicalTrials.gov Identifier: NCT04908189

A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX) ClinicalTrials.gov Identifier: NCT04882098 Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

ClinicalTrials.gov Identifier: NCT04804553

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04610476

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04527380

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

ClinicalTrials.gov Identifier: NCT04314544

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti- TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

ClinicalTrials.gov Identifier: NCT04314531

The psoriasis clinical trials listed below are all phase 3 and recruiting participants as of July 19, 2022. For additional information on the study design, eligibility criteria, and contacts/locations, visit ClinicalTrials.gov.

GENERALIZED PUSTULAR PSORIASIS

Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (GEMINI2)

ClinicalTrials.gov Identifier: NCT05366855

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

ClinicalTrials.gov Identifier: NCT05200247

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have No Other Treatment Options

ClinicalTrials.gov Identifier: NCT05239039

Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

ClinicalTrials.gov Identifier: NCT05352893

NAIL PSORIASIS

Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

ClinicalTrials.gov Identifier: NCT03897075

PALMOPLANTAR PUSTULOSIS

Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

ClinicalTrials.gov Identifier: NCT05174065

PLAQUE PSORIASIS

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04175613

A Phase III Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04839328

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

ClinicalTrials.gov Identifier: NCT04435600

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Adolescent Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04772079

Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults

ClinicalTrials.gov Identifier: NCT05203315

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04728360

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT05020249

Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (STELLAR-2)

ClinicalTrials.gov Identifier: NCT05335356

A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)(CIMcare)

ClinicalTrials.gov Identifier: NCT04123795

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT03997786

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

ClinicalTrials.gov Identifier: NCT05172726

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR)

ClinicalTrials.gov Identifier: NCT03451851

PSORIATIC ARTHRITIS

Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (AgAIN)

ClinicalTrials.gov Identifier: NCT04632927

A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

ClinicalTrials.gov Identifier: NCT05092269

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

ClinicalTrials.gov Identifier: NCT05083182

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT05046431

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04991116

To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04957550

PSORIATIC ARTHRITIS (continued)

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)

ClinicalTrials.gov Identifier: NCT04936308

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

ClinicalTrials.gov Identifier: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

ClinicalTrials.gov Identifier: NCT04908189

A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX) ClinicalTrials.gov Identifier: NCT04882098 Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

ClinicalTrials.gov Identifier: NCT04804553

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04610476

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04527380

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

ClinicalTrials.gov Identifier: NCT04314544

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti- TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

ClinicalTrials.gov Identifier: NCT04314531

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.