Psoriatic Arthritis ICYMI

People with psoriasis appear to have both an increased risk of cancer and an increased risk of cancer-related mortality, according to a meta-analysis of cohort and case-control studies.

Compared with a psoriasis-free population, having a diagnosis of severe psoriasis was associated with a 22% increase in cancer risk, Alex Trafford of the University of Manchester (England) and colleagues reported in JAMA Dermatology. The risk of cancer mortality was also increased by 22% among those with severe psoriasis.

The site-specific risks ranged from a low of 18% for colon cancer to more than a twofold increased risk for oral and esophageal cancer, according to the investigators.

Since these were associations only, any underlying mechanism is still unclear, they wrote. The chronic inflammation that drives psoriasis can also drive the development of cancer, but immunomodulatory therapies may also play a part, they suggested.

“Of particular relevance in this regard are biological therapies, which are being increasingly used for the management of psoriasis,” they added. “Although preliminary studies have suggested little to no increased risk of cancer incidence in patients with psoriasis receiving these therapies, further study allowing greater follow-up and increased power is required to properly examine the potential cancer risk, particularly for site-specific cancers.”

The analysis included 58 studies, published between 1983 and 2017. Nine of these reported risks for cancer incidence among patients with severe psoriasis, and seven reported the risk of cancer mortality among patients with all severities of psoriasis.

Overall, severe psoriasis was associated with an increased cancer risk of 22%; for all severities of psoriasis combined, the risk increase was 18%. Relative risks for specific cancer types were as follows: colon, 1.18; colorectal, 1.34; kidney, 1.58; laryngeal, 1.79; liver, 1.83; lymphoma, 1.40; non-Hodgkin lymphoma, 1.28; keratinocyte cancers, 1.71; esophageal 2.05; oral cavity, 2.80; and pancreatic, 1.41.

Overall cancer mortality risk was 22% higher in patients with severe psoriasis than the general population. Site-specific relative mortality risks included liver, 1.43; esophageal 2.53; and pancreatic, 1.31.

In light of these findings, clinicians should stress lifestyle modifications known to decrease cancer risk, the investigators said. “Although it has been noted that lifestyle behavior change is challenging for healthcare professionals to implement, the importance of a more holistic approach to psoriasis care involving lifestyle behavior change is reinforced through the results of this meta-analysis.”

Among the coauthors were Darren M. Ashcroft, PhD, the senior author, and Christopher Griffiths, MD, both of the University of Manchester. Dr. Ashcroft reported receiving research grants from AbbVie, Almirall, Celgene, Eli Lilly, Novartis, UCB, and the Leo Foundation. Dr. Griffiths reported receiving honoraria and/or research grants from AbbVie, Almirall, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Sandoz, and UCB. The lead author and the other authors had no disclosures. The Global Psoriasis Atlas (GPA) Collaborating Organizations (the International Federation of Psoriasis Associations, the International League of Dermatological Societies, and the International Psoriasis Council) were involved with funding of the study.
 

msullivan@mdedge.com

SOURCE: Trafford A et al. JAMA Dermatol. 2019 Oct 16. doi:10.1001/jamadermatol.2019.3056.

People with psoriasis appear to have both an increased risk of cancer and an increased risk of cancer-related mortality, according to a meta-analysis of cohort and case-control studies.

Compared with a psoriasis-free population, having a diagnosis of severe psoriasis was associated with a 22% increase in cancer risk, Alex Trafford of the University of Manchester (England) and colleagues reported in JAMA Dermatology. The risk of cancer mortality was also increased by 22% among those with severe psoriasis.

The site-specific risks ranged from a low of 18% for colon cancer to more than a twofold increased risk for oral and esophageal cancer, according to the investigators.

Since these were associations only, any underlying mechanism is still unclear, they wrote. The chronic inflammation that drives psoriasis can also drive the development of cancer, but immunomodulatory therapies may also play a part, they suggested.

“Of particular relevance in this regard are biological therapies, which are being increasingly used for the management of psoriasis,” they added. “Although preliminary studies have suggested little to no increased risk of cancer incidence in patients with psoriasis receiving these therapies, further study allowing greater follow-up and increased power is required to properly examine the potential cancer risk, particularly for site-specific cancers.”

The analysis included 58 studies, published between 1983 and 2017. Nine of these reported risks for cancer incidence among patients with severe psoriasis, and seven reported the risk of cancer mortality among patients with all severities of psoriasis.

Overall, severe psoriasis was associated with an increased cancer risk of 22%; for all severities of psoriasis combined, the risk increase was 18%. Relative risks for specific cancer types were as follows: colon, 1.18; colorectal, 1.34; kidney, 1.58; laryngeal, 1.79; liver, 1.83; lymphoma, 1.40; non-Hodgkin lymphoma, 1.28; keratinocyte cancers, 1.71; esophageal 2.05; oral cavity, 2.80; and pancreatic, 1.41.

Overall cancer mortality risk was 22% higher in patients with severe psoriasis than the general population. Site-specific relative mortality risks included liver, 1.43; esophageal 2.53; and pancreatic, 1.31.

In light of these findings, clinicians should stress lifestyle modifications known to decrease cancer risk, the investigators said. “Although it has been noted that lifestyle behavior change is challenging for healthcare professionals to implement, the importance of a more holistic approach to psoriasis care involving lifestyle behavior change is reinforced through the results of this meta-analysis.”

Among the coauthors were Darren M. Ashcroft, PhD, the senior author, and Christopher Griffiths, MD, both of the University of Manchester. Dr. Ashcroft reported receiving research grants from AbbVie, Almirall, Celgene, Eli Lilly, Novartis, UCB, and the Leo Foundation. Dr. Griffiths reported receiving honoraria and/or research grants from AbbVie, Almirall, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Sandoz, and UCB. The lead author and the other authors had no disclosures. The Global Psoriasis Atlas (GPA) Collaborating Organizations (the International Federation of Psoriasis Associations, the International League of Dermatological Societies, and the International Psoriasis Council) were involved with funding of the study.
 

msullivan@mdedge.com

SOURCE: Trafford A et al. JAMA Dermatol. 2019 Oct 16. doi:10.1001/jamadermatol.2019.3056.

People with psoriasis appear to have both an increased risk of cancer and an increased risk of cancer-related mortality, according to a meta-analysis of cohort and case-control studies.

Compared with a psoriasis-free population, having a diagnosis of severe psoriasis was associated with a 22% increase in cancer risk, Alex Trafford of the University of Manchester (England) and colleagues reported in JAMA Dermatology. The risk of cancer mortality was also increased by 22% among those with severe psoriasis.

The site-specific risks ranged from a low of 18% for colon cancer to more than a twofold increased risk for oral and esophageal cancer, according to the investigators.

Since these were associations only, any underlying mechanism is still unclear, they wrote. The chronic inflammation that drives psoriasis can also drive the development of cancer, but immunomodulatory therapies may also play a part, they suggested.

“Of particular relevance in this regard are biological therapies, which are being increasingly used for the management of psoriasis,” they added. “Although preliminary studies have suggested little to no increased risk of cancer incidence in patients with psoriasis receiving these therapies, further study allowing greater follow-up and increased power is required to properly examine the potential cancer risk, particularly for site-specific cancers.”

The analysis included 58 studies, published between 1983 and 2017. Nine of these reported risks for cancer incidence among patients with severe psoriasis, and seven reported the risk of cancer mortality among patients with all severities of psoriasis.

Overall, severe psoriasis was associated with an increased cancer risk of 22%; for all severities of psoriasis combined, the risk increase was 18%. Relative risks for specific cancer types were as follows: colon, 1.18; colorectal, 1.34; kidney, 1.58; laryngeal, 1.79; liver, 1.83; lymphoma, 1.40; non-Hodgkin lymphoma, 1.28; keratinocyte cancers, 1.71; esophageal 2.05; oral cavity, 2.80; and pancreatic, 1.41.

Overall cancer mortality risk was 22% higher in patients with severe psoriasis than the general population. Site-specific relative mortality risks included liver, 1.43; esophageal 2.53; and pancreatic, 1.31.

In light of these findings, clinicians should stress lifestyle modifications known to decrease cancer risk, the investigators said. “Although it has been noted that lifestyle behavior change is challenging for healthcare professionals to implement, the importance of a more holistic approach to psoriasis care involving lifestyle behavior change is reinforced through the results of this meta-analysis.”

Among the coauthors were Darren M. Ashcroft, PhD, the senior author, and Christopher Griffiths, MD, both of the University of Manchester. Dr. Ashcroft reported receiving research grants from AbbVie, Almirall, Celgene, Eli Lilly, Novartis, UCB, and the Leo Foundation. Dr. Griffiths reported receiving honoraria and/or research grants from AbbVie, Almirall, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Sandoz, and UCB. The lead author and the other authors had no disclosures. The Global Psoriasis Atlas (GPA) Collaborating Organizations (the International Federation of Psoriasis Associations, the International League of Dermatological Societies, and the International Psoriasis Council) were involved with funding of the study.
 

msullivan@mdedge.com

SOURCE: Trafford A et al. JAMA Dermatol. 2019 Oct 16. doi:10.1001/jamadermatol.2019.3056.

MADRID – Psoriasis patients aged 65 years and older are at more than twice the risk of serious bacterial and opportunistic infections, compared with younger patients, but that risk is not further elevated by being on biologic agents, Joseph F. Merola, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a large, propensity score–matched comparative safety study, which demonstrated that the infection risk of older psoriasis patients on biologics was not significantly different from that of similar patients on nonbiologic systemic medications or phototherapy. The study implications, he said, are clear: When moderate to severe psoriasis warrants consideration of highly effective biologic therapies, that therapeutic option shouldn’t be taken off the table on the basis of a mistaken belief that biologics pose a greater infection risk just because the affected patient is over age 65 years.

“We really think that older patients should be offered treatments at the same level of disease control as all the rest of our psoriasis patients, in the context of shared decision making,” said Dr. Merola, a dermatologist and rheumatologist who is the director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston.

