Dermatology

SINGAPORE – Treatment with an investigational oral interleukin-23 receptor (IL-23R) antagonist peptide – currently known as JNJ-2113 – significantly improved skin lesions in patients with moderate to severe plaque psoriasis across all doses, compared with placebo, according to results of the FRONTIER 1 trial.

In the 16-week phase 2b study, 255 adults with moderate to severe plaque psoriasis were randomly assigned into six treatment groups: placebo (n = 43), JNJ-2113 25 mg daily (n = 43), 25 mg twice daily (n = 41), 50 mg daily (n = 43), 100 mg daily (n = 43), or 100 mg twice daily (n = 42).

Of those who took the placebo, only 9.3% achieved the study’s primary endpoint of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI-75) by week 16. This was compared with 78.6% in the group that took the highest dose.

Sandy Ong, MDedge

“Additionally, the onset of action was fairly fast: at week 4, more than 20% of patients had achieved PASI 75,” said Robert Bissonnette, MD, CEO of Innovaderm Research in Montreal, who presented the findings during a late-breaker session at the World Congress of Dermatology.

Patients in the remaining groups demonstrated a response that corresponded to dosing level: with 37.2%, 51.2%, 58.1%, and 65.1% achieving PASI-75 in the 25 mg daily, 25 mg twice-daily, 50 mg daily, and 100 mg daily groups, respectively.

“These results are very interesting because in terms of psoriasis treatment, if this is confirmed in phase 3, it would give us an oral alternative that would be selective for IL-23,” said Dr. Bissonnette, referring to the signaling pathway that plays a critical role in the pathogenesis of several immune-mediated inflammatory diseases, including plaque psoriasis.

Although rarely life-threatening, the skin disorder is often intractable to treatment. In recent years, therapies that block IL-23 signaling and downstream inflammatory cytokine production have proven useful. “We have on the market a number of biological agents targeting IL-23 that we use on a regular basis,” said Dr. Bissonnette. “However, there are currently no orally delivered therapies.”

If successful, JNJ-2113 – a first-in-class oral IL-23 antagonist peptide developed by Janssen – could change the treatment paradigm for patients with moderate to severe plaque psoriasis. “When I was first introduced to the concept, I thought it wouldn’t work as it’s a peptide, that it would be digested by the stomach,” he told the audience. “But because of its GI stability and its potency, when you administer it orally, you can detect pharmacological activity.”
 

A well-tolerated alternative

Participants in the FRONTIER 1 trial were on average about 44 years old and weighed 88.9 kg (195 lb). Most had been living with psoriasis for about 18 years, with a total PASI score of 19.05. In addition, 43.1% had been treated with phototherapy in the past, 22% with biologics, and 78.4% with systemics.

PASI 90 and 100 were among some of the secondary outcomes measured. Similar to the primary outcome of PASI 75, all treatment groups demonstrated a statistically significant dose-response in PASI 90, compared with placebo. For those on the highest dose of JNJ-2113, 59.5% and 40.5% achieved PASI 90 and PASI 100, respectively, by week 16. The corresponding figures for those receiving placebo were 2.3% and 0%.

The safety profile for JNJ-2113 across all doses was similar to that of placebo, with no evidence of a dose-dependent increase in the occurrence of adverse events (AEs). The most frequently reported AEs were COVID-19 and nasopharyngitis. There were three serious AEs (COVID-19, infected cyst, suicide attempt) among those on the active drug, but the investigators assessed that they were not related to the study intervention. No deaths, major adverse cardiac events, or malignancies were reported during the study.

Approached for an independent comment, Marius-Anton Ionescu, MD, PhD, from the University Hospital Saint Louis, Paris, who specializes in psoriasis, told this news organization that the new development with JNJ-2113 “is really promising.”

Treatment for plaque psoriasis has improved to the point where some biologics, such as risankizumab (Skyrizi), only require patients to have “four shots a year,” he says. “This is the future of psoriasis treatment; it might go down to two shots a year” – a regimen that will be easier than taking an oral medication once or twice a day.

“But it’s good to have an oral option because you will always have some patients who say: ‘Shots are not for me, I’m afraid,’ ” he says.

However, Dr. Ionescu noted that if JNJ-2113 were to pass phase 3 trials, it might face stiff competition from the selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu), which the U.S. Food and Drug Administration approved for use in adults with moderate to severe plaque psoriasis last September. “It has very good results and is the first oral therapy that is comparable with biologics for plaque psoriasis,” he says.

But Dr. Bissonnette remains hopeful for the future. “I think JNJ-2113 goes way beyond psoriasis because this type of strategy using oral peptide–blocking receptors could be used in other immune-mediated diseases, including atopic dermatitis and other diseases outside of dermatology.” In addition to running a phase 3 study for moderate to severe plaque psoriasis, Janssen is planning to initiate a phase 2b clinical trial of JNJ-2113 in adults with ulcerative colitis.

The study was funded by Janssen. Dr. Bissonnette reports consulting and investigating for Janssen, and being on advisory panels and receiving research funding from multiple other pharmaceutical companies. Dr. Ionescu is an investigator for Psoriasis National Register France Psobioteq (no honoraria), and an investigator and speaker for Uriage cosmetics (honoraria).

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

SINGAPORE – Treatment with an investigational oral interleukin-23 receptor (IL-23R) antagonist peptide – currently known as JNJ-2113 – significantly improved skin lesions in patients with moderate to severe plaque psoriasis across all doses, compared with placebo, according to results of the FRONTIER 1 trial.

In the 16-week phase 2b study, 255 adults with moderate to severe plaque psoriasis were randomly assigned into six treatment groups: placebo (n = 43), JNJ-2113 25 mg daily (n = 43), 25 mg twice daily (n = 41), 50 mg daily (n = 43), 100 mg daily (n = 43), or 100 mg twice daily (n = 42).

Of those who took the placebo, only 9.3% achieved the study’s primary endpoint of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI-75) by week 16. This was compared with 78.6% in the group that took the highest dose.

Sandy Ong, MDedge

“Additionally, the onset of action was fairly fast: at week 4, more than 20% of patients had achieved PASI 75,” said Robert Bissonnette, MD, CEO of Innovaderm Research in Montreal, who presented the findings during a late-breaker session at the World Congress of Dermatology.

Patients in the remaining groups demonstrated a response that corresponded to dosing level: with 37.2%, 51.2%, 58.1%, and 65.1% achieving PASI-75 in the 25 mg daily, 25 mg twice-daily, 50 mg daily, and 100 mg daily groups, respectively.

“These results are very interesting because in terms of psoriasis treatment, if this is confirmed in phase 3, it would give us an oral alternative that would be selective for IL-23,” said Dr. Bissonnette, referring to the signaling pathway that plays a critical role in the pathogenesis of several immune-mediated inflammatory diseases, including plaque psoriasis.

Although rarely life-threatening, the skin disorder is often intractable to treatment. In recent years, therapies that block IL-23 signaling and downstream inflammatory cytokine production have proven useful. “We have on the market a number of biological agents targeting IL-23 that we use on a regular basis,” said Dr. Bissonnette. “However, there are currently no orally delivered therapies.”

If successful, JNJ-2113 – a first-in-class oral IL-23 antagonist peptide developed by Janssen – could change the treatment paradigm for patients with moderate to severe plaque psoriasis. “When I was first introduced to the concept, I thought it wouldn’t work as it’s a peptide, that it would be digested by the stomach,” he told the audience. “But because of its GI stability and its potency, when you administer it orally, you can detect pharmacological activity.”
 

A well-tolerated alternative

Participants in the FRONTIER 1 trial were on average about 44 years old and weighed 88.9 kg (195 lb). Most had been living with psoriasis for about 18 years, with a total PASI score of 19.05. In addition, 43.1% had been treated with phototherapy in the past, 22% with biologics, and 78.4% with systemics.

