Psoriasis

LAS VEGAS – Adults with localized psoriasis reported significant improvement in quality of life after 2 and 8 weeks of treatment with a combination topical suspension, based on data from 147 adults.

Calcipotriene 0.005% plus betamethasone diproprionate 0.064% (CBD) has shown safety and effectiveness in adults with psoriasis. Dr. Jerry Bagel, who is in group practice in East Windsor, N.J., and his colleagues documented real-life experiences with CBD and patient-reported outcomes. The findings were presented at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

Courtesy of the Centers for Disease Control and Prevention (CDC)

The average change in quality of life scores from baseline was –4.2 at week 2 and –5.5 at week 8; both were statistically significant. In addition, 38% and 42% of patients at 2 weeks and 8 weeks, respectively, met the secondary endpoint of at least a 5-point improvement on the Dermatology Life Quality Index (DLQI).

The mean percent change in the patients’ perceptions of itching was –19% at week 2 and –29% at week 8, based on an itch visual analog scale, Dr. Bagel noted. Patient satisfaction with treatment also was measured using the Treatment Satisfaction Questionnaire for Medication–9 (TSQM-9), and the average scores for treatment effectiveness, convenience, and satisfaction were greater than 65 on a scale of 0-100 at week 2 and week 8.

Dr. Bagel and his colleagues studied 147 adults aged 18 years and older; patients’ average age was 49 years. More than half (57%) were women; 78% of patients were white. Approximately 56% were characterized as having moderate disease, and the average disease duration was 11 years. Only two patients reported treatment-emergent adverse events, but these were deemed unrelated to the study drug by the researchers.

The findings were limited by the use of self-reports. However, “patients with an extensive history of psoriasis and various levels of disease severity were satisfied with the product” in this real-life treatment profile, he noted.

Dr. Bagel has served as a consultant, speaker, and investigator for multiple companies, including Leo Pharma, which sponsored this study. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]

LAS VEGAS – Adults with localized psoriasis reported significant improvement in quality of life after 2 and 8 weeks of treatment with a combination topical suspension, based on data from 147 adults.

Calcipotriene 0.005% plus betamethasone diproprionate 0.064% (CBD) has shown safety and effectiveness in adults with psoriasis. Dr. Jerry Bagel, who is in group practice in East Windsor, N.J., and his colleagues documented real-life experiences with CBD and patient-reported outcomes. The findings were presented at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

Courtesy of the Centers for Disease Control and Prevention (CDC)

The average change in quality of life scores from baseline was –4.2 at week 2 and –5.5 at week 8; both were statistically significant. In addition, 38% and 42% of patients at 2 weeks and 8 weeks, respectively, met the secondary endpoint of at least a 5-point improvement on the Dermatology Life Quality Index (DLQI).

The mean percent change in the patients’ perceptions of itching was –19% at week 2 and –29% at week 8, based on an itch visual analog scale, Dr. Bagel noted. Patient satisfaction with treatment also was measured using the Treatment Satisfaction Questionnaire for Medication–9 (TSQM-9), and the average scores for treatment effectiveness, convenience, and satisfaction were greater than 65 on a scale of 0-100 at week 2 and week 8.

Dr. Bagel and his colleagues studied 147 adults aged 18 years and older; patients’ average age was 49 years. More than half (57%) were women; 78% of patients were white. Approximately 56% were characterized as having moderate disease, and the average disease duration was 11 years. Only two patients reported treatment-emergent adverse events, but these were deemed unrelated to the study drug by the researchers.

The findings were limited by the use of self-reports. However, “patients with an extensive history of psoriasis and various levels of disease severity were satisfied with the product” in this real-life treatment profile, he noted.

Dr. Bagel has served as a consultant, speaker, and investigator for multiple companies, including Leo Pharma, which sponsored this study. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]

LAS VEGAS – Adults with localized psoriasis reported significant improvement in quality of life after 2 and 8 weeks of treatment with a combination topical suspension, based on data from 147 adults.

Calcipotriene 0.005% plus betamethasone diproprionate 0.064% (CBD) has shown safety and effectiveness in adults with psoriasis. Dr. Jerry Bagel, who is in group practice in East Windsor, N.J., and his colleagues documented real-life experiences with CBD and patient-reported outcomes. The findings were presented at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

Courtesy of the Centers for Disease Control and Prevention (CDC)

The average change in quality of life scores from baseline was –4.2 at week 2 and –5.5 at week 8; both were statistically significant. In addition, 38% and 42% of patients at 2 weeks and 8 weeks, respectively, met the secondary endpoint of at least a 5-point improvement on the Dermatology Life Quality Index (DLQI).

The mean percent change in the patients’ perceptions of itching was –19% at week 2 and –29% at week 8, based on an itch visual analog scale, Dr. Bagel noted. Patient satisfaction with treatment also was measured using the Treatment Satisfaction Questionnaire for Medication–9 (TSQM-9), and the average scores for treatment effectiveness, convenience, and satisfaction were greater than 65 on a scale of 0-100 at week 2 and week 8.

Dr. Bagel and his colleagues studied 147 adults aged 18 years and older; patients’ average age was 49 years. More than half (57%) were women; 78% of patients were white. Approximately 56% were characterized as having moderate disease, and the average disease duration was 11 years. Only two patients reported treatment-emergent adverse events, but these were deemed unrelated to the study drug by the researchers.

The findings were limited by the use of self-reports. However, “patients with an extensive history of psoriasis and various levels of disease severity were satisfied with the product” in this real-life treatment profile, he noted.

Dr. Bagel has served as a consultant, speaker, and investigator for multiple companies, including Leo Pharma, which sponsored this study. SDEF and this news organization are owned by Frontline Medical Communications.

[email protected]

AMSTERDAM– The spectacular long-term efficacy achieved with a novel biologic agent for psoriasis in a first-in-humans, proof-of-concept study has raised the prospect of clinical outcomes continuing to ratchet higher in the treatment of moderate-to-severe chronic plaque psoriasis.

How much higher? Six of nine treated patients followed long-term have maintained a PASI 100 response – that is, completely clear – for up to 66 months after a single subcutaneous injection of the agent known for now as BI 655066, Dr. James G. Krueger reported at the annual congress of the European Academy of Dermatology and Venereology.

“For me, this is one of the most interesting features of this proof-of-concept study,” he added. “If this kind of activity is confirmed in the ongoing phase IIb trial, I think this represents the potential for very long-term disease modification. This could become an important agent in the future to treat psoriasis.”

BI 655066 is a monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23. Unlike ustekinumab (Stelara), which blocks both IL-23 and IL-12, BI 655066 selectively blocks only IL-23, which Dr. Krueger believes is the central driving force in activating and sustaining the T-cell subsets responsible for the hyperproliferative and inflammatory reactions that define psoriasis.

“This study is all about testing for the specific pathogenic contribution of IL-23 to psoriasis in a first-in-humans study. Our findings really emphasize the importance of IL-23 in driving the key pathways of psoriasis,” observed Dr. Krueger, professor of investigative dermatology and director of the Milstein Medical Research Program at Rockefeller University, New York.

The study included 39 patients with moderate to severe plaque psoriasis. Their baseline PASI was 18, and they averaged more than a 20-year history of psoriasis. Twenty-four patients were randomized 3:1 to a single intravenous injection of BI 655066 at various doses ranging from 0.01 mg/kg to 5 mg/kg or to placebo in order to get an initial sense of the agent’s safety and tolerability.

In the second part of the study, 15 other participants received a single subcutaneous injection: two got placebo and the rest were randomized to BI 655066 at either 0.25 mg/kg or 1.0 mg/kg. Safety and efficacy were assessed at weeks 0, 2, 4, 12, and 24. In addition, skin biopsies were obtained at weeks 0 and 8 for immunohistochemistry studies and RNA sequencing analysis.

By week 12, the PASI 75 response rate in subcutaneous BI 655066 recipients was 87% and the PASI 90 rate was 58%. At week 24, nine patients elected to continue structured prospective follow-up while remaining off treatment, including six PASI 100 responders. Those six PASI 100 responders remained PASI 100 at ongoing follow-up 48-66 weeks after receiving their single dose of the agent.

Biopsy specimens obtained at week 8 showed normalization of the epidermal psoriasiform hyperplasia which had been present at baseline. A normal-looking granular layer had been reestablished. “This looks essentially like the pattern of normal or nonlesional skin,” according to the dermatologist.

RNA sequencing analysis and gene profiling showed normalized production of the IL-23/IL-17-induced proteins that had been strongly overexpressed at baseline, including lipocalin, beta-defensin, and psoriasin.

“The immune axis is turned down. The number of immune cells is way down, although they’re not completely eliminated. With placebo, you still see a psoriasislike pattern of the disease. With blockade of IL-23, most cases have a gene profile like nonlesional skin. This represents a profound cellular and disease modulation,” Dr. Krueger said.

Among all 39 participants, the only serious adverse event deemed possibly treatment related was a 5-minute transient ischemic attack (TIA) episode in a patient on BI 655066. This caught Dr. Krueger’s attention as a possible red flag; however, he noted that more than 200 patients have since received the biologic agent in the ongoing phase IIb trial, with no reported major adverse cardiovascular events.

“I think that TIA may just be bad luck with small numbers,” he added.

Asked what he thinks might explain the remarkably lengthy disease remission seen following a single dose of the biologic, Dr. Krueger offered two possibilities.

“It may be that IL-23 is necessary to sustain pathogenic clones of memory cells in the skin, and as we get rid of it those clones most likely apoptose. And if you’ve sufficiently removed the clones, then you don’t get the expansion. That’s guess one. Guess two would be that we’ve renormalized tolerance mechanisms in some way. Both of these hypotheses can be tested,” according to Dr. Krueger.

The study was funded by Boehringer Ingelheim. Dr. Krueger reported receiving funding from that pharmaceutical company and nearly two dozen others.

[email protected]

AMSTERDAM– The spectacular long-term efficacy achieved with a novel biologic agent for psoriasis in a first-in-humans, proof-of-concept study has raised the prospect of clinical outcomes continuing to ratchet higher in the treatment of moderate-to-severe chronic plaque psoriasis.

How much higher? Six of nine treated patients followed long-term have maintained a PASI 100 response – that is, completely clear – for up to 66 months after a single subcutaneous injection of the agent known for now as BI 655066, Dr. James G. Krueger reported at the annual congress of the European Academy of Dermatology and Venereology.

“For me, this is one of the most interesting features of this proof-of-concept study,” he added. “If this kind of activity is confirmed in the ongoing phase IIb trial, I think this represents the potential for very long-term disease modification. This could become an important agent in the future to treat psoriasis.”

BI 655066 is a monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23. Unlike ustekinumab (Stelara), which blocks both IL-23 and IL-12, BI 655066 selectively blocks only IL-23, which Dr. Krueger believes is the central driving force in activating and sustaining the T-cell subsets responsible for the hyperproliferative and inflammatory reactions that define psoriasis.

“This study is all about testing for the specific pathogenic contribution of IL-23 to psoriasis in a first-in-humans study. Our findings really emphasize the importance of IL-23 in driving the key pathways of psoriasis,” observed Dr. Krueger, professor of investigative dermatology and director of the Milstein Medical Research Program at Rockefeller University, New York.

The study included 39 patients with moderate to severe plaque psoriasis. Their baseline PASI was 18, and they averaged more than a 20-year history of psoriasis. Twenty-four patients were randomized 3:1 to a single intravenous injection of BI 655066 at various doses ranging from 0.01 mg/kg to 5 mg/kg or to placebo in order to get an initial sense of the agent’s safety and tolerability.