The study utilized longitudinal claims data from a very large U.S. database covering the years 2003-2017. Among the 185 million covered lives were 1.1 million individuals with psoriasis, including 150,000 aged 65 years or older. After excluding older psoriasis patients with comorbid cancer or autoimmune disease, the investigators were left with 11,218 older psoriasis patients initiating systemic therapy for the first time and therefore eligible for propensity score matching using a highly accurate proprietary platform. The final study population consisted of 2,795 older psoriasis patients newly initiating biologic therapy, 2,795 others newly initiating nonbiologic systemic agents, and 2,529 seniors starting phototherapy. The matching was based upon factors including age, sex, prior infections, comorbid psoriatic arthritis, diabetes, and obesity.

The primary study endpoint was the rate of serious bacterial or opportunistic infections requiring hospitalization during the first 6 months of treatment. The bottom line: The rates were closely similar across all three groups, with the most common serious infections being pneumonia and cellulitis.

In contrast, among a population of 115,047 senior psoriasis patients who never used systemic therapy, the risk of serious infection was 12.2 events per 1,000 patients over 6 months, compared with 5.3 events in 120,174 matched controls without psoriasis. That translates to a 2.24-fold increased risk.

One audience member commented that a limitation of the study was that all biologics were lumped together. He would expect that the tumor necrosis factor inhibitors, for example, would be associated with a significantly higher serious infection risk than biologics with other targets.

Dr. Merola conceded the point, adding that the investigators are trying to reanalyze the data in a more granular way to address that shortcoming. Other study limitations included an inability to access the specific doses of systemic treatments used or to stratify patients by disease severity.

Another audience member noted that dermatologists often reassure surgeons that there’s no increased risk of infection associated with psoriasis when in fact there is increased risk in older psoriasis patients, according to these new data.

“We’re not trying to send a message to surgeons to withhold a knee transplant because of a psoriasis plaque over the knee,” Dr. Merola replied. “I think we’ve all been there; we’ve all fought that battle.” Based on the data, he said, he would advise that “our patients who need to be on systemics should remain appropriately on systemics as we see fit.”

The study was entirely funded by Brigham and Women’s Hospital. Dr. Merola reported serving as a consultant to and/or recipient of research grants from nearly two dozen pharmaceutical companies.

bjancin@mdedge.com

MADRID – Psoriasis patients aged 65 years and older are at more than twice the risk of serious bacterial and opportunistic infections, compared with younger patients, but that risk is not further elevated by being on biologic agents, Joseph F. Merola, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a large, propensity score–matched comparative safety study, which demonstrated that the infection risk of older psoriasis patients on biologics was not significantly different from that of similar patients on nonbiologic systemic medications or phototherapy. The study implications, he said, are clear: When moderate to severe psoriasis warrants consideration of highly effective biologic therapies, that therapeutic option shouldn’t be taken off the table on the basis of a mistaken belief that biologics pose a greater infection risk just because the affected patient is over age 65 years.

“We really think that older patients should be offered treatments at the same level of disease control as all the rest of our psoriasis patients, in the context of shared decision making,” said Dr. Merola, a dermatologist and rheumatologist who is the director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston.

The study utilized longitudinal claims data from a very large U.S. database covering the years 2003-2017. Among the 185 million covered lives were 1.1 million individuals with psoriasis, including 150,000 aged 65 years or older. After excluding older psoriasis patients with comorbid cancer or autoimmune disease, the investigators were left with 11,218 older psoriasis patients initiating systemic therapy for the first time and therefore eligible for propensity score matching using a highly accurate proprietary platform. The final study population consisted of 2,795 older psoriasis patients newly initiating biologic therapy, 2,795 others newly initiating nonbiologic systemic agents, and 2,529 seniors starting phototherapy. The matching was based upon factors including age, sex, prior infections, comorbid psoriatic arthritis, diabetes, and obesity.

The primary study endpoint was the rate of serious bacterial or opportunistic infections requiring hospitalization during the first 6 months of treatment. The bottom line: The rates were closely similar across all three groups, with the most common serious infections being pneumonia and cellulitis.

In contrast, among a population of 115,047 senior psoriasis patients who never used systemic therapy, the risk of serious infection was 12.2 events per 1,000 patients over 6 months, compared with 5.3 events in 120,174 matched controls without psoriasis. That translates to a 2.24-fold increased risk.

One audience member commented that a limitation of the study was that all biologics were lumped together. He would expect that the tumor necrosis factor inhibitors, for example, would be associated with a significantly higher serious infection risk than biologics with other targets.

Dr. Merola conceded the point, adding that the investigators are trying to reanalyze the data in a more granular way to address that shortcoming. Other study limitations included an inability to access the specific doses of systemic treatments used or to stratify patients by disease severity.

Another audience member noted that dermatologists often reassure surgeons that there’s no increased risk of infection associated with psoriasis when in fact there is increased risk in older psoriasis patients, according to these new data.

“We’re not trying to send a message to surgeons to withhold a knee transplant because of a psoriasis plaque over the knee,” Dr. Merola replied. “I think we’ve all been there; we’ve all fought that battle.” Based on the data, he said, he would advise that “our patients who need to be on systemics should remain appropriately on systemics as we see fit.”

The study was entirely funded by Brigham and Women’s Hospital. Dr. Merola reported serving as a consultant to and/or recipient of research grants from nearly two dozen pharmaceutical companies.

bjancin@mdedge.com

MADRID – Psoriasis patients aged 65 years and older are at more than twice the risk of serious bacterial and opportunistic infections, compared with younger patients, but that risk is not further elevated by being on biologic agents, Joseph F. Merola, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a large, propensity score–matched comparative safety study, which demonstrated that the infection risk of older psoriasis patients on biologics was not significantly different from that of similar patients on nonbiologic systemic medications or phototherapy. The study implications, he said, are clear: When moderate to severe psoriasis warrants consideration of highly effective biologic therapies, that therapeutic option shouldn’t be taken off the table on the basis of a mistaken belief that biologics pose a greater infection risk just because the affected patient is over age 65 years.

“We really think that older patients should be offered treatments at the same level of disease control as all the rest of our psoriasis patients, in the context of shared decision making,” said Dr. Merola, a dermatologist and rheumatologist who is the director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston.

The study utilized longitudinal claims data from a very large U.S. database covering the years 2003-2017. Among the 185 million covered lives were 1.1 million individuals with psoriasis, including 150,000 aged 65 years or older. After excluding older psoriasis patients with comorbid cancer or autoimmune disease, the investigators were left with 11,218 older psoriasis patients initiating systemic therapy for the first time and therefore eligible for propensity score matching using a highly accurate proprietary platform. The final study population consisted of 2,795 older psoriasis patients newly initiating biologic therapy, 2,795 others newly initiating nonbiologic systemic agents, and 2,529 seniors starting phototherapy. The matching was based upon factors including age, sex, prior infections, comorbid psoriatic arthritis, diabetes, and obesity.

The primary study endpoint was the rate of serious bacterial or opportunistic infections requiring hospitalization during the first 6 months of treatment. The bottom line: The rates were closely similar across all three groups, with the most common serious infections being pneumonia and cellulitis.

In contrast, among a population of 115,047 senior psoriasis patients who never used systemic therapy, the risk of serious infection was 12.2 events per 1,000 patients over 6 months, compared with 5.3 events in 120,174 matched controls without psoriasis. That translates to a 2.24-fold increased risk.

One audience member commented that a limitation of the study was that all biologics were lumped together. He would expect that the tumor necrosis factor inhibitors, for example, would be associated with a significantly higher serious infection risk than biologics with other targets.

Dr. Merola conceded the point, adding that the investigators are trying to reanalyze the data in a more granular way to address that shortcoming. Other study limitations included an inability to access the specific doses of systemic treatments used or to stratify patients by disease severity.

Another audience member noted that dermatologists often reassure surgeons that there’s no increased risk of infection associated with psoriasis when in fact there is increased risk in older psoriasis patients, according to these new data.

“We’re not trying to send a message to surgeons to withhold a knee transplant because of a psoriasis plaque over the knee,” Dr. Merola replied. “I think we’ve all been there; we’ve all fought that battle.” Based on the data, he said, he would advise that “our patients who need to be on systemics should remain appropriately on systemics as we see fit.”

The study was entirely funded by Brigham and Women’s Hospital. Dr. Merola reported serving as a consultant to and/or recipient of research grants from nearly two dozen pharmaceutical companies.

bjancin@mdedge.com

MADRID – Serlopitant, an investigational once-daily oral neurokinin-1 receptor antagonist, resulted in clinically meaningful improvement in psoriatic itch in a phase 2, double-blind, placebo-controlled randomized trial, David M. Pariser, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The drug is not an effective stand alone treatment for psoriasis, though.

“The psoriasis itself did not improve during the trial. It’s the itch that improved. This drug is not designed for psoriasis; it’s going to be used for itching. If this does materialize as a treatment for psoriasis, it would be as an adjunct,” according to Dr. Pariser, a dermatologist at the Eastern Virginia School of Medicine, Norfolk.

Still, serlopitant addresses an unmet need for better treatment options for psoriatic itch. Up to 90% of psoriasis patients report experiencing pruritus, regardless of their disease severity.

“Although patients consider pruritus one of the most important, severe, and troublesome symptoms of psoriasis, clinicians have not historically recognized itch as a significant symptom, and treatments for psoriasis often don’t alleviate the associated pruritus,” he said.

Serlopitant has already shown efficacy and good tolerability in phase 2 studies in patients with prurigo nodularis and chronic pruritus.

The 8-week psoriatic itch trial included 204 adults with plaque psoriasis randomized to 5 mg of serlopitant once daily or placebo. Patients averaged 4.3% involved body surface area, and nearly two-thirds of them had moderate psoriasis by physician global assessment. The majority of patients rated their itch as severe; The average baseline score on the 0-10 Worst Itch Numeric Rating Scale was 8.2.

The primary study endpoint was achievement of at least a 4-point improvement on the Worst Itch Numeric Rating Scale. This was achieved in 33.9% of the serlopitant group and 21.1% of placebo-treated controls. The therapeutic benefit was consistent regardless of baseline body weight, gender, age, or extent of psoriasis-involved body surface area.