PASI 90 and 100 were among some of the secondary outcomes measured. Similar to the primary outcome of PASI 75, all treatment groups demonstrated a statistically significant dose-response in PASI 90, compared with placebo. For those on the highest dose of JNJ-2113, 59.5% and 40.5% achieved PASI 90 and PASI 100, respectively, by week 16. The corresponding figures for those receiving placebo were 2.3% and 0%.

The safety profile for JNJ-2113 across all doses was similar to that of placebo, with no evidence of a dose-dependent increase in the occurrence of adverse events (AEs). The most frequently reported AEs were COVID-19 and nasopharyngitis. There were three serious AEs (COVID-19, infected cyst, suicide attempt) among those on the active drug, but the investigators assessed that they were not related to the study intervention. No deaths, major adverse cardiac events, or malignancies were reported during the study.

Approached for an independent comment, Marius-Anton Ionescu, MD, PhD, from the University Hospital Saint Louis, Paris, who specializes in psoriasis, told this news organization that the new development with JNJ-2113 “is really promising.”

Treatment for plaque psoriasis has improved to the point where some biologics, such as risankizumab (Skyrizi), only require patients to have “four shots a year,” he says. “This is the future of psoriasis treatment; it might go down to two shots a year” – a regimen that will be easier than taking an oral medication once or twice a day.

“But it’s good to have an oral option because you will always have some patients who say: ‘Shots are not for me, I’m afraid,’ ” he says.

However, Dr. Ionescu noted that if JNJ-2113 were to pass phase 3 trials, it might face stiff competition from the selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu), which the U.S. Food and Drug Administration approved for use in adults with moderate to severe plaque psoriasis last September. “It has very good results and is the first oral therapy that is comparable with biologics for plaque psoriasis,” he says.

But Dr. Bissonnette remains hopeful for the future. “I think JNJ-2113 goes way beyond psoriasis because this type of strategy using oral peptide–blocking receptors could be used in other immune-mediated diseases, including atopic dermatitis and other diseases outside of dermatology.” In addition to running a phase 3 study for moderate to severe plaque psoriasis, Janssen is planning to initiate a phase 2b clinical trial of JNJ-2113 in adults with ulcerative colitis.

The study was funded by Janssen. Dr. Bissonnette reports consulting and investigating for Janssen, and being on advisory panels and receiving research funding from multiple other pharmaceutical companies. Dr. Ionescu is an investigator for Psoriasis National Register France Psobioteq (no honoraria), and an investigator and speaker for Uriage cosmetics (honoraria).

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

SINGAPORE – Treatment with an investigational oral interleukin-23 receptor (IL-23R) antagonist peptide – currently known as JNJ-2113 – significantly improved skin lesions in patients with moderate to severe plaque psoriasis across all doses, compared with placebo, according to results of the FRONTIER 1 trial.

In the 16-week phase 2b study, 255 adults with moderate to severe plaque psoriasis were randomly assigned into six treatment groups: placebo (n = 43), JNJ-2113 25 mg daily (n = 43), 25 mg twice daily (n = 41), 50 mg daily (n = 43), 100 mg daily (n = 43), or 100 mg twice daily (n = 42).

Of those who took the placebo, only 9.3% achieved the study’s primary endpoint of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI-75) by week 16. This was compared with 78.6% in the group that took the highest dose.

Sandy Ong, MDedge

“Additionally, the onset of action was fairly fast: at week 4, more than 20% of patients had achieved PASI 75,” said Robert Bissonnette, MD, CEO of Innovaderm Research in Montreal, who presented the findings during a late-breaker session at the World Congress of Dermatology.

Patients in the remaining groups demonstrated a response that corresponded to dosing level: with 37.2%, 51.2%, 58.1%, and 65.1% achieving PASI-75 in the 25 mg daily, 25 mg twice-daily, 50 mg daily, and 100 mg daily groups, respectively.

“These results are very interesting because in terms of psoriasis treatment, if this is confirmed in phase 3, it would give us an oral alternative that would be selective for IL-23,” said Dr. Bissonnette, referring to the signaling pathway that plays a critical role in the pathogenesis of several immune-mediated inflammatory diseases, including plaque psoriasis.

Although rarely life-threatening, the skin disorder is often intractable to treatment. In recent years, therapies that block IL-23 signaling and downstream inflammatory cytokine production have proven useful. “We have on the market a number of biological agents targeting IL-23 that we use on a regular basis,” said Dr. Bissonnette. “However, there are currently no orally delivered therapies.”

If successful, JNJ-2113 – a first-in-class oral IL-23 antagonist peptide developed by Janssen – could change the treatment paradigm for patients with moderate to severe plaque psoriasis. “When I was first introduced to the concept, I thought it wouldn’t work as it’s a peptide, that it would be digested by the stomach,” he told the audience. “But because of its GI stability and its potency, when you administer it orally, you can detect pharmacological activity.”
 

A well-tolerated alternative

Participants in the FRONTIER 1 trial were on average about 44 years old and weighed 88.9 kg (195 lb). Most had been living with psoriasis for about 18 years, with a total PASI score of 19.05. In addition, 43.1% had been treated with phototherapy in the past, 22% with biologics, and 78.4% with systemics.

PASI 90 and 100 were among some of the secondary outcomes measured. Similar to the primary outcome of PASI 75, all treatment groups demonstrated a statistically significant dose-response in PASI 90, compared with placebo. For those on the highest dose of JNJ-2113, 59.5% and 40.5% achieved PASI 90 and PASI 100, respectively, by week 16. The corresponding figures for those receiving placebo were 2.3% and 0%.

The safety profile for JNJ-2113 across all doses was similar to that of placebo, with no evidence of a dose-dependent increase in the occurrence of adverse events (AEs). The most frequently reported AEs were COVID-19 and nasopharyngitis. There were three serious AEs (COVID-19, infected cyst, suicide attempt) among those on the active drug, but the investigators assessed that they were not related to the study intervention. No deaths, major adverse cardiac events, or malignancies were reported during the study.

Approached for an independent comment, Marius-Anton Ionescu, MD, PhD, from the University Hospital Saint Louis, Paris, who specializes in psoriasis, told this news organization that the new development with JNJ-2113 “is really promising.”

Treatment for plaque psoriasis has improved to the point where some biologics, such as risankizumab (Skyrizi), only require patients to have “four shots a year,” he says. “This is the future of psoriasis treatment; it might go down to two shots a year” – a regimen that will be easier than taking an oral medication once or twice a day.

“But it’s good to have an oral option because you will always have some patients who say: ‘Shots are not for me, I’m afraid,’ ” he says.

However, Dr. Ionescu noted that if JNJ-2113 were to pass phase 3 trials, it might face stiff competition from the selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu), which the U.S. Food and Drug Administration approved for use in adults with moderate to severe plaque psoriasis last September. “It has very good results and is the first oral therapy that is comparable with biologics for plaque psoriasis,” he says.

But Dr. Bissonnette remains hopeful for the future. “I think JNJ-2113 goes way beyond psoriasis because this type of strategy using oral peptide–blocking receptors could be used in other immune-mediated diseases, including atopic dermatitis and other diseases outside of dermatology.” In addition to running a phase 3 study for moderate to severe plaque psoriasis, Janssen is planning to initiate a phase 2b clinical trial of JNJ-2113 in adults with ulcerative colitis.

The study was funded by Janssen. Dr. Bissonnette reports consulting and investigating for Janssen, and being on advisory panels and receiving research funding from multiple other pharmaceutical companies. Dr. Ionescu is an investigator for Psoriasis National Register France Psobioteq (no honoraria), and an investigator and speaker for Uriage cosmetics (honoraria).

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

SINGAPORE – Three oral Janus kinase (JAK) inhibitors – abrocitinib, baricitinib, and upadacitinib – have demonstrated a good treatment response in Asian patients with atopic dermatitis (AD), a small retrospective study conducted in Singapore has found.