In the second part of the study, 15 other participants received a single subcutaneous injection: two got placebo and the rest were randomized to BI 655066 at either 0.25 mg/kg or 1.0 mg/kg. Safety and efficacy were assessed at weeks 0, 2, 4, 12, and 24. In addition, skin biopsies were obtained at weeks 0 and 8 for immunohistochemistry studies and RNA sequencing analysis.

By week 12, the PASI 75 response rate in subcutaneous BI 655066 recipients was 87% and the PASI 90 rate was 58%. At week 24, nine patients elected to continue structured prospective follow-up while remaining off treatment, including six PASI 100 responders. Those six PASI 100 responders remained PASI 100 at ongoing follow-up 48-66 weeks after receiving their single dose of the agent.

Biopsy specimens obtained at week 8 showed normalization of the epidermal psoriasiform hyperplasia which had been present at baseline. A normal-looking granular layer had been reestablished. “This looks essentially like the pattern of normal or nonlesional skin,” according to the dermatologist.

RNA sequencing analysis and gene profiling showed normalized production of the IL-23/IL-17-induced proteins that had been strongly overexpressed at baseline, including lipocalin, beta-defensin, and psoriasin.

“The immune axis is turned down. The number of immune cells is way down, although they’re not completely eliminated. With placebo, you still see a psoriasislike pattern of the disease. With blockade of IL-23, most cases have a gene profile like nonlesional skin. This represents a profound cellular and disease modulation,” Dr. Krueger said.

Among all 39 participants, the only serious adverse event deemed possibly treatment related was a 5-minute transient ischemic attack (TIA) episode in a patient on BI 655066. This caught Dr. Krueger’s attention as a possible red flag; however, he noted that more than 200 patients have since received the biologic agent in the ongoing phase IIb trial, with no reported major adverse cardiovascular events.

“I think that TIA may just be bad luck with small numbers,” he added.

Asked what he thinks might explain the remarkably lengthy disease remission seen following a single dose of the biologic, Dr. Krueger offered two possibilities.

“It may be that IL-23 is necessary to sustain pathogenic clones of memory cells in the skin, and as we get rid of it those clones most likely apoptose. And if you’ve sufficiently removed the clones, then you don’t get the expansion. That’s guess one. Guess two would be that we’ve renormalized tolerance mechanisms in some way. Both of these hypotheses can be tested,” according to Dr. Krueger.

The study was funded by Boehringer Ingelheim. Dr. Krueger reported receiving funding from that pharmaceutical company and nearly two dozen others.

[email protected]

AMSTERDAM– The spectacular long-term efficacy achieved with a novel biologic agent for psoriasis in a first-in-humans, proof-of-concept study has raised the prospect of clinical outcomes continuing to ratchet higher in the treatment of moderate-to-severe chronic plaque psoriasis.

How much higher? Six of nine treated patients followed long-term have maintained a PASI 100 response – that is, completely clear – for up to 66 months after a single subcutaneous injection of the agent known for now as BI 655066, Dr. James G. Krueger reported at the annual congress of the European Academy of Dermatology and Venereology.

“For me, this is one of the most interesting features of this proof-of-concept study,” he added. “If this kind of activity is confirmed in the ongoing phase IIb trial, I think this represents the potential for very long-term disease modification. This could become an important agent in the future to treat psoriasis.”

BI 655066 is a monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23. Unlike ustekinumab (Stelara), which blocks both IL-23 and IL-12, BI 655066 selectively blocks only IL-23, which Dr. Krueger believes is the central driving force in activating and sustaining the T-cell subsets responsible for the hyperproliferative and inflammatory reactions that define psoriasis.

“This study is all about testing for the specific pathogenic contribution of IL-23 to psoriasis in a first-in-humans study. Our findings really emphasize the importance of IL-23 in driving the key pathways of psoriasis,” observed Dr. Krueger, professor of investigative dermatology and director of the Milstein Medical Research Program at Rockefeller University, New York.

The study included 39 patients with moderate to severe plaque psoriasis. Their baseline PASI was 18, and they averaged more than a 20-year history of psoriasis. Twenty-four patients were randomized 3:1 to a single intravenous injection of BI 655066 at various doses ranging from 0.01 mg/kg to 5 mg/kg or to placebo in order to get an initial sense of the agent’s safety and tolerability.

In the second part of the study, 15 other participants received a single subcutaneous injection: two got placebo and the rest were randomized to BI 655066 at either 0.25 mg/kg or 1.0 mg/kg. Safety and efficacy were assessed at weeks 0, 2, 4, 12, and 24. In addition, skin biopsies were obtained at weeks 0 and 8 for immunohistochemistry studies and RNA sequencing analysis.

By week 12, the PASI 75 response rate in subcutaneous BI 655066 recipients was 87% and the PASI 90 rate was 58%. At week 24, nine patients elected to continue structured prospective follow-up while remaining off treatment, including six PASI 100 responders. Those six PASI 100 responders remained PASI 100 at ongoing follow-up 48-66 weeks after receiving their single dose of the agent.

Biopsy specimens obtained at week 8 showed normalization of the epidermal psoriasiform hyperplasia which had been present at baseline. A normal-looking granular layer had been reestablished. “This looks essentially like the pattern of normal or nonlesional skin,” according to the dermatologist.

RNA sequencing analysis and gene profiling showed normalized production of the IL-23/IL-17-induced proteins that had been strongly overexpressed at baseline, including lipocalin, beta-defensin, and psoriasin.

“The immune axis is turned down. The number of immune cells is way down, although they’re not completely eliminated. With placebo, you still see a psoriasislike pattern of the disease. With blockade of IL-23, most cases have a gene profile like nonlesional skin. This represents a profound cellular and disease modulation,” Dr. Krueger said.

Among all 39 participants, the only serious adverse event deemed possibly treatment related was a 5-minute transient ischemic attack (TIA) episode in a patient on BI 655066. This caught Dr. Krueger’s attention as a possible red flag; however, he noted that more than 200 patients have since received the biologic agent in the ongoing phase IIb trial, with no reported major adverse cardiovascular events.

“I think that TIA may just be bad luck with small numbers,” he added.

Asked what he thinks might explain the remarkably lengthy disease remission seen following a single dose of the biologic, Dr. Krueger offered two possibilities.

“It may be that IL-23 is necessary to sustain pathogenic clones of memory cells in the skin, and as we get rid of it those clones most likely apoptose. And if you’ve sufficiently removed the clones, then you don’t get the expansion. That’s guess one. Guess two would be that we’ve renormalized tolerance mechanisms in some way. Both of these hypotheses can be tested,” according to Dr. Krueger.

The study was funded by Boehringer Ingelheim. Dr. Krueger reported receiving funding from that pharmaceutical company and nearly two dozen others.

[email protected]

NEWPORT BEACH, CALIF. – A history of severe cradle cap and diaper dermatitis helps to differentiate between pediatric psoriasis and atopic dermatitis, so be sure to ask, according to Dr. Alan Menter, chief of the dermatology division at the Baylor University Medical Center in Dallas.

“Both are markers for later onset of psoriasis, and are much more likely to be a marker for psoriasis than atopic eczema,” he said at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

The tip to ask about cradle cap and diaper dermatitis is based largely on clinical observation, but is more useful than asking about a family history of psoriasis, because people tend to keep psoriasis to themselves, he noted; family members and even spouses might not know. “It’s a very hidden disease, so family history is of little benefit,” he said.

Recent strep infection also may provide a clue, not only for guttate psoriasis but also probably for plaque psoriasis in children, Dr. Menter said. But the sooner pediatric psoriasis is caught and controlled, the better, no matter how it is detected. Aside from the suffering it causes on its own, psoriasis in children has been linked to diabetes, hypertension, fatty liver disease, obesity, and cardiovascular problems, he noted.

The mechanism of action for these comorbidities remains under investigation. Perhaps mothers with psoriasis gain more weight during pregnancy, and their children are heavier at birth, Dr. Menter said.

Crohn’s disease is far more likely in children with psoriasis, too. Dr. Menter noted that he has had referrals where the diagnosis has been missed, even in the setting of long-standing fatigue and diarrhea. “We have to look for it [Crohn’s] in our psoriasis population,” he said.

Children with psoriasis are often teased, taunted, and bullied, sometimes as young as kindergarten age. The emotional stress, loneliness, and depression can have a major impact on school and social growth, Dr. Menter said.

“Treatment of these kids goes beyond prescribing a topical steroid; they need [both] physical and psychological support,” he emphasized. Talk to parents and teachers about how the child is doing in school and other social settings. Parents might know about grades, but not much about their child’s social interactions. To help catch problems, also “take a quality of life index on all your patients with psoriasis,” he said.

It’s important to intervene early and get children’s skin cleared quickly. “[Although] we’d love to treat [everybody] with topicals and wet compresses,” effective treatment sometimes means systemic therapy, he said.

Cyclosporine is a valid rescue option, particularly for more inflammatory disease. “Rarely, if ever, have I seen any hypertension or serum creatinine issues,” Dr. Menter said. “You just have to warn parents to be careful about gums, because you can get gingival hyperplasia, and girls don’t like the mild hypertrichosis you sometimes get around the temples and forearms,” he said.

Etanercept is another option. It not approved for pediatric psoriasis, but if you try hard enough, you can get insurance companies to cover it, Dr. Menter said. “You have to talk about quality of life and how psoriasis has impacted schooling,” among other topics, he explained.

Clinicians looking for child-oriented resources and support materials can recommend the National Psoriasis Foundation to their patients, he noted. SDEF and this news organization are owned by Frontline Medical Communications.

Dr. Menter disclosed financial relationships with Abbott, AbbVie, and numerous other companies.

[email protected]

NEWPORT BEACH, CALIF. – A history of severe cradle cap and diaper dermatitis helps to differentiate between pediatric psoriasis and atopic dermatitis, so be sure to ask, according to Dr. Alan Menter, chief of the dermatology division at the Baylor University Medical Center in Dallas.

“Both are markers for later onset of psoriasis, and are much more likely to be a marker for psoriasis than atopic eczema,” he said at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

The tip to ask about cradle cap and diaper dermatitis is based largely on clinical observation, but is more useful than asking about a family history of psoriasis, because people tend to keep psoriasis to themselves, he noted; family members and even spouses might not know. “It’s a very hidden disease, so family history is of little benefit,” he said.

Recent strep infection also may provide a clue, not only for guttate psoriasis but also probably for plaque psoriasis in children, Dr. Menter said. But the sooner pediatric psoriasis is caught and controlled, the better, no matter how it is detected. Aside from the suffering it causes on its own, psoriasis in children has been linked to diabetes, hypertension, fatty liver disease, obesity, and cardiovascular problems, he noted.

The mechanism of action for these comorbidities remains under investigation. Perhaps mothers with psoriasis gain more weight during pregnancy, and their children are heavier at birth, Dr. Menter said.

Crohn’s disease is far more likely in children with psoriasis, too. Dr. Menter noted that he has had referrals where the diagnosis has been missed, even in the setting of long-standing fatigue and diarrhea. “We have to look for it [Crohn’s] in our psoriasis population,” he said.

Children with psoriasis are often teased, taunted, and bullied, sometimes as young as kindergarten age. The emotional stress, loneliness, and depression can have a major impact on school and social growth, Dr. Menter said.

“Treatment of these kids goes beyond prescribing a topical steroid; they need [both] physical and psychological support,” he emphasized. Talk to parents and teachers about how the child is doing in school and other social settings. Parents might know about grades, but not much about their child’s social interactions. To help catch problems, also “take a quality of life index on all your patients with psoriasis,” he said.

It’s important to intervene early and get children’s skin cleared quickly. “[Although] we’d love to treat [everybody] with topicals and wet compresses,” effective treatment sometimes means systemic therapy, he said.