The safety data were consistent with what was seen in prior phase 2 studies for other dermatologic disorders. There were no serious adverse events, and the type and frequency of adverse events deemed related to treatment was similar in the two study arms.

“These results support the ongoing development of serlopitant across the spectrum of psoriatic disease,” Dr. Pariser declared.

The study was funded by Menlo Therapeutics. Dr. Pariser reported receiving research funding from and/or serving as a consultant to or advisory board member for roughly two dozen pharmaceutical companies.

bjancin@mdedge.com

MADRID – Serlopitant, an investigational once-daily oral neurokinin-1 receptor antagonist, resulted in clinically meaningful improvement in psoriatic itch in a phase 2, double-blind, placebo-controlled randomized trial, David M. Pariser, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The drug is not an effective stand alone treatment for psoriasis, though.

“The psoriasis itself did not improve during the trial. It’s the itch that improved. This drug is not designed for psoriasis; it’s going to be used for itching. If this does materialize as a treatment for psoriasis, it would be as an adjunct,” according to Dr. Pariser, a dermatologist at the Eastern Virginia School of Medicine, Norfolk.

Still, serlopitant addresses an unmet need for better treatment options for psoriatic itch. Up to 90% of psoriasis patients report experiencing pruritus, regardless of their disease severity.

“Although patients consider pruritus one of the most important, severe, and troublesome symptoms of psoriasis, clinicians have not historically recognized itch as a significant symptom, and treatments for psoriasis often don’t alleviate the associated pruritus,” he said.

Serlopitant has already shown efficacy and good tolerability in phase 2 studies in patients with prurigo nodularis and chronic pruritus.

The 8-week psoriatic itch trial included 204 adults with plaque psoriasis randomized to 5 mg of serlopitant once daily or placebo. Patients averaged 4.3% involved body surface area, and nearly two-thirds of them had moderate psoriasis by physician global assessment. The majority of patients rated their itch as severe; The average baseline score on the 0-10 Worst Itch Numeric Rating Scale was 8.2.

The primary study endpoint was achievement of at least a 4-point improvement on the Worst Itch Numeric Rating Scale. This was achieved in 33.9% of the serlopitant group and 21.1% of placebo-treated controls. The therapeutic benefit was consistent regardless of baseline body weight, gender, age, or extent of psoriasis-involved body surface area.

The safety data were consistent with what was seen in prior phase 2 studies for other dermatologic disorders. There were no serious adverse events, and the type and frequency of adverse events deemed related to treatment was similar in the two study arms.

“These results support the ongoing development of serlopitant across the spectrum of psoriatic disease,” Dr. Pariser declared.

The study was funded by Menlo Therapeutics. Dr. Pariser reported receiving research funding from and/or serving as a consultant to or advisory board member for roughly two dozen pharmaceutical companies.

bjancin@mdedge.com

MADRID – Serlopitant, an investigational once-daily oral neurokinin-1 receptor antagonist, resulted in clinically meaningful improvement in psoriatic itch in a phase 2, double-blind, placebo-controlled randomized trial, David M. Pariser, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The drug is not an effective stand alone treatment for psoriasis, though.

“The psoriasis itself did not improve during the trial. It’s the itch that improved. This drug is not designed for psoriasis; it’s going to be used for itching. If this does materialize as a treatment for psoriasis, it would be as an adjunct,” according to Dr. Pariser, a dermatologist at the Eastern Virginia School of Medicine, Norfolk.

Still, serlopitant addresses an unmet need for better treatment options for psoriatic itch. Up to 90% of psoriasis patients report experiencing pruritus, regardless of their disease severity.

“Although patients consider pruritus one of the most important, severe, and troublesome symptoms of psoriasis, clinicians have not historically recognized itch as a significant symptom, and treatments for psoriasis often don’t alleviate the associated pruritus,” he said.

Serlopitant has already shown efficacy and good tolerability in phase 2 studies in patients with prurigo nodularis and chronic pruritus.

The 8-week psoriatic itch trial included 204 adults with plaque psoriasis randomized to 5 mg of serlopitant once daily or placebo. Patients averaged 4.3% involved body surface area, and nearly two-thirds of them had moderate psoriasis by physician global assessment. The majority of patients rated their itch as severe; The average baseline score on the 0-10 Worst Itch Numeric Rating Scale was 8.2.

The primary study endpoint was achievement of at least a 4-point improvement on the Worst Itch Numeric Rating Scale. This was achieved in 33.9% of the serlopitant group and 21.1% of placebo-treated controls. The therapeutic benefit was consistent regardless of baseline body weight, gender, age, or extent of psoriasis-involved body surface area.

The safety data were consistent with what was seen in prior phase 2 studies for other dermatologic disorders. There were no serious adverse events, and the type and frequency of adverse events deemed related to treatment was similar in the two study arms.

“These results support the ongoing development of serlopitant across the spectrum of psoriatic disease,” Dr. Pariser declared.

The study was funded by Menlo Therapeutics. Dr. Pariser reported receiving research funding from and/or serving as a consultant to or advisory board member for roughly two dozen pharmaceutical companies.

bjancin@mdedge.com

Liver abnormalities in patients with psoriatic arthritis are common and are associated with higher body mass index, more severe disease, and certain therapies, new research suggests.

Wavebreakmedia Ltd/ThinkStockPhotos.com

Patients with psoriatic arthritis (PsA) often have comorbidities such as cardiovascular disease, metabolic syndrome, inflammatory bowel disease, osteoporosis, malignancy, and ophthalmic disease, and liver disease is no exception, wrote Rattapol Pakchotanon, MD, of the department of internal medicine at Phramongkutlao Hospital and College of Medicine, Bangkok, and associates. Their report is in the Journal of Rheumatology.

In psoriasis patients, the prevalence of liver abnormalities has been 24%-36% in previous research, but research regarding liver disease in PsA has been limited.

Of 1,061 patients from the University of Toronto Psoriatic Arthritis Clinic who were included in the study, 343 (32%) had liver abnormalities, including 256 who developed a liver abnormality or disease after their first evaluation at the clinic. Liver abnormality was defined as having aspartate transaminase, alanine transaminase, or alkaline phosphatase levels 1.5 times the upper limit of normal or greater, and liver diseases included drug-induced liver injury, fatty liver, viral hepatitis, autoimmune liver disease, alcoholic liver disease, liver fibrosis, and cirrhosis.

Among the patients with PsA who developed liver abnormalities or disease after their first visit, liver abnormalities occurred after an average of 8.3 years of follow-up and at a mean age of 50.5 years. The average BMI in this group was 29.7 kg/m², and 11% of patients consumed alcohol daily. A total of 105 patients had recurrent liver abnormalities, and the rest had only one visit with an abnormality; those with transient abnormalities were significantly less likely to have evidence of liver disease (P less than .001).

The most common cause of liver disease was drug-induced hepatitis (14%) and fatty liver (13%). Alcohol-induced hepatitis occurred in 10 patients, and cirrhosis was reported in 2 patients.

In a multivariable analysis, factors found to be independently associated with liver abnormalities in PsA included BMI (odds ratio, 1.07; 95% confidence interval, 1.02-1.12; P = .007), daily alcohol intake (OR, 4.46; 95% CI, 1.30-15.28; P = .02), damaged joint count (OR, 1.04; 95% CI, 1.01-1.08; P = .01), elevated C-reactive protein (OR, 2.00; 95% CI, 1.04-3.85; P = .04), use of methotrexate or leflunomide (OR, 4.39; 95% CI, 1.67-11.54; P = .003), and use of tumor necrosis factor inhibitors (OR, 10.56; 95% CI, 3.63-30.69; P less than .0001).

“We recommend monitoring liver function tests in these high risk PsA patients,” the researchers concluded. “This is important in the management of patients with PsA as many of the therapeutic options may aggravate or even lead to liver abnormalities in this patient population.”

The study was funded in part by the Arthritis Society, the Canadian Institutes of Health Research, and the Krembil Foundation. The investigators reported that they had no conflicts of interest. Dr. Pakchotanon conducted the research while he was at the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Hospital.

lfranki@mdedge.com

SOURCE: Gladman DD et al. J Rheumatol. 2019 Oct 15. doi: 10.3899/jrheum.181312

Liver abnormalities in patients with psoriatic arthritis are common and are associated with higher body mass index, more severe disease, and certain therapies, new research suggests.

Wavebreakmedia Ltd/ThinkStockPhotos.com

Patients with psoriatic arthritis (PsA) often have comorbidities such as cardiovascular disease, metabolic syndrome, inflammatory bowel disease, osteoporosis, malignancy, and ophthalmic disease, and liver disease is no exception, wrote Rattapol Pakchotanon, MD, of the department of internal medicine at Phramongkutlao Hospital and College of Medicine, Bangkok, and associates. Their report is in the Journal of Rheumatology.

In psoriasis patients, the prevalence of liver abnormalities has been 24%-36% in previous research, but research regarding liver disease in PsA has been limited.

Of 1,061 patients from the University of Toronto Psoriatic Arthritis Clinic who were included in the study, 343 (32%) had liver abnormalities, including 256 who developed a liver abnormality or disease after their first evaluation at the clinic. Liver abnormality was defined as having aspartate transaminase, alanine transaminase, or alkaline phosphatase levels 1.5 times the upper limit of normal or greater, and liver diseases included drug-induced liver injury, fatty liver, viral hepatitis, autoimmune liver disease, alcoholic liver disease, liver fibrosis, and cirrhosis.

Among the patients with PsA who developed liver abnormalities or disease after their first visit, liver abnormalities occurred after an average of 8.3 years of follow-up and at a mean age of 50.5 years. The average BMI in this group was 29.7 kg/m², and 11% of patients consumed alcohol daily. A total of 105 patients had recurrent liver abnormalities, and the rest had only one visit with an abnormality; those with transient abnormalities were significantly less likely to have evidence of liver disease (P less than .001).

The most common cause of liver disease was drug-induced hepatitis (14%) and fatty liver (13%). Alcohol-induced hepatitis occurred in 10 patients, and cirrhosis was reported in 2 patients.