“Abrocitinib and upadacitinib surprisingly appeared to have better treatment efficacy compared to baricitinib,” said study lead Yik Weng Yew, MD, PhD, MPH, deputy head of research at Singapore’s National Skin Centre (NSC), who presented the results at the 25th World Congress of Dermatology. “But overall, as a group, I think they show a very good treatment response, as well as a good effect on itch response.”

Sandy Ong

JAK inhibitors are used to treat a variety of inflammatory diseases including alopecia areata, rheumatoid arthritis, and inflammatory bowel disease. Although treatment for severe eczema was previously limited to topical steroids and oral immunosuppressants, there are now two oral JAK inhibitors – abrocitinib and upadacitinib – approved in 2022 by the Food and Drug Administration for treating AD, which affects up to 2.4% of the global population. (A topical formulation of ruxolitinib, a JAK inhibitor, was approved for AD in 2021.)

The Singapore study is one of the few that have examined the safety and efficacy of JAK inhibitors for treatment of AD in a non-White population.
 

Chinese population

For the 12-week trial, conducted in 2022, Dr. Yew and associates recruited 35 patients from the NSC. More than half of participants (64%) were men and most (96%) were of Chinese ethnicity. Four of every five patients had previously received systemic agents: 17% had been treated with one systemic agent, 18.9% with two, 15.1% with three, 22.6% with four, and 3.8% with five. The most commonly used agents were cyclosporine (62.3%), methotrexate (47.2%), azathioprine (39.6%), and dupilumab (35.8%).  

“The switch in therapy could have been a result of inadequate efficacy or cost reasons because in Singapore patients pay out of pocket for AD treatments,” said Dr. Yew.

Additionally, he offered a caveat on the profile of participants: “Perhaps they were more difficult atopic eczema patients, and therefore, the efficacy [of JAK inhibitors] might be a bit different.”
 

Clearer skin, less itch

Patients received one of the three study drugs: baricitinib (66%), abrocitinib (21%), and upadacitinib (13%). The distribution was “affected by reimbursement patterns and availability of the drug,” explained Dr. Yew.

They were assessed at weeks 4 and 12. By study end, the proportion of patients who self-reported an improvement in their condition was 100% for upadacitinib, 90% for abrocitinib, and 69% for baricitinib. 

Scores on the Investigator Global Assessment (IGA) also improved with treatment. Patients in the baricitinib group saw their mean score fall from 4.0 to 3.0 by week 4, then to 2.0 by week 12. With upadacitinib and abrocitinib, “you can see that there is a nice decrease in IGA responses,” said Dr. Yew, referring to the larger improvement in scores experienced by patients on those two treatments. For patients on upadacitinib, IGA decreased from 3.5 to 2 at 4 weeks, then to 0.5 at 12 weeks, while those taking abrocitinib had their scores drop from 4.0 to 2.0 at 4 weeks, then to 1.0 at 12 weeks.

When it came to itch reduction, the abrocitinib group experienced the biggest reduction, with a median reduction of 5.5 points in itch score. Median reduction in itch score was 4 points for the other two groups. “Oral JAK inhibitors appear to have a good effect on itch response,” said Dr. Yew.

However, the researchers observed no significant reduction in percentage of body surface area affected, the last outcome assessed.

The most commonly reported adverse events were increased creatine kinase levels (11.3% of patients), increased LDL cholesterol levels (9.4%), and herpes zoster (9.4%). Those in the abrocitinib reported a higher number of these adverse events, compared with the other two treatment groups. (There were no herpes zoster cases among those taking baricitinib.)

For herpes zoster, Dr. Yew said “the common recommendation” is to give the inactivated shingles vaccine. “But the problem is that, number one, these patients would have probably failed multiple agents so they probably can’t wait for you to vaccinate before you initiate treatment.”

In addition, people in Singapore have to pay out-of-pocket for the two vaccine doses, “which is probably a month’s worth of medication,” he noted. “So we have a lot of resistance from patients.”

Additionally, Dr. Yew noted that contrary to what has previously been reported in the literature, there were few complaints of acne as a side effect in the Singaporean study population.
 

Toward greater representation

Dr. Yew pointed out that the study was limited by a few factors: neither the Eczema Area and Severity Index or Scoring of Atopic Dermatitis index data was used, and the study population was small and not representative of the real world.

Still, the new findings contribute to the overall safety and efficacy profile of JAK inhibitors in AD, which has so far been scarce in non-White populations.

“In Western studies, unfortunately, the representation of the population of skin of color or different ethnicities is underrepresented,” said Yousef Binamer, MD, chair of the dermatology department at King Faisal Specialist Hospital, Riyadh, Saudi Arabia, when approached for an independent comment on the results.

“This is now why researchers are looking into specific groups to study them,” which he pointed out, is crucial because “the immunophenotyping of AD is different for each background.”

The incidence and severity of AD tend to be higher in Asian and Middle Eastern populations, for instance, he noted. “It’s very common in Asia, and not so common in very white skin. I did my training in Canada so I see the difference,” said Dr. Binamer. “Asian people tend to be more itchy and have a tendency to scar on pigmentation.” Whereas White people “usually do not have this issue.” 

“So I think real-world evidence of JAK inhibitors in the other populations is important,” he said. Studies such as the one conducted in Singapore, as well as the recently reported QUARTZ3 study, which examined the use of the JAK inhibitor ivarmacitinib in 256 Chinese patients with AD, are helping to pave the way.

The study was independently supported. Dr. Yew and Dr. Binamer have reported no relevant financial relationships.

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

SINGAPORE – Three oral Janus kinase (JAK) inhibitors – abrocitinib, baricitinib, and upadacitinib – have demonstrated a good treatment response in Asian patients with atopic dermatitis (AD), a small retrospective study conducted in Singapore has found.

“Abrocitinib and upadacitinib surprisingly appeared to have better treatment efficacy compared to baricitinib,” said study lead Yik Weng Yew, MD, PhD, MPH, deputy head of research at Singapore’s National Skin Centre (NSC), who presented the results at the 25th World Congress of Dermatology. “But overall, as a group, I think they show a very good treatment response, as well as a good effect on itch response.”

Sandy Ong

JAK inhibitors are used to treat a variety of inflammatory diseases including alopecia areata, rheumatoid arthritis, and inflammatory bowel disease. Although treatment for severe eczema was previously limited to topical steroids and oral immunosuppressants, there are now two oral JAK inhibitors – abrocitinib and upadacitinib – approved in 2022 by the Food and Drug Administration for treating AD, which affects up to 2.4% of the global population. (A topical formulation of ruxolitinib, a JAK inhibitor, was approved for AD in 2021.)

The Singapore study is one of the few that have examined the safety and efficacy of JAK inhibitors for treatment of AD in a non-White population.
 

Chinese population

For the 12-week trial, conducted in 2022, Dr. Yew and associates recruited 35 patients from the NSC. More than half of participants (64%) were men and most (96%) were of Chinese ethnicity. Four of every five patients had previously received systemic agents: 17% had been treated with one systemic agent, 18.9% with two, 15.1% with three, 22.6% with four, and 3.8% with five. The most commonly used agents were cyclosporine (62.3%), methotrexate (47.2%), azathioprine (39.6%), and dupilumab (35.8%).  

“The switch in therapy could have been a result of inadequate efficacy or cost reasons because in Singapore patients pay out of pocket for AD treatments,” said Dr. Yew.

Additionally, he offered a caveat on the profile of participants: “Perhaps they were more difficult atopic eczema patients, and therefore, the efficacy [of JAK inhibitors] might be a bit different.”
 

Clearer skin, less itch

Patients received one of the three study drugs: baricitinib (66%), abrocitinib (21%), and upadacitinib (13%). The distribution was “affected by reimbursement patterns and availability of the drug,” explained Dr. Yew.

They were assessed at weeks 4 and 12. By study end, the proportion of patients who self-reported an improvement in their condition was 100% for upadacitinib, 90% for abrocitinib, and 69% for baricitinib. 