Cyclosporine is a valid rescue option, particularly for more inflammatory disease. “Rarely, if ever, have I seen any hypertension or serum creatinine issues,” Dr. Menter said. “You just have to warn parents to be careful about gums, because you can get gingival hyperplasia, and girls don’t like the mild hypertrichosis you sometimes get around the temples and forearms,” he said.

Etanercept is another option. It not approved for pediatric psoriasis, but if you try hard enough, you can get insurance companies to cover it, Dr. Menter said. “You have to talk about quality of life and how psoriasis has impacted schooling,” among other topics, he explained.

Clinicians looking for child-oriented resources and support materials can recommend the National Psoriasis Foundation to their patients, he noted. SDEF and this news organization are owned by Frontline Medical Communications.

Dr. Menter disclosed financial relationships with Abbott, AbbVie, and numerous other companies.

[email protected]

NEWPORT BEACH, CALIF. – A history of severe cradle cap and diaper dermatitis helps to differentiate between pediatric psoriasis and atopic dermatitis, so be sure to ask, according to Dr. Alan Menter, chief of the dermatology division at the Baylor University Medical Center in Dallas.

“Both are markers for later onset of psoriasis, and are much more likely to be a marker for psoriasis than atopic eczema,” he said at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

The tip to ask about cradle cap and diaper dermatitis is based largely on clinical observation, but is more useful than asking about a family history of psoriasis, because people tend to keep psoriasis to themselves, he noted; family members and even spouses might not know. “It’s a very hidden disease, so family history is of little benefit,” he said.

Recent strep infection also may provide a clue, not only for guttate psoriasis but also probably for plaque psoriasis in children, Dr. Menter said. But the sooner pediatric psoriasis is caught and controlled, the better, no matter how it is detected. Aside from the suffering it causes on its own, psoriasis in children has been linked to diabetes, hypertension, fatty liver disease, obesity, and cardiovascular problems, he noted.

The mechanism of action for these comorbidities remains under investigation. Perhaps mothers with psoriasis gain more weight during pregnancy, and their children are heavier at birth, Dr. Menter said.

Crohn’s disease is far more likely in children with psoriasis, too. Dr. Menter noted that he has had referrals where the diagnosis has been missed, even in the setting of long-standing fatigue and diarrhea. “We have to look for it [Crohn’s] in our psoriasis population,” he said.

Children with psoriasis are often teased, taunted, and bullied, sometimes as young as kindergarten age. The emotional stress, loneliness, and depression can have a major impact on school and social growth, Dr. Menter said.

“Treatment of these kids goes beyond prescribing a topical steroid; they need [both] physical and psychological support,” he emphasized. Talk to parents and teachers about how the child is doing in school and other social settings. Parents might know about grades, but not much about their child’s social interactions. To help catch problems, also “take a quality of life index on all your patients with psoriasis,” he said.

It’s important to intervene early and get children’s skin cleared quickly. “[Although] we’d love to treat [everybody] with topicals and wet compresses,” effective treatment sometimes means systemic therapy, he said.

Cyclosporine is a valid rescue option, particularly for more inflammatory disease. “Rarely, if ever, have I seen any hypertension or serum creatinine issues,” Dr. Menter said. “You just have to warn parents to be careful about gums, because you can get gingival hyperplasia, and girls don’t like the mild hypertrichosis you sometimes get around the temples and forearms,” he said.

Etanercept is another option. It not approved for pediatric psoriasis, but if you try hard enough, you can get insurance companies to cover it, Dr. Menter said. “You have to talk about quality of life and how psoriasis has impacted schooling,” among other topics, he explained.

Clinicians looking for child-oriented resources and support materials can recommend the National Psoriasis Foundation to their patients, he noted. SDEF and this news organization are owned by Frontline Medical Communications.

Dr. Menter disclosed financial relationships with Abbott, AbbVie, and numerous other companies.

[email protected]

VIENNA – Patients treated with an anti–tumor necrosis factor drug had a 5% annual rate of developing one or more psoriasiform skin lesions in a review of more than 400 patients who received these drugs to treat inflammatory bowel disease at a single center in Rome.

The cohort review confirmed prior reports that smoking is a risk factor for the appearance of psoriasislike skin lesions on patients being treated with an anti–tumor necrosis factor (TNF) drug, such as infliximab (Remicade) or adalimumab (Humira). The Rome experience also showed that in 28 of the 42 patients who developed a psoriasiform lesion, the eruption responded to topical treatment without need to stop or change the anti-TNF regimen. Ten of the 42 patients ultimately had to stop their anti-TNF regimen, Dr. Daniela Pugliese said at the United European Gastroenterology Global Congress.

Mitchel L. Zoler/Frontline Medical News

“There have been several case reports of this, but this is the largest cohort review yet reported by one center,” said Dr. Pugliese, a gastroenterologist in the inflammatory bowel disease (IBD) unit of Complesso Integrato Columbus, Catholic University in Rome.

The review included 402 patients treated with an anti-TNF drug at the unit during 2008-2013, with a median follow-up of 17 months. During follow-up, 42 patients developed a psoriasiform lesion with a biopsy-proven diagnosis, a rate of 5 cases/100 person-years on anti-TNF treatment. The IBD patients averaged 40 years old, and 60% had Crohn’s disease and 40% had ulcerative colitis. About 60% received infliximab treatment, and 40% adalimumab. Most lesions appeared in predilection sites, as well as on palmoplantar surfaces or on the scalp; nearly half the patients had lesions in two or more locations.

A multivariate regression analysis that assessed several demographic and clinical features of all 402 patients identified two parameters that significantly linked with lesion development. Smoking linked with a greater than twofold increased risk for having a psoriasiform lesion (78 of the patients, 19%, smoked), and concurrent treatment with a thiopurine such as azathioprine, linked with a 67% reduced rate of lesion development (85 patients, 21%, were on concurrent thiopurine treatment). All IBD patients seen at the Rome unit who smoked were counseled regarding smoking cessation, Dr. Pugliese said in an interview.

Among the patients who did not respond to topical treatment, four received some benefit from starting treatment with ustekinumab (Stelara), which especially benefited patients who were otherwise difficult to treat, Dr. Pugliese said. Other patients benefited from starting treatment with cyclosporine, methotrexate, or a transient treatment with an oral steroid. Two patients who developed lesions on infliximab switched to adalimumab, and two other patients who had lesions on adalimumab switched to infliximab.

Mitchel L. Zoler/Frontline Medical News

Dr. Pugliese and her associates did not have a good explanation of why patients on anti-TNF drugs develop these lesions, which Dr. Pugliese called “paradoxical.” One possible etiology is that inhibition of TNF-alpha results in uncontrolled production of interferon-alpha by plasmacytoid dendritic cells and this then triggers the psoriasiform eruptions.

A key element in managing these lesions may be early detection and topical treatment while they remain small, commented Dr. C. Janneke van der Woude, head of the IBD unit at Erasmus University Medical Center in Rotterdam, the Netherlands. “Every time we see an IBD patient who is on an anti-TNF drug, we ask whether they have had any itching, allergic reaction, arthritis, eye problem, or headache,” to facilitate early detection of an adverse effect from treatment, she said in an interview.

Dr. Pugliese had no disclosures. Dr. van der Woude said that she has been an adviser to Dr Falk, AbbVie, Janssen, Johnson & Johnson, and Cosmo.

[email protected]

On Twitter@mitchelzoler

VIENNA – Patients treated with an anti–tumor necrosis factor drug had a 5% annual rate of developing one or more psoriasiform skin lesions in a review of more than 400 patients who received these drugs to treat inflammatory bowel disease at a single center in Rome.

The cohort review confirmed prior reports that smoking is a risk factor for the appearance of psoriasislike skin lesions on patients being treated with an anti–tumor necrosis factor (TNF) drug, such as infliximab (Remicade) or adalimumab (Humira). The Rome experience also showed that in 28 of the 42 patients who developed a psoriasiform lesion, the eruption responded to topical treatment without need to stop or change the anti-TNF regimen. Ten of the 42 patients ultimately had to stop their anti-TNF regimen, Dr. Daniela Pugliese said at the United European Gastroenterology Global Congress.

Mitchel L. Zoler/Frontline Medical News

“There have been several case reports of this, but this is the largest cohort review yet reported by one center,” said Dr. Pugliese, a gastroenterologist in the inflammatory bowel disease (IBD) unit of Complesso Integrato Columbus, Catholic University in Rome.

The review included 402 patients treated with an anti-TNF drug at the unit during 2008-2013, with a median follow-up of 17 months. During follow-up, 42 patients developed a psoriasiform lesion with a biopsy-proven diagnosis, a rate of 5 cases/100 person-years on anti-TNF treatment. The IBD patients averaged 40 years old, and 60% had Crohn’s disease and 40% had ulcerative colitis. About 60% received infliximab treatment, and 40% adalimumab. Most lesions appeared in predilection sites, as well as on palmoplantar surfaces or on the scalp; nearly half the patients had lesions in two or more locations.

A multivariate regression analysis that assessed several demographic and clinical features of all 402 patients identified two parameters that significantly linked with lesion development. Smoking linked with a greater than twofold increased risk for having a psoriasiform lesion (78 of the patients, 19%, smoked), and concurrent treatment with a thiopurine such as azathioprine, linked with a 67% reduced rate of lesion development (85 patients, 21%, were on concurrent thiopurine treatment). All IBD patients seen at the Rome unit who smoked were counseled regarding smoking cessation, Dr. Pugliese said in an interview.

Among the patients who did not respond to topical treatment, four received some benefit from starting treatment with ustekinumab (Stelara), which especially benefited patients who were otherwise difficult to treat, Dr. Pugliese said. Other patients benefited from starting treatment with cyclosporine, methotrexate, or a transient treatment with an oral steroid. Two patients who developed lesions on infliximab switched to adalimumab, and two other patients who had lesions on adalimumab switched to infliximab.

Mitchel L. Zoler/Frontline Medical News

Dr. Pugliese and her associates did not have a good explanation of why patients on anti-TNF drugs develop these lesions, which Dr. Pugliese called “paradoxical.” One possible etiology is that inhibition of TNF-alpha results in uncontrolled production of interferon-alpha by plasmacytoid dendritic cells and this then triggers the psoriasiform eruptions.

A key element in managing these lesions may be early detection and topical treatment while they remain small, commented Dr. C. Janneke van der Woude, head of the IBD unit at Erasmus University Medical Center in Rotterdam, the Netherlands. “Every time we see an IBD patient who is on an anti-TNF drug, we ask whether they have had any itching, allergic reaction, arthritis, eye problem, or headache,” to facilitate early detection of an adverse effect from treatment, she said in an interview.

Dr. Pugliese had no disclosures. Dr. van der Woude said that she has been an adviser to Dr Falk, AbbVie, Janssen, Johnson & Johnson, and Cosmo.

[email protected]

On Twitter@mitchelzoler

VIENNA – Patients treated with an anti–tumor necrosis factor drug had a 5% annual rate of developing one or more psoriasiform skin lesions in a review of more than 400 patients who received these drugs to treat inflammatory bowel disease at a single center in Rome.

The cohort review confirmed prior reports that smoking is a risk factor for the appearance of psoriasislike skin lesions on patients being treated with an anti–tumor necrosis factor (TNF) drug, such as infliximab (Remicade) or adalimumab (Humira). The Rome experience also showed that in 28 of the 42 patients who developed a psoriasiform lesion, the eruption responded to topical treatment without need to stop or change the anti-TNF regimen. Ten of the 42 patients ultimately had to stop their anti-TNF regimen, Dr. Daniela Pugliese said at the United European Gastroenterology Global Congress.