In a multivariable analysis, factors found to be independently associated with liver abnormalities in PsA included BMI (odds ratio, 1.07; 95% confidence interval, 1.02-1.12; P = .007), daily alcohol intake (OR, 4.46; 95% CI, 1.30-15.28; P = .02), damaged joint count (OR, 1.04; 95% CI, 1.01-1.08; P = .01), elevated C-reactive protein (OR, 2.00; 95% CI, 1.04-3.85; P = .04), use of methotrexate or leflunomide (OR, 4.39; 95% CI, 1.67-11.54; P = .003), and use of tumor necrosis factor inhibitors (OR, 10.56; 95% CI, 3.63-30.69; P less than .0001).

“We recommend monitoring liver function tests in these high risk PsA patients,” the researchers concluded. “This is important in the management of patients with PsA as many of the therapeutic options may aggravate or even lead to liver abnormalities in this patient population.”

The study was funded in part by the Arthritis Society, the Canadian Institutes of Health Research, and the Krembil Foundation. The investigators reported that they had no conflicts of interest. Dr. Pakchotanon conducted the research while he was at the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Hospital.

lfranki@mdedge.com

SOURCE: Gladman DD et al. J Rheumatol. 2019 Oct 15. doi: 10.3899/jrheum.181312

Liver abnormalities in patients with psoriatic arthritis are common and are associated with higher body mass index, more severe disease, and certain therapies, new research suggests.

Wavebreakmedia Ltd/ThinkStockPhotos.com

Patients with psoriatic arthritis (PsA) often have comorbidities such as cardiovascular disease, metabolic syndrome, inflammatory bowel disease, osteoporosis, malignancy, and ophthalmic disease, and liver disease is no exception, wrote Rattapol Pakchotanon, MD, of the department of internal medicine at Phramongkutlao Hospital and College of Medicine, Bangkok, and associates. Their report is in the Journal of Rheumatology.

In psoriasis patients, the prevalence of liver abnormalities has been 24%-36% in previous research, but research regarding liver disease in PsA has been limited.

Of 1,061 patients from the University of Toronto Psoriatic Arthritis Clinic who were included in the study, 343 (32%) had liver abnormalities, including 256 who developed a liver abnormality or disease after their first evaluation at the clinic. Liver abnormality was defined as having aspartate transaminase, alanine transaminase, or alkaline phosphatase levels 1.5 times the upper limit of normal or greater, and liver diseases included drug-induced liver injury, fatty liver, viral hepatitis, autoimmune liver disease, alcoholic liver disease, liver fibrosis, and cirrhosis.

Among the patients with PsA who developed liver abnormalities or disease after their first visit, liver abnormalities occurred after an average of 8.3 years of follow-up and at a mean age of 50.5 years. The average BMI in this group was 29.7 kg/m², and 11% of patients consumed alcohol daily. A total of 105 patients had recurrent liver abnormalities, and the rest had only one visit with an abnormality; those with transient abnormalities were significantly less likely to have evidence of liver disease (P less than .001).

The most common cause of liver disease was drug-induced hepatitis (14%) and fatty liver (13%). Alcohol-induced hepatitis occurred in 10 patients, and cirrhosis was reported in 2 patients.

In a multivariable analysis, factors found to be independently associated with liver abnormalities in PsA included BMI (odds ratio, 1.07; 95% confidence interval, 1.02-1.12; P = .007), daily alcohol intake (OR, 4.46; 95% CI, 1.30-15.28; P = .02), damaged joint count (OR, 1.04; 95% CI, 1.01-1.08; P = .01), elevated C-reactive protein (OR, 2.00; 95% CI, 1.04-3.85; P = .04), use of methotrexate or leflunomide (OR, 4.39; 95% CI, 1.67-11.54; P = .003), and use of tumor necrosis factor inhibitors (OR, 10.56; 95% CI, 3.63-30.69; P less than .0001).

“We recommend monitoring liver function tests in these high risk PsA patients,” the researchers concluded. “This is important in the management of patients with PsA as many of the therapeutic options may aggravate or even lead to liver abnormalities in this patient population.”

The study was funded in part by the Arthritis Society, the Canadian Institutes of Health Research, and the Krembil Foundation. The investigators reported that they had no conflicts of interest. Dr. Pakchotanon conducted the research while he was at the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Hospital.

lfranki@mdedge.com

SOURCE: Gladman DD et al. J Rheumatol. 2019 Oct 15. doi: 10.3899/jrheum.181312

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

MADRID – Psoriasis patients on adalimumab for up to 10 years in the prospective, observational, international, real-world ESPRIT registry had a sharply reduced likelihood of all-cause mortality, compared with the age- and sex-matched general population in participating countries, Diamant T. Thaci, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“If someone tells you that you as a dermatologist can save patient lives by controlling psoriasis, you may not believe it. But look at this standardized mortality ratio data,” said Dr. Thaci, professor of dermatology and head of the Comprehensive Center for Inflammation Medicine at the University of Luebeck (Germany).

Indeed, the standardized mortality ratio in participants in the ESPRIT registry, featuring 6,014 psoriasis patients with a collective 28,161 person-years on adalimumab in routine clinical practice, was 58% lower than expected, based upon published mortality rate data for the general population in the United States, Canada, and the 10 participating European countries. A total of 144 deaths were predicted in the matched general population, yet only 60 deaths occurred in adalimumab-treated registry participants.

This finding is all the more remarkable because ESPRIT participants had high rates of cardiovascular risk factors, as well as a substantial burden of comorbid conditions, as is typical for patients with chronic moderate to severe psoriasis encountered in real-world clinical practice. It’s a different population than enrollees in the long-term, open-label extensions of phase 3, double-blind, randomized, controlled clinical trials of biologics in psoriasis, which at the outset typically excluded patients with baseline substantial comorbidities, he noted.

Moreover, the incidence rates of serious infections, malignancies, and cardiovascular events in ESPRIT participants remained stable over time and well within the range of published rates in psoriasis patients not on biologic therapy.

“All of this underscores the importance of good control of psoriasis,” Dr. Thaci commented.

The ESPRIT registry began enrolling patients and evaluating them every 6 months in 2008, when the vast majority of dermatologists in clinical practice relied upon Physician Global Assessment (PGA) to evaluate treatment efficacy. For this reason, the PGA, rather than the Psoriasis Area and Severity Index, was the main efficacy measure utilized in the registry. The rate of PGA “clear” or “almost clear” was steady over time at 57% at 1 year, 62.1% at 5 years, and 61.5% at 10 years. It should be noted that this was reported in an “as-observed” analysis, which introduces bias favoring a rosier picture of efficacy since by 10 years slightly under half of patients remained on the tumor necrosis factor inhibitor.

However, the primary focus of this ESPRIT analysis was safety, not efficacy. The rate of serious infections was 1.0 event per 100 person-years on adalimumab, compared with published rates of 0.3-2.1 events/100 person-years in psoriasis patients not on a biologic. Malignancies occurred at a rate of 1.3 events/100 person-years in ESPRIT, compared with published rates of 0.5-2.0/100 person-years in psoriasis patients not on biologic therapy. Acute MI occurred at a rate of 0.1 cases/100 person-years in ESPRIT, stroke at 0.2 events/100 person-years, and heart failure at less than 0.1 event/100 person-years, versus a collective rate of 0.6-1.5 events/100 person-years in the comparator population.

Another view of the data is that, at 10 years, 99.4% of ESPRIT participants had not experienced an acute MI, 95.9% hadn’t had a malignancy, and 96.1% remained free of serious infection while on adalimumab, Dr. Thaci continued.

Injection-site reactions, a significant source of concern when adalimumab first reached the marketplace, occurred at a rate of 0.2 events/100 person-years over the course of 10 years. Oral candidiasis, active tuberculosis, demyelinating disorders, and lupus-like reactions were rare, each occurring at an incidence of less than 0.1 event/100 person-years.

Dr. Thaci’s 10-year update from the ongoing registry follows an earlier report of the 5-year results (J Am Acad Dermatol. 2015 Sep;73[3]:410-9.e6).

The ESPRIT registry is sponsored by AbbVie. Dr. Thaci reported serving as a consultant to and/or receiving research grants from that pharmaceutical company and nearly two dozen others.

bjancin@mdedge.com

MADRID – Psoriasis patients on adalimumab for up to 10 years in the prospective, observational, international, real-world ESPRIT registry had a sharply reduced likelihood of all-cause mortality, compared with the age- and sex-matched general population in participating countries, Diamant T. Thaci, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“If someone tells you that you as a dermatologist can save patient lives by controlling psoriasis, you may not believe it. But look at this standardized mortality ratio data,” said Dr. Thaci, professor of dermatology and head of the Comprehensive Center for Inflammation Medicine at the University of Luebeck (Germany).

Indeed, the standardized mortality ratio in participants in the ESPRIT registry, featuring 6,014 psoriasis patients with a collective 28,161 person-years on adalimumab in routine clinical practice, was 58% lower than expected, based upon published mortality rate data for the general population in the United States, Canada, and the 10 participating European countries. A total of 144 deaths were predicted in the matched general population, yet only 60 deaths occurred in adalimumab-treated registry participants.

This finding is all the more remarkable because ESPRIT participants had high rates of cardiovascular risk factors, as well as a substantial burden of comorbid conditions, as is typical for patients with chronic moderate to severe psoriasis encountered in real-world clinical practice. It’s a different population than enrollees in the long-term, open-label extensions of phase 3, double-blind, randomized, controlled clinical trials of biologics in psoriasis, which at the outset typically excluded patients with baseline substantial comorbidities, he noted.

Moreover, the incidence rates of serious infections, malignancies, and cardiovascular events in ESPRIT participants remained stable over time and well within the range of published rates in psoriasis patients not on biologic therapy.

“All of this underscores the importance of good control of psoriasis,” Dr. Thaci commented.

