Psoriatic Arthritis

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

Higher body mass index and moderate – but not heavy – drinking may increase the risk of individuals with psoriasis going on to develop psoriatic arthritis, a study has found.

Around one in five people with psoriasis will develop psoriatic arthritis (PsA), wrote Amelia Green of the University of Bath (England) and coauthors in the British Journal of Dermatology.

Previous studies have explored possible links between obesity, alcohol consumption, or smoking, and an increased risk of developing psoriatic arthritis. However, some of these studies found conflicting results or had limitations such as measuring only a single exposure.

In a cohort study, the Ms. Green and her colleagues examined data from the U.K. Clinical Practice Research Datalink for 90,189 individuals with psoriasis, 1,409 of whom were subsequently also diagnosed with psoriatic arthritis.

The analysis showed a significant association between increasing body mass index (BMI) and increasing odds of developing psoriatic arthritis. Compared with individuals with a BMI below 25 kg/m², those with a BMI of 25.0-29.9 had a 79% greater odds of psoriatic arthritis, those with a BMI of 30.0-34.9 had a 2.10-fold greater odds, and those with a BMI at or above 35 had a 2.68-fold greater odds of developing psoriatic arthritis (P for trend less than .001). Adjustment for potential confounders such as sex, age, duration and severity of psoriasis, diabetes, smoking, and alcohol use slightly attenuated the association, but it remained statistically significant.

Researchers also examined the cumulative effect of lower BMIs over time, and found that over a 10-year period, reductions in BMI were associated with reductions in the risk of developing PsA, compared with remaining at the same BMI over that time.

“Here we have shown for the first time that losing weight over time could reduce the risk of developing PsA in a population with documented psoriasis,” the authors wrote. “As the effect of obesity on the risk of developing PsA may in fact occur with some delay and change over time, our analysis took into account both updated BMI measurements over time and the possible nonlinear and cumulative effects of BMI, which have not previously been investigated.”

Commenting on the mechanisms underlying the association between obesity and the development of PsA, the authors noted that adipose tissue is a source of inflammatory mediators such as adipokines and proinflammatory cytokines, which could lead to the development of PsA. Increasing body weight also could cause microtraumas of the connective tissue between tendon and bone, which may act as an initiating pathogenic event for PsA.

Moderate drinkers – defined as 0.1–3.0 drinks per day ­– had 57% higher odds of developing PsA when compared with nondrinkers, but former drinkers or heavy drinkers did not have an increased risk.

The study also didn’t see any effect of either past or current smoking on the risk of PsA, although there was a nonsignificant interaction with obesity that hinted at increased odds.

“While we found no association between smoking status and the development of PsA in people with psoriasis, further analysis revealed that the effect of smoking on the risk of PsA was possibly mediated through the effect of BMI on PsA; in other words, the protective effect of smoking may be associated with lower BMI among smokers,” the authors wrote.

Patients who developed PsA were also more likely to be younger (mean age of 44.7 years vs. 48.5 years), have severe psoriasis, and have had the disease for a shorter duration.

The study was funded by the National Institute for Health Research, and the authors declared grants from the funder during the conduct of the study. No other conflicts of interest were declared.

SOURCE: Green A et al. Br J Dermatol. 2019 Jun 18. doi: 10.1111/bjd.18227

Higher body mass index and moderate – but not heavy – drinking may increase the risk of individuals with psoriasis going on to develop psoriatic arthritis, a study has found.

Around one in five people with psoriasis will develop psoriatic arthritis (PsA), wrote Amelia Green of the University of Bath (England) and coauthors in the British Journal of Dermatology.

Previous studies have explored possible links between obesity, alcohol consumption, or smoking, and an increased risk of developing psoriatic arthritis. However, some of these studies found conflicting results or had limitations such as measuring only a single exposure.

In a cohort study, the Ms. Green and her colleagues examined data from the U.K. Clinical Practice Research Datalink for 90,189 individuals with psoriasis, 1,409 of whom were subsequently also diagnosed with psoriatic arthritis.

The analysis showed a significant association between increasing body mass index (BMI) and increasing odds of developing psoriatic arthritis. Compared with individuals with a BMI below 25 kg/m², those with a BMI of 25.0-29.9 had a 79% greater odds of psoriatic arthritis, those with a BMI of 30.0-34.9 had a 2.10-fold greater odds, and those with a BMI at or above 35 had a 2.68-fold greater odds of developing psoriatic arthritis (P for trend less than .001). Adjustment for potential confounders such as sex, age, duration and severity of psoriasis, diabetes, smoking, and alcohol use slightly attenuated the association, but it remained statistically significant.

Researchers also examined the cumulative effect of lower BMIs over time, and found that over a 10-year period, reductions in BMI were associated with reductions in the risk of developing PsA, compared with remaining at the same BMI over that time.