Mitchel L. Zoler/Frontline Medical News

“There have been several case reports of this, but this is the largest cohort review yet reported by one center,” said Dr. Pugliese, a gastroenterologist in the inflammatory bowel disease (IBD) unit of Complesso Integrato Columbus, Catholic University in Rome.

The review included 402 patients treated with an anti-TNF drug at the unit during 2008-2013, with a median follow-up of 17 months. During follow-up, 42 patients developed a psoriasiform lesion with a biopsy-proven diagnosis, a rate of 5 cases/100 person-years on anti-TNF treatment. The IBD patients averaged 40 years old, and 60% had Crohn’s disease and 40% had ulcerative colitis. About 60% received infliximab treatment, and 40% adalimumab. Most lesions appeared in predilection sites, as well as on palmoplantar surfaces or on the scalp; nearly half the patients had lesions in two or more locations.

A multivariate regression analysis that assessed several demographic and clinical features of all 402 patients identified two parameters that significantly linked with lesion development. Smoking linked with a greater than twofold increased risk for having a psoriasiform lesion (78 of the patients, 19%, smoked), and concurrent treatment with a thiopurine such as azathioprine, linked with a 67% reduced rate of lesion development (85 patients, 21%, were on concurrent thiopurine treatment). All IBD patients seen at the Rome unit who smoked were counseled regarding smoking cessation, Dr. Pugliese said in an interview.

Among the patients who did not respond to topical treatment, four received some benefit from starting treatment with ustekinumab (Stelara), which especially benefited patients who were otherwise difficult to treat, Dr. Pugliese said. Other patients benefited from starting treatment with cyclosporine, methotrexate, or a transient treatment with an oral steroid. Two patients who developed lesions on infliximab switched to adalimumab, and two other patients who had lesions on adalimumab switched to infliximab.

Mitchel L. Zoler/Frontline Medical News

Dr. Pugliese and her associates did not have a good explanation of why patients on anti-TNF drugs develop these lesions, which Dr. Pugliese called “paradoxical.” One possible etiology is that inhibition of TNF-alpha results in uncontrolled production of interferon-alpha by plasmacytoid dendritic cells and this then triggers the psoriasiform eruptions.

A key element in managing these lesions may be early detection and topical treatment while they remain small, commented Dr. C. Janneke van der Woude, head of the IBD unit at Erasmus University Medical Center in Rotterdam, the Netherlands. “Every time we see an IBD patient who is on an anti-TNF drug, we ask whether they have had any itching, allergic reaction, arthritis, eye problem, or headache,” to facilitate early detection of an adverse effect from treatment, she said in an interview.

Dr. Pugliese had no disclosures. Dr. van der Woude said that she has been an adviser to Dr Falk, AbbVie, Janssen, Johnson & Johnson, and Cosmo.

[email protected]

On Twitter@mitchelzoler

SONOMA, CALIF.– Data support dosage escalation or intensification for patients who don’t respond to biologic therapy for psoriasis, but only for three of the four biologic agents available in the United States, Dr. April W. Armstrong said at the annual Coastal Dermatology Symposium.

It may make sense to increase the dose or shorten the intervals between doses in some patients with psoriasis who don’t respond to etanercept, adalimumab, or ustekinumab, she suggested.

For infliximab, however, increasing the standard 5-mg/kg dose to 10 mg/kg in nonresponders did not significantly improve efficacy in one randomized study of patients with moderate to severe psoriasis. Consider combination therapy instead of dose escalation in those patients, said Dr. Armstrong, director of the psoriasis program at the University of Colorado, Denver.

Most clinical trials of dose escalation for psoriasis target patients in whom conventional doses produce only a partial response, defined as a Psoriasis Area and Severity Index (PASI) score of 50-75, or no response, defined as a PASI score below 50, she said.

A conventional dosage of etanercept for psoriasis uses 50 mg twice weekly for 12 weeks, followed by 50 mg once weekly for maintenance, Dr. Armstrong said. In an open-label extension of a study of 912 patients with moderate to severe psoriasis who received 12 weeks of etanercept therapy, nonresponders who escalated the maintenance dosage to 50 mg twice weekly boosted the likelihood of achieving a PASI 75 from 33% at 12 weeks to 44% at 48 weeks and 43% at 72 weeks (J. Drugs Dermatol. 2010;9:928-37).

Safety profiles were similar between standard dosing and escalated or intensified dosing in studies of all four biologic therapies, Dr. Armstrong said at the symposium, jointly presented by the University of Louisville (Ky.) and the Global Academy for Medical Education.

In the etanercept study, rates of serious infections were 0.9 events per 100 patient-years on standard maintenance therapy and 1.9 events per 100 patient-years on the escalated dosage. Myocardial infarctions occurred in none of 321 patients on standard maintenance therapy and in 2 of 591 patients on the twice-weekly dosage.

The conventional dosage of adalimumab for psoriasis is 80 mg at the start of therapy, followed by 40 mg every other week starting at week 1. In an open-label extension of a study of 147 patients, those who did not achieve a PASI 50 by week 25 were allowed to escalate the maintenance therapy dosage to 40 mg weekly. By week 60, 64% of patients in the dose-escalation group achieved a PASI 75, compared with 56% of patients who had been on the standard regimen and 45% of patients who had started with placebo for 12 weeks and then went on the standard dosage (J. Am. Acad. Dermatol. 2006;55:598-606). The mean PASI score improved by 27% after 8 weeks on the escalated dose, Dr. Armstrong said.

Three malignancies and two cardiovascular events (one leading to death) developed in the escalated-dosage group, compared with two malignancies and a serious case of coccidiomycosis in the standard-therapy group, she noted.

The conventional dosage for ustekinumab is 45 mg in patients weighing up to 100 kg or 90 mg in heavier patients, administered in subcutaneous injections at weeks 0 and 4, then every 12 weeks thereafter. In the only head-to-head study comparing biologic therapies for psoriasis, ustekinumab was more effective than etanercept in the first 3 months, Dr. Armstrong noted. The 12-week Active Comparator (CNTO1275/Enbrel) Psoriasis Trial (ACCEPT) found that 74% of 347 patients on 90 mg of ustekinumab and 68% of 209 patients on 45 mg of ustekinumab achieved a PASI 75, compared with 57% of 347 patients on etanercept (N. Engl. J. Med. 2010;362:118-28).

In a separate study of 158 patients with psoriasis who only partially responded to standard ustekinumab therapy after 24 weeks, maintenance dose escalation to every 8 weeks instead of 12 significantly improved response rates in patients on 90 mg but not in those on 45 mg. By week 52, 69% of patients receiving 90 mg ustekinumab every 8 weeks achieved a PASI 75, compared with 33% of patients on ustekinumab 90 mg every 12 weeks (Lancet 2008;371:1675-84). In the patients on 45 mg ustekinumab, the proportions achieving PASI 75 by week 52 did not differ significantly between those receiving the drug every 8 or 12 weeks.

One cutaneous malignancy, one noncutaneous malignancy, and two other serious adverse events occurred in the intensified-therapy groups, compared with one serious infection and two other serious adverse events in the standard-therapy groups.

The conventional dosage of infliximab for psoriasis is 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks. A study that randomized 33 patients with moderate to severe psoriasis to 10 weeks of therapy with placebo or 5 mg/kg or 10 mg/kg of infliximab at weeks 0, 2, and 6 found that 91% of patients on the escalated dose and 82% on the standard dose of infliximab achieved a Physician Global Assessment score of good, excellent, or clear, compared with 18% of patients on placebo (Lancet 2001;357:1842-7).

The proportions of patients achieving a PASI 75 were not significantly different between the standard-dosage group and the escalated-dosage group (82% vs. 73%, respectively), although both were significantly higher than in the placebo group (18%). “So, there’s not much difference if you give 5 or 10 mg/kg” of infliximab, Dr. Armstrong said.

One of 11 patients on 5 mg/kg infliximab developed a dental abscess, and 1 of 11 patients on 10 mg/kg infliximab developed pneumonia.

Dr. Armstrong reported financial associations with AbbVie, Amgen, Celgene, Lilly, Novartis, Merck, Pfizer, UCB, Modernizing Medicine, and Janssen. This publication and the Global Academy for Medical Education are owned by the same parent company.

[email protected]

On Twitter @sherryboschert

SONOMA, CALIF.– Data support dosage escalation or intensification for patients who don’t respond to biologic therapy for psoriasis, but only for three of the four biologic agents available in the United States, Dr. April W. Armstrong said at the annual Coastal Dermatology Symposium.

It may make sense to increase the dose or shorten the intervals between doses in some patients with psoriasis who don’t respond to etanercept, adalimumab, or ustekinumab, she suggested.

For infliximab, however, increasing the standard 5-mg/kg dose to 10 mg/kg in nonresponders did not significantly improve efficacy in one randomized study of patients with moderate to severe psoriasis. Consider combination therapy instead of dose escalation in those patients, said Dr. Armstrong, director of the psoriasis program at the University of Colorado, Denver.

Most clinical trials of dose escalation for psoriasis target patients in whom conventional doses produce only a partial response, defined as a Psoriasis Area and Severity Index (PASI) score of 50-75, or no response, defined as a PASI score below 50, she said.

A conventional dosage of etanercept for psoriasis uses 50 mg twice weekly for 12 weeks, followed by 50 mg once weekly for maintenance, Dr. Armstrong said. In an open-label extension of a study of 912 patients with moderate to severe psoriasis who received 12 weeks of etanercept therapy, nonresponders who escalated the maintenance dosage to 50 mg twice weekly boosted the likelihood of achieving a PASI 75 from 33% at 12 weeks to 44% at 48 weeks and 43% at 72 weeks (J. Drugs Dermatol. 2010;9:928-37).

Safety profiles were similar between standard dosing and escalated or intensified dosing in studies of all four biologic therapies, Dr. Armstrong said at the symposium, jointly presented by the University of Louisville (Ky.) and the Global Academy for Medical Education.

In the etanercept study, rates of serious infections were 0.9 events per 100 patient-years on standard maintenance therapy and 1.9 events per 100 patient-years on the escalated dosage. Myocardial infarctions occurred in none of 321 patients on standard maintenance therapy and in 2 of 591 patients on the twice-weekly dosage.

The conventional dosage of adalimumab for psoriasis is 80 mg at the start of therapy, followed by 40 mg every other week starting at week 1. In an open-label extension of a study of 147 patients, those who did not achieve a PASI 50 by week 25 were allowed to escalate the maintenance therapy dosage to 40 mg weekly. By week 60, 64% of patients in the dose-escalation group achieved a PASI 75, compared with 56% of patients who had been on the standard regimen and 45% of patients who had started with placebo for 12 weeks and then went on the standard dosage (J. Am. Acad. Dermatol. 2006;55:598-606). The mean PASI score improved by 27% after 8 weeks on the escalated dose, Dr. Armstrong said.

Three malignancies and two cardiovascular events (one leading to death) developed in the escalated-dosage group, compared with two malignancies and a serious case of coccidiomycosis in the standard-therapy group, she noted.

The conventional dosage for ustekinumab is 45 mg in patients weighing up to 100 kg or 90 mg in heavier patients, administered in subcutaneous injections at weeks 0 and 4, then every 12 weeks thereafter. In the only head-to-head study comparing biologic therapies for psoriasis, ustekinumab was more effective than etanercept in the first 3 months, Dr. Armstrong noted. The 12-week Active Comparator (CNTO1275/Enbrel) Psoriasis Trial (ACCEPT) found that 74% of 347 patients on 90 mg of ustekinumab and 68% of 209 patients on 45 mg of ustekinumab achieved a PASI 75, compared with 57% of 347 patients on etanercept (N. Engl. J. Med. 2010;362:118-28).