The ESPRIT registry began enrolling patients and evaluating them every 6 months in 2008, when the vast majority of dermatologists in clinical practice relied upon Physician Global Assessment (PGA) to evaluate treatment efficacy. For this reason, the PGA, rather than the Psoriasis Area and Severity Index, was the main efficacy measure utilized in the registry. The rate of PGA “clear” or “almost clear” was steady over time at 57% at 1 year, 62.1% at 5 years, and 61.5% at 10 years. It should be noted that this was reported in an “as-observed” analysis, which introduces bias favoring a rosier picture of efficacy since by 10 years slightly under half of patients remained on the tumor necrosis factor inhibitor.

However, the primary focus of this ESPRIT analysis was safety, not efficacy. The rate of serious infections was 1.0 event per 100 person-years on adalimumab, compared with published rates of 0.3-2.1 events/100 person-years in psoriasis patients not on a biologic. Malignancies occurred at a rate of 1.3 events/100 person-years in ESPRIT, compared with published rates of 0.5-2.0/100 person-years in psoriasis patients not on biologic therapy. Acute MI occurred at a rate of 0.1 cases/100 person-years in ESPRIT, stroke at 0.2 events/100 person-years, and heart failure at less than 0.1 event/100 person-years, versus a collective rate of 0.6-1.5 events/100 person-years in the comparator population.

Another view of the data is that, at 10 years, 99.4% of ESPRIT participants had not experienced an acute MI, 95.9% hadn’t had a malignancy, and 96.1% remained free of serious infection while on adalimumab, Dr. Thaci continued.

Injection-site reactions, a significant source of concern when adalimumab first reached the marketplace, occurred at a rate of 0.2 events/100 person-years over the course of 10 years. Oral candidiasis, active tuberculosis, demyelinating disorders, and lupus-like reactions were rare, each occurring at an incidence of less than 0.1 event/100 person-years.

Dr. Thaci’s 10-year update from the ongoing registry follows an earlier report of the 5-year results (J Am Acad Dermatol. 2015 Sep;73[3]:410-9.e6).

The ESPRIT registry is sponsored by AbbVie. Dr. Thaci reported serving as a consultant to and/or receiving research grants from that pharmaceutical company and nearly two dozen others.

bjancin@mdedge.com

MADRID – Psoriasis patients on adalimumab for up to 10 years in the prospective, observational, international, real-world ESPRIT registry had a sharply reduced likelihood of all-cause mortality, compared with the age- and sex-matched general population in participating countries, Diamant T. Thaci, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“If someone tells you that you as a dermatologist can save patient lives by controlling psoriasis, you may not believe it. But look at this standardized mortality ratio data,” said Dr. Thaci, professor of dermatology and head of the Comprehensive Center for Inflammation Medicine at the University of Luebeck (Germany).

Indeed, the standardized mortality ratio in participants in the ESPRIT registry, featuring 6,014 psoriasis patients with a collective 28,161 person-years on adalimumab in routine clinical practice, was 58% lower than expected, based upon published mortality rate data for the general population in the United States, Canada, and the 10 participating European countries. A total of 144 deaths were predicted in the matched general population, yet only 60 deaths occurred in adalimumab-treated registry participants.

This finding is all the more remarkable because ESPRIT participants had high rates of cardiovascular risk factors, as well as a substantial burden of comorbid conditions, as is typical for patients with chronic moderate to severe psoriasis encountered in real-world clinical practice. It’s a different population than enrollees in the long-term, open-label extensions of phase 3, double-blind, randomized, controlled clinical trials of biologics in psoriasis, which at the outset typically excluded patients with baseline substantial comorbidities, he noted.

Moreover, the incidence rates of serious infections, malignancies, and cardiovascular events in ESPRIT participants remained stable over time and well within the range of published rates in psoriasis patients not on biologic therapy.

“All of this underscores the importance of good control of psoriasis,” Dr. Thaci commented.

The ESPRIT registry began enrolling patients and evaluating them every 6 months in 2008, when the vast majority of dermatologists in clinical practice relied upon Physician Global Assessment (PGA) to evaluate treatment efficacy. For this reason, the PGA, rather than the Psoriasis Area and Severity Index, was the main efficacy measure utilized in the registry. The rate of PGA “clear” or “almost clear” was steady over time at 57% at 1 year, 62.1% at 5 years, and 61.5% at 10 years. It should be noted that this was reported in an “as-observed” analysis, which introduces bias favoring a rosier picture of efficacy since by 10 years slightly under half of patients remained on the tumor necrosis factor inhibitor.

However, the primary focus of this ESPRIT analysis was safety, not efficacy. The rate of serious infections was 1.0 event per 100 person-years on adalimumab, compared with published rates of 0.3-2.1 events/100 person-years in psoriasis patients not on a biologic. Malignancies occurred at a rate of 1.3 events/100 person-years in ESPRIT, compared with published rates of 0.5-2.0/100 person-years in psoriasis patients not on biologic therapy. Acute MI occurred at a rate of 0.1 cases/100 person-years in ESPRIT, stroke at 0.2 events/100 person-years, and heart failure at less than 0.1 event/100 person-years, versus a collective rate of 0.6-1.5 events/100 person-years in the comparator population.

Another view of the data is that, at 10 years, 99.4% of ESPRIT participants had not experienced an acute MI, 95.9% hadn’t had a malignancy, and 96.1% remained free of serious infection while on adalimumab, Dr. Thaci continued.

Injection-site reactions, a significant source of concern when adalimumab first reached the marketplace, occurred at a rate of 0.2 events/100 person-years over the course of 10 years. Oral candidiasis, active tuberculosis, demyelinating disorders, and lupus-like reactions were rare, each occurring at an incidence of less than 0.1 event/100 person-years.

Dr. Thaci’s 10-year update from the ongoing registry follows an earlier report of the 5-year results (J Am Acad Dermatol. 2015 Sep;73[3]:410-9.e6).

The ESPRIT registry is sponsored by AbbVie. Dr. Thaci reported serving as a consultant to and/or receiving research grants from that pharmaceutical company and nearly two dozen others.

bjancin@mdedge.com

The practice of dermatology is rife with bedside tools: swabs, smears, and scoring systems. First popularized in specialties such as emergency medicine and internal medicine, clinical scoring systems are now emerging in dermatology. These evidence-based scores can be calculated quickly at the bedside—often through a free smartphone app—to help guide clinical decision-making regarding diagnosis, prognosis, and management. As with any medical tool, scoring systems have limitations and should be used as a supplement, not substitute, for one’s clinical judgement. This article reviews 4 clinical scoring systems practical for dermatology residents.

SCORTEN Prognosticates Cases of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis

Perhaps the best-known scoring system in dermatology, the SCORTEN is widely used to predict hospital mortality from Stevens-Johnson syndrome/toxic epidermal necrolysis. The SCORTEN includes 7 variables of equal weight—age of 40 years or older, heart rate of 120 beats per minute or more, cancer/hematologic malignancy, involved body surface area (BSA) greater than 10%, serum urea greater than 10 mmol/L, serum bicarbonate less than 20 mmol/L, and serum glucose greater than 14 mmol/L—each contributing 1 point to the overall score if present.¹ The involved BSA is defined as the sum of detached and detachable epidermis.¹

The SCORTEN was developed and prospectively validated to be calculated at the end of the first 24 hours of admission; for this calculation, use the BSA affected at that time, and use the most abnormal values during the first 24 hours of admission for the other variables.¹ In addition, a follow-up study including some of the original coauthors recommends recalculating the SCORTEN at the end of hospital day 3, having found that the score’s predictive value was better on this day than hospital days 1, 2, 4, or 5.² Based on the original study, a SCORTEN of 0 to 1 corresponds to a mortality rate of 3.2%, 2 to 12.1%, 3 to 35.3%, 4 to 58.3%, and 5 or greater to 90.0%.¹

Limitations of the SCORTEN include its ability to overestimate or underestimate mortality as demonstrated by 2 multi-institutional cohorts.^3,4 Recently, the ABCD-10 score was developed as an alternative to the SCORTEN and was found to predict mortality similarly when validated in an internal cohort.⁵

PEST Screens for Psoriatic Arthritis

Dermatologists play an important role in screening for psoriatic arthritis, as an estimated 1 in 5 patients with psoriasis have psoriatic arthritis.⁶ To this end, several screening tools have been developed to help differentiate psoriatic arthritis from other arthritides. Joint guidelines from the American Academy of Dermatology and the National Psoriasis Foundation acknowledge that “. . . these screening tools have tended to perform less well when tested in groups of people other than those for which they were originally developed. As such, their usefulness in routine clinical practice remains controversial.”⁷ Nevertheless, the guidelines state, “[b]ecause screening and early detection of inflammatory arthritis are essential to optimize patient [quality of life] and reduce morbidity, providers may consider using a formal screening tool of their choice.”⁷

With these limitations in mind, I have found the Psoriasis Epidemiology Screening Tool (PEST) to be the most useful psoriatic arthritis screening tool. One study determined that the PEST has the best trade-off between sensitivity and specificity compared to 2 other psoriatic arthritis screening tools, the Psoriatic Arthritis Screening and Evaluation (PASE) and the Early Arthritis for Psoriatic Patients (EARP).⁸

The PEST is comprised of 5 questions: (1) Have you ever had a swollen joint (or joints)? (2) Has a doctor ever told you that you have arthritis? (3) Do your fingernails or toenails have holes or pits? (4) Have you had pain in your heel? (5) Have you had a finger or toe that was completely swollen and painful for no apparent reason? According to the PEST, a referral to a rheumatologist should be considered for patients answering yes to 3 or more questions, which is 97% sensitive and 79% specific for psoriatic arthritis.⁹ Patients who answer yes to fewer than 3 questions should still be referred to a rheumatologist if there is a strong clinical suspicion of psoriatic arthritis.¹⁰

The PEST can be accessed for free in 13 languages via the GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) app as well as downloaded for free from the National Psoriasis Foundation’s website (https://www.psoriasis.org/psa-screening/providers).