Scores on the Investigator Global Assessment (IGA) also improved with treatment. Patients in the baricitinib group saw their mean score fall from 4.0 to 3.0 by week 4, then to 2.0 by week 12. With upadacitinib and abrocitinib, “you can see that there is a nice decrease in IGA responses,” said Dr. Yew, referring to the larger improvement in scores experienced by patients on those two treatments. For patients on upadacitinib, IGA decreased from 3.5 to 2 at 4 weeks, then to 0.5 at 12 weeks, while those taking abrocitinib had their scores drop from 4.0 to 2.0 at 4 weeks, then to 1.0 at 12 weeks.

When it came to itch reduction, the abrocitinib group experienced the biggest reduction, with a median reduction of 5.5 points in itch score. Median reduction in itch score was 4 points for the other two groups. “Oral JAK inhibitors appear to have a good effect on itch response,” said Dr. Yew.

However, the researchers observed no significant reduction in percentage of body surface area affected, the last outcome assessed.

The most commonly reported adverse events were increased creatine kinase levels (11.3% of patients), increased LDL cholesterol levels (9.4%), and herpes zoster (9.4%). Those in the abrocitinib reported a higher number of these adverse events, compared with the other two treatment groups. (There were no herpes zoster cases among those taking baricitinib.)

For herpes zoster, Dr. Yew said “the common recommendation” is to give the inactivated shingles vaccine. “But the problem is that, number one, these patients would have probably failed multiple agents so they probably can’t wait for you to vaccinate before you initiate treatment.”

In addition, people in Singapore have to pay out-of-pocket for the two vaccine doses, “which is probably a month’s worth of medication,” he noted. “So we have a lot of resistance from patients.”

Additionally, Dr. Yew noted that contrary to what has previously been reported in the literature, there were few complaints of acne as a side effect in the Singaporean study population.
 

Toward greater representation

Dr. Yew pointed out that the study was limited by a few factors: neither the Eczema Area and Severity Index or Scoring of Atopic Dermatitis index data was used, and the study population was small and not representative of the real world.

Still, the new findings contribute to the overall safety and efficacy profile of JAK inhibitors in AD, which has so far been scarce in non-White populations.

“In Western studies, unfortunately, the representation of the population of skin of color or different ethnicities is underrepresented,” said Yousef Binamer, MD, chair of the dermatology department at King Faisal Specialist Hospital, Riyadh, Saudi Arabia, when approached for an independent comment on the results.

“This is now why researchers are looking into specific groups to study them,” which he pointed out, is crucial because “the immunophenotyping of AD is different for each background.”

The incidence and severity of AD tend to be higher in Asian and Middle Eastern populations, for instance, he noted. “It’s very common in Asia, and not so common in very white skin. I did my training in Canada so I see the difference,” said Dr. Binamer. “Asian people tend to be more itchy and have a tendency to scar on pigmentation.” Whereas White people “usually do not have this issue.” 

“So I think real-world evidence of JAK inhibitors in the other populations is important,” he said. Studies such as the one conducted in Singapore, as well as the recently reported QUARTZ3 study, which examined the use of the JAK inhibitor ivarmacitinib in 256 Chinese patients with AD, are helping to pave the way.

The study was independently supported. Dr. Yew and Dr. Binamer have reported no relevant financial relationships.

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

SINGAPORE – Three oral Janus kinase (JAK) inhibitors – abrocitinib, baricitinib, and upadacitinib – have demonstrated a good treatment response in Asian patients with atopic dermatitis (AD), a small retrospective study conducted in Singapore has found.

“Abrocitinib and upadacitinib surprisingly appeared to have better treatment efficacy compared to baricitinib,” said study lead Yik Weng Yew, MD, PhD, MPH, deputy head of research at Singapore’s National Skin Centre (NSC), who presented the results at the 25th World Congress of Dermatology. “But overall, as a group, I think they show a very good treatment response, as well as a good effect on itch response.”

Sandy Ong

JAK inhibitors are used to treat a variety of inflammatory diseases including alopecia areata, rheumatoid arthritis, and inflammatory bowel disease. Although treatment for severe eczema was previously limited to topical steroids and oral immunosuppressants, there are now two oral JAK inhibitors – abrocitinib and upadacitinib – approved in 2022 by the Food and Drug Administration for treating AD, which affects up to 2.4% of the global population. (A topical formulation of ruxolitinib, a JAK inhibitor, was approved for AD in 2021.)

The Singapore study is one of the few that have examined the safety and efficacy of JAK inhibitors for treatment of AD in a non-White population.
 

Chinese population

For the 12-week trial, conducted in 2022, Dr. Yew and associates recruited 35 patients from the NSC. More than half of participants (64%) were men and most (96%) were of Chinese ethnicity. Four of every five patients had previously received systemic agents: 17% had been treated with one systemic agent, 18.9% with two, 15.1% with three, 22.6% with four, and 3.8% with five. The most commonly used agents were cyclosporine (62.3%), methotrexate (47.2%), azathioprine (39.6%), and dupilumab (35.8%).  

“The switch in therapy could have been a result of inadequate efficacy or cost reasons because in Singapore patients pay out of pocket for AD treatments,” said Dr. Yew.

Additionally, he offered a caveat on the profile of participants: “Perhaps they were more difficult atopic eczema patients, and therefore, the efficacy [of JAK inhibitors] might be a bit different.”
 

Clearer skin, less itch

Patients received one of the three study drugs: baricitinib (66%), abrocitinib (21%), and upadacitinib (13%). The distribution was “affected by reimbursement patterns and availability of the drug,” explained Dr. Yew.

They were assessed at weeks 4 and 12. By study end, the proportion of patients who self-reported an improvement in their condition was 100% for upadacitinib, 90% for abrocitinib, and 69% for baricitinib. 

Scores on the Investigator Global Assessment (IGA) also improved with treatment. Patients in the baricitinib group saw their mean score fall from 4.0 to 3.0 by week 4, then to 2.0 by week 12. With upadacitinib and abrocitinib, “you can see that there is a nice decrease in IGA responses,” said Dr. Yew, referring to the larger improvement in scores experienced by patients on those two treatments. For patients on upadacitinib, IGA decreased from 3.5 to 2 at 4 weeks, then to 0.5 at 12 weeks, while those taking abrocitinib had their scores drop from 4.0 to 2.0 at 4 weeks, then to 1.0 at 12 weeks.

When it came to itch reduction, the abrocitinib group experienced the biggest reduction, with a median reduction of 5.5 points in itch score. Median reduction in itch score was 4 points for the other two groups. “Oral JAK inhibitors appear to have a good effect on itch response,” said Dr. Yew.

However, the researchers observed no significant reduction in percentage of body surface area affected, the last outcome assessed.

The most commonly reported adverse events were increased creatine kinase levels (11.3% of patients), increased LDL cholesterol levels (9.4%), and herpes zoster (9.4%). Those in the abrocitinib reported a higher number of these adverse events, compared with the other two treatment groups. (There were no herpes zoster cases among those taking baricitinib.)

For herpes zoster, Dr. Yew said “the common recommendation” is to give the inactivated shingles vaccine. “But the problem is that, number one, these patients would have probably failed multiple agents so they probably can’t wait for you to vaccinate before you initiate treatment.”

In addition, people in Singapore have to pay out-of-pocket for the two vaccine doses, “which is probably a month’s worth of medication,” he noted. “So we have a lot of resistance from patients.”

Additionally, Dr. Yew noted that contrary to what has previously been reported in the literature, there were few complaints of acne as a side effect in the Singaporean study population.
 

Toward greater representation

Dr. Yew pointed out that the study was limited by a few factors: neither the Eczema Area and Severity Index or Scoring of Atopic Dermatitis index data was used, and the study population was small and not representative of the real world.