In a separate study of 158 patients with psoriasis who only partially responded to standard ustekinumab therapy after 24 weeks, maintenance dose escalation to every 8 weeks instead of 12 significantly improved response rates in patients on 90 mg but not in those on 45 mg. By week 52, 69% of patients receiving 90 mg ustekinumab every 8 weeks achieved a PASI 75, compared with 33% of patients on ustekinumab 90 mg every 12 weeks (Lancet 2008;371:1675-84). In the patients on 45 mg ustekinumab, the proportions achieving PASI 75 by week 52 did not differ significantly between those receiving the drug every 8 or 12 weeks.

One cutaneous malignancy, one noncutaneous malignancy, and two other serious adverse events occurred in the intensified-therapy groups, compared with one serious infection and two other serious adverse events in the standard-therapy groups.

The conventional dosage of infliximab for psoriasis is 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks. A study that randomized 33 patients with moderate to severe psoriasis to 10 weeks of therapy with placebo or 5 mg/kg or 10 mg/kg of infliximab at weeks 0, 2, and 6 found that 91% of patients on the escalated dose and 82% on the standard dose of infliximab achieved a Physician Global Assessment score of good, excellent, or clear, compared with 18% of patients on placebo (Lancet 2001;357:1842-7).

The proportions of patients achieving a PASI 75 were not significantly different between the standard-dosage group and the escalated-dosage group (82% vs. 73%, respectively), although both were significantly higher than in the placebo group (18%). “So, there’s not much difference if you give 5 or 10 mg/kg” of infliximab, Dr. Armstrong said.

One of 11 patients on 5 mg/kg infliximab developed a dental abscess, and 1 of 11 patients on 10 mg/kg infliximab developed pneumonia.

Dr. Armstrong reported financial associations with AbbVie, Amgen, Celgene, Lilly, Novartis, Merck, Pfizer, UCB, Modernizing Medicine, and Janssen. This publication and the Global Academy for Medical Education are owned by the same parent company.

[email protected]

On Twitter @sherryboschert

SONOMA, CALIF.– Data support dosage escalation or intensification for patients who don’t respond to biologic therapy for psoriasis, but only for three of the four biologic agents available in the United States, Dr. April W. Armstrong said at the annual Coastal Dermatology Symposium.

It may make sense to increase the dose or shorten the intervals between doses in some patients with psoriasis who don’t respond to etanercept, adalimumab, or ustekinumab, she suggested.

For infliximab, however, increasing the standard 5-mg/kg dose to 10 mg/kg in nonresponders did not significantly improve efficacy in one randomized study of patients with moderate to severe psoriasis. Consider combination therapy instead of dose escalation in those patients, said Dr. Armstrong, director of the psoriasis program at the University of Colorado, Denver.

Most clinical trials of dose escalation for psoriasis target patients in whom conventional doses produce only a partial response, defined as a Psoriasis Area and Severity Index (PASI) score of 50-75, or no response, defined as a PASI score below 50, she said.

A conventional dosage of etanercept for psoriasis uses 50 mg twice weekly for 12 weeks, followed by 50 mg once weekly for maintenance, Dr. Armstrong said. In an open-label extension of a study of 912 patients with moderate to severe psoriasis who received 12 weeks of etanercept therapy, nonresponders who escalated the maintenance dosage to 50 mg twice weekly boosted the likelihood of achieving a PASI 75 from 33% at 12 weeks to 44% at 48 weeks and 43% at 72 weeks (J. Drugs Dermatol. 2010;9:928-37).

Safety profiles were similar between standard dosing and escalated or intensified dosing in studies of all four biologic therapies, Dr. Armstrong said at the symposium, jointly presented by the University of Louisville (Ky.) and the Global Academy for Medical Education.

In the etanercept study, rates of serious infections were 0.9 events per 100 patient-years on standard maintenance therapy and 1.9 events per 100 patient-years on the escalated dosage. Myocardial infarctions occurred in none of 321 patients on standard maintenance therapy and in 2 of 591 patients on the twice-weekly dosage.

The conventional dosage of adalimumab for psoriasis is 80 mg at the start of therapy, followed by 40 mg every other week starting at week 1. In an open-label extension of a study of 147 patients, those who did not achieve a PASI 50 by week 25 were allowed to escalate the maintenance therapy dosage to 40 mg weekly. By week 60, 64% of patients in the dose-escalation group achieved a PASI 75, compared with 56% of patients who had been on the standard regimen and 45% of patients who had started with placebo for 12 weeks and then went on the standard dosage (J. Am. Acad. Dermatol. 2006;55:598-606). The mean PASI score improved by 27% after 8 weeks on the escalated dose, Dr. Armstrong said.

Three malignancies and two cardiovascular events (one leading to death) developed in the escalated-dosage group, compared with two malignancies and a serious case of coccidiomycosis in the standard-therapy group, she noted.

The conventional dosage for ustekinumab is 45 mg in patients weighing up to 100 kg or 90 mg in heavier patients, administered in subcutaneous injections at weeks 0 and 4, then every 12 weeks thereafter. In the only head-to-head study comparing biologic therapies for psoriasis, ustekinumab was more effective than etanercept in the first 3 months, Dr. Armstrong noted. The 12-week Active Comparator (CNTO1275/Enbrel) Psoriasis Trial (ACCEPT) found that 74% of 347 patients on 90 mg of ustekinumab and 68% of 209 patients on 45 mg of ustekinumab achieved a PASI 75, compared with 57% of 347 patients on etanercept (N. Engl. J. Med. 2010;362:118-28).

In a separate study of 158 patients with psoriasis who only partially responded to standard ustekinumab therapy after 24 weeks, maintenance dose escalation to every 8 weeks instead of 12 significantly improved response rates in patients on 90 mg but not in those on 45 mg. By week 52, 69% of patients receiving 90 mg ustekinumab every 8 weeks achieved a PASI 75, compared with 33% of patients on ustekinumab 90 mg every 12 weeks (Lancet 2008;371:1675-84). In the patients on 45 mg ustekinumab, the proportions achieving PASI 75 by week 52 did not differ significantly between those receiving the drug every 8 or 12 weeks.

One cutaneous malignancy, one noncutaneous malignancy, and two other serious adverse events occurred in the intensified-therapy groups, compared with one serious infection and two other serious adverse events in the standard-therapy groups.

The conventional dosage of infliximab for psoriasis is 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks. A study that randomized 33 patients with moderate to severe psoriasis to 10 weeks of therapy with placebo or 5 mg/kg or 10 mg/kg of infliximab at weeks 0, 2, and 6 found that 91% of patients on the escalated dose and 82% on the standard dose of infliximab achieved a Physician Global Assessment score of good, excellent, or clear, compared with 18% of patients on placebo (Lancet 2001;357:1842-7).

The proportions of patients achieving a PASI 75 were not significantly different between the standard-dosage group and the escalated-dosage group (82% vs. 73%, respectively), although both were significantly higher than in the placebo group (18%). “So, there’s not much difference if you give 5 or 10 mg/kg” of infliximab, Dr. Armstrong said.

One of 11 patients on 5 mg/kg infliximab developed a dental abscess, and 1 of 11 patients on 10 mg/kg infliximab developed pneumonia.

Dr. Armstrong reported financial associations with AbbVie, Amgen, Celgene, Lilly, Novartis, Merck, Pfizer, UCB, Modernizing Medicine, and Janssen. This publication and the Global Academy for Medical Education are owned by the same parent company.

[email protected]

On Twitter @sherryboschert

Psoriasis is associated with multiple comorbidities, including cardiovascular diseases. With the advent of anti-inflammatory therapy, there has been much investigation into whether treatments for psoriasis may reduce the risk for cardiovascular events. In a Journal of the European Academy of Dermatology and Venereology article published online on October 10, Ahlehoff et al examined the rate of cardiovascular events—cardiovascular death, myocardial infarction, and stroke—in patients with severe psoriasis treated with systemic anti-inflammatory drugs.

Individual-level linkage of administrative registries was utilized to perform a longitudinal nationwide cohort study in Denmark. Time-dependent multivariable adjusted Cox regression was used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) of cardiovascular events associated with use of biological drugs, methotrexate, cyclosporine, retinoids, and other antipsoriatic therapies (ie, topical treatments, phototherapy, climate therapy).

The investigators included a total of 6902 patients (9662 treatment exposures) with a maximum follow-up of 5 years. Incidence rates per 1000 patient-years for cardiovascular events were highest for retinoids and other therapies (18.95 and 14.63, respectively) followed by methotrexate, cyclosporine, and biological drugs (6.28, 6.08, and 4.16, respectively). Relative to other therapies, methotrexate (HR, 0.53; 95% CI, 0.34-0.83) was associated with reduced risk for the composite end point. A comparable but nonsignificant protective effect was observed with biological drugs (HR, 0.58; 95% CI, 0.30-1.10), whereas no protective effect was apparent with cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) and retinoids (HR, 1.80; 95% CI, 1.03-2.96). Tumor necrosis factor inhibitors (HR, 0.46; 95% CI, 0.22-0.98) were linked to reduced event rates but the IL-12/IL-23 inhibitor ustekinumab (HR, 1.52; 95% CI, 0.47-4.94) was not.

The authors concluded that systemic anti-inflammatory treatment with methotrexate was associated with lower rates of cardiovascular events during long-term follow-up compared to patients treated with other antipsoriatic therapies.

What’s the issue?

This study is consistent with other investigations evaluating the cardioprotective benefit of therapies for psoriasis. The cardioprotective benefits of methotrexate and tumor necrosis factor inhibitors have been previously reported. Further investigation will help to elucidate the role of these drugs as well as newer therapies in the reduction of comorbidities. Does this study influence your perception of therapies for psoriasis?

We want to know your views! Tell us what you think.

Psoriasis is associated with multiple comorbidities, including cardiovascular diseases. With the advent of anti-inflammatory therapy, there has been much investigation into whether treatments for psoriasis may reduce the risk for cardiovascular events. In a Journal of the European Academy of Dermatology and Venereology article published online on October 10, Ahlehoff et al examined the rate of cardiovascular events—cardiovascular death, myocardial infarction, and stroke—in patients with severe psoriasis treated with systemic anti-inflammatory drugs.

Individual-level linkage of administrative registries was utilized to perform a longitudinal nationwide cohort study in Denmark. Time-dependent multivariable adjusted Cox regression was used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) of cardiovascular events associated with use of biological drugs, methotrexate, cyclosporine, retinoids, and other antipsoriatic therapies (ie, topical treatments, phototherapy, climate therapy).

The investigators included a total of 6902 patients (9662 treatment exposures) with a maximum follow-up of 5 years. Incidence rates per 1000 patient-years for cardiovascular events were highest for retinoids and other therapies (18.95 and 14.63, respectively) followed by methotrexate, cyclosporine, and biological drugs (6.28, 6.08, and 4.16, respectively). Relative to other therapies, methotrexate (HR, 0.53; 95% CI, 0.34-0.83) was associated with reduced risk for the composite end point. A comparable but nonsignificant protective effect was observed with biological drugs (HR, 0.58; 95% CI, 0.30-1.10), whereas no protective effect was apparent with cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) and retinoids (HR, 1.80; 95% CI, 1.03-2.96). Tumor necrosis factor inhibitors (HR, 0.46; 95% CI, 0.22-0.98) were linked to reduced event rates but the IL-12/IL-23 inhibitor ustekinumab (HR, 1.52; 95% CI, 0.47-4.94) was not.

The authors concluded that systemic anti-inflammatory treatment with methotrexate was associated with lower rates of cardiovascular events during long-term follow-up compared to patients treated with other antipsoriatic therapies.

What’s the issue?