ALT-70 Differentiates Cellulitis From Pseudocellulitis

Overdiagnosing cellulitis in the United States has been estimated to result in up to 130,000 unnecessary hospitalizations and up to $515 million in avoidable health care spending.¹¹ Dermatologists are in a unique position to help fix this issue. In one retrospective study of 1430 inpatient dermatology consultations, 74.32% of inpatients evaluated for presumed cellulitis by a dermatologist were instead diagnosed with a cellulitis mimicker (ie, pseudocellulitis), such as stasis dermatitis or contact dermatitis.¹²

The ALT-70 score was developed and prospectively validated to help differentiate lower extremity cellulitis from pseudocellulitis in adult patients in the emergency department (ED).¹³ In addition, the score has retrospectively been shown to function similarly in the inpatient setting when calculated at 24 and 48 hours after ED presentation.¹⁴ Although the ALT-70 score was designed for use by frontline clinicians prior to dermatology consultation, I also have found it helpful to calculate as a consultant, as it provides an objective measure of risk to communicate to the primary team in support of one diagnosis or another.

ALT-70 is an acronym for the score’s 4 variables: asymmetry, leukocytosis, tachycardia, and age of 70 years or older.¹⁵ If present, each variable confers a certain number of points to the final score: 3 points for asymmetry (defined as unilateral leg involvement), 1 point for leukocytosis (white blood cell count ≥10,000/μL), 1 point for tachycardia (≥90 beats per minute), and 2 points for age of 70 years or older. An ALT-70 score of 0 to 2 corresponds to an 83.3% or greater chance of pseudocellulitis, suggesting that the diagnosis of cellulitis be reconsidered. A score of 3 to 4 is indeterminate, and additional information such as a dermatology consultation should be pursued. A score of 5 to 7 corresponds to an 82.2% or greater chance of cellulitis, signifying that empiric treatment with antibiotics be considered.¹⁵

The ALT-70 score does not apply to cases involving areas other than the lower extremities; intravenous antibiotic use within 48 hours before ED presentation; surgery within the last 30 days; abscess; penetrating trauma; burn; or known history of osteomyelitis, diabetic ulcer, or indwelling hardware at the site of infection.¹⁵ The ALT-70 score is available for free via the MDCalc app and website (https://www.mdcalc.com/alt-70-score-cellulitis).

Mohs AUC Determines the Appropriateness of Mohs Micrographic Surgery

In 2012, the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and American Society for Mohs Surgery published appropriate use criteria (AUC) to guide the decision to pursue Mohs micrographic surgery (MMS) in the United States.¹⁶ Based on various tumor and patient characteristics, the Mohs AUC assign scores to 270 different clinical scenarios. A score of 1 to 3 signifies that MMS is inappropriate and generally not considered acceptable. A score 4 to 6 indicates that the appropriateness of MMS is uncertain. A score 7 to 9 means that MMS is appropriate and generally considered acceptable.¹⁶

Since publication, the Mohs AUC have been criticized for classifying most primary superficial basal cell carcinomas as appropriate for MMS¹⁷ (which an AUC coauthor¹⁸ and others^19,20 have defended), excluding certain reasons for performing MMS (such as operating on multiple tumors on the same day),²¹ including counterintuitive scores,²² and omitting trials from Europe²³ (which AUC coauthors also have defended²⁴). As with any clinical scoring system, the Mohs AUC has limitations; the creators acknowledge that “. . . these criteria should not be interpreted as setting a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results, even for those indications scored as inappropriate.”¹⁶ The Mohs AUC app (https://www.aad.org/members/aad-apps/mohs-auc) is free and allows users to enter tumor and patient characteristics to determine the score for their specific scenario.

Final Thoughts

Scoring systems are emerging in dermatology as evidence-based bedside tools to help guide clinical decision-making. Despite their limitations, these scores have the potential to make a meaningful impact in dermatology as they have in other specialties.

The practice of dermatology is rife with bedside tools: swabs, smears, and scoring systems. First popularized in specialties such as emergency medicine and internal medicine, clinical scoring systems are now emerging in dermatology. These evidence-based scores can be calculated quickly at the bedside—often through a free smartphone app—to help guide clinical decision-making regarding diagnosis, prognosis, and management. As with any medical tool, scoring systems have limitations and should be used as a supplement, not substitute, for one’s clinical judgement. This article reviews 4 clinical scoring systems practical for dermatology residents.

SCORTEN Prognosticates Cases of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis

Perhaps the best-known scoring system in dermatology, the SCORTEN is widely used to predict hospital mortality from Stevens-Johnson syndrome/toxic epidermal necrolysis. The SCORTEN includes 7 variables of equal weight—age of 40 years or older, heart rate of 120 beats per minute or more, cancer/hematologic malignancy, involved body surface area (BSA) greater than 10%, serum urea greater than 10 mmol/L, serum bicarbonate less than 20 mmol/L, and serum glucose greater than 14 mmol/L—each contributing 1 point to the overall score if present.¹ The involved BSA is defined as the sum of detached and detachable epidermis.¹

The SCORTEN was developed and prospectively validated to be calculated at the end of the first 24 hours of admission; for this calculation, use the BSA affected at that time, and use the most abnormal values during the first 24 hours of admission for the other variables.¹ In addition, a follow-up study including some of the original coauthors recommends recalculating the SCORTEN at the end of hospital day 3, having found that the score’s predictive value was better on this day than hospital days 1, 2, 4, or 5.² Based on the original study, a SCORTEN of 0 to 1 corresponds to a mortality rate of 3.2%, 2 to 12.1%, 3 to 35.3%, 4 to 58.3%, and 5 or greater to 90.0%.¹

Limitations of the SCORTEN include its ability to overestimate or underestimate mortality as demonstrated by 2 multi-institutional cohorts.^3,4 Recently, the ABCD-10 score was developed as an alternative to the SCORTEN and was found to predict mortality similarly when validated in an internal cohort.⁵

PEST Screens for Psoriatic Arthritis

Dermatologists play an important role in screening for psoriatic arthritis, as an estimated 1 in 5 patients with psoriasis have psoriatic arthritis.⁶ To this end, several screening tools have been developed to help differentiate psoriatic arthritis from other arthritides. Joint guidelines from the American Academy of Dermatology and the National Psoriasis Foundation acknowledge that “. . . these screening tools have tended to perform less well when tested in groups of people other than those for which they were originally developed. As such, their usefulness in routine clinical practice remains controversial.”⁷ Nevertheless, the guidelines state, “[b]ecause screening and early detection of inflammatory arthritis are essential to optimize patient [quality of life] and reduce morbidity, providers may consider using a formal screening tool of their choice.”⁷

With these limitations in mind, I have found the Psoriasis Epidemiology Screening Tool (PEST) to be the most useful psoriatic arthritis screening tool. One study determined that the PEST has the best trade-off between sensitivity and specificity compared to 2 other psoriatic arthritis screening tools, the Psoriatic Arthritis Screening and Evaluation (PASE) and the Early Arthritis for Psoriatic Patients (EARP).⁸

The PEST is comprised of 5 questions: (1) Have you ever had a swollen joint (or joints)? (2) Has a doctor ever told you that you have arthritis? (3) Do your fingernails or toenails have holes or pits? (4) Have you had pain in your heel? (5) Have you had a finger or toe that was completely swollen and painful for no apparent reason? According to the PEST, a referral to a rheumatologist should be considered for patients answering yes to 3 or more questions, which is 97% sensitive and 79% specific for psoriatic arthritis.⁹ Patients who answer yes to fewer than 3 questions should still be referred to a rheumatologist if there is a strong clinical suspicion of psoriatic arthritis.¹⁰

The PEST can be accessed for free in 13 languages via the GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) app as well as downloaded for free from the National Psoriasis Foundation’s website (https://www.psoriasis.org/psa-screening/providers).

ALT-70 Differentiates Cellulitis From Pseudocellulitis

Overdiagnosing cellulitis in the United States has been estimated to result in up to 130,000 unnecessary hospitalizations and up to $515 million in avoidable health care spending.¹¹ Dermatologists are in a unique position to help fix this issue. In one retrospective study of 1430 inpatient dermatology consultations, 74.32% of inpatients evaluated for presumed cellulitis by a dermatologist were instead diagnosed with a cellulitis mimicker (ie, pseudocellulitis), such as stasis dermatitis or contact dermatitis.¹²

The ALT-70 score was developed and prospectively validated to help differentiate lower extremity cellulitis from pseudocellulitis in adult patients in the emergency department (ED).¹³ In addition, the score has retrospectively been shown to function similarly in the inpatient setting when calculated at 24 and 48 hours after ED presentation.¹⁴ Although the ALT-70 score was designed for use by frontline clinicians prior to dermatology consultation, I also have found it helpful to calculate as a consultant, as it provides an objective measure of risk to communicate to the primary team in support of one diagnosis or another.

ALT-70 is an acronym for the score’s 4 variables: asymmetry, leukocytosis, tachycardia, and age of 70 years or older.¹⁵ If present, each variable confers a certain number of points to the final score: 3 points for asymmetry (defined as unilateral leg involvement), 1 point for leukocytosis (white blood cell count ≥10,000/μL), 1 point for tachycardia (≥90 beats per minute), and 2 points for age of 70 years or older. An ALT-70 score of 0 to 2 corresponds to an 83.3% or greater chance of pseudocellulitis, suggesting that the diagnosis of cellulitis be reconsidered. A score of 3 to 4 is indeterminate, and additional information such as a dermatology consultation should be pursued. A score of 5 to 7 corresponds to an 82.2% or greater chance of cellulitis, signifying that empiric treatment with antibiotics be considered.¹⁵

The ALT-70 score does not apply to cases involving areas other than the lower extremities; intravenous antibiotic use within 48 hours before ED presentation; surgery within the last 30 days; abscess; penetrating trauma; burn; or known history of osteomyelitis, diabetic ulcer, or indwelling hardware at the site of infection.¹⁵ The ALT-70 score is available for free via the MDCalc app and website (https://www.mdcalc.com/alt-70-score-cellulitis).