“Here we have shown for the first time that losing weight over time could reduce the risk of developing PsA in a population with documented psoriasis,” the authors wrote. “As the effect of obesity on the risk of developing PsA may in fact occur with some delay and change over time, our analysis took into account both updated BMI measurements over time and the possible nonlinear and cumulative effects of BMI, which have not previously been investigated.”

Commenting on the mechanisms underlying the association between obesity and the development of PsA, the authors noted that adipose tissue is a source of inflammatory mediators such as adipokines and proinflammatory cytokines, which could lead to the development of PsA. Increasing body weight also could cause microtraumas of the connective tissue between tendon and bone, which may act as an initiating pathogenic event for PsA.

Moderate drinkers – defined as 0.1–3.0 drinks per day ­– had 57% higher odds of developing PsA when compared with nondrinkers, but former drinkers or heavy drinkers did not have an increased risk.

The study also didn’t see any effect of either past or current smoking on the risk of PsA, although there was a nonsignificant interaction with obesity that hinted at increased odds.

“While we found no association between smoking status and the development of PsA in people with psoriasis, further analysis revealed that the effect of smoking on the risk of PsA was possibly mediated through the effect of BMI on PsA; in other words, the protective effect of smoking may be associated with lower BMI among smokers,” the authors wrote.

Patients who developed PsA were also more likely to be younger (mean age of 44.7 years vs. 48.5 years), have severe psoriasis, and have had the disease for a shorter duration.

The study was funded by the National Institute for Health Research, and the authors declared grants from the funder during the conduct of the study. No other conflicts of interest were declared.

SOURCE: Green A et al. Br J Dermatol. 2019 Jun 18. doi: 10.1111/bjd.18227

Higher body mass index and moderate – but not heavy – drinking may increase the risk of individuals with psoriasis going on to develop psoriatic arthritis, a study has found.

Around one in five people with psoriasis will develop psoriatic arthritis (PsA), wrote Amelia Green of the University of Bath (England) and coauthors in the British Journal of Dermatology.

Previous studies have explored possible links between obesity, alcohol consumption, or smoking, and an increased risk of developing psoriatic arthritis. However, some of these studies found conflicting results or had limitations such as measuring only a single exposure.

In a cohort study, the Ms. Green and her colleagues examined data from the U.K. Clinical Practice Research Datalink for 90,189 individuals with psoriasis, 1,409 of whom were subsequently also diagnosed with psoriatic arthritis.

The analysis showed a significant association between increasing body mass index (BMI) and increasing odds of developing psoriatic arthritis. Compared with individuals with a BMI below 25 kg/m², those with a BMI of 25.0-29.9 had a 79% greater odds of psoriatic arthritis, those with a BMI of 30.0-34.9 had a 2.10-fold greater odds, and those with a BMI at or above 35 had a 2.68-fold greater odds of developing psoriatic arthritis (P for trend less than .001). Adjustment for potential confounders such as sex, age, duration and severity of psoriasis, diabetes, smoking, and alcohol use slightly attenuated the association, but it remained statistically significant.

Researchers also examined the cumulative effect of lower BMIs over time, and found that over a 10-year period, reductions in BMI were associated with reductions in the risk of developing PsA, compared with remaining at the same BMI over that time.

“Here we have shown for the first time that losing weight over time could reduce the risk of developing PsA in a population with documented psoriasis,” the authors wrote. “As the effect of obesity on the risk of developing PsA may in fact occur with some delay and change over time, our analysis took into account both updated BMI measurements over time and the possible nonlinear and cumulative effects of BMI, which have not previously been investigated.”

Commenting on the mechanisms underlying the association between obesity and the development of PsA, the authors noted that adipose tissue is a source of inflammatory mediators such as adipokines and proinflammatory cytokines, which could lead to the development of PsA. Increasing body weight also could cause microtraumas of the connective tissue between tendon and bone, which may act as an initiating pathogenic event for PsA.

Moderate drinkers – defined as 0.1–3.0 drinks per day ­– had 57% higher odds of developing PsA when compared with nondrinkers, but former drinkers or heavy drinkers did not have an increased risk.

The study also didn’t see any effect of either past or current smoking on the risk of PsA, although there was a nonsignificant interaction with obesity that hinted at increased odds.

“While we found no association between smoking status and the development of PsA in people with psoriasis, further analysis revealed that the effect of smoking on the risk of PsA was possibly mediated through the effect of BMI on PsA; in other words, the protective effect of smoking may be associated with lower BMI among smokers,” the authors wrote.

Patients who developed PsA were also more likely to be younger (mean age of 44.7 years vs. 48.5 years), have severe psoriasis, and have had the disease for a shorter duration.

The study was funded by the National Institute for Health Research, and the authors declared grants from the funder during the conduct of the study. No other conflicts of interest were declared.

SOURCE: Green A et al. Br J Dermatol. 2019 Jun 18. doi: 10.1111/bjd.18227