This study is consistent with other investigations evaluating the cardioprotective benefit of therapies for psoriasis. The cardioprotective benefits of methotrexate and tumor necrosis factor inhibitors have been previously reported. Further investigation will help to elucidate the role of these drugs as well as newer therapies in the reduction of comorbidities. Does this study influence your perception of therapies for psoriasis?

We want to know your views! Tell us what you think.

Psoriasis is associated with multiple comorbidities, including cardiovascular diseases. With the advent of anti-inflammatory therapy, there has been much investigation into whether treatments for psoriasis may reduce the risk for cardiovascular events. In a Journal of the European Academy of Dermatology and Venereology article published online on October 10, Ahlehoff et al examined the rate of cardiovascular events—cardiovascular death, myocardial infarction, and stroke—in patients with severe psoriasis treated with systemic anti-inflammatory drugs.

Individual-level linkage of administrative registries was utilized to perform a longitudinal nationwide cohort study in Denmark. Time-dependent multivariable adjusted Cox regression was used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) of cardiovascular events associated with use of biological drugs, methotrexate, cyclosporine, retinoids, and other antipsoriatic therapies (ie, topical treatments, phototherapy, climate therapy).

The investigators included a total of 6902 patients (9662 treatment exposures) with a maximum follow-up of 5 years. Incidence rates per 1000 patient-years for cardiovascular events were highest for retinoids and other therapies (18.95 and 14.63, respectively) followed by methotrexate, cyclosporine, and biological drugs (6.28, 6.08, and 4.16, respectively). Relative to other therapies, methotrexate (HR, 0.53; 95% CI, 0.34-0.83) was associated with reduced risk for the composite end point. A comparable but nonsignificant protective effect was observed with biological drugs (HR, 0.58; 95% CI, 0.30-1.10), whereas no protective effect was apparent with cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) and retinoids (HR, 1.80; 95% CI, 1.03-2.96). Tumor necrosis factor inhibitors (HR, 0.46; 95% CI, 0.22-0.98) were linked to reduced event rates but the IL-12/IL-23 inhibitor ustekinumab (HR, 1.52; 95% CI, 0.47-4.94) was not.

The authors concluded that systemic anti-inflammatory treatment with methotrexate was associated with lower rates of cardiovascular events during long-term follow-up compared to patients treated with other antipsoriatic therapies.

What’s the issue?

This study is consistent with other investigations evaluating the cardioprotective benefit of therapies for psoriasis. The cardioprotective benefits of methotrexate and tumor necrosis factor inhibitors have been previously reported. Further investigation will help to elucidate the role of these drugs as well as newer therapies in the reduction of comorbidities. Does this study influence your perception of therapies for psoriasis?

We want to know your views! Tell us what you think.

SILVER SPRING, MD. – The human monoclonal antibody secukinumab is expected to be the first biologic that targets interleukin-17A to be approved by the agency for treating psoriasis, with a Food and Drug Administration advisory panel’s unanimous support for the approval.

At a meeting on Oct. 20, the FDA’s Dermatologic and Ophthalmic Drugs Advisory committee voted 7-0 to recommend approval of secukinumab for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the indication proposed by Novartis Pharmaceuticals. Secukinumab “selectively binds and neutralizes” IL-17A, a proinflammatory cytokine “that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis,” according to the company.

If approved, secukinumab would be the first IL-17A blocker available and would be available in a lyophilized formulation for reconstitution, and in a liquid formulation in a refilled syringe or autoinjector pen. The 300-mg dose was determined to be the best dose to achieve clear or almost clear skin, with a favorable safety profile that was comparable to that of the 150-mg dose, which was also studied in phase II and III studies, according to Novartis. The company has proposed a dose of 300 mg, administered with a subcutaneous injection, at 0, 1, 2, 3, and 4 weeks, followed by 300 mg once a month.

The panel agreed that the 300-mg dose was effective with an acceptable risk-benefit profile, but agreed that it would be useful to have the 150-mg dose, which was also effective in trials, be available as well. The panel also recommended that the 450-mg dose, which was not formally studied, be evaluated further in postmarketing studies, because it could be useful in nonresponders and for heavier patients weighing 90 kg (about 198 pounds) or more, because of evidence that the 300-mg dose was less effective in heavier patients.

Secukinumab has been studied in 10 phase II and III studies of almost 4,000 patients with psoriasis. In the two main phase III studies, the 150-mg and 300-mg doses were compared with placebo (and to a formulation of etanercept not available in the United States in one study); the primary endpoints were the Psoriasis Area and Severity Index (PASI) 75, a 75% improvement of psoriasis from baseline, and an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin).

In one study of 738 patients, PASI 75 scores at 12 weeks were achieved by almost 82% and almost 72% of those on the 300-mg and 150-mg doses respectively, vs. 4.5% of those on placebo. In the second study, PASI 75 scores at 12 weeks were achieved by 77% and 67% of those on the 300-mg and 150-mg doses respectively, vs. almost 5% of those on placebo. About 63%-65% of those on the 300-mg dose and about 51% of those on the 150-mg dose had an IGA of 0/1 at 12 weeks, vs. about 2.4%-2.8% of those on placebo. Differences in the responses were sustained at week 52, according to Novartis.

Concentration of the drug decreases as body weight increases, and in studies, weight had a significant effect on efficacy results. The proportion of patients who achieved the PASI 75 and IGA 0/1 endpoints was higher among those weighing under 90 kg than those weighing 90 kg or more at both the 150-mg and 300-mg doses tested.

Pooled data of phase III trial data were used to evaluate safety over 12 and 52 weeks. Serious infections, malignancies and serious cardiovascular events were low; there were no reports of reactivation of latent tuberculosis. No deaths were reported related to treatment. During the first 12 weeks of treatment, there was a higher rate of nonserious upper respiratory infections among the treated patients, and superficial Candida infections were more common among those on the 300-mg dose (1.2%) than among those on the 150-mg dose (0.4%) and placebo (0.3%). The FDA’s analysis of safety concluded that infection rates “tend to increase” as the concentration of secukinumab increases, but that most adverse events associated with greater exposure in patients weighing less than 90 kg were mild to moderate.

The panel agreed with the company’s plan to follow long-term safety in a postmarketing registry of patients with moderate to severe psoriasis, in at least 2,000 patients treated with secukinumab, 2,500 treated with other biologics, and 500 treated with other systemic medications. One panelist also recommended that long-term safety be evaluated in studies using large administrative databases for outcomes including malignancies and autoimmune events.

The FDA is expected to decide on approval by early 2015, according to Novartis, which plans to market secukinumab as Cosentyx if approved. The FDA usually follows the recommendations of its advisory panels. Members of these two panels had no conflicts to disclose; occasionally, panelists with a conflict are given a waiver, but not at this meeting. Secukinumab is not yet approved elsewhere, and is also under review in Europe. Phase III studies in patients with psoriatic arthritis are underway.

[email protected]

SILVER SPRING, MD. – The human monoclonal antibody secukinumab is expected to be the first biologic that targets interleukin-17A to be approved by the agency for treating psoriasis, with a Food and Drug Administration advisory panel’s unanimous support for the approval.

At a meeting on Oct. 20, the FDA’s Dermatologic and Ophthalmic Drugs Advisory committee voted 7-0 to recommend approval of secukinumab for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the indication proposed by Novartis Pharmaceuticals. Secukinumab “selectively binds and neutralizes” IL-17A, a proinflammatory cytokine “that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis,” according to the company.

If approved, secukinumab would be the first IL-17A blocker available and would be available in a lyophilized formulation for reconstitution, and in a liquid formulation in a refilled syringe or autoinjector pen. The 300-mg dose was determined to be the best dose to achieve clear or almost clear skin, with a favorable safety profile that was comparable to that of the 150-mg dose, which was also studied in phase II and III studies, according to Novartis. The company has proposed a dose of 300 mg, administered with a subcutaneous injection, at 0, 1, 2, 3, and 4 weeks, followed by 300 mg once a month.

The panel agreed that the 300-mg dose was effective with an acceptable risk-benefit profile, but agreed that it would be useful to have the 150-mg dose, which was also effective in trials, be available as well. The panel also recommended that the 450-mg dose, which was not formally studied, be evaluated further in postmarketing studies, because it could be useful in nonresponders and for heavier patients weighing 90 kg (about 198 pounds) or more, because of evidence that the 300-mg dose was less effective in heavier patients.

Secukinumab has been studied in 10 phase II and III studies of almost 4,000 patients with psoriasis. In the two main phase III studies, the 150-mg and 300-mg doses were compared with placebo (and to a formulation of etanercept not available in the United States in one study); the primary endpoints were the Psoriasis Area and Severity Index (PASI) 75, a 75% improvement of psoriasis from baseline, and an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin).

In one study of 738 patients, PASI 75 scores at 12 weeks were achieved by almost 82% and almost 72% of those on the 300-mg and 150-mg doses respectively, vs. 4.5% of those on placebo. In the second study, PASI 75 scores at 12 weeks were achieved by 77% and 67% of those on the 300-mg and 150-mg doses respectively, vs. almost 5% of those on placebo. About 63%-65% of those on the 300-mg dose and about 51% of those on the 150-mg dose had an IGA of 0/1 at 12 weeks, vs. about 2.4%-2.8% of those on placebo. Differences in the responses were sustained at week 52, according to Novartis.

Concentration of the drug decreases as body weight increases, and in studies, weight had a significant effect on efficacy results. The proportion of patients who achieved the PASI 75 and IGA 0/1 endpoints was higher among those weighing under 90 kg than those weighing 90 kg or more at both the 150-mg and 300-mg doses tested.

Pooled data of phase III trial data were used to evaluate safety over 12 and 52 weeks. Serious infections, malignancies and serious cardiovascular events were low; there were no reports of reactivation of latent tuberculosis. No deaths were reported related to treatment. During the first 12 weeks of treatment, there was a higher rate of nonserious upper respiratory infections among the treated patients, and superficial Candida infections were more common among those on the 300-mg dose (1.2%) than among those on the 150-mg dose (0.4%) and placebo (0.3%). The FDA’s analysis of safety concluded that infection rates “tend to increase” as the concentration of secukinumab increases, but that most adverse events associated with greater exposure in patients weighing less than 90 kg were mild to moderate.

The panel agreed with the company’s plan to follow long-term safety in a postmarketing registry of patients with moderate to severe psoriasis, in at least 2,000 patients treated with secukinumab, 2,500 treated with other biologics, and 500 treated with other systemic medications. One panelist also recommended that long-term safety be evaluated in studies using large administrative databases for outcomes including malignancies and autoimmune events.

The FDA is expected to decide on approval by early 2015, according to Novartis, which plans to market secukinumab as Cosentyx if approved. The FDA usually follows the recommendations of its advisory panels. Members of these two panels had no conflicts to disclose; occasionally, panelists with a conflict are given a waiver, but not at this meeting. Secukinumab is not yet approved elsewhere, and is also under review in Europe. Phase III studies in patients with psoriatic arthritis are underway.

[email protected]

SILVER SPRING, MD. – The human monoclonal antibody secukinumab is expected to be the first biologic that targets interleukin-17A to be approved by the agency for treating psoriasis, with a Food and Drug Administration advisory panel’s unanimous support for the approval.

At a meeting on Oct. 20, the FDA’s Dermatologic and Ophthalmic Drugs Advisory committee voted 7-0 to recommend approval of secukinumab for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the indication proposed by Novartis Pharmaceuticals. Secukinumab “selectively binds and neutralizes” IL-17A, a proinflammatory cytokine “that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis,” according to the company.