Mohs AUC Determines the Appropriateness of Mohs Micrographic Surgery

In 2012, the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and American Society for Mohs Surgery published appropriate use criteria (AUC) to guide the decision to pursue Mohs micrographic surgery (MMS) in the United States.¹⁶ Based on various tumor and patient characteristics, the Mohs AUC assign scores to 270 different clinical scenarios. A score of 1 to 3 signifies that MMS is inappropriate and generally not considered acceptable. A score 4 to 6 indicates that the appropriateness of MMS is uncertain. A score 7 to 9 means that MMS is appropriate and generally considered acceptable.¹⁶

Since publication, the Mohs AUC have been criticized for classifying most primary superficial basal cell carcinomas as appropriate for MMS¹⁷ (which an AUC coauthor¹⁸ and others^19,20 have defended), excluding certain reasons for performing MMS (such as operating on multiple tumors on the same day),²¹ including counterintuitive scores,²² and omitting trials from Europe²³ (which AUC coauthors also have defended²⁴). As with any clinical scoring system, the Mohs AUC has limitations; the creators acknowledge that “. . . these criteria should not be interpreted as setting a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results, even for those indications scored as inappropriate.”¹⁶ The Mohs AUC app (https://www.aad.org/members/aad-apps/mohs-auc) is free and allows users to enter tumor and patient characteristics to determine the score for their specific scenario.

Final Thoughts

Scoring systems are emerging in dermatology as evidence-based bedside tools to help guide clinical decision-making. Despite their limitations, these scores have the potential to make a meaningful impact in dermatology as they have in other specialties.

The practice of dermatology is rife with bedside tools: swabs, smears, and scoring systems. First popularized in specialties such as emergency medicine and internal medicine, clinical scoring systems are now emerging in dermatology. These evidence-based scores can be calculated quickly at the bedside—often through a free smartphone app—to help guide clinical decision-making regarding diagnosis, prognosis, and management. As with any medical tool, scoring systems have limitations and should be used as a supplement, not substitute, for one’s clinical judgement. This article reviews 4 clinical scoring systems practical for dermatology residents.

SCORTEN Prognosticates Cases of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis

Perhaps the best-known scoring system in dermatology, the SCORTEN is widely used to predict hospital mortality from Stevens-Johnson syndrome/toxic epidermal necrolysis. The SCORTEN includes 7 variables of equal weight—age of 40 years or older, heart rate of 120 beats per minute or more, cancer/hematologic malignancy, involved body surface area (BSA) greater than 10%, serum urea greater than 10 mmol/L, serum bicarbonate less than 20 mmol/L, and serum glucose greater than 14 mmol/L—each contributing 1 point to the overall score if present.¹ The involved BSA is defined as the sum of detached and detachable epidermis.¹

The SCORTEN was developed and prospectively validated to be calculated at the end of the first 24 hours of admission; for this calculation, use the BSA affected at that time, and use the most abnormal values during the first 24 hours of admission for the other variables.¹ In addition, a follow-up study including some of the original coauthors recommends recalculating the SCORTEN at the end of hospital day 3, having found that the score’s predictive value was better on this day than hospital days 1, 2, 4, or 5.² Based on the original study, a SCORTEN of 0 to 1 corresponds to a mortality rate of 3.2%, 2 to 12.1%, 3 to 35.3%, 4 to 58.3%, and 5 or greater to 90.0%.¹

Limitations of the SCORTEN include its ability to overestimate or underestimate mortality as demonstrated by 2 multi-institutional cohorts.^3,4 Recently, the ABCD-10 score was developed as an alternative to the SCORTEN and was found to predict mortality similarly when validated in an internal cohort.⁵

PEST Screens for Psoriatic Arthritis

Dermatologists play an important role in screening for psoriatic arthritis, as an estimated 1 in 5 patients with psoriasis have psoriatic arthritis.⁶ To this end, several screening tools have been developed to help differentiate psoriatic arthritis from other arthritides. Joint guidelines from the American Academy of Dermatology and the National Psoriasis Foundation acknowledge that “. . . these screening tools have tended to perform less well when tested in groups of people other than those for which they were originally developed. As such, their usefulness in routine clinical practice remains controversial.”⁷ Nevertheless, the guidelines state, “[b]ecause screening and early detection of inflammatory arthritis are essential to optimize patient [quality of life] and reduce morbidity, providers may consider using a formal screening tool of their choice.”⁷

With these limitations in mind, I have found the Psoriasis Epidemiology Screening Tool (PEST) to be the most useful psoriatic arthritis screening tool. One study determined that the PEST has the best trade-off between sensitivity and specificity compared to 2 other psoriatic arthritis screening tools, the Psoriatic Arthritis Screening and Evaluation (PASE) and the Early Arthritis for Psoriatic Patients (EARP).⁸

The PEST is comprised of 5 questions: (1) Have you ever had a swollen joint (or joints)? (2) Has a doctor ever told you that you have arthritis? (3) Do your fingernails or toenails have holes or pits? (4) Have you had pain in your heel? (5) Have you had a finger or toe that was completely swollen and painful for no apparent reason? According to the PEST, a referral to a rheumatologist should be considered for patients answering yes to 3 or more questions, which is 97% sensitive and 79% specific for psoriatic arthritis.⁹ Patients who answer yes to fewer than 3 questions should still be referred to a rheumatologist if there is a strong clinical suspicion of psoriatic arthritis.¹⁰

The PEST can be accessed for free in 13 languages via the GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) app as well as downloaded for free from the National Psoriasis Foundation’s website (https://www.psoriasis.org/psa-screening/providers).

ALT-70 Differentiates Cellulitis From Pseudocellulitis

Overdiagnosing cellulitis in the United States has been estimated to result in up to 130,000 unnecessary hospitalizations and up to $515 million in avoidable health care spending.¹¹ Dermatologists are in a unique position to help fix this issue. In one retrospective study of 1430 inpatient dermatology consultations, 74.32% of inpatients evaluated for presumed cellulitis by a dermatologist were instead diagnosed with a cellulitis mimicker (ie, pseudocellulitis), such as stasis dermatitis or contact dermatitis.¹²

The ALT-70 score was developed and prospectively validated to help differentiate lower extremity cellulitis from pseudocellulitis in adult patients in the emergency department (ED).¹³ In addition, the score has retrospectively been shown to function similarly in the inpatient setting when calculated at 24 and 48 hours after ED presentation.¹⁴ Although the ALT-70 score was designed for use by frontline clinicians prior to dermatology consultation, I also have found it helpful to calculate as a consultant, as it provides an objective measure of risk to communicate to the primary team in support of one diagnosis or another.

ALT-70 is an acronym for the score’s 4 variables: asymmetry, leukocytosis, tachycardia, and age of 70 years or older.¹⁵ If present, each variable confers a certain number of points to the final score: 3 points for asymmetry (defined as unilateral leg involvement), 1 point for leukocytosis (white blood cell count ≥10,000/μL), 1 point for tachycardia (≥90 beats per minute), and 2 points for age of 70 years or older. An ALT-70 score of 0 to 2 corresponds to an 83.3% or greater chance of pseudocellulitis, suggesting that the diagnosis of cellulitis be reconsidered. A score of 3 to 4 is indeterminate, and additional information such as a dermatology consultation should be pursued. A score of 5 to 7 corresponds to an 82.2% or greater chance of cellulitis, signifying that empiric treatment with antibiotics be considered.¹⁵

The ALT-70 score does not apply to cases involving areas other than the lower extremities; intravenous antibiotic use within 48 hours before ED presentation; surgery within the last 30 days; abscess; penetrating trauma; burn; or known history of osteomyelitis, diabetic ulcer, or indwelling hardware at the site of infection.¹⁵ The ALT-70 score is available for free via the MDCalc app and website (https://www.mdcalc.com/alt-70-score-cellulitis).

Mohs AUC Determines the Appropriateness of Mohs Micrographic Surgery

In 2012, the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and American Society for Mohs Surgery published appropriate use criteria (AUC) to guide the decision to pursue Mohs micrographic surgery (MMS) in the United States.¹⁶ Based on various tumor and patient characteristics, the Mohs AUC assign scores to 270 different clinical scenarios. A score of 1 to 3 signifies that MMS is inappropriate and generally not considered acceptable. A score 4 to 6 indicates that the appropriateness of MMS is uncertain. A score 7 to 9 means that MMS is appropriate and generally considered acceptable.¹⁶

Since publication, the Mohs AUC have been criticized for classifying most primary superficial basal cell carcinomas as appropriate for MMS¹⁷ (which an AUC coauthor¹⁸ and others^19,20 have defended), excluding certain reasons for performing MMS (such as operating on multiple tumors on the same day),²¹ including counterintuitive scores,²² and omitting trials from Europe²³ (which AUC coauthors also have defended²⁴). As with any clinical scoring system, the Mohs AUC has limitations; the creators acknowledge that “. . . these criteria should not be interpreted as setting a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results, even for those indications scored as inappropriate.”¹⁶ The Mohs AUC app (https://www.aad.org/members/aad-apps/mohs-auc) is free and allows users to enter tumor and patient characteristics to determine the score for their specific scenario.

Final Thoughts

Scoring systems are emerging in dermatology as evidence-based bedside tools to help guide clinical decision-making. Despite their limitations, these scores have the potential to make a meaningful impact in dermatology as they have in other specialties.

SEATTLE – The availability of biologics for treating psoriasis and psoriatic arthritis has exploded in recent years, with 11 biologics now approved by the Food and Drug Administration. Targets include four separate mechanisms: inhibition of tumor necrosis factor (TNF), interleukin (IL) 23, IL-12/23, and IL-17. The surfeit of treatment options can be a little overwhelming.

“It can be confusing. We have a lot of choices, but the good news is that most of our choices are excellent, and they treat both psoriasis and psoriatic arthritis. That’s very important because, when we think of our psoriasis patients, we need to think not only about their skin but also their joint involvement. Assessment of psoriatic arthritis will drive some of our therapeutic [decisions],” April Armstrong, MD, professor of dermatology at the University of Southern California, Los Angeles, said at the annual Coastal Dermatology Symposium.

In April, the American Academy of Dermatology came to the rescue with comprehensive guidelines. Aside from general advice, the guidelines “provide tips for monitoring as well as dose escalation, which will be very helpful in daily practice,” Dr. Armstrong said in an interview.

The best studied of the biologics with respect to psoriasis and psoriatic arthritis are the IL-17 inhibitors and TNF inhibitors, she said. While TNF inhibitors have traditionally been the treatment of choice for both conditions, “I think these days, people realize that IL-17 inhibitors can be just as good.”