Still, the new findings contribute to the overall safety and efficacy profile of JAK inhibitors in AD, which has so far been scarce in non-White populations.

“In Western studies, unfortunately, the representation of the population of skin of color or different ethnicities is underrepresented,” said Yousef Binamer, MD, chair of the dermatology department at King Faisal Specialist Hospital, Riyadh, Saudi Arabia, when approached for an independent comment on the results.

“This is now why researchers are looking into specific groups to study them,” which he pointed out, is crucial because “the immunophenotyping of AD is different for each background.”

The incidence and severity of AD tend to be higher in Asian and Middle Eastern populations, for instance, he noted. “It’s very common in Asia, and not so common in very white skin. I did my training in Canada so I see the difference,” said Dr. Binamer. “Asian people tend to be more itchy and have a tendency to scar on pigmentation.” Whereas White people “usually do not have this issue.” 

“So I think real-world evidence of JAK inhibitors in the other populations is important,” he said. Studies such as the one conducted in Singapore, as well as the recently reported QUARTZ3 study, which examined the use of the JAK inhibitor ivarmacitinib in 256 Chinese patients with AD, are helping to pave the way.

The study was independently supported. Dr. Yew and Dr. Binamer have reported no relevant financial relationships.

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

SINGAPORE – When injected subcutaneously, the interleukin-36 receptor antagonist spesolimab significantly reduced the risk for generalized pustular psoriasis (GPP) flares, according to results of a study presented in a late-breaker session at the World Congress of Dermatology,

In the phase 2b study, patients who received the high-dose regimen (a 600-mg subcutaneous loading dose, then 300-mg SC every 4 weeks) of spesolimab experienced 84% fewer GPP fares over 48 weeks, compared with those on placebo, reported Bruce Strober, MD, PhD, Central Connecticut Dermatology, Cromwell, and clinical professor of dermatology, Yale University, New Haven, Conn. “Additionally, no flares occurred after week 4, and this, in turn, translated into improved patient outcomes.”

GPP is a rare, chronic, systemic neutrophilic skin disease. The resulting flares, characterized by painful pustules all over the body, can lead to sepsis, shock, and other life-threatening complications. “People who have it are considerably burdened by it, so targeted therapy of this disease is incredibly important because it leads to lessened morbidity and, importantly, mortality for these patients,” Dr. Strober said.

“It’s important not only to treat the flares but also to prevent them,” he noted.

The intravenous formulation of spesolimab (Spevigo) was approved for the treatment of GPP flares in adults by the Food and Drug Administration in September 2022. It is now authorized in nearly 40 countries, including Japan, China, and the European Union.

The phase 2 Effisayil 2 study presented at the meeting evaluated the subcutaneous formulation of spesolimab. Data on subcutaneous spesolimab has been submitted to the FDA, and has received breakthrough therapy designation, according to the manufacturer, Boehringer Ingelheim.

Flare prevention

In the study, 123 patients with GPP were randomly assigned 1:1:1:1 to one of four groups: high-dose spesolimab, medium-dose (600-mg SC loading dose, then 300-mg SC every 12 weeks), low-dose (300-mg SC loading dose, then 150-mg SC every 12 weeks), or placebo. In the event of a flare during the randomized treatment period, a patient was administered a single, 900-mg intravenous dose of spesolimab.

Nearly two-thirds of the participants were female and nearly two-thirds were Asian, with a mean age of about 39-43 years.

The mean numbers of GPP flares experienced annually by those in the low-, medium-, and high-dose spesolimab groups were 2.7, 1.9, and 2.4, respectively (2.4% in the placebo group). Fewer than a third had concurrent plaque psoriasis at baseline. Most (48.4%-63.3%) did not have an IL-36RN mutation.

Additionally, the Generalized Pustular Psoriasis Physician Global Assessment total score was 1 in 74.2%-93.5% of participants, and 0 in the remainder.

The primary study endpoint was the time to GPP flare by week 48. The risk of developing a flare among those on high-dose spesolimab was 84% lower, compared with that of those on placebo (hazard ratio, 0.16; 95% confidence interval, 0.05-0.54; P = .0005). No patients on the high dose had a flare after the 4th week of the study.

Similarly, for the secondary endpoint (occurrence of at least one GPP flare by week 48). Dr. Strober and his colleagues reported that high-dose spesolimab was superior to placebo with a risk difference of -39% (95% CI, –0.62 to –0.16; P = .0013). By contrast, the risk differences for the medium- and low-dose spesolimab arms were –0.23 (95% CI, –0.46 to 0.01) and -0.31 (95% CI, –0.54 to –0.08), respectively.

The safety profile of subcutaneous spesolimab across all three doses was similar to that of placebo, and there was no dose-dependent trend. Reported adverse events (AEs) were mild. There were five (5.4%) AEs leading to discontinuation of the drug in the medium- and high-dose groups, but none in the low-dose group. Overall, there were nine (9.7%) serious AEs reported in the spesolimab groups, and three (10%) in the high-dose group; no deaths occurred on any dose.

Participants most often reported injection-site erythema, reported in 13 (14%) of the patients on spesolimab versus 1 (3.3%) of those on placebo.

“Overall, the study demonstrates that subcutaneous spesolimab is effective at controlling GPP flares, especially at a high dose relative to placebo, and supports subcutaneous spesolimab for the therapy for GPP flare prevention,” Dr. Strober said at the meeting.
 

Targeting the IL-36 pathway

In a comment, Todd Schlesinger, MD, Clinical Research Center of the Carolinas, Charleston, S.C., who moderated the session, said: “It’s very exciting to be able to have a subcutaneous version of the medication.”

“I think the IL-36 is a great pathway,” he said, referring to the signaling pathway within the immune system that is central to the pathogenesis of GPP and several other autoinflammatory diseases.

However, Dr. Schlesinger said that he would have liked to have seen data on how many patients ended up treated with intravenous spesolimab.

He added that he would like future studies of subcutaneous spesolimab to examine the effect in different populations that vary by parameters such as weight, race, and disease severity. “Just seeing how somebody who’s flaring five times a year and you give them this medication and they’re now flaring once a year – that’s interesting data that we might like to know in the future.”

Other than for preventing GPP flares, spesolimab is being studied for treating other IL-36–mediated skin diseases, such as palmoplantar pustulosis.

The study was funded by Boehringer Ingelheim; both Dr. Strober and Dr. Schlesinger do research and consulting for BI, and receive funding from multiple other pharmaceutical companies.

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

SINGAPORE – When injected subcutaneously, the interleukin-36 receptor antagonist spesolimab significantly reduced the risk for generalized pustular psoriasis (GPP) flares, according to results of a study presented in a late-breaker session at the World Congress of Dermatology,

In the phase 2b study, patients who received the high-dose regimen (a 600-mg subcutaneous loading dose, then 300-mg SC every 4 weeks) of spesolimab experienced 84% fewer GPP fares over 48 weeks, compared with those on placebo, reported Bruce Strober, MD, PhD, Central Connecticut Dermatology, Cromwell, and clinical professor of dermatology, Yale University, New Haven, Conn. “Additionally, no flares occurred after week 4, and this, in turn, translated into improved patient outcomes.”

GPP is a rare, chronic, systemic neutrophilic skin disease. The resulting flares, characterized by painful pustules all over the body, can lead to sepsis, shock, and other life-threatening complications. “People who have it are considerably burdened by it, so targeted therapy of this disease is incredibly important because it leads to lessened morbidity and, importantly, mortality for these patients,” Dr. Strober said.

“It’s important not only to treat the flares but also to prevent them,” he noted.

The intravenous formulation of spesolimab (Spevigo) was approved for the treatment of GPP flares in adults by the Food and Drug Administration in September 2022. It is now authorized in nearly 40 countries, including Japan, China, and the European Union.

The phase 2 Effisayil 2 study presented at the meeting evaluated the subcutaneous formulation of spesolimab. Data on subcutaneous spesolimab has been submitted to the FDA, and has received breakthrough therapy designation, according to the manufacturer, Boehringer Ingelheim.