If approved, secukinumab would be the first IL-17A blocker available and would be available in a lyophilized formulation for reconstitution, and in a liquid formulation in a refilled syringe or autoinjector pen. The 300-mg dose was determined to be the best dose to achieve clear or almost clear skin, with a favorable safety profile that was comparable to that of the 150-mg dose, which was also studied in phase II and III studies, according to Novartis. The company has proposed a dose of 300 mg, administered with a subcutaneous injection, at 0, 1, 2, 3, and 4 weeks, followed by 300 mg once a month.

The panel agreed that the 300-mg dose was effective with an acceptable risk-benefit profile, but agreed that it would be useful to have the 150-mg dose, which was also effective in trials, be available as well. The panel also recommended that the 450-mg dose, which was not formally studied, be evaluated further in postmarketing studies, because it could be useful in nonresponders and for heavier patients weighing 90 kg (about 198 pounds) or more, because of evidence that the 300-mg dose was less effective in heavier patients.

Secukinumab has been studied in 10 phase II and III studies of almost 4,000 patients with psoriasis. In the two main phase III studies, the 150-mg and 300-mg doses were compared with placebo (and to a formulation of etanercept not available in the United States in one study); the primary endpoints were the Psoriasis Area and Severity Index (PASI) 75, a 75% improvement of psoriasis from baseline, and an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin).

In one study of 738 patients, PASI 75 scores at 12 weeks were achieved by almost 82% and almost 72% of those on the 300-mg and 150-mg doses respectively, vs. 4.5% of those on placebo. In the second study, PASI 75 scores at 12 weeks were achieved by 77% and 67% of those on the 300-mg and 150-mg doses respectively, vs. almost 5% of those on placebo. About 63%-65% of those on the 300-mg dose and about 51% of those on the 150-mg dose had an IGA of 0/1 at 12 weeks, vs. about 2.4%-2.8% of those on placebo. Differences in the responses were sustained at week 52, according to Novartis.

Concentration of the drug decreases as body weight increases, and in studies, weight had a significant effect on efficacy results. The proportion of patients who achieved the PASI 75 and IGA 0/1 endpoints was higher among those weighing under 90 kg than those weighing 90 kg or more at both the 150-mg and 300-mg doses tested.

Pooled data of phase III trial data were used to evaluate safety over 12 and 52 weeks. Serious infections, malignancies and serious cardiovascular events were low; there were no reports of reactivation of latent tuberculosis. No deaths were reported related to treatment. During the first 12 weeks of treatment, there was a higher rate of nonserious upper respiratory infections among the treated patients, and superficial Candida infections were more common among those on the 300-mg dose (1.2%) than among those on the 150-mg dose (0.4%) and placebo (0.3%). The FDA’s analysis of safety concluded that infection rates “tend to increase” as the concentration of secukinumab increases, but that most adverse events associated with greater exposure in patients weighing less than 90 kg were mild to moderate.

The panel agreed with the company’s plan to follow long-term safety in a postmarketing registry of patients with moderate to severe psoriasis, in at least 2,000 patients treated with secukinumab, 2,500 treated with other biologics, and 500 treated with other systemic medications. One panelist also recommended that long-term safety be evaluated in studies using large administrative databases for outcomes including malignancies and autoimmune events.

The FDA is expected to decide on approval by early 2015, according to Novartis, which plans to market secukinumab as Cosentyx if approved. The FDA usually follows the recommendations of its advisory panels. Members of these two panels had no conflicts to disclose; occasionally, panelists with a conflict are given a waiver, but not at this meeting. Secukinumab is not yet approved elsewhere, and is also under review in Europe. Phase III studies in patients with psoriatic arthritis are underway.

[email protected]

AMSTERDAM – The investigational biologic agent secukinumab continued to show strong efficacy through 52 weeks of treatment in a new secondary analysis of the pivotal phase III ERASURE trial.

For example, 60% of patients treated for moderate-to-severe chronic plaque psoriasis at the 300-mg dose of secukinumab continued to maintain a PASI 90 response through 52 weeks of therapy, Dr. Mark G. Lebwohl reported at the annual congress of the European Academy of Dermatology and Venereology.

Secukinumab is a fully human monoclonal antibody directed against interleukin-17A. While the Food and Drug Administration requested that the primary outcome in ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) should be the degree of skin clearing at week 12, the efficacy actually peaked at 16 weeks and was then sustained with only modest tailoff through the remainder of the 52-week study (see graphic).

This is important new information, Dr. Lebwohl noted, because 12-week outcomes don’t provide a full picture regarding potent therapies. Psoriasis is a chronic disease requiring long-term therapy, and some biologic agents now marketed for psoriasis tend to show a loss of effect over time. Reassuringly, the long-term ERASURE data show that’s not the case for secukinumab, explained Dr. Lebwohl, professor and chairman of the department of dermatology at Mt. Sinai Medical Center in New York.

ERASURE involved 738 patients randomized double-blind to secukinumab at either 150 mg or 300 mg, or to placebo. Following an initial loading-dose phase when the biologic was given subcutaneously once weekly for 5 weeks, it was then administered every 4 weeks for the remainder of the year-long trial.

The safety profile of secukinumab was similar to placebo with one exception: Upper respiratory tract infections were three- to fourfold more common in patients on the IL-17A inhibitor.

Novartis funded the ERASURE trial, whose primary results were recently published (N. Engl. J. Med. 2014;371:326-38). Dr. Lebwohl reported serving as a consultant to Novartis and more than a dozen other pharmaceutical companies.

[email protected]

AMSTERDAM – The investigational biologic agent secukinumab continued to show strong efficacy through 52 weeks of treatment in a new secondary analysis of the pivotal phase III ERASURE trial.

For example, 60% of patients treated for moderate-to-severe chronic plaque psoriasis at the 300-mg dose of secukinumab continued to maintain a PASI 90 response through 52 weeks of therapy, Dr. Mark G. Lebwohl reported at the annual congress of the European Academy of Dermatology and Venereology.

Secukinumab is a fully human monoclonal antibody directed against interleukin-17A. While the Food and Drug Administration requested that the primary outcome in ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) should be the degree of skin clearing at week 12, the efficacy actually peaked at 16 weeks and was then sustained with only modest tailoff through the remainder of the 52-week study (see graphic).

This is important new information, Dr. Lebwohl noted, because 12-week outcomes don’t provide a full picture regarding potent therapies. Psoriasis is a chronic disease requiring long-term therapy, and some biologic agents now marketed for psoriasis tend to show a loss of effect over time. Reassuringly, the long-term ERASURE data show that’s not the case for secukinumab, explained Dr. Lebwohl, professor and chairman of the department of dermatology at Mt. Sinai Medical Center in New York.

ERASURE involved 738 patients randomized double-blind to secukinumab at either 150 mg or 300 mg, or to placebo. Following an initial loading-dose phase when the biologic was given subcutaneously once weekly for 5 weeks, it was then administered every 4 weeks for the remainder of the year-long trial.

The safety profile of secukinumab was similar to placebo with one exception: Upper respiratory tract infections were three- to fourfold more common in patients on the IL-17A inhibitor.

Novartis funded the ERASURE trial, whose primary results were recently published (N. Engl. J. Med. 2014;371:326-38). Dr. Lebwohl reported serving as a consultant to Novartis and more than a dozen other pharmaceutical companies.

[email protected]

AMSTERDAM – The investigational biologic agent secukinumab continued to show strong efficacy through 52 weeks of treatment in a new secondary analysis of the pivotal phase III ERASURE trial.

For example, 60% of patients treated for moderate-to-severe chronic plaque psoriasis at the 300-mg dose of secukinumab continued to maintain a PASI 90 response through 52 weeks of therapy, Dr. Mark G. Lebwohl reported at the annual congress of the European Academy of Dermatology and Venereology.

Secukinumab is a fully human monoclonal antibody directed against interleukin-17A. While the Food and Drug Administration requested that the primary outcome in ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) should be the degree of skin clearing at week 12, the efficacy actually peaked at 16 weeks and was then sustained with only modest tailoff through the remainder of the 52-week study (see graphic).

This is important new information, Dr. Lebwohl noted, because 12-week outcomes don’t provide a full picture regarding potent therapies. Psoriasis is a chronic disease requiring long-term therapy, and some biologic agents now marketed for psoriasis tend to show a loss of effect over time. Reassuringly, the long-term ERASURE data show that’s not the case for secukinumab, explained Dr. Lebwohl, professor and chairman of the department of dermatology at Mt. Sinai Medical Center in New York.

ERASURE involved 738 patients randomized double-blind to secukinumab at either 150 mg or 300 mg, or to placebo. Following an initial loading-dose phase when the biologic was given subcutaneously once weekly for 5 weeks, it was then administered every 4 weeks for the remainder of the year-long trial.

The safety profile of secukinumab was similar to placebo with one exception: Upper respiratory tract infections were three- to fourfold more common in patients on the IL-17A inhibitor.

Novartis funded the ERASURE trial, whose primary results were recently published (N. Engl. J. Med. 2014;371:326-38). Dr. Lebwohl reported serving as a consultant to Novartis and more than a dozen other pharmaceutical companies.

[email protected]

AMSTERDAM – Does pushing for a PASI 90 response instead of settling for a PASI 75 matter to patients being treated for moderate-to-severe chronic plaque psoriasis?

You bet it does, Dr. Mark G. Lebwohl asserted at the annual congress of the European Academy of Dermatology and Venereology.

He presented a pooled analysis of data from two large pivotal phase III randomized trials of secukinumab for psoriasis. The primary endpoints in the analysis were how often and how soon patients who achieved a PASI 75 or PASI 90 response at 12 weeks reported obtaining a Dermatology Life Quality Index (DLQI) response, defined as a score of 0 or 1.

The answer: More patients who had a PASI 90 response (meaning almost clear at 12 weeks) had a DLQI response, and it occurred a full 4 weeks faster than in PASI 75 responders – at a median of 8 weeks, compared with 12 weeks, reported Dr. Lebwohl, professor and chairman of the department of dermatology at Mt. Sinai Medical Center in New York.

Scores on the DLQI can range from 0, meaning no psoriasis-related impairment of the patient’s quality of life, up to 30. The average baseline score in this study population was 13.5, so a DLQI response dropping the score down to 0 or 1 represents a dramatic improvement in this patient-reported outcome.

Study participants completed the DLQI questionnaire at weeks 4, 8, 12, 24, 36, and again at week 52. The subjects’ mean baseline PASI score was 23.2.

The two double-blind, randomized, placebo-controlled clinical trials that formed the basis for this analysis were the recently published 52-week ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis) studies (N. Engl. J. Med. 2014;371:326-38), in which patients were assigned to secukinumab at a dose of either 150 mg or 300 mg, placebo, or in the case of FIXTURE, to etanercept. The PASI 75 and 90 response rates at 12 weeks were markedly higher at both doses of secukinumab than with etanercept.

Dr. Lebwohl’s pooled analysis was restricted to the 1,470 study participants in the two studies who were randomized to active therapy. A total of 612 patients achieved a PASI 90 response by week 12. Another 365 had a PASI 75 response. Fully 89% of PASI 90 responders also had a DLQI response maintained out to week 52, as did 77% of PASI 75 responders.

The key finding: The median time to a DLQI response in the PASI 90 responders was 8 weeks, compared with 12 weeks in the PASI 75 responders. Thus, patients with a PASI 90 response obtained virtually total relief from what had previously been a debilitating disease a full month sooner than PASI 75 responders. And that, as reported by the patients themselves, constitutes a meaningful advantage, Dr. Lebwohl stated.

Secukinumab is a fully human monoclonal antibody directed against a novel target: interleukin-17A. Novartis has filed for marketing approval of the biologic agent with an indication for psoriasis both with the Food and Drug Administration and European regulators. Secukinumab is also being developed as a treatment for psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis.

Novartis funded the analysis. Dr. Lebwohl reported serving as a consultant to Novartis and more than a dozen other pharmaceutical companies.