A head-to-head study of the IL-17 inhibitor ixekizumab and the TNF inhibitor adalimumab, presented at the EULAR Congress, looked at a combined outcome of skin and joints and found ixekizumab to be superior, though the study design’s inclusion of a skin outcome may have favored ixekizumab (Ann Rheum Dis. 2019 Jun. doi: 10.1136/annrheumdis-2019-eular.8709).

A few other head-to-head studies have been performed, but properly ranking all 11 biologics would require dozens of clinical trials. At the American Academy of Dermatology meeting last March, Dr. Armstrong presented the results of a network meta-analysis of anti-TNF agents, anti-interleukin agents, anti–phosphodiesterase 4 agents, and fumaric acid esters (J Am Acad Dermatol. doi: 10.1016/j.jaad.2019.06.488). That study, funded by AbbVie, compared the individual agents to a collective placebo group and concluded that anti-interleukin agents generate the highest level of PASI 90/100 response rate. Risankizumab, ixekizumab, brodalumab, and guselkumab, all IL inhibitors, achieved the best marks over the primary response period.

The AAD guidelines include recommendations for tests to be done upon initiation of a biologic, including a tuberculosis test, complete blood count, comprehensive metabolic panel, and tests for hepatitis B and C. TB testing should be performed annually during treatment.

The guidelines also include recommendations for dose escalation, which can provide leverage for getting coverage approved. “One can use those guidelines to show payers how dose escalation can be done, so that [physicians] can potentially get more access to medications for their patients,” Dr. Armstrong said at the meeting jointly presented by the University of Louisville and Global Academy for Medical Education.

The guideline also ranks the existing evidence supporting individual biologics for the treatment of psoriasis subtypes. For example, for the treatment of moderate to severe scalp psoriasis, etanercept and guselkumab have consistent and good-quality patient-oriented evidence supporting them; infliximab, adalimumab, secukinumab, and ixekizumab are recommended based on inconsistent or limited quality patient-oriented evidence; and ustekinumab is supported only by consensus opinion, case studies, or disease-oriented evidence. The guidelines provide similar categorization of biologics for the treatment of moderate to severe plaque type palmoplantar psoriasis, moderate to severe psoriasis affecting the nails, adults with pustular or erythrodermic psoriasis, and adults with psoriatic arthritis.

Dr. Armstrong is a research investigator and/or advisor to AbbVie, Janssen, Lily, LEO Pharma, Novartis, UCB, Ortho Dermatologics, Dermera, Regeneron, BMS, Dermavant, and KHK. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – The availability of biologics for treating psoriasis and psoriatic arthritis has exploded in recent years, with 11 biologics now approved by the Food and Drug Administration. Targets include four separate mechanisms: inhibition of tumor necrosis factor (TNF), interleukin (IL) 23, IL-12/23, and IL-17. The surfeit of treatment options can be a little overwhelming.

“It can be confusing. We have a lot of choices, but the good news is that most of our choices are excellent, and they treat both psoriasis and psoriatic arthritis. That’s very important because, when we think of our psoriasis patients, we need to think not only about their skin but also their joint involvement. Assessment of psoriatic arthritis will drive some of our therapeutic [decisions],” April Armstrong, MD, professor of dermatology at the University of Southern California, Los Angeles, said at the annual Coastal Dermatology Symposium.

In April, the American Academy of Dermatology came to the rescue with comprehensive guidelines. Aside from general advice, the guidelines “provide tips for monitoring as well as dose escalation, which will be very helpful in daily practice,” Dr. Armstrong said in an interview.

The best studied of the biologics with respect to psoriasis and psoriatic arthritis are the IL-17 inhibitors and TNF inhibitors, she said. While TNF inhibitors have traditionally been the treatment of choice for both conditions, “I think these days, people realize that IL-17 inhibitors can be just as good.”

A head-to-head study of the IL-17 inhibitor ixekizumab and the TNF inhibitor adalimumab, presented at the EULAR Congress, looked at a combined outcome of skin and joints and found ixekizumab to be superior, though the study design’s inclusion of a skin outcome may have favored ixekizumab (Ann Rheum Dis. 2019 Jun. doi: 10.1136/annrheumdis-2019-eular.8709).

A few other head-to-head studies have been performed, but properly ranking all 11 biologics would require dozens of clinical trials. At the American Academy of Dermatology meeting last March, Dr. Armstrong presented the results of a network meta-analysis of anti-TNF agents, anti-interleukin agents, anti–phosphodiesterase 4 agents, and fumaric acid esters (J Am Acad Dermatol. doi: 10.1016/j.jaad.2019.06.488). That study, funded by AbbVie, compared the individual agents to a collective placebo group and concluded that anti-interleukin agents generate the highest level of PASI 90/100 response rate. Risankizumab, ixekizumab, brodalumab, and guselkumab, all IL inhibitors, achieved the best marks over the primary response period.

The AAD guidelines include recommendations for tests to be done upon initiation of a biologic, including a tuberculosis test, complete blood count, comprehensive metabolic panel, and tests for hepatitis B and C. TB testing should be performed annually during treatment.

The guidelines also include recommendations for dose escalation, which can provide leverage for getting coverage approved. “One can use those guidelines to show payers how dose escalation can be done, so that [physicians] can potentially get more access to medications for their patients,” Dr. Armstrong said at the meeting jointly presented by the University of Louisville and Global Academy for Medical Education.

The guideline also ranks the existing evidence supporting individual biologics for the treatment of psoriasis subtypes. For example, for the treatment of moderate to severe scalp psoriasis, etanercept and guselkumab have consistent and good-quality patient-oriented evidence supporting them; infliximab, adalimumab, secukinumab, and ixekizumab are recommended based on inconsistent or limited quality patient-oriented evidence; and ustekinumab is supported only by consensus opinion, case studies, or disease-oriented evidence. The guidelines provide similar categorization of biologics for the treatment of moderate to severe plaque type palmoplantar psoriasis, moderate to severe psoriasis affecting the nails, adults with pustular or erythrodermic psoriasis, and adults with psoriatic arthritis.

Dr. Armstrong is a research investigator and/or advisor to AbbVie, Janssen, Lily, LEO Pharma, Novartis, UCB, Ortho Dermatologics, Dermera, Regeneron, BMS, Dermavant, and KHK. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – The availability of biologics for treating psoriasis and psoriatic arthritis has exploded in recent years, with 11 biologics now approved by the Food and Drug Administration. Targets include four separate mechanisms: inhibition of tumor necrosis factor (TNF), interleukin (IL) 23, IL-12/23, and IL-17. The surfeit of treatment options can be a little overwhelming.

“It can be confusing. We have a lot of choices, but the good news is that most of our choices are excellent, and they treat both psoriasis and psoriatic arthritis. That’s very important because, when we think of our psoriasis patients, we need to think not only about their skin but also their joint involvement. Assessment of psoriatic arthritis will drive some of our therapeutic [decisions],” April Armstrong, MD, professor of dermatology at the University of Southern California, Los Angeles, said at the annual Coastal Dermatology Symposium.

In April, the American Academy of Dermatology came to the rescue with comprehensive guidelines. Aside from general advice, the guidelines “provide tips for monitoring as well as dose escalation, which will be very helpful in daily practice,” Dr. Armstrong said in an interview.

The best studied of the biologics with respect to psoriasis and psoriatic arthritis are the IL-17 inhibitors and TNF inhibitors, she said. While TNF inhibitors have traditionally been the treatment of choice for both conditions, “I think these days, people realize that IL-17 inhibitors can be just as good.”

A head-to-head study of the IL-17 inhibitor ixekizumab and the TNF inhibitor adalimumab, presented at the EULAR Congress, looked at a combined outcome of skin and joints and found ixekizumab to be superior, though the study design’s inclusion of a skin outcome may have favored ixekizumab (Ann Rheum Dis. 2019 Jun. doi: 10.1136/annrheumdis-2019-eular.8709).

A few other head-to-head studies have been performed, but properly ranking all 11 biologics would require dozens of clinical trials. At the American Academy of Dermatology meeting last March, Dr. Armstrong presented the results of a network meta-analysis of anti-TNF agents, anti-interleukin agents, anti–phosphodiesterase 4 agents, and fumaric acid esters (J Am Acad Dermatol. doi: 10.1016/j.jaad.2019.06.488). That study, funded by AbbVie, compared the individual agents to a collective placebo group and concluded that anti-interleukin agents generate the highest level of PASI 90/100 response rate. Risankizumab, ixekizumab, brodalumab, and guselkumab, all IL inhibitors, achieved the best marks over the primary response period.

The AAD guidelines include recommendations for tests to be done upon initiation of a biologic, including a tuberculosis test, complete blood count, comprehensive metabolic panel, and tests for hepatitis B and C. TB testing should be performed annually during treatment.

The guidelines also include recommendations for dose escalation, which can provide leverage for getting coverage approved. “One can use those guidelines to show payers how dose escalation can be done, so that [physicians] can potentially get more access to medications for their patients,” Dr. Armstrong said at the meeting jointly presented by the University of Louisville and Global Academy for Medical Education.

The guideline also ranks the existing evidence supporting individual biologics for the treatment of psoriasis subtypes. For example, for the treatment of moderate to severe scalp psoriasis, etanercept and guselkumab have consistent and good-quality patient-oriented evidence supporting them; infliximab, adalimumab, secukinumab, and ixekizumab are recommended based on inconsistent or limited quality patient-oriented evidence; and ustekinumab is supported only by consensus opinion, case studies, or disease-oriented evidence. The guidelines provide similar categorization of biologics for the treatment of moderate to severe plaque type palmoplantar psoriasis, moderate to severe psoriasis affecting the nails, adults with pustular or erythrodermic psoriasis, and adults with psoriatic arthritis.

Dr. Armstrong is a research investigator and/or advisor to AbbVie, Janssen, Lily, LEO Pharma, Novartis, UCB, Ortho Dermatologics, Dermera, Regeneron, BMS, Dermavant, and KHK. This publication and Global Academy for Medical Education are owned by the same parent company.