Flare prevention

In the study, 123 patients with GPP were randomly assigned 1:1:1:1 to one of four groups: high-dose spesolimab, medium-dose (600-mg SC loading dose, then 300-mg SC every 12 weeks), low-dose (300-mg SC loading dose, then 150-mg SC every 12 weeks), or placebo. In the event of a flare during the randomized treatment period, a patient was administered a single, 900-mg intravenous dose of spesolimab.

Nearly two-thirds of the participants were female and nearly two-thirds were Asian, with a mean age of about 39-43 years.

The mean numbers of GPP flares experienced annually by those in the low-, medium-, and high-dose spesolimab groups were 2.7, 1.9, and 2.4, respectively (2.4% in the placebo group). Fewer than a third had concurrent plaque psoriasis at baseline. Most (48.4%-63.3%) did not have an IL-36RN mutation.

Additionally, the Generalized Pustular Psoriasis Physician Global Assessment total score was 1 in 74.2%-93.5% of participants, and 0 in the remainder.

The primary study endpoint was the time to GPP flare by week 48. The risk of developing a flare among those on high-dose spesolimab was 84% lower, compared with that of those on placebo (hazard ratio, 0.16; 95% confidence interval, 0.05-0.54; P = .0005). No patients on the high dose had a flare after the 4th week of the study.

Similarly, for the secondary endpoint (occurrence of at least one GPP flare by week 48). Dr. Strober and his colleagues reported that high-dose spesolimab was superior to placebo with a risk difference of -39% (95% CI, –0.62 to –0.16; P = .0013). By contrast, the risk differences for the medium- and low-dose spesolimab arms were –0.23 (95% CI, –0.46 to 0.01) and -0.31 (95% CI, –0.54 to –0.08), respectively.

The safety profile of subcutaneous spesolimab across all three doses was similar to that of placebo, and there was no dose-dependent trend. Reported adverse events (AEs) were mild. There were five (5.4%) AEs leading to discontinuation of the drug in the medium- and high-dose groups, but none in the low-dose group. Overall, there were nine (9.7%) serious AEs reported in the spesolimab groups, and three (10%) in the high-dose group; no deaths occurred on any dose.

Participants most often reported injection-site erythema, reported in 13 (14%) of the patients on spesolimab versus 1 (3.3%) of those on placebo.

“Overall, the study demonstrates that subcutaneous spesolimab is effective at controlling GPP flares, especially at a high dose relative to placebo, and supports subcutaneous spesolimab for the therapy for GPP flare prevention,” Dr. Strober said at the meeting.
 

Targeting the IL-36 pathway

In a comment, Todd Schlesinger, MD, Clinical Research Center of the Carolinas, Charleston, S.C., who moderated the session, said: “It’s very exciting to be able to have a subcutaneous version of the medication.”

“I think the IL-36 is a great pathway,” he said, referring to the signaling pathway within the immune system that is central to the pathogenesis of GPP and several other autoinflammatory diseases.

However, Dr. Schlesinger said that he would have liked to have seen data on how many patients ended up treated with intravenous spesolimab.

He added that he would like future studies of subcutaneous spesolimab to examine the effect in different populations that vary by parameters such as weight, race, and disease severity. “Just seeing how somebody who’s flaring five times a year and you give them this medication and they’re now flaring once a year – that’s interesting data that we might like to know in the future.”

Other than for preventing GPP flares, spesolimab is being studied for treating other IL-36–mediated skin diseases, such as palmoplantar pustulosis.

The study was funded by Boehringer Ingelheim; both Dr. Strober and Dr. Schlesinger do research and consulting for BI, and receive funding from multiple other pharmaceutical companies.

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

SINGAPORE – When injected subcutaneously, the interleukin-36 receptor antagonist spesolimab significantly reduced the risk for generalized pustular psoriasis (GPP) flares, according to results of a study presented in a late-breaker session at the World Congress of Dermatology,

In the phase 2b study, patients who received the high-dose regimen (a 600-mg subcutaneous loading dose, then 300-mg SC every 4 weeks) of spesolimab experienced 84% fewer GPP fares over 48 weeks, compared with those on placebo, reported Bruce Strober, MD, PhD, Central Connecticut Dermatology, Cromwell, and clinical professor of dermatology, Yale University, New Haven, Conn. “Additionally, no flares occurred after week 4, and this, in turn, translated into improved patient outcomes.”

GPP is a rare, chronic, systemic neutrophilic skin disease. The resulting flares, characterized by painful pustules all over the body, can lead to sepsis, shock, and other life-threatening complications. “People who have it are considerably burdened by it, so targeted therapy of this disease is incredibly important because it leads to lessened morbidity and, importantly, mortality for these patients,” Dr. Strober said.

“It’s important not only to treat the flares but also to prevent them,” he noted.

The intravenous formulation of spesolimab (Spevigo) was approved for the treatment of GPP flares in adults by the Food and Drug Administration in September 2022. It is now authorized in nearly 40 countries, including Japan, China, and the European Union.

The phase 2 Effisayil 2 study presented at the meeting evaluated the subcutaneous formulation of spesolimab. Data on subcutaneous spesolimab has been submitted to the FDA, and has received breakthrough therapy designation, according to the manufacturer, Boehringer Ingelheim.

Flare prevention

In the study, 123 patients with GPP were randomly assigned 1:1:1:1 to one of four groups: high-dose spesolimab, medium-dose (600-mg SC loading dose, then 300-mg SC every 12 weeks), low-dose (300-mg SC loading dose, then 150-mg SC every 12 weeks), or placebo. In the event of a flare during the randomized treatment period, a patient was administered a single, 900-mg intravenous dose of spesolimab.

Nearly two-thirds of the participants were female and nearly two-thirds were Asian, with a mean age of about 39-43 years.

The mean numbers of GPP flares experienced annually by those in the low-, medium-, and high-dose spesolimab groups were 2.7, 1.9, and 2.4, respectively (2.4% in the placebo group). Fewer than a third had concurrent plaque psoriasis at baseline. Most (48.4%-63.3%) did not have an IL-36RN mutation.

Additionally, the Generalized Pustular Psoriasis Physician Global Assessment total score was 1 in 74.2%-93.5% of participants, and 0 in the remainder.

The primary study endpoint was the time to GPP flare by week 48. The risk of developing a flare among those on high-dose spesolimab was 84% lower, compared with that of those on placebo (hazard ratio, 0.16; 95% confidence interval, 0.05-0.54; P = .0005). No patients on the high dose had a flare after the 4th week of the study.

Similarly, for the secondary endpoint (occurrence of at least one GPP flare by week 48). Dr. Strober and his colleagues reported that high-dose spesolimab was superior to placebo with a risk difference of -39% (95% CI, –0.62 to –0.16; P = .0013). By contrast, the risk differences for the medium- and low-dose spesolimab arms were –0.23 (95% CI, –0.46 to 0.01) and -0.31 (95% CI, –0.54 to –0.08), respectively.

The safety profile of subcutaneous spesolimab across all three doses was similar to that of placebo, and there was no dose-dependent trend. Reported adverse events (AEs) were mild. There were five (5.4%) AEs leading to discontinuation of the drug in the medium- and high-dose groups, but none in the low-dose group. Overall, there were nine (9.7%) serious AEs reported in the spesolimab groups, and three (10%) in the high-dose group; no deaths occurred on any dose.

Participants most often reported injection-site erythema, reported in 13 (14%) of the patients on spesolimab versus 1 (3.3%) of those on placebo.

“Overall, the study demonstrates that subcutaneous spesolimab is effective at controlling GPP flares, especially at a high dose relative to placebo, and supports subcutaneous spesolimab for the therapy for GPP flare prevention,” Dr. Strober said at the meeting.
 