[email protected]

AMSTERDAM – Does pushing for a PASI 90 response instead of settling for a PASI 75 matter to patients being treated for moderate-to-severe chronic plaque psoriasis?

You bet it does, Dr. Mark G. Lebwohl asserted at the annual congress of the European Academy of Dermatology and Venereology.

He presented a pooled analysis of data from two large pivotal phase III randomized trials of secukinumab for psoriasis. The primary endpoints in the analysis were how often and how soon patients who achieved a PASI 75 or PASI 90 response at 12 weeks reported obtaining a Dermatology Life Quality Index (DLQI) response, defined as a score of 0 or 1.

The answer: More patients who had a PASI 90 response (meaning almost clear at 12 weeks) had a DLQI response, and it occurred a full 4 weeks faster than in PASI 75 responders – at a median of 8 weeks, compared with 12 weeks, reported Dr. Lebwohl, professor and chairman of the department of dermatology at Mt. Sinai Medical Center in New York.

Scores on the DLQI can range from 0, meaning no psoriasis-related impairment of the patient’s quality of life, up to 30. The average baseline score in this study population was 13.5, so a DLQI response dropping the score down to 0 or 1 represents a dramatic improvement in this patient-reported outcome.

Study participants completed the DLQI questionnaire at weeks 4, 8, 12, 24, 36, and again at week 52. The subjects’ mean baseline PASI score was 23.2.

The two double-blind, randomized, placebo-controlled clinical trials that formed the basis for this analysis were the recently published 52-week ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis) studies (N. Engl. J. Med. 2014;371:326-38), in which patients were assigned to secukinumab at a dose of either 150 mg or 300 mg, placebo, or in the case of FIXTURE, to etanercept. The PASI 75 and 90 response rates at 12 weeks were markedly higher at both doses of secukinumab than with etanercept.

Dr. Lebwohl’s pooled analysis was restricted to the 1,470 study participants in the two studies who were randomized to active therapy. A total of 612 patients achieved a PASI 90 response by week 12. Another 365 had a PASI 75 response. Fully 89% of PASI 90 responders also had a DLQI response maintained out to week 52, as did 77% of PASI 75 responders.

The key finding: The median time to a DLQI response in the PASI 90 responders was 8 weeks, compared with 12 weeks in the PASI 75 responders. Thus, patients with a PASI 90 response obtained virtually total relief from what had previously been a debilitating disease a full month sooner than PASI 75 responders. And that, as reported by the patients themselves, constitutes a meaningful advantage, Dr. Lebwohl stated.

Secukinumab is a fully human monoclonal antibody directed against a novel target: interleukin-17A. Novartis has filed for marketing approval of the biologic agent with an indication for psoriasis both with the Food and Drug Administration and European regulators. Secukinumab is also being developed as a treatment for psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis.

Novartis funded the analysis. Dr. Lebwohl reported serving as a consultant to Novartis and more than a dozen other pharmaceutical companies.

[email protected]

AMSTERDAM – Does pushing for a PASI 90 response instead of settling for a PASI 75 matter to patients being treated for moderate-to-severe chronic plaque psoriasis?

You bet it does, Dr. Mark G. Lebwohl asserted at the annual congress of the European Academy of Dermatology and Venereology.

He presented a pooled analysis of data from two large pivotal phase III randomized trials of secukinumab for psoriasis. The primary endpoints in the analysis were how often and how soon patients who achieved a PASI 75 or PASI 90 response at 12 weeks reported obtaining a Dermatology Life Quality Index (DLQI) response, defined as a score of 0 or 1.

The answer: More patients who had a PASI 90 response (meaning almost clear at 12 weeks) had a DLQI response, and it occurred a full 4 weeks faster than in PASI 75 responders – at a median of 8 weeks, compared with 12 weeks, reported Dr. Lebwohl, professor and chairman of the department of dermatology at Mt. Sinai Medical Center in New York.

Scores on the DLQI can range from 0, meaning no psoriasis-related impairment of the patient’s quality of life, up to 30. The average baseline score in this study population was 13.5, so a DLQI response dropping the score down to 0 or 1 represents a dramatic improvement in this patient-reported outcome.

Study participants completed the DLQI questionnaire at weeks 4, 8, 12, 24, 36, and again at week 52. The subjects’ mean baseline PASI score was 23.2.

The two double-blind, randomized, placebo-controlled clinical trials that formed the basis for this analysis were the recently published 52-week ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis) studies (N. Engl. J. Med. 2014;371:326-38), in which patients were assigned to secukinumab at a dose of either 150 mg or 300 mg, placebo, or in the case of FIXTURE, to etanercept. The PASI 75 and 90 response rates at 12 weeks were markedly higher at both doses of secukinumab than with etanercept.

Dr. Lebwohl’s pooled analysis was restricted to the 1,470 study participants in the two studies who were randomized to active therapy. A total of 612 patients achieved a PASI 90 response by week 12. Another 365 had a PASI 75 response. Fully 89% of PASI 90 responders also had a DLQI response maintained out to week 52, as did 77% of PASI 75 responders.

The key finding: The median time to a DLQI response in the PASI 90 responders was 8 weeks, compared with 12 weeks in the PASI 75 responders. Thus, patients with a PASI 90 response obtained virtually total relief from what had previously been a debilitating disease a full month sooner than PASI 75 responders. And that, as reported by the patients themselves, constitutes a meaningful advantage, Dr. Lebwohl stated.

Secukinumab is a fully human monoclonal antibody directed against a novel target: interleukin-17A. Novartis has filed for marketing approval of the biologic agent with an indication for psoriasis both with the Food and Drug Administration and European regulators. Secukinumab is also being developed as a treatment for psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis.

Novartis funded the analysis. Dr. Lebwohl reported serving as a consultant to Novartis and more than a dozen other pharmaceutical companies.

[email protected]

Psoriasis Patients Have a Higher Risk for Myocardial Infarction

To determine if psoriasis is associated with a higher risk for myocardial infarction (MI), Wu et al (J Dermatolog Treat. doi:10.3109/09546634.2014.952609) performed a retrospective cohort study of 50,865 control patients matched to 10,173 patients with mild psoriasis and 19,205 control patients matched to 3841 patients with severe psoriasis. Multivariate analysis revealed that patients with mild and severe psoriasis had a higher risk for MI compared to matched control patients.

Practice Point: Psoriasis is associated with a higher risk for MI compared to control patients.

>>Read more at Journal of Dermatological Treatment

Screen Children With Psoriasis for Cardiovascular Comorbidities

Most evidence of the cardiovascular effects on psoriasis patients has focused on adults. Torres et al (Eur J Dermatol. 2014;24:229-235) evaluated the prevalence of excess adiposity, cardiovascular risk factors, metabolic syndrome, and lipid profile in children with psoriasis (age range, 5–15 years) compared to a control group. Children with psoriasis had a higher prevalence and greater odds of excess adiposity compared to controls. A higher prevalence of metabolic syndrome also was observed in children with psoriasis compared to controls.

Practice Point: Cardiovascular comorbidities known to be associated with adult psoriasis also are observed in children with psoriasis, warranting the need to screen children with psoriasis and promote healthy lifestyle choices.

>>Read more at European Journal of Dermatology

Psoriasis Patients Have a Greater Risk for Heart Failure

Khalid et al (Eur J Heart Fail. 2014;16:743-748) investigated the risk for new-onset heart failure in a nationwide cohort of psoriasis patients. They found that the overall incidence rates of new-onset heart failure were higher for patients with mild and severe psoriasis. Compared with the reference population, the fully adjusted hazard ratios for new-onset heart failure were increased in patients with mild and severe psoriasis.

Practice Point: Psoriasis may be associated with a disease severity–dependent increased risk for new-onset heart failure.

>>Read more at European Journal of Heart Failure

Psoriasis Patients Have a Higher Risk for Myocardial Infarction

To determine if psoriasis is associated with a higher risk for myocardial infarction (MI), Wu et al (J Dermatolog Treat. doi:10.3109/09546634.2014.952609) performed a retrospective cohort study of 50,865 control patients matched to 10,173 patients with mild psoriasis and 19,205 control patients matched to 3841 patients with severe psoriasis. Multivariate analysis revealed that patients with mild and severe psoriasis had a higher risk for MI compared to matched control patients.

Practice Point: Psoriasis is associated with a higher risk for MI compared to control patients.

>>Read more at Journal of Dermatological Treatment

Screen Children With Psoriasis for Cardiovascular Comorbidities

Most evidence of the cardiovascular effects on psoriasis patients has focused on adults. Torres et al (Eur J Dermatol. 2014;24:229-235) evaluated the prevalence of excess adiposity, cardiovascular risk factors, metabolic syndrome, and lipid profile in children with psoriasis (age range, 5–15 years) compared to a control group. Children with psoriasis had a higher prevalence and greater odds of excess adiposity compared to controls. A higher prevalence of metabolic syndrome also was observed in children with psoriasis compared to controls.

Practice Point: Cardiovascular comorbidities known to be associated with adult psoriasis also are observed in children with psoriasis, warranting the need to screen children with psoriasis and promote healthy lifestyle choices.

>>Read more at European Journal of Dermatology

Psoriasis Patients Have a Greater Risk for Heart Failure

Khalid et al (Eur J Heart Fail. 2014;16:743-748) investigated the risk for new-onset heart failure in a nationwide cohort of psoriasis patients. They found that the overall incidence rates of new-onset heart failure were higher for patients with mild and severe psoriasis. Compared with the reference population, the fully adjusted hazard ratios for new-onset heart failure were increased in patients with mild and severe psoriasis.

Practice Point: Psoriasis may be associated with a disease severity–dependent increased risk for new-onset heart failure.

>>Read more at European Journal of Heart Failure

Psoriasis Patients Have a Higher Risk for Myocardial Infarction

To determine if psoriasis is associated with a higher risk for myocardial infarction (MI), Wu et al (J Dermatolog Treat. doi:10.3109/09546634.2014.952609) performed a retrospective cohort study of 50,865 control patients matched to 10,173 patients with mild psoriasis and 19,205 control patients matched to 3841 patients with severe psoriasis. Multivariate analysis revealed that patients with mild and severe psoriasis had a higher risk for MI compared to matched control patients.

Practice Point: Psoriasis is associated with a higher risk for MI compared to control patients.

>>Read more at Journal of Dermatological Treatment

Screen Children With Psoriasis for Cardiovascular Comorbidities

Most evidence of the cardiovascular effects on psoriasis patients has focused on adults. Torres et al (Eur J Dermatol. 2014;24:229-235) evaluated the prevalence of excess adiposity, cardiovascular risk factors, metabolic syndrome, and lipid profile in children with psoriasis (age range, 5–15 years) compared to a control group. Children with psoriasis had a higher prevalence and greater odds of excess adiposity compared to controls. A higher prevalence of metabolic syndrome also was observed in children with psoriasis compared to controls.

Practice Point: Cardiovascular comorbidities known to be associated with adult psoriasis also are observed in children with psoriasis, warranting the need to screen children with psoriasis and promote healthy lifestyle choices.

>>Read more at European Journal of Dermatology

Psoriasis Patients Have a Greater Risk for Heart Failure

Khalid et al (Eur J Heart Fail. 2014;16:743-748) investigated the risk for new-onset heart failure in a nationwide cohort of psoriasis patients. They found that the overall incidence rates of new-onset heart failure were higher for patients with mild and severe psoriasis. Compared with the reference population, the fully adjusted hazard ratios for new-onset heart failure were increased in patients with mild and severe psoriasis.

Practice Point: Psoriasis may be associated with a disease severity–dependent increased risk for new-onset heart failure.

>>Read more at European Journal of Heart Failure