Targeting the IL-36 pathway

In a comment, Todd Schlesinger, MD, Clinical Research Center of the Carolinas, Charleston, S.C., who moderated the session, said: “It’s very exciting to be able to have a subcutaneous version of the medication.”

“I think the IL-36 is a great pathway,” he said, referring to the signaling pathway within the immune system that is central to the pathogenesis of GPP and several other autoinflammatory diseases.

However, Dr. Schlesinger said that he would have liked to have seen data on how many patients ended up treated with intravenous spesolimab.

He added that he would like future studies of subcutaneous spesolimab to examine the effect in different populations that vary by parameters such as weight, race, and disease severity. “Just seeing how somebody who’s flaring five times a year and you give them this medication and they’re now flaring once a year – that’s interesting data that we might like to know in the future.”

Other than for preventing GPP flares, spesolimab is being studied for treating other IL-36–mediated skin diseases, such as palmoplantar pustulosis.

The study was funded by Boehringer Ingelheim; both Dr. Strober and Dr. Schlesinger do research and consulting for BI, and receive funding from multiple other pharmaceutical companies.

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

Well-demarcated symmetrical scaly plaques and dactylitis are consistent with psoriasis and psoriatic arthritis (PsA). Even in the absence of significant skin disease, a patient like this should be evaluated by Rheumatology for initiation of disease-modifying antirheumatic drugs (DMARDs).

Psoriatic arthritis manifests as a peripheral arthritis affecting the small joints of the wrists and hands, pain at the insertion of tendons and ligaments (enthesitis), or as axial arthritis. This variable presentation and the lack of specific serological marker can make diagnosis challenging. Associated symptoms beyond the musculoskeletal system include uveitis, inflammatory bowel disease, and cutaneous psoriasis.¹ In contrast to osteoarthritis, PsA symptoms are often worse in the morning and improve over the course of the day. Patients with a history of psoriasis on the skin have about a 10% chance of developing PsA, with increased rates in patients who have more widespread plaques and patients with psoriasis at a young age.² Although not pathognomonic for PsA, pitting of the fingernails may reflect episodic enthesitis in the extensor tendons of the fingers.³ Radiographs of the hands in severe cases may demonstrate narrowing of the proximal portion of the distal or proximal interphalangeal joints with a cup-like concavity of the distal half of the joint.

Conventional DMARDs (such as methotrexate and azathioprine) and biologic DMARDs (including TNF-alpha inhibitors, IL-17 inhibitors, IL-23 inhibitors) are first-line treatments and can stop or slow the progression of disease but will not reverse existing damage. For this reason, it is important to promptly start DMARD therapy after the diagnosis has been established.⁴

This patient was initiated on adalimumab 40 mg subcutaneously every other week. Her pain improved after 2 months of therapy and her skin plaques almost entirely resolved at 6 months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Well-demarcated symmetrical scaly plaques and dactylitis are consistent with psoriasis and psoriatic arthritis (PsA). Even in the absence of significant skin disease, a patient like this should be evaluated by Rheumatology for initiation of disease-modifying antirheumatic drugs (DMARDs).

Psoriatic arthritis manifests as a peripheral arthritis affecting the small joints of the wrists and hands, pain at the insertion of tendons and ligaments (enthesitis), or as axial arthritis. This variable presentation and the lack of specific serological marker can make diagnosis challenging. Associated symptoms beyond the musculoskeletal system include uveitis, inflammatory bowel disease, and cutaneous psoriasis.¹ In contrast to osteoarthritis, PsA symptoms are often worse in the morning and improve over the course of the day. Patients with a history of psoriasis on the skin have about a 10% chance of developing PsA, with increased rates in patients who have more widespread plaques and patients with psoriasis at a young age.² Although not pathognomonic for PsA, pitting of the fingernails may reflect episodic enthesitis in the extensor tendons of the fingers.³ Radiographs of the hands in severe cases may demonstrate narrowing of the proximal portion of the distal or proximal interphalangeal joints with a cup-like concavity of the distal half of the joint.

Conventional DMARDs (such as methotrexate and azathioprine) and biologic DMARDs (including TNF-alpha inhibitors, IL-17 inhibitors, IL-23 inhibitors) are first-line treatments and can stop or slow the progression of disease but will not reverse existing damage. For this reason, it is important to promptly start DMARD therapy after the diagnosis has been established.⁴

This patient was initiated on adalimumab 40 mg subcutaneously every other week. Her pain improved after 2 months of therapy and her skin plaques almost entirely resolved at 6 months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Well-demarcated symmetrical scaly plaques and dactylitis are consistent with psoriasis and psoriatic arthritis (PsA). Even in the absence of significant skin disease, a patient like this should be evaluated by Rheumatology for initiation of disease-modifying antirheumatic drugs (DMARDs).

Psoriatic arthritis manifests as a peripheral arthritis affecting the small joints of the wrists and hands, pain at the insertion of tendons and ligaments (enthesitis), or as axial arthritis. This variable presentation and the lack of specific serological marker can make diagnosis challenging. Associated symptoms beyond the musculoskeletal system include uveitis, inflammatory bowel disease, and cutaneous psoriasis.¹ In contrast to osteoarthritis, PsA symptoms are often worse in the morning and improve over the course of the day. Patients with a history of psoriasis on the skin have about a 10% chance of developing PsA, with increased rates in patients who have more widespread plaques and patients with psoriasis at a young age.² Although not pathognomonic for PsA, pitting of the fingernails may reflect episodic enthesitis in the extensor tendons of the fingers.³ Radiographs of the hands in severe cases may demonstrate narrowing of the proximal portion of the distal or proximal interphalangeal joints with a cup-like concavity of the distal half of the joint.

Conventional DMARDs (such as methotrexate and azathioprine) and biologic DMARDs (including TNF-alpha inhibitors, IL-17 inhibitors, IL-23 inhibitors) are first-line treatments and can stop or slow the progression of disease but will not reverse existing damage. For this reason, it is important to promptly start DMARD therapy after the diagnosis has been established.⁴

This patient was initiated on adalimumab 40 mg subcutaneously every other week. Her pain improved after 2 months of therapy and her skin plaques almost entirely resolved at 6 months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

Click here to view more from Cancer Data Trends 2023.

Click here to view more from Cancer Data Trends 2023.

Click here to view more from Cancer Data Trends 2023.

When the nails peel off from the proximal nail folds, the clinical term is onychomadesis and it is important to ask about recent infections or severe metabolic stressors. In children and adults, onychomadesis on multiple fingers may occur after infections and has been associated with hand-foot-mouth disease caused by common viral infections—especially strains of coxsackievirus.¹

Because shed nails show evidence of viral infection, one hypothesis for their peeling off is that the tissue of the nail matrix is infected, leading to metabolic changes. As the nail matrix returns to normal function, a new nail is made and ultimately will replace the nail that has come off. In healthy US adults, fingernails grow 3.47 mm per month on average while toenails grow 1.62 mm per month on average.²

Sometimes it’s hard to elicit a history of a very mild viral illness weeks or months after it has resolved. Asking specifically about mouth ulcers may help. If there is a history of a viral illness, no specific work-up or treatment is necessary. Patients may be reassured that nails will improve over several months without lasting effects.

In this case, the patient and her family were given reassurance and the nails returned to normal within a few months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

When the nails peel off from the proximal nail folds, the clinical term is onychomadesis and it is important to ask about recent infections or severe metabolic stressors. In children and adults, onychomadesis on multiple fingers may occur after infections and has been associated with hand-foot-mouth disease caused by common viral infections—especially strains of coxsackievirus.¹

Because shed nails show evidence of viral infection, one hypothesis for their peeling off is that the tissue of the nail matrix is infected, leading to metabolic changes. As the nail matrix returns to normal function, a new nail is made and ultimately will replace the nail that has come off. In healthy US adults, fingernails grow 3.47 mm per month on average while toenails grow 1.62 mm per month on average.²

Sometimes it’s hard to elicit a history of a very mild viral illness weeks or months after it has resolved. Asking specifically about mouth ulcers may help. If there is a history of a viral illness, no specific work-up or treatment is necessary. Patients may be reassured that nails will improve over several months without lasting effects.

In this case, the patient and her family were given reassurance and the nails returned to normal within a few months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

When the nails peel off from the proximal nail folds, the clinical term is onychomadesis and it is important to ask about recent infections or severe metabolic stressors. In children and adults, onychomadesis on multiple fingers may occur after infections and has been associated with hand-foot-mouth disease caused by common viral infections—especially strains of coxsackievirus.¹

Because shed nails show evidence of viral infection, one hypothesis for their peeling off is that the tissue of the nail matrix is infected, leading to metabolic changes. As the nail matrix returns to normal function, a new nail is made and ultimately will replace the nail that has come off. In healthy US adults, fingernails grow 3.47 mm per month on average while toenails grow 1.62 mm per month on average.²

Sometimes it’s hard to elicit a history of a very mild viral illness weeks or months after it has resolved. Asking specifically about mouth ulcers may help. If there is a history of a viral illness, no specific work-up or treatment is necessary. Patients may be reassured that nails will improve over several months without lasting effects.

In this case, the patient and her family were given reassurance and the nails returned to normal within a few months.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.

Those are among 46 evidence- and consensus-based recommendations about the use of MTX for inflammatory skin disease in pediatric patients that were developed by a committee of 23 experts and published online in Pediatric Dermatology.

“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”

• MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
• Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
• Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
• Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
• Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
• Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
• Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.

According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.

Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.

The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.

While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.

Those are among 46 evidence- and consensus-based recommendations about the use of MTX for inflammatory skin disease in pediatric patients that were developed by a committee of 23 experts and published online in Pediatric Dermatology.

“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”

• MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
• Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
• Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
• Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
• Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
• Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
• Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.

According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.

Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.

The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.

While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.

Those are among 46 evidence- and consensus-based recommendations about the use of MTX for inflammatory skin disease in pediatric patients that were developed by a committee of 23 experts and published online in Pediatric Dermatology.

“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”

• MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
• Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
• Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
• Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
• Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
• Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
• Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.

According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.

Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.

The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.

Researchers may have discovered the elusive cure to baldness in an unlikely place: Those unsightly hairs that sometimes grow out of skin moles.

The researchers found that a specific molecule in those hairy moles “causes normally dormant and diminutive hair follicles to activate their stem cells for robust growth of long and thick hairs,” lead researcher Maksim Plikus, PhD, professor of developmental and cell biology at the University of California, Irvine, said in a statement.

The findings could lead to new treatments for the hair loss condition known as androgenetic alopecia, which researchers said occurs in both men and women. It is also known as male-pattern baldness in men. 

The global team led by researchers at the university analyzed hair follicle stem cells and discovered that a molecule called osteopontin drives accelerated hair growth. Stem cells can develop into different kinds of cells, whether they are in the body or in a laboratory, and are often involved in regenerative or repair processes, according to the Mayo Clinic.

This latest study, published in the journal Nature, was done on mice. A drug company cofounded by Dr. Plikus said in a news release that it had further tested the hair growth technique on human hair follicles, and “the researchers were able to induce new growth by human hair follicles in a robust preclinical model.” The company, Amplifica, said in the release that it has an exclusive licensing agreement with the university for the new hair growth “inventions” described in the newly published findings.

Hair loss from androgenetic alopecia occurs in two out of every three men, according to the Cleveland Clinic. Amplifica said the condition affects an estimated 50 million men and 30 million women in the United States. 

The hair loss and thinning can begin as early as the late teens, the Cleveland Clinic says. The condition is progressive and can follow a specific pattern, such as the hairline creating an “M” or “U” shape midway through the process toward complete baldness on the top of the head, with a remaining thin band of hair around the sides of the head.

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

Researchers may have discovered the elusive cure to baldness in an unlikely place: Those unsightly hairs that sometimes grow out of skin moles.

The researchers found that a specific molecule in those hairy moles “causes normally dormant and diminutive hair follicles to activate their stem cells for robust growth of long and thick hairs,” lead researcher Maksim Plikus, PhD, professor of developmental and cell biology at the University of California, Irvine, said in a statement.

The findings could lead to new treatments for the hair loss condition known as androgenetic alopecia, which researchers said occurs in both men and women. It is also known as male-pattern baldness in men. 

The global team led by researchers at the university analyzed hair follicle stem cells and discovered that a molecule called osteopontin drives accelerated hair growth. Stem cells can develop into different kinds of cells, whether they are in the body or in a laboratory, and are often involved in regenerative or repair processes, according to the Mayo Clinic.

This latest study, published in the journal Nature, was done on mice. A drug company cofounded by Dr. Plikus said in a news release that it had further tested the hair growth technique on human hair follicles, and “the researchers were able to induce new growth by human hair follicles in a robust preclinical model.” The company, Amplifica, said in the release that it has an exclusive licensing agreement with the university for the new hair growth “inventions” described in the newly published findings.

Hair loss from androgenetic alopecia occurs in two out of every three men, according to the Cleveland Clinic. Amplifica said the condition affects an estimated 50 million men and 30 million women in the United States. 

The hair loss and thinning can begin as early as the late teens, the Cleveland Clinic says. The condition is progressive and can follow a specific pattern, such as the hairline creating an “M” or “U” shape midway through the process toward complete baldness on the top of the head, with a remaining thin band of hair around the sides of the head.

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

Researchers may have discovered the elusive cure to baldness in an unlikely place: Those unsightly hairs that sometimes grow out of skin moles.

The researchers found that a specific molecule in those hairy moles “causes normally dormant and diminutive hair follicles to activate their stem cells for robust growth of long and thick hairs,” lead researcher Maksim Plikus, PhD, professor of developmental and cell biology at the University of California, Irvine, said in a statement.

The findings could lead to new treatments for the hair loss condition known as androgenetic alopecia, which researchers said occurs in both men and women. It is also known as male-pattern baldness in men. 

The global team led by researchers at the university analyzed hair follicle stem cells and discovered that a molecule called osteopontin drives accelerated hair growth. Stem cells can develop into different kinds of cells, whether they are in the body or in a laboratory, and are often involved in regenerative or repair processes, according to the Mayo Clinic.

This latest study, published in the journal Nature, was done on mice. A drug company cofounded by Dr. Plikus said in a news release that it had further tested the hair growth technique on human hair follicles, and “the researchers were able to induce new growth by human hair follicles in a robust preclinical model.” The company, Amplifica, said in the release that it has an exclusive licensing agreement with the university for the new hair growth “inventions” described in the newly published findings.

Hair loss from androgenetic alopecia occurs in two out of every three men, according to the Cleveland Clinic. Amplifica said the condition affects an estimated 50 million men and 30 million women in the United States. 

The hair loss and thinning can begin as early as the late teens, the Cleveland Clinic says. The condition is progressive and can follow a specific pattern, such as the hairline creating an “M” or “U” shape midway through the process toward complete baldness on the top of the head, with a remaining thin band of hair around the sides of the head.

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

The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.

“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”

Biologics versus biosimilars

In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.

Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”

Systematic review

Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.

Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.

The researchers found the following:

At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.

At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.

In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.

At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.

At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).

Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.

Experts weigh in

Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.

However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.

“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”

Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.

“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.

Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.

“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”

Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.

Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.

The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.

“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”

Biologics versus biosimilars

In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.

Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”

Systematic review

Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.

Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.

The researchers found the following:

At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.

At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.

In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.

At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.

At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).

Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.

Experts weigh in

Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.

However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.

“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”

Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.

“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.

Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.

“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”

Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.

Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.

The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.

“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”

Biologics versus biosimilars

In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.

Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”

Systematic review

Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.

Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.

The researchers found the following:

At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.

At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.

In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.

At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.

At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).

Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.

Experts weigh in

Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.

However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.

“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”

Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.

“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.

Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.

“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”

Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.

Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.